Public_Access

Comment_ID	Source	Entry_Date	ContactLast	ContactFirst	ContactDegree	ContactAffiliation	ContactState	ContactCountry	Role	Question_1	Question_2	Question_3	Question_4	Attachment_1	Attachment_Full	Comment_Format
1	Web RFI	03/31/2008 at 10:30:28 AM (229)	Burns	Robert	B.A.	Individual	VA	USA	Other Member of the Public	As an alternative means of implementing the NIH policy, I’d like to suggest allowing publishers to voluntarily enter into a binding memorandum of understanding (MOU) with NIH. Such a voluntary agreement would detail how a publisher would help their NIH-funded authors comply with the new policy (e.g., copyright transfer agreements, submission procedures, etc.). It should enable publishers to submit journal articles on behalf of their authors, control the quality of the articles submitted, and do so in a manner consistent with copyright law. In exchange, however, the publisher would have to assume the NIH-funded investigator’s liability for complying with the agency's public access policy.						Web Form
2	Web RFI	03/31/2008 at 11:30:31 AM (523)	Hildebrand	John G.	Ph.D.	University of Arizona	AZ	USA	NIH-funded Investigator	Instead of requiring submission of an article as soon as the manuscript has been accepted for publication, it would be wiser and more palatable to require submission AFTER publication. Articles often undergo final editing when in galley proof, and in fact serious mistakes sometimes are corrected then. It would be best to have the version submitted to PubMed be identical to the version ultimately published.						Web Form
3	Web RFI	03/31/2008 at 02:03:22 PM (292)	Harnad	Stevan	PhD	Universite du Quebec a Montreal & Southampton University	Quebec	Canada	Representative NIH Funding Recipient Organization	Yes. Modify the procedure for fulfilling the deposit requirement of the NIH self-archiving mandate in order to make it compatible with, and to reinforce, university self-archiving mandates (such as Harvard's): In the NIH interface, at the point of deposit, add a feature that allows the full-text deposit to be downloaded from the URL where the full-text has already been deposited in the fundee's institution's Institutional Repository (IR). And stipulate in the overall instructions that the preferred way to fulfill NIH's self-archiving mandate is to deposit the full-text directly in the fundee's IR and then download it to the NIH deposit site.	Yes. The optimal way to monitor and ensure compliance is by making it part of the fulfillment conditions for the fundee's institution that it must monitor and ensure that the deposit is made. The best and easiest way that an institution can monitor and ensure deposit -- and at the same time encourage or mandate the self-archiving of all the rest of the institution's research output in all disciplines (not just NIH-funded research) -- is to require direct deposit in the institution's own IR. See: "How To Integrate University and Funder Open Access Mandates" http://openaccess.eprints.org/index.php?/archives/369-guid.html		The NIH policy is splendid, timely, historic. But it can be made orders of magnitude more successful, effective, and worthy of emulation worldwide if the one small implementational detail I have recommended is adopted. There will then be a synergy between funder OA self-archiving mandates like NIH's and institutional OA self-archiving mandates like Harvard's, with one point of direct deposit (the institution) and both the institution and NIH jointly monitoring and ensuring compliance.			Web Form
4	Web RFI	03/31/2008 at 06:09:49 PM (550)	Gudas	Lorraine	PhD	Weill Cornell Medical College	New York	USA	NIH-funded Investigator	I think that this policy puts one more administrative burden on researchers, who are already being overwhelmed with new mandates, even as the competition for funding becomes greater and greater. My recommendation is that the journals submit these manuscripts for public access 6 months after publication.	No, I don't think the policy is wise or necessary.	I have no idea.	It is not necessary and a waste of time and money. Duplication of time and effort.			Web Form
5	Web RFI	04/01/2008 at 08:44:34 AM (244)	Antonuccio	David	Ph.D.	University of Nevada School of Medicine	NV	USA	Other Member of the Public	I think the NIH Public Access Policy is a step in the right direction of fulfilling our obligation of beneficence to the human subjects who volunteer for scientific studies with the hope, promise, and expectation that they will be making a contribution to science and the well-being of other human beings. I would encourage NIH to consider going a step further and requiring that raw human subject data also be made publicly accessible (absent identifying information) so findings from publicly funded studies can be independently analyzed and verified by other scientists (please see rapid response entitled Universal Human Subjects Commitment at http://www.bmj.com/cgi/eletters/336/7643/532 or Researcher's Credo at http://www.bmj.com/cgi/content/extract/336/7645/629). Actually, I believe we owe such access to all human subjects who volunteer for scientific studies, whether they be publicly funded or privately funded. NIH is in a position to set the standard.						Web Form
6	Web RFI	04/01/2008 at 09:28:28 AM (823)	Milgram	Eric	Ph.D.	Individual	NC	USA	Other Member of the Public	No. Clearly, much effort was put into planning the policy and I don't see any obvious problems with it.	By making publication on PubMed one of the conditions of receiving a grant, I believe that most people will comply. I recommend clearly stating what penalties a researcher will incur should they not comply with the policy. Also, grants currently are reviewed for progress, and as part of this review process, one of the items should be to check that all peer reviewed publications have been submitted in accordance with the NIH Public Access Policy.	At this point, I do not understand how violations of the policy will be handled. Specifically, I read that violations will not affect funding outcomes, and will be dealt with "administratively." I would like to see more detail here. The penalties for not complying should be clearly stated, and should also be of such a nature to serve as a strong deterrent for not complying with the policy.	I am very happy that this policy was enacted. Although I recognize the important role that publishers have in the process of disseminating scientific information, I also recognize that without public funding of the research itself, those publishers would have no content. The internet and the WWW have changed the options for publication tremendously. Understandably, the publishers who have provided a valuable service to the scientific community, while simultaneously building a very successful and profitable business, do not want that to change. However, just as the digital camera changed the field of photography by making it cheaper and more accessible, the WWW is doing the same thing for publishing. Many successful photographers who had built their business using the constraints of the pre-digital era had a hard time transitioning to the digital era. In this same way, some publishers will not make the transition, but there will be many opportunities for those publishers who embrace the digital age and think innovatively.			Web Form
7	Web RFI	04/01/2008 at 11:51:59 AM (426)	LaValle	Craig		Prologic Technology Systems	TX	USA	Other Member of the Public	I would like to see all taxpayer funded research, in whole or in part, published and accessible free of charge in the public domain.			One of the foundations of science is communication. Open access will allow communication and ideas to flow more freely and stoke the fires of scientific inquiry and progress. It will also help prevent needless duplication of effort. In short, this is a common sense proposal that can only help humanity.			Web Form
8	Web RFI	04/01/2008 at 12:18:33 PM (448)	Romans	Ehs	PhD	UT	TX	USA	NIH-funded Investigator	NOW YOU LISTEN TO ME. PUBLIC TAX PAYER MONEY MEANS YOU NEED TO KEEP THE SYSTEM ___OPEN___	`NOW YOU LISTEN TO ME. PUBLIC TAX PAYER MONEY MEANS YOU NEED TO KEEP THE SYSTEM ___OPEN___	NOW YOU LISTEN TO ME. PUBLIC TAX PAYER MONEY MEANS YOU NEED TO KEEP THE SYSTEM ___OPEN___	NOW YOU LISTEN TO ME. PUBLIC TAX PAYER MONEY MEANS YOU NEED TO KEEP THE SYSTEM ___OPEN___			Web Form
9	Web RFI	04/01/2008 at 12:46:10 PM (703)	Dante	Doug	Bachelors	Personal	MI	USA	Other Member of the Public	I would like all NIH funded research to be freely available under the broadest possible copyright, so that anyone may comment, quote, or redistribute that research in any context whatsoever.	All NIH funded grants subject to the public access requirement should be available to the public on a web site with information at the time that the grant is made. All grants not subject to that requirement should also be listed and a reason why they can't be given to the public should be included. (e.g. National Security)	All NIH funded grants subject to the public access requirement should be available to the public on a web site with information at the time that the grant is made. All grants not subject to that requirement should also be listed and a reason why they can't be given to the public should be included. (e.g. National Security)	I would like all NIH funded research to be freely available under the broadest possible copyright, so that anyone may comment, quote, or redistribute that research in any context whatsoever. All NIH funded grants subject to the public access requirement should be available to the public on a web site with information at the time that the grant is made. All grants not subject to that requirement should also be listed and a reason why they can't be given to the public should be included. (e.g. National Security)			Web Form
10	Web RFI	04/01/2008 at 01:50:27 PM (198)	Foster	Ryan	PhD Candidate	University of Florida College of Medicine	FL	USA	NIH-funded Investigator	No	Ensuring compliance is quite simple really. In grant renewal applications, only allow researchers to cite their own papers from the public access database. When applying for grant renewals, researchers cite the papers that resulted from the last iteration of that grant. Kind of a track record proving that the grant generated real advances in the field and thereby making a case for continuing to fund that grant. If researchers were compelled to cite only their public access papers they would fall all over themselves to do so.	Nothing useful to add.	I would be intensely interested in how the NIH funded research has been used to generate treatments and drugs for various diseases. I am especially interested in publicly funded research that has been directly used to generate a patented drug or treatment. It would be easy to ask NIH funded researchers to provide a brief synopsis of drug developments that immediately stem from their work. 2-3 sentences per paper per year would be sufficient and that blurb could be used to track publicly funded drugs and treatments.			Web Form
11	Web RFI	04/01/2008 at 01:58:18 PM (987)	Simpson	S	BS	Self	ID	USA	Patient or Representative of a Public Health Advocacy Organization	I have a rare disoorder. I use pubmed and other online resources to learn about my disorder. I am often frustrated by only being able to access the abstract. Accessing a single full article typically costs in excess of $30 (which is ridiculous). I'm glad to see the NIH making the publications that they sponsor available freely to the public.						Web Form
12	Web RFI	04/01/2008 at 02:09:30 PM (117)	Freytag	Richard	Masters	Freytag & Company, LLC	VA	USA	Other Member of the Public	If publishers continue to pressure against the Public Access Policy then NIH implement a voluntary online peer-review mechanism through the NIH website along with PubMed. Even the threat should quelly publisher resistance.	I suggest that NIH require all recipients of funds when publishing their research acknowledge both the NIH funding but the exact PubMed citation(s) (including URLs for the paper(s) on PubMed). The presence of these URLs will make checking compliance very easy. The absence of the citation will also make non-compliance easy to detect.		This public access policy is overdue and an excellent policy that I can only hope other national research funding agencies will emulate.			Web Form
13	Web RFI	04/01/2008 at 02:39:15 PM (180)	Rubin	Ethel	PhD	BioFortis	MD	USA	Other Member of the Public	I think the final copy of the article is most useful, both for the public and the PI or publisher to post. I do worry about the administrative burden for all PIs, who are already swamped in an ever-increasing regulatory environment. The policy only states that the PI on a grant is ultimately responsible for ensuring the article is submitted. I suspect, like many other admin duties, this too will be delegated to someone else, perhaps rightly so. Suggestions that this become part of an institutions library services might be a solution for overburdened PIs.	The only thing for sure is that money talks. If non-compliance carried the penalty of failure or demotion for further rounds of funding, this NIH policy will be a success. Monitoring compliance is difficult. Program managers may need to routinely sweep Pubmed for any of the PIs citation which does not carry the biomed central ID to turn up 'noncompliant papers' before a grant award is made. A policy without consequences for noncompliance (reward for compliance) is useless.	Communicating the policy to patient advocacy groups is very important. Patients have been frustrated for years to have liimited access to journal articles or paying for access to the data they seek.	It is about time!			Web Form
14	Web RFI	04/01/2008 at 02:44:18 PM (871)	Ritchie	Thomas	B.S. of Biology	Rutgers University	NJ	USA	Other	No. I am happy with the changes.	Provide a means for the scientific community, even individuals acting independently from their organization, to anonymously report to the NIH any compliance violations. There are enough of us interested in keeping the scientific knowledge gained open and available to the public that this should provide a good level of oversight without much overhead cost.	The use of podcasts to go along with powerpoint presentations provides for much better context-specific interpretation of the slides offered. The USPTO provides audio lectures to go along with downloadable slideshows to educate patent practitioners about new USPTO policies and it has been both popular and successful.	Allowing public access to full HTML text documents of all research using Federal money is the best change for the advancement of scientific knowledge currently possible. I've been annoyed that it took the PLoS to finally goad the NIH into enacting this policy, but I won't complain so long as I can access research papers that for so long have been inaccessible due to exorbitant fees that I as a student couldn't hope to afford.			Web Form
15	Web RFI	04/01/2008 at 03:38:07 PM (369)	Hulbert II	Leland		None	NY	USA	Other Member of the Public	No. I applaud the change to make public funded research more open and accessible to the public.	Any applicant for NIH funding can be searched for previous NIH funded projects. These projects would then be checked to verify that their final results exist in the public repository. Any previous publicly funded project that has not been already published in the public archive would bar the applicant from receiving any future funding. This will make the applicants themselves responsible for policing the policy.					Web Form
16	Web RFI	04/01/2008 at 03:42:50 PM (476)	Cook	Andrew	PhD	Physics	OR	USA	Other Member of the Public	Research financed by the public should be publicly available on the Internet. Referees aren't paid and they do the lion's share of the work in publishing a paper. If old prestigious journals refuse to make publicly-funded research available, new journals will become more prestigious.	Let professionals in the field report on transgressions. Let the NIH without a portion of funds from researchers who don't allow their material to become publicly available.	Information regarding the NIH's communication with the NSF on this policy.	The public access policy is very important. The National Science Foundation and Department of Energy should follow suit immediately. As a physicist, I often have trouble accessing publicly funded research in a timely manner due to my University's decreased journal budget.			Web Form
17	Web RFI	04/01/2008 at 04:29:25 PM (694)	Silterra	Jacob	B.S.	None	MA	USA	Other Member of the Public		I would recommend that any institution which receives a certain level of funding from NIH be required to notify NIH whenever any research, even non-NIH funded research, is published. They wouldn't need to send the article, or make it publicly available, just notify NIH they published something. This would make sure that NIH could track publications, so they could easily monitor whether works being published privately should also be published publicly.					Web Form
18	Web RFI	04/01/2008 at 04:45:44 PM (194)	Murphy-Ullrich	Joanne	PhD	UAB	AL	USA	NIH-funded Investigator	The requirement to include the PMCID number in NIH applications is an undue burden. This means modifying each investigator's endNote or Ref Manager libraries one by one to include this number. This is going to be time consuming and cumbersome.						Web Form
19	Web RFI	04/01/2008 at 06:14:25 PM (511)	Snider	Marc	BS Computer Science	citizen	NH	USA	Other Member of the Public	I absolutely concur with the proposal that all researchers supported via public funding be mandated to provide their research results for free public access at the NIH pubmed facility. There is no defensible reason as to why mandatory public access to research subsidized by public funds should be precluded. I also do much research online using the NIH and pubmed facilities. I, too, have also been frustrated by the requirement to purchase research articles published by third party outfits which profit using this publicly funded research as a means to sell their publications. If the public funds the research then the public should have access to the results. I suggest the following minor modifications to the proposal. 1) mandatory publication of research data at the time of acceptance for publication. If the subsequently published article has changed for any reason then the later published article should also be entered into the pubmed facility. The original submission (prior to publishing) should then be archived at pubmed, thus allowing access to the later published article from the original pubmed submission and vice versa. Such a mechanism would be very useful, I believe, in terms of later auditing for the purpose of establishing how many articles had been changed between the time of research completion/initial-pubmed-submission and the time of journal publication. Such changes of article content may thus shed light later on any differences between the two articles and help to establish a historical chain of information which may prove useful for several different reasons. The more transparency the better... In the event an article changes between the time of original pubmed submission (publication acceptance time) then the updated/changed article should be required for submission to pubmed no later than 2 weeks after original article publication (and hopefully even sooner).	I suggest that all publications which [ever] publish articles based on research funded by NIH (public) funds be required to inquire the following of all article authors/co-authors: 1.) Was any of the research encompassed by your article funded using NIH or other public funds? The aforementioned question should be answered in writing by *all* authors/co-authors listed on all published articles along with that author's/co-author's signature. In the event that any author or co-author answers 'yes' to the question then the publication (publishing entity) should then be required to submit a copy of that paperwork to the NIH (or pubmed facility). In the event an author/co-author answers the question untruthfully then sanctions should be applied that individual. In the event the document is not properly procured by the publishing entity and/or not submitted to NIH (or pubmed) prior to publication then the sanctions should be attendant upon the publishing entity. It should also be mandatory for all authors having answered 'yes' to the question to retain a copy of the signed disclosure form so as to indemnify themselves against sanction in such cases as the publishing entity neglected to submit the disclosure form to the NIH.	Nothing really. The public access mechanism provided by pubmed is truly one of the shining lights of the federal government (which too often otherwise does not act in the real public interest). Ensuring timely and unfettered public access to research data supported by public funds is an extremely valuable and laudable pursuit.				Web Form
20	Web RFI	04/01/2008 at 08:33:01 PM (190)	yu	hong	phd	uw-milwaukee	WI	USA	NIH-funded Investigator		Since PubMed is widely used by biomedical researchers, NIH may demand that an article can only be indexed by PubMed if it is compliant with the PAP.					Web Form
21	Web RFI	04/01/2008 at 11:09:13 PM (570)	DuBose	Terry	MS, RDMS	Univ. Arkansas for Medical Sciences	Arkansas	USA	Representative NIH Funding Recipient Organization	NIH and tax payer funded research publications should be available to the public at no charge. This is the best way to promote advances in the sciences.	The more widely available the publications, the better.					Web Form
22	Web RFI	04/01/2008 at 12:53:03 AM (890)	Ammann	Arthur	MD	Univeristy of California	CA	USA	Patient or Representative of a Public Health Advocacy Organization	Clarification of the policy is required I have spoken to many individuals regarding the new policy and it is still not clear if NIH support means any author in a multi-author article or whether all of the authors. Several years ago when one of the NIH funded authors objected to copyright of an article, the New England Journal of medicine removed the author from the article in order to publish and used the other authors. As I interpret US copyright law, the intent was to protect the public from inappropriate ownership of publicly funded projects which now would include research grant results. Would the policy therefore also include articles written in publications that are not traditional medical journals such as textbooks, educational items supported by promotional companies but which include work performed by NIH funded investigators, PowerPoint presentations at scientific meetings etc. clarification of exactly what this policy covers is critical.	you may already have in place a reporting procedure. I review many articles for our web site www.womenchildrenhiv.org - we are frustrated by not being able to provide the full text articles. As you know the abstracts are often inaccurate and often are not supported by the data in the text. It is essential that individuals with limited access to the Internet such as in resource poor countries be provided fulltext PDF articles.if after one year such articles are not available to who would report a violation and would receive a response so that we could go ahead with publication of fulltext articles?	see above	I am aware that there was a debate as to whether the time limit should be three months, six months or 12 months. The 12 month time period is much too long for information that relates to life-saving information both in the US and especially in resource poor countries. Since carrying out conclusions of articles often requires the entire methodology and the discussion includes cautions and alternatives it is essential that the article and not just the contract be available in a timely manner. I would argue that the TRIPS agreement is applicable to publication of articles just as it is applicable to patented drugs. It makes no sense that generic drugs can be manufactured in countries one life-threatening health situations exist but the articles which tell us how to use the drugs are still under intellectual property control. As the HIV epidemic moves more and more into resource poor countries, the physicians who perform the studies, the patients who are participants in the study, and the health care professionals who are responsible for health care require that the information be provided to them in a timely manner. A12 month delay is just too long.			Web Form
23	Web RFI	04/02/2008 at 01:59:18 PM (292)	Labuhn	Denis	MD	Einstein	NY	USA	Other Member of the Public	Yes. Obviously this undermines copyright laws and by extension patent law and other intellectual property laws. This needs doing in the digital age. Once the idea is out then it belongs to everyone and should be used freely. The one year grace period will ease the transition and destruction of private journals like Cell and Nature. That is OK. They are dinosaurs and need to go along with all intellectual property rights laws. Pharmaceutical companies will be the next to go. There is a problem there because withoug patents they will not be able to recoup their research and development costs. That 3/4 billion dollar FDA regulation will stop new drug discovery and keep them from being brought to US markets. That is OK. The Chinese will do it for us soon anyway. Please please information must be free. No restrictions. Let's destroy our intellectual economic base and get on with the brave new world. China will give us what we need.	I would suggest immediate and permanent halt of all funding to the investigator and his institution if they do not comply with this destruction of intellectual property. If Universities do not fight this idiocy then make them pay. They should know better than to go quietly but hey no one at a University understands money anyway. It has always come from the Government and the State, AND always will. Why protect the intellectual property they generate? All that counts is continuing to get NIH funding. So threaten to cut if off and see if they respond. They just might.	The idea is simply. If the US government through NIH pays for it then it belongs to them and not the PI or the University so who needs to worry what they think. All that matters is what NIH thinks.	Keep stop this nonsense but thanks for asking.			Web Form
24	Web RFI	04/03/2008 at 02:32:40 PM (874)	Watson	Cheryl	PhD	University of Texas Medical Branch	TX	USA	NIH-funded Investigator	I think that all withholding of government-supported published information from the public is unacceptable. This puts up unnecessary roadblocks of many kinds to every scientist and member of the public who would like to make use of this information. By having delayed revealing of the published information after several months to a year, you are creating an extra burden on scientists and their staff to manage this process. This is a lot extra work for something that is completely unnecessary.	Keep it simple. Require that all publications be made available immediately. Then you will not have to manage it in such a complicated way.	I would like it to be such a simple system that no one requires any training. Just make the information available as soon as it is published.	If it is not possible for commercial publishers to abide by rules of total and immediate disclosure of publically funded studies, then scientists should adopt a completely different system for publishing their papers.			Web Form
25	Web RFI	04/03/2008 at 04:37:20 PM (306)	Williamson	Peter	MD/PhD	Univ IL at Chicago	IL	USA	NIH-funded Investigator	The stated policy will serve to transfer costs from university library budgets to the investigator. The NIH will need to reimburse investigators for this increased costs, either thorough commensorate reductions in indirect costs or by direct funding of publication lines in budgets.	Providing funding by NIH for the increased burden of this regulation to the investigator would serve to improve compliance.					Web Form
26	Web RFI	04/04/2008 at 05:27:23 AM (149)	Salamon	Peter	PhD	San Diego State University	CA	USA	Other Member of the Public	No.	No.	Don't know.	I think that the policy is a great step forward!			Web Form
27	Web RFI	04/04/2008 at 10:25:41 AM (353)	Buchwald	Stephen	Ph.D.	MIT Department of Chemistry	MA	United States	NIH-funded Investigator	Require the publishers to submit the manuscript, as many have voluntarily agreed to do, to PubMed. Placing the burden on the P.I.'s will further take away from valuable research time.	Although at first blush it sounds like a bad idea, requiring publishers to do this in order to submission to their journals will quickly get everyone to go along with my suggestion in question 1.	Having an automated way to do this would be helpful. Going about it in a piecemeal way invites chaos. Also, I can imagine trying to submit a proposal without the required information. There needs to be some way to handle cases where computer or other issues come up unexpectedly.	Was the intent of the law really to do this or was it really			Web Form
29	Web RFI	04/04/2008 at 11:25:28 AM (756)	sanders	pat	ged	na	nh	USA	Other Member of the Public	no	no	depression	no			Web Form
30	Web RFI	04/04/2008 at 01:08:51 PM (405)	Boyden	Edward	Ph.D.	MIT	MA	USA	NIH-funded Investigator	The current policy is going to be very difficult, if not impossible, for investigators to achieve. Individuals have far less bargaining power with journals than the NIH would. To place the burden of securing copyright, etc. on the individual is a big burden. If the NIH could work directly with journals, compliance would be possible.						Web Form
31	Web RFI	04/04/2008 at 02:24:06 PM (585)	Reinhard	Robert	M.A.	Member Community Advisory Board, ACTG and HVTN within NIH	CA	USA	Patient or Representative of a Public Health Advocacy Organization	NIH can provide overhead and funding support in its grants to allow investigators to use the option many journals provide to subsidize immediate open access publication of specific articles. However, NIH can make this option much more cost effective if it uses its negotiating power to secure reduced rates for funded authors from journals who use this option. The current costs of these options are not based solely on true publishing costs alone; they may include premiums to subsidize other profit interests unrelated to publication, there is no rationale a subsidized payment should pay for the externatlities. This procedure would mitigate concerns of journals, benefit the public and accelerate deposit in pubmed central. Also the policy shouod be revised to require deposit no later than 6 months or as soon as possible rather than the 12 month rule	In any future grant applications, the application form or electronic submittal should include a field requiring citation to all previoulsy required pubmed central deposits, failure to cite would be considered reason to return the application as incomplete					Web Form
32	Web RFI	04/04/2008 at 03:36:56 PM (882)	Resnick	Rachelq	MS	Abramson Ctr. for Jewish Life/Polisher Research Inst.	PA	USA	Other	If a publisher provides public access to an article within 12 months of publication on its own website, allow that to be an acceptable form of publication, as long as they also provide a link to the free, full-text from PubMed and PubMed Central. If a publisher should go out of business or transfer management of a journal to another publisher, mandate that the publisher upload all relevant articles into PMC before the changeover.	Follow up with grantees each year up to three years after the end of a project to request the citations and PMCID numbers of the articles that have resulted from the research. If none are provided after three years, bar all of the relevant grantee investigators' organizations from receiving further funding until they are in compliance.	How long does it take between the time the manuscript and related files are uploaded, and the PI is asked to approve the final version? Is the version of record going to be the PMCID HTML file, the PMCID PDF version, or the publisher's version? Will having three versions out there affect the way authors cite the resources within their papers? If, after an article is published on PMC or in a journal, a mistake is found, how are corrections (or retractions) handled?	As a librarian, I thank you for making this mandatory.			Web Form
33	Web RFI	04/09/2008 at 10:08:59 AM (389)	Shera	Christopher	PhD	Harvard Medical School	MA	USA	NIH-funded Investigator	NIH should not reformat, repackage, retypeset, or otherwise corrupt pdfs provided by the author or journal. Reformatting wastes time and resources and introduces substantial errors. To maintain the integrity of the science, and the value of the repository, manuscripts should be posted exactly as received from the author or journal.						Web Form
34	Web RFI	04/09/2008 at 01:44:35 PM (980)	Cohen	Zohara	PhD	National Institute of Biomedical Imaging and Bioengineering / NIH	MD	USA	Other			I understand that the current policy does not cover non-peer-reviewed conference papers. The policy is not clear regarding peer-reviewed conference papers. Please make sure this is clear in the final version.				Web Form
35	Web RFI	04/09/2008 at 09:25:24 PM (129)	Kobertz	William	Ph. D.	UMASS Medical School	MA	USA	NIH-funded Investigator	This (uploading the pdf file of accepted manuscripts) should be done when we file our annual progress report in the commons. It is redundant to have to send the pubmed ID in the progress report and then upload the pdf file via another website.	Compliance is going to be poor since the current help on the NIH website is confusing for even the most computer savvy person. Compliance could be improved if the uploading process was included in the eSNAP portion of the progress report.	The term electronic version is very vague. Do you mean the final pdf version that the journal publishes. Alternatively, you could imagine submitting the word document and figures as a pdf that is not formatted by the journal. This version would probably not be covered under the copywrite laws, but then again as a PI, I really have no idea. I think clear, concise language needs to be used to inform the PI's of how to deal with publications that are not open access.	The issue of copywrite infringement with the ACS (american chemical society) journals is an issue. Do we just upload the pdf file to the NIH even if it is not publically avialable. The FAQ is totally vague and recommends that the PIs contact the journal. This is ridiculous. The journal will tell us that we can't do it because they want to make money and not have the paper freely available.			Web Form
36	Web RFI	04/11/2008 at 01:12:27 PM (623)	Kurtz	Mark	AB, MTS, MA	BioOne	DC	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)			BioOne (www.bioone.org) has recently released a model publication agreement that addresses current trends in copyright assignment and requirements by NIH and other funding agencies for digital repository deposits. While the Agreement was developed at the request of several BioOne publishers, it may be of interest to any scholarly publishing organization that is seeking a clear, concise, and legally vetted publication agreement. In March 2007, the legal firm Morrison & Foerster LLC (www.mofo.com) generously agreed to provide pro bono legal assistance to BioOne in drafting a Model Publication Agreement. Ms. Pamela Pasti, Of Counsel in the Technology Transactions Group of Morrison & Foerster’s San Francisco office, was assigned to the project. Over the course of the following year, Ms. Pasti worked with BioOne to review existing publication agreements, notable author’s addenda, and articles describing emerging trends in copyright law as it relates to academic publishing. The resulting agreement allows author(s) to retain copyright, while granting the publisher both a temporally limited and exclusive right to first publish, and a perpetual, non-exclusive right to publish, distribute, and sublicense. In response to NIH’s Public Access Policy (passed by Congress in December 2007) and other institutional and subject repository deposit mandates, the Agreement allows authors to deposit their work in digital repositories directly, or permits the publisher to deposit to the National Library of Medicine on their behalf. The BioOne Model Author Agreement reflects over a year of work for all involved in this important project. From the onset, we felt strongly that BioOne was in a unique position as a collaborative publishing endeavor to draft an equitable agreement, which would not have been possible without the legal guidance of Morrison & Foerster, and the invaluable feedback garnered from the publisher and library community. The final Agreement is freely available on the BioOne website at www.bioone.org. An accompanying “roadmap” is also available to provide publishers adopting the Agreement with guidance on specific author and publisher rights and amendable sections.		BioOne_Model_Publication_Agreement_FINAL_-_27_March_08.txt	Publication Agreement The [society/institution name] ("[acronym/abbreviation]") is pleased to undertake the publication of your work tentatively entitled _________________________________________ (the "Contribution") in its publication ____________________________________________ (the "Publication"). You, the undersigned individual(s), will retain copyright to the Contribution as author(s); and you grant us, as publisher, the limited rights detailed below, which are expressly conditioned on the terms of this agreement. We both acknowledge that a static agreement may not be able to contemplate all possible licensing arrangements, technologies or future developments, and therefore we both agree to cooperate in good faith to achieve our mutual goals of maximizing dissemination of your Contribution while ensuring the sustainability of scholarly publishing. Accordingly, we submit the following terms of publication for your consideration. 1. License grant. You grant to [acronym/abbreviation] a worldwide, royalty-free, non-exclusive license to: (a) reproduce, publicly display, publicly perform and distribute the Contribution in the Publication; (b) authorize third party users of the Publication in electronic or digital (or other intangible) form to download and print out copies of the Contribution for their personal or internal institutional use; (c) authorize others to reproduce, publicly display, publicly perform and distribute the Contribution as part of the Publication through any distribution channels and in any media or format through which [acronym/abbreviation] may distribute or make available substantially all the contents of the Publication; and (d) deposit with or otherwise make the Contribution available to digital repositories as required by your funding sources upon your request. The above rights may be exercised in all media and formats, whether now known or hereafter devised, [and in all languages] in which the Publication as a whole (or substantially all its contents) may be distributed, whether or not the Contribution may be individually or partially accessed or retrieved. The above rights include the right to edit [and translate] the Contribution and to make such modifications as are technically necessary or desirable to exercise these rights in differing media and formats. 2. Exclusive rights. You grant to [acronym/abbreviation] the worldwide, royalty-free, exclusive right to first publish the Contribution, and you agree not to publish or authorize any third party to publish the Contribution in any [language,] media or format, for a period ending [six (6) months] after the date of first publication of the Contribution in the Publication ("Exclusivity Period"), except as provided below. You retain the rights at any time during the Exclusivity Period: (i) reproduce and distribute a reasonable number of copies of any version of the Contribution, including but not limited to the published version, or portions or derivative works thereof, in the course of your teaching, research, conference presentations and similar professional, scientific, or academic activities (but not permit commercial publication or widespread distribution of the Contribution or any significant portion or derivative work thereof); (ii) post or otherwise make any version of the Contribution, or portions or derivative works thereof, available on your personal web site; and (iii) [if and as required by your employing institution(s) or your funding source(s),] make any version of the Contribution available on digital repositories; provided in each case [acronym/abbreviation] (and Publication) is cited as the first/forthcoming publisher of the Contribution and you accurately distinguish any modified version of the Contribution from that published or to be published by us. 3. Editing. [Acronym/abbreviation] will make no material modification to the content of the Contribution without your consent. However, if you fail to return the edited manuscript or proofs of the Contribution by the reasonable deadline set by us, you will be deemed to have consented to that modified version. 4. Credit. [Acronym/abbreviation] agrees to make commercially reasonable efforts to include (and require its sublicensees to include) appropriate credit to the author(s) in customary placement with every copy or use of the Contribution as described in Sections 1 and 2. 5. Complimentary copies. [Acronym/abbreviation] will provide you with a .pdf file (i.e., an Adobe Acrobat Portable Document Format (.pdf), with the security settings set at "no security") or similar electronic file corresponding to the Contribution as it appeared in the Publication. Following first publication of the Contribution in the Publication, in every instance in which you or others authorized by you republish the Contribution as it appeared in the Publication (whether as a .pdf or otherwise), or substantial portions thereof, or modified versions of the Contribution, you agree to include attribution to the following effect: "This article [or, if applicable: Portions of this article] first appeared in the [issue date] issue of [publication name] published by [publisher name]", and to accurately distinguish any modified version of the Contribution from that published by us. Subject to your credit obligations and our exclusive rights, you remain free to use and license the Contribution in any manner you deem appropriate. 6. Warranties. You warrant that (i) you are the creator of the Contribution or otherwise have the rights necessary to grant the licenses granted to [acronym/abbreviation] herein; and (ii) the Contribution contains no material that infringes or violates any intellectual property or contractual rights of others or that constitutes defamation or invasion of privacy. The foregoing warranties apply only to the Contribution in the form submitted by you to [acronym/abbreviation], and not to any modifications or additions made by [acronym/abbreviation], reviewers or other third parties. 7. Termination. If we do not publish the Contribution in the Publication within [twelve (12)] months following submission of the Contribution, extended to the extent of any delays caused by you, you may terminate this agreement and the licenses granted to us hereunder by providing us with written notice of termination, unless we publish the Contribution within [three (3)] months following receipt of such notice. Such termination of this agreement will be your exclusive remedy for any failure by us to publish the Contribution. 8. Reservation of rights. Except for the express licenses granted above, you retain all rights, title, and interest in and to the Contribution. Subject to Section 2, nothing in this agreement will prevent or limit you from creating or publishing the same, similar or derivative works on the same or similar topics. The license rights granted by you are limited to the version(s) of the Contribution submitted by you and the version(s) approved by you pursuant to Section 3, the copyright of which versions shall be owned by you. 9. Miscellaneous. This agreement contains the entire understanding of the parties and will be governed by the laws of the State of [state], without reference to its conflicts of laws principles. This agreement can only be modified by an agreement in writing signed by the parties. This agreement may be executed in one or more counterparts (including, without limitation, by facsimile or .pdf signature) each of which will be deemed an original and all of which will be taken together and deemed to be one instrument. [Acronym/abbreviation] may assign this agreement in connection with a sale of the Publication or a sale, merger or reorganization of our organization. If the foregoing terms are acceptable, please sign and date this agreement. All joint authors must sign. Please return the original to [acronym/abbreviation] immediately and retain a copy for your records. Corresponding author name (print or type): ____________________________________________________________ Author signature: _________________________________________________ Date:___________________________ Address: ________________________________________________________________________________________ _______________________________________________________________________________________________ Joint author name (print or type): _____________________________________________________________________ Author signature: _________________________________________________ Date: ___________________________ Joint author name (print or type): _____________________________________________________________________ Author signature: _________________________________________________ Date: ___________________________ Joint author name (print or type): _____________________________________________________________________ Author signature: _________________________________________________ Date: ___________________________ Joint author name (print or type): _____________________________________________________________________ Author signature: _________________________________________________ Date: ___________________________ Joint author name (print or type): _____________________________________________________________________ Author signature: _________________________________________________ Date: ___________________________ Joint author name (print or type): _____________________________________________________________________ Author signature: _________________________________________________ Date: ___________________________ BioOne Model Publication Agreement - 1 - March 2008	Web Form
37	Web RFI	04/15/2008 at 01:14:45 PM (529)	Myers	Gary	MD	University of Rochester Medical Center	NY	USA	NIH-funded Investigator	It is reasonable to require that NIH investigators submit a pdf of any published manuscripts that result from NIH funding. It is not reasonable to require each individual investigator to place them in the public domain. In essence this means that thousands of investigators must divert valuable resources and time to learning the system. It would be more reasonable to have an office at NIH that is responsible for obtaining the PubMed number and placing them in the public domain, a process that requires learning the copyright restrictions of thousands of journals.	A simple search of the literature by a central office on each investigators name would determine compliance and then reminders could be sent.		The public access of these manuscripts is desirable, but requiring thousands of investigators to learn new procedures and invest large amounts of time is not cost efficient.			Web Form
38	Web RFI	04/16/2008 at 02:27:52 AM (288)	Dean	David	Ph.D.	retired, writing RO1 proposal to be submitted via Oregon Health Sciences University	Oregon	USA	Other	I have a number of recommendations. If they are not presented in a useful format, please let me know and I will modify them. …………………………………………………………………………………………………………….. 1) I strongly support the NIH policy requiring that all peer-reviewed manuscripts arising from NIH funds be submitted to PubMed Central upon acceptance for publication. 2) I am encouraged by the recently passed law requiring that, beginning May 2, 2008,full-text versions of journal articles describing NIH-funded research be provided free via the internet to the public. For two reasons, however, I believe there should be NO DELAY in providing articles online after they have been reviewed and approved in final form. I can imagine only two reasons for delaying access: (1) compensation of publishers for revenue lost from reduced sale of print versions of journals, and (2) preservation of the privileges that prestigious journals and the prestigious contributing authors and institutions now enjoy because of the high quality of their personnel and research, and their ability to pay the high costs required to maintain extensive, up-to-date collections of print journals. In my opinion, it makes no sense to provide everyone in the world with free, searchable access to abstracts of the world’s literature, but, for those unable to pay, delay access to full-text versions of individual articles, and permanently deny the opportunity to browse whole journal issues. The benefits to the whole world of providing free total access are obvious: (1) The costs of providing it to millions of people may be little more than those of providing it to the elite because the digitized copy of every article is already available and instantly transmissible to any number of recipients, from one location (PubMed Central). (2) The process would be further simplified by standardized online entry of individual requests (as is already done), and automated online transmission of recurring requests for specific journals sent monthly to lists of libraries and laboratories (as presumable is already done, and updated regularly). (3) The internet already provides tutorials and academic lessons on many scientific topics. These could be better accessed if managed by or linked to PudMed Central. (4) The reason for not delaying free access is to provide individuals and institutions unable to purchase it (e.g., students and almost everyone in the third world) the same access as the more privileged. The technology required for rapid and affordable dissemination of knowledge throughout the world is now available and in place. It should be embraced without delay, hopefully with the full cooperation of publishers. 3) It seems to me that the process required for the production of pure on-line journals is identical to that required for the online versions of print journals. PubMed Central is able to provide up-to-date online access to full text versions of all biomedical journal articles. It may be time to seriously consider a total transition to print-free journals. I have read arguments for preserving the traditional publishing infrastructure, i.e., the paper printing equipment and professional printers involved in scientific/biomedical publishing. I honestly don’t think that any arguments against electronic publishing and universal free access can hold up against an internet-based system for submitting, reviewing and publishing manuscripts; for providing a forum for public and private comments, questions, debate, and establishment of contacts; and for permanently archiving these publications linked to such feedback. One of the early criticisms of electronic publishing was that the quality of printed photographs, figures and text would be superior. We all know now that that is no longer the case, due to technological advances in digital scanning, electronic display and personal printers. 4) Practical reasons for converting entirely to online production and distribution of biomedical journal articles: (1) Expense: (a) The print journal industry already produces electronic versions, starting with the interactions between publishers, authors, reviewers and editors, and thereafter with NIH, PubMed Central, research institutions and libraries throughout world, and anyone in the world with internet access and the ability to pay. (b) Print versions are very expensive to produce and distribute. It appears that they may soon become a luxury of well-heeled customers, assuming that even that market will remain viable. The print industry has undergone many technological changes. The technologies now available, however, may prove to be the most revolutionary and the most favorable for everyone, including publishers. It is possible that the number and quality of scientists involved in electronic-only publishing would be the same as those now involved in the combined paper-electronic publishing. Possibly the same people would continue to do the work. Academic editors, who are often senior professors, work very hard and are proud to do this important job. I and many of my peers have similarly considered it an honor to serve voluntarily as reviewers throughout much of our careers. All of these factors taken together indicate that the current production of print articles could be duplicated by purely electronic publishing, but without the tremendous time and costs required for the conversion of electronic manuscripts to paper and the mailing of journals. (c) For those who feel the need to have a physical copy in their hands, high quality personal printers are becoming universally available. In the not too distant future, electronic-paper hybrids may end up becoming the standard tools for downloading and viewing scientific and other literature. At this moment, such alternatives to traditional books are proliferating, competing with each other, and winning converts. (d) Communication satellites may represent a practical and affordable means of providing information to the most isolated areas of the world. These areas have the greatest need for medical information, and for other information consistent with local regulations and customs. Summary: I think that the importance and economics of providing universal access to biomedical literature and professional contacts far outweigh those of any other alternatives, and that there should be no delay or compromise in providing this access. The costs of providing internet access throughout the world would be dwarfed by the costs of maintaining the print journal industry. The following examples emphasize the urgency of this need. (1) Many talented people from poor countries obtain advanced degrees from western medical schools, but upon return to their home communities are unable to solve many medical problems they face. Many of the most talented of these people remain in or return to advanced countries. For such people, state of the art facilities for keeping up to date and discovering important contacts would provide an essential lifeline and incentive to stay in their home countries. (2) During a six year period I spent doing research and providing training in Egypt, a country with eleven medical schools, three of which are in Cairo, there was very little access to current medical literature. (3) The situation is much worse in parts of the world that are now facing catastrophic epidemics and other medical problems. It is only through the efforts of Doctors Without Borders and other volunteer organizations that some communities are surviving at all. Enabling local doctors to obtain up-to-date information, and to share data and publish jointly with contacts elsewhere, would save many lives and revolutionize third-world medical education.						Web Form
39	Web RFI	04/22/2008 at 04:13:56 PM (992)	Tooey	M.J.	MLS	Health Sciences and Human Services Library, University of Maryland, Baltimore	Maryland	USA	Representative NIH Funding Recipient Organization		One recommendation that I have heard from UMB's research office and from colleagues is that we would like to see a procedure where a notification is sent to the campus office of research when an article from that campus relating to research has been deposited into PubMedCentral. This would close the loop and involve the office of research more closely since the grants and contracts belong to the university, not the p.i. They would be made aware of the PMC ID and could reference it for future communication and tracking.					Web Form
40	Web RFI	04/24/2008 at 07:45:43 PM (996)	Thiagarajan	Balasubramanian	Ph.D	Annamalai University	Tamil Nadu	India	Other	No	No	Nothing more	It is a boon to researchers in developing countries like India who can not simply afford to access subscribed journals.			Web Form
41	Web RFI	04/27/2008 at 11:58:10 PM (932)	Burack	Jeffrey	J.D.	n/a	NY	USA	Other Member of the Public	1) Reduce the embargo time to the shortest possible period. 12 months is too long. If necessary, implement an modest access fee, shared with publishers, which decreases with the age of the article, becoming zero at, say, six months after publication. 2) Find some way to establish greater access to NIH-funded articles that pre-date the April 8, 2008 policy.	Create an easy-to-use form/link that allows members of the public to easily and anonymously report access violations. For instance: "report an access violation," or "Having trouble gaining access?"		Great policy advance. Long overdue.			Web Form
42	Web RFI	04/28/2008 at 02:46:45 PM (708)	Sattler	Alison		University of Washington School of Medicine	WA	USA	Other			I support several faculty members who need to add PMCID numbers to PUBLISHED works for their progress reports that are due in June. I know how to enter manuscripts into the PubMedCentral database, but not published works. Currently, no information exists for how to add published articles and the journals these were published in aren't included in your list of journals that automatically submit artiles to you upon acceptance. What do you recommend? How can we comply with the law for adding the PMCID # to articles in grants that were published after April if we don't have a PMCID for the article and can't add it to the system to get a number?				Web Form
43	Web RFI	04/28/2008 at 03:19:30 PM (893)	caplan	steve	PhD	University of Nebraska Medical Center	ne	USA	NIH-funded Investigator	While I think that the overall idea of freely disseminating inormation from the scientific journals has merit, if the currentsytem is employed, I firmly believe that this idea will turn into a nightmare for the scientific community at large. My comments are based on my experience with PubMed Central, in being asked to submit one of my papers to this forum. While the submission process itself was not particularly difficult, the problem lay in the reformatting of my manuscript that was done to meet the criteria ofPubMed Central. I do not know how my manuscript was typeset, but it was sent to me to "proof' with a tremendous number of errors. I spent an enormous amount of time correcting and proofreading figure legends that were altered- probably 3 entire days worth of work to do so. I did not hear from PubMed Central for another 2-3 months, and then was sent the 'revised' proofs. In beginning to go through these, I could see that 80% of my time consuming corrections were either incorrectly implemented, or not at all. It took another 2 days of work to resubmit this and wait another 2 months for an additional round of corrections. In short, if this system is now mandatory and will be in effect for every paper, I may end up as a researcher spending more time revising and correcting ALREADY PUBLISHED PAPERS than doing anything else. My suggestion to overcome this would be the publishing of a PDF formatted manuscript supplied by the author(s). If PubMed Central would like to make these 'uniform', perhaps simply making a uniform title page would suffice. The submission of a PDF document by the author would ensure that no typesetting errors/changes will detract from the manuscript, and obliviate the need for the 'proofing' and revisions stages.						Web Form
44	Web RFI	04/28/2008 at 03:19:38 PM (122)	Brash	Douglas	PhD	Yale School of Medicine	CT	USA	NIH-funded Investigator	no	no	no	My institution tells us that we must now include the PMC ID number of papers from OTHER laboratories when we cite these papers in our grant proposal or report. But on the NIH website, I only see rules about adding PMC numbers to citations of our own papers. Which is correct? Thanks			Web Form
45	Web RFI	04/28/2008 at 03:33:56 PM (148)	Lawton	Teri	PhD	Perception Dynamics Institute	CA	USA	NIH-funded Investigator	You have made an NIH policy that is already out of date if you are referring to easy access to published work, since most scientists post their publications on their website. You now have created such a tedious, laborious process for publication that I will never submit a grant proposal to NIH again. You have ascertained that original, creative, productive ideas such as pathtoreading.com are funded elsewhere.						Web Form
46	Web RFI	04/28/2008 at 03:38:43 PM (158)	Means	Michael		President, Health First	Florida	USA	Other Member of the Public	I have received the following email notice from you four times. Please stop sending repeatedly. >>>April 28, 2008 Dear Members of the NIH Research Community: I am writing to remind you that the mandatory NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) applies to final peer-reviewed manuscripts accepted for publication on or after April 7, 2008. Making published research funded by NIH accessible to everyone, including health care providers, patients, educators and scientists, helps advance science and improve human health. We all have a role to play in achieving this goal, and I appreciate your efforts to make the NIH Public Access Policy successful. The NIH Public Access Policy implements Division G, Title II, Section 218 of PL 110-161 (see http://publicaccess.nih.gov/policy.htm), which was signed into law late last year. Compliance with this Policy is a legal requirement and a term and condition for all active grants and contracts awarded as of April 7, 2008. Failure to comply may trigger one or more enforcement actions, depending on the severity and duration of the non-compliance. Please see the Public Access Web site for the tools you need to comply with the Policy. The Web site houses Frequently Asked Questions (FAQs), training information, and other resources. To ensure compliance with the Policy, please remember to: Address Copyright - Make sure that any copyright transfer or other publication agreements allow your paper to be submitted to NIH in accordance with the Policy. Submit Papers upon Acceptance for Publication 1. Some journals will submit the final published article on your behalf, without your involvement. See http://publicaccess.nih.gov/submit_process_journals.htm for a list of these journals. 2. For any journal other than those on this list, please: a. When submitting a paper for publication, inform the journal that the final peer-reviewed manuscript is subject to the NIH Public Access Policy. b. Make sure that any copyright transfer or other publication agreement allows the final peer-reviewed manuscript to be submitted to NIH in accordance with the Policy. For more information, see the FAQ Whose approval do I need to submit my article to PubMed Central? and consult with your Institution. c. Submit the final peer-reviewed manuscript to NIH upon acceptance for publication at http://www.nihms.nih.gov/. See the Submission Process for more information. Cite Papers § When citing your NIH-funded papers in NIH applications, proposals or progress reports, please include the PubMed Central reference number (PMCID) for each paper. § NIH will monitor compliance through citations. Effective May 25, 2008, when your NIH Program Officer reviews your progress report or application, he or she will be expecting a PMCID in the citation of every applicable paper that arose out of your NIH funding, or a manuscript submission system reference number (NIHMSID) if the PMCID has not been issued. See Section C of our FAQ for examples. § If you publish through a journal listed under http://publicaccess.nih.gov/submit_process_journals.htm, there might be a slight delay in assignment of a PMCID. That is okay. We have signed agreements with these journals that allow NIH to resolve submission with them without your involvement. To facilitate your Program Officer’s job, we ask that you indicate ‘PMC Journal- In Process’ until the PMCID is available. The NIH Public Access Policy is a legal requirement and represents an important opportunity for science and medicine. We are very interested in your feedback on the Policy and are soliciting input through a request for information from March 31, 2008 to May 31, 2008. Please send any comments or suggestions to http://publicaccess.nih.gov/comments.htm. Sincerely, Norka Ruiz Bravo, PhD NIH Deputy Director for Extramural Research For the latest in NIH grants policies and initiatives, subscribe to the NIH Extramural Nexus ----------------------------------------------------------------- CONFIDENTIALITY NOTICE: This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential, proprietary, and/or privileged information protected by law. If you are not the intended recipient, you may not use, copy, or distribute this e-mail message or its attachments. If you believe you have received this e-mail message in error, please contact the sender by reply e-mail and destroy all copies of the original message						Web Form
47	Web RFI	04/28/2008 at 03:55:37 PM (924)	Emery	David	PhD	University of Washington	WA	USA	NIH-funded Investigator	As currently implemented, this constitutes a significant new burden on NIH investigators, a burden that is unfunded. The NIH's public access policy should be enacted at the level of the NIH, using NIH funds. All papers of consequence are cited on PubMed - why then couldn't the PubMed infrastructure be used to transfer NIH-funded publications to the public domain? Investigators should be able to list their publications as always, and the NIH should shoulder the responsibility thereafter. It is hard enough to get our work published - why is the NIH putting up yet another hurdle?	See answer to Question 1 above. The NIH should take the responsibility of implementing the public access policy, not individual investigators.	The issue is not one of training, but one of unfunded mandates. The NIH should take the responsibility of implementing the public access policy, not individual investigators.	It is a good policy in principle. However, the NIH needs to appreciate the significant burden this places on investigators. The NIH should take the responsibility of implementing the public access policy, not individual investigators.			Web Form
48	Web RFI	04/28/2008 at 04:41:40 PM (528)	Taylor	Russell	PhD	Johns Hopkins University	Md	USA	NIH-funded Investigator	The policy as proposed seems extremely burdensome on investigators. It is also ambiguous. You seem to equate "peer reviewed publication" with "journal article". This is wrong, since in some fields funded by NIH peer-reviewed conferences have equal or higher prestige and impact. If you mean "journal", say "journal". IF you mean something else, you need to say that. There is often no feasible way for an investigator to force compliance with a journal that does not routinely (and almost exclusively) publish NIH-funded research. First off, the relevant person to contact is not routinely and easily available. Second, the delay involved may cause publication deadlines to be missed. The situation with conferences is even worse. The net effect is likely to be to DETER publication, thus delaying or even preventing dissemination of NIH-funded research results.	See above. It would help immensely if NIH can pro-actively enter into agreements with the major engineering and medical societies. Within engineering, key would include IEEE (publishes many biomed engineering, medical imaging, and other pertinent journals), ASME, MICCAI, CARS/CAS. There are any number of medical societies as well. You should delay enforcement of this rule until these agreements are in place.	Much greater clarification of what is covered and how to go about it. Some description of what efforts NIH staff are taking to ease implementation of this policy. E.g., see answer to question #2. You might say whom you are approaching and give a contact email address for investigators to query status or suggest additional journals or societies to contact.	This is a good idea, but will be a nightmare for investigators unless much more groundwork is laid before it is enforced.			Web Form
49	Web RFI	04/28/2008 at 07:47:20 PM (924)	Roepe	Paul	PhD	Georgetown University	DC	USA	NIH-funded Investigator	I don't have a recommendation for alternative implementation, but I do not understand why publications from key scientific societies (such as American Chemical Society) are apparently not participating in automatic deposit, preferring instead to burden investigators. We pay dues to these societies, perform enormous pro bono peer review for their journals, etc. and they cannot work with NIH to find a fast and efficient way to do this automatically ? What gives ? Even more troubling, some journals appear to be charging fees to unknowing or confused investigators (up to a ridiculous one thousand dollars to satisfy pubic posting requirements). That is just disgusting, the community (and NIH) should be responding strongly to such practices.						Web Form
50	Web RFI	04/28/2008 at 10:39:13 PM (394)	Lustig	Arthur	PhD	Tulane University	LA	USA	NIH-funded Investigator	I just published in Chromosoma, a journal that gives you two alternatives. Pay 3000.00 to keep the copyright and have open transfer or pay no cost and allow viewing only for those to pay. Other journals have similar policies that are inconsistent with NIH policy. What action should I take?						Web Form
51	Web RFI	04/28/2008 at 11:52:47 PM (262)	Cutter	Gary	PhD	University of Alabama	AL	USA	NIH-funded Investigator	IF NIH wants to mandate this policy, why unload another round of burdens on investigators? This leaves each investigator to negotiate with each journal and a paper by paper basis. This one sided coin, you can only fail is not cost effective. Currently we sign conflict of interest forms, copywrite transfers and the giving of intellectual property to a journal for sale along with all types of additional burdens on investigators without reciprocity. If the journal doesn't make the citation available or an investigator isn't saavy enough to understand copywrite violations and sign the wrong agreement, you are just setting someone up for failure, violations and problems. If this is so important and a legal requirement, and in spirit it is a good idea, why not simply state that NIH will not allow any investigator using public funds for their research to publish in any journal that does not adhere to this policy. One statement and the journal will comply saving thousands of dollars in compliance monitoring. The journals will comply or not have material to publish and compliance will no longer be an issue. Why seek to make criminals of already burdent scientists with threats of legal violations when you could make the norm happen? These are incredible wastes of the greatest resources this country has, our human capital, as is increasingly common with the enormous amount of NIH mandates. The collective hours of cost is not really worth the repetition of the same effort. You have the power to make this happen and dumping the task on individuals is just setting up people for failure. Where is the thinking about translational science?	Yes, NIH take a stand, state the policy and boycott journals that do not adhere to this principal.	If NIH is unwilling to strongly negotiate with journals on behalf of the scientific community, it should provide a cadre of legal staff to review each and every nuance a journal could provide in order to capitalize on the intellectual property it now takes to publish in their journal.				Web Form
52	Web RFI	04/29/2008 at 10:57:32 AM (545)	Vogt	Brent	Ph.D.	SUNY Upstate Medical University	NY	USA	NIH-funded Investigator				The journal publication mechanism is well established and this NIH process is redundant and unnecessary. What the government has managed to accomplish is to generate a new level of detail and compliance that is not necessary; a process that removes resources from performing research. Once again we have been given a mandate that will do nothing to improve communication but it will remove the funds we need to get our work done. Since this is a mandate, we need to develop a way to reverse the mandate rather than come up with a method for wasting precious resources.			Web Form
53	Web RFI	04/29/2008 at 11:22:32 AM (528)	Slater	Michael	Ph.D.	Ohio State University	OH	USA	NIH-funded Investigator	Yes. The April 7 date for all accepted ms. potentially puts investigators in an extremely awkward position, if an article is currently in the review and revision process--which can take over a year and represent many dozens of hours of work in revisions--and the journal at which it is in review does not currently have a copyright policy permitting posting of a public access version of the article. The investigator either must withdraw the article, losing perhaps a year or more in the publication cycle process; continue forward, hoping that the journal will revise their policy by the time publication is scheduled and, if not, violate copyright in order to avoid violating federal regulation. Had the date applied to all ms submitted by April 7 instead of accepted, investigators would have at least had the option of seeking out journals that had already announced compliance mechanisms or revisions to their copyright agreements, avoiding this dilemna. Some provision for cases such as these (under review but not accepted as of 7 April, and evidence of refusal by the publisher to provide copyright release) would be reasonable, it seems to me!						Web Form
54	Web RFI	04/30/2008 at 02:59:24 PM (324)	MacLennan	John	PhD	University of Cincinnati	OH	USA	NIH-funded Investigator	NIH should go after the journals directly if they really think this is worth it and settle it.	No	An NIH office should do the screening and posting themselves instead of NIH paying PI time to very inefficiently do it. In terms of research bang for the NIH buck the current system does not seem the best.	I am now in the situation of having to either dump a paper that just got accepted after revisions and start all over with another journal (at clearly a cost of $1000s) or pay $2600 of NIH funds to make it available to everyone even though essentially everyone who will read the paper already will have access to it through their institutions. I can not believe this policy is a good use of the very limited NIH funds.			Web Form
55	Web RFI	04/30/2008 at 03:49:03 PM (881)	Lackner	andrew	DVM, PhD	Tulane University	LA	USA	NIH-funded Investigator	It makes little sense to go after individual NIH funded investigators for this. You should work with the journals to get this information. This represents a significant additional burden on investigators.It makes little sense to require accepted manuscripts to be posted if it does not come through the journal. You are going to end up with someone submitting a manuscript as submitted that isn't and then this will get used as an example of how scientists can not be trusted.	NIH should rely more on the journals to have the materials submitted and strongly discourage people from submitting to journals that don't follow the policy.	If NIH is not going to address this with the directly with the journals then they should provide additional funding to the institutions of all NIH Funded grantees to hire the legal staff to deal with the problem.	A wonderful idea in concept but a disaster in implementation. The investigators are not the problem.			Web Form
56	Web RFI	05/01/2008 at 10:59:25 AM (287)	Sweet	Douglas	PhD	VCU	VA	USA	NIH-funded Investigator	N/A	N/A	When I sign onto PubMed all of my articles appear and have a PMID# - is this compliance?I can not find out what a "PMCID" number [NIH info] is versus the "PMID" I see associated with my articles in PubMed - is there a difference?	N/A			Web Form
57	Web RFI	05/01/2008 at 04:12:05 PM (182)	Ryley	James	PhD	FreePatentsOnline.com	MD	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	Consideration needs to be given to retroactive open access for already-published documents, rather than just new documents. Oherwise, complete databases of full-text will never be openly available, severly limiting the use of the available full-text.The issue here is comprehensiveness: If even a small portion of the full-text data is missing, users must fear missing something during literature searches, and are therefore pushed to use fee-based options rather than free ones.						Web Form
58	Web RFI	05/02/2008 at 05:53:11 PM (406)	Boothby	Mark	M.D., Ph.D.	Vanderbilt University	TN	USA	NIH-funded Investigator	Yes. Many many many.As implemented, it's horrific, arguably a violation of the law (poorly written in any case, and - even where NOT a direct violation of the law - ham-handed, counterproductive, and set to waste massive amounts of very scarce NIH $$$ to achieve the portion of the underlying objective that is laudable.Rec #1 -- Work more constructively than you have with the many scientific societies whose journals provide open access to the information after a reasonable period (6-12 mo) post-publication. For instance, accept their offer of invisible autolinking from High-Wire (or their own WWW sites, autolinked already from NLM PubMed) to PMC (sneakily named PubMedCentral - distinct from PubMed). In addition, just program an autodownload conversion from PubMed entries (and their active journal links) to PMC, which don't become activated until investigator performs one simple click within 12 mo of publication date (or earlier, specifying a length of Embargo period). Apart from those that already are on the NIH list of journals taking care of PMC transmission of papers on behalf of investigators, there remain two classes of journal: a. those that already make the information openly available to all with WWW access within 6 or 12 mo of publication, and therefore achieve your present objective, versusb. those that do not, and may be almost impossible to drag into doing so because of their unique branding and (over)weighting in the cultural consciousness of medicine or science [i.e., NEJM, Nature and baby natures, Cell and baby cell press journals]. If you work constructively, instead of the current obstinate obstructionism, to bring journals of group a into the fold, the mass of high-value content will increase the pressure on the hold-outs.2. Provide a clear path whereby scientists can use a PMID and embedded link {rather than a PMCID; heuristic point = PubMed and PubMedCentral are different units} in those instances where the open access need is already met as a matter of course. [Didn't Congress' appropriation include a specific point to the effect that "open access, as long as it does not violate copyright law"? So, NIH wants to implement things about like Mafiosi or the like (with the metaphorical gun to the head): don't publish in journals with concerns about PMC, too bad if your paper was under review at a journal with "non-compliant" copyright policy and got accepted April 10, and it's all your problem - we'll just make you certify that you were compliant.Similarly, grant applications, progress reports, and other forms of reporting should allow ANY open access link that Congress, staff, NIH officials, other govt officials, reviewers, and the public can all use. [Is it not true that under current Federal Law, the simplest and lowest cost means of achieving compliance with the requirement incorporated into the appropriation is MANDATED?]3. Better clarity, simpler path to compliance, and acceptance with no further action on the part of the investigator. I previewed the site, having just had a paper accepted into a journal that apparently will take care of the upload within 6 months of publication, but I see no reason to spend an extra $700 of scarce and precious taxpayer money to select their "Open Access Option", and in the meantime (nest 8-9 mo), what's the PMCID? Am I supposed to sit around deemed 'non-compliant' even though I am or will be compliant?	Yes.First, honestly consider and implement ways of using PubMed / PMID with autouploads to PMC as a mechanism - the simpler things are, the less the time, and the more transparent (and less high-handed) NIH behaves, the better the compliance will be).Second, as noted above, monitor whether the NIH-funded investigator’s work becomes publicly accessible (free of charge other than internet access) within a year of publication date (or, in cases when journals use an e-publication date that is earlier than the print date, set the clock going at the ePub date. Third, minimize the loss of precious $$$ that will be wasted on pig-headed insistence on imperfect, cost-wasteful means of implementing the policy by using accepted principles of statistical sampling (auditing) for purposes of reporting to Congress on the progress each year from 4% compliance (NIH Open Access voluntary) to xy % compliance (Open Access mandatory).Fourth, during at least the first two years, monitor and ensure compliance in line with principles used for monitoring and accepting compliance with laws such as the speed limit on interstate highways (speed kills, short-term shortfalls in public access do not).If the NIH and Congress are really serious about enhancing research, and making taxpayer $$$ be used in the most effective ways possible, it should direct its effort more toward effective enforcement of the mandate that unique reagents (mouse lines, plasmids, etc) be shared in a timely and effective manner, in line with written investigator assurances that they will do so [and, for that matter, better screening for overlap in funding between R01’s and PPG’s, etc] than toward the flawed NIH choice of system for achieving Open Access.	1. Honest Information on a. how much the chosen mechanism will cost to implement (as opposed to incorporation of alternative approaches), including not just the servers and the I.T. support but also the direct and indirect costs charged in the cases where desirable journals (e.g., those that impress grant reviewers) start charging several thousand $$$ for the alternative of having author own copyright – see testimony already logged in response to this RFI) AND a reasonable estimate of the increases in page charges that publishers inevitably will start charging to defray the shift in revenue away from subscriptions – extra page charges that will be shouldered by NIH funds and subtract from the real goals, which are getting and disseminating new data and insights, followed by flow of those insights into better health.b. how many aggregate NIH $$$ will be spent to cover the direct and indirect cost component of having this dumped on investigators and covered as a direct cost to the grant (as opposed inclusion of an automated system at NIH that is based on PI’s submitting PMID and an NLM computer program pulling the open access text in instances where it was already available, and simply requiring that the PMID be submitted between time of publication and 12 mo thereafter) (number of papers per year x $75 / hr (a low-end estimate of direct + indirect cost of PI time) x at least 60 min / paper -- US government estimates of how little time things take are always ludicrously on low side because of legal mandate that policies be cost-effective; uploading takes longer than 15 min, and then there’s the follow-up emails, the inevitable screw-ups of conversions, etc) [10,000 papers per year would mean at least 2 R01’s gone, which these days means 2 scientists gone; probably 4 gone is more realistic as, after queries and re-edits, this may take 2 hr per paper on average] c. how many R01’s of average size will not be funded per year because of this form of implementation and construction of PMC (after y’all presumably asked Congress specifically to name PMC as the mechanism for achieving the goal of allowing public to view the fruits of research they funded)? 2. Send an email to all NIH grantees with each of the information links embedded in text, and with each of the instruction presentations attached (slide show on public access policy, 15 slides; NIHMS System Slide Show).	In implementation, it is unfortunate and has major unacknowledged costs that were avoidable and, at a time when each decrease of 1 R01 is spelling one less trained scientist as PI in the system, highly regrettable. Probably also is one of those instances where there are two conflicting laws (mandatory review for cost-benefit analysis e.g., in selection of implementation method versus weird set-aside specification of PMC in Sec 218 od PL 110-161) and the whole mess will end up in court – costing further money and undercutting optimal implementation of the general goal.Among hidden costs –1. more NIH-funded scientists just saying ‘screw it’ (international competition for scientists)2. one more bit of bureaucratic creep and reason to advise talented young folks to steer clear of scientific career3. probably large amounts of money diverted away from actually doing science.4. Top-quality peer-review (and other aspects of NIH) depend on mutuality with the PI community, and constantly dumping on us or taking such high-handed approaches is not likely to foster the spirit that enhances other NIH needs.And more . .. .that said, if it were implemented betterA reasonable general notion – that the taxpaying public (and congressional staff, etc) should, within a reasonable period of time, have access to articles representing the fruits of the support. A reasonable general notion, that building access with some database characteristics might help NIH get a better handle on its own portfolio and help its program and scientific review officers a bit.			Web Form
59	Web RFI	05/05/2008 at 03:52:04 AM (612)	Madhusoodanan	Ramakrishnan	PhD	NCCAM	Kerala	India	Representative NIH Funding Recipient Organization				Some NIH portfolio journal's current trend have some uninterested policy to handling the NIH accepted author manuscripts.This may cause at least rather four month delay period in one journal submission to another and its respective, peer review . This may cause potential burden to comply NIH Public Access policy in some NIH supported investigator's manuscript publication at the proper time.I humbly request perusal NIH attention to this subject.			Web Form
60	Web RFI	05/06/2008 at 12:15:37 PM (266)	Hickey	Damon	PhD	Director of Libraries, The College of Wooster	OH	USA	Representative NIH Funding Recipient Organization	I am the Director of Libraries at the College of Wooster, a midwestern liberal-arts college that has long led among American colleges and universities in the percentage of its alumni who pursue graduate study in the sciences. Our record is due in part to our program of Independent Study, which requires all of our students to engage in original research in their major fields in their junior and senior years. Accessibility to published research, especially in the sciences, is therefore essential to the education of these students, many of whom will go on to be the next generation of American scientists and researchers.I want to thank the NIH for their openness to comments from those of us who have a primary interest in the availability of scientific research. We support the Public Access Policy (NOT-OD-05-022) as currently articulated, because it will expand access by our faculty and students to NIH-funded research, accelerate research on our campus, contribute to our core mission as a research-based undergraduate institution, improve access for other institutions with fewer financial resources to important research, and ensure that citizens of this nation are able to get and use the results of the research their tax dollars have paid for.Those who have opposed the legislation that led to this policy and who have demanded that an additional period for comments be opened have made false claims that the policy will result in the cancellation of journal subscriptions en masse. As the person responsible for purchasing these subscriptions, I can assure you that this is not the case. The fact that public access is not required for 6-12 months after publication means that we will continue to subscribe in order to obtain the results of research as soon as it is available. We know full well that crippling the scholarly publishing industry would not be in our interest, our faculty’s, or our students’.						Web Form
61	Web RFI	05/06/2008 at 02:55:14 PM (682)	Palazzo	Robert	PhD	President, Federation of American Societies for Experimental Biology	MD	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	The Federation of American Societies for Experimental Biology (FASEB) is a coalition of 21 scientific societies, representing more than 80,000 investigators. Our mission is to enhance the ability of scientists to improve, through their research, the health, well-being and productivity of all people. FASEB and member societies collectively publish approximately 50 journals using a range of publishing models. They will be affected differently by the policy, and some of them will raise additional issues. All believe that the NIH public access policy does not represent the best method of achieving NIH’s goals of public access, portfolio management, and archiving of manuscripts reporting on NIH-funded research. In addition; we believe the policy will duplicate private publishers’ services using public funds, undermine the integrity of the scientific literature, and impose an unnecessary burden on investigators and institutions. The NIH approach is inferior to innovations that publishers currently offer and continue to invest in improving. Most of our member society journals make their entire content available freely after 12 months or sooner, offer content at low subscription and pay-per-article fees, and provide enhanced functionality including integrated links to research databases. FASEB is proud that its member societies are in the forefront of electronic publishing and archiving. We believe that NIH should work collaboratively with publishers to encourage and promote these efforts, not attempt to duplicate or compete with them. The RFI asks for recommendations for alternative implementation approaches. We continue to believe that a partnership between NIH and journal publishers would better achieve NIH’s goals while also addressing our community’s concerns about the policy as outlined above. Instead of NIH undertaking a whole new publishing venture that involves formatting and publishing unfinished manuscripts of authors, NIH should use existing links from NIH’s highly respected PubMed to journals’ websites for reader access to final, published articles. To address NIH’s desire to create an archive of manuscripts reporting NIH-funded research, journals would provide to NIH immediate access to journal content for internal use. This mechanism has several advantages to the current implementation plan. It would relieve the administrative burden on NIH-funded scientists because they would not have to take any additional steps to comply. They would simply continue submitting manuscripts to journals, as they always have. The integrity of the scientific literature would be ensured because only the final, published version of the article would be publicly available and archived by NIH. Articles would be available at significantly lower cost since publishers are already publishing, editing, and posting articles at no additional charge to the public. The database of articles would be more comprehensive and accurate for NIH portfolio analysis and strategic planning. This proposal was put forward by 56 organizations and publishers on October 15, 2005, and we urge NIH to reconsider it. This proposal would fulfill the public access policy as enacted by the Consolidated Appropriations Act of 2008 and would also specifically address copyright law concerns expressed by Congress.It is FASEB’s recommendation that NIH efforts should focus on ways to work with publishers to achieve common goals, and we stand ready to work with NIH on this effort.			The NIH policy may cause confusion about the article of record. Changes made by NIH that will result in variations from the original manuscript are of considerable concern. NIH needs to identify precisely how manuscripts will be linked to databases and other resources to ensure the integrity of the underlying work.The revised mandatory public access policy now calls for submission of review articles. NIH previously encouraged publishers to add review articles to journals as a way to sustain the subscription base under the voluntary policy. Editors commission the review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants. Furthermore, requiring that review articles be included will seriously undermine the many journals that publish review articles only. The policy imposes an unnecessary administrative burden on researchers and their institutions. We question if this is the best use of investigators’ time and public funds. Given the magnitude of the policy, we remain concerned about the lack of rigorous analysis and public discussion of the cost involved. We request that NIH examine and publish the cost of this policy. We are concerned that the NIH publication policy will draw resources from other areas of critical research investment, particularly in this time of constrained budgets.We are aware that there are calls for NIH to reduce the time of manuscript release to six months or less. This would seriously compromise the ability of most of the FASEB member society journals to provide quality peer review, editing, and publishing of NIH funded research results. We urge NIH to maintain the 12-month upper limit.			Web Form
62	Web RFI	05/08/2008 at 04:21:49 PM (598)	Newman	Katie	Ph D	University of Illinois	IL	USA	Representative NIH Funding Recipient Organization			I think it would be helpful if the NIH site provided more information for scholars on how they can assure themselves that they have the RIGHT to put their manuscripts in PMC. For so long they have been blithely signing the publishers copyright agreement forms -- frequently giving away ALL their rights, that I feel this is an area with great opportunity for education. In ALA jargon, this would be "Author Rights" education.I appreciate the verbiage that NIH has provided. But they could also point folks to the Sherpa/Romeo site <http://www.sherpa.ac.uk/romeo.php>, where authors can see if their publisher, de facto, is "NIH compliant".	The University of Illinois has put up a support site for our researchers. But as the NIHMS submission process is really quite straightforward, I feel that the real added value we are providing our NIH grantees is the guidance concerning their copyrights. See:http://uiuc.libguides.com/content.php?pid=8114Additionally, we are offering to do third-party submissions for our authors. And we are using the NIH Public Access mandate conversation as an opening for suggesting that our researchers also put their manuscripts in our institutional repository, IDEALS.			Web Form
63	Web RFI	05/12/2008 at 08:45:36 AM (423)	Krementsov	Nikolai	PhD	University of Toronto	Ontario	Canada	NIH-funded Investigator				Does NIH public Access Policy apply to a book-length manuscript/monograph?			Web Form
64	Web RFI	05/12/2008 at 10:50:53 AM (165)	Van Orsdel	Lee	MLS	Grand Valley State University	MI	USA	Other	Cut the embargo to 6 months. Timing is everything in health and related research, and 12 months is too long to let new information remain inaccessible for those who need it and cannot afford to purchase it. Particulary when we, the taxpayers, have already paid for it once (salaries and laboratories of researchers in state-supported schools) or twice (subscriptions paid by the same institutions). Publishers worry that this policy will threaten their livelihoods, but universities are not going to cancel critical research journals with a 6 month embargo. Faculty would not stand for it.	Universities are prepared to take a role in facilitating compliance with NIH, and a link between the grantees' institutional repository and the NIH would facilitate both monitoring for compliance and the uploading of documents into PMC. Most universities have an office of research, even if the institution is not rated as a research institution. These university officers of research would be the logical contact to work with the NIH in an ongoing, routine manner.	Health-related research is exploding in western Michigan,with a new medical school, several new hospitals, and expanding health-related research institutions expanding or building new facilities. My university is the major regional hub for educating students for health related fields--nursing, physical therapy, physician's assistants, occupational therapy, lab techs, etc. We are well-funded but can't begin to purchase all of the relevant journals to those fields. Information fuels education and invention. The more freely it is shared, the faster society feels the benefit. Subscriptions put barriers between practitioners and the information they need to treat patients. Their patients have already paid taxes to generate this information--having timely access to it may save their life or that of a child or parent. It is unconscionable not to make the information free and open to everyone who can benefit from it.	The NIH Public Access Policy if one of the best examples in my lifetime (61 years) of the government truly deciding for the people. I'm so proud of all that it represents, both theoretically and practically. It takes courage to face the opposition from the commercial sector, who fear the demise of their industry as a result. My colleagues and I, in academic institutions of all sizes, believe their fears are overblown. You have done the right thing, and that pretty much says it all.			Web Form
65	Web RFI	05/12/2008 at 12:55:37 PM (524)	Williams, II.	James	MS	University of Colorado - Boulder	CO	USA	Representative NIH Funding Recipient Organization				Thanks to NIH for the opportunity to comment. Th policy sustains the gift culture among faculty while expanding access to NIH-funded research and its use. The policy will accelerate research and discovery on this campus while generally supporting the development of new knowledge within and beyond the academy. We have already devoted considerable institutional time to the development of protocols that will ensure compliance with the current implementation. And, in the meantime, the library will not cancel journals as a result of this policy; we have developed a faculty rights website that points to the new policy; and I encourage NIH to develop automatic notification and submittal procedures and protocols in order to streamline and leverage the ingest of papers to PMC. Lastly, please continue to reconsider shortening the embargo period to 6 months. I fully support the policy and its implementation. Thanks again for the opportunity to comment.			Web Form
66	Web RFI	05/12/2008 at 01:33:59 PM (663)	Schwartz	Elliot		Committee for Economic Development	DC	United States	Other Member of the Public	The Committee for Economic Development is a 65-year old, independent, nonpartisan organization of business and education leaders dedicated to research and outreach to the public and private sectors on major economic and social issues. I am writing with regard to The National Institutes of Health (NIH) Public Access Policy (NOT-OD-05-022).CED most recently issued a report entitled Harnessing Openness to Transform American Health Care (February 2008). The report (available at http://www.ced.org/docs/report/report_healthcare2007dcc.pdf) made the following recommendations regarding openness, publishing and disclosure of research results: • The explicit policy of the federal government should be to promote the broadest possible access to research results in the healthcare arena, particularly government-supported research. • Those federal agencies supporting research should positively respond to requests for funding to pay for publication/disclosure of sponsored research.• In evaluating applicants for research funding, federal agencies supporting research should recognize the scientific value of database science and scholarly work that may be validated by means other than traditional scholarly publication.• Federal agencies supporting research should require that sponsored researchers disclose potential conflicts of interest in any publications/disclosure of the sponsored research. • Federal agencies supporting research should target efforts to reduce the interval between publication/disclosure of research and its implementation in accepted treatment regimes.The report took a favorable view of the National Institutes of Health’s leadership on these issues critical to accelerating the pace of research, promoting new discoveries and stimulating innovation. CED, consistent with these principles, supports the NIH public access policy as articulated. If any changes were to be made, CED would favor a shorter embargo.						Web Form
67	Web RFI	05/12/2008 at 03:50:06 PM (242)	Alley	Keith	Ph.D.	University of California, Merced	California	USA	Representative NIH Funding Recipient Organization				As the first American research university of the Twenty-First Century, the University of California, Merced is committed to the kind of new thinking and innovation that informs the NIH Public Access Policy. UC Merced is deeply appreciative of the leadership and foresight shown by the NIH in implementing this policy. The UC Merced Library provides access to some 20,000 full-text journals but carries no print-format journals. We believe it is only a matter of time until this strategy becomes the norm rather than the exception. Clearly, the NIH Public Access Policy enhances this emerging way of managing a research-library journal collection.Even more important is the long-term impact the NIH Public Access Policy, in conjunction with similar policies, will have on the future UC Merced School of Medicine. Designed to bring medical education and improved medical care to California’s Central Valley, our state’s most medically underserved region, the UC Merced School of Medicine will follow a distributed model in which students and faculty are spread up and down the Central Valley rather than being clustered around a single teaching hospital. Unimpeded access to online medical research of the sort made possible by the NIH Public Access Policy will be vital under such an educational model, with the ultimate beneficiaries being the residents of California’s Central Valley.The University of California, Merced commends the NIH for moving access to medical research into the Twenty-First Century and encourages NIH to stand by, and eventually expand, its Public Access Policy.			Web Form
68	Web RFI	05/13/2008 at 09:00:24 AM (651)	Miller	Jonathan	MLS	Rollins College	Florida	USA	Other	Just make it as easy as possible for authors to submit their manuscripts. In my experience with other institutional repositories , users need a lot of support in successfully submitting documents. Make it flexible and simple and you will avoid non-compliance.	See my answer to question 1.	None, i think you have done a fine job so far. Keep it up!	As a library director of a small private liberal arts college with good, but limited, library resources, open access initiatives like yours are a very helpful way of enabling our students and faculty to get access to a wide range of high quality research materials. Previously, they would have had to travel to a major research library or rely on interlibrary loan for in depth research in a wide range of subjects. With access to PubMed and the fulltext of these NIH funded articles our studetns are far better prepared for graduate school and professional careers. In the long term this should help with the shortage of health care professional in Florida.			Web Form
69	Web RFI	05/13/2008 at 02:39:02 PM (230)	Teschner	Craig	MBA, BSMT	Genetic Therapeutics International	MA	USA	Patient or Representative of a Public Health Advocacy Organization	Recommedations would include requiring grantees to publish results of their investigations in the public access forum: The Public Access Policy which has access to published results of NIH/NCI funded research and clinical trials in through the PubMedCentral.						Web Form
70	Web RFI	05/13/2008 at 03:39:18 PM (873)	Koopman	Ann	M.A.	Thomas Jefferson University	PA	USA	Other	Speaking as a librarian and manager of the University's institutional repository, I strongly encourage the NIH to reduce the permitted publisher embargo period to 6 months, instead of 12. Existing web-based support information and third-party deposit options are extremely helpful. Our library has created a brochure and webpage to educate our faculty. We strongly support the NIH Public Access Policy, and are providing staff assistance (for copyright education, deposit, and PMCID searching) to assure its success with our faculty.	I am concerned that some researchers will regard the policy as just so much busy work, and will ignore it or seek ways to avoid compliance. Early feedback from our research staff includes a fair amount of irritation at the additional requirement.					Web Form
71	Web RFI	05/14/2008 at 03:45:25 PM (942)	Vinson	Daniel	MD	University of Missouri	MO	USA	NIH-funded Investigator	Require only the abstract.In CRISP, link all publications to the grant that funded the work.			Some journals are proposing to charge a few thousand dollars to publish an article with open access. Because many papers are published after grant funding ends, this will create a burden for investigators and/or their institutions. It will likely cause shifts in which journals we submit papers to.Thanks for reading.Dan Vinson			Web Form
72	Web RFI	05/15/2008 at 05:17:53 AM (589)	Shields	Peter	MD	Georgeown University	DC	United States	NIH-funded Investigator	Do not place pre-prints in the depository, but only the final publication. The way it is now, there will be multiple versions of a manuscript in the public domain. The one you require may have errors that do not get corrected until the final proof.			Do not place pre-prints in the depository, but only the final publication. The way it is now, there will be multiple versions of a manuscript in the public domain. The one you require may have errors that do not get corrected until the final proof.			Web Form
74	Web RFI	05/16/2008 at 02:50:17 PM (969)	Lewis	Margaret		University of Illinois	Ill.	USA	Other Member of the Public	Not at this time. I am new to this issue. I strongly support wide access to all publicly funded research. As a library employee I know that decisions to cut journal subscriptions are made daily because of the cost and libraries limited funding.	No	More information directed to the general public. This is an issue everyone should be interested in.	Sounds like a reasonable plan.			Web Form
75	Web RFI	05/16/2008 at 03:34:01 PM (362)	Emmett	Ada		n/a	KS	USA	Other Member of the Public	It is reasonable that the embargo period be shorted to 6 months. Publishers can easily still make their needed profits in the first 6 months (and beyond) since most researchers prefer/require the most recent research. The shorter embargo period however gives the general public (who has funded the research through tax dollars at both the state and federal level-- funding the salaries of researchers/faculty at state universities and colleges and through federal grants). It is time that a balance be struck, where there has thus far been none, between the need for commercial and non-profit publishers to earn at least a modest profit for their value-added work and the (thus far ignored) need for the public to have rights to the social and public good it funds.	In addition to the methods currently in place perhaps the institution/agency that monitors the grant for the individual researcher, should supply documentation of compliance.		Let me add that although it is more work for the researcher to submit their final manuscript (one more step in a bureaucratic maze of steps)—it is time that scholars/researchers/academics accept the fact that they play a pivotal role in the cycle of knowledge production and consumption. As scholars they must have access to the products of other's research and they must make their results known. The products of scholarship are a public good. Even if they are researchers for the sheer joy of research (with no sense of owing something back to humanity, the Knowledge Commons, society,—whatever one chooses to call it) they must realize that the current system is not sustainable as it is and that the entire world is waiting for a variety of shifts to take place and establish a just balance between the needs of the public (reading, researching and tax-paying public) and the needs of Big Business.The NIH requirement is a first important step.			Web Form
76	Web RFI	05/17/2008 at 10:15:31 AM (590)	Firnhaber	Gina	MSN, MLS	Laupus Library, East Carolina University	NC	USA	Other	I work as a librarian assisting researchers in medicine, nursing and various allied health professions perform literature searches to support and design their research. If studies are being supported with government (ie taxpayer) monies there should not be an entire year lapse before the results of these activities are available to other researchers. I support the rights of publishers to make money but placing an embargo on information that has been gained using government funding gives second place to the people who really funded its creation in the first place. Perhaps a simple draft of study results should be publicly accessible initially and a cleaner, crafted paper required 1 year after publication. Researchers could access the early information and the public could be encouraged to focus on the more complete work.	I think ensuring public access should be included as part of the grant process, not left up to individual researchers or organizations to police. If this requirement is written into the grant and followed up as such compliance will not be an issue.		Much of medical research today is building upon other work and open access is essential for researchers. It also seems useless to fund research that does nothing but sit in a journal. In many cases the time between the discovery of information and implementation in the field is years, mostly from poor diffusion rates rather than access, but requiring research be avaible may help diminish this time lag, especially in research and research based practices.			Web Form
77	Web RFI	05/18/2008 at 08:44:09 AM (649)	Eichenbaum	Howard	PhD	Boston University	MA	USA	NIH-funded Investigator	I think the private publication system that has evolved for dissemination of research results works rather well, both for investigators and for the public. The information contained in publications is readily available already. I am highly concerned about the costs to NIH that will occur as a consequence of the new initiative. Journals will have to pass on their costs to investigators, who will request those costs in their grant applications. And I am concerned about the archiving organization and protections offered through the current system.						Web Form
78	Web RFI	05/18/2008 at 06:12:43 PM (236)	Fister	Barbara	MLIS, MA	Gustavus Adolphus College	MN	USA	Other Member of the Public	I don't have particular concerns about the implementation; I just am happy that the NIH is taking this leadership role. As a librarian at a small college, our ability to support the work of young people getting started in the sciences and to support the work of their faculty mentors has been limited by a budget that can't sustain expensive STM journals. It makes sense for publicly-funded research results to be available for all, and it's a great help to us.	I hope that the researchers involved will understand that their research will reach a wider audience through this process. That has both personal and public benefits.	I think what you've made available already is quite helpful.	Thank you for taking these steps. It's much appreciated.			Web Form
79	Web RFI	05/30/2008 at 12:24:58 PM (417)	Connolly	Anne		Research Foundation of SUNY (RF)	NY	USA	Representative NIH Funding Recipient Organization	The Research Foundation of State University of New York (RF) offers these thoughts as recommendations for the NIH to consider for implementation, from actions put in practice by some of the State University of New York (SUNY) campuses. 1. SUNY campuses have enhanced and supplemented the implementation recommendations of the NIH. For example, letters have been and/or will be sent to individual NIH faculty, including Chairs and Deans to make them informed and aware in the attempt to ensure compliance. These letters will be posted on individual SUNY campus websites and will also appear in campus newsletters. 2. SUNY campuses are also discussing ways to target employees (e.g., post-doctoral) on NIH grants who may also be publishing. 3. SUNY campuses have and/or soon will include statements on internal notice-of-award forms (i.e., information abstracts) that are sent to investigators identifying the need for compliance. 4. SUNY campuses have also engaged their library services to post similar information on their specific webpages. 5. SUNY campuses may maintain their own database of publications in their campus libraries, and include the library staff in the compliance process. 6. SUNY campuses have also discussed having the research administrators remind investigators to include additional publication costs (in addition to page charges and illustrations) if they are considering publishing their manuscripts in journals they know charge for submission to PubMed Central.	The Research Foundation of State University of New York (RF) provides these thoughts as recommendations for the NIH to consider for monitoring and ensuring compliance, from actions being discussed by some of the State University of New York (SUNY) campuses. 1. SUNY campuses have discussed adding questions to their application routing forms and the yes/no questions of the COEUS system to identify if investigators have and/or plan to publish manuscripts supported by NIH grants. 2. SUNY campuses also plan to implement a review process when investigators submit their noncompetitive continuation applications to assure the publications are duly noted along with the PubMed Central numbers.	The Research Foundation of State University of New York (RF) suggests this recommendation for the NIH to consider for additional training and/or communications, from thoughts provided by some of the State University of New York (SUNY) campuses. 1. SUNY campuses recommend that the FDP (Federal Demonstration Partnership) subaward boilerplate should include the PubMed Central language as well as all subcontract agreements.	The Research Foundation of State University of New York (RF) includes these other comments for the NIH to consider as related to the policy. 1. The RF acknowledges and appreciates the NIH for providing the research community with time, communications, and guidance to inform investigators to help them assure compliance with the mandatory requirement. 2. The RF applauds the NIH for developing good resources (e.g., Frequently Asked Questions) further helping research administrators and investigators understand the applicability of the policy and how to meet the requirements. 3. The RF suggests the NIH needs to clarify the policy to reflect the relationship between NIH funding (as described in the FAQ) and acceptance for publication – the sole criteria described in the policy. 4. The RF appreciates that NIH has included an example of language that can be used in copyright agreements to meet the requirement. 5. The RF feels that the NIH should engage publishers and the research community in collaboration with meeting the mandatory requirement (e.g., modifying standard copyright agreements to include a provision acknowledging that the author retains the right to provide a copy of the final peer-reviewed manuscript to the NIH, and to make the article available in PubMed Central within 12 months after publication by the journal.). 6. The RF suggests that the NIH address and clarify the consequences to investigators who inadvertently fail to reserve their rights to submit to PubMed Central. 7. The RF intends to meets its responsibilities under the mandatory requirements as implemented by the NIH Public Access Policy, and we appreciate the opportunity to participate in the NIH’s request for information (RFI) by providing these observations and comments.			Web Form
80	Web RFI	05/30/2008 at 12:38:54 PM (168)	Givler	Peter		Executi8ve Director, Association of American University Presses	New York	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	NIH requested specific comments on its implementation approaches, compliance monitoring, and training offered. Assuming that the current "implementation approaches" are in fact the policies and procedures now spelled out in the PubMedCentral and NIH websites, we offer these suggestions that we believe would enhance implementation and observance of the Policy.1. PMC now offers publishers various types of Participation Agreements, and under these publishers may submit NIH-funded articles to PMC on behalf of authors. The current file submission guidelines state: A journal must provide PubMed Central the full text of articles in an XML or SGML format that conforms to an acceptable journal article DTD (Document Type Definition). The original high-resolution, digital image files must also be provided for all figures. A PDF may be submitted in addition to the XML/SGML version of an article, but not as the primary (or only) form. andA journal that does not currently produce XML or SGML versions of its articles would have to add this process to its production stream or contract with a vendor to create XML from the article source files.Most university presses do not now operate production processes that would support production of these XML files. To suggest that they "add this process to the production stream," is not reasonable, when one considers that a press might only have a small number of NIH-funded articles to handle. We recommend that PMC alter the requirement and accept PDFs from publishers, just as PMC now does accept PDFs from authors. This would reduce the burden on many university presses and increase both required and voluntary participation.2. The descriptive information about PMC explains that PMC is not intended to replace the original publication of the journal articles, rather to archive them and make them accessible in a particular way. The integrity of the contents then continues to rely on the editorial selection processes, peer-review processes, and to some extent on the editorial and production work provided by the journal editorial advisors and on the publishers. In order to present PMC readers with complete information about each article, we recommend that PMC incorporate the name of each journal's publisher in the primary citation of each article. Publishers should be offered the opportunity to provide a link through which readers could access the journal's and publisher's editorial policies, peer-review standards, and funding sources.			American university presses contribute enormously to the body of research-based English-language publications offered worldwide each year. All of these member presses publish books, and 57 of the members publish 800 scholarly journals. Over 10,000 new book titles and about 12,000 journal articles are professionally selected, peer reviewed, and published through these presses each year. While many of our members' publications address the humanities and social sciences, a substantial number of our publications present information in the life and biomedical sciences. We believe that our publications are a highly efficient way for university faculty to share their peer-reviewed work both with one another and with a large general public. The NIH has requested general as well as specific comment on its Public Access Policy. We will address the broadest question first AAUP is concerned about the possible long-term indirect impact of the limitation on author publishing rights that is implicit in NIH's Public Access Policy. The Policy asserts that the funder of research has a prior claim on the publishing rights an author normally possesses under copyright law. We believe that however well-intentioned and well-executed this transfer of rights may be, it represents a major shift in rights ownership whose impact on the entire system of scientific communication is not known and cannot reliably be predicted. This transfer of rights could trigger a general shift from a "market economy" to a "subsidy economy" to organize the dissemination of articles based on NIH research. While NIH may be well prepared to step in and fund PubMedCentral at a level required to support this system, we doubt there is a likelihood of success if such a change occurs in other areas such as the humanities and social sciences. Where NIH goes others less well-funded may follow, to the detriment of their publishing institutions and infrastructure. While AAUP member presses are not at all averse to adjusting their business models, and creating new ways of doing things, AAUP suggests that unintended negative consequences to these institutions, from unplanned actions, be weighed as NIH implements its Policy. So as not to overburden this letter with information present elsewhere, we refer you to the AAUP's Statement on Open Access available at http://aaupnet.org/aboutup/issues/oa/statement.pdf			Web Form
81	Web RFI	05/30/2008 at 12:42:25 PM (139)	Pendleton	Andrea		American Association of Anatomists	MD	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	Reversing gears on review articles NIH previously encouraged publishers to add review articles to journals as a way to sustain our subscription base under the voluntary policy. The revised mandatory public access policy now calls for the submission of review articles to PMC. Journal editors commission review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants. We request that NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews. NIH might consider review articles as ?low-hanging fruit? in regard to possible changes in the public access policy. It is a simple change that the scientific publishing community would appreciate.Compensation for value addedThe research published in our journals is rarely obsolete within a year; it generally has a shelf life well beyond the 12-month public access window. When copyrighted articles are freely available online, their commercial value is significantly eroded. While NIH may pay for the actual research, it is the journal publisher who bears the expense of creating the publication?from peer review to copyediting, layout, production, distribution, and archiving both digitally and in print. When publishers are no longer able to recoup these costs through subscription revenues (i.e., from the readers), they will have to recoup them at the front end from the authors. We note that the NIH policy allows reimbursement of publication costs if they are ?actual, allowable, and reasonable to advance the objectives of the award.? We ask that NIH be more explicit about what is considered ?allowable? and ?reasonable? and make it very clear to grantees that funds may be used to cover open access fees. In addition, we would like to know how such funds will be identified in a grant and how much NIH has budgeted per year for publication costs.	Why Doesn?t Compliance = Compliant? AAA?s scientific research journals?The Anatomical Record and Developmental Dynamics?are now fully compliant with the NIH?s current public access policy, as mandated by Congress. Upon publication of each issue, our publisher will deposit the final peer-reviewed version of all NIH-funded articles to PubMed Central (PMC) and authorize public availability 12 months after publication. Although we object to the mandate, we are abiding by it.However, this compliance apparently does not make us compliant enough for NIH. Only journals that make the final published version of NIH-funded articles available to PMC within 12 months will appear on the NIH list of compliant journals, the list that researchers are encouraged to check prior to submitting a manuscript for publication. Why doesn?t actual compliance with the law entitle a journal to appear on this list? Why is NIH misleading our prospective authors by not acknowledging that we are, indeed, compliant? Isn?t it NIH that is out of compliance for seeking to go beyond the law and penalizing those who are actually fulfilling the terms of the congressional mandate?		?in a manner consistent with copyright law?While we are not experts on congressional intent, we find it difficult to believe that ?in a manner consistent with copyright law? was meant to be the congressional equivalent of ?make copyright someone else?s problem.? Nonetheless, that is precisely what NIH has done. Researchers are told by NIH that the first step in complying with the public access policy is to ?Address Copyright. Before you sign a publication agreement or similar copyright transfer agreement, make sure that the agreement allows the paper to be submitted to NIH in accordance with the Public Access Policy.? With that brief instruction, NIH appears to think that the congressional intent has been followed. Copyright protection is intended to give the copyright holder the right to determine who can adapt the work to other forms. In reality, NIH has simply redefined the term ?copyright? to suit its PMC model, forcing authors to comply because of their dependence on NIH grant support. The copyright issues raised by implementation of this policy have been addressed in lengthy documents submitted to NIH by both commercial and non-profit publishers. We list just some of these issues here:a. PMC is reformatting and altering submitted author manuscripts. Why is this preferable to linking to the originally published document?b. NIH is exceeding its legal mandate by distributing copies of the PMC version to Web sites hosted outside the U.S., depositing manuscripts on an international mirror site with plans for additional such sites. How do these sites serve the needs of U.S. taxpayers?c. How will international copyright considerations be addressed to protect rights holders? These issues raise important questions and concerns regarding copyright protections that would prevail both within and outside U.S. borders. By appropriating and redefining copyright in this manner, NIH has clearly gone beyond congressional intent in regard to making manuscripts publicly available and has disregarded congressional intent related to consistency with copyright law.	AAA_Public_Access_Submitted_Response_5-30-08.txt	NIH Public Access Staff National Institutes of Health Transmitted via http://publicaccess.nih.gov/comments2/comments.htm RE: Request for Information: NIH Public Access Policy NOT-OD-08-060 (March 28, 2008) May 30, 2008 To the National Institutes of Health: The American Association of Anatomists (AAA)* wrote to NIH Director Elias Zerhouni on October 27, 2004, to voice its strong objection to his proposal for “Enhanced Public Access to National Institutes of Health (NIH) Research Information” with its “optional” free access to our journal content after six-months. After several years of frustration, we now find ourselves responding to an NIH request for feedback on how to establish a similar process that has already been launched. Our organization and our sister professional societies expend significant time and energy in support of NIH programs—in particular advocating for increased funding. Therefore, it troubles us to acknowledge that we are not convinced that all NIH “players” in the “public access” arena have negotiated and acted in good faith on this issue. We are very much concerned that the ultimate NIH goal is to shorten the compliance timeline leading to immediate access. Given our ongoing support of NIH, it dismays us to feel as if a long-time partner is letting us down. The AAA Board of Directors recently affirmed its opposition to any legislative mandate related to open access of journal manuscripts. Nonetheless, we are realistic enough to recognize that the public access mandate is not likely to go away. Therefore, the first and most important point we must make is to urge NIH to maintain the 12-month upper limit on public release of manuscripts. Anything less could significantly reduce the resources available for most scientific journals – especially professional society journals – to provide quality peer review, editing, and publishing of NIH-funded research results. Beyond that essential request, we would like to raise a number of other concerns and questions regarding NIH public access implementation. For reference, here is the law upon which this implementation has been based: SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law. Why Doesn’t Compliance = Compliant? AAA’s scientific research journals—The Anatomical Record and Developmental Dynamics—are now fully compliant with the NIH’s current public access policy, as mandated by Congress. Upon publication of each issue, our publisher will deposit the final peer-reviewed version of all NIH-funded articles to PubMed Central (PMC) and authorize public availability 12 months after publication. Although we object to the mandate, we are abiding by it. However, this compliance apparently does not make us compliant enough for NIH. Only journals that make the final published version of NIH-funded articles available to PMC within 12 months will appear on the NIH list of compliant journals, the list that researchers are encouraged to check prior to submitting a manuscript for publication. Why doesn’t actual compliance with the law entitle a journal to appear on this list? Why is NIH misleading our prospective authors by not acknowledging that we are, indeed, compliant? Isn’t it NIH that is out of compliance for seeking to go beyond the law and penalizing those who are actually fulfilling the terms of the congressional mandate? “in a manner consistent with copyright law” While we are not experts on congressional intent, we find it difficult to believe that “in a manner consistent with copyright law” was meant to be the congressional equivalent of “make copyright someone else’s problem.” Nonetheless, that is precisely what NIH has done. Researchers are told by NIH that the first step in complying with the public access policy is to “Address Copyright. Before you sign a publication agreement or similar copyright transfer agreement, make sure that the agreement allows the paper to be submitted to NIH in accordance with the Public Access Policy.” With that brief instruction, NIH appears to think that the congressional intent has been followed. Copyright protection is intended to give the copyright holder the right to determine who can adapt the work to other forms. In reality, NIH has simply redefined the term “copyright” to suit its PMC model, forcing authors to comply because of their dependence on NIH grant support. The copyright issues raised by implementation of this policy have been addressed in lengthy documents submitted to NIH by both commercial and non-profit publishers. We list just some of these issues here: a. PMC is reformatting and altering submitted author manuscripts. Why is this preferable to linking to the originally published document? b. NIH is exceeding its legal mandate by distributing copies of the PMC version to Web sites hosted outside the U.S., depositing manuscripts on an international mirror site with plans for additional such sites. How do these sites serve the needs of U.S. taxpayers? c. How will international copyright considerations be addressed to protect rights holders? These issues raise important questions and concerns regarding copyright protections that would prevail both within and outside U.S. borders. By appropriating and redefining copyright in this manner, NIH has clearly gone beyond congressional intent in regard to making manuscripts publicly available and has disregarded congressional intent related to consistency with copyright law. Compensation for value added The research published in our journals is rarely obsolete within a year; it generally has a shelf life well beyond the 12-month public access window. When copyrighted articles are freely available online, their commercial value is significantly eroded. While NIH may pay for the actual research, it is the journal publisher who bears the expense of creating the publication—from peer review to copyediting, layout, production, distribution, and archiving both digitally and in print. When publishers are no longer able to recoup these costs through subscription revenues (i.e., from the readers), they will have to recoup them at the front end from the authors. We note that the NIH policy allows reimbursement of publication costs if they are “actual, allowable, and reasonable to advance the objectives of the award.” We ask that NIH be more explicit about what is considered “allowable” and “reasonable” and make it very clear to grantees that funds may be used to cover open access fees. In addition, we would like to know how such funds will be identified in a grant and how much NIH has budgeted per year for publication costs. If a tree falls, but we have no data… NIH appears more intent on drawing users to PMC than to connecting users with the final published article. Why else would NIH (1) refuse to link from PMC directly to the original journal and (2) use its own system of article identification (PubMed Identifiers) rather than adopt the widely- accepted Digital Object Identifier (DOI) as a means of identifying authoritative material and associating it with the rights holder of record? This extra identifier can only contribute to reader confusion and adds no apparent value. Libraries make their journal purchasing decisions based on usage data. As journal usage moves from paper to electronic, the provision of detailed online usage data becomes more and more important. It is inevitable that the public access policy will cut into journal subscription revenue. NIH is drawing usage away from our online journals, then compounding this situation by not providing publishers with the comprehensive usage statistics that would enable us to assess the impact of this policy. Reversing gears on review articles NIH previously encouraged publishers to add review articles to journals as a way to sustain our subscription base under the voluntary policy. The revised mandatory public access policy now calls for the submission of review articles to PMC. Journal editors commission review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants. We request that NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews. NIH might consider review articles as “low-hanging fruit” in regard to possible changes in the public access policy. It is a simple change that the scientific publishing community would appreciate. Our taxpayer dollars at work * How much will it cost NIH to effectively implement the public access policy? * How does this cost translate into lost opportunities for research? * Why does NIH continue to believe that building a duplicative resource via PubMed Central is preferable to simply linking to publishers’ Web sites where the research is already available at no additional cost to taxpayers? As NIH is the steward of medical research for the nation, AAA is the steward of research for our discipline. We believe that the “public access” process, as presently implemented by NIH, threatens our ability to fulfill this mission over the long term. Our hope is that NIH will take our concerns and those of other journal publishers seriously. We do not believe that the NIH intent is to bring about the demise of scholarly biomedical journals. It is therefore imperative that NIH consider the potential unintended consequences of its actions as the public access mandate is put into practice. Scientific journal publishers have an important role to play in the preservation and dissemination of research literature. We would much prefer to do this as NIH’s partner than as an adversary. Sincerely, David Burr, Ph.D. President, American Association of Anatomists *The American Association of Anatomists, based in Bethesda, MD, was founded in 1888 for the "advancement of anatomical science." Today, AAA is the professional home for biomedical researchers and educators focusing on anatomical form and function. In addition to being the primary educators of medical students in their first year of medical school, AAA members worldwide work in imaging, cell biology, genetics, molecular development, endocrinology, histology, neuroscience, forensics, microscopy, physical anthropology, and numerous other exciting and developing areas. AAA publishes two scientific research journals—The Anatomical Record and Developmental Dynamics—plus an education journal—Anatomical Sciences Education—and a quarterly newsletter. Among its other programs and services, the organization sponsors an Annual Meeting (part of Experimental Biology) and maintains a Web site that offers members and others a variety of tools to enhance their teaching and research.	Web Form
84	Web RFI	05/30/2008 at 01:13:35 PM (942)	Suber	Peter	Ph.D., J.D.	Earlham College, Yale Law School Information Society Project, SPARC	Maine	USA	Other Member of the Public	(A) The NIH should reduce the permissible embargo period to from 12 months to six months. Around the world, every other funder of medical research with a public access policy caps the permissible embargo at six months: the Arthritis Research Campaign (UK), British Heart Foundation, Canadian Breast Cancer Research Alliance, Canadian Institutes of Health Research, European Research Council, Cancer Research UK, Chief Scientist Office of the Scottish Executive Health Department, Department of Health (UK), Fund to Promote Scientific Research (Austria), Genome Canada, Howard Hughes Medical Institute, Joint Information Systems Committee (UK), and the Wellcome Trust (UK). These agencies recognize that delaying public access to publicly-funded research is a compromise with the public interest, and that delays are more harmful in medicine than in any other field. If reducing the embargo period quickly or suddenly is politically impossible, then the NIH could reduce it gradually. For example, it could announce that a year from now it will reduce the maximum embargo to six months, giving stakeholders time to prepare. Or it could first reduce it to nine months, then six, and then three, over a period of years with ample notice to all.The NIH mission is to advance medical research and healthcare, not to protect the revenue of publishers. The current embargo period is much too long and inverts these priorities.(B) PubMed Central should develop the means to harvest copies of the full-text papers it needs from institutional repositories at universities, if it doesn't already have this capability. Then NIH should allow grantees (optionally) to deposit in their local repository and send PMC the URL. This change should not affect the timing of deposits within PMC, the completeness of the PMC collection, or the ability of the NIH to monitor compliance. But it might make compliance easier for authors, by enlisting local help with the initial deposits. It would also build up institutional repositories nationwide, giving them a critical mass and helping them to change expectations in every discipline. Conversely, PMC should also allow institutional repositories to harvest copies of full-text papers in PMC. When grantees choose to deposit directly into PMC rather than their institutional repository, this would allow the author's institution to maintain a complete, open-access portfolio of its own research output. (C) NIH already maintains a list of journals willing to submit articles directly to PMC on behalf of authors,http://publicaccess.nih.gov/submit_process_journals.htmIt should also maintain a list of journals whose standard copyright transfer agreements are already consistent with the NIH policy, requiring no negotiation or "author addendum" by authors. This list will overlap with the first, but would very likely be larger.(D) Some subscription-based journals plan to charge NIH-funded authors a fee for the right to comply with the NIH policy. Some "hybrid" journals may force NIH-authors to "choose" the free-access option and pay the accompanying fee. NIH-funded authors needn't publish in those journals, of course, but some may sincerely believe that every other publisher would also charge such a fee and some may feel other pressures to acquiesce. The NIH cannot directly stop journals from charging such fees, but it should look for creative, indirect ways to deter the practice. For example, NIH could list journals engaged in the practice and inform its grantees that this is not the norm and not required by the NIH policy. In addition, it could decide that it would *not* allow grantees to use grant funds to pay publication fees or color charges at journals engaged in the practice. (To use jargon common in the open access movement, the NIH would still allow grantees to use grant funds to pay for gold OA at full OA journals; but it would not allow the use of grant funds to pay for green OA or to pay for gold OA at hybrid journals which force NIH-funded authors to select the fee-based free-access option.)		The NIH already says in many places that deposit is required at the time an article is accepted for publication, not 12 months after publication. But many grantees, universities, and publishers are not getting the message. Can you make this explicit statement in even more places?	The new NIH public access policy serves the public interest and is long overdue. It accelerates medical research and promotes the translation of research into clinical practice and new cures. I oppose attempts by the publishing lobby to water it down or interrupt its implementation. Congress asked for a mandatory policy in 2004, but the NIH adopted a voluntary policy instead. The compliance rate for the voluntary policy ranged from 4% to 15%, and failed to meet the objectives of Congress and the agency. It's no exaggeration to say that we've waited more than three years for the strengthened policy to take effect and exert its beneficial effects on medical research and healthcare. Further delay would further delay those benefits. Since the strengthened policy was announced in January, and took effect in April, researchers and their institutions throughout the United States have geared up to comply with it. Here's a list of some of the institutions with web pages devoted to their efforts to educate their faculty about the policy and assist them in compliance.http://www.earlham.edu/~peters/fos/newsletter/04-02-08.htm#nihThe policy has been thoroughly vetted. The NIH released its first draft policy for a 60 day period of public comments, ending on November 2, 2004, and later extended the period by two weeks. The agency received more than 6,000 comments, which Director Elias Zerhouni described as "overwhelmingly supportive." The NIH solicited a second set of public comments as recently as March 2008 (the comment period ended March 17, 2008). The current round of public comments is the third. Publishers have been heard. As SPARC documented in its public comment (May 30, 2008), "the Office of the NIH Director has met with publishers to discuss the policy 29 times between 2003 and March 2008, versus 20 meetings with all other stakeholders."I submitted a shorter version of this comment in the second round of public comments, on March 14, 2008.http://publicaccess.nih.gov/comments/comments_via_email.htmPublishers are mistaken to say that the policy violates copyright. Indeed, the policy uses a simple, effective method to avoid any question of copyright infringement. When NIH grantees publish articles based on NIH-funded research, they must now retain the right to comply with the public access policy, even if they transfer all their other rights to publishers. As a result, public access by the NIH is expressly authorized by the copyright holders. The public access policy is badly needed to insure that the large volume of high-quality medical research produced by the NIH is made available to everyone who can make use of it: researchers whose universities cannot afford access to the full range of biomedical journals, practicing physicians without university or large-hospital affiliations, non-profit disease advocacy organizations, and patients and their families. It's not true that all who need access already have it. The best evidence that free online access to peer-reviewed research meets a large unmet need is that open-access articles are cited 50-250% more often than non-open-access articles published in the same issues of the same journals. For the empirical evidence underlying this claim, see the empirical studies collected in the Hitchcock bibliography,http://opcit.eprints.org/oacitation-biblio.htmlIt's not true that the rise of free online access to peer-reviewed literature will jeopardize peer review itself. Publishers who make that argument cite no evidence and ignore abundant counter-evidence. For a detailed analysis of the question, see my article from September 2007,http://www.earlham.edu/~peters/fos/newsletter/09-02-07.htm#peerreviewSome publishers have proposed an alternative under which PMC would be a "dark archive" and merely link to the articles at publisher web sites. This proposal is very far from adequate. It does not satisfy the terms laid down Congress and the President, which require that PMC make articles "publicly available". It makes public access depend on publishers, when publishers might change their access policies or go out of business. Publisher delays and omissions would be inevitable; and even when inadvertent, either NIH would spend time and money on monitoring and enforcement, or some valuable NIH-funded research would not be publicly available. Long-term preservation would suffer because libraries and other third-party curators would have to seek permission from many different publishers to make copies for storage and to migrate those copies to new formats to keep them readable as technology changed. Finally, users would fail to get the benefit of the enhancements PMC makes to submitted articles, including XML markup, OAI-interperability, and links to relevant content in the many public NIH databases. Users would be stuck with the publishers' PDFs, which are not readable in bandwidth-poor parts of the world, which frequently lack working links, and which impede text processing by users, text mining and automated translation by software, handicapped access, and mark-up by third parties. I thank the NIH for its repeatedly demonstrated willingness to take comments from stakeholders.			Web Form
85	Web RFI	05/30/2008 at 01:19:29 PM (972)	Sinn	Robin	MS	Sheridan Libraries; Johns Hopkins University	MD	USA	Other Member of the Public	It would be useful to have NIH provide some guidelines for authors dealing with online click through copyright agreements.	Not particularly. NIH has been very good about providing opportunities for feedback from everyone involved. If the current procedures don't work, I'm sure NIH will involve everyone in improving those procedures.	A way to submit a test manuscript would be nice, so that librarians could demonstrate the full procedure to faculty needing assistance.	I am thrilled that this step is being taken. I believe the publishers will not lose money, due to the ability to embargo articles up to 12 months. I believe US taxpayers will be able to see how some of their tax dollars are being spent. Researchers around the globe should benefit since they will have access to research that might not have been available to them previously.			Web Form
86	Web RFI	05/19/2008 at 12:33:39 PM (126)	Reiter	Allan	PhD	US DoD, Defense Threat Reduction Agency	VA	USA	Other	Make some arrangements to go back 5-10 years in the peer reviewed literature.	A web site where apparent lapses can be reported for compliance and follow-up.	None at this time, but I have found fedbizops (grants.gov) has a good notifier system for keeping my abreast of BAA's/RFI's, etc. from sister agencies.	Highest of kudos for this first step! Long needed.It has been very difficult to review submitted research proposals against my agency's $millions in BAAs when our token library closed down five years ago. Even peer reviewed pubs from DoD laboratories often required a call to obtain. I hope all federal departments, including mine, would mandate the same requirement. We turn down many promising proposals for lack of "preliminary data". Citing a pub in a proposal does not work and we do not have the resources or time to track down the cited pubs during the vetting process. The new generation of doctoral scientists that we hire to manage R&D programs have no way to keep up with the literature without access to the peer reviewed literature. The cost of this new policy will more that pay its way by leading to better awards in the future.			Web Form
87	Web RFI	05/21/2008 at 05:43:29 PM (640)	Tagler	John	Masters of Library & Information Science	Association of American Publishers, Professional & Scholarly Publishing Division	NY	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	Since PubMed Central will compete with publishers’ own websites as more PMC content overlaps with content on publishers’ sites, how will NIH maintain the primacy of the publishers’ websites and ensure that the manuscript on PMC does not displace or act as a substitute for the final published journal article (i.e., the authoritative version of record, which resides on a publisher’s site)? Will NIH work with publishers to ensure that readers know and are directed to where the final published versions can be obtained?	Many publishers have already been providing free access to authors’ manuscripts or final published articles twelve months after publication or even sooner. NIH does not consider this access compliant with the NIH policy. Would NIH consider including author manuscripts only in its administrative database and archive, while providing public access via display only through publisher sites? If not, what is the rationale for maintaining an unedited manuscript for public consumption if the final, authoritative version has been made available for free access on the publisher’s site?	What will NIH do in cases of noncompliance with its policy guidelines? What action will be taken when a grantee’s article is published, but NIH is not provided with the peer-reviewed manuscript? What actions will be taken against noncompliant grantees when they apply for future NIH grants?	How does NIH anticipate securing and sustaining a source of funding to maintain the database of articles that will accumulate over time, including costs to migrate to new platforms? Under the new policy, US taxpayers will be funding public access to science to any person anywhere in the world with Internet access. Has the NIH considered the ramifications of providing such international access, and how this might affect national security or other US government trade regulations? Considering the far-reaching implications of the substantial change in the NIH public access policy, we urge HHS and NIH to address these and other issues raised during the review period before the NIH Public Access Policy implementation moves too far along without taking into consideration the points raised during the public review period. As we have repeatedly communicated, we would welcome the opportunity to work closely with NIH to resolve issues and concerns raised by the publishing community.			Web Form
89	Web RFI	05/22/2008 at 11:29:23 AM (411)	Lupton	Joanne	PhD	President, American Society for Nutrition	MD	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	1. The inclusion of new language extending the policy to review articles is of serious concern for the following reasons: (1) the original work cited in the article, if funded by NIH, would already have been disclosed and made available; (2) review articles are not original research that could be tied to a specific NIH grant; and, (3) journals and their subscribers place a high value on review articles, as they represent unique content and include added analysis. Loss of such articles as a benefit to paid subscribers has significant financial implications.2. In many cases, deposition of the manuscript is duplicative since they are available free of charge on the publisher’s site after 12 months. NIH should consider the costs that could be saved by simply linking to the publisher's sites and not duplicating existing services already provided by publishers.			The American Society for Nutrition is the professional scientific society dedicated to bringing together the world's top researchers, clinical nutritionists and industry to advance our knowledge and application of nutrition. Our focus ranges from the most critical details of research and application to the broadest applications in society, in the United States and around the world. ASN publishes The American Journal of Clinical Nutrition (AJCN) and The Journal of Nutrition (JN), the two leading, peer-reviewed scientific journals in the areas of nutrition science and dietetics. ASN appreciates this opportunity to provide comment on the implementation of the NIH Public Access Policy.ASN supports the principle of public access to science and voluntarily has taken the following significant steps to accomplish this:• The abstracts of ASN journals are indexed in MedLine, which is accessible over the Internet from NIH’s PubMed website.• In 2000, ASN began offering free public access to articles 12 months after publication.• By 2006, the ASN put its entire journal collection, including over 110 years of archival content, online through Stanford University’s High Wire Press. Approximately 98% of online journal content is freely accessible to both subscribers and non-subscribers. • Since 1997, the Society has included free access to the online journal collection as a membership benefit.ASN is part of a group of more than 59 scholarly publishers who jointly developed the D.C. Principles for Free Access to Science. The DC Principles include a commitment to these forms of free access:• Selected articles of public interest are free from the time of publication• The full text of articles is made freely available either immediately or within months of publication, depending upon what is economically feasible for the journal• Journals are freely available to scientists in many low-income nations• Relevant articles are freely available to individuals in case of compassionate need, i.e. to those seeking information about their own health or that of a family member• Public access to content is facilitated through indexing agreements with Internet search enginesASN, like many non-profit scholarly publishers, reinvests the revenues from our journals in direct support of science through scientific meetings, research grants, educational outreach, advocacy, dissemination of information to the public, and improvements in scientific publishing. We believe our efforts constitute a sustainable approach to public access.Notwithstanding our commitment to public access, ASN has serious concerns about the Public Access Policy currently being implemented by NIH. Our concerns are outlined below.Administrative BurdenThe new policy places a significant administrative burden on authors, institutions and publishers. The low compliance with the voluntary policy (five percent of NIH funded articles in 2006 were deposited by the author) suggests this is the case. The fact that someone, be it the publisher or the scientist, must deposit the manuscript represents time and money. In many cases, deposition of the manuscript is duplicative since they are available free of charge on the publisher’s site after 12 months. Review ArticlesThe inclusion of new language extending the policy to review articles is of serious concern for the following reasons: (1) the original work cited in the article, if funded by NIH, would already have been disclosed and made available; (2) review articles are not original research that could be tied to a specific NIH grant; and, (3) journals and their subscribers place a high value on review articles, as they represent unique content and include added analysis. Loss of such articles as a benefit to paid subscribers has significant financial implications.CopyrightThe inclusion of blanket requirements in grant contracts has the potential to deny authors and publishers the benefits of their copyrights, among those being the freedom to decide how and in what form their works may be distributed. Moreover, the policy as proposed by NIH may conflict with fundamental copyright principles and does not take into account the value added by publishers and editors. The NIH policy as currently proposed is not, in our opinion, consistent with the legislative mandate to implement said policy in a manner that is consistent with copyright. Impact on not-for-profit publishers and scientific societiesThe NIH has not given appropriate consideration to the potential economic impacts of its proposal on publishers and the fundamental roles and services scientific societies provide to their membership and the scientific community at-large. These impacts may be especially severe for scholarly societies and not-for-profit publishers. NIH has stated in past notices that economic and business implications of any policy changes should be taken into account, and the danger that mandated access will interfere with the ability of journals to recover costs still exists. As ASN has implemented policies to improve public access to the research it publishes, the economic impact of these new policies was carefully considered. Certain considerations influence how soon free public access is economically feasible for a particular journal. These include revenue sources, production costs, utilization patterns, time needed for cost recovery, and frequency of publication. For example, it costs on average $3,500 to publish an article in AJCN or JN. NIH should have the same consideration for these factors. Ironically, it is possible that the NIH plan may have the greatest deleterious impact on not-for-profit publishers who already provide some form of free access. Societies such as ASN derive the bulk of their revenue from journal operations. The membership of these societies – the very scientists who are also NIH-funded investigators – derive important benefits from membership in these societies. Such benefits include access to scientific meetings, organization and review of abstracts, provision of continuing medical education programs, mentorship programs for young scientists, and many more. It is clear that hobbling these societies is a major unintended consequence of the current proposal, and one that is not in the interests of researchers, NIH, or the American public.Impact on researchersThis proposal initially was intended to benefit researchers by broadening access to the scientific literature, but since the NIH policy would affect approximately 10 percent of that literature, it is not clear how helpful it would be. At the same time, journals that publish large amounts on NIH-funded research would suffer the greatest negative repercussions. If the NIH plan indeed undermines journal operations, ASN may have to scale back its publications programs or curtail the activities it supports to advance nutritional science. This could mean fewer opportunities for scientists to share research findings in a timely manner, expand collaborate projects, and train junior scientists. Should journals like ours seek to recover lost production costs by increasing fees charged to authors, research funding also would be affected. Regardless of where the money to pay fees originates—taken from existing grant funds or charged to the research institution or funding agency—the net result is less money for research.ConclusionWe respectfully request that NIH address the concerns as outlined above, and we urge you to fully involve publishers in the implementation of this policy. We look forward to continued dialogue on this important issue. If you have any questions, please contact John Courtney, ASN’s Executive Officer, at (301) 634-7050 or jcourtney@nutrition.org.	letter_to_NIH_on_Public_Access_Policy_FINAL.txt	May 22, 2008 Dr. Norka Ruiz Bravo Deputy Director, Extramural Research National Institutes of Health Building 1 - Shannon Bldg, 144 1 Center Dr Bethesda, MD 20892 Re: Notice of Public Meeting and Comments on the Implementation of the NIH Public Access Policy; 73 FR 12745 (March 10, 2008) Dear Dr Bravo: The American Society for Nutrition is the professional scientific society dedicated to bringing together the world's top researchers, clinical nutritionists and industry to advance our knowledge and application of nutrition. Our focus ranges from the most critical details of research and application to the broadest applications in society, in the United States and around the world. ASN publishes The American Journal of Clinical Nutrition (AJCN) and The Journal of Nutrition (JN), the two leading, peer-reviewed scientific journals in the areas of nutrition science and dietetics. ASN appreciates this opportunity to provide comment on the implementation of the NIH Public Access Policy. ASN supports the principle of public access to science and voluntarily has taken the following significant steps to accomplish this: * The abstracts of ASN journals are indexed in MedLine, which is accessible over the Internet from NIH’s PubMed website. * In 2000, ASN began offering free public access to articles 12 months after publication. * By 2006, the ASN put its entire journal collection, including over 110 years of archival content, online through Stanford University’s High Wire Press. Approximately 98% of online journal content is freely accessible to both subscribers and non-subscribers. * Since 1997, the Society has included free access to the online journal collection as a membership benefit. ASN is part of a group of more than 59 scholarly publishers who jointly developed the D.C. Principles for Free Access to Science. The DC Principles include a commitment to these forms of free access: * Selected articles of public interest are free from the time of publication * The full text of articles is made freely available either immediately or within months of publication, depending upon what is economically feasible for the journal * Journals are freely available to scientists in many low-income nations * Relevant articles are freely available to individuals in case of compassionate need, i.e. to those seeking information about their own health or that of a family member * Public access to content is facilitated through indexing agreements with Internet search engines ASN, like many non-profit scholarly publishers, reinvests the revenues from our journals in direct support of science through scientific meetings, research grants, educational outreach, advocacy, dissemination of information to the public, and improvements in scientific publishing. We believe our efforts constitute a sustainable approach to public access. Notwithstanding our commitment to public access, ASN has serious concerns about the Public Access Policy currently being implemented by NIH. Our concerns are outlined below. Administrative Burden The new policy places a significant administrative burden on authors, institutions and publishers. The low compliance with the voluntary policy (five percent of NIH funded articles in 2006 were deposited by the author) suggests this is the case. The fact that someone, be it the publisher or the scientist, must deposit the manuscript represents time and money. In many cases, deposition of the manuscript is duplicative since they are available free of charge on the publisher’s site after 12 months. Review Articles The inclusion of new language extending the policy to review articles is of serious concern for the following reasons: (1) the original work cited in the article, if funded by NIH, would already have been disclosed and made available; (2) review articles are not original research that could be tied to a specific NIH grant; and, (3) journals and their subscribers place a high value on review articles, as they represent unique content and include added analysis. Loss of such articles as a benefit to paid subscribers has significant financial implications. Copyright The inclusion of blanket requirements in grant contracts has the potential to deny authors and publishers the benefits of their copyrights, among those being the freedom to decide how and in what form their works may be distributed. Moreover, the policy as proposed by NIH may conflict with fundamental copyright principles and does not take into account the value added by publishers and editors. The NIH policy as currently proposed is not, in our opinion, consistent with the legislative mandate to implement said policy in a manner that is consistent with copyright. Impact on not-for-profit publishers and scientific societies The NIH has not given appropriate consideration to the potential economic impacts of its proposal on publishers and the fundamental roles and services scientific societies provide to their membership and the scientific community at-large. These impacts may be especially severe for scholarly societies and not-for-profit publishers. NIH has stated in past notices that economic and business implications of any policy changes should be taken into account, and the danger that mandated access will interfere with the ability of journals to recover costs still exists. As ASN has implemented policies to improve public access to the research it publishes, the economic impact of these new policies was carefully considered. Certain considerations influence how soon free public access is economically feasible for a particular journal. These include revenue sources, production costs, utilization patterns, time needed for cost recovery, and frequency of publication. For example, it costs on average $3,500 to publish an article in AJCN or JN. NIH should have the same consideration for these factors. Ironically, it is possible that the NIH plan may have the greatest deleterious impact on not-for-profit publishers who already provide some form of free access. Societies such as ASN derive the bulk of their revenue from journal operations. The membership of these societies – the very scientists who are also NIH-funded investigators – derive important benefits from membership in these societies. Such benefits include access to scientific meetings, organization and review of abstracts, provision of continuing medical education programs, mentorship programs for young scientists, and many more. It is clear that hobbling these societies is a major unintended consequence of the current proposal, and one that is not in the interests of researchers, NIH, or the American public. Impact on researchers This proposal initially was intended to benefit researchers by broadening access to the scientific literature, but since the NIH policy would affect approximately 10 percent of that literature, it is not clear how helpful it would be. At the same time, journals that publish large amounts on NIH-funded research would suffer the greatest negative repercussions. If the NIH plan indeed undermines journal operations, ASN may have to scale back its publications programs or curtail the activities it supports to advance nutritional science. This could mean fewer opportunities for scientists to share research findings in a timely manner, expand collaborate projects, and train junior scientists. Should journals like ours seek to recover lost production costs by increasing fees charged to authors, research funding also would be affected. Regardless of where the money to pay fees originates—taken from existing grant funds or charged to the research institution or funding agency—the net result is less money for research. Conclusion We respectfully request that NIH address the concerns as outlined above, and we urge you to fully involve publishers in the implementation of this policy. We look forward to continued dialogue on this important issue. If you have any questions, please contact John Courtney, ASN’s Executive Officer, at (301) 634-7050 or jcourtney@nutrition.org. Sincerely, Joanne R. Lupton, PhD President 9650 Rockville Pike, Bethesda, MD 20814-3990 · Tel (301) 634-7050 · FAX (301) 634-7892	Web Form
90	Web RFI	05/22/2008 at 01:31:10 PM (864)	Canizares	Claude	Ph.D.	Massachusetts Institute of Technology (MIT)	MA	USA	Representative NIH Funding Recipient Organization	MIT is pleased to comment again in support of the 2008 NIH Public Access Policy. MIT’s mission to “generate, disseminate, and preserve knowledge” is reflected in and supported by this policy, which will advance science and make publicly funded research more widely accessible, leading to benefits for taxpayers and for society. Since our comments in March, a group of staff from our Office of Sponsored Programs, Office of General Counsel, the Libraries, and the Vice President for Research, in conjunction with faculty, have been working on several aspects of implementation. We have:• Announced and explained the policy to our NIH Principle Investigators and research administrators campus-wide;• Prepared two web pages for authors: an overview, and a step-by-step guide for compliance;• Created a submission letter and revised MIT amendment to publisher agreements for authors’ use;• Presented to research administrators about the policy and compliance with it;• Modified our internal grant application process to flag the new policy;• Worked with the NIH on search strategies to properly identify MIT-authored works via PubMed and PubMed Central;• Consulted with colleagues and NIH on possible third-party submission support that might be offered to MIT authors;• Investigated key publisher policies for NIH-funded research and documented them for MIT authors;• Communicated about the policy with many publishers, and received responses from some of them. We have been working with individual authors on preparing appropriate publisher agreement amendments so that they can comply with the new policy without coming into conflict with any publisher copyright policy. This activity forms part of our overall author support program that assists MIT authors in considering how to manage the rights to their work.	While MIT applauds this new Public Access Policy, our recent implementation efforts have suggested several approaches that would be useful moving forward:• To the extent that publishers can be encouraged to reduce or eliminate delays in public access from the current 12-month maximum, MIT’s and society’s goals will be more fully served, without any impact on library subscriptions. (The NIH policy, which affects only some articles in some journals, will not alter the purchase of subscriptions at MIT.)• The development of inter-institutional partnerships could simultaneously support authors, universities, and the overall goals of the policy:o Collaboration between NIH and universities to develop methods for exchanging data and papers between PMC and institutional repositories could maximize efficiencies in making research openly available.o Collaborations between publishers, universities, and NIH to develop institutional policies and systems would reduce the burden on individual authors in complying with the policy. During this phase, while compliance with the policy lies largely in the hands of individual authors and relies on adequate rights retention when publishing, we need the full cooperation of publishers, particularly in smoothly accepting amendments to standard publisher agreements.• More immediate, smaller changes from NIH would smooth efforts to comply with the policy, including:o Notifying the grantee when a relevant paper is submitted to PubMed Central (whether by publisher, author, or third party). o Altering workflows such that it would be possible to construct a simple PubMed search that consistently offers an exhaustive list of papers affiliated with an institution and funded by NIH.o Indexing all NIH funded papers, not just those published in life sciences journals, in PubMed.		We welcome the opportunity to support this policy and its goal of more open access to research. We are optimistic that in working with publishers, NIH, and others, we can together refashion the scholarly communication process in ways that harness technology’s potential to benefit society through quick, open sharing of scientific research.			Web Form
91	Web RFI	05/22/2008 at 02:15:09 PM (773)	Roberts	Richard	Ph.D.	New England Biolabs	MA	USA	Other	12 months is too long to wait. This should be reduced to 6 months as soon as possible and then to 3 months and finally to 0. NIH should engage the publishers so that it is they, and not the PI, who is responsible for deposition into PubMed Central. Funds must be mae available to NIH grantees specifically to cover the costs of this. NIH has sufficient clout that it shoukld be able to negotiate reasonable costs with the publishers to ensure that the published manuscripts can be deposited in PubMed Central. Deposition on a publisher's web site is not satisfactory since we need the literature in a single location where it can be searched or downloaded for local searching. This literature is our heritage and it belongs to the scientists who generated it and the funding agencies that paid for it. There can be no excuse for we scientists (I am a Nobel Laureate and work as Chief Scientific Officer for a small company. I am also chief US editor of an open access journal, Nucleic Acids Research) to have to repay the publishers to read our own work.	NIH must talk to the publishers so that they assist in this endeavour. The sooner the publishers are convinced that this move to open access is inevitable then the sooner they will be prepared to help make it happen. This will require talk and good faith negotiations. Ultimately, it is funding agencies like the NIH that has the clout to make it work. We sacientists can only help by publishing in compliant joournals, refereeing for compliant journals and serving as editors for them. This does give us some bargaining chips, but far less than the NIH and the other finding agencies.	Some stronger words about how best to convince our Universities and employers to deal with the publishers over copyright to the publishers. All they need is a license to publish.	This is long overdue and very much a step in the right direction. When the literature is fully available on line for free that will do more for science than almost any other initiative I can think of.			Web Form
92	Web RFI	05/23/2008 at 02:43:02 PM (153)	Andreadis	Debra		Denison University	OH	USA	Representative NIH Funding Recipient Organization	I believe that the embargo period should be shortened to 6 months given the speed with which publishing in the sciences occurs. I do not believe that this will threaten the publishers livelihood, as our researchers will still need active subscriptions to current publications to further their research.	There should be an automated way for grant offices in universities to be advised of the posting of their researchers' papers in PubMed Central. I also think that grant proposals from those who have previously received grants should require a section for the links to previously published work within PubMed Central.	I think you have done a good job with the information on this website. I currently do not have any further suggestions in that area.	I want to commend the NIH on this initiative. I support it wholeheartedly and look forward to its continuance.			Web Form
93	Web RFI	05/23/2008 at 03:36:05 PM (367)	Brash	Douglas	PhD	Yale School of Medicine	Connecticut	USA	NIH-funded Investigator	no	no; inclusion of our own PMCID numbers in our grants is ok	The posting itself is a minor nuisance.But including PMC ID numbers in bibliographies is a real problem, especially if we need them for all published papers (not just our own). This is because companies such as EndNote and RefManager (and they are nearly all owned by Thompson now) do not correctly retrieve or cite PMC ID numbers.It would be very helpful if NIH or HHS leaned on Thompson to fix this problem and distribute an "NIH Style" file.	no			Web Form
94	Web RFI	05/23/2008 at 04:02:13 PM (541)	Folsom	Aaron	MD	University of Minnesota	MN	USA	NIH-funded Investigator				I have two comments:1. This policy is an extreme waste of time and should be rescinded, or journals, not PIs, should be required to take care of it. Why is it crucial that articles be made public a few months before publication, when people can wait and get the publication in other ways? How much money is this costing, and for what gain? It's a prime example of wasteful governmental bureaucracy.2. One problem with implementation is that PIs are responsible for ensuring articles are submitted and cited, but papers are written by authors that may not include the PI. So, there is a disconnect between who knows about the acceptance for publication and who is held responsible.			Web Form
95	Web RFI	05/26/2008 at 02:39:35 PM (832)	Steele	Patricia		Indiana University Libraries	IN	USA	Other Member of the Public	I very much support the NIH Public Access Policy and believe that it is critical to libraries and to the scholars they serve. I believe it is implementable in its present form.	I believe that the plans for implementation that universities are developing will assure good compliance. Aside from plans NIH already has determined, I have no further monitoring usggestions.	I have sufficient information.	Just to reiterate the importance of this policy and all the work we can do to assure its robust implementation.			Web Form
97	Web RFI	05/27/2008 at 09:02:42 AM (516)	Eaton	Nancy	MLS	Penn State University	PA	USA	Representative NIH Funding Recipient Organization	Penn State University appreciates the opportunity to again submit comments expressing support for the NIH Public Access Policy. We believe the policy provides an unprecedented opportunity to create a publically accessible archive of NIH supported research that has the potential to accelerate the pace of research and discovery, promote innovation and serve patient needs and the public good. The following comments supplement earlier remarks made during the original request for information period (March 2008). Since that time the University Libraries, the Senior VP for Research and University Legal Counsel have been working on implementation of the Policy. We have:• Disseminated information explaining the policy to our NIH Principle Investigators and research administrators across all Penn State Campuses.• Developed a comprehensive website addressing issues related to compliance with the policy, including information on copyright, links to NIH Policy FAQ’s, and PubMed Central.• Developed a copyright addendum, using the language suggested by NIH, which has been vetted and approved by University Legal Counsel for use with publisher agreements. • Created a practical “How to Submit Your Manuscript to PubMed Central” training class with step-by-step instructions for use across the Penn State campuses.• Periodically send out targeted e-mails to NIH funded researchers with updated information in order to keep them informed.	While Penn State University recognizes the concerns expressed by the publishing industry and others we feel these are largely unfounded. We reiterate the following:• Encourage publishers to reduce barriers to submission and work with authors to ensure compliance with both the policy and copyright law.• The NIH Policy affects only articles supported by NIH funding. This is a subset of all the articles published and affects only certain articles across a large cross-section of journals. University Libraries has no plans to cancel journals as a direct result of the policy. In addition both the 12 month embargo and the requirement for the author’s final peer-reviewed manuscript prevent this.• Retain a list of publishers whose publishing agreements take into consideration the need for depositing with PubMed Central consistent with copyright law. Continue to update the list of publishers who directly submit articles to PMC.• Consider developing a process for communicating with campus offices of research in order to ensure compliance.• Consider developing an automated approach to coordinating deposit between PMC and institutional repositories.• Consider some type of automated notification that would be sent to the institution/campus office for research when articles are submitted.• Provide a mechanism to construct a simple PubMed search that would provide an exhaustive list of papers affiliated with an institution and funded by NIH.	We find the updated FAQ’s very helpful. Providing current information on the NIH Public Access site contributes to our ability to keep our faculty and researches informed.	Penn State University welcomes this opportunity to express our appreciation and support for the NIH Public Access Policy and its goal of public access to the published results of NIH-funded research. We are confident that in working together we can positively impact the scholarly communication process in ways that benefit society as a whole.			Web Form
98	Web RFI	05/27/2008 at 09:31:52 AM (830)	Frank	Martin	Ph.D.	American Physiological Society	MD	USA	NIH-funded Investigator	The RFI asks for recommendations for alternative implementation approaches. We continue to believe that a partnership between NIH and journal publishers would better achieve NIH’s goals while also addressing our community’s concerns about the policy as outlined above. Instead of NIH undertaking a whole new publishing venture that involves formatting and publishing unfinished manuscripts of authors, NIH should use existing links from NIH’s highly respected PubMed to journals’ websites for reader access to final, published articles. To address NIH’s desire to create an archive of manuscripts reporting NIH-funded research, journals would provide to NIH immediate access to journal content for internal use. This mechanism has several advantages to the current implementation plan. It would relieve the administrative burden on NIH-funded scientists because they would not have to take any additional steps to comply. They would simply continue submitting manuscripts to journals, as they always have. The integrity of the scientific literature would be ensured because only the final, published version of the article would be publicly available and archived by NIH.Articles would be available at significantly lower cost since publishers are already publishing, editing, and posting articles at no additional charge to the public. The database ofarticles would be more comprehensive and accurate for NIH portfolio analysis and strategic planning. This proposal was put forward by 56 organizations and publishers on October 15,2005, and we urge NIH to reconsider it. This proposal would fulfill the public access policy as enacted by the Consolidated Appropriations Act of 2008 and would also specifically address copyright law concerns expressed by Congress.			It is critically important for NIH to comply with the policy especially if it expects its investigator community to do the same. Consequently, NIH must not accept articles that are not within the time frame of the policy. Specifically, NIH should not accept articles published prior to May 2, 2005 or April 7, 2008, which ever date NIH decides is the designated start date. NIH should also provide assistance to investigators by working with publishers to create a database of journal embargo dates. How can an investigator publishing in multiple journals remember the policies of all of them. Just as one can search by journal in PubMed, the manuscript submission site for PMC should include a journal search capacity that would allow for the release period to be populated by default from the NIH created database.The release date of 12 months should be defined as 12 months after final publication, not 12 months after the journal's posting of the accepted manuscript on a journal website two to three months in advance of final publication.It is also strongly recommended that NIH only accept researh related mansucripts and/or papers into PMC, not the review articles, editorials, and commentaries commissioned by editors to scientific journals. In advance of the voluntary plan, NIH and Dr. Zerhouni encouraged editors to enhance the value of their subscription based journals by inviting reviews, editorials and commentaries. To now require that such peer-reviewed material be depositied in PMC is inappropriate and not reflective of the earlier policy.			Web Form
99	Web RFI	05/27/2008 at 11:58:14 AM (527)	Durniak	Anthony	BEE and MS	IEEE	NJ	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	Yes, the IEEE believes that the NIH should seriously consider enlisting experienced scholarly publishers to help implement the Public Access Policy in a way that will provide maximum benefit to the public. For instance, the NIH could offer the metadata and references of published articles from NIH-funded research and simply link from Pub Med Central to the publisher’s final version of the manuscript. The publisher could easily make the paper freely available from its own web site.An alternative for NIH could be to adopt a SCOAP3 model (Sponsoring Consortium for Open Access Publishing in Particle Physics) for supporting NIH-funded research. Like SCOAP3, NIH would reimburse publishers for the cost of making NIH-funded research publicly available, in lieu of an author payment. IEEE recently expressed an interest in working with CERN and SCOAP3 to experiment in this area.Another alternative would be to have the NIH contract with one or more publisher to host all published NIH-funded research on existing digital archives such as the IEEE’s Xplore platform. Such an arrangement would give readers access to existing specialized search tools (like Scitopia) as well as to cross linking with other STM literature.We urge the NIH to consider these alternatives to ensure that it will not unnecessarily waste taxpayer funds building an article repository and web delivery system that duplicates what already exists in the operations of scholarly publishers.	There are two compliance issues that will need to be monitored: 1) whether the article is submitted at all, and 2) whether the version posted on the NIH’s Pub Med Central is an accurate representation of the published article.The IEEE sees significant complications in this second issue that will make ensuring compliance difficult. Although the NIH requires that NIH-funded investigators submit an electronic version of the author’s final manuscript resulting from the peer review process, this nuance is likely to cause a difference in the version posted to PMC and the final publisher’s version of the article. In addition, it is our experience that it is challenging to capture the attention of the author to review the copyedited version of the manuscript before it is finally published. Thus, the NIH’s practice of converting the article to XML and then requiring authors to again review the NIH version, after it’s been converted to XML, is redundant and will ultimately cause even a greater difference between the PMC and publisher’s own version of the manuscript. Experienced publishers are aware that conversion to XML needs to be done very carefully in order to avoid introducing errors. How will NIH monitor conversions that it undertakes, and how will it ensure that only errors introduced in the XML conversion process are corrected, while maintaining the integrity of the content itself? If PMC linked metadata, in lieu of the full manuscript, to the publisher’s web site (for the final version of the manuscript), it will have accomplished its goal of ensuring compliance and meeting the directive to implement the public access policy in a manner consistent with copyright law. Moreover, it will ensure that the production qualities of the manuscripts to which it provides public access are as high as possible.	The posted information is fairly massive, and it is not easy to find answers to the questions that might occur to an author or grantee. One question that comes to mind is: Does NIH have a procedure in place to notify all those responsible that the required submission has been successfully completed?	We hope you will review IEEE’s set of “Principles of Scholarly Publishing” at http://www.ieee.org/web/publications/rights/PublishingPrinciples.html. We believe that these principles are important in order to carry out our publishing mission successfully. The IEEE is committed to providing access to scholarly and professional publications in a convenient, timely, and affordable manner. We are supportive of alternative publishing models, like public access, as long as there is a business model to sustain these activities.Among the publishing principles IEEE has adopted are: • Society benefits from an objective and intellectually free scholarly publishing environment that is unfettered by censorship or bias based on personal, commercial, or government agenda.• In order to perpetuate itself, scholarly publishing requires financial support from self-sustaining business models.• Copyright and intellectual property rights of authors and publishers must be protected in any publishing activity, including those that involve government-mandated policies on access to government sponsored research.We urge NIH to consider using IEEE’s well-established and proven online content delivery platform, IEEE Xplore, to serve the needs of the NIH and the public instead of allocating potential grant funds to duplicate publishers’ activities.			Web Form
101	Web RFI	05/27/2008 at 01:42:55 PM (923)	St. Clair	Gloriana	Ph.D.	Carnegie Mellon University Libraries	PA	USA	Representative NIH Funding Recipient Organization		The best way to ensure the submission of articles and the inclusion of PubMed Central reference numbers in citations is to delay or prevent the distribution of funds. When investigators see that funding will be impacted, they will comply. The recent addition to the NIH FAQ that provides information about actions the NIH may take when investigators and institutions fail to take steps to ensure compliance with the NIH Public Access Policy is very helpful in this regard. Concerns about investigators submitting articles to PubMed Central that are not covered by the NIH Public Access Policy can be addressed through education. Concerns about investigators retaining the necessary rights to submit to PubMed Central articles that are covered by the NIH Public Access Policy can be addressed through education and by developing partnerships with more publishers so that the publisher will submit final published articles on behalf of the authors. In the absence of publisher partnerships, NIH must trust the institutions and investigators they fund to comply with the Public Access Policy - just as publishers must trust the authors they publish to comply with the terms of the copyright agreement. Institutions are working to educate faculty about their copyrights and responsibilities, including the NIH Public Access Policy and publisher policies regarding open access. Some publishers have suggested that NIH should closely monitor submissions to PubMed Central to prevent copyright infringement. This is not feasible because only the author and the publisher know what rights were transferred and what rights were retained. For this reason only copyright owners can legally claim copyright infringement. If copyright infringement occurs in PubMed Central, the copyright owner should notify NIH and the author(s) and the infringing work should be removed from PubMed Central. Expecting a government agency to monitor and ensure that funded authors comply with publisher copyright transfer agreements introduces a new approach to copyright law enforcement that would have implications far beyond the implementation of the NIH Public Access Policy. Serious consideration of this approach would require a much broader discussion.	The NIH Public Access Policy is profoundly important. Public access to the results of NIH-funded research will accelerate scientific discovery and give the American public vital information. The pattern that the NIH has established for gathering input from stakeholders and addressing their concerns is to be praised. The policy has just been implemented. Experience will indicate where clarification or modification is needed. For example, initial public comments revealed inconsistencies in the language used on the NIH website to describe procedures. These inconsistencies were a source of confusion. We are pleased that NIH responded promptly and made the language consistent. Over time, as researchers and their assistants work with the procedural information and tools provided by the NIH, other problems might surface that need to be addressed. Periodic requests for public comment will ensure that the dialog with stakeholders and the fine tuning of tools, training and documentation continue.	Respect for copyrightIn the academic environment, the original copyright owners of written works are typically the authors who conducted the research. They are free to choose what rights, if any, they want to transfer and to whom. Concerns that publisher copyrights are being infringed by the mandatory NIH Public Access Policy are unfounded. Publishers have no copyrights unless or until authors grant them rights. Furthermore publishers have only the rights that authors grant to them. Publishers must respect author copyrights and the legal authority of authors to manage their copyrights as they see fit. Publisher approval or disapproval of how authors choose to manage their copyrights is irrelevant under the law. The NIH Public Access Policy does not introduce a new limitation or exception in copyright law, but rather constrains the contract terms to which funded authors can agree. This constraint does not constitute a compulsory license because authors as copyright owners are not legally required to permit others to use their work without permission. What they are legally required to do - if and only if they accept NIH funding - is to retain the rights necessary to deposit their work in PubMed Central. The NIH is not the copyright owner of peer-reviewed work based on the research it funds. To comply with the legislative mandate that the NIH Public Access Policy be implemented "in a manner consistent with copyright law," NIH must look to the original copyright owners (the authors) to retain the necessary rights to comply with the policy. NIH has no authority to manage or to negotiate authors' rights. Researchers are free to seek funding from the NIH, in which case they must comply with the NIH Public Access Policy, or to seek funding elsewhere. Publishers are free to allow authors to retain the necessary rights to comply with the NIH policy or to refuse to publish the results of NIH-funded research. Requiring authors to manage their copyrights and requiring publishers to respect author copyrights are positive developments in keeping with the letter and spirit of U.S. copyright law. Author – publisher relationshipsConcerns that the NIH Public Access Policy places authors in conflict with publishers suggest that the traditional practice, whereby authors routinely transferred all copyrights to their publishers, has become so entrenched that some publishers feel entitled to the transfer of all copyrights and question or resent the authors' freedom to choose otherwise. There is no legal basis for this entitlement or questioning. The recommendation offered by some publishers that the NIH simply pay publishers for the articles rather than requiring authors or their institutions to negotiate copyright suggests that economic concerns might be driving publisher interest in retaining all copyrights.Concerns that the NIH Public Access Policy will influence the selection of publishers are real. However the claim that this influencing is unethical masks an underlying discrepancy in operating principles presumed to be allowable for different stakeholders. Publishers understandably want to manage the copyrights granted to them by authors. All copyright owners should want to manage their copyrights. Why, then, is it problematic for authors to manage their copyrights? Under the publish or perish paradigm, authors unreflectively transferred all of their copyrights to the publisher. This paradigm is crumbling, being replaced by a publish and perish paradigm because restricted access and the cost of scholarly journals are shrinking readership. The impact advantage of providing open access to scholarly work and new metrics for evaluating the quality and influence of scholarly work are changing relationships. Authors are beginning to reflect on their copyrights and to decide what rights they want or need to retain. The NIH Public Access Policy might accelerate a trend that has already begun, but the policy did not initiate the trend. Rather, the policy results from the trend.If indeed the list of PubMed Central (PMC) journal partners available on the NIH website encourages authors to publish in these journals (for the convenience of having the publisher submit their work in compliance with the NIH policy), publishers are free to become PMC partners. If indeed the NIH public access policy leads authors to favor journals with access policies consistent with the NIH policy, that will be beneficial. Publishers are free to change their journal policies. Competitive advantage is a key factor in the free enterprise system. Business models that lose their competitive advantage gain nothing by bucking the trends. I'm reminded of the story of the fellow who continued to manufacture buggy whips long after the horse and buggy were replaced by the automobile. His lamentations did not bring back the horse and buggy.Publishers are understandably concerned about retaining the commercial value of their copyrights. The allowable twelve-month embargo period will protect their interests. NIH-funded researchers work in disciplines where access to the most up-to-date information is essential to their work and continued funding. They cannot wait until the embargo period is over to see the newest research results. Furthermore reviews, commentaries, and research not funded by the NIH will not be available in PMC. Subscriptions and interlibrary loan will continue to be the primary means of prompt access to this information. The integrity and usefulness of the scientific recordSome publishers have claimed that the NIH Public Access Policy will harm the integrity and usefulness of the scientific record because multiple versions of a given article will confuse readers and because final peer-reviewed manuscripts in PubMed Central might contain errors. These conditions predate and are irrelevant to the NIH policy. Multiple versions of many articles have been available on the Internet for many years (e.g., technical reports, conference papers, pre-prints, post-prints). Furthermore even published journal articles can contain errors; errata are issued later. Certainly scholars and medical professionals know that the published article is the scientific record. The many citizens who responded to the NIH's call for comments, eager to have free access to research findings, will no doubt raise and discuss what they read with medical professionals. NIH archive and public access Many publishers have recommended replacing public access to peer-reviewed manuscripts of NIH-funded work in PubMed Central (PMC) with a link from PMC to the final published version on the publisher's website. However, doing this would not accomplish one of the primary goals of the NIH, which is to create a searchable archive of the work it funds. An alternative recommendation that acknowledges the importance of an NIH archive suggests that PubMed Central become a dark archive used only by NIH and NLM for administrative purposes. Other users would access the published articles on publisher websites. The dangers of dark archives are well known. For example, a single dark archive offers a very low assurance level and requires elaborate systems to ensure that bit integrity is maintained. Currently the only efficient, affordable way to ensure the integrity and usefulness of a digital collection is to allow its use. The dangers of relying on publisher websites for open access to NIH-funded articles are also well known. Publishers can go out of business or fail to maintain their archive. Furthermore, they are free to change their access policies. Thus the only way for NIH to ensure that the research it funds is publicly accessible and preserved over time is to maintain an active, replicated archive.	NIH_RFI_May2008_948.txt	Office of the Dean of University Libraries Carnegie Mellon 4909 Frew St., Pittsburgh, PA 15213 May 27, 2006 Elias A. Zerhouni, M.D., Director National Institutes of Health 9000 Rockville Pike Bethesda, MD 20892 RE: NIH Request for Comments Dear Dr. Zerhouni, On behalf of Carnegie Mellon and the roughly 4,000 faculty and staff we represent, I am writing in response to your Request for Information posted to the Federal Register on March 31, 2008. 1. Do you have recommendations for alternative implementation approaches to those already reflected in the NIH Public Access Policy? We have no recommendations for alternative implementation approaches at this time. 2. Do you have recommendations for monitoring and ensuring compliance with the NIH Public Access Policy? The best way to ensure the submission of articles and the inclusion of PubMed Central reference numbers in citations is to delay or prevent the distribution of funds. When investigators see that funding will be impacted, they will comply. The recent addition to the NIH FAQ that provides information about actions the NIH may take when investigators and institutions fail to take steps to ensure compliance with the NIH Public Access Policy is very helpful in this regard. Concerns about investigators submitting articles to PubMed Central that are not covered by the NIH Public Access Policy can be addressed through education. Concerns about investigators retaining the necessary rights to submit to PubMed Central articles that are covered by the NIH Public Access Policy can be addressed through education and by developing partnerships with more publishers so that the publisher will submit final published articles on behalf of the authors. In the absence of publisher partnerships, NIH must trust the institutions and investigators they fund to comply with the Public Access Policy – just as publishers must trust the authors they publish to comply with the terms of the copyright agreement. Institutions are working to educate faculty about their copyrights and responsibilities, including the NIH Public Access Policy and publisher policies regarding open access. Some publishers have suggested that NIH should closely monitor submissions to PubMed Central to prevent copyright infringement. This is not feasible because only the author and the publisher know what rights were transferred and what rights were retained. For this reason only copyright owners can legally claim copyright infringement. If copyright infringement occurs in PubMed Central, the copyright owner should notify NIH and the author(s) and the infringing work should be removed from PubMed Central. Expecting a government agency to monitor and ensure that funded authors comply with publisher copyright transfer agreements introduces a new approach to copyright law enforcement that would have implications far beyond the implementation of the NIH Public Access Policy. Serious consideration of this approach would require a much broader discussion. 3. In addition to the information already posted at http://publicaccess.nih.gov/communications.htm, what additional information, training or communications related to the NIH Public Access Policy would be helpful to you? The NIH Public Access Policy is profoundly important. Public access to the results of NIH-funded research will accelerate scientific discovery and give the American public vital information. The pattern that the NIH has established for gathering input from stakeholders and addressing their concerns is to be praised. The policy has just been implemented. Experience will indicate where clarification or modification is needed. For example, initial public comments revealed inconsistencies in the language used on the NIH website to describe procedures. These inconsistencies were a source of confusion. We are pleased that NIH responded promptly and made the language consistent. Over time, as researchers and their assistants work with the procedural information and tools provided by the NIH, other problems might surface that need to be addressed. Periodic requests for public comment will ensure that the dialog with stakeholders and the fine tuning of tools, training and documentation continue. 4. Do you have other comments related to the NIH Public Access Policy? Respect for copyright In the academic environment, the original copyright owners of written works are typically the authors who conducted the research. They are free to choose what rights, if any, they want to transfer and to whom. Concerns that publisher copyrights are being infringed by the mandatory NIH Public Access Policy are unfounded. Publishers have no copyrights unless or until authors grant them rights. Furthermore publishers have only the rights that authors grant to them. Publishers must respect author copyrights and the legal authority of authors to manage their copyrights as they see fit. Publisher approval or disapproval of how authors choose to manage their copyrights is irrelevant under the law. The NIH Public Access Policy does not introduce a new limitation or exception in copyright law, but rather constrains the contract terms to which funded authors can agree. This constraint does not constitute a compulsory license because authors as copyright owners are not legally required to permit others to use their work without permission. What they are legally required to do – if and only if they accept NIH funding – is to retain the rights necessary to deposit their work in PubMed Central. The NIH is not the copyright owner of peer-reviewed work based on the research it funds. To comply with the legislative mandate that the NIH Public Access Policy be implemented “in a manner consistent with copyright law,” NIH must look to the original copyright owners (the authors) to retain the necessary rights to comply with the policy. NIH has no authority to manage or to negotiate authors’ rights. Researchers are free to seek funding from the NIH, in which case they must comply with the NIH Public Access Policy, or to seek funding elsewhere. Publishers are free to allow authors to retain the necessary rights to comply with the NIH policy or to refuse to publish the results of NIH-funded research. Requiring authors to manage their copyrights and requiring publishers to respect author copyrights are positive developments in keeping with the letter and spirit of U.S. copyright law. Author – publisher relationships Concerns that the NIH Public Access Policy places authors in conflict with publishers suggest that the traditional practice, whereby authors routinely transferred all copyrights to their publishers, has become so entrenched that some publishers feel entitled to the transfer of all copyrights and question or resent the authors’ freedom to choose otherwise. There is no legal basis for this entitlement or questioning. The recommendation offered by some publishers that the NIH simply pay publishers for the articles rather than requiring authors or their institutions to negotiate copyright suggests that economic concerns might be driving publisher interest in retaining all copyrights. Concerns that the NIH Public Access Policy will influence the selection of publishers are real. However the claim that this influencing is unethical masks an underlying discrepancy in operating principles presumed to be allowable for different stakeholders. Publishers understandably want to manage the copyrights granted to them by authors. All copyright owners should want to manage their copyrights. Why, then, is it problematic for authors to manage their copyrights? Under the publish or perish paradigm, authors unreflectively transferred all of their copyrights to the publisher. This paradigm is crumbling, being replaced by a publish and perish paradigm because restricted access and the cost of scholarly journals are shrinking readership. The impact advantage of providing open access to scholarly work and new metrics for evaluating the quality and influence of scholarly work are changing relationships. Authors are beginning to reflect on their copyrights and to decide what rights they want or need to retain. The NIH Public Access Policy might accelerate a trend that has already begun, but the policy did not initiate the trend. Rather, the policy results from the trend. If indeed the list of PubMed Central (PMC) journal partners available on the NIH website encourages authors to publish in these journals (for the convenience of having the publisher submit their work in compliance with the NIH policy), publishers are free to become PMC partners. If indeed the NIH public access policy leads authors to favor journals with access policies consistent with the NIH policy, that will be beneficial. Publishers are free to change their journal policies. Competitive advantage is a key factor in the free enterprise system. Business models that lose their competitive advantage gain nothing by bucking the trends. I’m reminded of the story of the fellow who continued to manufacture buggy whips long after the horse and buggy were replaced by the automobile. His lamentations did not bring back the horse and buggy. Publishers are understandably concerned about retaining the commercial value of their copyrights. The allowable twelve-month embargo period will protect their interests. NIH-funded researchers work in disciplines where access to the most up-to-date information is essential to their work and continued funding. They cannot wait until the embargo period is over to see the newest research results. Furthermore reviews, commentaries, and research not funded by the NIH will not be available in PMC. Subscriptions and interlibrary loan will continue to be the primary means of prompt access to this information. The integrity and usefulness of the scientific record Some publishers have claimed that the NIH Public Access Policy will harm the integrity and usefulness of the scientific record because multiple versions of a given article will confuse readers and because final peer-reviewed manuscripts in PubMed Central might contain errors. These conditions predate and are irrelevant to the NIH policy. Multiple versions of many articles have been available on the Internet for many years (e.g., technical reports, conference papers, pre-prints, post-prints). Furthermore even published journal articles can contain errors; errata are issued later. Certainly scholars and medical professionals know that the published article is the scientific record. The many citizens who responded to the NIH’s call for comments, eager to have free access to research findings, will no doubt raise and discuss what they read with medical professionals. NIH archive and public access Many publishers have recommended replacing public access to peer-reviewed manuscripts of NIH-funded work in PubMed Central (PMC) with a link from PMC to the final published version on the publisher’s website. However, doing this would not accomplish one of the primary goals of the NIH, which is to create a searchable archive of the work it funds. An alternative recommendation that acknowledges the importance of an NIH archive suggests that PubMed Central become a dark archive used only by NIH and NLM for administrative purposes. Other users would access the published articles on publisher websites. The dangers of dark archives are well known. For example, a single dark archive offers a very low assurance level and requires elaborate systems to ensure that bit integrity is maintained. Currently the only efficient, affordable way to ensure the integrity and usefulness of a digital collection is to allow its use. The dangers of relying on publisher websites for open access to NIH-funded articles are also well known. Publishers can go out of business or fail to maintain their archive. Furthermore, they are free to change their access policies. Thus the only way for NIH to ensure that the research it funds is publicly accessible and preserved over time is to maintain an active, replicated archive. Thank you for inviting and considering our comments. Sincerely, Gloriana St. Clair, Ph.D. Dean of University Libraries	Web Form
102	Web RFI	05/27/2008 at 04:00:09 PM (680)	Baker	Nancy	MLS, MA	University of Iowa	Iowa	USA	Representative NIH Funding Recipient Organization	I am pleased to have this opportunity to indicate, once again, our strong support for the current NIH Public Access Policy. We believe that this policy promotes new discovery, fosters innovation, increases accountability for public funding, and makes medical research available to patients and other members of the public. These are all core to the mission of a pubic research university. At the University of Iowa, our librarians have offered small seminars on how to comply with this new policy for specific campus departments, as well as open sessions to anyone who might be interested. An informational website has been created, linking to the information at NIH. Librarians have been available to assist and consult with individual campus researchers about the submission of manuscripts to PubMed Central. The concerns offered by many who have opposed this policy remain unfounded. The University of Iowa has not cancelled any journals as a result of this policy nor do we anticipate any such cancellations in the future. Publishers of scientific journals have regularly indicated to the library community that the market for their new publications is 6 months, sometimes less. So we know that a 12 month embargo is protecting them from financial harm. Moreover a 6 month embargo would also be more consistent with terms of other countries, specifically the European Union, UK and Canada. The University of Iowa has also endorsed an author addemdum that enables faculty to retain rights to their work while giving the publisher license to publish. If NIH had information available on which publishers support such addenda, that would likely be helpful to our authors.	As noted above, an automatic, routine process for communicating with campus research offices when an article has been deposited into PubMed Central would assist compliance. For those universities with institutional repositories, some automatic way that manuscripts could be submitted jointly deposited would be helpful. Any additional ways that NIH might make the submission of articles easier for authors in the future as technologies improve would be welcomed.	Since many libraries link their information websites on this policy directly to NIH, it will be important to NIH to keep their electronic information on any changing procedures up-to-date.	There is a tremendous amount of federal money that is invested into medical research each year. The NIH Public Access Policy also creates a single, publicly accessible testament to the fruits of this public investment that could potentially lead to increased public support for this critical research. Finally, I appreciate NIH's continued willingness to solicit this feedback from stakeholders.			Web Form
103	Web RFI	05/27/2008 at 07:43:51 PM (733)	Lee	Daniel	M.A., M.L.S.	University of Arizona	Arizona	USA	Representative NIH Funding Recipient Organization	The submission process needs to be as simple as possible, ideally as simple as emailing a reprint to a colleague. Although there are tools available to help PIs, the recommended implementation still requires an understanding of a range of publisher policies and, often, negotiation to ensure necessary rights are retained to comply with the policy. Compliance also requires following a process that is outside a normal workflow. Admittedly, The NIH is working within a publishing environment that is not of their making and the NIH has no easy way to compel publishers to participate themselves. However, it would benefit all parties if NIH would work with publishers to increase the number who automatically submit manuscripts for funded authors. Researchers can help drive this by requesting publisher participation, but the leverage of a large funding agency reaching out to publishers will help ease the transition. Ultimately, to have the greatest impact, NIH support should take advantage of the scientific skills of researchers rather than requiring even modest bureaucracies.	Easing the submission process will help ensure compliance. In general, researchers want to share their results. The low rate of participation in the voluntary program is a reasonable indication that the submission process is/was seen as a barrier.	Besides the link to a list of journals that will submit manuscripts for authors, it would be helpful to have access from the policy site to easily understood information about publishers’ policies that comply with the new policy. Other than that, a simple submission process will reduce the need for training.	The goals of new policy and the Congressional mandate are most welcome. As noted above, researchers want to share their results. A policy that promotes broad access to these results will allow more people to benefit from the sponsored research and for others to build on prior work. Other disciplines have a long history of sharing research results through pre-prints without having a negative impact on publishers’ ability to maintain a sufficient revenue stream and viable business models. There is no reason to expect a different result here. Rather, this policy is an important step towards improved public access to publicly funded research. It is essential for NIH to work out practicable processes as similar policies are adopted by other government funding agencies.			Web Form
104	Web RFI	05/28/2008 at 11:09:32 AM (478)	Johnson	Scott	PhD	Towson University	MD	USA	Other	I am the chair of the Publications Committee of a small scientific society. Our primary function is to publish papers in a peer-reviewed scientific journal. At present, we rely on a major publisher to produce our journal. The publisher is only going to continue this endeavor if it is reasonably profitable for them. We are concerned that our publisher’s subscription revenue will decline when the public is given free access to papers published in our journal in Pub Med Central within such a short time frame. We do not understand why NIH cannot work out an agreement with publishers to establish public access to articles, through publisher’s websites, within a reasonable amount of time. Such a system would also save taxpayers and enormous amount of money.						Web Form
105	Web RFI	05/28/2008 at 11:50:38 AM (133)	Goodell	Heather	MIS	American Heart Association	TX	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	On behalf of the president of the American Heart Association, Dr. Daniel W. Jones, and the chair of the AHA Scientific Publishing Committee, Dr. David Gutterman, I am submitting a letter with the AHA's response to this policy. I am the Director of Scientific Publishing for the AHA. The text of the letter is in question #4.	Please see our letter	Please see our letter	The American Heart Association appreciates the opportunity to comment on the mandatory Open Access Policy. Articles in AHA journals that are original research articles are freely accessbile to all users after six months and all AHA journal content is freely available after one year. We also appreciate the NIH pledge to work constructively with publishers to fully address copyright concerns and make the policy work. However, we would like to echo the comments made via the DC Principles Coalition, our concerns are the same already put forward, and broadly include, as stated already by the DC Principles Coalition (1):Copyright: Blanket requirements in grant contracts would effectively deny authors and publishers the benefits of their copyrights—the most fundamental of which is the ability to decide how and in what form their works may be distributed—in conflict with fundamental copyright principles and without compensation for the value added by publishers and editors. In effect, the application of the NIH policy is an imposition of an extraordinary and unprecedented exception or burden to the copyright works—and thus diminishes their value for any journal business model that relies on exclusivity to drive traffic, advertising and subscriptions. The NIH policy essentially mandates a business model that can accommodate this “burdened” copyright, a model that must be based on up-front submission or publication charges, rather than the current models of the vast majority of journal publishers. This does not seem to us to be consistent with the legislative mandate to implement the NIH policy consistent with copyright. Other alternatives to the NIH policy of mandated centralized posting on PMC can and should be considered, alternatives that would still be consistent with the legislative mandate of public access within 12 months of publication. For example, given our entire journals are free online after a year, shouldn’t NIH support the full value of copyright and their use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central ?Quality Control and Compliance with Publisher Policies: Many manuscripts currently appear on PubMed Central (PMC) in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? For publishers submitting directly, how will NIH ensure that articles will not be accepted from individuals or entities other than the publisher? Scope: The revised mandatory public access policy now calls for submission of review articles. This is of concern to publishers especially since NIH previously encouraged us to add review articles to our journals as a way to protect our subscription base under the voluntary policy. Editors commission the review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants. Furthermore, requiring that review articles be included will seriously undermine the many journals that publish review articles only. Repurposing: Changes made by NIH or authors that will result in variations from the original manuscript are of considerable concern for a number of reasons, not least of which is the potential introduction of errors. NIH needs to ensure that no changes, such as substantive editorial changes, are made to the manuscripts other than obvious errors in NIH production process or perhaps improved graphics for related illustrations. Links to other databases also raise concerns about changing an article’s principal context and focus. NIH needs to identify precisely how manuscripts will be linked to databases and other resources to ensure the editorial integrity of the underlying work. Patient education. Although we understand that the principal motivation of the legislative mandate to be patient information and education, the NIH policy implementation does not address this need directly (focusing instead on building researcher infrastructure). Publishers have been working actively with voluntary health organizations (VHOs), as you are aware, and we believe more should be done in this area by NIH, hopefully working with publishers and VHOs. We actively participate, for example, in the PatientINFORM effort.Piracy: Third parties could commercially exploit content that appears on PMC without the consent of the publisher. What safeguards will NIH put in place to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? As stated at the beginning of this letter, these are some of the key issues that deserve continued discussion. We thank the NIH for the opportunity to comment.Sincerely,David Gutterman, MD; Daniel W. Jones, MD			Web Form
106	Web RFI	05/28/2008 at 12:38:31 PM (437)	Mullaly-Quijas	Peggy	PhD	University of Missouri - Kansas City	MO	USA	Other	I would recommend that the embargo be 6 months long, not 12.	I would make this policy no different than the other policies that PIs must follow when receiving NIH funding.	An up-to-date list of publishers that will submit manuscripts to NIH on the behalf of PIs	I appreciate NIH asking for these comments as they implement policy. While I submitted comments before, I wanted to update my thoughts.The new NIH Public Access Policy is a great opportunity to get NIH funded research out to my faculty and researchers to accelerate the rate of research on my campus. As a Librarian supporting those faculty and researchers, I have spent a great deal of time creating a resource to help educate the faculty on this new policy. Please see: http://libguides.library.umkc.edu/content.php?pid=5230I understand that the largest concern with the policy from the publishers is that libraries would cancel their subscription to a journal title based on this policy. For my perspective, this is ungrounded. We do not cancel titles for this reason. The embargo alone would require we have access to the most recent journals to support our faculty. If copyright issues are a concern – though I am not sure how! – I am working to educate my faculty on their rights as copyright holders.My only suggestion is to please consider making the embargo 6 months. Again, as a professional librarian supporting the faculty, I would not be canceling a journal because of this policy.			Web Form
108	Web RFI	05/28/2008 at 01:32:07 PM (721)	ness	roberta	MD, MPH	University of Pittsburgh	PA	USA	NIH-funded Investigator	Yes. NIH could work with journals directly, as they do through PubMed, and in that way provide timely public access to publications. In other words, rather than shifting responsibility to investigators, they could take primary responsibility for assuring public access.		Many journals are now assessing large surcharges (in the thousands of dollars per publication) to assure compliance with the policy. Most investigators do not know that these surcharges are not mandatory. Specifically, investigators do not know that they can upload final accepted drafts, and not only the final publication directly. To the extent that many researchers believe they must pay these fees, this will have a chilling impact on students, trainees, and investigators in developing countries, as well as on any investigator that is not well funded. It is imperative that NIH clearly and concisely warn all NIH-funded investigators that they need not pay these fees and how to avoid doing so.Imbedding this information on page 5 of a website is not adequate. A brief, clear warning should be sent to all funded investigators regarding this situation.				Web Form
109	Web RFI	05/28/2008 at 01:40:09 PM (433)	Oliver	Kathleen	MSLS, MPH	Johns Hopkins University Libraries Council	MD	USA	Representative NIH Funding Recipient Organization	We believe the following suggestions, if implemented, would facilitate compliance for investigators, authors and institutions. They are • NIH could publish recommendations for authors on reserving rights with publishers who use on-line one click contracts, and• NIH could enable libraries to make submissions on behalf of faculty.	We appreciate the opportunity to express our support for the NIH Public Access Policy and its implementation as currently stated, and supplement our expressions of support as submitted March 17. The continued engagement of NIH with its stakeholders is both wise and productive.On May 15, 2008, the Johns Hopkins University Council of Deans voted to require Johns Hopkins University (JHU) researchers supported by NIH funds to retain sufficient rights to all papers published in the course of their NIH-sponsored research. Having retained rights to permit submission to PubMed, JHU faculty members must then submit their articles in a timely fashion. To retain rights, the Council of Deans recommended two alternate addenda and a notification letter that JHU faculty members can employ. The first addendum, http://openaccess.jhmi.edu/ADDENDUM1.pdf, constitutes the bare minimum for compliance with the NIH Public Access requirement. The second addendum, http://openaccess.jhmi.edu/AddendumToPublicationAgreement.pdf, allows faculty members to comply with the NIH requirement while retaining broader rights for their own benefit as apparent from the provisions of this addendum. The Council of Deans voted to encourage faculty members to use Addendum 2 if possible as it is in every scholar’s interest to retain broader rights to their intellectual products. However, to assure compliance with the NIH mandate, the University requires that faculty members at a minimum use Addendum 1.	NIH could publish recommendations for authors on reserving rights with publishers who use on-line one click contracts.	Johns Hopkins University Comment on NIH Public Access PolicyMay 31, 2008We appreciate the opportunity to express our support for the NIH Public Access Policy and its implementation as currently stated, and supplement our expressions of support as submitted March 17. The continued engagement of NIH with its stakeholders is both wise and productive.On May 15, 2008, the Johns Hopkins Council of Deans voted to require Johns Hopkins University (JHU) researchers supported by NIH funds to retain sufficient rights to all papers published in the course of their NIH-sponsored research. To do so, there are two alternate addenda and a recommended notification letter that JHU faculty members can employ. The first addendum, http://openaccess.jhmi.edu/ADDENDUM1.pdf, constitutes the bare minimum for compliance with the NIH Public Access requirement. The second addendum, http://openaccess.jhmi.edu/AddendumToPublicationAgreement.pdf , allows faculty members to comply with the NIH requirement while retaining broader rights for their own benefit as apparent from the provisions of this addendum. The Council of Deans voted to encourage faculty members to use Addendum 2 if possible as it is in every scholar’s interest to retain broader rights to their intellectual products. However, to assure compliance with the NIH mandate, the University requires that faculty members at a minimum use Addendum 1. At Johns Hopkins University, the University Libraries Council strongly supports the NIH Public Access Policy. The new NIH reporting requirement will benefit Hopkins authors as well as the public. The requirement provides an important opportunity to make published research funded by NIH and written by Hopkins authors accessible to all - thepublic, health care providers, educators and scientists, among others. This improved access will help advance science and, ultimately, improve human health.Deposit in PubMed Central ensures that research results will be preserved in a state-of- the-art digital repository. Free access within a 12-month period will maximize the visibility of Hopkins’ research and ensure that researchers and students around the world will be able to read and build on Hopkins’ work, regardless of their ability to subscribe to the journal in which the research is published. Preliminary research suggests that articles freely available are cited more often and have a greater impact than articles locked away behind subscription walls. NIH public access will foster development of new research tools, open doors to new research avenues, and advance scientific discovery. At Johns Hopkins University, we have taken the following steps in response to the NIH Public Access Policy:1. The Dean of University Libraries, Winston Tabb, the Director of the Welch Medical Library, Nancy Roderer, and the Vice Provost for Research met to explore how the University and its Libraries can assist its authors in meeting the NIH mandate and support open access to the scholarly output of the University. 2. From that meeting came a recommendation from the Provost to the Deans that the University adopt an authors’ addendum to publication agreements, enabling Hopkins faculty to make their research results freely available through PubMed Central. 3. Created a scholarly communications website (openaccess.jhu.edu) with an FAQ on the NIH policy, including the Johns Hopkins’ authors’ addendum. The FAQ also directs authors to the SCAE, a tool to customize addenda and designed to enable authors to reserve their rights in support of peer exchange, teaching, and public access. The FAQ includes contact information for two members of the Scholarly Communications Group of the University Libraries Council, who will respond to questions from our authors. 4. Advised our Vice Deans for Research in the Schools of Medicine, Public Health and Nursing of the FAQ; remain in close contact with the Office of the General Counsel, sharing the Carroll White Paper and other relevant analysis of implications of the Policy for the University and its authors. 5. Broadcast emails from the Deans and the Provost alerting faculty to their responsibilities under the new mandate have been sent. The emails direct authors to an FAQ on the NIH Policy developed by the University’s Scholarly Communications Group. The School of Public Health and the School of Medicine have linked to the resource from their research administration sites.6. Initiated discussions on how we might develop an interface between our repository and PubMed Central in collaboration with other institutions and software developers. At our request, the Association of Research Libraries has agreed to play a leadership role in bringing interested parties into the discussion, including the National Library of Medicine.7. Joined fellow members of the American Association of Health ScienceLibraries in strong support of the NIH Public Access Policy.8. Have conducted educational sessions on the policy and how to comply with faculty and staff across the University, and are working with our authors to ensure copyright compliance through the use of addenda to publication agreements, directing them to the NIH Public Access Policy FAQ as needed.9. JScholarship, the Johns Hopkins institutional repository, is taking an active role in promoting open access publishing activities. The Graduate Board for the University has mandated submission of all theses and dissertations into JScholarship beginning in 2009. JScholarship personnel are currently putting in place a submission workflow to enable students to self-submit their theses into the repository. In addition, we are developing a process by which an author may make his or her work available under a Creative Commons license. We plan to promote the use of these licenses to enable the widest possible use our research materials. Finally, we have devoted a section of our JScholarship "help" pages to copyright issues. This page http://library.jhu.edu/collections/institutionalrepository/irhelppage.html offers advice to authors about copyright issues in the repository, and contains information about the SHERPA/RoMEO database.10. In sum, the policy has created a valuable opportunity to collaborate across campus, involving faculty, libraries and academic administrators to ensure the broadest level of compliance and exposure of our research results.11. Finally, the University Libraries Council values the services provided by publishers, and does not believe that we can cancel journals and still provide our faculty, students and researchers the current information necessary for their work.			Web Form
110	Web RFI	05/28/2008 at 01:44:27 PM (253)	Case	Kathleen	MS	American Association for Cancer Research	PA	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	Many publishers, especially not-for-profit publishers, make ALL of the final content of their journals available free at 12 months. These publishers have offered many times to have PubMed and/or PubMedCentral link to these final articles on the publishers' websites and to implement links from those websites to other NLM databases. Implementing this linking would save thousands of researchers from having to load articles on PubMedCentral because the publishers already load the articles on their websites. These publishers' websites are stable, archived, and are permanently available worldwide. Further, linking would ensure that there was only one version, the final and best version, of an article available to the public. Minimally, the mandatory deposit requirement should be waived for authors who publish in journals that make their articles available free online at 12 months or less. The NIH policy reflects a basic misunderstanding of the Internet--an article that is available online free on a website IS available to everyone. The mandatory deposit on PubMedCentral policy should apply only to articles reporting NIH-funded research that are not made freely availble by publishers. Double deposit of different versions of articles is wasteful, redundant, and potentially dangerous to the public.	There is no way NIH will be able to monitor effectively the quality of thousands of deposited manuscripts without checking them against a final version on a publisher's website. Such version comparison cannot be automated and would require considerable human resources. There already exist on PubMedCentral papers that should not have been deposited under the previous mandatory policy (too old, wrong versions, not allowed by copyright agreements, etc.). If errors could not be monitored when there were only several thousand papers deposited under the voluntary policy, how could NIH monitor an eventual hundreds of thousands? Compliance would require sanctions to be available, such as lawsuits, fines, withholding grants, or reporting to institutions if a researcher:1. Fails to load the papers within the timeframe required.2. Makes mistakes in loading papers (partial text, etc.) or has serious text mistakes in the PMC-loaded papers (later corrected by copy-editing). 3. Publishes in a journal that does not allow deposit in PMC. Is this the role NIH wishes to assume: to punish researchers? If so, how much will NIH spend in becoming a watchdog of author compliance? Will NIH refuse to fund promising research that might lead to cures because the researcher previously failed to load an article on PMC? Consequences for complying with this mandate may cause more harm to the public than noncompliance.	If the articles on PMC are to be a public service, then there needs to be instruction to the public on how to interpret an animal study, a study with an insufficient number of subjects, a report of an experimental new drug that has not been proven in a trial, a phase 1 study versus a phase 3 study, etc. Also, there needs to be a VERY CLEAR warning that the articles in PMC are not final articles and do not represent all of the literature on a topic. For the public or anyone, a fragment of the literature could be a dangerous thing, and an unedited article could also be dangerous. There are few if any warnings on PMC now.	The NIH public access mandate was made possible by convincing a few members of Congress that people were suffering and dying because publishers charge fees for subscriptions to journals. Free the literature and all will be possible, went one open access advertisement. Science deals with proof, and where is the proof that free journal articles will do anything? People are suffering and dying because there are no cures for some diseases; because even when preventive measures are possible they aren't applied (eliminating smoking will save lots of lives); because so many have poor or no access to medical care, including the over 47 million people who are uninsured in one of the richest countries in the world. Now that rich country is cutting research funding when other countries are increasing theirs. Surely more people will suffer and die because research funding is being cut than will ever be affected by access to any or all of the journal literature. For the past decade the NIH's National Library of Medicine (NLM), an organization that would simply not exist were there no publishers, has been leading an attack on commercial and not-for-profit publishers while NLM seeks to become one of the largest publishers in the world, first with eBioMed, then with PubMedCentral. The irony of this is apparent. In the latest implementation of its publishing plans--the mandatory deposit policy--NLM mandates that review articles by NIH-funded authors be deposited on PubMedCentral. Review articles are not original research and therefore not funded by research dollars but by publishers who commission them. They were not covered by the previous, voluntary deposit policy and never discussed by Congress. Thus the decision to require the deposit of review articles was made internally at NIH, without public discussion or legislative ruling. The NLM is funded by our tax dollars but there is no publicly available information on how much has been spent for PubMedCentral or how its effect will be evaluated. Taxpayers' assets should be put to better use than for redundancy--duplicating publishing services already provided by private funding. The real problems of health care have nothing to do with journal articles. We need more research, not more redundancy.			Web Form
111	Web RFI	05/28/2008 at 02:29:45 PM (445)	DeCrappeo	Anthony		Council on Governmental Relations	DC	USA	Representative NIH Funding Recipient Organization	Much of the burden of meeting this statutory requirement would be eased if more journals would collaborate with the research community in meeting the statutory obligation. The most effective way to meet this obligation would be if publishers modify standard copyright agreements to include a provision that acknowledges that the author retains the right to provide a copy of the final peer-reviewed manuscript to the NIH and to make the article available in PubMed Central (PMC) no later than 12 months after publication by the journal. As an alternative, journals could agree to deposit the final published article in PubMed Central. In this case, a significant portion of the burden on the grantee institution and its investigators is relieved and the public has timely access to the results of federally supported research. We recognize that the business models for many of the professional society-based journals do not anticipate this approach. Nonetheless, the society members are the very investigators that will be unable to meet their grant obligations and, as a consequence, jeopardize future federal funding. Conversely, NIH can assist the research community by reconsidering its strategy for meeting its obligations under the Consolidated Appropriations Act of 2008. The language in the statute does not preclude NIH from providing links to journal websites as a way to make research results publicly available. There is no apparent expectation for a permanent archive of publications, per se, or a prescribed format for the publicly available electronic versions. A link to journal websites can meet NIH’s obligations under Consolidated Appropriations Act.	The process for monitoring compliance with the policy is built into the policy itself. The requirement for a PMC or NIH Manuscript Submission number on references included in applications, proposals or progress reports will serve as a useful reminder and monitor. Over time, these submission to PubMed Central will become a usual and customary part of process of article publication. We would urge NIH to avoid building a more elaborate monitoring mechanism and rely on the slow but inevitable change in culture. The near-term problem will be how to address the compliance question with investigators who inadvertently fail to reserve their rights to submit to PubMed Central. We hope that NIH will recognize that this transition will take some time before it is complete. Institutions and investigators will not want to be forced into a position to violate signed copyright agreements	Our concern remains grounded in the nature of the institution’s relationship – or lack thereof – to the process of publication. Normally, institutions do not join in the relationship between authors and journals. However, as the grantee, a research institution is obligated to meet the terms and conditions of all its agreements. As such, institutions must act to ensure compliance with this NIH requirement. We will remind our investigators to maintain their rights individually to provide a copy of the final peer-reviewed manuscript that has been accepted for publication to PubMed Central (PMC) under current copyright law provisions. We will provide them with proposed language to insert in copyright agreements to enable posting to PMC. With respect to our subrecipients, we will include the requirements of the Public Access policy in our subagreements.	COGR offered comment at the public meeting on March 20, 2008. We noted our responsibilities to assist our investigators to meet our shared obligation and expressed our appreciation for the resources that NIH has made available on its web site directed to this issue. As NIH has moved forward with this policy, investigators have discovered the significant costs of providing public access. Journal charges for public access for a single article have reached, in some cases, $3,000. NIH has reminded the community that publication charges are an allowable expense against a grant. However, charging these publication costs to a grant will result in a considerable reduction in funds available to conduct research. Moreover, we expect that in many cases publications will be accepted after a grant has closed. As a result, research institutions will be expected to assist investigators in meeting these unexpected costs, putting greater strain on institutions that currently provide more than 20 percent of the funds to conduct research in the US. Combined with increasing unfunded compliance costs for the institutions and reductions in NIH’s budget, in general, this policy will contribute to a real reduction in funds available to conduct biomedical research. We remain concerned for investigators – particularly junior investigators – whose career advancement may be jeopardized if some journals refuse to accept the reservation of rights or the investigator lacks access to sufficient resources to pay the price for public access. We hope that NIH will continue to engage the publishing community in discussions that seek a resolution of outstanding issues including cooperation in the reservation of rights to submit to PMC and fees associated with providing public access. A copy of these comments in letter format will be forwarded by USPS.			Web Form
112	Web RFI	05/28/2008 at 03:16:13 PM (681)	Adler	Prudence	MLS, MA	Association of Research Libraries	District of Columbia	USA	Other	ARL encourages NIH to reconsider the current embargo period of 12 months. An embargo period of 6 months or less is more appropriate as a 12 month embargo is too long a delay for individuals to access needed research information. Research libraries will not cancel needed STM journal subscriptions if a 6 month embargo is implemented. Finally, given that scientific research is global, a 6 month embargo is more consistent with international public access policies.	It would be helpful if NIH posted and routinely updated a list of publishers whose author agreements permit authors/institutions to comply with the NIH Public Access Policy. It would also be helpful if NIH could automatically notify the appropriate campus entity ( e.g. Office of Sponsored Research, the Library, etc.) when a manuscript or article has been deposited in PubMed Central (PMC). Finally, it would be helpful if NIH would work with academic institutions on coordinated manuscript deposit between PMC and institutional repositories.		These comments on the revised NIH Public Access Policy are submitted on behalf of the Association of Research Libraries (ARL). Public support for science is enhanced when the public sees the benefits from our Nation's investment in scientific research. There is no doubt that scientific research is advanced by greater access to and dissemination of knowledge and the building upon the work of others. ARL commends NIH for soliciting additional comments on the revised Policy while at the same time, implementing the congressionally approved change in policy. Because the NIH Policy is integrally tied to the mission of higher education, research libraries are collaborating with others across the academic enterprise to ensure effective compliance with the revised Policy. This entails assisting individual researchers, working with campus research offices, developing or extending existing policies to ensure effective compliance, creating informational websites and more. Copyright management and access have been the focus of ARL libraries for quite some time. This involves helping authors make informed decisions so that they exercise their rights and interests in the ownership and use of copyrighted works in a manner that promotes the greatest possible scholarship and public use of their work. As a result, implementation of the NIH Policy builds on existing policies and initiatives and is seen as one more opportunity to support the interests of the academy.			Web Form
113	Web RFI	05/28/2008 at 04:00:29 PM (469)	Galea	Sandro	MD, DrPH	University of Michigan	MI	USA	NIH-funded Investigator	The current policy offloads a lot of responsibilities on the investigator. It seems that investigators have one of two options, neither entirely optimal. First, we can upload manuscripts (after seeking permission from the publisher) that are pre-prints, and hence which may be not identical to the post-print published by the publisher. Second, we can pay rather high fees to the publisher for public access. Neither of these options are ideal. Clearly a far more desirable option would be for publishers to have an understanding that allows public access to the final, published version, of NIH-funded manuscripts that satisfies the desire for public access to these manuscripts. Perhaps a read-only repository could be established? Or a way for download of temporary files? Either way, the current system, requiring either the creation of an imperfect parallel track of manuscripts or the payment of rather large sums of money by the investigator seems subpar.	The integration of PMIDs in progress reports and the links between PMIDs to the public repository should take care of compliance. It is hard to see how an NIH funded investigator can get around this.	The information that is available for this has been filtered through many different Universities, often couched in legal language that is not terribly useful for day-to-day purposes. For example, our institution recommends ensuring that the publisher accepts the NIH open policy. This, once again, shifts the onus to the investigator and clears all large bodies (NIH, publishers, universities) of potential liability. Clear, unequivocal guidelines (step-by-step) about what investigators should do, and clear explication that doing so does not put the investigators in jeopardy from either NIH or publishers would go a long way to clearing the confusion around this new policy and to ensure compliance.	No.			Web Form
114	Web RFI	05/28/2008 at 04:17:55 PM (207)	Sacks	Susan	PhD	Joint Policy Committee of the Epidemiology Societies	NJ	USA	Other	I am the current chairman of the Joint Policy Committee of the Epidemiology Societies. We represent 14 epidemiology organizations and would like to provide comments on this policy. I am writing to request a 6-week extension to provide comments as we only recently were alerted to this webpage and we need to obtain feedback from our individual societies before we can submit a set of comments from the Joint Policy Committee as a whole. Please let me know if it will be possible to have this extension. If so, will this website continue to be active so that I can submit the comments to this website. Thank you very much for your consideration.						Web Form
115	Web RFI	05/28/2008 at 05:48:50 PM (479)	Reichel	Mary	Ph.D	Appalachian State University	NC	USA	Representative NIH Funding Recipient Organization	The Public Access Policy is an effective move in the right direction, yet changing the embargo from 12 to 6 months would make a crucial impact on health sciences research and discovery. Our campus would not cancel journals as a result of the policy whether a six- or twelve-month embargo is in place. However, a shorter embargo time will help accelerate the dissemination of knowledge, contributing to important scientific and medical findings among partners who do not currently have access to this type of information due to cost restrictions.	Our library’s effort in informing more faculty about copyright and developing an institutional repository will work in tandem with the new Public Access Policy as we help to spread awareness of the policy and its importance. In most colleges and universities the library, as well as the institutional Office of Research would be a nexus of information about copyright and granting-agency policies, and help to ensure compliance with the new rules in a clear, consistent fashion.	As health science issues grow increasingly important to North Carolina. My university is developing a health sciences college and new degrees and programs to satisfy the need for health care professionals and top-tier research. Any ongoing communication about the NIH Public Access Policy would not only help ensure our compliance as potential grantees, but help us communicate the value of PubMed as a repository for peer-reviewed, taxpayer-funded research. Though North Carolina is well-known for its excellent support of education and research, our faculty throughout the state system need access to more information in order to speed the process of healthcare discovery and cures.	I would like to express appreciation for NIH’s willingness to engage librarians, university administrators, researchers, and other stakeholders in the shaping of the Public Access Policy and encourage the NIH to continue to strongly support the new policy and implementation as currently articulated. The Policy is an excellent example of government doing the right thing to speed medical knowledge and discovery around the world.			Web Form
116	Web RFI	05/29/2008 at 10:15:27 AM (951)	Green	David	MA, DPhil	Global Journals Publishing Director, Taylor & Francis, Informa plc	Abingdon	UK	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	Taylor & Francis and Informa Healthcare are part of the Academic and Scientific Division of Informa plc, which provides specialist, high value information to the global Academic & Scientific, Professional, and Commercial markets via Publishing, Events and Performance Improvement.At the heart of every Informa product and service is research-based knowledge and information for a highly targeted expert audience. Informa publishes approximately 2,500 subscription based products and services delivered both electronically and in hardcopy, and 45,000 books.Each year Informa produces over 12,000 events around the world powered by a marketing database of over 20 million contacts. Informa operates in over 80 countries, employing more than 10,000 people. 2000 of these employees are US citizens.We are grateful for the opportunity to respond to the National Institutes of Health (NIH) request for information regarding its Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research (the NIH Public Access Policy). Response: 1) NIH should establish a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to attaining a balanced implementation of the policy that achieves the public access objectives without a negative impact on peer review and other scientific publishing. The Senate committee report (110-107) to the fiscal year 2008 Labor Health and Human Services (LHHS) Appropriations bill directed NIH “…to seek and carefully take into account the advice of journal publishers on the implementation of this policy.” In addition, the Senate report highly encouraged “…collaborations with journal publishers that would enable them to deposit manuscripts on behalf of the funded investigator, if all parties agree.”2) NIH should follow its Congressional mandate to receive a copy of final, peer-reviewed manuscripts and work with publishers to create a robust, distributed electronic network which openly and clearly displays links from unedited manuscripts in PubMed Central (PMC) which have not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication to a final authoritative version available either from the publisher’s website or, if publishers agree, from PubMed Central. NIH should further work with publishers to enhance the MedLine/PubMed Central web site to enable full text searches of articles on the journals’ own websites. Such searches would yield links to finished articles on those websites rather than access to manuscripts as PMC now provides. Such a comprehensive search engine would do for biomedical research what search engines such as Google and Yahoo do for the web as a whole. We urge NIH to revisit this approach because it has a number of advantages to all parties. For NIH, this arrangement would make it possible to search the text of all biomedical research articles and not just the 10% that are based on NIH-funded research. Journals, and especially high-quality journals that publish a significant proportion of NIH-funded research, would still be able to determine their own access policies within a 12-month window and based upon their own cost recovery requirements. Finally, and perhaps most importantly, instead of access to manuscripts, this would make it possible to locate the final copy-edited articles of record presented in context with links to related materials such as commentaries and corrections.In working with publishers to pursue this alternate implementation of its Public Access Policy, NIH should consider the example of the America Competes Act (ACA) of 2007 which shows how the goal of public access to government funded research can be solved in a way which does not endanger the intellectual property rights of private industry, its support for peer review, and the integrity of the scientific record. Section 7010 of the ACA states: The Director (of the National Science Foundation) shall ensure that all final project reports and citations of published research documents resulting from research funded, in whole or in part, by the Foundation, are made available to the public in a timely manner and in electronic form through the Foundation’s Web site.	NIH should establish a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to the following specific compliance goals:1) Ensure that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements2) For publishers who submit manuscripts directly into PubMed Central, ensure that articles will not be accepted from individuals or entities other than the publisher3) Create and disseminate to publishers detailed and robust PMC bibliographic usage statistics to monitor and identify piracy and other inappropriate usage of manuscripts and other copyrighted material posted on PubMed Central4) Identify and implement specific safeguards to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose 5) Establish specific procedures, including notification of publishers, that will be implemented if piracy is discovered as a result of downloading content from PubMed Central6) Ensure that the Policy is, and continues to be implemented in a manner consistent with copyright law	• Regarding Copyright: We strongly urge NIH to consider public access requirements fulfilled when publishers make articles substantially funded by NIH grants available without charge immediately on publication on the publishers’ own open Web sites.• Regarding Patent Rights: Has NIH fully considered the public-access requirements’ impact on patent rights? Articles may be jointly authored by NIH-supported and privately supported researchers – indeed, some industry researchers also receive NIH grants. Posting of accepted manuscripts to PubMedCentral may well be considered publication, imposing time limits on commercial collaborators’ ability to file patents on their inventions. Unless authors are fully aware of these implications, public-access posting could jeopardize researchers’ ability to patent and commercialize their inventions. These requirements could, moreover, jeopardize NIH-funded researchers’ access to non-NIH-funded collaborations. This would be have a negative impact on innovation and commercially exploitable scientific knowledge.The Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition have prepared and submitted a thorough list of the information and communications related to the NIH Public Access Policy that would be helpful to publishers. We agree that these questions should be fully and publicly addressed by NIH.Informa supports the Association of American Publishers’ request for information and communications, which are as follows:1) Regarding Consultation with Publishers, Societies and Authors• Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals?• What is NIH’s timeline for amending this policy moving forward?• What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed?2) Regarding Copyright • Why hasn’t the NIH supported the full value of copyright and its use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central? 3) Regarding Brand Protection, Repurposing and Piracy• What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers?• Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus?• How will NIH ensure proper protection of publisher or society trademarks and branding? There been no affirmation of these markers of quality, and often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain.• How will NIH respect the rights of copyright holders and stipulate what NIH will or will not allow related to third-party use of its works? Will NIH, for example, ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher?• How will NIH prevent piracy of the articles from PubMed Central? Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers?• If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites?4) Regarding Compensation• What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done?• The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?5) Regarding Scope• If other public or private funders support research also supported by NIH, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central?• Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based?• The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision?• What will the repercussions be for investigators and journals that do not follow the process?• NIH’s 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews?6) Regarding Integrity of Research, Quality Control and Meaningful Public Access• How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal?• Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted?• For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher?• How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? Will NIH to develop, for example, a special section within PMC for members of general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to voluntary health organizations (VHOs), Patient Inform, publisher sites?• How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?7) Regarding Cost• NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy?• Does this cost detract from funds to grantees actually conducting the innovative research that advances science?8) Regarding Measuring Impact and Effectiveness• Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions?• What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)?• What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?	As a trusted partner of the international research community and an indispensable link in the pursuit, distribution, preservation, and usage of scientific discovery and knowledge we appreciate the NIH’s vision for an interconnected world of science and support efforts to enhance public access to scientific research. Our investments have made more information available to more people in more ways than at any time in human history and we continue to innovate. Like other publishers, we are experimenting with data mining and visualisation tools, semantic web applications, online navigation aids, flexible displays, free access to the recent archive of published articles, and Web 2.0 applications. We are also actively supporting the development of international standards to enhance online publications and websites and maximise the discoverability of science.This investment of resources has created and continues to fuel a system of scholarly communication which is vital to the advancement of science and the determination of critically important personal and professional rewards for scientists throughout the world. While we appreciate NIH’s pledge to work constructively with publishers to fully address copyright concerns and make the policy work, we are troubled by NIH’s lack of concern for any dislocation that will result from adhering to NIH’s “implement and steer” approach for the major shift in policy from voluntary to mandatory submission. Improper implementation of this sweeping mandate has serious implications for all stakeholders in the research community (publishers, authors, and the public) and for science itself. It is important that these implications be fully considered and addressed as soon as possible and we welcome the opportunity to work with NIH to establish the kind of productive ongoing dialog that we feel will best serve the public interest.			Web Form
117	Web RFI	05/29/2008 at 12:12:03 PM (188)	Mower	Allyson	MA	University of Utah	UT	USA	Representative NIH Funding Recipient Organization	Institutional repositories, similar to publishers/journals, could be used a source of content.	The current method seems sufficient.	N/A	Public access is essential! The results of publicly funded research needs to remain open to the public. PMC should NOT be a dark archive with only links to publishers web sites. The role of NIH and NLM is to preserve biomedical literature and merely providing links does not constitute preservation. A file along with description is required and libraries such as the NLM can provide this professional work.			Web Form
118	Web RFI	05/29/2008 at 12:19:39 PM (275)	Cameron-Vedros	Crystal	MLS	Univesity of Kansas Medical Center	KS	USA	Representative NIH Funding Recipient Organization	We are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.	Consider developing routine communication process with campus offices of research to collaborate on ensuring compliance Consider automatic notification to be sent to the campus office of research when an article from that institution has been deposited into PubMed Central Consider automatic means of coordinating manuscript deposit between PMC and institutional repositories, possibly in batch uploads or downloads. (Indicate if you or your institution would be willing to help facilitate). Make sure that, in all future grant NIH applications, the application form or electronic submission includes a field requiring citation to all previously required PubMed Central deposits; failure to cite would be considered reason to return the application as incomplete	Researchers would like the NIH feedback forms requesting the PI approve submitted manuscripts to be cc'd to all authors and other submitters who are listed in the submission process. Researchers realize that PI's and authors come from all numerous institutions and having all parties automatically copied to all email correspondence to and from the NIH submission process would help keep all parties involved and informed of status.	The A. R. Dykes Library of The University of Kansas Medical Center has developed a web site containing helpguides to the NIH submission process. Library staff are presenting informational sessions and communicating the message of public access to public funded research results. See our website and recorded training events: http://www2.kumc.edu/copyright/NIHPublicAccessPolicy.htmlhttp://www2.kumc.edu/comptraining/events.html			Web Form
119	Web RFI	05/29/2008 at 12:51:22 PM (748)	Courtois	Martin	Master of Arts Library Science	Kansas State University	KS	USA	Representative NIH Funding Recipient Organization	Public access needs to separated from publishers' business models. The present implementation is sound, but all embargo periods should be eliminated. Publishers fear that immediate access will threaten subscriptions, but they should remember that libraries have been canceling subscriptions for decades, and publishers are still in business. Those people who need (and who can afford) subscriptions will not cancel them simply because an article is freely available online.	Authors/PIs should be responsible for ensuring compliance. Future funding should be contingent on compliance.A possible avenue for compliance may exist by having authors submit to their academic institution's repository, then export those records and items to NIH. A researcher's local institution may be able to provide assistance with compliance, although this does raise some technical concerns about importing items from various repository platforms.	The information available is helpful, even tho it is a lot to digest.	As publishers bring their business concerns to this discussion, it's important to remember that publishers are not the "peers" in "peer review." Publishers provide useful administrative functions, but scientists and researchers are the ones who provide the essential service of peer review.			Web Form
120	Web RFI	05/29/2008 at 12:53:47 PM (402)	Butter	Karen	ML	University of California, San Francisco	CA	USA	Representative NIH Funding Recipient Organization	The current policy relies upon a 12 month embargo to preserve the financial interests of publishers. Moving to a 6 month embargo would better serve the interests of taxpayers without harming publishers. As one example: immediate availability of physics pre-prints has not harmed the market for physics journals. More generally, the demand of researchers for access to the latest research effectively guarantees that libraries will not carry out widespread cancellations. Another benefit of a 6 month embargo is that it aligns NIH policy with those of other respected funding organizations such as the Wellcome Trust, the European Research Council, and the Canadian Institutes of Health Research.Simplified procedures are essential to identify compliance policies by journal title. For the future we look forward to publisher’s submission on behalf of their authors and urge NIH to collaborate with publishers in this regard. In the interim we strongly encourage NIH to partner publishers to produce a searchable index by journal title. The limited list by publisher is of little value to authors who do not know publishers nor does it include the majority of journal titles.	Citing the PMCID in regular grant reports and new grant proposals is an effective step toward monitoring compliance with the Public Access Policy. One way to increase incentives for compliance is for NIH to collaborate closely with campus research officers, who have more direct contact with researchers. Whenever an article from any institution is successfully deposited in PubMed Central or the NIHMS, the appropriate campus research office should be notified.	Guidance for how to address the following scenario would be appreciated:o How should authors deal with “one-click” copyright transfer agreements, through which they have no opportunity to negotiate for the authority to deposit their manuscripts to PubMed Central?We commend NIH for the materials currently available on the NIH website– they have been helpful in our outreach efforts to authors and in work with the research office and for rapid response to questions about the policy.Below is a summary of activities to date at the University of California, San Francisco (UCSF) and those planned for the near future:o Development of a prominent page about the NIH Public Access Policy on the Library’s web site: http://library.ucsf.edu/research/scholcomm/nih.html; o Targeted outreach to faculty, in coordination with the UCSF Office of Research;o In-service trainings for Library staff members to become familiar with the basics of the policy. These trainings rely upon the “Public Access Training” presentation developed by NIH;o Collaboration on educational and advocacy activities across the ten 10 University of California campuses;o External trainings for UCSF faculty and staff about the policy; and,o Establishment of an email address that UCSF researchers or administrative assistants can use to submit questions about the policy	The NIH Public Access Policy has afforded an excellent opportunity for the Library to educate researchers about the extensive copyright protections they enjoy as authors. Copyright is not under attack because of the NIH Policy, but just being utilized in a different way. Rather than casually signing these protections away as a condition of publication, authors must now assert their copyright in recognition of funding by taxpayers.Given the significant commitment of local resources allocated to support compliance with the NIH Public Access Policy, and the stated aims of the policy, we feel that the policy should remain stable for the next year at least. (However, as stated above, a shortening of the embargo period to 6 months would be preferable.) This policy is the first of its kind in the United States, and it would be distressing to see it scaled back significantly so soon after it was enacted.The NIH Public Access Policy balances the legitimate interests of publishers with wide dissemination of the results of taxpayer-funded research. Deposit of the final peer-reviewed manuscript in a respected archive such as PubMed Central—with its easy linkages to sources of genomic, clinical, and chemical information—will facilitate scientific research and improve public health. I fully support the goals of the NIH Public Access Policy.			Web Form
121	Web RFI	05/29/2008 at 01:25:46 PM (154)	Newman	Kathleen	PhD	University of Illinois Library	IL	USA	Representative NIH Funding Recipient Organization	I have heard that there is a proposal that PMC become a preservation archive, unaccessible to all except in a cataclysm. And that instead of making papers available directly from PMC, links to the publisher's websites be made available, instead. This is totally not within the spirit or meaning of the law whereby biomedical literature was to be made freely and publicly available to all. Merely pointing to a publishers site does not guarantee that the paper will be openly available, nor that it will be available for all time (publishers frequently merge, buy titles, etc.) An advantage I can see to this proposal is that the reader would truly have access to the absolute final, published version of the paper, as opposed to, in some cases, just the penultimate version of the paper. But I think studies currently underway will show that this is not a huge problem, and thus do not override the guaranteed availability of the research findings.	I think the current plan of tying compliance to the possibility of obtaining future grants is adequate.	We have set up a support site for our local researchers, http://uiuc.libguides.com/NIH. The most difficult part of submitting papers is making sure that one has retained the right to do so. So that's what we focused on (Step 1). You might beef up your support of this endeavor, e.g., by pointing to the Sherpa Romeo db.	Although some researchers have commented on how onerous the submission process is, I think instead we should focus on how many have not found it onerous and are, in fact, supportive of the process. Researchers are, by in large, interested in sharing their research. PMC provides an elegant method for doing so. I look forward to the time when all funding agencies require that the fruits of their money be freely available. I hope work is underway to create, at least, a government-wide research archive!			Web Form
122	Web RFI	05/29/2008 at 02:32:50 PM (485)	Van Kampen	Doris	EdD	Saint Leo University	FL	USA	Representative NIH Funding Recipient Organization	To provide a permanent, stable archive of NIH's research, including all grant funded entities it is critical that NIH be in charge of and accountable to the tax payer and to the research community. Vendors are bought out; journals go under; links are ephemeral. If the NIH is reponsible for all aspects of the open archives there will be a permanent record available. If this is left to the entrepreneurs, the vendors, and the individual researchers, documents will go missing, vendors will be bought out or go under, and researchers will eventually turn their interests to other topics or leave this earth, with the record of their research going into the limbo realm of orphan works, or worse yet, completely disappearing. ERIC was a commercial product, funded in part by tax payer dollars; that in and of itself is a reminder as to what happens when the only record is in the hands of the commercial sector. Is that what we want to have happen to our research tax dollars, and to research information which may be critical to our understanding of cancer research, Parkinson's research, or other medical research??? A dark archive is no archive; it is a temporary measure which will eventually be scuttled. NIH needs to mandate an open archive, with open access.D Van Kampen						Web Form
123	Web RFI	05/29/2008 at 02:59:36 PM (606)	Baker	Shirley K.	MA, MA	Washington University	MO	USA	Representative NIH Funding Recipient Organization				It has been brought to our attention that there an alternative has been proposed for implementation of the Public Access Policy. This alternative would have NIH as a dark archive with links to publishers' websites. The permanent, stable archive for research is a major goal of the NIH policy and would not be achieved by this alternative proposal. To guarantee permanence, a database must be used constantly and curated carefully. Libraries have a long history in archiving and preservation issues, and we can say emphatically that a dark archive that links to publishers’ websites is an unacceptable alternative that NIH has consistently and wisely rejected.Shirley K. BakerVice Chancellor for Scholarly Resources and Dean of LibrariesWashington University in St. Louis			Web Form
124	Web RFI	05/29/2008 at 03:27:59 PM (569)	Hair	William	BS, MDiv, MLS	Baylor University	TX	USA	Representative NIH Funding Recipient Organization	I am aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would not achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.						Web Form
125	Web RFI	05/29/2008 at 03:42:57 PM (263)	Goetsch	Lori	MLS	Kansas State University	Kansas	USA	Representative NIH Funding Recipient Organization	I am opposed to the alternative proposal for NIH to serve as a dark archive with lines to publishers' web sites. This does not achieve the goal of creating an open access research archives.My	Institutions like my own have already committed to compliance as currently outlined, and the library is part of the effort to inform and educate our university community. I encourage efforts to develop and support automated means of deposit such as batch uploading or downloading to facilitate compliance.	Clarify to the research community that this policy does not jeopardize copyright. Also, dispel concerns that open access, and this policy in particular, harms the bottom line for journal publishers. Speaking as a member of the library community, it is both unrealistic and not in anyone's best interest to seriously think that massive journal cancellations would ensue as a result of this policy. Embargo periods provide sufficient safeguards to the revenue streams of publishers, and our goal as librarians is to get the relevant research our faculty need and demand out to them in a timely manner through continued subscriptions.				Web Form
127	Web RFI	05/29/2008 at 03:46:52 PM (978)	Michalak	Sarah	MLS	University of North Carolina at Chapel Hill	NC	USA	Representative NIH Funding Recipient Organization	Along with many institutions many institutions, we work to educate faculty about their copyrights and related responsibilities; clear guidance and greater assistance from NIH to researchers would be beneficial.	UNC-Chapel Hill has signaled our commitment to open access and to the NIH open access policy by providing institutional education, training, and financial support (http://www.hsl.unc.edu/scholcom/OAFundAnnounce.cfm) to facilitate compliance by our researchers. It would be a benefit to our office and our efforts to receive automatic notification whenever an article has been deposited by a UNC researcher.UNC is also developing an institutional repository and would welcome a means to coordinate manuscript deposit between PubMed Central and the repository. We would eagerly participate in, facilitate, test, or otherwise help to advance such an arrangement.	Consider developing routine communication process with campus offices of research to collaborate on ensuring compliance	This submission supplements our earlier comments and reiterates our support for this policy. We applaud the commitment NIH has shown in pursuing this policy and engaging with all stakeholders. We also wish to express the commitment of UNC’s libraries to maintaining journal subscriptions. Journals continue to play a unique role in the scholarly communications process and we have no intention of canceling subscriptions as a result of the NIH Public Access Policy.We take the position that open access to federally funded research is not simply an educational or economic issue, but also a moral one that will place vital information into the hands of the very public whose taxes support the advance of science.--Sarah C. Michalak, University Librarian and Associate Provost for Libraries, on behalf also of Tony Waldrop, Vice Chancellor for Research and Economic Development, and Carol Jenkins, Director of the Health Sciences Library			Web Form
128	Web RFI	05/29/2008 at 04:31:54 PM (600)	Anderson	Norman	Ph.D.	CEO, American Psychological Association	DC	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	The American Psychological Association (APA) is the largest scientific and professional organization representing psychology in the United States and the world's largest association of psychologists with 148,000 researchers, educators, clinicians, consultants, and students. APA is also the largest publisher of behavioral science research, with 37 of the premier scholarly journals in the field of psychology. Given that behavioral factors contribute to six of the leading causes of death in the U.S., it is clear that psychological science has a critical role to play in improving the health status of our nation.Accordingly, APA strongly supports efforts to enhance public access to scientific publications that advance science and benefit the public, while safeguarding the copyright interests of publishers. Our overriding concern with the new mandatory NIH public access policy is that it uses public taxpayer funds to duplicate services that are currently provided by publishers. Moreover, when peer-reviewed manuscripts are made widely and freely available on line, the commercial value of the finished, published work is likely to be seriously diminished, with resulting declines in subscriptions and licensing agreements. This loss of income, which will be particularly acute for non-profit scientific society publishers like APA, is likely to lead to less science publishing, and thereby, less public access to research findings. A compelling alternative way to accomplish the goals of the NIH policy would be for publishers to provide NIH with immediate access to journal articles for internal portfolio management and archiving of publications arising from NIH-funded research and for NIH to provide public access to the final published articles through existing PubMed Central (PMC) links to journal Web sites. In response to the NIH Request for Information, we would like to raise a number of specific concerns about the NIH procedures currently in effect to implement the new mandatory public access policy and suggest ways that they might be addressed:a) Preserving Copyright InterestsIt is essential to realize that publishers add immense value to the scientific enterprise through such functions as editorial selection, peer review, copyediting, and design production. Underlying the new public access policy is the faulty presumption that publishers will not experience significant financial hardship due to the 12-month lag between date of publication and posting of the peer-reviewed manuscript in PMC. While this may be true for a handful of publishers, it hardly applies to the industry as a whole, and certainly not to our association. This is due to the fact that the cutting-edge research that APA publishes is rarely obsolete within a year, and may have a shelf life of five to ten years. Moreover, only 15 percent of the eventual “lifetime” usage of our journal articles -- in the form of downloads -- occurs within the first year after publication. In clear violation of copyright principles, the NIH public access policy requires publishers for the first time ever to essentially forego their copyright interests without just compensation for their investments. As a means to address this concern, the NIH policy does allow for the use of grant funds for the payment of publication fees for NIH-funded authors provided that certain stipulated conditions are met. This approach could work provided that NIH grant reviewers approve publication costs included in biomedical, behavioral, and social science research grants. Alternatively, NIH could set aside funds to enter into direct licensing arrangements with publishers to deposit copyrighted work on behalf of authors as some other non-governmental funding agencies have done, such as the Wellcome Trust and the Howard Hughes Medical Institute.b) Maintaining Quality of Scientific Publishing The public access policy by its very nature compromises the quality of scientific publishing by ultimately making available two versions of scientific papers. The first is the inferior, peer-reviewed manuscript that has not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication, and the second is the definitive, publisher-authenticated version. To distinguish between these two versions and increase accessibility to the published version, the following changes should be made to PMC to: 1) ensure that the NIHPA author manuscript bar or some other watermark appears on the printed version of manuscripts as it does on the on-line and PDF versions; 2) make the “Author Manuscript” label larger and more obvious on abstract and html pages; 3) make the link to the published version at least as large as to the manuscript version on the abstract landing page; 4) change the title of the link to the published version, e.g., from “APA Full Text” to “APA Published Version;” 5) ensure that the links to the journal citation on the publisher sites are functional; and 6) ensure that the html and publisher sites are fully branded. c) Narrowing Scope of Policy Coverage The relevant statutory provision in the Consolidated Appropriations Act applies to “all investigators funded by the NIH,” yet does not specify whether the NIH funding is in whole or in part. NIH takes the view that the policy applies to investigators with any NIH intramural research funds or any amount of direct costs funded by NIH, even if the funding is insignificant and supplemented by other public or private sources. But what if these other sources oppose the posting of their funded work on PMC? To address these concerns, NIH should stipulate that its requirement for the deposit of peer-reviewed manuscripts in PMC only applies when NIH funding represents the majority of funding for the scholarly work.It is also of concern that NIH has expanded its claimed domain of manuscripts required for PMC deposit from reports of NIH grant-supported empirical research to include literature reviews. This is a significant expansion without a statutory basis. Literature reviews can arise from various contexts, which may or may not be directly related to a funded NIH grant. It is essential to clarify which review articles must be deposited. Accordingly, the language in the FAQ should be modified to explain that only those review articles that are anticipated by, and described in, an NIH-funded grant proposal are subject to the PMC deposit requirement. The guidelines should be further modified to stipulate that the policy does not apply to any grants issued before its effective date of April 7, 2008. The guidelines currently apply to NIH grants or cooperative agreements “active” in FY 2008 (which began on October 1, 2007). This sets in place an unfair, retroactive imposition of grant terms and conditions that could extend back for years prior to the official implementation date.	NIH would be well advised to reconsider the burden that it is placing on investigators and institutions and to implement procedures and protections to secure the copyright interests of publishers. These specific concerns are addressed more fully below:a) Undue Burden on Authors and InstitutionsAccording to the relevant statutory provision, it is the responsibility of NIH, not the institutions or investigators as NIH contends, to “implement the public access policy in a manner consistent with copyright law.” Yet the policy states that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” This even includes the submission of manuscripts that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure that these other authors are “aware of and comply with” the NIH policy. This provision should be removed, because authors cannot reasonably be expected to comply with it.b) Needed Procedural ChangesAs a means to help protect the copyright interests of publishers, the following procedural issues need to be addressed. First, highly visible links need to be put in place in PMC to publishers’ copyright and disclaimer documents, not just to those developed by NIH. Second, any NIH revisions to the publisher-submitted, peer-reviewed manuscript need to be approved by the publisher, as well by as the author, prior to PMC posting, including links to databases and other resources. And third, when there is a publisher agreement in force, the author should not be able to designate an embargo date in PMC and thereby potentially alter an embargo date already agreed upon with the publisher; rather NIH should defer to the embargo policy of that particular publisher. c) Needed ProtectionsAlso, there needs to be a process in place to determine and monitor whether peer-reviewed manuscripts are and will be appropriately posted in PMC, and if improperly placed by authors, that manuscripts are promptly removed from PMC. In this regard, APA has identified close to 100 peer-reviewed manuscripts of articles published in our journals that have been improperly placed by authors in PMC in violation of copyright (prior to the implementation of the mandatory policy). Furthermore, protections need to be put in place to ensure that third parties cannot exploit PMC-posted content for commercial purposes and that publisher and society trademarks and branding are safeguarded.	Although the various PowerPoint training materials posted on NIH’s Public Access Communications and Training Web site are helpful in explaining the public access policy and its overall implementation with respect to authors and institutions, there needs to be more attention directed to publishers. The general message is clear, “authors of articles arising from NIH funds are responsible for ensuring that publishing agreements allow for full compliance with the policy.” However, guidance such as that provided in the January 2008 NIH Extramural Nexus article entitled, “What the new public access requirement means to the NIH-supported investigator” can be seen as undermining the role of many publishers by posing the following questions:"Does your institution wish to develop or amend a standard copyright transfer agreement for all institutional authors?""Does your institution wish to designate an individual or department to help investigators submit their own manuscripts?"In addition to this one Web site and the explanatory page linked from the citation sites, it would be helpful to have some guidance on the actual pages that provide links to the peer-reviewed manuscripts and final published journal articles to help inform both the scientific community and the lay public about the difference between the two and how the latter can be obtained from the publishers.Furthermore, NIH’s instructions to authors about the PMC manuscript deposit process should include language directing authors, when preparing their grant proposals, to check on the deposit fees and charges required by the journal(s) to which they intend to submit their work for publication. NIH also needs to change the wording of its FAQ about publication costs to clarify that publication fees, page charges, and NIH deposit fees are authorized for payment with NIH grant funds.	To date, NIH has engaged in a highly unconventional process of signaling its intent to put a new policy into effect with little advance notice and then soliciting public comment within three weeks of its expected implementation date, with the prospect of announcing possible amendments to the policy six months later. Apparently, NIH considers the transformation of its current voluntary public access policy into a mandatory one as merely an interpretation of an existing policy that requires only the posting of a “revised” policy rather than a formal Notice and Comment Rulemaking.However, this reflects a woeful miscalculation of the potential impact of this policy on our economy and international trade. Journals published by U.S. scientific, technical, and medical (STM) publishers represent about $3 billion in annual revenue, and North America-based STM publishers account for 45% of all peer-reviewed research papers published annually worldwide. The mandatory NIH public access policy would provide free, world-wide access to U.S. scientific research to countries that are competing with American business and industry, undermining the intent of the America Competes Act. Therefore, NIH would be well advised to carefully consider the input that it receives from publishers and other key stakeholders and amend the policy to effectively address their compelling concerns. Such a deliberative approach would be in keeping with the guidance provided by the U.S. Senate in report language that accompanied the omnibus appropriations bill. Specifically, the Senate requested that NIH “seek the advice of journal publishers on the implementation of the mandate to ensure that publishers’ copyright protections are maintained.” The scientific publishing community is dedicated to the widespread dissemination of scientific research and welcomes the opportunity to work closely with NIH to ensure that the goals of the public access policy are achieved and that the scientific publishing industry is preserved in the process.			Web Form
129	Web RFI	05/29/2008 at 04:45:49 PM (469)	Jakubs	Deborah	Ph.D.	Duke University	NC	USA	Representative NIH Funding Recipient Organization				Comments submitted in attached letter on behalf of Deborah Jakubs, Duke University Librarian and Vice-Provost for Library Affairs and Patricia L. Thibodeau, Associate Dean for Library Services, Duke University Medical Center.	NIH_comments_may08_w_additions.txt	The Duke University Libraries and the Duke University Medical Center Library are grateful for the opportunity to continue to engage the National Institutes of Health in the ongoing efforts to craft the best possible policy for public access to NIH funded research. Duke has been and remains supportive of those efforts, as evidenced by our earlier comments in response to an NIH request, by our Provost’s decision to sign a 2006 letter in support of taxpayer access to federally funded research and by the ongoing involvement of the University Vice-Provost for Research and the School of Medicine’s Vice-Dean for Clinical Research in planning for implementation of the policy effective as of April 7, 2008. Because Duke has been planning for compliance with the NIH public access policy at a high level and for almost six months, we want to emphasize that changes in the policy should be implemented carefully, if at all, to avoid a substantial loss of resources that have already been allocated. It would be very difficult to step back from the commitment to public access at this point. We also feel that our researchers and the institution gain significant opportunities and benefits from having Duke research, as well as the research done at other institutions, made available in PubMed Central; we have been working to demonstrate that benefit to our researchers and would be extremely disappointed if the NIH reversed or weakened its own commitment in that regard. As we have proceeded with educational efforts to help researchers comply with the new policy, we have been pleased at many of the reactions we have received. We have been relieved to find that the submission process is not at all difficult. The interface provided for submission is easy to use. In general, our researchers have indicated a positive attitude towards both the process and the policy. In fact, one reservation that we have heard is that the potential for a twelve month delay after publication for research to be publicly available is too long. Researchers generally see the value of public access for supporting their own continuing research as well as for meeting the needs of the public, and some are concerned that such a long delay will hamper the pace of research in a digital age. While the submission process is simple, we do urge NIH to work with the publishers and gain their cooperation in submitting manuscripts or the final published version on behalf of authors. The publishers that are willing to submit on behalf of authors should be added to the list maintained by NIH, and not limited to PMC publishers. Both of these actions would greatly reduce the compliance burden on authors and their institutions, while ensuring timely submission of all manuscripts. It would also help eliminate the concerns of both authors and librarians that inaccurate versions of manuscripts will be submitted and accessible through PMC. The length of the potential embargo leads us to make one final comment. As the University officials with final responsibility for library purchasing decisions, we have no expectation (as well as no specific plans) that we will cancel journal subscriptions because of increased access to research articles through PubMed Central. Although loss of subscription revenues has been frequently cited as a potential negative effect of the Public Access Policy, such cancellations are simply not a practical option given the realities of how research is conducted, the contents of the PubMed Central database, and the speed with which information in the bio-medical sciences is disseminated and used. Sincerely, Deborah L. Jakubs Patricia L. Thibodeau Rita DiGiallonardo Holloway University Associate Dean for Library Librarian & Vice Provost for Library Affairs Services, Duke Medicine	Web Form
130	Web RFI	05/29/2008 at 04:49:01 PM (171)	Smith	Kevin	J.D.	Duke University	NC	USA	Representative NIH Funding Recipient Organization	In general Duke researchers have been pleased with the simplicity of the interface provided by PubMed Central for submission of articles. The most difficult and time consuming issue in terms of compliance has been the education needed to help faculty deal with copyright issues and the wide variety of publication agreements with which they are confronted. Although this is a significant opportunity to help faculty adopt more appropriate copyright management strategies in general, much of the stress for researchers could be eliminated if the NIH would take two steps:1. Solicit and complete participation agreements with as many publishers as possible, including those who publish the “top-name” journals in fields covered by NIH research funding.2. Maintain communication with those publishers who decline to enter into participation agreements to negotiate the smoothest possible terms of submission. Agreements and policies that are not full participation agreements but that facilitate submission should be communicate on the NIH website, just as the list of participating publishers is now.Because we believe that there is both an advantage to our researchers and to the general public in having a stable and permanent archive of taxpayer-funded research, we must view the suggestion sometimes heard for a “dark archive” of articles with links to publisher websites as an unacceptable alternative. This suggestion would not achieve the goals articulated by the NIH, nor would it provide the benefits which are the reason for the support of so many institutions of higher education and research. This alternative was wisely rejected by NIH in its initial consideration and should not be reconsidered at this time. Our institution, like many others, has already invested substantial resources in compliance with the policy as now written, and a substantial change, particularly one that would undermine the benefits we see in the policy, would be a serious problem.	Duke has already adopted policies and taken significant steps toward educating our faculty researchers about managing copyright and submitting articles, as detailed in our earlier submission of comments. The information we provide for researchers can be seen at http://www.mclibrary.duke.edu/nihpolicy. The most helpful thing that NIH can do to help us monitor and ensure compliance with the public access policy is to adopt a clear policy and stick with it without significant alteration. A consistent and stable policy will allow institutions to develop their own mechanisms for compliance. Institutions can also use the NIH policy as a part of overall efforts to managing the intellectual property assets created at a university in a more efficient and beneficial way.	Two specific steps that NIH could take would help to facilitate communication and make compliance with the public access policy smoother and more efficient. First, it would be best to send the final PMC version of an article for verification before it is uploaded to the database to BOTH the principle investigator and the lead author listed on the article. This would help PIs remain aware of work being done, especially on widely diffuse research projects, and it would reduce the bottleneck of articles that are pending PMC availability because a PI fails to complete this final step; lead authors, when different from the PI, will have a much greater incentive to complete this verification. Second, it would be tremendously helpful to institutional monitoring efforts, and beneficial to the smooth implementation of the policy, if notification could be sent to the designated institutional research office if, after a designated period of time, there had been no response to a request for verification of a final article text for PMC. Grantee institutions have a significant stake in compliance, and notice of this impediment is important if the research support offices are to be of material assistance in overseeing compliance.	General comments regarding the overall policy of Duke University regarding the NIH public access policy have been submitted by Deborah Jakubs, University Librarian & Vice Provost for Library Affairs, and Pat Thibodeau, Duke Medicine Associate Dean for Library Services.			Web Form
131	Web RFI	05/29/2008 at 04:53:38 PM (684)	Graves	Diane	MLn	Trinity University, San Antonio, TX	TX	USA	Representative NIH Funding Recipient Organization		RE: the proposal of an alternative implementation of the Public Access Policy, with NIH acting as a dark archive, providing links to publishers' web sites. In effect, this would limit public access and thereby defeat the intent of the program. From a library perspective, I don't see this as an effective, feasible, or reliable alternative. Public access to a collection of publicly funded research is what is needed, not a dark archive. In many cases, PORTICO is answering that need, which addresses long-term preservation, not public access.					Web Form
132	Web RFI	05/29/2008 at 05:04:56 PM (978)	Lougee	Wendy	MA, MLS	University of Minnesota Libraries	MN	USA	Representative NIH Funding Recipient Organization	The University of Minnesota Libraries support the efforts that NIH is taking to ensure an effective implementation of the updated Public Access Policy. We believe that this policy will speed the pace of discovery by expanding access to research findings supported with federal tax dollars in order to better advance science and improve health. The NIH public access policy directs welcomed attention to the issue of author rights. Our University encourages faculty and students to exercise their interests in ownership and use of their copyrighted works in a manner that provides the greatest possible scholarly and public access to their work. We have worked over the past year on a number of initiatives to support this goal including conducting an educational campaign on author rights (http://www.lib.umn.edu/scholcom/au-rights.phtml) and the creation of an institutional repository (http://conservancy.umn.edu/). The University of Minnesota, as a member of the Committee on Institutional Cooperation (Big 10 schools plus Chicago) has endorsed an “addendum to publication agreements” for authors to use with their publishers to retain rights for use of their work in their teaching, for posting on their personal websites, or depositing to institutional or subject repositories, such as PubMed Central. University Libraries have invested significant resources ensuring that our staff are informed about the policy and are prepared to assist authors with the submission process. We have developed a successful partnership with the Office of the Vice President for Research to implement the policy. We have created a website to centralize all information and institutional advisories about the policy (http://www.lib.umn.edu/scholcom/NIHaccess.phtml); met with faculty and administrative committees to discuss the policy and plan its implementation; provided notice to Principal Investigators about their responsibilities; and created a letter to publishers from the Vice President for Research for use by authors in the first submission of a manuscript that informs publishers of University of Minnesota intent to comply with the NIH policy and requests their support in permitting deposit of manuscripts. Finally, we have shared best practice experiences with colleagues at other institutions.We encourage NIH to work toward reducing the maximum embargo period from 12 months to 6 months, which would be more in sync with other funding agencies in the UK and Canada, and the Howard Hughes Medical Institute. A 6 month embargo maximum would also be consistent with the CIC addendum mentioned above, creating less confusion for our authors.A 6 month embargo provides a sufficient safeguard for publishers. The faculty and students at the University of Minnesota require the most current information for their research and study – a delay of 6 months for access to critical information is not acceptable. The journals to which we subscribe are based on faculty needs, quality and use of the journals in our setting, and our budget situation which changes from year to year. The NIH Public Access Policy is NOT a factor in our cancellation decisions. However, it COULD be a factor in our assessment of journals to subscribe to in the future – favoring those journals which comply with the NIH Policy and are supportive of our authors in facilitating that compliance.	We urge the NIH to work with all stakeholders to reduce the administrative burden of compliance on institutions and authors, and to streamline the process wherever possible. One example would be for NIH to generate a message to the institution upon the deposit of a manuscript for their respective authors. Ideally, over time, our authors will have ensured the right to deposit these manuscripts in institutional repositories as well as PubMed Central. When that is the case, we would like to see an efficient mechanism for the PubMedCentral manuscript to also be deposited in our own IR.The submission process would be facilitated by the availability of a comprehensive, up-to-date location for recording individual publisher policies. NIH could work with SHERPA and others to create and maintain this and integrate it with the submission system. NIH should work to influence additional publishers to participate as “fully compliant” partners. In addition, NIH should ensure that all NIH grant application forms or electronic submission sites include a prompt or a field for inclusion of the PMCID on the PI’s cited references that fall within the policy.PubMed Central should develop the functionality to identify how many times a particular article has been accessed in order to add to the growing evidence of increased use of publicly accessible research.	We encourage the NIH to continue to update the Public Access website, and provide as much detail as possible in the FAQs. We rely on this information to inform our authors of new developments or clarifications. NIH should consider an RSS feed on the appropriate pages so that we can be alerted to updates.NIH could clarify in the FAQs that authors need not pay OA fees to publishers to comply with the NIH mandate.	We appreciate NIH efforts to ensure a smooth implementation of the Public Access Policy. We believe the policy will result in a significant improvement in access to health information that will benefit both our university and the publics it serves. This result would not be achieved if suggestions of a "dark archive" were pursued. We encourage NIH to reject that approach and continue to focus on the development of PubMed Central as a permanent stable archive.			Web Form
133	Web RFI	05/29/2008 at 05:24:46 PM (625)	Soules	Aline	MA, MSLS, MFA	California State University, East Bay	CA	USA	Representative NIH Funding Recipient Organization	This is an addendum to comments I posted on May 27:It has come to my attention that there is a proposal that the NIH policy be implemented through a dark archive that links to publishers' web sites. This is not an appropriate alternative. The requirement is for “public” access. There's nothing public about directing the public to sites where it has to pay for information that has already been paid for through public funds. An important goal is to make public the information discovered or created through NIH-funded endeavors. Another major goal is to provide a permanent, stable archive. This requires that the material be centralized (not scattered among publishers' web sites and in various forms). A central repository ensures that the information will be curated, preserved, and used on a regular basis. As a librarian, I can assure you that a dark archive does not achieve appropriate archiving and preservation needs. NIH has consistently and sensibly rejected this alternative in the past and I urge NIH to continue to reject this idea in favor of promoting the public dissemination of information through the access of PubMed Central.						Web Form
134	Web RFI	05/29/2008 at 05:24:56 PM (801)	Ruff	Christopher	Ph.D.	Editor, American Journal of Physical Anthropology	MD	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	Creating a parallel system for copy editing, proof-reading by authors, and archiving is a waste of taxpayers' money and authors' time. These processes are already carried out by authors and publishers in the course of publishing journal articles. If publishers agree to make publications resulting from NIH-funded research freely available within 12 months of publication, this will achieve the same goals as those specified in the NIH mandate, at a much lower cost to NIH. Allowing complete public access to such archives could be arranged and I'm sure would be preferable to publishers than the proposed policy. If publishers did not agree to these stipulations, then authors could be required to deposit articles on the PMC site. Furthermore, creating a dual manuscript preparation and archiving system will inevitably result in discrepancies between two available versions, leading to confusion over which one is considered the "official" version. It is also not clear why NIH is not including a link in PMC to the original publication website.		Clarification regarding the applicability of the mandate to researchers with partial support from NIH is needed. For example, is the mandate intended to apply to any research carried out with NIH support, regardless of how small that portion was, or to new studies that make use of data originally collected with NIH support? What if other funding agencies involved in support of the research have alternative policies regarding public deposition of papers?	Publishers and small scientific societies rely on subscription revenue to support their operations. Reduction of paid subscriptions could negatively impact the ability of editorial offices to function, and by extension, the quality of scientific papers.			Web Form
135	Web RFI	05/29/2008 at 06:29:12 PM (408)	Watson	Linda	MLS	Association of Academic Health Sciences Libraries	WA	USA	Representative NIH Funding Recipient Organization	I submit these comments on behalf of the Association of Academic Health Sciences Libraries (AAHSL), an organization of library directors of the 142 accredited and American and Canadian medical schools that belong to the Association of American Medical Colleges. AAHSL expresses its deep appreciation for the efforts that NIH is taking to ensure an effective implementation of the updated Public Access Policy (NOT-OD-08-033) and its continued willingness to engage all stakeholders in this process. We are optimistic that this policy will speed the pace of discovery by expanding access to research findings supported with federal tax dollars in order to better advance science and improve health. AAHSL is a strong supporter of the NIH Public Access Policy. Our member libraries lend strong support to their institutions’ efforts to comply with the policy. We have been recognized as leaders on our campuses in addressing policy issues related to author’s rights. We have worked to educate our faculty about the need to retain rights when signing publication agreements with publishers. We have encouraged our faculty to retain rights to use their work in teaching, for posting on their personal websites, or depositing to our institutional or subject repositories. This new public access policy that affects so many of our researchers directs increased attention to the issue of author rights, an issue of high importance to the advancement of scholarship.During the Medical Library Association Annual Meeting in May an overflow audience attended a session on the public access policy with participation from staff at NLM. It is clear there are many unanswered questions for both libraries and authors. Of particular concern are issues around deposit requirements, copyright and version control. For the latter, there are questions about which copy authors cite and how to address significant editorial changes after the author’s final manuscript is submitted.To date our member libraries have limited experience upon which to base comments regarding the policy and its implementation. To assist authors our members have developed outstanding training materials and guides that supplement the material supplied by NIH. Additionally, the policy has offered a valuable opportunity for members to collaborate across the campus involving libraries, faculty and research offices.We urge that NIH work with publishers and institutions to develop a consistent and streamlined procedure for deposit that addresses rights questions and other implementation issues, and which can be used by all NIH-funded PIs without reference to the specific policies and practices of individual journals and publishers. AAHSL would be glad to work with NIH and interested peer institutions to develop and implement this procedure. We also suggest NIH develop a means to coordinate manuscript deposit between PMC and institutional repositories.	The process for monitoring is a concern for many of our members. We suggest that NIH consider providing routine communications to research offices on compliance issues.	We urge NIH to continue its work to streamline the deposit process and the timely updating of its website along with announcements of the updates.	We thank NIH for its efforts to ensure a smooth implementation of the Public Access Policy. We believe the policy will result in a significant improvement in access to health information for our faculty, students and the academic medical centers that we serve.			Web Form
136	Web RFI	05/29/2008 at 06:54:21 PM (727)	Ogburn	Joyce	MSLS, MA	University of Utah, University Librarian	UT	USA	Representative NIH Funding Recipient Organization	The University of Utah fully supports the NIH Public Access Policy and looks forward to the enormous benefits that will result from its implementation. Researchers, patients and others would benefit from changing the requirement for deposit from 12 months to 6 months. This would not harm the market for journals while it places information in the hands of medical practitioners and researchers much sooner. Many rural communities, health care workers, American Indian communities, and others that lack access to a big research institution and availability to research results need this information without ado. Our libraries will continue to subscribe to journals for our researchers and practitioners who need access upon publication. Alternate access means have been proposed to have the NIH point or link to articles at the publishers’ sites. This approach is not true public access since the articles would not be in a public space and there are no guarantees that this method would be permanent or stable. It does not meet the goals of preservation and curation. This approach also does not lend itself to data mining by the NIH, which may seek to understand trends or the impact of NIH funding programs. The content and the control of access and use still remains in the hands of the publishers, not the NIH.	Developing an automated system for alerting institutions when an article has been submitted would be a terrific way to allow institutions to track the submission. Additionally we would like to harvest or be sent the metadata to place in our repository to link to research generated at our institution. We would then have an institution specific, searchable record of compliance and success in publishing research results. The Marriott Library has developed software to enable easy deposit of articles and we would be interested in working with the NIH on envisioning an alert system that works with repositories.	The University of Utah supports the public access policy and has commented before. We have committed fully to compliance and want to hear that the policy is in full implementation mode and achieving its goals. Keeping information and FAQs current will be helpful in answering our researchers’ questions. We would also appreciate information about how publishers, libraries or others are lending their support by providing deposit services or tools.	The University of Utah believes that this policy supports our mission and presents a tremendous opportunity to transform access, use and generation of research, the processes of discovery and innovation, and patient care. We thank the NIH for the opportunity to reiterate our support.			Web Form
137	Web RFI	05/29/2008 at 10:34:08 PM (732)	Dobbs	Aaron	MSLS, MSM	Shippensburg Univeristy of Pennsylvania	PA	USA	Other Member of the Public	There is a pattern emerging among responses to the NIH call for comments that indicates opponents are pressing for PubMed Central to be made into a dark archive that links to publishers’ Web sites. This does NOT meet the goals of public access and is NOT an acceptable approach to the policy.	Consider developing routine communication process with campus offices of research to collaborate on ensuring complianceConsider automatic notification to be sent to the campus office of research when an article from that institution has been deposited into PubMed CentralConsider automatic means of coordinating manuscript deposit between PMC and institutional repositories, possibly in batch uploads or downloads. (Indicate if you or your institution would be willing to help facilitate). All future grant NIH applications should include a field requiring citation to all previously required PubMed Central deposits; failure to cite would be considered reason to return the application as incomplete	A published list of publishers whose author publishing agreements provide for deposit with PMC in a manner that is consistent with copyright law would help steer research to publications with compatible aims.	Could the embargo period be shortened to 6 months? This would reflect the pace of biomedical research and discovery, align NIH policy with others in place worldwide, and keeps US research institutions competitive with rest of world.			Web Form
138	Web RFI	05/30/2008 at 04:45:26 AM (822)	Herrmann	Guido F.	PhD, MBA	Managing Director Thieme Chemistry, Thieme Publishers	Germany	Germany	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	Thieme Publishing Group, based in Stuttgart, Germany, is a privately held, medical and scientific publishing company. Thieme employs 900 people and maintains offices in 7 cities, including New York, Beijing, Delhi and Stuttgart. For 120 years, Thieme's high-quality books and journals have been a vital resource for scientists, physicians, researchers and academics. Thieme publishes 130 peer-reviewed journals and over 500 new books annually. All scientific and an increasing number of medical publications are also available online. Please visit www.thieme-connect.com for more information.Thieme is grateful for the opportunity to respond to the National Institutes of Health (NIH) request for information regarding its Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research (the NIH Public Access Policy). Our written comments follow.1) NIH should establish a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to attaining a balanced implementation of the policy that achieves the public access objectives without a negative impact on peer review publishing. The Senate committee report (110-107) to the fiscal year 2008 Labor Health and Human Services (LHHS) Appropriations bill directed NIH “…to seek and carefully take into account the advice of journal publishers on the implementation of this policy.” In addition, the Senate report highly encouraged “…collaborations with journal publishers that would enable them to deposit manuscripts on behalf of the funded investigator, if all parties agree.”2) NIH should follow its Congressional mandate to receive a copy of final, peer-reviewed manuscripts and work with publishers to create a robust, distributed electronic network which openly and clearly displays links from unedited manuscripts in PubMed Central (PMC) which have not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication to a final authoritative version available either from the publisher’s website or, if publishers agree, from PubMed Central. NIH should further work with publishers to enhance the MedLine/PubMed Central web site to enable full text searches of articles on the journals’ own websites. Such searches would yield links to finished articles on those websites rather than access to manuscripts as PMC now provides. Such a comprehensive search engine would do for biomedical research what search engines such as Google and Yahoo do for the web as a whole. We urge NIH to revisit this approach because it has a number of advantages to all parties. For NIH, this arrangement would make it possible to search the text of all biomedical research articles and not just the 10% that are based on NIH-funded research. Journals, and especially high-quality journals that publish a significant proportion of NIH-funded research, would still be able to determine their own access policies within a 12-month window and based upon their own cost recovery requirements. Finally, and perhaps most importantly, instead of access to manuscripts, this would make it possible to locate the final copy-edited articles of record presented in context with links to related materials such as commentaries and corrections.In working with publishers to pursue this alternate implementation of its Public Access Policy, NIH should consider the example of the America Competes Act (ACA) of 2007 which shows how the goal of public access to government funded research can be solved in a way which does not endanger the intellectual property rights of private industry, its support for peer review, and the integrity of the scientific record. Section 7010 of the ACA states: The Director (of the National Science Foundation) shall ensure that all final project reports and citations of published research documents resulting from research funded, in whole or in part, by the Foundation, are made available to the public in a timely manner and in electronic form through the Foundation’s Web site.	NIH should establish a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to the following specific compliance goals:1)Ensure that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements2)For publishers who submit manuscripts directly into PubMed Central, ensure that articles will not be accepted from individuals or entities other than the publisher3)Create and disseminate to publishers detailed and robust PMC bibliographic usage statistics to monitor and identify piracy and other inappropriate usage of manuscripts and other copyrighted material posted on PubMed Central4)Identify and implement specific safeguards to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose 5)Establish specific procedures, including notification of publishers, that will be implemented if piracy is discovered as a result of downloading content from PubMed Central6)Ensure that the Policy is, and continues to be implemented in a manner consistent with copyright law	The Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition have prepared and submitted a thorough list of the information and communications related to the NIH Public Access Policy that would be helpful to publishers. Thieme agrees that these questions should be fully and publicly addressed by NIH.The information and communications requested are as follows:1) Regarding Consultation with Publishers, Societies and Authors•Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals?•What is NIH’s timeline for amending this policy moving forward?•What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed?2) Regarding Copyright •Why hasn’t the NIH supported the full value of copyright and its use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central?3) Regarding Brand Protection, Repurposing and Piracy•What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers?•Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus?•How will NIH ensure proper protection of publisher or society trademarks and branding? There been no affirmation of these markers of quality, and often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain.•How will NIH respect the rights of copyright holders and stipulate what NIH will or will not allow related to third-party use of its works? Will NIH, for example, ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher?•How will NIH prevent piracy of the articles from PubMed Central? Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers?•If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites?4) Regarding Compensation•What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done?•The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?5) Regarding Scope•If other public or private funders support research also supported by NIH, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central?•Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based?•The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision?•What will the repercussions be for investigators and journals that do not follow the process?•NIH’s 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews?6) Regarding Integrity of Research, Quality Control and Meaningful Public Access•How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal?•Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted?•For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher?•How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? Will NIH to develop, for example, a special section within PMC for members of general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to voluntary health organizations (VHOs), Patient Inform, publisher sites?•How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?7) Regarding Cost•NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy?•Does this cost detract from funds to grantees actually conducting the innovative research that advances science?8) Regarding Measuring Impact and Effectiveness•Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions?•What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)?•What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?	Thieme appreciates the NIH’s vision for an interconnected world of science and support efforts to enhance public access to scientific research. The STM publishers’ investments have made more information available to more people in more ways than at any time in human history and the STM publishers’ continue to innovate. Like other publishers, the STM publishers’ are experimenting with data mining and visualisation tools, semantic web applications, online navigation aids, flexible displays, free access to the recent archive of published articles, and Web 2.0 applications. The STM publishers’ are also actively supporting the development of international standards to enhance online publications and websites and maximise the discoverability of science.This investment of resources has created and continues to fuel a system of scholarly communication which is vital to the advancement of science and the determination of critically important personal and professional rewards for scientists throughout the world. While Thieme appreciates NIH’s pledge to work constructively with publishers to fully address copyright concerns and make the policy work, Thieme is troubled by NIH’s lack of concern for any dislocation that will result from adhering to NIH’s “implement and steer” approach for the major shift in policy from voluntary to mandatory submission. Improper implementation of this sweeping mandate has serious implications for all stakeholders in the research community (publishers, authors, and the public) and for science itself. It is important that these implications be fully considered and addressed as soon as possible and Thieme welcomes the opportunity to work with NIH to establish the kind of productive ongoing dialog that we feel will best serve the public interest.			Web Form
139	Web RFI	05/30/2008 at 09:35:29 AM (352)	Till	Jim	PhD	University of Toronto	ON	Canada	Other	I hope that NIH will work toward reducing the maximum embargo period from 12 months to 6 months, which would be more in harmony with other funding agencies in Canada and the UK.						Web Form
140	Web RFI	05/30/2008 at 10:05:29 AM (430)	Mercer	Holly	MLIS	University of Kansas	KS	USA	Representative NIH Funding Recipient Organization				The University of Kansas is aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would not achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.			Web Form
141	Web RFI	05/30/2008 at 10:23:00 AM (137)	Crawford	Brian	Ph.D.	American Chemical Society	DC	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	The attached ACS comments broadly cover all four questions posed by NIH but by extension also cover many issues attendant to a larger more expanded response to each of the questions.	The attached ACS comments broadly cover all four questions posed by NIH but by extension also cover many issues attendant to a larger more expanded response to each of the questions.	The attached ACS comments broadly cover all four questions posed by NIH but by extension also cover many issues attendant to a larger more expanded response to each of the questions.	The attached ACS comments broadly cover all four questions posed by NIH but by extension also cover many issues attendant to a larger more expanded response to each of the questions.	ACS_RFI_Submission_053008.txt	The American Chemical Society Response to the Request For Information: NIH Public Access Policy1 *** GENERAL OBSERVATIONS & OVERVIEW OF COMMENTS *** In the Federal Register notice announcing the Request for Information (RFI) the National Institutes of Health (NIH) poses three questions regarding the new mandate. The American Chemical Society (ACS) is concerned that the questions posed are insufficient to garner the type of input necessary to lead to a comprehensive and meaningful evaluation of the mandate. Further, the format for submitting comments discourages the submission of comprehensive, cohesive and thoughtful input. An examination of input received at the NIH web-site as of the date of this submission seems to substantiate the fact that much of it is far from comprehensive and may be of limited use towards producing a meaningful analysis by NIH at the conclusion of the comment period on May 31, 2008. The following ACS comments broadly cover all three questions posed by NIH but by extension also cover many issues attendant to a larger more expanded response to each of the questions. In short, we believe that: * NIH missed an opportunity to make its 2005 voluntary initiative a success – and has failed to address the underlying problems associated with the voluntary policy and those impediments to success will now become exacerbated under a mandatory policy. * NIH has not implemented the mandate pursuant to Congressional intent to ensure consistency with copyright law, and instead is forcing the research community to divert time and effort away from advancing the frontiers of knowledge to perform this task in NIH’s place. * NIH should have followed the federal Administrative Procedures Act, not an RFI, to solicit public comment on the implementation of the mandate. The APA, the federal rule-making standard for over six decades provides a more structured and meaningful process and could have been accomplished within the same timeframe as the RFI. * NIH must proactively address a number of copyright, intellectual property, and other concerns raised by ACS and other publishers to make the mandate a success (as outlined on pages 5-9) *** ACS AND SCHOLARLY PUBLISHING – WHY COPYRIGHT IS IMPORTANT *** The ACS is the world's largest scientific society with more than 160,000 members. We care deeply about the advancement of scholars and scholarship and pursue these goals through advocacy, publishing, conferences, information resources and professional development efforts. We have been doing so ever since publishing our first journal – The Journal of the American Chemical Society – in 1879. Our 36 peer-reviewed scientific journals are distributed globally in print and electronic media and showcase the world’s finest research in chemistry and related sciences. Articles that appear in our journals are widely regarded having received recognition of excellence and the visibility that content in ACS journals receives not only helps scholars achieve new scientific breakthroughs but also leads to practical applications that directly benefit human health and welfare and the world’s economy. Collectively our peer-reviewed journals form an informal but widely recognized hierarchy used by funding bodies and the academic community itself to assess research quality, impact, and priority—key factors used to allocate funding resources, evaluate levels of personal achievement, and determine professional advancement. We believe that it is in the public interest to foster this beneficial publishing activity and toward that end we invest heavily in staff and technology resources required to be successful in this endeavor. Copyright creates the opportunity for us to do this by sustaining our publishing enterprise. This is why, we trust, Congress directed NIH to implement its Public Access Policy in a manner consistent with copyright law and respect for its underlying principles and why the Senate Appropriations Committee, in Report 110-107, directed NIH to “seek and carefully take into account the advice of journal publishers on the implementation of this policy” and “to ensure that publishers’ copyright protections are maintained”. We also believe that Congress considers, as we do, that the integrity of intellectual property is an essential criterion for the advancement of science as well as for innovation and creative activity. *** IMPEDIMENTS TO THE SUCCESS OF THE VOLUNTARY POLICY STILL EXIST UNDER THE MANDATE *** The American Chemical Society supports public access to the results of federally funded research but asserts that the implementation plan for the NIH Public Access Policy mandate does not abide with the law creating the mandate or with the sentiment and direction of the U.S. Congress, particularly as outlined in the Senate Appropriations Committee report that directed NIH to work with scientific journal publishers in implementing the new policy mandate. The NIH missed an opportunity to make its May 2005 voluntary public access policy a success by not proactively including scientific journal publishers as it developed its procedures and policies for the deposit of manuscripts reporting on NIH-funded research into PubMed Central. Consultation with publishers is critical in 2008 to prevent the agency from embarking on a similar collision course as it proceeds to implement the new mandate. Key to success will be NIH taking an active role, one based on openness and inclusiveness, to resolve the outstanding copyright and intellectual property issues that cut across a very broad and deep swath of the scientific journal publishing community. The ACS publishes annually approximately 4,000 articles that acknowledge NIH as a research funding source. ACS has tried to resolve outstanding copyright and intellectual property issues with NIH in connection with the Society’s efforts to deposit manuscripts directly with NIH PubMed Central on behalf of ACS authors who have elected to “opt in” to have the Society do so on their behalf. Despite ACS’ efforts, the NIH instructed ACS in December 2005 to suspend article deposition into PubMed Central; that prohibition has prevented the Society from depositing more than 3,000 manuscripts on behalf of ACS authors. During the 2005-2008 time period, NIH PubMed Central has accepted unauthorized postings of ACS copyrighted material, and repurposed and openly displayed such postings without adhering either to NIH’s own policy guidelines, or terms and conditions as set forth to NIH by ACS as rights holder. Issues of concern to ACS remain unresolved and will continue to be problematic and exacerbated under the new mandatory policy as outlined in NIH’s implementation plan issued on January 11, 2008. ACS hastens to point out that the vast majority, if not all, the Society’s copyright and intellectual property concerns could be resolved if NIH would abide the original intent of the Public Access policy and post without alteration or modification the unedited author versions of peer-reviewed manuscripts on PubMed Central—without any reformatting, repurposing or modification or any mirroring of content to third-party websites—and simply link back to the final published article as the authoritative version for readers on the Society’s own website. *** NIH HAS NOT IMPLEMENTED THE MANDATE PURSUANT TO CONGRESSIONAL INTENT *** The American Chemical Society (ACS) expresses concern that NIH has not abided by the law in creating the new mandatory public access policy as stipulated in Division G, Title II, Section 218 of Public Law 110-161 (the Consolidated Appropriations Act of 2007) In enacting Section 218, ACS believes that Congress was aware that flawed implementation of a mandatory public access policy could create serious problems for the scientific publishing community which is why it included the statutory proviso directing “That NIH shall implement the public access policy in a manner consistent with copyright law.” In its implementation plan published on the NIH website on January 11, 2008, NIH placed the burden of ensuring copyright compliance on the individual researcher or institution, a directive that ACS asserts does not comport with the Congressional intent or guidance. Shortly after P.L. 110-161 was enacted, ACS submitted a letter to NIH Director Zerhouni wherein we proposed a constructive path forward for implementation of the new mandatory policy in consultation with publishers as rights holders. That letter, sent several hours before NIH posted its implementation plan, asked that NIH seek broad input into the formulation of its implementation plan, and recommended the appropriate method to do this is through the rulemaking procedures under the Administrative Procedures Act (APA), an Act that has guided federal regulatory activities for over 60 years. Following the APA would assure that all stakeholders have an opportunity to provide input into the implementation process and the oversight of NIH’s administration of the policy. ACS asserts that following the APA would be consistent with Senate Committee Report 110-107 which conveyed with P.L. 110-161. The report directed NIH to take the following course of action when implementing the new mandatory policy. The Report reads, in part: “…The Committee highly encourages collaborations with journal publishers that would enable them to deposit manuscripts on behalf of the funded investigator, if all parties agree. The committee directs the NIH to seek and carefully take into account the advice of journal publishers on the implementation of this policy. In particular, the Committee directs the NIH to ensure that publishers’ copyright protections are maintained…” Following an APA process would also have been consistent with the approach NIH followed when it published its proposed voluntary public access policy on September 17, 2004, in the Federal Register and the public was invited to offer comment. NIH noted in publishing its final voluntary policy in the February 9, 2005 Federal Register that it was not required to follow the APA because of the voluntary nature of the policy, but had done so in order to obtain public comment on the proposed policy. NIH noted that it received over 6,000 public comments at that time. The public comments received were quite thoughtful and provided value to the process, as NIH modified its original proposal and increased the timeframe for manuscript deposition into PubMed Central from 6 to 12 months, citing the need to “ensure that peer review of scientific articles is preserved.” It would only seem logical and fair that since the policy is now mandatory, and carries with it full enforceability of federal law that its implementation should now be subject to the APA process. That process would allow comment from all concerned parties to ensure the policy is implemented fairly and comports with the Congressional intent of complying fully with the protections that rights holders are afforded under copyright. It is hard to see how NIH’s implementation announcement on January 11, 2008 – 16 days after enactment – followed either the statutory language or the above referenced Senate Committee report language. ACS is unaware of any scientific journal publishers that were consulted in this 16 day window. By contrast, the RFI process initiated by NIH on March 31, 2008 is a much more informal process than the APA and has only attracted about 1% of the responders to the NIH notice seeking public comment on its voluntary policy as outlined above. ACS believes that the lack of response to the RFI is due primarily to the fact that NIH has already gone ahead and fully implemented the mandate on April 7, 2008 just seven days after announcing the RFI leaving scores of potential responders wondering what value their time and effort in offering thoughtful input might yield. ACS is unaware of any other federal mandate being implemented in such a disjointed fashion. A policy as important as this should be initiated only after a period of public comment and those comments have been carefully weighed and considered and any amendments found necessary have been made. ACS believes that an APA process would best abide the Congressional intent in both that statute and committee report and does not feel that the RFI will yield the input that an APA process could generate. In fact, an examination of input received at the NIH web-site as of the date of the ACS submission seems to substantiate the fact that much of the input is far from comprehensive and may be of limited use towards producing a meaningful analysis by NIH at the conclusion of the comment period on May 31, 2008. *** COMMENTS AND CONCERNS RELATIVE TO COPYRIGHT AND INTELLECTUAL PROPERTY *** Since 2005, ACS has made voluntary and good-faith efforts to facilitate the deposit of NIH-funded research into PubMed Central in a manner consistent with the Society’s interests in copyright. We have been prevented from doing so by NIH-generated intellectual property and process-related roadblocks that remain unaddressed by the agency to this day. We are concerned that such problems will remain unaddressed, and may even be exacerbated under the new mandatory policy. By way of example, ACS has in excess of 3,000 unedited peer-reviewed author manuscripts pending deposit with PubMed Central, as a consequence of NIH’s having refused to accept such deposits from ACS. NIH has rejected ACS’ right, as copyright holder, to establish reasonable safeguards on use of this material. Instead, NIH has sought to appropriate copyright for itself - reformatting and altering submitted author manuscripts; “repurposing” deposited manuscripts in connection with their display in PubMed Central; and expatriating versions of that repository to countries elsewhere around the globe. In our view, implementing the Public Access Policy in a manner consistent with copyright law, and the intent of that aspect of its Congressional mandate, would mean that: A. NIH would respect the integrity of the copyrighted content it receives and ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles are undertaken only when consistent with copyright. Not only are there no mechanisms in place to do this, but also the range of uses outlined in NIH’s terms and conditions for manuscript deposit take substantial liberty with content to create unauthorized derivative works. ACS questions how NIH can proceed in this manner, as doing so would seem to disregard the intent of Congress. B. NIH would respect ACS’ right, as the copyright holder, to stipulate what it will or will not allow related to third-party use of its works. Instead, NIH has rejected ACS terms and conditions, designed to protect the integrity of the scientific record and, without permission or consultation, has linked content to a variety of online resources (or seeks the latitude to do so). For example, nothing in NIH’s implementation guidelines explicitly prohibits the licensing, selling, or distributing of links or access to content deposited within the PubMed Central database. C. NIH would acknowledge and support ACS as the copyright holder in the works deposited. Instead, the NIH website directs users to information which we assert undermines ACS’ copyright. In some cases, ACS’ copyright notice is not displayed or NIH’s site links to its own copyright information rather than that of ACS as rights holder. D. NIH would respect the trademarks and branding of the ACS. Not only has there been no affirmation of these markers of quality, but all too often branding information is missing ? Potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain. E. NIH would take steps to ensure copyright compliance for material deposited into PubMed Central. No mechanisms to do this are in place, even for content that that has been erroneously deposited by authors without authorization, or that does not fall within the scope of the NIH Policy, and thus should not have been made publicly available. This causes potential economic harm to ACS as publisher. F. NIH would provide a mechanism to incorporate the concerns of publishers as the policy evolves over time. No mechanisms to do this are in place or have been proposed ? Indeed, the implementation guidelines in connection with the mandated Public Access Policy were announced almost immediately after enactment of P.L. 110-161, without consultation with publishers, even as the NIH proceeded to inform other stakeholders. G. NIH would respect ACS’ right, as copyright holder, to decide how its content will be disseminated. Instead, NIH, without permission or consultation, has made arrangements to mirror ACS content deposited on its site. A mirror site for PubMed Central has been established in the United Kingdom, and our understanding is that other mirror sites are planned or proposed to be located internationally. This raises important questions and concerns regarding copyright protections that would prevail in such circumstances for content located outside the borders of the U.S. We question also how such international mirror sites serve the needs of the U.S. taxpayer and the intended purpose of the NIH Public Access Policy as directed by Congress. H. NIH would support the integrity of the scientific record. Instead, NIH has declined to use a link to the final published article at a specified URL on the ACS’ own website as an alternative to the deposit and display of the unedited author’s version on PubMed Central. Furthermore, NIH has also chosen to use its own system of article identification (PubMed Identifiers) rather than adopt the widely- accepted Digital Object Identifier (DOI) as a means of identifying authoritative material and associating it with the rights holder of record. This adds to reader confusion as to the definitive version of the article, and by diverting web traffic from ACS’ final published article, poses economic harm in the process. It is unclear to us how NIH will manage and maintain such an identifier system, or the value that this system adds on behalf of the taxpayer. I. NIH would seek only the deposit of final, peer-reviewed manuscripts upon acceptance for publication. Instead, under the scope of the policy NIH allows, and even encourages, the deposit by authors of the final published version (article) ? Without any provision for distinguishing the two versions, or for compensation in recognition of this federal taking of the publisher’s investment in the peer-reviewed version of the manuscript. In so doing, NIH is placing authors in potential conflict with publishers and their copyright or other publishing policies, or (at worst) steering authors to favor journals with policies consistent with a particular business model. ACS questions whether the intent of Congress was to enable NIH to engage in this interference with the private sector and authors’ right to assign and transfer their copyrights in an unfettered manner. In addition to the issues summarized above, we note that the NIH has not implemented its current voluntary Public Access Policy in a manner consistent with its own self-created guidelines. For example, articles, including those from ACS, falling outside the NIH Public Access Policy implementation date of May, 2005 have been posted on the PubMed Central repository. Those and other posted articles are made openly available that should have been embargoed for 12 months. Final published articles in journal formal and with content copyrighted by ACS have been converted into NIH’s XML format and posted regardless of publication date. One of our own journal editors has expressed surprise that PubMed Central includes open access to articles he published prior to the policy implementation date ? Articles that were posted by others without his knowledge. These experiences indicate that NIH lacks adequate control over the posting of manuscripts on its own website. This must be addressed. Mindful of these unaddressed implementation problems that affect protections provided under copyright, ACS is concerned that the new mandatory NIH Public Access Policy leaves key policy and implementation questions unaddressed, such as: 1. By what process will NIH establish criteria to ensure that publishers’ copyright protections are maintained? Why has NIH refused to engage in a notice and comment rulemaking that would help to assure publishers that such protections can be put in place? 2. By what process will NIH seek and take into account the advice of journal publishers in determining if it is implementing its Public Access Policy in a manner consistent with protections under copyright law, and the spirit of NIH’s Congressional mandate? 3. If deposited content will be “mirrored” to other sites outside the U.S., what process will be entailed for the establishment of such sites, and how would national and international copyright considerations be addressed to protect rights holders? 4. What limitations, if any, would be imposed on PubMed Central as an “aggregator” of content from sources such as HHMI, Wellcome Trust, other U.S. government agencies, etc? 5. Will NIH negotiate terms and conditions with publishers for the use of NIH grant funds to enable the deposit of copyrighted works on behalf of authors? Will NIH make such payment directly to publishers on behalf of its grantee authors? 6. How will NIH identify grant funds allowable to be used for the payment of publication fees? Will supplemental funds be made available to support author compliance with the mandate? 7. What steps will NIH take if it is found that its Public Access Policy is harming publishers? 8. Why has NIH refused to work with publishers to gather and share PubMed Central usage statistics on copyrighted content? Should this information not be considered as in the public domain, as it is funded with taxpayer monies? Why should articles be freely available, but information about the usage of those same articles be hidden? 9. How will NIH ensure that articles on PubMed Central meet ACS requirements, such as the access-control period, and that the policy actually applies to the articles that it is posting? 10. How will NIH prevent piracy of the articles from PubMed Central? At present, publishers are not protected from systematic downloading that could occur from the NIH website; pirates also could disseminate paper copies of article content, and undermine publishers’ economic interests. What will happen if piracy is discovered as a result of downloading of content from PubMed Central? 11. What provisions will be made to evaluate whether the policy is effective in achieving its intended purpose of promoting public access by US taxpayers to NIH-funded research? As announced, the policy makes no mention of mechanisms for oversight of NIH’s implementation efforts, to ensure that the policy’s scope and operational costs are contained. What “sunset” provisions will be made so that the policy mandate may be amended or phased out if it proves to be ineffective, too costly to maintain, or too disruptive to the peer-reviewed scientific publications on which ultimately it relies? Regardless of the questions and serious nature of the issues raised above, we choose not to believe that NIH is willfully disregarding copyright law and Congressional intent in the implementation of its Public Access Policy. However, ongoing consultation with publishers such as ACS is needed to ensure that NIH does not misapply its Congressional mandate and do irreparable harm to the very fabric of scholarly publishing that supports scientific research and our nation’s competitiveness. ACS is willing and able to work with NIH and other key stakeholders to establish the kind of productive ongoing dialog that we feel will truly maximize the sustainable dissemination and discoverability of knowledge in chemistry and the allied sciences, and fulfill the intended purpose of the Congressional mandate in serving the public interest. Thank you for this opportunity to share the views of the American Chemical Society with you. Submitted By: Brian Crawford President, Publications Division American Chemical Society 1155 Sixteenth Street, NW Washington, DC 20036 E-Mail – b_crawford@acs.org 1 Published in the Federal Register on March 31, 2008, Vol. 73, No 62	Web Form
142	Web RFI	05/30/2008 at 11:15:43 AM (873)	Joseph	Heather	MS	The Scholarly Publishing and Academic Resources Coalition	DC	USA	Other	SPARC fully supports the NIH Public Access Policy in its current form, and commend the NIH’s extensive efforts to seek input from the full range of stakeholders throughout the policy's development. We believe the agency’s overall response to constructive input has been commendable and that a fundamentally balanced and workable policy has resulted from this process. We offer further comments in the attachment below to demonstrate the strategic soundness and overall balance of the policy, and to underscore our community’s continued willingness to work with NIH to ensure that the benefits of this policy are be fully realized by all stakeholders.	We encourage the NIH to closely monitor key aspects of the Public Access Policy’s implementation, including: 1) Experience of publishers with six-month or shorter embargos: It is in the public's interest to reduce the duration of the public access embargo to as short a period as possible. NIH should collect data on the sustainability of biomedical journals that offer open access within six months of publication in order to evaluate the potential to reduce the maximum PubMed Central embargo. and 2) Extent to which eligible articles are captured in PubMed Central: For the policy to succeed, it is imperative that deposit of articles from NIH-funded research be nearly universal. We trust the agency will track this and take reasonable, appropriate steps to ensure success.	Additional comments on the policy and implementation are included the full SPARC comment submission attached to this form.	The NIH Public Access Policy embraces the potential of the Internet to enable new and increased usage of NIH-funded research findings by millions of scientists, physicians and health clinicians, public health officials, patients, small businesses, students, teachers, and others. SPARC commends NIH for its vision and leadership in putting forward this important policy.	SPARC_NIH-PA_RFI_FINAL_TXT.txt	Scholarly Publishing & Academic Resources Coalition ---- Support for National Institutes of Health (NIH) Implementation of the Revised Public Access Policy May 30, 2008 ---- The following comments are submitted by SPARC (Scholarly Publishing and Academic Resources Coalition) in response to the National Institutes of Health (NIH) "Request for Information: NIH Public Access Policy" issued on March 31, 2008 (73 Federal Register 16881). SPARC, established in 1997, is an alliance of hundreds of academic libraries and research institutions that advocate expanded availability and use of scientific and scholarly research findings via adoption of new scholarly communication practices that effectively utilize the capabilities of the Internet. We commend NIH's extensive efforts to seek input from the full range of stakeholders throughout the public access policy development process. We believe the agency's overall response to constructive input has been commendable and that a fundamentally workable policy has resulted from the consultative process. We offer these further comments in order to demonstrate the strategic soundness and overall balance of the policy, and to underscore our community's continued willingness to work with NIH to ensure that the benefits of this policy may be fully realized by all stakeholders. Need for a Public Access Policy SPARC believes widespread dissemination of research results is an essential, inseparable component of the U.S. Government's investment in science. It is only through application of findings that funders-and, by extension, taxpayers-obtain adequate value from their investment. Faster and wider sharing of knowledge fuels the advance of science and thus the return of health, economic, and social benefits to the public. Until relatively recently, funding agencies could rightly feel satisfied that their investment in research was being adequately leveraged via dissemination of findings exclusively in toll-access journals. It would have been inefficient and cost-prohibitive for them to take on or supplement publishers' dissemination of the results in a paper-based environment. However, the Internet can now bring timely and universal access to the ~80,000 articles that arise each year from NIH funding. The marginal cost of doing so, which is less than 0.02% of NIH's annual budget, is trivial relative to the tremendous leverage it offers. A growing number of studies document that when scientific research is accessed more freely on the Internet it is cited sooner and more often in subsequent research.(1) According to economists Houghton and Sheehan, the most immediate impacts of enhanced access would be likely to be felt within research, and include: * Speeding up the research and discovery process, increasing returns to investment in R&D, and potentially reducing the time/cost involved for given outcomes; * Enabling better-informed research, reducing the pursuit of blind alleys and reducing duplicative research, saving duplicative R&D expenditures, and improving their efficiency; * Enhancing opportunities for multi-disciplinary research, inter-institutional and -sectoral collaborations, and enabling researchers to study their context more broadly, potentially leading to increased opportunities for and rates of commercialization; and * Improving education outcomes, enabling a given education spend to produce a higher level of educational attainment, leading to an improvement in the capabilities of future researchers. Enhanced access, such as the kind provided by the NIH Public Access Policy, also presents important new opportunities for private industry, including the potential to: * Accelerate and widen opportunities for adoption and commercialization of research findings, increasing returns on public investment in R&D and on private investment in discovery and commercialization-related activities; * Enable much wider access for doctors/nurses, teachers/students, small firms in consulting, biotechnology, nanotechnology, etc., with a positive impact on quality of services and, possibly, productivity of entities/sectors and their customers and clients; * Encourage the emergence of new industries based upon open access content-similar to the weather derivatives industry based on public meteorological data; * Open new opportunities for publishers to add value-added services overlaying open access content (e.g., peer review, bibliometrics and webometrics for research evaluation, etc.), which might, in turn, enhance research evaluation and lead to better focused R&D expenditures.(2) In addition to these benefits, public access to NIH-funded research will enable new computational research techniques and pathways such as text mining, creation of text-data linkages, and identifying and visualizing of relationships that could not otherwise be observed. The texts of journal articles in PubMed Central are linked to other public databases such as GenBank and PubChem, enabling researchers to explore relationships in powerful new ways. New kinds of interactivity between users and content and collaboration among geographically diverse researchers are also facilitated when all parties have access to a shared knowledge base. Such innovation is only feasible in the open environment and is precluded when research articles are locked up on proprietary websites. The desirability of such an environment has been spotlighted by more than two-dozen Nobel Laureates who in 2007 pointed to its vital importance and emphasized the necessity of an investigator deposit mandate to enable public access: As we noted in a letter to Congress urging action on this policy nearly three years ago, we object to barriers that hinder, delay or block the spread of scientific knowledge supported by federal tax dollars-including our own works. Thanks to the internet, we can transform the speed and ease with which the results of research can be shared and built upon. Despite best intentions, the voluntary policy enacted by NIH over two years ago has simply not improved public access significantly. As active scientists, it does not surprise us that a request-with neither incentives nor consequences attached-to submit our articles so that they are freely available simply does not make the lengthy "to-do" lists of our colleagues. We firmly agree with NIH Director Elias Zerhouni, who indicated in his testimony to the Senate LHHS Appropriations Subcommittee that only a mandatory policy will be an effective policy. Requiring compliance is not a punitive measure, but rather a simple step to ensure that everyone, including scientists themselves, will reap the benefits that public access can provide. We have seen this amply demonstrated in other innovative efforts within the NIH-most notably with the database that contains the outcome of the Human Genome Project.(3) The higher education and research institute communities-recognizing that the broad dissemination of research is central to their core mission-have been vocal in support of NIH public access, as evidenced in public statements of the Association of American Universities (AAU)(4), the National Association of State Universities and Land-Grant Colleges (NASULGC)(5), and the Association of Independent Research Institutes (AIRI).(6) Public access accommodates not just researchers' increasing needs to communicate rapidly, collaborate widely, and utilize emerging computational research methods, it also addresses the public's rising interest in self-education on health matters and need to see the results of their investment. Unfortunately, the access barriers faced by non-scientists such as teachers, patients, health practitioners, or small businesses are far greater than those encountered by scientists. Sharon Terry, President of the Genetic Alliance and mother of two children with a rare genetic disease called PXE, has described the problem in personal terms: My children have a genetic disease. It is rare, not well understood, and there is no treatment or cure. However, the most disturbing obstacle we face is the wall around published scientific research. Information critical to health and biomedical research is held hostage by questionable and arcane publishing practices. It is time for publishers, both private and academic, to respond to a new age of information sharing and a stronger sense of the scientific commons....(7) The extent of public support is illustrated by Harris Poll findings released May 31, 2006, showing eight out of ten (82%) adults surveyed believe that "if tax dollars pay for scientific research, people should have free access to the results of the research on the Internet." Six out of ten (62%) adults believe that if these research results are easily available (for free and online), it will help speed up finding potential cures for diseases.(8) The US Chamber of Commerce, the world's largest business federation, also recognizes the benefits of NIH public access to America's business sector. "American businesses will benefit tremendously from improved access to NIH research," according to William Kovacs, the organization's vice president for environment, technology and regulatory affairs. "The Chamber encourages the free and timely dissemination of scientific knowledge produced by the NIH as it will improve both the public and industry's ability to become better informed on developments that impact them-and on opportunities for innovation."(9) The publishing industry analysts at Credit Suisse First Boston have described the imperative for public access from another pertinent public-accountability perspective: [W]e would expect governments (and taxpayers) to examine the fact that they are essentially funding the same purchase three times: governments and taxpayers fund most academic research, pay the salaries of the academics who undertake the peer review process and fund the libraries that buy the output, without receiving a penny in exchange from the publishers for producing and reviewing the content....We do not see this as sustainable in the long term, given pressure on university and government budgets.(10) NIH is hardly alone among research funders in recognizing the importance of public access. It is part of a broad worldwide movement to leverage the benefits of sharing research findings.(11) For example, the UK's publicly funded Medical Research Council (MRC) "requires electronic copies of any research papers that have been accepted for publication in a peer-reviewed journal, and are supported in whole or in part by MRC funding, to be deposited into PubMed Central (PMC) or UK PMC, to be made freely available as soon as possible and in any event within six months of the journal publisher's official date of final publication."(12) Major private biomedical funders Howard Hughes Medical Institute(13) and Wellcome Trust(14) also both require availability of their funded research in PubMed Central or UK PubMed Central within six months of journal publication. Even without the growing international take-up of public access, it would be in the U.S. taxpayer's interest to make it easier for the rest of the world to access the results of U.S.-funded research. We collectively benefit from medical advances by scientists who often work collaboratively across national boundaries. Substantial leverage on the U.S. research investment is obtained when a discovery reported by an US-based NIH investigator leads to a further advance by a researcher elsewhere. This leverage needs to be encouraged and expanded if we are to effectively meet such complex global challenges as avian influenza and HIV/AIDS. Enhancement of NIH management capabilities is yet another rationale for investigator deposit of their funded research findings in PubMed Central. As Director Zerhouni has pointed out, this will permit NIH to monitor, mine, and develop its portfolio of funded research more effectively and will make it easier for all scientists to pursue NIH's research priorities effectively.(15) The NIH Public Access Policy is a critical element of the larger adaptation to opportunities for innovation brought about by the Internet and networked technology. It will result in a more dynamic and faster-moving scientific process, better suited to address increasingly complex health challenges. Sufficiency of the NIH Policy Development Process The protracted and deliberative process leading to the NIH Public Access Policy that took effect on April 7, 2008 has resulted in an implementation approach that effectively balances the reasonable interests of all stakeholders. In the months since its announcement on January 11, 2008, NIH and its grantee institutions have made substantial headway in introducing the new policy to investigators. As a result, investigator deposits in PubMed Central have surged in 2008-nearly doubling in the short time the policy has been mandatory.(16) This welcome and anticipated upturn in compliance comes after a long consultative process that began in 1999, when then-NIH Director Harold Varmus articulated a proposal that ultimately led to establishment of NIH's PubMed Central online digital archive.(17) PubMed Central, as originally deployed in February 2000 and expanded in the following several years, succeeded in securing voluntary deposit of research articles by a number of publishers and clearly demonstrated the benefits and scalability of an open online biomedical research resource and the absence of material risk to participating publishers. But, being voluntary, it failed to capture more than a tiny fraction of NIH-funded research. At the same time, the U.S. Congress took a growing bipartisan interest. In 2004, the House Appropriations Committee expressed concern about the lack of public access to NIH research and put forward a solution recognizing the role of the Internet in advancing NIH's mission: The Committee is very concerned that there is insufficient public access to reports and data resulting from NIH-funded research. This situation, which has been exacerbated by the dramatic rise in scientific journal subscription prices, is contrary to the best interests of the U.S. taxpayers who paid for this research. The Committee recommends that NIH develop a policy, to apply from FY 2005 forward, requiring that a complete electronic copy of any manuscript reporting work supported by NIH grants or contracts be provided to PMC upon acceptance of the manuscript for publication in any scientific journal listed in the NLM's PubMed directory. Under this proposal, NLM would commence making these reports, together with supplemental materials, freely and continuously available six months after publication....(18) Signaling the issue's importance to the agency, NIH Director Elias Zerhouni personally engaged the discussion by conducting multiple public meetings with publishers, scientists, and patient groups in 2004. Based on these meetings, NIH published a proposal for public access to NIH-funded research in the NIH Guide on September 3, 2004. It called on all NIH-funded investigators to "provide the NIH with electronic copies of all final version manuscripts upon acceptance for publication" for free public availability through PubMed Central "six months after an NIH supported research study's publication-or sooner if the publisher agrees." The proposal explicitly highlighted NIH's desire for stakeholder input: The economic and business implications of any changes to the current paradigm must be considered as the NIH weighs options to ensure public access to the results of studies funded with public support without compromising the quality of the information being provided. The NIH has established and intends to maintain a dialogue with publishers, investigators, and representatives from scientific associations and the public to ensure the success of this initiative.(19) Between September 3 and November 16, 2004, NIH received 6,249 comments on the proposal, the overwhelming majority of which were supportive.(20) Nevertheless, moving conservatively in the face of narrowly focused journal publisher concern, NIH implemented on May 2, 2005 an initial Public Access Policy that requested (rather than mandated) deposit of articles stemming from NIH-funded research and pushed the embargo on public access to as much as 12 months after publication. As part of its policy document, NIH presented an inventory of key issues raised in public comments and a detailed explanation of how the policy implementation takes account of these. They also articulated the agency's three sound strategic objectives: 1) Create a stable archive of peer-reviewed research publications resulting from NIH-funded research to ensure the permanent preservation of these findings; 2) Secure a searchable compendium of these peer-reviewed research publications that NIH and its awardees can use to manage more efficiently and to understand better their research portfolios, monitor scientific productivity, and ultimately, help set research priorities; and 3) Make published results of NIH-funded research more readily accessible to the public, health care providers, educators, and scientists.(21) Within a year of the voluntary policy's implementation, it was clear that this approach-which resulted in deposit of fewer than five percent of eligible articles-failed to address the agency's stated objectives. Responding to the striking shortfall, the NIH Public Access Working Group-established by the NIH and composed of publishers, societies, researchers, patient groups, and libraries-recommended on November 15, 2005, that researchers be required to deposit articles in PubMed Central and that public access be provided within six months of journal publication. On February 8, 2006 the National Library of Medicine's Board of Regents endorsed this recommendation.(22) The U.S. Congress agreed, inserting language into the LHHS Appropriations bill in 2006 and again in 2007, calling for deposit to become mandatory. This change, endorsed by both the House and the Senate, was signed into law in December 2007. The current policy implementation is the outcome of nearly a decade of information gathering, broad and probing community discussion, and continuing bipartisan encouragement and direction from Congress. The issues have been extensively covered in the scientific press (e.g., Science, Nature, New England Journal of Medicine, The Lancet) and mainstream media (e.g., NBC Nightly News(23), National Public Radio, USA Today, Wall Street Journal, Washington Post). Scientists and the public support it, as do the current NIH director and his predecessor. Despite this long history, a handful of publisher organizations, which do not speak for all journal publishers, continue to charge that the policy has been framed without adequate publisher consultation. This claim is absurd and groundless. NIH has gone to great lengths to understand and, within reason, accommodate the needs of publishers. Indeed, the Office of the NIH Director has met with publishers to discuss the policy 29 times between 2003 and March 2008, versus 20 meetings with all other stakeholders.(24) In addition, publishers have had numerous meetings with the staff of the National Center for Biotechnology Information in the National Library of Medicine, where PubMed Central is maintained, to work out procedural matters associated with the policy implementation. The policy has undergone a lengthy, thorough and extremely public vetting process, which has amply demonstrated that: * NIH's objectives are important and well focused; * Agency consultation with stakeholders (including journal publishers) on how best to implement the NIH Public Access Policy has been extensive; * The various interests at issue and potential impacts are well understood by NIH; * NIH has gone to great lengths to accommodate publisher demands, in particular by incorporating a lengthy access embargo provision in its policy; * The peer review process will not be harmed by NIH's announced policy implementation; and * Further delay or dilution of the policy is damaging to the public interest. Strengths of the Current Policy Implementation SPARC believes the policy now in force is a smart, well-considered, and effectively balanced means of accomplishing the agency's important objectives. Several features are the foundation of its strength: PubMed Central Ensures Archiving and Access Only by requiring deposit of articles in NIH's PubMed Central online archive can NIH ensure that: * Articles will be systematically preserved over time in digital form; * Persistent access will be assured to all potential users; and * The potential of new computational research techniques will be unlocked. No other solution put forward over the years meets these objectives or NIH and Congressional aims. Providing a digital archive of NIH-funded research is entirely consistent with the mission of the National Library of Medicine, which for over 150 years has provided the public with access to and preservation of the biomedical literature. In the digital arena, its National Center for Biotechnology Information, home of PubMed Central and other online resources, already serves millions of users. It has been efficiently, effectively preserving and delivering full-text journal articles through PubMed Central for the past eight years, and has the proven infrastructure and expertise to handle the estimated 80,000 articles that will be deposited annually as a result of the policy. Publishers, on the other hand, have never had archiving in their business plans, a responsibility that has fallen squarely on the shoulders of libraries. Archival stability could be further enhanced if the NLM archive contents were replicated at multiple sites, such as institutional digital repositories at the universities of NIH investigators and digital archives maintained by other nations' national libraries or research funders. Inadequate Alternative Proposals Several times over the years, opponents of the NIH proposal have called for publishers' web servers to substitute for PubMed Central. While we enthusiastically support the continuing role of journals and publishers' online journal aggregations, we reject in the strongest possible terms the notion that they can substitute for PubMed Central. NIH thoroughly studied a publisher-developed linking proposal, conducted discussions of this with the publishers, and ultimately, dismissed it as failing to address adequately the needs of either taxpayers or the government. As an alternative to PubMed Central, linking would fail to address the need for stable, long-term digital preservation of and access to the public resource represented by articles resulting from NIH funding. Publishers cannot guarantee that they will continue to provide open access to the linked articles over the long term since they may someday change their business models, go out of business, or sell their journals. Perhaps most crucially, under this proposal, NIH and the public would be left with a "dark" archive-one that can only be accessed by a handful of individuals with proper permissions-and thus would be extremely vulnerable to erosion in the quality of its contents. It is widely accepted that, for a large database to be properly curated, as many people as possible should access it and use the content on a regular basis, thus ensuring its continuing integrity. Given the compelling and widely acknowledged need for digital preservation, linking will not save the government money since it does not obviate the relatively modest cost of transforming manuscripts into appropriate, standardized digital archiving formats and maintaining web access to these. Furthermore, the linking alternative would fail to address the computational research opportunities offered by a homogeneous database. Maintaining the federally underwritten scientific record on PubMed Central is a uniquely effective, scalable, economical, and practical solution to a pressing need and opportunity. Suitability of Final Peer-reviewed Manuscripts We are aware that questions have been raised about the impact of PubMed Central capturing "final peer reviewed manuscripts" rather than published articles (except when instigated by the publisher). We are convinced the strategy of capturing final peer-reviewed manuscripts in PubMed Central is a perfectly suitable approach. It well serves scientists and the public while reinforcing the differentiation between journals and PubMed Central. It is no different than the long tradition of releasing scientific findings in conference proceedings that precede peer-reviewed publication or the well-established practice of posting pre-prints by many journals (including many biomedical journals). It is similar to the experience in physics, where the arXiv.org pre-print server has co-existed with journals for a more than a decade. To our knowledge, none of these longstanding practices has resulted in damage to the scientific record or its users. There are practical ways to mitigate any potential ambiguity of having pre- and post-print versions, such as by including links between article versions or embedding metadata to indicate the version.(25) There is no valid reason for such concerns to alter the NIH plan. A Fair Balance of Interests in an Environment of Change Before the Internet, the best available means of fulfilling the government's obligation to maximize sharing and application of its funded research findings was through the exclusive use of toll-gated channels offered by journal publishers. But in the digital networked environment, it is possible to do far better. It is thus fair, reasonable, and responsible for the government to attach requirements pertaining to dissemination of the article as a condition of the grantee acceptance of funds. And it is no less reasonable for the grantee to make those conditions a part of the author's transfer of rights to a publisher. The publisher pays nothing to obtain the rights granted by the author. The quid pro quo is that the publisher will maximize availability of the article so that its findings are used and applied as widely as feasible. The expense of any value addition by the publisher is undertaken with full awareness of the author's obligation to the research funder. Given the unprecedented publicity surrounding the NIH Public Access Policy, it is unimaginable that the NIH requirement is unknown to any publisher of biomedical journals. In a letter supporting the current NIH policy, Michael Rossner, Executive Director of the Rockefeller University Press, publisher of two high-impact biological science journals, frames the motives of policy opponents: All scientific publishers understand several truths: 1) that their content is generated in large part through federally funded research, 2) that the peer review process is carried out in large part by federally funded individuals, and 3) that a significant portion of their subscription revenue is obtained from government funded institutions. Many publishers believe they have an obligation to give something back to the public that has provided those funds, and they make their online content free after a short delay under subscription control. However, a few large, highly profitable publishers have refused to do this, and have thus forced the NIH into the position of mandating deposition of NIH-funded research publications in PubMed Central to make them available to the public.(26) For some time, the Rockefeller University Press, like a growing number of other journal publishers, has taken a forward-looking approach, depositing their journals in PubMed Central and permitting public access after a six-month embargo. In the long course of considering the NIH Public Access Policy, no evidence has ever been presented that journals whose articles are available via PubMed Central have been rendered unable to financially sustain themselves. Some publishers have pointed to the heavy use of articles in the years after lapse of the PubMed Central embargo, suggesting this demonstrates that PubMed Central will reduce the value to them of the articles-and thus NIH should compensate them. However, publishers receive most of their revenue based on pre-paid subscriptions to journals, not use of articles. Their revenue does not increase with any particular shape of a usage curve. No Impact on Copyright Disposition or US Copyright Law Some opponents of the policy continue to claim that the NIH policy interacts adversely with U.S. copyright law. To the contrary, the NIH policy does not create a statutory exception or limitation to an investigator's copyright. It merely requires the agency to condition its grant of funding on the investigator's agreement to provide PubMed Central with a copy of his article for the purpose of making the article publicly available via PubMed Central. If an investigator chooses not to receive NIH funding, he need not provide his article to PubMed Central. But if he elects to receive NIH funding, he must accept certain reasonable conditions, including deposit of the article with PubMed Central so that the article can be made publicly accessible. This condition serves the interests of the public, which funded the research, and of NIH, which depends on awareness of and application of its research findings to drive medical advances. The policy also does not implicate the publisher's copyright. Many STM publishers require the investigator to transfer the copyright in the article as a condition to agreeing to publish the article. If, as a condition of receiving NIH funding, the investigator grants NIH a non-exclusive license to use the article, then the copyright the investigator subsequently transfers to the publisher is already subject to this license. This means that the proposed provision does not change the scope of the publisher's copyright after the publisher has acquired it. Rather, the investigator will have agreed to grant PubMed Central a license long before the publisher even enters into the picture. Contrary to the suggestion of some publishers, the NIH policy does not constitute a "compulsory license" or a "taking." A compulsory license arises when the statute requires the copyright owner to permit others to use his work without his authorization. By contrast, under the NIH policy, the copyright owner retains complete control of his work, unless he chooses to accept NIH funding. The proposed provision simply provides that, in exchange for public funding, the investigator must deposit a copy of the articles stemming from that funding with PubMed Central so that NIH can make it publicly available. Significantly, there is nothing unusual about a federal agency placing conditions on its funding of research projects. These conditions relate to a wide range of issues, including intellectual property rights. The policy is consistent with this tradition. No Impact on International Agreements Several publishers have argued that the NIH Public Access Policy would violate U.S. treaty obligations under Article 13 of TRIPS and Article 9 of the Berne Convention, and potentially constitute a "compulsory license." These arguments have no merit. The policy concerns contract terms, not copyright exceptions. As such, it in no way implicates Article 13 of TRIPS or Article 9 of the Berne Convention, which address permissible copyright exceptions. These treaty provisions are completely silent on the issue of the terms a funder or other licensee can require of a copyright owner in exchange for valuable consideration. Properly Placed Compliance Responsibility By providing for deposit of articles by funds recipients, the policy correctly recognizes that the only operative legal relationship that can support the long-term preservation of articles in PubMed Central is the relationship between the grantee or contractor and NIH, as framed by the agency's award terms. Investigators have the option of either depositing their final peer-reviewed manuscript in PubMed Central as soon as it has been accepted for publication or publishing it in a journal that will deposit the article on their behalf. It is the singular responsibility of the recipient of federal funds to ensure compliance with federal grant guidelines and requirements. The publisher cannot and should not be presumed to have inserted itself into the relationship between the federal government and the funding recipient, where the sole responsibility for grant compliance and accountability resides. The publisher has no obligation or incentive to cooperate. There is no assurance that publishers will actually comply, now or in the future after close public and Congressional scrutiny has faded. Reasonable Expectations of Researchers Grant Recipients In the near term, author/investigators will be required to navigate new territory to retain rights in their publication agreements consistent with their NIH public access obligation. However, NIH and campus education programs are well underway and can be expected to facilitate compliance in the months ahead.(27) Also, there are several legally vetted and well-publicized addenda forms that authors may attach to journal publishers' copyright agreements to ensure retention of rights to deposit in PubMed Central.(28) The need of an author to comply with the NIH policy will certainly not influence acceptance an article by any reputable journal. Many research universities also can be expected to take steps ensuring their investigators have the right to deposit their works in PubMed Central. Several strategies for institutional action have been outlined in a recent white paper by Prof. Michael Carroll of Villanova University law school.(29) Harvard University set an example of institutional action recently when the Faculty of Arts and Sciences voted to give the university a worldwide license to make each faculty member's scholarly articles available and to exercise the copyright in the articles, provided that the articles are not sold for a profit, ensuring the university has the rights necessary to provide NIH with articles arising from the agency's funding.(30) In addition, there is every reason to believe that publisher policies will quickly adapt to recognize the needs of their authors and thus streamline the process. This is no different than journals' virtually universal recognition in their publication agreements that works by U.S. Government employees are in the public domain. It is safe to say that publishers, as a practical matter, will likewise implement contractual provisions acknowledging the NIH Public Access requirement. Even before the NIH policy, a growing number of publishers had begun permitting authors to offer access to their articles in open online repositories such as PubMed Central.(31) And in just the past several months many publishers have adapted their agreements in response to the NIH policy.(32) BioOne, an online publishing platform used by approximately 140 biosciences journals, has recently released a model publication agreement that would grant publishers an exclusive right of first publication and a perpetual, non-exclusive right to distribute articles while also allowing authors to deposit their work in digital repositories such as PubMed Central directly or permitting the publisher to deposit to the National Library of Medicine on their behalf. NIH's taxpayer obligations are perhaps hastening the reshuffling of rights in articles, but the overall change is part of a larger process set in motion by the capabilities of the Internet. An example is Rockefeller University Press, which recently acknowledged the need for journal publishers to revise their perspective on copyright in the Internet age by announcing a new copyright policy under which authors will retain the copyright to their published work and are obliged only to attribute the work to its original publication. Six months after publication, third parties can use the material under the terms of a Creative Commons license, which will allow computational and other reuses.(33) Upholding the Peer Review Process The NIH policy is careful to avoid any negative impact on the continuity of journal subscriptions and, more importantly, the peer review process.(34) The PubMed Central access embargo leaves journals as the exclusive source of access for up to 12 months. Few journal subscribers are prepared to wait this long to know about the latest research in their field. While SPARC believes 12 months is an excessive delay, we recognize that an embargo of some duration may be necessary-at least for the time being-as a means to balance important interests.(35) The embargo is a blunt, unambiguous means of guaranteeing the journal's uniqueness while ensuring that research eventually becomes widely available. An abundance of data on prestigious and profitable publishers demonstrates that when access to journals is available free after as little as a two-month embargo, neither institutional nor individual subscription renewal rates are materially affected. A survey of libraries by a publisher organization, the Association of Learned and Professional Society Publishers (ALPSP), reinforces this experience, indicating that the vast majority of librarians are not considering canceling journal subscriptions in response to public availability of research.(36) Moreover, many commercial and nonprofit publishers today allow authors to immediately archive their accepted articles under terms and conditions substantially similar to those proposed for NIH. In fact, more than 340 journals have made their articles available via PubMed Central, with embargoes ranging from zero to 12 months, without being forced out of business. Several have publicly shared their positive experiences, including the American Society for Cell Biology, which since 2001has made its journal, Molecular Biology of the Cell, available on PubMed Central after only a two-month embargo. Despite this "liberal" access policy, the journal has profited and grown. Similarly, the American Society for Microbiology, publisher of 11 journals (including Molecular and Cellular Biology, Journal of Virology, and Eukaryotic Cell), recently reduced the embargo period on all of its primary research articles from six to four months, having decided on the basis of experience that such a move would not endanger the financial position of the society.(37) Abundant Protection for Publishers' Interests The embargo permitted by the NIH policy is just one of several ways in which journals are differentiated from PubMed Central. There are many other factors that underscore the continuing demand for journals in the era of public access, including these: * The vast majority of research articles in most life sciences journals do not arise from NIH-funded research. This reinforces libraries' need to maintain their subscriptions to journals, which provide access to the articles that will not be available in PubMed Central. The ALPSP survey reported that for most librarians (76%) an archive would have to contain over 90% of the journal's content, and nearly half would need to see 100% duplication before they would view it as a potential substitute for a journal. * Most journals publish a great deal more content than just research articles, which are the only component required to be deposited under the NIH policy. Many journals also offer letters, editorials, opinion pieces, book reviews, news, and conference information. These value-added features will be found only in journals, not in online archives unless the publisher so chooses. Our member libraries are not apt to cancel subscriptions to journals that successfully deliver these kinds of value-added services. * Under the policy, NIH captures only the author's final accepted manuscript-not the formatted, paginated, copyedited, published version of the article preferred by authors for citation purposes-unless the publisher consents. While the quality of papers included in PubMed Central has been certified and they are suitable for use by individual taxpayers, most scientists and researchers in institutional settings will insist on access to the most authoritative version published in journals. Many commercial and nonprofit publishers have already acknowledged the safety and utility of multiple versions by allowing authors to immediately self-archive the penultimate peer-reviewed version of an accepted article under terms and conditions substantially similar to those proposed for NIH. * Researchers use PubMed Central in ways that differ greatly from their journal reading. As part of NIH's richly interlinked system, articles in PubMed Central are integrated with comprehensive links to the world's biomedical journal literature and other resources such as DNA and protein sequence databases, 3D protein structure and protein domain data, population study datasets, expression data, assemblies of complete genomes, and taxonomic information. This unique environment enhances users' ability to follow a research thread and is part of what makes PubMed Central a uniquely useful and important research tool. However, it is not a replacement for the convenience of browsing a journal. Timely public access to NIH-funded research findings via PubMed Central will leverage the federal investment without undermining longstanding business interests. Experience in other fields has demonstrated that online archives do not displace journals. For example, most new articles in physics are freely available from their creation in the arXiv (http://www.arxiv.org/) open-access archive, developed in the early 1990s with U.S. Department of Energy funding and in continuous operation since then. Yet subscription-based physics journals have continued to thrive, indicating that open archiving is not a threat to journals. The American Physical Society and Institute of Physics Publishing are unable to identify any subscriptions lost as a result of arXiv in its entire existence.(38) Potential Policy Enhancement We believe that a maximum 12-month embargo on public access is too long and a six-month maximum is a better balance of important interests. Six months allows adequate time for publishers to recoup their costs while ensuring that research is widely available while it still is useful. SPARC has no less a stake than publishers and the NIH in supporting the review of scientific research to ensure its quality. We are confident that a policy requiring public access within six months of first publication does not fundamentally threaten the ability of journals to sustain themselves and the research certification process they orchestrate. As stated previously, there is no credible evidence of a risk to journals from an embargo of six months or less. Monitoring of the Policy We encourage the NIH to closely monitor key aspects of the Public Access Policy's implementation, including: * Experience of publishers with six-month or shorter embargos: It is in the taxpayer interest to reduce the duration of the public access embargo to as short a period as possible. NIH should collect data on the sustainability of biomedical journals that offer open access within six months of publication in order to evaluate the potential to reduce the maximum PubMed Central embargo. * Extent to which eligible articles are captured in PubMed Central: For the policy to succeed, it is imperative that deposit of articles from NIH-funded research be nearly universal. We trust the agency will track this and take reasonable, appropriate steps to ensure success. Conclusion The NIH Public Access Policy embraces the potential of the Internet to enable new and increased usage of NIH-funded research findings by millions of scientists, physicians and health clinicians, public health officials, patients, small businesses, students, teachers, and others. SPARC commends NIH for its vision and leadership in putting forward this important policy. The essential elements of the policy are sound and should go forward as outlined in the current implementation. We urge NIH to monitor the rates of deposit, along with the experiences of publishers who choose a six-month or shorter timeframe. If possible, it should reduce the length of the access embargo or eliminate it altogether. * * * 1 See "The effect of open access and downloads ('hits') on citation impact: a bibliography of studies," available at http://opcit.eprints.org/oacitation-biblio.html. 2 John Houghton and Peter Sheehan, "The Economic Impact of Enhanced Access to Research Findings," CSES Working Paper No. 23, July 2006, pp. 7-8. Available at http://www.cfses.com/documents/wp23.pdf. 3 Open letter to the U.S. Congress, July 8, 2007. Available at https://mx2.arl.org/Lists/SPARC-OAForum/Message/3858.html. 4 Statement of Patrick White, Association of American Universities, at NIH Public Meeting, March 20, 2008, available at http://www.aau.edu/intellect/Comments_White_NIH_PAP_32008.pdf. 5 "NASULGC Offers Support for NIH Public Access Policy" available at http://nasulgc.org/NetCommunity/Page.aspx?pid=896&srcid=836 . 6 "AIRI Statement on Open Access, Released October 28, 2004." Available at http://www.airi.org/washington/statement_access.aspx. AIRI statements in support of the current mandatory NIH Public Access Policy implementation were presented at the March 20, 2008 NIH Public Meeting (http://videocast.nih.gov/ram/grants032008.ram) and posted on NIH's Comment Results web page (http://publicaccess.nih.gov/comments/comments_web_listing.htm). 7 Sharon Terry, "In the Public Interest: Open Access," C&RL News, July/August 2005, Vol. 66, No. 7. Available at http://www.ala.org/ala/acrl/acrlpubs/crlnews/backissues2005/julyaugust05/publicinterest.cfm. 8 Harris Interactive, "Large Majorities of U.S. Adults Support Easy - and Free - Online Access to Federally-Funded Research Findings on Health Issues and Other Topics," The Harris Poll #44, May 31, 2006, http://www.harrisinteractive.com/harris_poll/index.asp?PID=671. 9 Quoted in Alliance for Taxpayer Access, "Mandate for Public Access to NIH-Funded Research Poised to Become Law," October 24, 2007, available at http://www.taxpayeraccess.org/media/release07-1024.html. The Chamber of Commerce's support is also conveyed in "U.S. Chamber Applauds NIH Open Access Proposal; Action Will Make Taxpayer-Funded Research Freely Available to Public," a September 9, 2004 press release from the Chamber available at http://www.uschamber.com/press/releases/2004/september/04-121.htm. 10 Credit Suisse First Boston, Sector Review: Scientific, Technical and Medical Publishing. April 6, 2004. 11 Research funders' open access policies are compiled by SHERPA and available at http://www.sherpa.ac.uk/juliet/. 12 Medical Research Council (UK), "MRC position statement in support of open and unrestricted access to published research." April 2008, available at http://www.mrc.ac.uk/PolicyGuidance/EthicsAndGovernance/OpenAccessPublishingandArchiving/PositionStatement/index.htm. 13 Howard Hughes Medical Institute, "Research Policies: Public Access to Publications (SC-320)," June 11, 2007, available at http://www.hhmi.org/about/research/sc320.pdf. 14 Wellcome Trust, "Position statement in support of open and unrestricted access to published research," February 2008, http://www.wellcome.ac.uk/About-us/Policy/Spotlight-issues/Open-access/Policy/index.htm. 15 Elias A. Zerhouni, "The NIH Public Access Policy: Overview and Context," presentation at the NIH Open Meeting on Public Access, Mar. 20, 2008. http://publicaccess.nih.gov/comments/Overview_Context.pdf. 16 Statistics available at: http://www.nihms.nih.gov/stats/index.html 17 Dr. Varmus's proposal and selected comments are available at http://www.nih.gov/about/director/pubmedcentral/ebiomedarch.htm. 18 House Report 108-636, Departments of Labor, Health And Human Services, And Education, And Related Agencies Appropriation Bill, 2005. http://thomas.loc.gov/cgi-bin/cpquery/?&db_id=cp108&r_n=hr636.108&sel=TOC_338641&. 19 Available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-064.html. Also published in the Federal Register on September 17, 2004 (http://edocket.access.gpo.gov/2004/pdf/04-21097.pdf). 20 Presentation by Director Zerhouni at March 20, 2008 Open Meeting on Public Access, slide 12. Available at http://publicaccess.nih.gov/comments/Overview_Context.pdf. 21 "Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research," NIH Guide for Grants and Contracts, NOT-OD-05-022, February 3, 2005. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html. 22 National Library of Medicine, Minutes of the Board of Regents, February 7-8, 2006. Available at http://www.nlm.nih.gov/od/bor/2-06bor.pdf. 23 In December 2004, NBC Nightly News called the lack of public access to NIH-funded research a "Fleecing of America." See http://www.msnbc.msn.com/id/6660340. 24 Presentation by Director Zerhouni at March 20, 2008 Open Meeting on Public Access, slide 12. Available at http://publicaccess.nih.gov/comments/Overview_Context.pdf. 25 Protocols for addressing this are under development by the National Information Standards Organization and the Version Identification Framework project of UK's Joint Information Systems Committee. 26 Michael Rossner, letter to Tevi Troy, Deputy Secretary, US Department of Health and Human Services, Feb. 26, 2008. Available at http://publicaccess.nih.gov/comments/files/DHHS_letter.doc. 27 The NIH requirement that applications, proposals, and progress reports must include the PubMed Central reference number when citing an article will spur vastly expanded awareness of the policy. In addition, a substantial number of institutionally organized educational efforts are underway, some of which are listed in the Association of Research Libraries' web resource, "NIH Public Access Policy: Guide for Research Universities," at http://www.arl.org/sc/implement/nih/guide/nih-resources.shtml. NIH-sponsored Public Access communications and training activities are listed at http://publicaccess.nih.gov/communications.htm. 28 See, for example, the Science Commons Scholar's Copyright Addendum Engine at http://scholars.sciencecommons.org/. 29 Michael Carroll, "Complying with the National Institutes of Health Public Access Policy: Copyright Considerations and Options," published by SPARC, the Association of Research Libraries, and Science Commons. Available at http://www.arl.org/news/pr/carroll-paper-29feb08.shtml. 30 "Harvard to collect, disseminate scholarly articles for faculty," Harvard University Gazette Online, Feb. 13, 2008. Available at http://www.news.harvard.edu/gazette/2008/02.14/99-fasvote.html. 31 A current summary of rights retained by authors as part of each publisher's copyright agreement is available at http://www.sherpa.ac.uk/romeo.php. 32 The Edward G. Miner Library of the University of Rochester Medical Center has posted a selective list of publishers' policies issued in response to NIH's Public Access policy. See http://www.urmc.edu/hslt/miner/research_and_publishing/PublishersPoliciesonPubMedCentralMinerLibrary.cfm. 33 Emma Hill and Mike Rossner, "You wrote it; you own it!" Journal of Cell Biology, Vol. 181, No. 3, pp. 405-406, published online April 30, 2008. http://www.jcb.org/cgi/content/full/jcb.200804037. 34 It is important to recognize that, in virtually all cases, the peer review itself is done on a voluntarily basis by scientists. The publisher does not pay them; their institution and funders underwrite this contribution. The publisher role in peer review is to organize the solicitation of potential reviewers. 35 SPARC has long advocated a six-month embargo as a compromise that better balances reasonable taxpayer expectations with publisher interests. 36 Mark Ware. ALPSP Survey of Librarians on Factors in Journal Cancellation. Association of Learned and Professional Society Publishers (March 2006). Summary and conclusions available at http://www.alpsp.org/publications/libraryreport-summary.pdf. 37 Gary Ward, "Deconstructing the Arguments Against Improved Public Access," ASCB Newsletter, vol. 29, no. 11 (Nov. 2006), p. 6. 38 Key Perspectives. Open access self-archiving: An author study (May 2005), p. 3. Available at http://www.keyperspectives.co.uk/openaccessarchive/reports/Open%20Access%20II%20(author%20survey%20on%20self%20archiving)%202005.pdf.	Web Form
143	Web RFI	05/30/2008 at 12:03:02 PM (456)	Case	Mary	MALS	University of Illinois at Chicago	IL	USA	Representative NIH Funding Recipient Organization	UIC supports the revised NIH Public Access Policy. We believe, however, that NIH would more effectively leverage the investment in government dollars in health sciences research by mandating an embargo of 6 months or less rather than the 12-month embargo of the current public access policy. UIC recognizes that publishers have some concern that libraries will cancel journals as a result of the NIH mandate. However, UIC will not cancel journal subscriptions due to the NIH Public Access policy, even if there were a 6 month embargo—6 or more months is too long of a delay for access to needed research while a significant number of journal articles will not be covered by the NIH Policy. UIC is also are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.	We recommend advice for researchers who encounter one-click copyright agreements during article submission.	The updated FAQ's and current information on the NIH Public Access site help us to keep researchers well informed. UIC has adopted a copyright addendum, developed a NIH Policy website, and targeted mailings to NIH researchers as well as to all faculty, in a joint effort by the Provost, Office of the Vice Chancellor for Research, and the Library. Issues may arise in the next year as implementation progresses, and periodic requests for comment will allow a continuing dialog among all stakeholders.	UIC welcomes this opportunity to express our support for the revised NIH Public Access Policy and its goal of public access to the published results of NIH-funded research. These comments are submitted on behalf of UIC Vice Chancellor for Academic Affairs and Provost Michael Tanner, Interim Vice Chancellor for Research Larry Danziger, and Mary Case, University Librarian.			Web Form
144	Web RFI	05/30/2008 at 01:59:43 PM (277)	Yeager	Lynn	MLS	University of Oklahoma - Tulsa	OK	United States	Representative NIH Funding Recipient Organization				We are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.			Web Form
145	Web RFI	05/30/2008 at 02:03:36 PM (951)	Dylla	H. Frederick	PhD	American Institute of Physics	MD	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	The American Institute of Physics (AIP), an umbrella organization for 10 physics-related societies representing 130,000 scientists and engineers and a nonprofit publisher of physics journals, remains concerned about government-mandated public access. We believe that making the results of tax-payer funded research widely available is an important objective that may accelerate scientific discovery and increase the probability that important discoveries will be used in a more timely fashion. Although the intent of public-access policy is laudable, the issues underlying the implementation of this policy are economic and legal, and may result in unintended consequences detrimental to scientific societies.The reliance on authors to deposit articles is problematic. Publishers want to perform this action on behalf of their authors, but the NIH implementation requirements make this unnecessarily difficult. NIH should form a working group that includes publishers and the NIH representatives to work out the details of implementation.AIP as publisher retains copyright but grants authors rights to deposit their manuscripts into Pub Med Central (PMC). That permission does not grant NIH the right to provide the manuscripts to other entities, domestic or international, unless agreed to by the publisher. The public law that had created the mandate said nothing about NIH sharing the deposited works with other entities. AIP will consider such actions to be a violation of its copyright and take action to protect its interest. In addition, we ask that NIH ensure all possible measures are taken to eliminate article piracy. Should a piracy occur, publishers are to be notified and provided with any information NIH may have about the infringer. Furthermore, it should be stated for the record that Congress recently addressed the research-access issue in Title VII of the America COMPETES Act by establishing an access policy to research funded by the National Science Foundation (NSF). In the National Science Foundation Authorization Act, which was signed into law by the President in August 2007 as Title VII of the America COMPETES Act (P.L.110-69), Congress addressed the issue of ensuring public access to the results of government-funded research. The Act directed NSF to make all “final project reports and citations of published research documents” resulting from NSF funded research available to the public in a timely manner and in electronic form through the NSF’s Web site. The Conference agreement (House Report 110-289) further clarified that NSF is required “to provide the public a readily accessible summary of the outcomes of NSF-sponsored projects,” along with “citations to journal publications,” in which funded researchers have published articles regarding such research. Since the NSF research-access policy was developed by Congress and is now public law, and since NSF funds research for all disciplines (and 20% of all basic research), other Federal research-funding agencies should follow this model in making their research widely available to the public. The NSF research-access model helps meet the important objective of widespread dissemination of research findings without undermining the important intellectual property and copyright protections that help sustain the scientific publishing community. Who pays for the value-added after an author submits his/her manuscript to a publisher or institutional online platform is an important question that needs to be addressed. Should institutional platforms—such as PMC—be using government funds to reproduce what is already effectively supplied by the private sector? Publishers (both for-profit and nonprofit) invest considerable resources in the editorial and production processes that underlie high-quality journals. The result is high-quality articles that have been peer reviewed, copyedited, and properly referenced to the world’s scientific literature. The articles are then made available in online versions on highly reliable, digital platforms that constantly evolve to meet the changing needs of their readers. They are also published and distributed in print versions—the only form accepted by some archivists and librarians as archival. Publishers who provide this value-added to the submitted manuscripts are compensated for this service under several business models. The models typically involve the reader paying (through institutional or individual subscriptions) or the author paying (through open-access fees or page charges) or a combination of the two. If the NIH public-access policy is implemented without real engagement of the publishing community, the viability of the journal publishing enterprise—a significant asset to the scientific community and valuable means of distribution to the international scientific community—could be adversely affected. Scientific journals help assure the integrity of science by organizing and managing peer review of scientific manuscripts to guarantee their accuracy as well as publishing, archiving and disseminating the articles. Publishers invest hundreds of millions of dollars each year in the peer-review process that ensures all research articles are rigorously reviewed by experts in specialized fields before they are published. Federal agency research-access policies that would undermine our nation’s scientific enterprise must be avoided.	A useful way to minimize the negative unintended consequences of the current mandatory policy would be to establish, maintain and empower a working group of representatives from the publishing community and the NIH to help guide implementation and modifications to the current policy.	The previous voluntary policy (2005) failed, in part, because there was no significant collaboration between NIH and publishers of scientific journals, to either optimize the implementation of the policy or to examine the unintended consequences of the policy. To avoid a similar failed implementation this time, NIH should work collaboratively with the publishing community.	Although AIP disapproves the NIH implementation of the NIH Public Access Policy, it is so important that the accurate record of scientific progress not be distorted by the appearance of multiple and differing versions of the purported final manuscript that AIP is prepared to bear the full cost involved in handling the deposit of the final published version of the article on behalf of the author. AIP is committed to staying engaged to ensure that improvements are made in the NIH implementation process.			Web Form
146	Web RFI	05/30/2008 at 02:22:55 PM (752)	Kenney	Anne	PhD	Cornell University Library	NY	USA	Representative NIH Funding Recipient Organization					NIH_RFC_Cornell_f.txt	May 30,2008 To: Neil Thaker Special Assistant to the NIH Deputy Director for Extramural Research National Institutes of Health From: Anne R. Kenney, Carl A. Kroch University Librarian, Cornell University Library Carolyn Anne Reid, M.A., AHIP, The Frances and John L. Loeb Librarian of Medicine and Director, Weill Cornell Medical Library Pamela T. Plotkin, Deputy Director, Office of Sponsored Programs, Cornell University Catherine E. Long, Associate Vice President, Research, Cornell University Subject: Response to Request for Information: NIH Public Access Policy, FR Doc. E8-6579 (NOT-OD-08-060) Cornell University Library, including the Weill Cornell Medical College and Cornell Office of Sponsored Programs, submit on behalf of Cornell University the following responses to the questions in the Request for Comments found at http://publicaccess.nih.gov/comments.htm. #1 Do you have recommendations for alternative implementation approaches to those already reflected in the NIH Public Access Policy? The implementation seems to be going very well right now. The NIH FAQ is excellent, and the NIH tutorials are good. We are loath to see any quick changes that would have an impact on the system as it now stands. There are, however, some improvements that NIH should implement: 1. Require researchers to retain the right to submit the PDF as published, rather than their final manuscript. There are several reasons why this change should be implemented: * Our experience has been that Cornell authors would prefer that their best work-meaning the authoritative published version-be what is available to the public. The author's final manuscript, while better than nothing, is not as valuable. It would eliminate the confusion created by having two public versions of a paper. * Requiring the deposit of the article as published would also obviate the extra step of having the manuscript as reworked by NIH subsequently approved by the PI. Anything that can be done to make the process less demanding of the PIs time should be implemented. * The change is not as radical as one might think. Already the PMC partner journals deposit the published article for the authors. Many other journals will allow deposit of published articles after payment of an open access fee. There are no copyright implications for this, since NIH researchers would only be able to publish in journals that permit such deposit. If a journal does not wish to have the published version made available through PMC, it can refuse to publish NIH-funded research. 2. As we stated in our previous submission of comments in March 2008 (http://publicaccess.nih.gov/comments/comments_web_listing.htm), it would be very helpful if the maximum embargo period were much shorter, at most 6 months. A 12-month embargo constitutes too long a delay for access to needed research information. Research libraries will not cancel needed biomedical journal subscriptions even if a 6-month embargo is implemented. No journal publishes only NIH-funded research. In order to have ready access to the significant amount of biomedical information not covered by the revised NIH Public Access Policy, research libraries will need to maintain current subscriptions. A shorter embargo period would allow greater use by the public of the NIH-funded research without harming the subscription market for publishers. In addition, a shorter embargo period would conform to existing Cornell practice. In September 2007, the Cornell University Faculty Senate passed a resolution encouraging all faculty to attach to their publishing contracts the SPARC Author's Addendum. The addendum calls for at most a 6-month moratorium on access. The NIH policy is therefore in conflict with existing Cornell practice. 3. We understand that the single most important change that needs to be made is underway and should be implemented soon, changing the NIHMS system so that Corresponding Authors, in addition to PIs, can approve manuscripts after formatting. In many cases, and especially with training grants, the PI is often only tangentially involved with a publication. The author designated to correspond with publishers should be the one able to approve manuscripts in the NIHMS system. #2 In light of the change in law that makes NIH's public access policy mandatory, do you have recommendations for monitoring and ensuring compliance with the NIH Public Access Policy? Compliance should be the responsibility of the PI. The institution should be responsible for informing the PI about his or her responsibilities under the NIH mandate and educating the PI should the policy not be followed. In extreme cases of repeated refusal to comply with the mandate, it may be necessary to exclude PIs from consideration for future grants or even ban an institution from eligibility. This "death threat," however should exist in theory only, as a spur to enhanced educational activities. We see a model comparable to FERPA (Family Educational Rights and Privacy Act) implementations on campuses. While repeated FERPA violations could in theory cause an institution to lose all federal funding, in practice FERPA violations are handled on an ad hoc basis through education and training. Formal institutional review of the publishing practices of researchers in order to ensure compliance with the new requirements should be avoided. It is logistically impossible for our Office of Sponsored Programs (OSP) to confirm that all of the researchers submitting NIH applications, proposals, and progress reports have included the PubMed Central reference number for all papers that they cite that fall under the policy. Nor would it be appropriate for OSP to approve the selection of a publisher or the terms of a publication contract for this would have serious implications for academic freedom. We are happy to publicize requirements of the NIH grant, but it is ultimately the responsible for the PI to assure compliance. #3 In addition to the information already posted at http://publicaccess.nih.gov/communications.htm, what additional information, training or communications related to the NIH Public Access Policy would be helpful to you? It is critical for the success of this initiative that NIH continues to invest in the infrastructure that makes it easy to implement. There are at least three things that NIH should be doing: actively soliciting more journals to become full NIH partners; maintaining, in addition to the list of partner journals, a current list of titles for which journal publishers will submit author manuscripts on behalf of the authors; and coordinating with groups such as SHERPA/RoMEO and OAKLIST to ensure that they contain accurate information on the compliance/non-compliance of STM publishers with the PMC mandate. Additional comments related to the NIH Public Access Policy We commend NIH for soliciting comments while moving ahead in a timely manner with this critically important, congressionally mandated policy. Cornell University supports the revised NIH Policy because it is integrally tied to the mission of higher education. Public support for science is enhanced when the public can see the benefits from our investments in scientific research. Scientific research itself is advanced when there is wide dissemination of new knowledge. Many parts of our institution including the Vice-Provost for Research, the University Counsel's Office, the Office of Sponsored Programs, and the Cornell University Library, have been actively engaged in assisting NIH-funded researchers in complying with the revised policy. Working together we have established an informational website at http://www.library.cornell.edu/nihmandate/ and a mailing list to answer questions at nihmandate@cornell.edu. We have also revised our "Form 10 Addendum for NIH proposals", the mandatory NIH certification statement that is required of all PIs when they submit a grant proposal to the NIH. This form has been modified to include a reminder about the PI's responsibility under the NIH Public Access Policy. A series of workshops have been held for interested faculty, staff, and graduate students, and a mailing to all current NIH-funded PIs has been completed. The Weill Cornell Medical Library and Office of Research and Sponsored Programs have undertaken similar steps specifically to inform medical college PIs and authors. In short, the University has made a substantial investment in educating NIH researchers and in complying with the new requirements. We welcome incremental improvements to the program such as we suggested above. Any hiatus in the current implementation, however, would only confuse and anger researchers, negate the substantial investment our institution has already made in compliance, and make the successful implementation of any revised program much harder. Cornell University is an equal opportunity, affirmative action educator and employer.	Web Form
147	Web RFI	05/30/2008 at 02:34:05 PM (893)	Russell	Ian	BSc	ALPSP	North Somerset	UK	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	The Association of Learned and Professional Society Publishers (ALPSP) is the international association for non-profit publishers and those that work with them. ALPSP is the only international association that represents scholarly and professional publishers across all disciplines of academic endeavour. Its broad and diverse membership includes publishers of journals operating on author-side payment models, subscription models and hybrid business models combining these. ALPSP has more than 360 organizational members including more than 40 in the United States. We have members in 36 countries who collectively publish more than 10,000 journals – around half the world’s total - as well as books, databases and other resources.ALPSP’s mission is to play an active part in shaping the future of academic and scholarly communication, and we welcome the opportunity given by the National Institutes of Health to comment on the ‘Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research’ (NOT-OD-08-057) (Revised Policy) by responding to the ‘Request for Information: NIH Public Access Policy’ (NOT-OD-08-060).This submission will only comment on those questions which we consider relevant to the ALPSP membership.Many journal publishers, and most of those publishing in the biomedical sciences, make the final ‘version of record’ journal article freely available on the Internet a maximum of 12 months after publication. We believe that it would be highly preferable if NIH linked PubMed and/or PubMed Central to final published journal articles on publishers’ website and adapted PubMed and PubMed Central to allow for full-text searching across the publishers’ websites.This approach does not constitute a “dark archive” as some have suggested since articles appearing in journals operating a delayed open access publishing model are available freely on the Internet in compliance with the NIH public access requirement. We would suggest that the policy mandating deposit of peer-reviewed manuscripts in PubMed Central should be reserved for only those articles published in journals that do not make content freely available on the publishers website after 12 months or less.There are numerous advantages to this approach:* It would provide a more comprehensive ‘one-stop-shop’ for searching the biomedical literature which would include vastly more than the 10% of articles that arise from NIH funded research* It would assist with version control and enable readers to access the trustworthy version of record with corrections, links to corrigenda and errata and thus maintain the integrity of the corpus of literature* Journals would be able to determine their own access policies within a 12 month timeframe based upon the requirements of their business models* It would eliminate needless and expensive duplication of the storage, curation and preservation of a large number of research articlesWe therefore urge NIH to reconsider this proposal.We note the confusion that has arisen from the use of the term “journal articles” in the Public Access Frequently Asked Questions (FAQs) posted on January 11, 2008 and the continued use of the terms “journal manuscripts” and “journal papers” used in the amended version of the FAQs (http://publicaccess.nih.gov/FAQ.htm) as updated on May 2, 2008. We believe that NIH should be clear and unambiguous in referring to the final peer-reviewed manuscript in order to avoid confusion with the final journal version of record.We would draw your attention to the NISO / ALPSP project on Journal Article Versions (see http://www.niso.org/workrooms/jav) which will shortly produce a standard nomenclature for versions of journal articles. We urge NIH to utilize these definitions once the standard has been formally announced by NISO.We note that Congress directed the NIH to ensure copyright agreements and rights were preserved and it seems onerous, unfair and an avoidance of this responsibility to transfer that obligation to researchers. At the very least the NIH should implement procedures during the process of uploading manuscripts to PubMed Central to check that the version of the article uploaded is consistent with copyright law and that institutions and investigators are complying with their obligation to ensure that “any publishing or copyright agreements concerning submitted articles fully comply with this Policy”.The Revised Policy now calls for the deposit of review articles. Review articles are commissioned by Publishers and Editors and are written based on the scientific expertise of the author; they are not based on the specific research projects supported by NIH grants and we therefore respectfully suggest that review articles should not be subject to the mandatory Revised Policy.	As mentioned in above, ALPSP believes that NIH should implement measures to ensure that manuscripts deposited in Pub Med Central in response to the Revised Policy are the correct version and that the Revised Policy is therefore implemented in a manner consistent with journal policies and copyright law.To assist with version control, adherence to copyright law and to minimize duplication of costs, NIH should implement measures to ensure that where manuscripts are deposited by journals on behalf of their authors the submission of duplicate copies or different versions are not accepted for ingress into PubMed Central.We believe that NIH should implement measures to detect inappropriate usage of manuscripts and other copyrighted material posted on PubMed Central and should immediately alert the publisher of any articles so abused. NIH should also implement specific safeguards to prevent copyrighted material available on PubMed Central from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose.	ALPSP fully supports the thorough list of concerns regarding the NIH public access policy and its implementation advanced by the Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition. These questions were raised in a letter (see www.dcprinciples.org/Zehouni-4-16-08.pdf) to Dr E A Zerhouni on April 16, 2008 and are repeated below for your convenience.Questions / comments raised by Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition1) Regarding Consultation with Publishers, Societies and Authors• Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals?• What is NIH’s timeline for amending this policy moving forward?• What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed?2) Regarding Copyright • Why hasn’t the NIH supported the full value of copyright and its use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central?3) Regarding Brand Protection, Repurposing and Piracy• What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers?• Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus?• How will NIH ensure proper protection of publisher or society trademarks and branding? There been no affirmation of these markers of quality, and often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain.• How will NIH respect the rights of copyright holders and stipulate what NIH will or will not allow related to third-party use of its works? Will NIH, for example, ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher?• How will NIH prevent piracy of the articles from PubMed Central? Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers?• If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites?4) Regarding Compensation• What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done?• The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?5) Regarding Scope• If other public or private funders support research also supported by NIH, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central?• Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based?• The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision?• What will the repercussions be for investigators and journals that do not follow the process?• NIH’s 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews?6) Regarding Integrity of Research, Quality Control and Meaningful Public Access• How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal?• Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted?• For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher?• How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? Will NIH develop, for example, a special section within PMC for members of the general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to voluntary health organizations (VHOs), Patient Inform, publisher sites?• How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?7) Regarding Cost• NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy?• Does this cost detract from funds to grantees actually conducting the innovative research that advances science?8) Regarding Measuring Impact and Effectiveness• Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions?• What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)?• What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?	ALPSP supports the principle of public access to scientific literature but believes that the aims of the NIH public access policy are best met by NIH consulting and working in conjunction with all relevant stakeholders, including publishers, on an ongoing basis and in a robust and meaningful manner.We believe that by implementing the Revised Policy on April 7, 2008 - before completing a thorough consultation - the approach taken by NIH regarding the Revised Policy does not adhere to the Administrative Procedure Act. We also note the short timescales between the announcement on March 7, 2008 of a public meeting regarding the Revised Policy, the meeting taking place on March 20, 2008 and the Revised Policy coming into effect on April 7, 2008.We therefore respectfully request that the NIH suspend the Revised Policy and undertake a formal rulemaking according to the provisions of the Administrative Procedure Act. A Rulemaking would allow all interested stakeholders the opportunity to comment with adequate deadlines and offer a formal procedure via which the NIH could address the issues raised.In addition, we are aware of calls for the NIH to reduce the upper limit of the Revised Policy’s embargo period from 12 months to six months or less. Research (see for example Self-Archiving and Journal Subscriptions: Co-existence or Competition? (Beckett and Inger 2007; www.publishingresearch.net/documents/Self-archiving_summary2.pdf) and ALPSP Survey of Librarians on Factors in Journal Cancellation (Ware 2006; www.alpsp.org)) has indicated that the upper limit of 12 months is the minimum required for publishers of biomedical journals supported by subscription revenues to have a chance of recovering their costs. We therefore urge NIH to commit retaining the upper limit at 12 months and allow journals to choose a shorter embargo period if it is compatible with their business model.	ALPSP_Response_to_NIH_RFI.txt	ALPSP’s response to Request for Information: National Institutes of Health Public Access Policy (NOT-OD-08-060) To: Office of Extramural Research National Institutes of Health 1 Center Drive, Room 144 Bethesda, MD 20892-0152 Email: PublicAccess@nih.gov From: Ian Russell Chief Executive Association of Learned and Professional Society Publishers Bluebell Lodge, 8 Rickford Road Nailsea, BRISTOL BS48 4PY UK 1 Introduction The Association of Learned and Professional Society Publishers (ALPSP) is the international association for non-profit publishers and those that work with them. ALPSP is the only international association that represents scholarly and professional publishers across all disciplines of academic endeavour. Its broad and diverse membership includes publishers of journals operating on author-side payment models, subscription models and hybrid business models combining these. ALPSP has more than 360 organizational members including more than 40 in the United States. We have members in 36 countries who collectively publish more than 10,000 journals – around half the world’s total - as well as books, databases and other resources. ALPSP’s mission is to play an active part in shaping the future of academic and scholarly communication, and we welcome the opportunity given by the National Institutes of Health to comment on the ‘Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research’ (NOT-OD-08-057) (Revised Policy) by responding to the ‘Request for Information: NIH Public Access Policy’ (NOT-OD-08-060). This submission will only comment on those questions which we consider relevant to the ALPSP membership. 2 General comments ALPSP supports the principle of public access to scientific literature but believes that the aims of the NIH public access policy are best met by NIH consulting and working in conjunction with all relevant stakeholders, including publishers, on an ongoing basis and in a robust and meaningful manner. We believe that by implementing the Revised Policy on April 7, 2008 - before completing a thorough consultation - the approach taken by NIH regarding the Revised Policy does not adhere to the Administrative Procedure Act. We also note the short timescales between the announcement on March 7, 2008 of a public meeting regarding the Revised Policy, the meeting taking place on March 20, 2008 and the Revised Policy coming into effect on April 7, 2008. We therefore respectfully request that the NIH suspend the Revised Policy and undertake a formal rulemaking according to the provisions of the Administrative Procedure Act. A Rulemaking would allow all interested stakeholders the opportunity to comment with adequate deadlines and offer a formal procedure via which the NIH could address the issues raised. 3 Question 1 - Do you have recommendations for alternative implementation approaches to those already reflected in the NIH Public Access Policy? 3.1 Many journal publishers, and most of those publishing in the biomedical sciences, make the final ‘version of record’ journal article freely available on the Internet a maximum of 12 months after publication. We believe that it would be highly preferable if NIH linked PubMed and/or PubMed Central to final published journal articles on publishers’ website and adapted PubMed and PubMed Central to allow for full-text searching across the publishers’ websites. This approach does not constitute a “dark archive” as some have suggested since articles appearing in journals operating a delayed open access publishing model are available freely on the Internet in compliance with the NIH public access requirement. We would suggest that the policy mandating deposit of peer- reviewed manuscripts in PubMed Central should be reserved for only those articles published in journals that do not make content freely available on the publishers website after 12 months or less. There are numerous advantages to this approach: * It would provide a more comprehensive ‘one-stop-shop’ for searching the biomedical literature which would include vastly more than the 10% of articles that arise from NIH funded research * It would assist with version control and enable readers to access the trustworthy version of record with corrections, links to corrigenda and errata and thus maintain the integrity of the corpus of literature * Journals would be able to determine their own access policies within a 12 month timeframe based upon the requirements of their business models * It would eliminate needless and expensive duplication of the storage, curation and preservation of a large number of research articles We therefore urge NIH to reconsider this proposal. 3.2 We note the confusion that has arisen from the use of the term “journal articles” in the Public Access Frequently Asked Questions (FAQs) posted on January 11, 2008 and the continued use of the terms “journal manuscripts” and “journal papers” used in the amended version of the FAQs as updated on May 2, 2008. We believe that NIH should be clear and unambiguous in referring to the final peer-reviewed manuscript in order to avoid confusion with the final journal version of record. We would draw your attention to the NISO / ALPSP project on Journal Article Versions which will shortly produce a standard nomenclature for versions of journal articles. We urge NIH to utilize these definitions once the standard has been formally announced by NISO. 3.3 We note that Congress directed the NIH to ensure copyright agreements and rights were preserved and it seems onerous, unfair and an avoidance of this responsibility to transfer that obligation to researchers. At the very least the NIH should implement procedures during the process of uploading manuscripts to PubMed Central to check that the version of the article uploaded is consistent with copyright law and that institutions and investigators are complying with their obligation to ensure that “any publishing or copyright agreements concerning submitted articles fully comply with this Policy”. 3.4 The Revised Policy now calls for the deposit of review articles. Review articles are commissioned by Publishers and Editors and are written based on the scientific expertise of the author; they are not based on the specific research projects supported by NIH grants and we therefore respectfully suggest that review articles should not be subject to the mandatory Revised Policy. 4 Question 2 - In light of the change in law that makes NIH’s public access policy mandatory, do you have recommendations for monitoring and ensuring compliance with the NIH Public Access Policy? 4.1 As mentioned in 3.3 above, ALPSP believes that NIH should implement measures to ensure that manuscripts deposited in Pub Med Central in response to the Revised Policy are the correct version and that the Revised Policy is therefore implemented in a manner consistent with journal policies and copyright law. 4.2 To assist with version control, adherence to copyright law and to minimize duplication of costs, NIH should implement measures to ensure that where manuscripts are deposited by journals on behalf of their authors the submission of duplicate copies or different versions are not accepted for ingress into PubMed Central. 4.3 We believe that NIH should implement measures to detect inappropriate usage of manuscripts and other copyrighted material posted on PubMed Central and should immediately alert the publisher of any articles so abused. NIH should also implement specific safeguards to prevent copyrighted material available on PubMed Central from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose. 5 Question 3 - In addition to the information already posted at http://publicaccess.nih.gov/communications.htm, what additional information, training or communications related to the NIH Public Access Policy would be helpful to you? 5.1 ALPSP fully supports the thorough list of concerns regarding the NIH public access policy and its implementation advanced by the Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition. These questions were raised in a letter to Dr E A Zerhouni on April 16, 2008 and are attached to our response as Appendix I for your convenience. 6 Question 4 - Do you have other comments related to the NIH Public Access Policy? Please see our general comments in section 2 above. In addition, we are aware of calls for the NIH to reduce the upper limit of the Revised Policy’s embargo period from 12 months to six months or less. Research has indicated that the upper limit of 12 months is the minimum required for publishers of biomedical journals supported by subscription revenues to have a chance of recovering their costs. We therefore urge NIH to commit retaining the upper limit at 12 months and allow journals to choose a shorter embargo period if it is compatible with their business model. Ian Russell Chief Executive, ALPSP May 2008 Appendix I – Questions / comments raised by Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition 1) Regarding Consultation with Publishers, Societies and Authors • Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals? • What is NIH’s timeline for amending this policy moving forward? • What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed? 2) Regarding Copyright • Why hasn’t the NIH supported the full value of copyright and its use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central? 3) Regarding Brand Protection, Repurposing and Piracy • What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers? • Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus? • How will NIH ensure proper protection of publisher or society trademarks and branding? There been no affirmation of these markers of quality, and often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain. • How will NIH respect the rights of copyright holders and stipulate what NIH will or will not allow related to third-party use of its works? Will NIH, for example, ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher? • How will NIH prevent piracy of the articles from PubMed Central? Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers? • If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites? 4) Regarding Compensation • What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done? • The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years? 5) Regarding Scope • If other public or private funders support research also supported by NIH, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central? • Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based? • The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH- funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision? • What will the repercussions be for investigators and journals that do not follow the process? • NIH’s 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews? 6) Regarding Integrity of Research, Quality Control and Meaningful Public Access • How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal? • Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted? • For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher? • How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? Will NIH develop, for example, a special section within PMC for members of the general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to voluntary health organizations (VHOs), Patient Inform, publisher sites? • How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions? 7) Regarding Cost • NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy? • Does this cost detract from funds to grantees actually conducting the innovative research that advances science? 8) Regarding Measuring Impact and Effectiveness • Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions? • What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)? • What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research? http://publicaccess.nih.gov/FAQ.htm http://www.niso.org/workrooms/jav See http://www.dcprinciples.org/Zehouni-4-16-08.pdf See for example Self-Archiving and Journal Subscriptions: Co-existence or Competition? (Beckett and Inger 2007; www.publishingresearch.net/documents/Self-archiving_summary2.pdf) and ALPSP Survey of Librarians on Factors in Journal Cancellation (Ware 2006; www.alpsp.org) ALPSP RESPONSE TO REQUEST FOR INFORMATION: NIH PUBLIC ACCESS POLICY (NOT-OD-08-060) 7 of 7 The Association of Learned and Professional Society Publishers Shaping the Future of Learned and Professional Publishing	Web Form
148	Web RFI	05/30/2008 at 02:41:48 PM (821)	Giesecke	Joan	Doctorate	University of Nebraska-Lincoln	Nebraska	USA	Other	At the University of Nebraska-Lincoln we have developed a simple, cost effective system to alert faculty to the deposit requirement and have provided resources in the library to assit eith or to deposit publications for the faculty. We have found that so far faculty are publishing in journals where the publisher is depositing the article in PubMed for the authors. The process of depositing papers in Pub MEd is not impacting the decision of the library to purchase any given journal title.	Anything NIH can do to notify the campus research compliance office when an article is deposited would be helpful. While the faculty will be notified, it will help campus accounting to have the information directly from NIH.	Continuing updates on which journals will deposit in PubMEd for the author is greatly appreciated.	This policy is helping to make NIH funded resaerch more readily available. It is not impacting our decisions on which journals to purchase. It has not created a work load problem as we incorporated the requirement into already established campus procedures.			Web Form
149	Web RFI	05/30/2008 at 02:46:02 PM (146)	Todaro	Julie	D.L.S.	Association of College and Research Libraries	IL	USA	Other	The Association of College and Research Libraries (ACRL), a division of the American Library Association (ALA), represents more than 13,000 academic and research librarians and interested individuals. ACRL has long supported the National Institutes of Health’s Public Access Policy, believing that ensuring public access to the fruits of publicly-funded research is a logical, feasible, and widely beneficial goal. We appreciate NIH’s continued, consistent willingness to engage with stakeholders. These comments supplement the ones we submitted this past March.ACRL reiterates its support for the policy as it stands. Public access to publicly funded biomedical research will advance research and education at the nation's colleges and universities, helping undergraduates, graduate students, faculty, and researchers remain competitive with their peers elsewhere in the world. Research in the biomedical sciences advances rapidly, and 12 months, as stipulated in the current policy, is the longest period for which this research should be embargoed if the benefits of public access for education and research are to be realized and our colleges and universities remain globally competitive.Evidence continues to build that the cost of validating, packaging, and disseminating research results can be met through a variety of business models that are consistent with public access. Public access to selected articles is not the primary determinant for most libraries in making subscription decisions -- relevance, quality, and affordable pricing are the key factors. Indeed, a shorter embargo period (6 months) would bring US policy into greater alignment with policies already in place in Canada, the UK, and the European Union, and would better reflect the rapid pace of research in the biomedical fields. We encourage the NIH to consider shortening the embargo period as the U.S. and other countries gain experience with public-access science.Moreover, we understand that the current policy operates within and in accordance with U.S. copyright law and international copyright conventions, and is consistent with the authors' rights in their original manuscripts. Implementation of this policy on member campuses is providing an important opportunity for those communities to discuss intellectual property law and compliance. ACRL has supported member education in this area by, for example, co-hosting (with ARL and SPARC) a special one-hour Webcast for librarians called “Understanding Author Rights.”Academic and research libraries across the country have already invested significant time in helping their campuses prepare for and implement the new policy, through outreach, copyright education, technical support, and other means. ACRL, guided in part by its Scholarly Communication Committee, will continue to assist its members with implementation of the policy by, for example, documenting and sharing best practices, promulgating model publication agreements, and providing education about the rapidly changing scholarly publishing environment in which this policy fits. The ARL-ACRL Institute on Scholarly Communication and a new shorter workshop on scholarly communication, currently in development, both cover the NIH policy.Alternative arrangements, such as links to publishers' web sites, would not serve the public well or achieve the NIH goal of assuring a permanent, stable public archive of the research it has funded. Over the long term, as publishers and journals change ownership, links would inevitably break and more work would be required of NIH staff to maintain the links than would be needed to maintain a central repository. Advanced researchers will still rely on the published record for citation and other purposes. NIH has wisely rejected the model of a dark archive in the past, and should continue to do so.	Individual campuses are in the best position to explain their needs and circumstances with respect to encouraging and monitoring compliance with the new policy. However, ACRL encourages the NIH to work with campuses on two fronts:First, establishing routine communication with campus offices of research. These are the campus entities best positioned to ensure consistent, timely communication with investigators who might be planning an NIH grant application. Increasingly, campus offices of research are collaborating with their university libraries to help investigators understand the policy and comply with it, and NIH might consider encouraging such collaboration where appropriate.Second, collaborating with the institutional repository community -- and with individual campuses that maintain open repositories of the scholarship of their faculty and students -- to identify ways to coordinate manuscript deposit between PubMed Central and institutional repositories, possibly in batch uploads or downloads.					Web Form
150	Web RFI	05/30/2008 at 03:15:25 PM (313)	Becker	Mila	JD	American Society of Hematology	DC	USA	Other Member of the Public	In 2006, the American Society of Hematology (ASH) developed an agreement with the National Institutes of Health (NIH) creating a new option for its journal, Blood, to comply with the NIH policy on enhanced access. All Blood authors who published NIH-funded articles from May 2005 forward have no obligation to submit manuscripts to the NIH archive because Blood does this on their behalf. The PMC (NIH Portfolio) Archive Program was the result of efforts by ASH and a group of nonprofit publishers to improve compliance with the voluntary NIH public access policy while maintaining the publisher-mandated access embargoes. The PMC (NIH Portfolio) Archive Program has the following terms: The participating project provides NIH with final articles representing NIH-funded research. NIH has internal use of the articles during participating journals’ embargo period, which can be no longer than 12 months. During the embargo period, NIH can link to the journal web sites to provide access to NIH-funded research articles; following the embargo period, NIH can provide links to the journal, but can also distribute articles directly from its PMC web site (NIH’s view of an article includes a page banner that identifies the corresponding journal and provides a link to the journal’s own web site). ASH volunteered to have Blood be the first participant in the program and agreed to provide articles going back to the original May 2005 implementation date of the original NIH Public Access Policy. ASH has implemented the PMC (NIH Portfolio) Archive Program for almost two years, and the Society strongly believes that this option meets the NIH Public Access Policy goals while providing a better alternative for journals and authors than the newly mandated policy. Consequently, ASH’s comments below focus on the importance of maintaining this option and promoting participation in it to other nonprofit publishers.ASH strongly believes that the PMC (NIH Portfolio) Archive Program provides a better alternative for journals and authors than the newly mandated policy. Through this option, NIH obtains one hundred percent compliance in the policy by participating journals because the journals submit to NIH the final version of NIH funded research articles upon publication on behalf of their authors. NIH also has the ability to create a stable archive of peer-reviewed research publications resulting from NIH-funded research and a secure searchable compendium of these peer-reviewed research publications that NIH can use to manage research portfolios and set research priorities. In addition, this program protects the integrity of journal articles by allowing the journal to submit the final article, maintains journal business models by protecting the embargo period and the peer-review system, and, importantly, continues to allow enhanced access of science to researchers and the public. ASH believes NIH should take steps to increase its outreach to other nonprofit publishers to promote participation in this program.	The American Society of Hematology (ASH) strongly believes that the PMC (NIH Portfolio) Archive Program provides a better alternative for journals and authors than the newly mandated policy. Through this option, NIH obtains one hundred percent compliance in the policy by participating journals because the journals submit to NIH the final version of NIH funded research articles upon publication on behalf of their authors. NIH also has the ability to create a stable archive of peer-reviewed research publications resulting from NIH-funded research and a secure searchable compendium of these peer-reviewed research publications that NIH can use to manage research portfolios and set research priorities. In addition, this program protects the integrity of journal articles by allowing the journal to submit the final article, maintains journal business models by protecting the embargo period and the peer-review system, and, importantly, continues to allow enhanced access of science to researchers and the public. ASH believes NIH should take steps to increase its outreach to other nonprofit publishers to promote participation in this program.	The American Society of Hematology (ASH) has several comments related to the information and responses provided in the Frequently Asked Questions material posted at http://publicaccess.nih.gov/FAQ.htm#content. They are as follows:Section A-General Information - The information provided to question 1 states, “It [NIH Public Access Policy] requires scientists to submit journal articles that arise from NIH funds to the digital archive PubMed Central.” ASH recommends that this information reference that scientists are required to submit or publish in a journal that will submit on their behalf. In this way, NIH acknowledges upfront the option of the PMC (NIH Portfolio) Archive Program. The Society believes that researcher authors may want to eliminate the burden of submitting their articles to NIH and may be attracted to submitting their articles that will provide this service for them.Section B-Scope of the Policy - The information provided in response to question 2 states, “The Policy applies to all peer-reviewed journal articles, including research reports and reviews. The Policy does not apply to non-peer-reviewed materials such as correspondence, book chapters, and editorials.” It has come to the Society’s attention, however, that several non-peer-reviewed materials have been submitted and posted to PMC. Therefore, ASH urges NIH to make sure implementation of the Policy is consistent with this response.The information provided in response to question 4 concerns whether submission is required for research funded by a grant or cooperative agreement that expired before FY 2008. ASH recommends that NIH include in this response that the author should check with the journal to make sure the submission is not duplicative, if he or she decides to submit.Section C-How to Comply With the Policy – ASH is pleased that NIH has included in the response to question 1 that some publishers have agreed to make the final published article of every NIH-funded article publicly available in PubMed Central within 12 months of publication and for these journals, authors do not need to do anything to fulfill the submission requirement. The Society recommends, however, that this language also be included prominently upfront in the General Information section as well in order to make sure authors are aware of this option and to prevent duplication of submission or incorrect submission by well-intended authors.ASH is also pleased that NIH notes in response to question 2 that authors should work with the publisher before any rights are transferred to ensure that all conditions of the NIH Public Access Policy can be met. It is critical that authors be encouraged to work with their publishers in order to meet the requirements of the NIH Public Access Policy and also the requirements of the publisher. Similarly, ASH recommends that in response to question 3 concerning language for the copyright agreement, NIH should refer authors back to their publishers to ensure that the authors adhere to the publishers’ requirements and legal counsel. On this point, ASH is particularly concerned that NIH intramural investigators recently were instructed to only use the NIH publishing agreement, not accept a publisher’s copyright transfer agreement, and to submit their manuscript (not final article) to PubMed Central upon acceptance. Further, the recent instructions to intramural researchers state that if the journal rejects the NIH Publishing Agreement or wants to change it, the author must recall the manuscript and submit it to another journal. These instructions are not only inconsistent with the Public Access FAQ, but they undermine the terms of the PMC (NIH Portfolio) Archive Program. ASH believes that if an article is based on NIH-funded research by a NIH intramural researcher the information is in the public domain. Legally, therefore, the intramural researcher author cannot assign copyright to ASH or to the NIH. ASH would like to discuss this more thoroughly with NIH to resolve issues raised in these instructions following the Request for Information comment period.		RFI_Comments_5-30-08.txt	May 30, 2008 Via Electronic Submission to PublicAccessComments@NIH.gov RE: Request for Information: NIH Public Access Policy The American Society of Hematology (ASH) appreciates this opportunity to provide input on the NIH Public Access Policy and the responses to frequently asked questions available through NIH’s public access website. ASH represents over 16,000 clinicians and scientists committed to the study and treatment of blood and blood-related diseases. These diseases encompass malignant hematologic disorders such as leukemia and lymphoma, non-malignant conditions including anemia and hemophilia, and congenital disorders such as sickle cell anemia and thalassemia. ASH members are active participants in NIH’s programs, recipients of NIH grants, and contributors to NIH’s research accomplishments. The Society publishes the premier scientific journal in hematology, Blood, and is committed to a collaborative relationship with NIH to assure that important research findings are published and disseminated by print and electronic means to the public through rigorous independent peer review. In 2006, ASH developed an agreement with the National Institutes of Health (NIH) creating a new option to comply with the NIH policy on enhanced access. All Blood authors who published NIH-funded articles from May 2005 forward have no obligation to submit manuscripts to the NIH archive because Blood does this on their behalf. The PMC (NIH Portfolio) Archive Program was the result of efforts by ASH and a group of nonprofit publishers to improve compliance with the voluntary NIH public access policy while maintaining the publisher-mandated access embargoes. The PMC (NIH Portfolio) Archive Program has the following terms: The participating project provides NIH with final articles representing NIH-funded research. NIH has internal use of the articles during participating journals’ embargo period, which can be no longer than 12 months. During the embargo period, NIH can link to the journal web sites to provide access to NIH-funded research articles; following the embargo period, NIH can provide links to the journal, but can also distribute articles directly from its PMC web site (NIH’s view of an article includes a page banner that identifies the corresponding journal and provides a link to the journal’s own web site). ASH volunteered to have Blood be the first participant in the program and agreed to provide articles going back to the original May 2005 implementation date of the original NIH Public Access Policy. ASH has implemented the PMC (NIH Portfolio) Archive Program for almost two years, and the Society strongly believes that this option meets the NIH Public Access Policy goals while providing a better alternative for journals and authors than the newly mandated policy. Consequently, ASH’s comments below focus on the importance of maintaining this option and promoting participation in it to other nonprofit publishers. Recommendations for Alternative Implementation Approaches to those Already Reflected in the NIH Public Access Policy – As stated above, ASH strongly believes that the PMC (NIH Portfolio) Archive Program provides a better alternative for journals and authors than the newly mandated policy. Through this option, NIH obtains one hundred percent compliance in the policy by participating journals because the journals submit to NIH the final version of NIH funded research articles upon publication on behalf of their authors. NIH also has the ability to create a stable archive of peer-reviewed research publications resulting from NIH-funded research and a secure searchable compendium of these peer-reviewed research publications that NIH can use to manage research portfolios and set research priorities. In addition, this program protects the integrity of journal articles by allowing the journal to submit the final article, maintains journal business models by protecting the embargo period and the peer-review system, and, importantly, continues to allow enhanced access of science to researchers and the public. ASH believes NIH should take steps to increase its outreach to other nonprofit publishers to promote participation in this program. Recommendations for Monitoring and Ensuring Compliance with the NIH Public Access Policy – ASH believes many stakeholders continue to be confused about the NIH Public Access Policy. We recommend that NIH provide clear and concise information about how to comply with the Policy and alternatives like the PMC (NIH Portfolio) Archive Program to authors and potential publisher partners. Recommendations Concerning the Information and Responses to the Public Access Frequently Asked Questions – Section A-General Information - The information provided to question 1 states, “It [NIH Public Access Policy] requires scientists to submit journal articles that arise from NIH funds to the digital archive PubMed Central.” ASH recommends that this information reference that scientists are required to submit or publish in a journal that will submit on their behalf. In this way, NIH acknowledges upfront the option of the PMC (NIH Portfolio) Archive Program. The Society believes that researcher authors may want to eliminate the burden of submitting their articles to NIH and may be attracted to submitting their articles that will provide this service for them. Section B-Scope of the Policy - The information provided in response to question 2 states, “The Policy applies to all peer-reviewed journal articles, including research reports and reviews. The Policy does not apply to non-peer-reviewed materials such as correspondence, book chapters, and editorials.” It has come to the Society’s attention, however, that several non-peer-reviewed materials have been submitted and posted to PMC. Therefore, ASH urges NIH to make sure implementation of the Policy is consistent with this response. The information provided in response to question 4 concerns whether submission is required for research funded by a grant or cooperative agreement that expired before FY 2008. ASH recommends that NIH include in this response that the author should check with the journal to make sure the submission is not duplicative, if he or she decides to submit. Section C-How to Comply With the Policy – ASH is pleased that NIH has included in the response to question 1 that some publishers have agreed to make the final published article of every NIH-funded article publicly available in PubMed Central within 12 months of publication and for these journals, authors do not need to do anything to fulfill the submission requirement. The Society recommends, however, that this language also be included prominently upfront in the General Information section as well in order to make sure authors are aware of this option and to prevent duplication of submission or incorrect submission by well-intended authors. ASH is also pleased that NIH notes in response to question 2 that authors should work with the publisher before any rights are transferred to ensure that all conditions of the NIH Public Access Policy can be met. It is critical that authors be encouraged to work with their publishers in order to meet the requirements of the NIH Public Access Policy and also the requirements of the publisher. Similarly, ASH recommends that in response to question 3 concerning language for the copyright agreement, NIH should refer authors back to their publishers to ensure that the authors adhere to the publishers’ requirements and legal counsel. On this point, ASH is particularly concerned that NIH intramural investigators recently were instructed to only use the NIH publishing agreement, not accept a publisher’s copyright transfer agreement, and to submit their manuscript (not final article) to PubMed Central upon acceptance. Further, the recent instructions to intramural researchers state that if the journal rejects the NIH Publishing Agreement or wants to change it, the author must recall the manuscript and submit it to another journal. These instructions are not only inconsistent with the Public Access FAQ, but they undermine the terms of the PMC (NIH Portfolio) Archive Program. ASH believes that if an article is based on NIH-funded research by a NIH intramural researcher the information is in the public domain. Legally, therefore, the intramural researcher author cannot assign copyright to ASH or to the NIH. ASH would like to discuss this more thoroughly with NIH to resolve issues raised in these instructions following the Request for Information comment period. Again, thank you for the opportunity to provide information concerning the NIH Public Access Policy. If the NIH has questions regarding ASH’s comments, please do not hesitate to contact ASH Director of Government Relations & Practice Mila Becker at mbecker@hematology.org or 202.776.0544.	Web Form
151	Web RFI	05/30/2008 at 03:16:04 PM (658)	Goni	Félix	MD	FEBS	Bizkaia	Spain	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	Federation of European Biochemistry SocietiesDepartment of Biochemistry, University College London, Darwin Building, Gower Street, London WC1E 6BT, UKDr ZerhouniNational Institutes of Health9000 Rockville PikeBethesda, MD 2089230th May 2008Dear Dr Zerhouni,Re: National Institutes of Health (NIH) Mandatory Public Access PolicyI am writing on behalf of the Federation of European Biochemistry Societies (FEBS) in response to a request for information (RFI) in the Federal Register, seeking public comment on the NIH Mandatory Public Access Policy.FEBS provides dedicated focal points for its vast network of members in molecular biology and promotes excellence in the molecular life sciences in Europe, through an extended programme of activities, ranging from fellowships, courses and workshops, conferences and scientific publications. FEBS is a not-for-profit scientific organization.Whilst our organization supports the principle of public access to government-funded research and efforts made to enhance public access to science, we have significant concerns about the impact of the public access policy. The policy will affect all stakeholders in the scientific research community but it is likely to have a particularly severe impact on societies such as ourselves, who rely on subscription revenue derived from our journal operations to fund the activities outlined above. We believe that the NIH policy must be implemented in a way that maximizes its effectiveness to the public and the scientific research community, whilst maintaining our journals and Societies.Importance of peer reviewOur organization believes strongly in high-quality journals as a means of ‘sorting the wheat from the chaff’, where readers can be sure that only the best studies have been accepted for publication. Our editorial boards consist of scientists who have demonstrated experimental insight and expertise in their own field and offer a fair and thorough peer-review of submitted manuscripts. In fields of research heavily dependent on experimental findings the quality of the data and the understanding of the limitations that need to be applied to its interpretation require review by scientists who are themselves intimately involved with these same techniques and are crucial to having the findings widely accepted by those in the field. In short, journals add considerable value by performing peer review. The effort and expense of this process is supported entirely by journals and not the NIH. It is a vital service for science and it is imperative that such a system of expert filtering continues. As subscription revenues decline alongside the free availability of these peer-reviewed manuscripts on PMC there is a real risk that the funds supporting the editorial costs of peer-review (funding the electronic editorial office and financial support of editors) will disappear. InfrastructureIn the same way that learned societies act as experts in peer review, it is the active collaboration of our publishers which has aided the efficient transmission of the findings of research to others. This collaboration between experts in science and experts in communication is the principle element in making experimental data, interpretation and analysis available to other researchers world-wide. Just as our Societies’ income derived from our journal operations is fed back into science, publisher profits fund online developments. Once such example is Cross Ref where publishers have collaborated on this initiative bringing about great value to researchers. The notion that secure archiving and continued evolution can be delivered without the involvement of professional publishers who have developed this system seems to defy reason. In an ‘open access’ environment will repositories provide the infrastructure currently offered and continue the evolution of this scientific information process? Quality controlIn addition to undertaking the marketing, distribution and preservation of our journals, our publishers ensure that copyright protections are maintained, take action against piracy and protect authors’ copyright interests. How will the NIH ensure that the policy respects the integrity of the copyrighted content? We feel that subscription-based publishing has succeeded in providing quality assurance, and it important that the journal sites maintain the final published version which authors should cite. As such, NIH should link the accepted manuscript versions on PMC to the definitive published version on the journal sites (via the DOI) as a version of record. On a final note, how is NIH planning to continue the dialogue with stakeholders? We would be keen to learn further how the policy develops and to see if our concerns might be addressed.Yours sincerely,Prof. Félix M. Goñi, Chairman, Publications Committee, FEBS	See our letter under "Question 1".	See our letter under "Question 1".	See our letter under "Question 1".			Web Form
152	Web RFI	05/30/2008 at 04:01:53 PM (223)	Johnson	JQ	M.A.	University of Oregon Libraries	OR	USA	Representative NIH Funding Recipient Organization	- NIH should negotiate additional agreements with journals to allow authors to deposit their author's final version, and publicize the list along with the one in submit_process_journals.htm- Embargo period should be decreased- NIH should set up improved notification and communications tools between PMC and other systems- NIH should not consider major changes to current implementationSee response to Q4 for expansion.	- Change electronic forms to require PMCID as appropriate.See response to Q4 for expansion.	- Easy mechanisms for grantee institutions to receive notification of all items submitted by their faculty in compliance with the Public Access Policy.See response to Q4 for expansion.	The University of Oregon Libraries are very enthusiastic supporters of the NIH Public Access Policy as currently implemented. We have found that implementation costs were low, that short-term side benefits were high, and that long term there is significant enthusiasm among our faculty for the larger public access goals. We have also been very appreciative of NIH willingness to engage all stakeholders, both through public comments such as this and through responses to questions and concerns posted to the NIH website; we have received very rapid and informative responses to questions we have posed.The University of Oregon has invested significant resources in implementing the Public Access Policy. The implementation brought together stakeholders from across campus who do not normally interact, including our library, office of technology transfer, research and sponsored activities, research institutes, and most importantly our research faculty. It has been part of, and a driving force behind, a library initiative to create a new department of “Scholarly Communications and Instructional Support.” We have begun to build a better database of faculty publications, organized training sessions for librarians and research faculty, developed template copyright transfer addenda that retain the rights necessary to comply with the Public Access mandate, and are developing instructional materials for faculty. The mandate was also the major focus of a UO Faculty Senate subcommittee on authors’ rights.The policy has been particularly beneficial in encouraging research faculty to engage in thinking critically about scholarly communications, copyright, and authors’ rights. We note that the public law required implementation consistent with copyright law. We feel that the policy has achieved that goal admirably, simply by forcing faculty members to become more aware of their rights and responsibilities under the law. We even suspect that it is increasing compliance with copyright law among faculty who aren’t directly affected by the policy since it has raised awareness by faculty who had engaged in uses of the works they originally authored that were arguably in violation of the copyright they transferred to the publisher.We are aware that some publishers have expressed concern about the Public Access policy, and believe that concern is misguided. We see no evidence that public access would undermine commercial publishers. Quite to the contrary, the citations to commercial publishers that appear in PubMed Central are free advertising for those publishers, who continue to maintain the copy of record for the published works and through an embargo period continue to have a safeguarded period in which they are providing exclusive access to the information. The evidence is accumulating that providing open access through a repository like PubMed Central increases the visibility and impact of a paper and hence the prestige of the journal in which it is published. By increasing the citation rate and hence the impact factor of the journal, deposit in Pub Med Central increases the probability that our library will continue to subscribe to the journal. Our initial perceptions as a library are that the Public Access Policy is having no impact on journal subscriptions, though we hypothesize a positive impact (increased investment in highly visible journals) in the future.Interestingly, it appears that the implementation of Pub Med Central has also increased the willingness of our faculty to accept embargo periods for their publications, a common request from commercial publishers. In February of this year our faculty Senate passed a resolution encouraging faculty members to use an author’s addendum to insure that they would retain the rights they needed to their work when they transferred copyright. The general consensus at the time was that the SPARC “Access-Reuse” addendum was most appropriate. Largely in response to the Public Access Policy, our Senate modified its recommendation, and in May recommended that faculty members use the “delayed access” addendum that mirrors the Public Access Policy in granting publishers an embargo period.As we look ahead to evolution of the policy, we are concerned that some have called for an alternative to the Public Access Policy in which NIH would create a dark archive. Such an archive would not be maintainable; if a database like this is not used regularly it will not be effectively maintained and preserved. It would not increase the visibility of the research, and hence would not accomplish one of the important benefits of the current Public Access Policy – accelerating access and hence the pace of research and new discoveries. In addition, a dark archive would fail to meet the crucial public policy goal of providing easy public access to medical research by the ordinary citizens whose tax dollars fund that research.For the typical researcher, navigating the complexity of copyright law is the hardest part of complying with the Public Access Mandate. Compliance is made much easier by the large list of journals with whom NIH has negotiated agreements to handle deposit on behalf of the author; this list should be expanded. In addition, it would be very helpful if NIH were to negotiate with other journals agreements that granted authors the right to deposit their author’s final version, and then publicized that list as well.Another change to the current policy that would be desirable would be a shortened maximum embargo period, perhaps to 6 months. The NIH embargo period is likely to become a standard for other uses of academic works, and a standard period that has broad consensus is particularly desirable. Many of our faculty prefer no embargo period, but could be comfortable with a 6 month period, which is also consistent with the widely used Science Commons delayed access author’s addendum.Also, it would be very desirable to improve notification of the availability of items in PubMed Central. It should be easy for an university office of research to subscribe to an RSS feed and receive alerts for all new items deposited from their institution, and easy to coordinate PubMed Central with other repositories, including support for automated transfers using OAI-PMH. To aid monitoring of compliance as well as to increase visibility, NIH electronic forms should be modified to include required fields for PMCID as appropriate in citations. It would also be very desirable for the major bibliographical standards such as APA Format and Science format to mandate the inclusion of a PMCID in references if one exists.The goal of a research university such as the University of Oregon is primarily the creation and conveyance of knowledge. As a public university, we have a particularly strong duty to provide that service for the general public. The Public Access Policy furthers that mission.			Web Form
153	Web RFI	05/30/2008 at 04:06:44 PM (713)	Fox	Christopher	DMD, DMSc	International Association for Dental Research	VA	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)					IADR-AADR_Response_to_NIH_Public_Access_053108_as_submitted.txt	May 30, 2008 NIH Public Access Staff National Institutes of Health Transmitted via http://publicaccess.nih.gov/comments2/comments.htm RE: The International and American Associations for Dental Research Response to the NIH Public Access Policy Request for Information NOT-OD-08-060 (March 28, 2008) To the National Institutes of Health: The International Association for Dental Research (IADR) and its American Division, the American Association for Dental Research (AADR), are owners and publishers of the Journal of Dental Research (JDR), a specialized scientific journal that uniquely serves the craniofacial and dental research community. The IADR, with over 10,500 members worldwide, including 4,500 members in the AADR, is dedicated to advancing research to improve oral health and to facilitating the communication and application of research findings. One method of research communication is through our flagship journal, the JDR, which has the highest Scientific Impact Factor (SIF) of any peer-reviewed dental journal. The main source of revenue to cover the expenses of the peer review infrastructure, print publication and online version comes from individual and institutional subscriptions. In a typical year, the JDR will have about 30% of its accepted research manuscripts with some NIH funding, so the currently enacted NIH policy will have a significant impact on the JDR. Any significant disruption of subscription revenue will adversely affect the financial viability of the JDR. The IADR and AADR strongly support the concept of free access to scientific literature online and, in recent years, have taken significant steps toward that goal. We invested substantial resources in information and Web technologies so that the JDR was able to go full-text online in January, 2002. The IADR and AADR Boards adopted the Washington, DC Principles for Free Access to Science (www.dcprinciples.org). Since January 2005, all online JDR articles have been free to the scientific community and public at-large 12 months after initial publication. And to further enhance free access to the JDR, we digitized all content back to the journal’s inception in 1919 – again, at significant cost to the Associations. This is providing a unique free access resource to over 86 years of the most pivotal published literature in the dental field. Our present record emphasizes our commitment to and responsibility for moving toward the goal of free access and acting as custodians of this literature in the long term. The IADR and AADR expressed opposition to NIH’s earlier voluntary policy of public access, as outlined in NIH NOT–OD–05–022, mainly because of our concern that, in a flat to declining budget environment, the NIH would be investing resources to duplicate a function that was already being handled by the private and, in our case and many other cases, the non-profit sectors. We expressed concern that by favoring one business model of publishing (author-pays) over another (reader-pays), the NIH policy could very well have the unintended consequence of limiting public access to scientific literature by causing the collapse of a number of society-published scientifically important journals. Another serious concern regarded the potential undermining of the publisher’s copyright. Our concerns and those of many others in the scientific and publishing communities notwithstanding, Congress passed and the President signed, in December 2007, the Consolidated Appropriations Act, 2008, which included Division G, Title II, Section 218 of PL 110-161: SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final peer- reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law. On January 11, 2008, the NIH issued a revised policy implementing this law, as described in the NIH Guide for Grants and Contracts (NOT–OD–08–03), with an effective date of April 7, 2008. An open meeting was held on March 20, 2008 on the NIH campus, and the IADR/AADR had an opportunity to comment along with other stakeholders. On March 28, 2008, a Request for Information was issued (NOT-OD-08- 060). While the IADR/AADR supports free access to science as described above, we strongly object to the NIH’s interpretation and current implementation of the mandatory language contained in Division G, Title II, Section 218 of the Consolidated Appropriations Act, 2008. Specifically and most importantly, we do not believe that the NIH has adequately addressed Congress’ proviso that “the NIH shall implement the public access policy in a manner consistent with copyright law.” Requiring NIH grantees and NIH intramural scientists to deposit their final accepted manuscript to NIH PubMed Central (PMC) inherently denies our journal the main benefit of our copyright, namely, the ability to decide how and in what form our journal is distributed. Requiring that the accepted manuscript be placed in PMC, even with a 12- month delay from publication for public access, diminishes the value of our journal business model, which relies on exclusivity to drive traffic, advertising and subscriptions. As mentioned previously, the IADR and AADR have been proactive in allowing free access to all of our journal content, with a 12-month embargo period to non-subscribers. We are able to offer JDR content free of access controls only by the value we derive from driving traffic to our own Web site. It is a source of advertising, attracts new subscribers for the newest content, and recruits new members to our association. We do not have that opportunity if non-subscribers access our copyrighted material only through the earlier accepted manuscript available on PMC. We do not believe that, by so burdening our copyright, the NIH has addressed the legislative mandate to implement the policy “in a manner consistent with copyright law”. Other alternatives to the NIH policy of mandated centralized posting on PMC can and should be considered, alternatives that would still be consistent with the legislative mandate of public access within 12 months of publication. The IADR and AADR, as publishers of the Journal of Dental Research, are willing to provide PMC with a link to the final authoritative version of the published article, with the same embargo period. As the NIH is aware, significant value is added by publishers in the copy-editing process. Yet, the current implementation of the public access policy retains the earlier non- authoritative version of the accepted manuscript on the PMC site. Surely the interest of the public would be better served by having access to the final authoritative publication, rather than to an unedited manuscript. In addition, our online platform provided by HighWire Press of Stanford University provides extensive linkages to related research, references, the ISI Web of Science, Google Scholar, and PubMed - significant advantages provided only by the final authoritative version of the published article. The current implementation of the public access policy now also includes review articles in the mandatory submission of accepted peer-reviewed manuscripts. This is of concern to us, especially since the NIH previously encouraged us to add review articles to our journals as a way to protect our subscription base under the voluntary policy. The Journal of Dental Research now features content from Critical Reviews in Oral Biology & Medicine. The Associate Editor for this section of the JDR solicits review articles based on the scientific expertise of the invited authors, not on their NIH funding status. Even if the author is NIH-funded, the time devoted to writing a thorough scientific review would typically be outside the percent time claimed on the “% effort on the project” on any NIH grant. Unless the NIH is specifically funding the review article through a grant mechanism, or the review is being written by an NIH employee, it seems unfair and a further burden on our copyright to usurp review articles as well in this blanket policy. In closing, the IADR and AADR do not believe that the NIH has adequately addressed Congress’ proviso that “the NIH shall implement the public access policy in a manner consistent with copyright law.” We look forward to the NIH response to our concerns and remain firmly committed to the concept of free access to science as signatories to the DC Principles for Free Access to Science (www.dcprinciples.org). Sincerely, Christopher H. Fox, DMD, DMSc Executive Director International and American Associations for Dental Research Professor Anthony J. Smith, BSc, PhD Editor-in-Chief Journal of Dental Research	Web Form
154	Web RFI	05/30/2008 at 04:19:35 PM (637)	Hirtle	Peter	M.A., M.L.S.	Cornell University	NY	USA	Other Member of the Public	NIH should require that the version of the research as published, and not the author's final manuscript, should be submitted. In my discussions with faculty at Cornell University, they almost always want their best work - the published version of the paper - to be what is read and cited. I see two ways this could happen. One, NIH could just require that researchers submit NIH-funded research to journals that allow the published version to be available through NIH. There would be no copyright or ownership issues associated with this, since journals that will not allow the published version to be distributed by NIH would be off limits to NIH researchers.Alternatively, NIH could encourage the use of paid Open Access publishing alternatives. Researchers here are reluctant, however, to use existing grant funds to pay the Open Access charges of major publishers. While grantees recognize that their existing grant funds can be used to pay open access fee, the grant funds they receive are never enough to pay for the work that needs to be done under the grant. Most are therefore reluctant to divert any of the funding to publication costs. Grantees are also worried that including publication costs in proposed grants would make their grants appear to be expensive and less competitive. A solution would be for NIH to implement a separate fund upon which PIs can draw to pay open access fees from publishers. Such a fund would also save NIH money in the long run since institutions would not be claiming Facilities and Administrative (F&A) costs on grant funds devoted to publication.						Web Form
155	Web RFI	05/30/2008 at 04:46:29 PM (135)	Boyle	Jeanne	MLS	Rutgers University Libraries	NJ	USA	Representative NIH Funding Recipient Organization	Our NIH-funded researchers are concerned about proper citation of their work. They would prefer to submit the final published version of articles to assure that PubMed Central (PMC) has the most canonical and easily cited form. It would be reassuring to our authors if the NIH policy stated clearly that they had the option of submitting the final published version of their article, if the publisher were in agreement. It is desirable to include the full citation to the published form, but if readers do not have access to the published form they will be under the impression that PMC has only a preliminary or less authoritative version of the article.It has been suggested that this policy would harm journal publishers and lead to the cancelation of STM journals. This is a misunderstanding of the decision process in libraries for journal selection. Scholarly journals are typically subscribed within packages, and it is not possible to establish a correlation between individual NIH-funded articles in open access repositories such as PMC and journal cost. Furthermore, libraries are unable to predict which journals will publish NIH-funded articles, so this factor would be a specious one on which to base journal acquisition. Finally, even if the embargo period were reduced to six months, this period would be too long to make the unavailability of the journal a palatable option. We have never used public access availability as a criterion for journal cancelation.	We have invested considerably to ensure that Rutgers scholars comply with the requirements of the current legislation. The libraries have played a lead role in formulating university policies on copyright and ensuring that scholars and library services conscientiously observe copyright. Copyright education needs to be a part of every institution’s compliance with the policy. It is to the benefit of both authors and publishers that this conversation takes place. The NIH Open Access policy has enabled our education efforts as no other event has before.We believe the rate of compliance would benefit from two developments: 1) having the final PMC version of an article sent for verification to both the principle investigator and the lead author listed on the article and accepting verification from one or the other, and 2) developing a strategy for working with publishers which use click through licenses that allow no negotiation.	We appreciate all of NIH’s efforts to date to disseminate information and to communicate in a timely manner. We urge continued updating of the FAQ’s and other website information as well as broad announcement of changes and progress.	The Rutgers University Libraries appreciate the intention of Congress and the NIH to ensure that the results of publicly funded research be made available to the public. This goal is close to our hearts as the largest public research university in New Jersey, one of the states whose citizens contribute more in taxes to the federal budget than they receive in federal contributions.We require that submission to our institutional repository include actual content -- not links -- because that is the function of the repository. By analogy, NIH/PMC should have the same requirement. Mere citations with links to the actual content on the publisher’s website, or a “dark archive,” will not fulfill the purpose of the policy. Furthermore, it assigns part of the responsibility for access to publicly-funded research to a private entity. Additionally, to further the wide availability of this valuable content, we urge development of methods of interoperability for exchange of content between PMC and institutional repositories.These comments are submitted on behalf of the Rutgers University Libraries by Rhonda Marker, Jim Neissen, and Jeanne Boyle.			Web Form
156	Web RFI	05/30/2008 at 05:10:29 PM (442)	Israel	Beth		Arizona State University	Arizona	USA	Representative NIH Funding Recipient Organization	The descriptive information about PMC explains that PMC is not intended to replace the original publication of the journal article, rather to archive them and make them accessible in a particular way. The integrity of the contents then continues to rely on the editorial selection processes, peer-review processes, and to some extent on the editorial and production work provided by the journal editorial advisors and on the publishers. In order to present PMC readers with complete information about each article, we recommend that PMC incorporate the name of each journal’s publisher in the primary citation of each article. Publishers should be offered the opportunity to provide a link through which readers could access the journal’s and publisher’s editorial policies, peer-review standards, and funding sources. We are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers’ web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a free, digital and permanent stable archive of biomedical and life sciences journal literature. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues. We can say emphatically that a dark archive that links to publishers’ web sites is an unacceptable alternative to PMC that NIH has consistently and wisely rejected. Arizona State University fully supports the NIH Public Access Policy in its current form, and commends the NIH’s extensive efforts to seek input from the full range of stakeholders. ASU also supports the efforts of all to move to implement this congressionally approved policy. This policy is supportive of our institution’s and higher education’s commitment to making the results of scientific inquiry available as well as enabling the building on the discoveries of others to enhance understanding. Simply put, the public, as the funding source of this research, is entitled to have free access to the discoveries. One of ASU’s faculty members commented, “I think NIH’s recent policy of open-access to research results is long overdue.” Several parts of ASU worked together to insure our ability to comply with this mandate. The Office of the Vice President for Research and Economic Affairs communicated multiple times with faculty members already receiving support and has established a mechanism for timely reminders to researchers of the requirement to deposit. This office worked with the University Libraries to develop useful web pages. Both of these units encouraged researchers to become familiar with the requirements of the mandate and a webinar on the topic was well-attended. The Office of General Counsel advised all of us on the issues of copyright management. There is mixed opinion at ASU regarding a six month or one-year embargo. However, it is the case that journals would not be cancelled at ASU for the reason that articles are available in open access repositories. The pace of science renders ASU faculty members less competitive when subscriptions are canceled. It was further noted by a faculty member that publisher archives are “more tidy” than the current PUBMED Central. It would be useful if NIH would maintain a list of publishers whose author publishing agreements are consistent with deposit to PMC, without additional copyright addendums. This enables faculty members to “do science” and not be troubled by bureaucracy.	In light of the change in law that makes NIH’s public access policy mandatory, do you have recommendations for monitoring and ensuring compliance with the NIH Public Access Policy?Recognize that it is difficult for institutions to monitor compliance with this policy. Manuscripts and articles are written and submitted by the principal investigator. The sponsored projects office does not get involved in this process. A potential way to monitor compliance is to have NIH ensure that all NIH grant application forms or electronic submission sites include a prompt or field for inclusion of the PMCID on the PI’s cited references that fall within the policy. Perhaps a routine communication process with campus offices of research could be established to ensure compliance. We recommend advice for researchers who encounter one-click copyright agreements during article submission. Developing an automated system for alerting institutions when an article has been submitted would be a terrific way to allow institutions to track the submission. Additionally we would like to harvest or be sent the metadata to place in a local repository to link to research generated at our institution-specific, searchable record of compliance and success in publishing research results.Advice for researchers who encounter one-click copyright agreements during article submission should be made available.PMC should develop the functionality to identify how many times a particular article has been accessed in order to add to the growing evidence of increased use of publicly accessible research.	Enhanced and updated FAQs and current information on the NIH Public Access site to help keep researchers well informed.Update and maintain lists of journals that comply with NIH policy and that do not charge a fee.Advice directed to publishers.	These comments were prepared by Beth H. Israel, Associate Vice President for Research Administration and Sherrie Schmidt, University Librarian in consultation with ASU faculty members.	nih_public_access_policy.txt	Question 1 Do you have recommendations for alternative implementation approaches to those already reflected in the NIH Public Access Policy. The descriptive information about PMC explains that PMC is not intended to replace the original publication of the journal article, rather to archive them and make them accessible in a particular way. The integrity of the contents then continues to rely on the editorial selection processes, peer-review processes, and to some extent on the editorial and production work provided by the journal editorial advisors and on the publishers. In order to present PMC readers with complete information about each article, we recommend that PMC incorporate the name of each journal’s publisher in the primary citation of each article. Publishers should be offered the opportunity to provide a link through which readers could access the journal’s and publisher’s editorial policies, peer-review standards, and funding sources. We are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers’ web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a free, digital and permanent stable archive of biomedical and life sciences journal literature. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues. We can say emphatically that a dark archive that links to publishers’ web sites is an unacceptable alternative to PMC that NIH has consistently and wisely rejected. Arizona State University fully supports the NIH Public Access Policy in its current form, and commends the NIH’s extensive efforts to seek input from the full range of stakeholders. ASU also supports the efforts of all to move to implement this congressionally approved policy. This policy is supportive of our institution’s and higher education’s commitment to making the results of scientific inquiry available as well as enabling the building on the discoveries of others to enhance understanding. Simply put, the public, as the funding source of this research, is entitled to have free access to the discoveries. One of ASU’s faculty members commented, “I think NIH’s recent policy of open-access to research results is long overdue.” Several parts of ASU worked together to insure our ability to comply with this mandate. The Office of the Vice President for Research and Economic Affairs communicated multiple times with faculty members already receiving support and has established a mechanism for timely reminders to researchers of the requirement to deposit. This office worked with the University Libraries to develop useful web pages. Both of these units encouraged researchers to become familiar with the requirements of the mandate and a webinar on the topic was well-attended. The Office of General Counsel advised all of us on the issues of copyright management. There is mixed opinion at ASU regarding a six month or one-year embargo. However, it is the case that journals would not be cancelled at ASU for the reason that articles are available in open access repositories. The pace of science renders ASU faculty members less competitive when subscriptions are canceled. It was further noted by a faculty member that publisher archives are “more tidy” than the current PUBMED Central. It would be useful if NIH would maintain a list of publishers whose author publishing agreements are consistent with deposit to PMC, without additional copyright addendums. This enables faculty members to “do science” and not be troubled by bureaucracy. Question 2 In light of the change in law that makes NIH’s public access policy mandatory, do you have recommendations for monitoring and ensuring compliance with the NIH Public Access Policy? Recognize that it is difficult for institutions to monitor compliance with this policy. Manuscripts and articles are written and submitted by the principal investigator. The sponsored projects office does not get involved in this process. A potential way to monitor compliance is to have NIH ensure that all NIH grant application forms or electronic submission sites include a prompt or field for inclusion of the PMCID on the PI’s cited references that fall within the policy. Perhaps a routine communication process with campus offices of research could be established to ensure compliance. We recommend advice for researchers who encounter one-click copyright agreements during article submission. Developing an automated system for alerting institutions when an article has been submitted would be a terrific way to allow institutions to track the submission. Additionally we would like to harvest or be sent the metadata to place in a local repository to link to research generated at our institution-specific, searchable record of compliance and success in publishing research results. Advice for researchers who encounter one-click copyright agreements during article submission should be made available. PMC should develop the functionality to identify how many times a particular article has been accessed in order to add to the growing evidence of increased use of publicly accessible research. Question 3 Enhanced and updated FAQs and current information on the NIH Public Access site to help keep researchers well informed. Update and maintain lists of journals that comply with NIH policy and that do not charge a fee. Advice directed to publishers. Question 4 These comments were prepared by Beth H. Israel, Associate Vice President for Research Administration and Sherrie Schmidt, University Librarian, in consultation with ASU faculty members.	Web Form
157	Web RFI	05/30/2008 at 05:13:17 PM (876)	Peccei	Roberto	PhD	UCLA	CA	USA	Representative NIH Funding Recipient Organization				We are writing in response to the request for information about the NIH Public Access Policy (NOT-OD-05-022). As one of the nation's leading public research universities, UCLA takes very seriously its responsibility to serve the people of Southern California, the U.S., and the world through its mission of education, research, and service. An integral part of that mission is the dissemination of scholarly information as broadly and freely as possible, which is essential to furthering scientific discoveries, creating innovative solutions to pressing problems, and improving the lives and well-being of individuals and of society.To ensure NIH-funded researchers' awareness of and compliance with the public access policy, staff from the Office of Intellectual Property – Industry Sponsored Research, the Office of the Vice Chancellor for Research, and the UCLA Library have collaborated on designing a multi-pronged approach involving both education and assistance. This coordinated effort targeted at faculty, librarians, and staff aims to inform, educate, and assist researchers and to support the broadest possible dissemination of their work. Staff from all three of these organizations participated in a webinar organized by the University of California Office of the President. At UCLA, the Library has taken the lead in providing individual assistance to authors who have questions about the submission process.We support the NIH Public Access Policy as a very strong step taken toward ensuring that the results of publicly funded research are widely disseminated and available in a permanent, stable archive, though we are aware that some problems must still be overcome. The submission process must be simplified, by persuading all publishers either to join those who submit papers to PubMed on behalf of their authors or to permit authors to deposit papers without additional charges or difficult contract negotiations. In addition, a clearer explanation is needed to clarify the difference between the PubMed Central identification number and the PubMed identification number and about whether either can be used in submitting the paper to PubMed Central. Thank you for the opportunity to comment. Roberto PecceiUCLA Vice Chancellor for ResearchKathryn AtchisonUCLA Vice Provost of Intellectual Property and Industrial Relations; Associate Vice Chancellor for ResearchGary E. StrongUCLA University Librarian			Web Form
158	Web RFI	05/30/2008 at 05:15:03 PM (767)	Jacob	Richard		Associate Vice President for Federal Relations, Yale University	CT	USA	Representative NIH Funding Recipient Organization					Yale_Comments_on_Public_Access_Policy.txt	Comments of Yale University on Implementation of NIH's Public Access Policy Thank you for the opportunity to comment on the implementation of NIH's Public Access Policy. Yale University agrees with the aims of the NIH's Public Access Policy. We favor widespread access to the results of federally sponsored research and the intellectual resources of universities. The established traditions of the scientific community, which demand that research results be published to enable other scientists to test and replicate the findings before they become established fact or working hypotheses, provide broad dissemination of scientific findings. In addition, Yale has taken specific initiatives to expand access. Yale has played a leading role with the United Nations in creating programs for very low cost subscriptions to scientific journals through Health InterNetwork Access to Research Initiative (HINARI) and Online Access to Research in the Environment (OARE). In addition, Yale has launched its Open Yale Courses initiative which is placing entire courses online for use by anyone in the world. In all of these efforts we have sought to expand access while preserving the strengths of the existing system of scholarly publishing. Yale has also taken steps to comply with the NIH Public Access Policy. We have advised all recipients of NIH funding about their obligations under the policy; we have provided model copyright agreements for use by faculty; and will be providing, on an ongoing basis, comprehensive education and support for all university faculty. In taking those steps to implement the NIH policy at Yale, we have identified a few issues of concern that we wish to raise with the NIH. Alternative Models. NIH has requested suggestions about alternative models. The Public Access Policy is awkward in that it imposes a burden on NIH-funded investigators when it may be more efficient for NIH to negotiate directly with publishers about the distribution of articles through PubMed Central. NIH is, in essence, using the means it has readily available - conditions on grant funding, which investigators cannot avoid - to expand access to scholarly articles. This approach is expedient but it may not be the best approach. We would encourage NIH to have constructive conversations with publishers about how to simplify the process for submitting papers to PubMed Central. For example, faculty who submit papers to the more than 300 open access journals listed on the NIH website have the option of requesting the publisher to submit the article to PubMed Central. Faculty can make the request at the time they send a manuscript to the journal for review; no further action is required on their part. The submission process for all other journals is significantly more burdensome on faculty. Faculty will appreciate the ability to fulfill their obligations in one step, at the time they submit a paper to a journal, and to avoid any further obligation that may come due months later. We recommend that NIH undertake serious discussions with publishers to achieve a similarly user-friendly option for submissions to any journal. Limitations on Institutional Oversight. It will be difficult for institutions to ensure that their investigators comply fully with the Public Access Policy. We recognize that it is common for NIH and other funding agencies to require institutions to ensure that investigators as well as subcontractors comply with various federal rules, such as human subjects rules, that govern the conduct of research. The Public Access Policy differs from those requirements in at least three aspects, which will make it difficult for institutions to ensure that investigators are in full compliance. First, the conduct that is regulated by the policy - reporting of research results through journal articles - often occurs after the research award is completed and in some cases after the author has left the institution. Some former investigators will be at other institutions; some may be independent; some will be located outside the country, This would hold true for faculty and especially for postdoctoral fellows and students. In contrast, most of the policies that govern NIH-funded research are applied and monitored during the course of the research project or are fulfilled soon after a project's conclusion. In applying those rules an institution can exert considerable leverage over the investigators to compel them to comply. In the case of publications, an institution may have little or no leverage over authors who have left, will generally not know that the author is submitting a manuscript for publication, and may not even know where the author is. Second, the Public Access Policy governs contractual relationships to which the institution is not a party. Contrast the Policy with the way that funding agencies promote integrity in research, where they do not have direct control over how faculty conduct and present their research. Rather than imposing a requirement on institutions that governs the scientific communications, the federal policies establish standards for how the institutions manage allegations of research misconduct. Institutions have control over that process, and can fully comply. Third, the Public Access Policy puts institutions in the middle of investigators' decisions about publication, which are of course close to the core of academic freedom. For institutions to exercise adequate oversight to ensure that the research publication agreements comply with the Policy, they must monitor or even participate in publication decisions of faculty, fellows, and students to an unprecedented degree. This is a marked departure from other policies and conditions that funding agencies impose on research. By extension, these same issues impact on institutions' ability to satisfactorily monitor their sub-awardees to which these requirements must be passed on. Institutions, in these cases, have even less leverage or ability to monitor author-publisher relationships. Because the prime awardee is responsible for the actions of the sub-awardee, institutions may face additional liabilities which seem out of proportion to any harm done. For these reasons we believe it will be difficult for institutions to guarantee full compliance with the Public Access Policy by authors. Institutions can be held accountable for establishing clear policies about submission of articles to PubMed Central, providing technical assistance to faculty, and requiring faculty to certify that they will comply with NIH's policy. We recommend that NIH provide a "safe harbor" for institutions which have met those conditions and thus demonstrated that they are making a good faith effort to comply. We believe that such a safe harbor would protect grantees from consequences that are unrelated to their own neglect without absolving them of the responsibility for ensuring, to the maximum extent possible, the success of the new policy. Creating a safe harbor may also help to clarify the ambiguity about consequences of failure to submit an article to PubMed Central. Does NIH intend to demand that federal funds be returned for failure to comply with the Public Access Policy? That penalty would seem heavy-handed, especially since the compliance "tail" would have no end date - any award could be placed in noncompliance many years after it closes if a former institutional investigator fails to negotiate an adequate publication contract. We would contend that institutions which qualify for a safe harbor should not be subject to financial penalties. Monitoring and Cost of Compliance. NIH has requested comments about monitoring of the Public Access Policy. We recommend that any requirements for monitoring and reporting be as efficient and streamlined as possible. We also recommend that NIH, or the National Academy of Sciences, analyze at least two issues as the Public Access Policy is implemented. First, what is the effect on scholarly publishing? Have some journals become economically unviable; have investigators migrated to or away from certain journals or forms of scholarly publication? Second, what is the incremental cost for institutions that receive NIH funding? What is the cost associated with institutional compliance, including training; the oversight of subcontractors; and the acquisition of rights to submit articles to PubMed Central? In conclusion, Yale believes universities should make the results of scientific research widely available to the public. We recommend that NIH clarify important issues about the implementation of the Public Access Policy, especially the extent to which institutions would be held accountable for the actions of individual investigators. As we note above, the Public Access Policy differs from other conditions imposed on NIH grantees in that compliance is not fully within the control of the grantee. Providing a safe harbor for institutions that make a good faith effort to comply would help to address those concerns. We also recommend that NIH continue to explore whether there are more efficient ways to make scholarly articles available, including negotiating directly with publishers. Finally, we recommend that NIH evaluate the implementation of the Public Access Policy. Thank you for the opportunity to comment on the Public Access Policy. Public Access Policy page 3	Web Form
159	Web RFI	05/30/2008 at 05:17:49 PM (668)	Gross	Lauren	J.D.	The American Association of Immunologists	MD	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)					AAI_Comments_on_NIH_Public_Access_Policy.053008.txt	Comments of The American Association of Immunologists In Response to the National Institutes of Health Request for Information: NIH Public Access Policy (NOT-OD-08-060 - March 28, 2008) May 30, 2008 Transmitted via http://publicaccess.nih.gov/comments2/comments.htm The American Association of Immunologists (AAI), a professional association of more than 6,500 research scientists and physicians dedicated to understanding the immune system, and the publisher of The Journal of Immunology (The JI), the world’s most cited immunology journal, respectfully submits the following comments in response to the National Institutes of Health’s (NIH) March 28, 2008 “Request for Information: Public Access Policy” (RFI) (Notice number NOT-OD-08-060). AAI has deep concerns about the NIH Public Access Policy (“Policy”) and plans for its implementation. The Policy, as enacted by the Consolidated Appropriations Act of 2008 (P.L. 110-161), requires that “all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.” While AAI strongly supports - and successfully implements - activities to enhance access to scientific information and publications, we continue to believe that the Policy will duplicate, at great cost to NIH and to taxpayers, publication services which are already provided cost-effectively and well by the private sector. The private sector, including not-for-profit scientific societies, already publishes - and makes publicly available - thousands of scientific journals that report cutting-edge research funded by both NIH and other public and private entities. Rather than creating a new government bureaucracy, a particular burden in this era of severe budget constraints, NIH should partner with these publishers to develop a plan that enhances public access while also addressing publishers’ key concerns, which include ensuring journals’ continued ability to provide high quality, independent peer review of NIH-supported research. AAI is concerned that the information that NIH has provided to investigators and institutions is confusing and, in some cases, mischaracterizes the plain language of the federal law. The Consolidated Appropriations Act of 2008 (P.L. 110-161) requires “(t)hat the NIH implement the public access policy in a manner consistent with copyright law.” And yet, in its Notice and Revised Policy Statement dated January 11, 2008 (NOT-OD-08-033), NIH shifts what is clearly its legislative responsibility to ensure (i.e., that the Policy respects publishers’ copyright rights) to institutions and investigators: “Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy.” This is clearly creating concern and confusion among investigators and institutions and must be addressed in a way that eases compliance for authors while respecting publishers’ rights. As the NIH deflects this responsibility, it accepts whatever the authors send to PubMed Central (PMC) without confirming the existence of copyright agreements with the publishers. This has resulted in NIH consistently posting material which violates copyright agreements with publishers, requiring publishers to seek out the violations and bring them to NIH’s attention. In addition, a recent NIH directive by Michael Gottesman, Deputy Director of Intramural Research (“NIH Employee Procedures for Complying with NIH Public Access Policy,” May 15, 2008), which requires intramural investigators to use NIH submission forms for all journals and to reject the use of publishers’ forms (irrespective of whether they comply with the Policy), has created confusion for NIH investigators and an administrative burden for publishers. [Publishers’ submission forms often include - in addition to copyright transfer agreements - statements regarding Conflict of Interest and Author Responsibility (e.g., appropriate approval for human and animal use, prior publication history, the availability of unique materials, responsibility for scientific integrity, etc.) that authors are required to sign.] AAI also has serious concerns about the legality of the Policy. Many of these concerns were addressed in great detail in a legal analysis commissioned by AAI and the American Physiological Society (APS) in 2004, when NIH had proposed a mandatory program (NOT-OD-04-64, September 3, 2004). This legal analysis, which was submitted to NIH on November 16, 2004, and resubmitted via an electronic link in our March 14, 2008 comments (responding to NOT-OD-08-057), addresses legal issues that NIH had dismissed as irrelevant when the NIH plan was initially implemented as a voluntary policy. With the passage of the Consolidated Appropriations Act of 2008 (P.L. 110-161), which made the Policy mandatory, key legal issues raised in this analysis (see http://www.aai.org/News_Board/CommentsNIHPublicAccess.pdf), including the following, must now be addressed: 1. whether NIH has complied with the Freedom of Information Act (and has considered its impact on patent applications); 2. whether NIH has complied with the provisions of the Administrative Procedures Act, including whether the notice provided to the public under this Act, and the opportunity for public comment, has been satisfied; 3. whether NIH has complied with the provisions of OMB Circular A-76; 4. whether NIH has complied with the Regulatory Flexibility Act; and 5. whether NIH has complied with the Paperwork Reduction Act. Other legal/procedural concerns include the following: 1. NIH moved forward with the implementation of this Policy even as it announced the imminent publication of this RFI. In its March 7, 2008 notice [NOT-OD-08-057], NIH announced that it would issue an RFI later in March and respond to comments after a 60-day comment period. Yet NIH went ahead to implement this Policy with an effective date of April 7, 2008. In addition to the obvious legal flaws with this approach, it creates a sense that the NIH is neither interested in, nor willing to work with, the stakeholders who are deeply affected by this new Policy. NIH should proceed with implementing this Policy only after formal Notice and Rulemaking. 2. There are problems with the implementation guidance on the NIH website. While NIH appears to have corrected many of these errors in early May, there were serious problems for several months, including but not limited to the frequent incorrect use of the phrase “journal article” when it should have used “final peer reviewed manuscript.” 3. NIH has created an appearance of favoritism by posting on its website a list of journals which submit authors’ articles directly to PMC (http://publicaccess.nih.gov/submit_process_journals.htm). Authors might perceive these publishers as preferred by NIH, their funding agency, dealing an unfair blow to other publishers who are not submitting authors’ articles but who comply fully with the Policy. In written (March 14, 2008) and oral (March 20, 2008) comments to NIH regarding the implementation of the Policy, AAI identified and requested additional information that stakeholders needed in order to be able to submit thoughtful comments in response to this RFI. This information has not been provided; therefore, AAI again respectfully requests that NIH respond to the following questions and provide stakeholders with an opportunity to comment before the Policy is implemented or enforced: 1. What are the total funds that were expended on implementing the voluntary NIH Public Access Policy (May 2, 2005 – January 11, 2008)? 2. What is the cost anticipated for implementation of the mandatory Policy in FiscalYear (FY) 2009? 3. How much of the cost anticipated for implementation in FY 2009 will be a one-time implementation cost, and how much will be an annual implementation cost? 4. In responding to the above three questions, please report the cost incurred by the National Library of Medicine (NLM) as well as the various NIH Institutes, Centers, and Offices involved, including: a) the number of FTEs and contracted services used to accommodate this initiative; b) the cost of personnel and administrative services for this program (including associated space for infrastructure and personnel); c) time spent directly on the promotion, management, enforcement and assessment of this program to/by NIH grantees and the public; and d) all costs associated with network infrastructure improvements including but not limited to bandwidth capabilities, server capacity, and equipment. 5. What steps is NIH taking to ensure that it posts only articles that comply with a particular publisher’s embargo period? 6. Who will be responsible if the publisher’s embargo period (and therefore the publisher’s copyright rights) is violated? 7. Who will ensure that NIH complies with a publisher’s copyright rights once a manuscript is submitted (i.e., who will make sure that NIH does not transfer a manuscript to any other entity/repository without permission from the publisher)? 8. Who within NIH/the various Institutes will be responsible for determining whether a grantee is in compliance? (Institute directors, Program officers, etc.?) 9. What will be the penalties for non-compliance by a grantee? Will it matter if the non-compliance is intentional or inadvertent? 10.Why won’t NIH accept the “Linking Proposal” offered to NIH in 2005 by fifty-seven not-for-profit scientific publishers, which would provide seamless links on PMC to the journals’ websites, enable readers to access the full text of any article funded by NIH (and in many instances, the full text of all articles published in the journal, irrespective of funding source). This proposal has the following advantages: a) it provides the public with free access to all published articles funded by the NIH; b) it provides access to the final, copy-edited article of record (and any related materials, including corrections); c) it is cost effective, since the NIH would not have to create a new repository, educate grantees about compliance and copyright, or monitor for compliance; d) it addresses publishers’ copyright concerns; e) it satisfies the new law; and f) it complies with copyright law by ensuring that an article cannot be posted before the journal’s embargo period is over. In subsequent conversations with NIH about this Linking Proposal, publishers offered to consider ways to satisfy NIH’s need for a repository of all NIH-funded works, i.e. to help NIH populate a “dark archive” for internal NIH use only. In addition to the above questions, AAI respectfully requests answers to the following questions: 1. How will NIH address allegations of/evidence regarding plagiarism, including issuing corrections and retractions? 2. How will NIH ensure that manuscripts accepted for publication but not ultimately published (due to legal or other issues arising between the date of acceptance and the date of publication) are not posted? 3. How will NIH provide publishers with the data necessary to evaluate the effect of this Policy on their business model (including their subscription base)? Will NIH provide publishers with PMC usage (and other relevant) statistics? 4. Since publishers invest millions of dollars in the publication process (including peer review, editing, design, printing, and posting online), will NIH compensate publishers for their loss of revenue when PMC posts articles within 12 months after publication? 5. How will NIH ensure that it posts only manuscripts eligible for posting under this Policy, and how will NIH ensure the prompt removal of manuscripts which should not have been posted? To date, the burden of ensuring compliance has fallen to publishers who have been forced to expend time and resources monitoring the PMC site and contacting NIH to request removal of articles which have been posted in violation of journals’ copyright rights. 6. How will NIH prevent the piracy, alteration, re-publication, or other illegal use of copyrighted material that is published on PMC? Will NIH notify publishers and provide them with the information necessary to protect their copyright? 7. How will NIH prevent “repurposing,” i.e., modifications to the manuscript by authors or NIH that result in variations from the original manuscript? This includes inadvertent repurposing (e.g., inserting links to databases or other articles). 8. How will NIH ensure the inclusion of - and protect - publisher and society trademarks and branding? Absence of these proprietary marks may confuse or mislead readers as to the owner of the copyright (or the existence of copyright), and may result in inadvertent misuse. 9. How will NIH prevent the distribution of copyrighted material to sites outside the United States if publishers do not grant approval? 10. Since the law applies to “all investigators funded by the NIH,” how will NIH address situations where investigators have minimal NIH funding and depend on another primary funder who objects to submitting to PMC? 11. How will NIH educate Principal Investigators (“PIs”) and their institutions about their responsibilities to ensure that all authors submitting manuscripts based on funds from their grants are aware of, and comply with, the Policy? What will be the penalties to PIs and their institutions for failure to comply? Will it matter if there has been a good faith effort to comply? 12. What is NIH doing to ensure that authors, institutions, and publishers are aware of this Policy and have an avenue for prompt responses to questions arising under it? 13. How will NIH ensure that the law is being followed, particularly the following provision: “Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law”?	Web Form
160	Web RFI	05/30/2008 at 05:26:26 PM (720)	Adler	Allan		Association of American Publishers	DC	USA	Other	IntroductionThe members of the Professional & Scholarly Publishing Division of the Association of American Publishers appreciate NIH’s vision for “an interconnected world of science” and continue to support efforts to enhance public access to scientific research with many of our own innovative online tools. However, we are troubled both by NIH’s unwillingness to acknowledge the Public Access Policy’s flawed legislative process to date and by the lack of concern for any dislocation that will result from adhering to NIH’s “implement and steer” approach for this major shift in policy. Improper implementation of this sweeping mandate has serious implications for all stakeholders in the research community (publishers, authors, the public) and for science itself, and these implications should be fully considered and addressed as soon as possible. Our key policy and implementation concerns include: Copyright. Blanket requirements in grant contracts would effectively deny authors and publishers the benefits of their copyrights—the most fundamental of which is the ability to decide how and in what form their works may be distributed—in conflict with fundamental copyright principles and without compensation for the value added by publishers and editors. In effect, the application of the NIH policy is an imposition of an extraordinary and unprecedented exception or burden to the copyright works—and thus diminishes their value for any journal business model that relies on exclusivity to drive traffic, advertising and subscriptions. The NIH policy essentially mandates a business model that can accommodate this “burdened” copyright, a model that must be based on up-front submission or publication charges, rather than the current models of the vast majority of journal publishers. This does not seem to us to be consistent with the legislative mandate to implement the NIH policy consistent with copyright. Other alternatives to the NIH policy of mandated centralized posting on PMC can and should be considered, alternatives that would still be consistent with the legislative mandate of public access within 12 months of publication. Quality Control and Compliance with Publisher Policies. Many manuscripts currently appear on PubMed Central (PMC) in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? For publishers submitting directly, how will NIH ensure that articles will not be accepted from individuals or entities other than the publisher? Scope. The revised mandatory public access policy now calls for submission of review articles. This is of concern to publishers especially since NIH previously encouraged us to add review articles to our journals as a way to protect our subscription base under the voluntary policy. Editors commission the review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants. Furthermore, requiring that review articles be included will seriously undermine the many journals that publish review articles only. Repurposing. Changes made by NIH or authors that will result in variations from the original manuscript are of considerable concern for a number of reasons, not least of which is the potential introduction of errors. NIH needs to ensure that no changes, such as substantive editorial changes, are made to the manuscripts other than obvious errors in NIH production process or perhaps improved graphics for related illustrations. Links to other databases also raise concerns about changing an article’s principal context and focus. NIH needs to identify precisely how manuscripts will be linked to databases and other resources to ensure the editorial integrity of the underlying work. Patient education. Although we understand that the principal motivation of the legislative mandate to be patient information and education, the NIH policy implementation does not address this need directly (focusing instead on building researcher infrastructure). Publishers have been working actively with voluntary health organizations (VHOs), and we believe that more should be done in this area by NIH – hopefully, working with publishers and VHOs. Piracy. Third parties could commercially exploit content that appears on PMC without the consent of the publisher. What safeguards will NIH put in place to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? These represent only a few of our many practical concerns related to implementation of the mandatory policy. Below is a more expansive “checklist” of publisher questions. We hope it is clear that publisher concerns reflect not only critical issues related to the spirit and protection of copyright but those aspects affecting day-to-day management of the policy and how effectively it achieves its stated objectives. We believe that we can work with NIH to arrive at practical solutions to these concerns, but that will require regular, ongoing consultation and discussion. In light of the substantial nature of these questions and NIH’s commitment to the advancement of science, we believe it is important that NIH fully address these questions. We look forward to a positive and constructive interaction with NIH that will result in balanced implementation of the new public access mandate in a way that addresses our concerns, advances science and benefits the public.		Implementation of the NIH Mandatory Public Access PolicyAdditional Publisher Concerns Raises Many Questions: NIH needs to ensure that the implementation of the policy will respect the basic principles embodied in copyright and not undermine those rights that provide incentives for publishers to invest in peer-review, publishing and the communication of scientific and medical research. Without review and significant changes, the mandatory Public Access Policy could have unintended and undesirable consequences. The issues that must be addressed include: Consultation: NIH Dialogue with Publishers, Societies and Authors Non-profit and commercial publishers, societies and researchers are not only seriously affected, but also critical to the proper implementation of the policy. A formal and ongoing consultative body that includes stakeholders, and with Administration and Congressional oversight, will help ensure that a successful public access model is developed. We urge NIH to conduct regular meetings with publishers and provide regular progress reports on the matters raised by publishers. · Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals? · What is NIH’s timeline for amending this policy moving forward? · What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed? Overview: Copyright Concerns Journals add considerable value to published papers by managing peer review and providing copyediting and design revisions to improve the validity of the published product, benefiting researchers, the public, and the scientific community. The expense and effort of this process is supported entirely by the journals, not by NIH. Under the mandatory policy, significant copyright interests are being taken from publishers, without compensation for their investments. Other related responsibilities undertaken by publishers that bolster the scientific enterprise and thereby add value to individual scholarly works include: editorial selection of manuscripts to be published, marketing, distribution, and preservation. Publisher business models involving subscriptions, transactional paid access to individual articles, and advertising support within traditional publishing and on publisher web sites driven by the distribution of “new” articles, all of which depend on traditional copyright protection, will be impacted by the policy as announced. · Shouldn’t NIH support the full value of copyright and their use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central? Brand Protection, Repurposing and Piracy It is critical that NIH implement the Public Access Policy in a manner consistent with intellectual property protection and the intent of the related Congressional mandate, and work with publishers in ensuring such implementation. · What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers? · Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) Would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus? · How will NIH ensure proper protection of publisher or society trademarks and branding? Not only has there been no affirmation of these markers of quality, but all too often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain. · It is critical that NIH respect the rights of copyright holders to stipulate what NIH will or will not allow related to third-party use of its works. Will NIH ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher? · How will NIH prevent piracy of the articles from PubMed Central? Third parties could commercially exploit content that appears on PMC without the consent of the publisher. Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers? · If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites? Compensation While taxpayers pay for the scientific research on which journal articles are based, non-profit and commercial publishers expend hundreds of millions of dollars a year in the peer-review of manuscripts and in preparing journal articles for publication and timely dissemination in print and online. The cutting-edge research that the many societies publish is rarely obsolete within a year, and may have a shelf life of five to ten years. It is imperative that NIH provide reasonable compensation to publishers for their investments and the well-recognized value that they provide to peer-reviewed manuscripts based on NIH-funded research. · What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done? · The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years? Scope The statutory language of the mandatory Public Access Policy applies to “all investigators funded by the NIH,” yet does not specify whether the NIH funding is in whole or in part. NIH takes the view that the policy applies to investigators with any NIH intramural research funds or any amount of direct costs funded by NIH, even if the funding is insignificant and supplemented by other public or private sources. · If there are other funders, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central? · Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based? · The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision? · What will the repercussions be for investigators and journals that do not follow the process? · Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does NOT apply to literature reviews? Integrity of Research, Quality Control and Meaningful Public Access The NIH posting of peer-reviewed manuscripts accepted for publication compromises the quality of scientific publishing by ultimately making available two different versions of scientific papers. The first is the inferior, peer-reviewed manuscript that has not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication, and the second is the definitive, publisher-authenticated version. Given the new policy requiring deposit of NIH-funded manuscripts in PubMed Central upon acceptance, there are some procedural issues that are unclear. In addition, the benefit of access to manuscripts by patients and the general public has never been fully assessed and alternatives such as lay summaries may be far more useful. NIH should ensure that the implementation of the policy is truly beneficial to the public and does not displace other useful models. · How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal? · Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted? · For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher? · How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? One possibility is for NIH to develop a special section within PMC for members of general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to VHOs, Patient Inform, publisher sites. · How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions? Cost The mandatory public access policy will not change the cost of scientific publishing, but will shift the burden of that cost away from scientific publishers and onto authors and the government, in other words, onto taxpayers. · NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy? · Does this cost detract from funds to grantees actually conducting the innovative research that advances science? Measuring Impact and Effectiveness The policy will affect all stakeholders in the scientific research community and may have a particularly severe impact on small society publishers as subscription revenue will likely decline with increased free access on PubMed Central. It is important for NIH to ensure that content on PMC will not displace the definitive published version and that publishers brands are not diminished. NIH needs to ensure that PMC does not undermine the viability of journals whose economic stability varies widely. · Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions? · What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)? · What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?	Yes, we are submitting two documents for the RFI record in a timely manner via email to PublicAccessComments@NIH.gov, as directed by Neil M. Thakur, Special Assistant to the NIH Deputy Director for Extramural Research, in a May 29-30 email exchange with James F. Segroves of the law firm of Proskauer Rose LLP, based on Mr. Thakur’s confirmation that the PDF format used for those documents is not suitable for posting to NIH through this submission template. Unfortunately, the transformation of these documents to a "txt" format could not be achieved in a practical manner. The two documents submitted for the RFI record are, respectively:A letter addressed to me by Jon A. Baumgarten of Proskauer Rose LLP, dated May 30, 2008, in response to my request for an analysis of the relationship between the NIH Final Policy on Public Access and certain aspects of U.S. and international copyright law; and, A letter addressed to Dr. Elias Zerhouni by the Chair and Vice Chair of the Executive Council of the Professional & Scholarly Publishing Division of the Association of American Publishers, dated March 17, 2008, which originally was timely submitted to NIH in response to its request for comments on the implementation of the NIH Public Access Policy pursuant to NOT-OD-08-057 (March 7, 2008). Both of these documents raise important issues regarding compliance with the statutory proviso that Congress included in Division G, Title II, Section 218 of the Consolidated Appropriations Act, 2008 (Public Law 110-161) to make sure that “the NIH shall implement the public access policy in a manner consistent with copyright law.”We appreciate the opportunity to provide these additional materials to NIH and thank you for ensuring that they will also become part of the record in response to the RFI.			Web Form
161	Web RFI	05/30/2008 at 05:46:18 PM (803)	Duranceau	Ellen	MLS	Massachusetts Institute of Technology (MIT)	MA	USA	Representative NIH Funding Recipient Organization				Some have called for NIH to offer links to journal articles at publishers’ websites, supporting only a dark archive. At MIT, we believe this method would not result in a reliable, permanent archive or in stable open access to NIH’s publicly funded research. Frequent shifts that occur among publishers, journal titles, and interfaces would make it extremely labor-intensive to offer consistent access through a list of links. The result is likely to be many broken links, with attendant barriers to access. In addition, preservation is more difficult to manage well when an archive is not actively used. These problems, along with the loss of a simple, direct access model, would undermine the concept of the archive.			Web Form
162	Web RFI	05/30/2008 at 05:49:30 PM (345)	White	Patrick	M.A.	Association of American Universities	DC	USA	Representative NIH Funding Recipient Organization	The Association of American Universities (AAU) is an association that includes 60 leading public and private U.S. research institutions. AAU focuses on issues important to research intensive universities, such as funding for research and scholarship, science policy issues, and graduate education. The goals of university research are the discovery, creation and dissemination of new knowledge for the benefit of society. Scholarly publishing is one of the major means of dissemination of new knowledge, and, accordingly, AAU also focuses on scholarly communication and related intellectual property issues. AAU, on behalf of its member university presidents and chancellors, has repeatedly endorsed NIH’s efforts to increase public access to the results of NIH-funded research through the implementation of its Public Access Policy. Most recently, as the FY08 House Labor/HHS Appropriations Act was about to be debated on the House floor last summer, AAU President Robert M. Berdahl wrote to Subcommittee Chairman David Obey endorsing the Section 217 language that prompted NIH’s new guidelines. We welcome this additional opportunity to offer our support for the appropriations language and NIH’s progress in implementing it. Indeed, NIH’s effort to assure that everyone who has a view is heard has been much appreciated in the research university community. Our member institutions have responded to NIH by developing policies and procedures to alert, educate and assist faculty in complying with the new requirements. Generally speaking, our administrators appreciate the effort that NIH has put into the complex exercise of developing and communicating the new requirements.	We offer the following suggestions about how to improve NIH’s implementation of the Public Access Policy’s mandatory submissions requirement. • We seek NIH’s help in negotiating a blanket permissions agreement with the publishers that will greatly ease the transaction costs that are currently borne not only by individual authors and, by extension their institutions, but also by publishers. What is needed is a modified standard copyright agreement acknowledging that the author retains the right to provide a copy of the final manuscript to NIH for posting by NIH on PubMed Central within 12 months of publication by a given journal. We request that NIH work to encourage publishers to adopt such agreements.• If, as we hope, more publishers adopt such agreements over time, it would be helpful if NIH maintained and posted an easily accessible and authoritative list of publishers whose author agreements provide blanket permissions for authors to comply with the NIH Public Access Policy. • NIH might also consider an automatic notification system for designated campus entities (an institution’s Office of Sponsored Research, for example) when a faculty member from that institution has deposited an article in PubMed Central. If the relevant institutional office is also notified when a faculty member receives electronic confirmation that his or her paper has been deposited, institutions would not have to go to additional and unnecessary effort to confirm the transaction. • As institutions have put significant effort into establishing policies for the submission of articles to PubMed Central, educating and providing technical assistance to faculty, and requiring faculty to certify that they have complied, we would request that NIH develop a “safe harbor” for institutions that have met their responsibilities. If grantee institutions which have made good faith efforts to assure compliance of faculty, we believe such institutions should be shielded from the consequences of non-compliance, especially when that non-compliance arises from circumstances beyond the institution’s control. • NIH should monitor (or perhaps have a third party such as the National Academies of Science analyze) the impact of the implementation of its Public Access Policy on scholarly publishing and trends in faculty publishing decisions as well as the costs associated with compliance under the new policy.		Thank you for the additional opportunity to comment on implementation of NIH’s Public Access Policy.			Web Form
163	Web RFI	05/30/2008 at 06:37:36 PM (330)	McGraw	Kate	MA, MLS	University of North Carolina at Chapel Hill Health Sciences Library	NC	USA	Other Member of the Public				Based on a recent experience working with a student, I am concerned about the difficulty students (and perhaps some more advanced authors) will have in distinguishing the different kinds of articles available in PubMed Central. Link icons in PubMed send users to “Free Author Manuscript in PubMed Central” and “Free Full Text Article in PubMed Central”. The link icons for both of these options look very similar. In addition, the user following these link icons goes to articles with very similar formatting and coloring.A student preparing a published work such as a masters’ paper, a doctoral thesis or a journal article should read and cite the final edited paper whenever possible. In order for students (and other researchers) to distinguish the author manuscripts from the final articles in PubMed Central, they need to look very different. The information on the author manuscript that a final edited version is available elsewhere needs to be made much more prominent (perhaps enclosed in a box.) The appearance of the author manuscripts should be quite distinctive from the final articles in PubMed Central (perhaps with a different color header.) It would also be helpful to add information about how to cite an author manuscript as an author manuscript on both the web version and the PDF version of the author manuscript.Look at the following two citations in PubMed, and the two articles in PubMed Central to see how difficult it is to distinguish between final articles and author manuscripts: Cruz GD, Salazar CR, Morse DE. Oral and pharyngeal cancer incidence and mortality among Hispanics, 1996-2002:the need for ethnoregional studies in cancer research. Am J Public Health. 2006 Dec;96(12):2194-200. Epub 2006 Oct 31.PMID: 17077408 [PubMed - indexed for MEDLINE]Ramirez A, Farmer GC, Grant D, Papachristou T. Disability and preventive cancer screening: results from the 2001 CaliforniaHealth Interview Survey. Am J Public Health. 2005 Nov;95(11):2057-64. Epub 2005 Sep 29.PMID: 16195509 [PubMed - indexed for MEDLINE]			Web Form
164	Web RFI	05/30/2008 at 06:39:32 PM (525)	Hume	Wyatt R.	Ph.D.	University of California	CA	USA	Representative NIH Funding Recipient Organization	As discussed in the response to Question 4 below and in the attachment, to reduce the administrative burden and confusion resulting from the varied and uncoordinated roles of authors, PIs, institutions and publishers in ensuring compliance with the NIH public access policy, UC strongly recommends that NIH undertake a systematic program, working with publishers and institutions, to develop a consistent and streamlined procedure for deposit that addresses rights questions and other implementation issues and can be used by all NIH-funded PIs without reference to the specific policies and practices of individual journals and publishers. UC would be glad to work with NIH and interested peer institutions to develop and implement this.	The development of the simplified procedures described Question 4 below and in the attachment would represent a great stride in reducing barriers to compliance for PIs and institutions and consequently would significantly diminish the need for case-by-case monitoring. In addition, in view of the complexities discussed above, we believe it important for NIH to acknowledge that full implementation of the policy and associate compliance measures will require an extended period of transition from current practices. It will be important not only to provide clarifications that will be helpful to investigators and their institutions, as suggested in the response to item 3 below, but to provide assurances that any penalties for non-compliance will not be unreasonably applied as long as significant uncertainties remain.	Simplification would greatly reduce operational complexity and therefore the burden that must now be borne by NIH and institutional information, training and communication activities. In addition, as noted above, we recommend that NIH develop tools and informational resources addressing:o How to deposit, including how to use the deposit tools provided by NIH, and clarification of the respective responsibilities of the author(s) and the Principal Investigators.o What to deposit, including more expansive information about which version of the work to deposit, and clarification of the applicability of the policy with respect to the funding year for the supporting grant. In this regard, we note that NIH's own documents conflict with one another: the Policy says that it applies to all articles arising from NIH funding that are accepted for publication on or after 4/7/08, but the FAQ has a further limitation to articles that arise from FY08 funding.o How to identify, control and manage the multiple versions of works; we continue to hear continued expressions of concern and uncertainty about the existence of multiple versions	UC continues to be deeply concerned about a significant and fundamental structural issue: the current policy does little to address underlying complexities associated with the loosely-coupled roles of authors, Principal Investigators, institutions, and publishers. This situation gives rise to several problems that the University has experienced in the early days of implementation of the policy. For example, publishers are under no obligation to assist, or even permit, authors to retain the rights needed to deposit their manuscripts in PMC in compliance with the policy, and the authors' institutions generally have neither the legal standing nor the means to intervene. The ambiguity about rights is amplified by the fact that publishers have a variety of practices that relate to NIH compliance: some automatically deposit either the final published article or the author's final peer-reviewed manuscript in PMC, others have publication agreements that permit the authors to deposit, others authorize compliance only through the mechanism of an optional "author pays" publication agreement, yet others provide unrestricted open access to all their publications, and so on. The requirement to track the details of this complex environment, to respond correctly for each NIH-sponsored publication, and to deal with the situations where the necessary rights are unavailable, or only available for a fee, gives rise to most of the implementation problems UC has experienced to date and imposes a substantial administrative burden on the NIH, on grantee institutions, and on NIH-supported researchers. We note further that confusion on this point is likely to have its greatest effect on younger researchers who may be disproportionately disadvantaged when the most prestigious publisher in their field does not comply with the Policy, and that the unresolved ambiguities may lead more publishers to offer "author pays" models as a means to comply with the policy, unnecessarily diluting the funding available to directly support research and forcing authors to confront yet another difficulty when publication occurs after the award period.UC therefore strongly recommends that NIH address this problem by establishing a systematic program, working with publishers and institutions, to define a single, simple model that facilitates and supports deposit of NIH-sponsored works in PMC. The submission of Anthony De Crappeo, on behalf of the Council on Governmental Relations, on May 28, 2008, expresses concerns similar to those of UC and reaches a similar conclusion. The University of California has extensive relationships with most major biomedical publishers, both as a purchaser of journal publications, and, through its faculty, as a supplier of the work that they publish. UC is willing to work with NIH and like-minded peer institutions to plan and implement such a program.	U-Cal_public-access-policy_2008-05-30.txt	[Submitted on behalf of Provost Hume by Gary Lawrence, Director, Systemwide Library Planning, University of California, (510) 987-9461, gary.lawrence@ucop.edu] May 30, 2008 Dr. Norka Ruiz Bravo Deputy Director, Extramural Research National Institutes of Health Building 1 - Shannon Bldg, 144 1 Center Dr Bethesda, MD 20892 Dear Dr. Bravo: I am pleased once again to write on behalf of the University of California in support of the National Institutes of Health Public Access Policy (NOT-OD-05-022) as revised by the NIH Guide for Grants and Contracts (NOT-OD-08-033) to comply with the provisions of Public Law 110-161. On September 24, 2007, I wrote to Senator Feinstein to convey the University's support for the legislation leading to the establishment of the current policy, and the reasons for our position remain valid; the text of that letter is appended here. As the requirement to deposit the final peer-reviewed manuscripts of articles resulting from NIH-supported research only went into effect on April 7, the University has only limited experience upon which to base comments regarding the policy and its implementation. I would, however, like to summarize the steps that have been taken both at the ten UC campuses and on a systemwide basis to support compliance with the NIH public access policy, and then remark on some concerns that have arisen in our experience to date. Finally, I will address the three specific questions posed by NIH in this request for comments. At both the systemwide and campus levels, the University has taken significant steps to inform our campus communities about and to support compliance with the NIH policy. UC's planning and action has involved broad and effective collaborations among offices of research administration, research policy, academic health science research, libraries and others. In our limited experience to date with implementation of the NIH policy, we have heard of problems and expressions of concern in the following areas, and urge NIH to develop tools and informational resources to address these: * How to deposit, including how to use the deposit tools provided by NIH, and clarification of the respective responsibilities of the author(s) and the Principal Investigators. * What to deposit, including more expansive information about which version of the work to deposit, and clarification of the applicability of the policy with respect to the funding year for the supporting grant. In this regard, we note that NIH's own documents conflict with one another: the Policy says that it applies to all articles arising from NIH funding that are accepted for publication on or after 4/7/08, but the FAQ has a further limitation to articles that arise from FY08 funding. * How to identify, control and manage the multiple versions of works; we continue to hear continued expressions of concern and uncertainty about the existence of multiple versions In addition to these specific concerns, UC continues to be deeply concerned about a significant and fundamental structural issue: the current policy does little to address underlying complexities associated with the loosely-coupled roles of authors, Principal Investigators, institutions, and publishers. This situation gives rise to several problems that the University has experienced in the early days of implementation of the policy. For example, publishers are under no obligation to assist, or even permit, authors to retain the rights needed to deposit their manuscripts in PMC in compliance with the policy, and the authors' institutions generally have neither the legal standing nor the means to intervene. The ambiguity about rights is amplified by the fact that publishers have a variety of practices that relate to NIH compliance: some automatically deposit either the final published article or the author's final peer-reviewed manuscript in PMC, others have publication agreements that permit the authors to deposit, others authorize compliance only through the mechanism of an optional "author pays" publication agreement, yet others provide unrestricted open access to all their publications, and so on. The requirement to track the details of this complex environment, to respond correctly for each NIH-sponsored publication, and to deal with the situations where the necessary rights are unavailable, or only available for a fee, gives rise to most of the implementation problems UC has experienced to date and imposes a substantial administrative burden on the NIH, on grantee institutions, and on NIH-supported researchers. We note further that confusion on this point is likely to have its greatest effect on younger researchers who may be disproportionately disadvantaged when the most prestigious publisher in their field does not comply with the Policy, and that the unresolved ambiguities may lead more publishers to offer "author pays" models as a means to comply with the policy, unnecessarily diluting the funding available to directly support research and forcing authors to confront yet another difficulty when publication occurs after the award period. UC therefore strongly recommends that NIH address this problem by establishing a systematic program, working with publishers and institutions, to define a single, simple model that facilitates and supports deposit of NIH-sponsored works in PMC. The submission of Anthony De Crappeo, on behalf of the Council on Governmental Relations, on May 28, 2008, expresses concerns similar to those of UC and reaches a similar conclusion. The University of California has extensive relationships with most major biomedical publishers, both as a purchaser of journal publications, and, through its faculty, as a supplier of the work that they publish. UC is willing to work with NIH and like-minded peer institutions to plan and implement such a program. In addition to the observations recounted above, UC would like to respond to the specific questions set out by NIH in its request for comments. 1. Do you have recommendations for alternative implementation approaches to those already reflected in the NIH Public Access Policy? As discussed above, to reduce the administrative burden and confusion resulting from the varied and uncoordinated roles of authors, PIs, institutions and publishers in ensuring compliance with the NIH public access policy, UC strongly recommends that NIH undertake a systematic program, working with publishers and institutions, to develop a consistent and streamlined procedure for deposit that addresses rights questions and other implementation issues and can be used by all NIH-funded PIs without reference to the specific policies and practices of individual journals and publishers. UC would be glad to work with NIH and interested peer institutions to develop and implement this. 2. In light of the change in law that makes NIH's public access policy mandatory, do you have recommendations for monitoring and ensuring compliance with the NIH Public Access Policy? The development of the simplified procedures described above would represent a great stride in reducing barriers to compliance for PIs and institutions and consequently would significantly diminish the need for case-by-case monitoring. In addition, in view of the complexities discussed above, we believe it important for NIH to acknowledge that full implementation of the policy and associate compliance measures will require an extended period of transition from current practices. It will be important not only to provide clarifications that will be helpful to investigators and their institutions, as suggested in the response to item 3 below, but to provide assurances that any penalties for non- compliance will not be unreasonably applied as long as significant uncertainties remain. 3. In addition to the information already posted at http://publicaccess.nih.gov/ communications.htm, what additional information, training or communications related to the NIH Public Access Policy would be helpful to you? Simplification would greatly reduce operational complexity and therefore the burden that must now be borne by NIH and institutional information, training and communication activities. In addition, as noted above, we recommend that NIH develop tools and informational resources addressing: o How to deposit, including how to use the deposit tools provided by NIH, and clarification of the respective responsibilities of the author(s) and the Principal Investigators. o What to deposit, including more expansive information about which version of the work to deposit, and clarification of the applicability of the policy with respect to the funding year for the supporting grant. In this regard, we note that NIH's own documents conflict with one another: the Policy says that it applies to all articles arising from NIH funding that are accepted for publication on or after 4/7/08, but the FAQ has a further limitation to articles that arise from FY08 funding. o How to identify, control and manage the multiple versions of works; we continue to hear continued expressions of concern and uncertainty about the existence of multiple versions The University of California is a committed participant and leader in research in all fields, and views the widest possible dissemination of research results as an essential foundation for effective research and teaching. For this reason, we fully support the NIH policy, and appreciate the opportunity to help identify ways to make it stronger and more effective. Yours truly, Wyatt R. Hume Provost and Executive Vice President Academic and Health Affairs University of California cc: President Dynes President-Designate Yudoff Executive Vice President Lapp Vice President Beckwith Vice Provost Greenstein Vice Provost Justus Assistant Vice President Sudduth ================= Attachment ================= September 24, 2007 The Honorable Dianne Feinstein United States Senate 331 Hart Senate Office Building Washington, D.C. 20510-0504 Dear Senator Feinstein: On behalf of the University of California, I write in support of Section 221 of S.1710, the Departments of Labor, Health and Human Services, Education and Related Agencies Appropriations Act of 2008. Section 221 directs the National Institutes of Health (NIH) to change its Public Access Policy requiring all investigators funded by NIH to submit an electronic version of their final peer-reviewed manuscripts to the on-line archive of the National Library of Medicine's PubMed Central (PMC), which would then make the manuscript available within twelve months of the official date of publication and in a manner consistent with copyright law. An identical provision is included in the FY 2008 LHHS bill approved by the House in July. This change in research publication policy was requested by NIH to achieve goals that are shared by UC health scientists and by researchers worldwide: to expand use of NIH research findings in the advancement of science and public health, enhance management of NIH's invaluable research portfolio and provide for a timely, sustainable and openly accessible archive of research results arising from the substantial investments of U.S. taxpayers, and of public and private institutions where that research is conducted, including the campuses of the University of California. The provision maximizes research impact and dissemination of new knowledge and appropriately recognizes and preserves the integrity of peer-reviewed journals, whose role is vital to the conduct of science, by providing a twelve month embargo period that protects publishers' subscription revenue. The University of California echoes the sentiments of a recent open letter of 26 Nobel laureates (four of whom are affiliated with UC, including UC San Francisco Chancellor Michael Bishop), that stated, "the time is now for Congress to enact this enlightened policy to ensure that the results of research conducted by NIH can be more readily accessed, shared and built upon to maximize the return on our collective investment in science and to further the public good." Thank you for your tireless support of the University of California and our commitment to enhancing the nation's public health through the endless pursuit of knowledge and scientific discovery. Sincerely, Wyatt R. Hume Provost and Executive Vice President Academic and Health Affairs cc: President Dynes Executive Vice President Darling Vice Provost Coleman Vice Provost Greenstein Vice Provost Justus Assistant Vice President Sudduth 1	Web Form
165	Web RFI	05/30/2008 at 07:54:30 PM (840)	Boney	Evans	Ph. D. Candidate	Caltech Graduate Student Council	CA	USA	Representative NIH Funding Recipient Organization				The Caltech Graduate Student Council (with myself as chair) is a strong advocate of this policy, views the NIH as particularly progressive in this respect, and would go so far as to recommend a similar system to the NSF and other government funding agencies. At our meeting on June 5 we will be considering a resolution urging Caltech to take action along these lines, and are actively seeking alliances with other graduate student councils to encourage similar measures at universities nation-wide.We think that journals should not have the sole right to reproduction of our work, and that maintenance of this copyright is fundamental to our careers in science. From a political standpoint, we think that no government organization should provide support for research that is not accessible to the public for free through a service like this. As future researchers having spent the majority of our academic lives with the aid of the internet, we recognize that a change to open-access is coming. In previous generations, part of the service provided by journals was dissemination of knowledge, and maintenance of copyright was necessary to this service. In the age of the internet, this is an already obsoleted role, as a simple pub-med search will show. We are routinely surprised that publishing involves a transfer of copyright, and we no longer accept this as a necessity of the dissemination of information.To the creators of the NIH Public Access Policy: Please stand by your change. Complaints about being unable to cope with the "huge inconveniences" imposed by the plan are overstated, and complying with additional requirements by funding agencies is part of the job as far as we are concerned. We look forward to putting our papers in a Caltech repository in the not-too-distant future, and, those of us supported by NIH grants jump at the chance to put them here.			Web Form
166	Web RFI	05/30/2008 at 09:57:40 PM (373)	Douglas	Kimberly	M.A., MSLS	California Institute of Technology (Caltech)	CA	USA	Representative NIH Funding Recipient Organization	Caltech appreciates the opportunity to comment and to also register its support for NIH's policy to ensure broad-based public benefit from research for discovery innovations, learning enrichment, and clinical care.The Offices of the Vice Provost for Research, Sponsored Research, Library, and General Counsel at Caltech undertook the following for successful implementation of the NIH Public Access Policy:1) Crafted text for authors to include in their manuscript submission letters to address copyright in a manner consistent with the law.2) Individually notified every NIH grantee of the steps to undertake.3) Met with research groups to address compliance needs.4) Created and added a number of web pages announcing, explaining, and providing compliance steps to the Caltech community.5) Consulted and advised one-on-one in labs and offices, as well as electronically, regarding the policy and related PubMed Central manuscript submission process The NIH should continue to urge publishers to automatically deposit papers in the PMC and find appropriate ways to recognize those who do. In addition, with incentives from funding agencies such as the NIH and given today's available technologies, universities and publishers need to establish effective new mechanisms for handling peer-review certification and optimizing world-wide research paper distribution. New more collaborative approaches borne of the network are needed.	It will be helpful for the NIH to consider the following: 1) Automatic notifications of author institutions when papers are submitted to the PMC, 2)Straightforward search or link in PubMed to identify institution NIH funded papers, 3) Collaboration with institutional repositories to achieve the stated goal of public access in the most cost effective and persistent manner for all.		We observe that the NIH Public Access Policy is consistent with the Copyright Law Title 17 U.S. Code in which the authors who originate the work in tangible fixed medium claim the copyright and can license the work's use or transfer the copyright as suits their purpose. The Copyright Law does not support one business model over another. Also, Caltech has no intention of canceling journal subscriptions due to the NIH policy. However, like all organizations, it must operate within a budget. Regrettably, it does occur that some publisher prices exceed our ability to pay. Therein rests the source of any journal cancellations, not public access mandates. Therefore the limits on an embargo could easily be shortened to 6 months without changing the decision-making process we undertake.University based research is fundamentally driven by the desire for public benefit. Caltech welcomes the leadership of the NIH in creating change and dialog so that publicly funded research can realize the full potential made possible by the global network.			Web Form
167	Web RFI	05/30/2008 at 11:55:38 PM (186)	Bitkower	Jay	MS	Actoin to Cure Kidney Cancer	NY	USA	Patient or Representative of a Public Health Advocacy Organization				I recommend that researchers deposit their articles to the NIH within 6 months of publication. As a cancer advocacy organization, we advise cancer survivors as to the trial results of latest therapies and other information relevant to the survival issues of cancer patients and caregivers. Currency of the information can be crucial to one making critical helath care decisions. For us to subscribe to several journals or evenhave to pay $30-80 for each individual article would be prohibitive. The 6-month timeframe is fair to the journals because the vast amount of their subscriptions comes from libraries, which would retain their subscriptions in any case. Therefore, the journals would lose little revenue, but the cancer community would greatly benefit fromthis change of policy.			Web Form
168	Web RFI	05/31/2008 at 07:15:53 AM (907)	Arunachalam	Subbiah	M Sc	Independent Researcher / Writer	Tamil Nadu	India	Other Member of the Public	You might wish to hold both the institution and the individual receiving NIH funds responsible for depositing the full text of the papers resulting from NIH funding immediately on acceptance.	It is OK to have a law in place, but it ill not be of much use if it is not implemented well. It is absolutely necessary to have a mechanim of monitoring compliance of the law and make sure that every author who receives NIH funding deposits the full text of all papers resulting from the NIH funds. There should be a penalty clause for those who fail to comply.	Ther should be continuing advocacy campaign. One of the problems today is that not many publishing researchers are fully aware of OA and its advantages.	The embargo (of up to one year) should be abolihed and you should insist on immediate open access. Also, the US Government should pass a legislation to the effect that would make it illegal for journal publishers to forbid authors from placing the full text of their papers in an open access repository such as PubMed central or institutional repositories.			Web Form
169	Web RFI	05/31/2008 at 11:37:44 AM (269)	English	Ray	Ph.D.	Director of Libraries, Oberlin College	OH	USA	Representative NIH Funding Recipient Organization	I support the NIH policy in its current form. It is a major step forward that will produce significant new benefits for researchers and the general public. It will greatly increase the effectiveness of our government's investment in scientific research. While I favor the policy wholeheartedly, I do encourage NIH to develop a strategy to reduce the embargo period from the current twelve months. Given the time-sensitive nature of biomedical research, a six-month embargo, for example, would substantially increase the benefits realized from the policy. It would also make NIH's policy consistent with public access policies in other countries. Suggestions have been made by some publishers that NIH should implement a policy that involves linking to publishers' websites. NIH should reject this idea, not only because it would be a poor substitute for the current policy, but also because it would be contrary to the legal obligations of the agency. The language of the law is clear: electronic versions of final peer-reviewed manuscripts must be submitted to PubMedCentral and those manuscripts must be made publicly available in PubMedCentral.	1. NIH should track and provide regular and frequent public updates on the percentage of eligible articles that are deposited and made public. 2. NIH should commission a study, or collect data, on any impact that the policy may have on journal subscriptions. Such a study could help resolve the issue of the policy's potential impact on journal cancellations and resultant threats to peer review. As a librarian, I am confident that libraries will not cancel journal subscriptions as a result of the policy. Final peer-reviewed manuscripts in scientific fields (biomedicine in particular) that become available well after publication are not an adequate substitute for current journals. A carefully crafted empirical study could document whether or not my view is valid. It could also document any potential effects from policies that incorporate shorter embargo periods. 3. NIH should maintain a list of publishers that have publishing agreements that are consistent with the policy.	NIH should increase its efforts to make clear that investigators are required to submit their manuscripts upon acceptance for publication, and not upon publication itself or at a later date. While the language of the law is very specific in that regard, there is significant misunderstanding about the required time of deposit.	I greatly appreciate NIH's willingness, which now extends over several years, to consider comments from all parties concerned about the public access policy. The policy has now been vetted in numerous ways in numerous venues; everyone has had ample opportunity to comment. NIH's implementation plan follows the language of the statute carefully and it is fully in compliance with copyright law. The law is a well-thought out compromise that is appropriate at this juncture. The twelve-month embargo clearly protects publishers interests while ensuring eventual access to the results of all NIH-funded research. I congratulate NIH on the implementation of the policy and look forward to seeing data that will document its success.			Web Form
170	Web RFI	05/31/2008 at 11:49:24 AM (456)	Ruben	George	PH.D.	Dartmouth College & Editor-chief-Microscopy Research & Technique	NH	USA	Representative NIH Funding Recipient Organization	Whatever version of the article PubMed Central lands up with the publisher is responsible for producing and maintaining the final published version which authors, for example, will need to cite. ?? Why is PubMed Central using its own article numbering system (PMCIDs) and not the internationally accepted DOI (Digital Object Identifier) system on which the CrossRef linking is based? ?? Why is PubMed Central not giving clear acknowledgement to the original publication and a link to this on the publisher’s site? The statutory language of the mandatory Public Access Policy applies to “all investigators funded by the NIH,” yet does not specify whether the NIH funding is in whole or in part. NIH takes the view that the policy applies to investigators with any NIH intramural research funds or any amount of direct costs funded by NIH, even if the funding is insignificant and supplemented by other public or private sources. ?? What if these other sources oppose the posting of their funded work on PubMed Central? The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure that these other authors are “aware of and comply with” the NIH policy. How could they possibly be able to comply with this provision? What will the repercussions be for investigators and journals who do not follow the process? Will NIH stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents the sole funding for the scholarly work? Will NIH also modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does NOT apply to literature reviews?	Since journals are responsible for maintaining proof edited & corrected published paper on line, doesn't it make sense to ask the journals to deposit a web site link with pubMed on the date that an article is published in the paper journal version. The acknowledgements will have to state clearly that the work was funded by NIH for this to occur. This could eliminate a huge expense of independently putting papers onto a Pubmed website and maintaining that website into the future and the final version of the paper will be the same at the journal publisher and at Pubmed.This will also maintain the watermark of the original copyrighted paper.	The new policy will affect all stakeholders in the scientific research community and may have a particularly severe impact on small society publishers as subscription revenue will decline with increased free access on Pub Med Central. Will NIH provide publishers with detailed and robust PMC usage statistics that will enable them to assess the impact of PMC usage of their subscriptions? What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose is a) met; b) not costly for the taxpayer; c) not burdensome on research investigators; or d) does not have a demonstrably negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)? What limitations, if any, would be imposed on PubMed Central as an “aggregator” of content from sources such as HHMI, Wellcome Trust, other U.S. government agencies, etc? What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?	The cutting-edge research that the many societies publish is rarely obsolete within a year, and may have a shelf life of five to ten years. It is imperative that adequate financial compensation be offered by NIH to offset the loss of income that publishers will experience resulting from all accepted, peer-reviewed manuscripts funded by NIH being made publicly available within such a short period of time. What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Specifically, will NIH be empowered to negotiate such licensing terms, including payment, on a publisher-by-publisher basis, as certain non-government funding agencies have done? The policy provides for publisher deposit of final published articles on behalf of authors, and includes allowance for the use of grant funds in the payment of publication fees levied on NIH-funded authors. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?			Web Form
171	Web RFI	05/31/2008 at 12:55:26 PM (224)	Murray-Rust	Peter	D Phil (Oxon)	University of Cambridge	none	UK	Other Member of the Public	There is an urgent requirement in bioscience to use machines to extract information from the full-text of papers (”text-mining” mining and “data-mining”). Examples of this use are the machine-assisted annotation of genomes, the extraction of concepts from text and the linking of information from many different disciplines. In my own field of molecular informatics it is possible to scan a million Pubmed abstracts a day and extrcat mention of new chemical compounds of biological interest. It is now well known that abstracts alone do not give sufficient information and that access to the full-text is required.Many publications are accompanied by data, and indeed for many of these (e.g. about sequences and structures of biomolecules) the data are often more important than the fulltext. Although the STM publishers have urged their members to regard data as facts and therefore free of copyright, several publishers label data as copyright, thus effectively barring the legitimate re-use of data. It is important that the NIH challenges this and forbids it on PMC.Many data are embedded in the full text and can be extracted by machines (”text-mining”). This process is made more tractable if the text is available in XML form (including XHTML) and I support the use of these formats.Text-mining” and “data-mining” are hardly mentioned - if at all - in the NIH’s description and requirements. I would therefore wish to see positive indication that the NIH supports the re-use of the material, in high-throughput mode.		The information provided gives users very little positive indication that the can legitimately re-use the material published on PMC. I write a blog on Open Access and Open Data (http://wwmm.ch.cam.ac.uk/blogs/murrayrust) and the informed opinion was that PMC does not allow data- or text-mining and that attempts to do this will result in the NIH server cutting off access to the given IP. The words “fair use” are useless. In practice no scientist has enough knowledge of case law to know what is and is not fair use and the term effectively frightens many into “no use”.I would urge that the NIH make clear what their policy on data- and text-mining is, using those terms. I would also suggest that the NIH add machine-readable versions of licences or similar documents so that robots are aware of what they may and not do.	I am a user of the material available on the NIH sites, including PubChem, and PubMed. The volume of information is now so great that machines are essential to use it properly. I believe it is essential for the NIH to enable text/data-mining of its information if it is to recoup the maximum value of its research investment.			Web Form
172	Web RFI	05/31/2008 at 01:26:19 PM (424)	Colson	Karen		Association for Research in Vision and Ophthalmology	MD	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	May 30, 2008NIH Public Access StaffNational Institutes of HealthTransmitted via http://publicaccess.nih.gove/comments2/comments.htmRe: Request for Information: NIH Public Access Policy: NOT-OD-08-060 (March 28, 2008) ARVO, the Association for Research in Vision and Ophthalmology, is grateful for the opportunity to respond to the above mentioned NIH Public Access Policy. As stated in previous correspondence, ARVO has over 12,000 members worldwide and publishes two of the top five peer-reviewed journals in ophthalmology, as demonstrated by the Institute of Scientific Information’s Impact and Immediacy Factors. Investigative Ophthalmology & Visual Science (IOVS) receives over 1,600 submissions and publishes over 750 peer-reviewed articles annually; all articles are freely available online to everyone within twelve months after publication. The Journal of Vision includes 300 articles online only, all of which are freely accessible as they are published. Our concerns continue to be as follows.Intramural Researchers: Policy Interpretation• ARVO recognizes that US-government funded research is in the public domain but does not recognize NIH’s redistribution or claim of ownership of public domain content.• ARVO does not support NIH’s stated practice of depositing US taxpayer-funded articles and/or selected content in non-US sponsored or controlled databases.• ARVO supports the practice of deep archives of scientific articles and is willing to work with NIH to establish a perpetual, deep archive.• The Policy is confusing for authors and PIs; it states that the PI is responsible for submission of accepted articles whether or not they are authors of the articles. In addition, publishers do not have information regarding who is the PI for every grant.• NIH’s unfunded mandate for required deposit of accepted manuscripts policy for intra- and extramural scientists whose research is supported in whole or in part by NIH fails to recognize the value-added features included in the publishing process. ARVO supports and encourages NIH to link to final, published articles and associated supplementary data on trusted publishers’ sites such as HighWire Press.• ARVO explicitly states in its Copyright Form for government employees that NIH-funded authors may submit final, accepted electronic files to PubMed Central. Additional forms are redundant and potentially confusing to authors, institutions, and publishers.Overall Policy Concerns• NIH’s unfunded mandate for required deposit of accepted manuscripts policy for intra- and extramural scientists whose research is supported in whole or in part by NIH fails to recognize the value-added features included in the publishing process. ARVO supports and encourages NIH to link to final, published articles and associated supplementary data on trusted publishers’ sites such as HighWire Press.• Many associations, including ARVO, have free online access to all back issue content published since the inception of the journal (volume 1, issue 1).Suite 250 • 12300 Twinbrook Parkway • Rockville, MD 20852–1606 • TEL (240) 221-2900 • FAX (240) 221-0370 • www.arvo.org• This policy severely inhibits publishers’ oversight and control of the use and potential misuse of its intellectual property.• The fundamental financial models of subscriptions and advertising supporting the peer-review process as well as the ongoing educational opportunities and member support provided by Associations’ publications are threatened. The Policy is forcing model changes but does not support publisher charges if an article is accepted and published after the grant has expired, regardless of funding included in the grant.• The Policy and NIH submission process impose the additional burden of proofing and verification activities on Principal Investigators (PIs), affecting research in the short- and long-term.• There are no procedures at the NLM and PubMed Central (PMC) for ensuring that only those articles funded by NIH are made publically available. Currently publishers must monitor PMC and request removal of articles that do not meet NIH’s stated criteria.ARVO looks forward to working with NIH’s Public Access and NLM staff to resolve these significant issues.Sincerely yours,Sally Atherton, PhDExecutive Vice PresidentNicholas Delamere, PhDChair, Publications Committee Joanne AngleExecutive Director						Web Form
173	Web RFI	05/31/2008 at 01:28:46 PM (182)	Serene	Joseph	Ph.D.	American Physical Society	Md	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)	The American Physical Society (APS) is a nonprofit professional organization representing 46,000 scientists in physics and related disciplines. APS publishes approximately 16,000 peer-reviewed papers per year in nine journals. We have long supported the goal of wide access to the scientific literature through mechanisms consistent with the continuing health of peer-reviewed scientific publishing. For example, we have supported arXiv.org since shortly after it was established, we have no embargoes of any sort, and we allow authors to post our final PDF of their articles on their own websites and on their employers’ websites. We also pioneered tiered-pricing models to enhance the accessibility of our journals to smaller educational institutions.Nevertheless, we have grave reservations about the announced NIH implementation of the Public Access Policy, because we fear that this implementation runs the risk of unnecessarily damaging the economic viability of scientific-society publishers and the integrity of the scientific literature, while at the same time costing the taxpayers significantly more than is needed to achieve the central goals of the congressional public access mandate.The announced implementation effectively establishes NIH as a duplicate publisher for an unknown fraction of the literature (all papers not directly submitted by publishers) and provides no compensation to publishers for their significant investment in peer-review, scientific editing, composition, copyediting, and electronic hosting and archiving (for example, APS maintains three geographically distributed, continuously updated mirrors of all its content). Furthermore, we are concerned that the final XML files produced by PMC will not be as accurate as those produced by scientific-society publishers, with close scientific oversight (e.g., APS employs approximately 50 full-time Ph.D. editors).We believe that NIH should immediately begin serious and substantive consultations with publishers to explore a variety of cost-effective alternatives that show more appreciation for the service to the scientific community provided by nonprofit society publishers, and that avoid producing variant archival copies of the same paper. The latter seems a near-certain result of PMC’s plans to perform independent and duplicative composition and copyediting, at taxpayer expense. For example, it would be completely consistent with the public-access legislation for PMC to simply operate a well-indexed repository of publisher-prepared PDFs of all NIH supported articles, including links to publishers’ websites. Nothing in the legislation requires PMC to host full XML files of articles, let alone to spend public funds on the production of its own XML versions. APS is particularly concerned by the plans of NIH to provide its archive to other entities, including repositories outside of the United States. We see nothing in the legislation that supports the right of NIH to do this, and we believe that it is in clear violation of our copyright agreement and those of other publishers. We urge NIH to abandon these plans voluntarily and immediately.We are profoundly committed to the dissemination of scientific knowledge. This is central to the APS mission “to advance and diffuse the knowledge of physics.” However, we are equally committed to guaranteeing the accuracy of the public record of the collective scientific literature. We believe that these two objectives are best achieved by nonprofit scientific societies that combine the highest standards of the academy, long-term stability, and the ingenuity and expertise of private enterprise.						Web Form
174	Web RFI	05/31/2008 at 02:44:29 PM (578)	Gallant	Caroline	Ph.D.	Universities Allied for Essential Medicines & McGill University	Massachusetts	USA	Representative NIH Funding Recipient Organization	First of all, we would like to thank the NIH for continuing to engage with stakeholders. Universities Allied for Essential Medicines (UAEM), an university student organization with chapters at nearly 40 universities in the United States, Canada and the United Kingdom, believes that the current system established by the NIH represents the best method for ensuring a long-term, stable and effective scientific resource. Scientific innovation is best served when the fewest barriers possible stand in the way of access to knowledge. We applaud the uniform, accessible system that has been adopted by the NIH and would strongly urge that the NIH not consider alternatives that would diminish this simplicity or threaten the long-term viability of the NIH system as a one-stop location for articles resulting from public funding. The current system correctly builds upon the core mission of the university which is to widely disseminate knowledge for the public good.	In order for the policy to be effective, enforcement needs to carry a true penalty for failure to comply. For example, in all future NIH grant applications, it should be mandatory that references are included to all previously required PubMed Central deposits. Lack of monitoring and ensuring compliance has led to regular underreporting of university inventions to federal funding agencies under the Bayh-Dole Act.		At the most recent World Health Organization meeting of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property, the policy of promoting access to publicly-funded research through submission of final, peer-reviewed manuscripts to an open access database was adopted. However, the policy recommendation is to strongly encourage and not to make submission mandatory. Given that access to publicly-funded research is becoming the global norm, the NIH has an opportunity to establish the gold standard by maintaining a mandatory and effective system in place.			Web Form
175	Web RFI	05/31/2008 at 02:56:21 PM (510)	Luce	Richard	MA	Emory University	GA	USA	Representative NIH Funding Recipient Organization	The current embargo period of 12 months is longer than necessary to address the economic concerns of publishers who are interested in protecting their subscription revenue stream and is much too long to effectively promote the advancement of research in the sciences. An embargo period of 6 months would better ensure that the public has access to the published results of NIH funded research. A 6 month embargo would not endanger the revenues of the publishers because libraries will not cancel journal subscriptions because some articles from a journal will appear in PubMed Central after six months.	If the NIH manuscript submission process could include a mechanism to notify the institutions of the article’s authors, that information would be very useful to the offices charged with overseeing NIH grant administration. The notification could be at the time of submission or at the time of depositing in PubMed Central. An alternative would be the ability to identify articles deposited in PubMed Central by author’s institution and whether funded by NIH.	It would be helpful if the NIH webpage included an RSS feed so notifications of changes could be promptly distributed. An RSS feed would help our institution ensure that the materials we have prepared for our faculty and researchers continues to include the most recent information from NIH. We have found the updated FAQs to be very helpful, but would also appreciate having revisions to the FAQ noted by the date of the revision. We have also shown some slides from the training PowerPoints in our information sessions with faculty and researchers. The list of journals that submit final published articles to PubMed Central is very helpful. A similar list of journals which allow submission to PubMed Central in the language of their publishing agreements would also be helpful to NIH grant-funded authors.	Emory University appreciates the opportunity to express its support for the NIH Public Access Policy. The implementation of this policy on our campus has included ensuring faculty and researcher awareness through a broadcast memo, websites, information sessions and newsletters. The Libraries and the Office of Research continue to serve as resources for questions and to collaborate on incorporating compliance with the policy into training programs and information sessions for NIH grant recipients. Implementation of the Public Access Policy has also provided an opportunity for faculty and researchers to more fully understand their rights as copyright owners as well as their obligations under this policy. A greater understanding of copyright as a bundle of rights and the implications of following the traditional model of transferring ALL of their rights under copyright to publishers has provided an opportunity for faculty and researchers to more thoughtfully consider what rights they want and need to retain when publishing. Although authors must take additional steps when publishing their research to ensure compliance with the NIH Public Access Policy, the availability and accessibility of their research in PubMed is appealing to some faculty members since this is their primary search tool (one faculty member asked how he could get all of his previously published articles deposited in PubMed). The accessibility in PubMed of articles by members of the Emory community is congruent with Emory’s vision of working for positive transformation by making discoveries that benefit Emory, Atlanta, and the world. With continued collaboration, the goal of the NIH Public Access Policy to ensure that the public has access to the published results of NIH funded research is both attainable and beneficial to our society.	Emory_University_NIH_Public_Access_Policy_comments.txt	Question 1 - Do you have recommendations for alternative implementation approaches to those already reflected in the NIH Public Access Policy? The current embargo period of 12 months is longer than necessary to address the economic concerns of publishers who are interested in protecting their subscription revenue stream and is much too long to effectively promote the advancement of research in the sciences. An embargo period of 6 months would better ensure that the public has access to the published results of NIH funded research. A 6 month embargo would not endanger the revenues of the publishers because libraries will not cancel journal subscriptions because some articles from a journal will appear in PubMed Central after six months. Question 2 - In light of the change in law that makes NIH’s public access policy mandatory, do you have recommendations for monitoring and ensuring compliance with the NIH Public Access Policy? If the NIH manuscript submission process could include a mechanism to notify the institutions of the article’s authors, that information would be very useful to the offices charged with overseeing NIH grant administration. The notification could be at the time of submission or at the time of depositing in PubMed Central. An alternative would be the ability to identify articles deposited in PubMed Central by author’s institution and whether funded by NIH. Question 3 - In addition to the information already posted at http://publicaccess.nih.gov/communications.htm, what additional information, training or communications related to the NIH Public Access Policy would be helpful to you? It would be helpful if the NIH webpage included an RSS feed so notifications of changes could be promptly distributed. An RSS feed would help our institution ensure that the materials we have prepared for our faculty and researchers continues to include the most recent information from NIH. We have found the updated FAQs to be very helpful, but would also appreciate having revisions to the FAQ noted by the date of the revision. We have also shown some slides from the training PowerPoints in our information sessions with faculty and researchers. The list of journals that submit final published articles to PubMed Central is very helpful. A similar list of journals which allow submission to PubMed Central in the language of their publishing agreements would also be helpful to NIH grant-funded authors. Question 4 - Do you have other comments related to the NIH Public Access Policy? Emory University appreciates the opportunity to express its support for the NIH Public Access Policy. The implementation of this policy on our campus has included ensuring faculty and researcher awareness through a broadcast memo, websites, information sessions and newsletters. The Libraries and the Office of Research continue to serve as resources for questions and to collaborate on incorporating compliance with the policy into training programs and information sessions for NIH grant recipients. Implementation of the Public Access Policy has also provided an opportunity for faculty and researchers to more fully understand their rights as copyright owners as well as their obligations under this policy. A greater understanding of copyright as a bundle of rights and the implications of following the traditional model of transferring ALL of their rights under copyright to publishers has provided an opportunity for faculty and researchers to more thoughtfully consider what rights they want and need to retain when publishing. Although authors must take additional steps when publishing their research to ensure compliance with the NIH Public Access Policy, the availability and accessibility of their research in PubMed is appealing to some faculty members since this is their primary search tool (one faculty member asked how he could get all of his previously published articles deposited in PubMed). The accessibility in PubMed of articles by members of the Emory community is congruent with Emory’s vision of working for positive transformation by making discoveries that benefit Emory, Atlanta, and the world. With continued collaboration, the goal of the NIH Public Access Policy to ensure that the public has access to the published results of NIH funded research is both attainable and beneficial to our society.	Web Form
176	Web RFI	05/31/2008 at 03:01:06 PM (176)	Newcomb	Douglas	Master of Science	Special Libraries Association	VA	USA	Other	The Special Libraries Association (SLA) appreciates the manner in which the NIH has consistently and willingly engaged its stakeholders in an open and transparent fashion. Independently, and as one of several national library organizations acting in unison, SLA has repeatedly expressed support for open public access to the results of research funded by the NIH and will continue to do so. SLA supports the NIH Public Access Policy in general and its implementation as currently articulated. This policy is a significant opportunity for researchers to expand access to NIH-funded research, and to use and build upon this information in unprecedented ways. The policy will promote new discoveries, help to stimulate innovation, and accelerate the pace of research in general.One recommendation SLA would make to improve the policy is to shorten the embargo period to six months. A shorter embargo period would more accurately reflect the pace of research and discovery within the biomedical field, and at the same time align the NIH policy with those in around the world, such as Canada, the European Union. A six-month embargo is supported by the increasing adoption of author addenda, which enables authors to retain rights to their work while providing the publisher the license to publish. In our highly competitive global economy, a shortened embargo is an important component to ensure that U.S. policy keeps our research institutions competitive with rest of world.	It would be usefull to have the NIH produce a list of publishers whose author publishing agreements provide for deposit with PMC in a manner that is consistent with copyright law.		On a note of concern, SLA is aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. SLA strongly opposes this proposal as it would NOT achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. To effectively curate a database, and for the quality of material it contains to be preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative, one which the NIH has consistently and wisely rejected.			Web Form
177	Web RFI	05/31/2008 at 04:49:09 PM (866)	Crews	Kenneth	J.D., Ph.D.	Columbia University	New York	USA	Representative NIH Funding Recipient Organization	No reponse to this question at this time.	No response to this question at this time.	No response to this question at this time.	Columbia University expresses its support for the NIH Public Access Policy, and most experiences at Columbia with implementation have been favorable. Because of the many comments submitted to NIH from other interested parties, we would like to emphasize one particular point: We have found that the policy has yielded some unexpected and important benefits, in addition to the intended consequences of the policy for the public interest.First, inside the university, implementation of the policy has created an opportunity for several offices and many scientists to work together to address an important development in the law and to devise new policies and procedures that may ultimately increase accessibility of research results. The effort has been an important occasion to review existing positions on related matters and to share ideas within the university on critical issues related to research, publishing, and funding.Most notably, implementation at Columbia has involved a cooperative interaction among many diverse offices, such as the University Library, the Office of Research Administration, the Office of Research Compliance and Training, the Office of GeneralCounsel, and the Copyright Advisory Office, as well as a many research programs and academic disciplines. One outcome of the process has been a website specifically developed to guide faculty members and others seeking to comply with the NIH policy(http://scholcomm.columbia.edu/nih-public-access-policy/). The website includes explanations of the law and tools and documents for compliance. Second, we are seeing numerous examples of publishers revising their policies and often implementing standards that are supportive of the public interest beyond the requirements of the law. Scientists at Columbia have appreciated those publishers that have offered to undertake the submission procedures, and those publishers that have chosen to make their works available in final form or on an earlier schedule.These unexpected benefits of the NIH policy underscore the policy’s fundamental importance to the creation and dissemination of research results. The NIH policy is much more than legal mechanics; it is proving to be an invaluable motivation for universities, scientists, government agencies, and publishers to reevaluate their polices and to implement standards that can more effectively reflect the public interest and the needs of diversestakeholders. Thank you for this opportunity to submit comments.			Web Form
178	Web RFI	05/31/2008 at 04:54:47 PM (781)	Lichter	Allen	MD	Ami\erican Society of Clinical Oncology	VA	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)					ASCO_NIH_Comment_0508.txt	American Society of Clinincal Oncology 1900 Duke Street Alexandria, VA 22314 May 30, 2008 Elias A. Zerhouni, M.D. Director National Institutes of Health One Center Drive Bldg. 1 -- Room 126 Bethesda, Maryland 20892-0148 RE: Request for Information: NIH Public Access Policy Submitted electronically at http://publicaccess.nih.gov/comments.htm Dear Dr. Zerhouni: The American Society of Clinical Oncology (ASCO), publisher of the Journal of Clinical Oncology (JCO), appreciates the opportunity to offer comments regarding implementation of the National Institutes of Health (NIH) Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research. ASCO shares the NIH goal of connecting the world of science and ensuring broad public access to research supported by NIH. We agree that information and information-sharing policies must be developed for the 21st century and must not look back to the past century. ASCO has developed a number of initiatives to advance public access to research published in JCO. The public enjoys free access to JCO-published research reports one year after publication, and ASCO provides free access to JCO for low-income countries through the World Health Organization’s HINARI program. A significant amount of JCO content is available to the public immediately through www.JCO.org and through www.cancer.net, ASCO’s web site for cancer patients and the public. We understand that the request for information from interested parties is part of the NIH plan for implementing the Public Access Policy and subsequently evaluating and adjusting the implementation standards or policy, if necessary. In keeping with this implementation philosophy, ASCO offers one specific proposal related to immediate implementation and recommends a broader consideration -- through a structured discussion involving NIH officials, publishers, NIH-supported researchers, and other interested parties -- regarding the relationship between public access and the creation of an archive of NIH-funded research. Public Access by Links to Publishers’ Web Sites ASCO strongly recommends that NIH consider public access to be accomplished by a link from PubMed Central to publishers’ web sites. A linking policy has significant advantages for the intended beneficiaries, as well as for others affected by the Public Access Plan. The most significant advantage of providing public access through a link to the published article on the publisher’s web site would be to eliminate any confusion about content of the published article. Under the plan outlined by NIH, there exists the potential for confusion between the manuscript that is accepted for publication but that is not text edited -- the version that would be submitted by the NIH-supported researcher -- and the final published version of the article. The possibility of confusion could be addressed by permitting the researcher to submit at the time of acceptance for publication of an NIH-funded study a simple notification of acceptance; the responsibility for providing the link to the published manuscript could be shifted to the publisher. Providing public access through a link to the publisher’s web site would also remove the burden on researchers to negotiate changes to copyright agreements to permit public access. There is administrative simplicity to a linking policy that should make it a cornerstone for implementation of the Public Access Policy. Creating an Archive of Peer-Reviewed Publications from NIH-Funded Research We understand that NIH has rejected a policy that would rely on linking to publishers’ web sites because of its interest in creating “a stable archive of peer-reviewed research publications resulting from NIH-funded research to ensure the permanent preservation of these vital published research findings.” NIH suggests that it cannot rely on publishers’ web sites and must create its own. ASCO can make commitments only for its own publishing web site, although we are not aware of serious stresses and strains in other publishers’ sites that would suggest they are unreliable now or would be in the future. ASCO also participates in the Portico service, a non-profit service which provides a permanent archive of electronic scholarly journals for both publishers and libraries. We are not persuaded that duplicating publishers’ web sites with a public one at NIH is a 21st century solution to information technology needs. We urge that there be a serious debate, including all interested public and private sector parties, regarding development of this archive. Because the need for this archive is driving to a significant degree the manner in which the Public Access Policy is implemented, a serious review of this archive is in order. Evaluation of Public Access Policy Implementation With publication of the Request for Information, NIH has provided significant information regarding its philosophy and plans for the Public Access Policy. In additional conversations with interested parties, NIH officials have said that the policy will be evaluated and that the agency is willing to make adjustments, if required. ASCO urges that NIH strive for transparency in its evaluation of the Public Access Policy and suggests that the agency report on a regular basis (on a quarterly or semi-annual schedule) regarding the progress in implementing Public Access. We look forward to additional discussion with NIH regarding the Public Access Policy. Sincerely, Allen S. Lichter, MD CEO American Society of Clinical Oncology	Web Form
237	Town Hall Form Comments	03/10/2008 at 07:20:38 AM (813)	Johnson	Richard	BA	Inspira Strategic	MD	US	Other Member of the Public						I enthusiastically welcome the revised Public Access Policy (NOT-OD-08-033) developed by NIH in response to Congressional direction. The range of policy options have been thoroughly discussed and weighed since at least 2004 in Congress, at NIH, in the scientific community, and in public fora. Support for public access has been broad and opposition has been limited to a relative handful of prosperous publishers. NIH has taken a thoughtful, conservative approach, embracing a mandatory policy only after the failure of a voluntary approach. It has gone to great lengths to consult with the range of interested parties and the resulting policy fairly balances their preferences with the public interest. Vested interests must not be allowed to further stall NIH public access.Prompt NIH action to implement the newly announced policy will ensure that NIH-funded research findings are available to all. Any delay will only hold back scientific advancement and impede the public’s access to high-quality health information. The April 7, 2008 implementation date announced by NIH must not be held up. Particularly in the current, difficult economic climate, taxpayers have a right to expect that they are getting their money’s worth from the federal investment in research. Universal access to NIH research will unlock the full health, economic, and social benefits that motivate NIH appropriations. Any delay will reduce the return on public investment.	Web Form
240	Town Hall Form Comments	03/11/2008 at 02:36:25 PM (915)	Salo	Dorothea		University of Wisconsin	WI	US	Representative NIH Funding Recipient Organization						It would be very helpful for PIs, grant administrators, librarians, and others involved in the process of compliance with the NIH Public Access policy to know how the NIH plans to measure compliance with the policy, and whether there will be opportunity for instances of non-compliance to be cured. This question is of particular importance with respect to PIs who wish to comply, but are prevented from doing so by intransigent publishers.	Web Form
242	Town Hall Form Comments	03/11/2008 at 02:45:25 PM (478)	Rohlfing	Torsten	PhD	SRI International	CA	US	NIH-funded Investigator						The public access policy is unclear as to what types of publications it applies to. According to Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008), it applies to " final, peer-reviewed manuscripts." However, the instructions and FAQs on the NIH website refer more specifically to "journal articles" (see http://publicaccess.nih.gov/FAQ.htm#c1). These two are not the same. It should be clarified whether the policy applies only strictly to journal articles, or whether it also extends to peer-reviewed conference papers. In the latter case, it needs to be further clarified under what circumstances a conference paper is considered peer reviewed. Does this cover only papers that were reviewed in full, or also papers for which only an (extended) abstract was reviewed, but not the final paper as such (example: annual SPIE Medical Imaging conference).	Web Form
243	Town Hall Form Comments	03/11/2008 at 02:55:25 PM (746)	Harnad	Stevan	PhD	Universite du Quebec a Montreal & Southampton Univefrsity	Quebec	Canada	Representative NIH Funding Recipient Organization						Universities (and research institutions) are the natural ones to monitor compliance with the NIH Open Access self-archiving mandate -- as well as to reinforce it with institutional self-archiving mandates of their own. The universities receive the indirect costs and overheads from NIH grants; it should be made part of the institutional fulfillment conditions for receiving NIH funding that the university must ensure the self-archiving of the published output. But to make this part of the university's natural work flow, and to integrate it with the university's own self-archiving mandates (like Harvard's), and the monitoring of compliance therewith, the locus of the deposit must in all cases be the university's own Institutional Repository. That means each university monitors deposit of all of its research output in one repository: its own. Optimize the NIH Mandate Now: Deposit Institutionally, Harvest Centrally http://eprints.ecs.soton.ac.uk/15002/	Web Form
244	Town Hall Form Comments	03/11/2008 at 03:27:26 PM (692)	Wynne	Richard	B.Com	Private individual with 20+ years technology and publishing experience	MA	US	Other Member of the Public						Assertion 1: The taxpayer pays for the development of the content in a scholarly manuscript so it should be accessible to the public at no charge. Rebuttal 1: If the assertion is valid then ALL research output including books, patents and discoveries should be made available for free. Publishers add value, and should be entitled to do so, in the same way that countless other individuals and organizations are able to build businesses around Government funded research. The taxpayer funds many activities and services that are not provided to the public for free. Assertion 2: In the Internet age the marginal cost of delivering content is almost zero, so scholarly manuscripts should be disseminated for free. Rebuttal 2: Controlling access to content acts as a proxy for access control for value added capabilities (e.g. specialized search engines, discovery tools, branding etc) provided by publishers. Free access, undermines this revenue recovery mechanism and will drive out innovation from publishing. Assertion 3: Authors and scientists work for “free”, so the content should be free. Rebuttal 3: Just because the raw ingredients of a product are extremely low cost, does not entitle the Government to mandate free distribution. The cost of the ingredients used to make Coke are negligible (water and sugar), does that mean that Coke has to be provided to the public for free? In fact, publishers invest heavily in branding and marketing that helps to connect appropriate readers with appropriate content. Without a financial incentive this important work of branding and marketing will disappear.	Web Form
245	Town Hall Form Comments	03/11/2008 at 05:54:43 PM (452)	Ford	Gail	BA	UC Berkeley	CA	US	Representative NIH Funding Recipient Organization						The NIH mandate to post NIH-funded research for immediate open access is a good decision that * positively contributes to the advancement of science * serves the public--enabling discovery, speeding treatment, and cures * leverages the public investment in the NIH to deliver better public health * keeps us in step with other countries who have recently enacted similar polices * democratizes teaching and learning--providing new resources forscientists to use in new and innovative ways.	Web Form
246	Town Hall Form Comments	03/11/2008 at 06:00:47 PM (866)	Aickin	Mikel	PhD	University of Arizona	AZ	US	NIH-funded Investigator						The NIH can easily expand public access to publicly-funded research in two meaningful ways. (1) Guarantee that every NIH funded grant has access to a means to publish its results, by providing a publication-of-last-resort facility. Require every PI to make at least one submission, either to a regular journal, or failing that, to this publication-of-last-resort facility, within a reasonable time after the grant terminates. (2) Make the raw data of any NIH funded study available to any qualified researcher, consistent with confidentiality protections, but without any additional conditions. It is not sensible that vast amounts of publicly-funded research data are being casually allowed to slip into oblivion, when they could be used to improve biomedical research. Thirdly, abandon this absurd, redundant publication of research results burden. The NIH obviates the requirement to deal with existing copyright law by pitting the researchers against the journals. The fundamental problems in biomedicine at the moment have nothing to do with availability of published articles. They have to do with (1) non-publication by funded studies, and (2) lack of access to raw data. We should try to find a way to divert resources from plausible but useless programs to disseminate information, into actual disseminations of actual information, where it will do some good.	Web Form
247	Town Hall Form Comments	03/12/2008 at 08:18:29 AM (615)	Ryley	James	Ph.D.	http://www.FreePatentsOnline.com	MD	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						While the policy as it stands is certainly a step in the right direction, without access to pre-existing publications this policy does not serve the public good by providing Public Access to a *comprehensive* set of documents. I strongly suggest that the policy apply to all documents which have been published over X months ago, not just documents published after the policy goes into effect. I realize that legally, legacy documents are a somewhat different issue than newly-published documents. But, certainly this can be worked out with the copyright holders as part of the overall plan. NIH is in the driver's seat here; they can always prohibit publishing of any future NIH-funded manuscripts by copyright holders who do not agree to reasonable terms on the legacy documents. Without such terms for legacy documents, NIH is relegating Public Access to a database that starts in 2008. Can any researcher reasonably use such a database in the course of their work with confidence that they have knowledge of all the relevant literature? Of course not.	Web Form
248	Town Hall Form Comments	03/12/2008 at 08:43:23 AM (975)	Mullaly-Quijas	Peggy	PhD	Univesrity of Missouri - Kansas City	Missouri	US	Other						This new policy will be a boon for the researchers and clinicians I work with. To ensure the great research funded by the federal government is readily available without an additional cost for the individual needing that information will improve the dissemination of information needed for teaching and research. It will further the work of the University. And most importantly, lives will be helped (maybe even saved) with the access to this important research. I will be helping the researchers in submitting their manuscripts to PubMed Central, and offering training to those who which to do it themselves.	Web Form
249	Town Hall Form Comments	03/12/2008 at 09:27:12 AM (773)	Gluud	Christian	MD, DrMedSci	Copenhagen Trial Unit	Denmark	Denmark	Representative NIH Funding Recipient Organization						The proposed NIH policy should become the norm for all clinical research as the transparency positively contributes to the advancement of science. In this way it serves the public health—by enabling discovery, speeding treatment, and cures of diseased people. It makes the USA as a front runner compared with a number of other countries who have not yet enacted similar polices - but it must come to all.	Web Form
250	Town Hall Form Comments	03/12/2008 at 09:27:31 AM (960)	alberola-Ila	jose	md, phd	oklahoma medical research foundation	oK	US	NIH-funded Investigator						I think open access is a very positive development, which serves public health and facilitates learning and research, especially in small research institutions, and developing countries. I only wish the time limit to make research freely available was much shorter. One year is too long!	Web Form
251	Town Hall Form Comments	03/12/2008 at 09:30:31 AM (165)	Futrelle	Robert	PhD	Computer Science, Northeastern University	MA	US	Other Member of the Public						I have been funded to do research (mostly by NSF) and have published about 60 papers over the last 30 years, so I understand research and publishing. Though a Biology faculty member at U. Illinois for ten years, my research today is on knowledge extraction from the Biomedical literature. The goal of the work is to build far better systems than we have today for the retrieval of important content, both the text and graphics content. But with the great majority of the literature residing behind the walls set up by commercial publishers, it is impossible to mine the full text of published research papers. The publishers are reluctant to adopt the modern approaches that I and others are developing, because all their attention is focused on the bottom line. Fortunately, BioMed Central makes freely available some 100 million words of text - all of the papers they publish, as well as the 250 thousand figures contained in the papers. These form the basis of my research. But my most serious concern is the lack of access to health-related research by physicians and patients. I can walk over to Harvard's Countway Library and for $35 a day have excellent access. That is no solution, and certainly an impossible one for someone in a rural area of the US, far from any source of medical information, but suffering from a life-threatening medical condition. In conclusion, for the health and well-being of our nation, it is important to make taxpayer-funded research on Biology and Medicine freely available to our citizens. Thank you	Web Form
252	Town Hall Form Comments	03/12/2008 at 09:31:30 AM (903)	Abraham	Edathara	Ph.D.	University of Arkansas for Medical Sciences	Arkansas	US	NIH-funded Investigator						Enhances the advancement of science Provides a direct return on investment of public funds in NIH Keeps the United States in step with other countries	Web Form
253	Town Hall Form Comments	03/12/2008 at 09:50:30 AM (813)	Crusio	Wim	PhD	Centre National de la Recherche Scientifique	N/A	France	NIH-funded Investigator						As an editor of several scientific journals (both Open Access -OA- and "classical") and as a referee, I get to see many manuscripts. I am really not interested in seeing even more manuscripts and have therefore yet to use PubMedCentral. I have a strong preference for the final publisher-corrected and -formatted PDF of an article. In my opinion, the creation of the PubMedCentral database is a waste of money and effort, duplicating the existing online platforms that every major publisher now has in place. It would be much more effective if NIH would provide grantees with funds to permit them to pay the publication fees that OA publishers are charging. However, it should be realized that OA publishing will, in the final count, cost more to the academic community than the current system (because, for example, industry is a relatively larger consumer of than contributor to the scientific literature). OA publishing will only be sustainable if funded researchers obtain additional funds to defray publication costs and simultaneously a just mechanism is put in place to ascertain that unfunded researchers will still have the possibility to publish their results. Without the latter, much original research would get lost to the community, to the detriment of these researchers and, in the end, scientific progress. A final concern is that under the OA model, it is in a publisher's interest to publish as many manuscripts as possible. In the classical publishing model, editors are constrained by their page-budget, leading to a heavy selection of articles for publication. In OA publishing, thresholds are definitely lower. Whether this will lead to lower scientific standards in the future is something that is difficult to predict at this point, but the dangers are clear.	Web Form
254	Town Hall Form Comments	03/12/2008 at 10:04:32 AM (882)	Gladfelter	Amy	Ph.D.	Dartmouth College	NH	US	Representative NIH Funding Recipient Organization						I am a new investigator not yet funded by NIH but seeking funding. Ensuring open access to journals is an ethical responsibility of NIH and effort must be taken to make science funded by the public, available to the public. What will not change in this new rule is the actual cost of publishing. In making open access the law, publishers will likely transfer the costs of publications to investigators that may have been in the past recovered through subscriptions. This financial reality will have to be addressed in grant awards and in some sense the NIH will accept a burden of a financial cost associated with publishing. Nonetheless, the publication is as important as funding the work itself so this is a necessary element to add to the budget.	Web Form
255	Town Hall Form Comments	03/12/2008 at 10:14:31 AM (113)	Papavasiliou	Nina	PhD	The Rockefeller University	NY	US	NIH-funded Investigator						Lack of open access constitutes a double burden on the US taxpayer, who a) invests in the NIH (and the vast majority of science in the US is funded by the NIH) and b) has to pay for access of what their taxes have helped produce! It is by now clear (to the unbiased eye) that open access will not sink publishers - so I think we should all fully support the bill and its immediate implementation.	Web Form
256	Town Hall Form Comments	03/12/2008 at 10:27:59 AM (184)	Gross	Liza	B.S.	Public Library of Science	ca	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						I urge you to go forward with the planned April 7 implementation of the NIH public access policy without delay. While I believe NIH should require immediate access to research that is funded by US taxpayers, at the very least, the 12 month requirement must be implemented as soon as possible, because it will accelerate scientific discovery and thus benefit public health by speeding development of new treatments and cures. But most importantly, the NIH has a responsibility to the taxpayer that funds its research; it is unacceptable for members of the public to have to pay to access the results of research they funded.	Web Form
257	Town Hall Form Comments	03/12/2008 at 11:07:09 AM (702)	McMahon	Martin	PhD	UCSF Comprehensive Cancer Center	CA	US	NIH-funded Investigator						I write in strong support of the proposed new NIH policy on open access publishing. Open access publishing is an important new development that allows free and timely access to research funded by the NIH. Despite the continued value of the traditional model of publishing in private sector run journals, it has always seeemed incongruous that research funded by the public purse should then not be made freely available to the public-at-large who funded the research. Moreover, the policy of publishing houses claiming copywrite on publicly funded research seems entirely inappropriate. Furthermore, open access publishing positively contributes to the advancement of science, it serves the public--enabling discovery and speeding new treatments and cures for human disease. In addition, it leverages the public investment in the NIH to deliver better public health. Open access further keeps the USA in step with other countries such as the UK who have recently enacted similar open access publishing polices. Finally, open access democratizes teaching and learning--providing new resources for scientists to use in new and innovative ways.	Web Form
258	Town Hall Form Comments	03/12/2008 at 12:36:33 PM (782)	STEINHARDT	RICHARD	PHD	UC BERKELEY	CA	US	NIH-funded Investigator						OPEN ACCESS TO RESEARCH RESULTS IS ABSOLUTELY ESSENTIAL TO RAPID SCIENTIFIC PROGRESS. THE PROFITEERING OF A FEW MEGA PUBLISHERS SHOULD NOT BE ALLOWED TO IMPEDE PROGRESS.	Web Form
259	Town Hall Form Comments	03/12/2008 at 12:50:00 PM (477)	Vickers	Andrew	PhD	Memorial Sloan Kettering Cancer Center	NY	US	NIH-funded Investigator						To whom it may concern I am fully supportive of the new regulations that research paid for by the US public should be available to the US public. I am somewhat surprised to hear that certain groups with a clear self-interest (e.g. publishers) are trying to block the regulations. Whatever the reasons they give for this must surely be a smokescreen: it is ridiculous to think that science or the public interest could best be served by blocking access to research findings. best Andrew Vickers	Web Form
260	Town Hall Form Comments	03/12/2008 at 12:53:39 PM (195)	Nalin	David	M.D.	Retired director, Merck Vaccine Division	PA	US	Other						I fully support the new NIH Public Access Policy, which will help speed access to important and innovative medical research data and will enhance the speed of research progress as well as making publicly funded research available to the public in the most efficient and facilitated manner. David Nalin, MD	Web Form
261	Town Hall Form Comments	03/12/2008 at 12:57:37 PM (971)	Hart	Anne	Ph.D.	MGH and Harvard Medical School	MA	US	NIH-funded Investigator						I strongly support open public access to all published results of scientific studies funded by the government. The policy requiring PubMed Central deposition of published results within a year is entirely reasonable and should be implemented immediately- or at least in April as scheduled. There should be no delay. As an active researcher and educator, the lack of access to published research is a constant drag on my efforts.	Web Form
262	Town Hall Form Comments	03/12/2008 at 01:13:10 PM (506)	Robinson	John	Ph..D.	Govt, laboratory but speaking as a Private citizen	British Columbia	Canada	Other Member of the Public						I use scientific journal articles each and every day in my job as a veterinary diagnostic virologist. Often publications are NOT available to me because we do not have funding to purchase these articles at what I consider to be exhorbitant fees. The open access policy is a very important next step in making extremely valuable information available to everyone whether they work in a scientific endeavor or not. We cannot afford to allow the publishing industry to dictate who is or isn't allowed important information. Research is based on knowledge and research moves our world forward in medicine and all areas of science. The more our knowledge base increases and is free to all mankind the greater our progress in solving the world's problems. The information explosion via the internet has proven that and now it's time to be able to freely call up all information related to scientific research and especially research funded by the taxpayers of the United States and Canada through their government agencies.	Web Form
263	Town Hall Form Comments	03/12/2008 at 02:36:19 PM (686)	Priestly	Beatrice	MLS Projected MBA summer 2008	Long Branch Public Library	New Jersey	US	Other						I agree with the NIH proposal that research be posted to PUB Med within 12 months of publication. Research is often extrememly expensive to get a hold of if it is possible at all. it is quite difficult in a public library with lack of funds for expensive databases. And i am sure the widen availability of the data would benefit those considering further research and the public whom we all ultimately serve. thank you to all parties who have come together to bring this proposal to the table. it makes sense and allows for publishers to make money on the critical first 12 months of publication time period. when it comes to research we all stand on the shouldiers of giants before us. how high up into the sky would we reach if we all had a leg up to great heights. i am not just talking about advancing the next researcher down the line I mean we would be contributing to advancing society as a whole. I think all will see great advances for mankind come out of this proposal. tahnks you for yur time and attention. i speak as an author, a librarian researcher and a member of the public. thsnk you.	Web Form
264	Town Hall Form Comments	03/12/2008 at 03:15:25 PM (797)	Schaffer	Joseph	none	none	TX	US	Other Member of the Public						I support this mandate, in fact would like to see it extended to be made available to anyone in the public, whether professional or not, and since it is in the public interest be provided at no cost, or at least the minimal cost of maintaining it for availability on PubMed.	Web Form
265	Town Hall Form Comments	03/12/2008 at 03:30:36 PM (983)	Turner	Erick	M.D.	Oregon Health & Science University; Portland VA Medical Center	Oregon	US	Representative NIH Funding Recipient Organization						I am the lead author of a Jan 17, 2008 article in the New England Journal of Medicine titled "Selective Publication of Antidepressant Trials and Its Influence on Antidepressant Efficacy". Our study showed that the true efficacy of this drug class is less than what has been portrayed in medical journals. This is because of a combination of nonpublication of negative results and "spin". I believe strongly that it is the best interest of the public health to have a clear and unbiased picture of the results of all clinical trials. If investigators can pick and choose what to publish, they will certainly be tempted to find reasons not to publish negative results. But we need to know the bad news as well as the good news. As US taxpayers, we deserve the right to know the fruits of our investment, even if the "fruit" is not as sweet as what we had imagined. Otherwise, we will be living in a polyannish world in which the only results that get disseminated are ones that fulfilled the investigator's hope. When negative studies don't get published, future investigators may embark on the very same study, not knowing that they may be investing their time and additional government money into a blind alley.	Web Form
266	Town Hall Form Comments	03/12/2008 at 04:05:35 PM (367)	Yunger	Libby	PhD	Sigma-Aldrich Corp	MO	US	Other						I applaud NIH for asking that reports of publicly funded research be easily available to other researchers (and to the public)- after all, we paid for it via our taxes. Many industrial organizations no longer have libraries and ask their scientists to search and access the scientific literature via PubMed, HighWire and other internet sources. You would probably be amazed by the number of review articles that are based only on the information available in abstracts! This does a huge disservice to other scientists reading those papers. In my own case, Sigma-Aldrich does buy access to some journals, but only those used by a large number of our staff. One of my responsibilities is to search the literature for trends in nutrition and cancer research, to write reviews for our customers, and to make recommendations regarding updates to our product line to support these research areas. Generally I have NO access to important articles in these research areas because 1) nobody else at S-A has need of these journals and 2) the needed journals are not open access, even though much of the research has been publicly funded through NIH. It is usually possible to get e-versions of the papers directly from the researchers, but that is a cumbersome and unreliable process, and sometimes the papers are not made available in a timely fashion. I refuse to pay for access since too often in the past I have paid $15-$25 for access to a paper that turned out not to be useful. Scientists PAY to have their papers published; publishers greatly increase their own expenses by refusing to sell internet-only subscriptions to their journals. Pay-per-view for old literature is just another cash cow for the publishers. I would support letting the publishers have a 6 month "pay per view" period for research papers to recoup their costs, but after that time all articles should be open access. That way publishers could still make money without gouging the researchers and their institutions.	Web Form
267	Town Hall Form Comments	03/12/2008 at 07:18:09 PM (215)	Hubbard	Tim	PhD	Wellcome Trust Sanger Institute	Cambridgeshire	UK	NIH-funded Investigator						As an externally NIH funded researcher, I fully support the implementation of this policy. As a genome annotation database provider, I particularly support the move to open access as it offers the chance to discover links between publications and database symbols such as gene names, via text mining and to build web links to the point within the document where this is discussed. I believe that this and other web based integration around open access text will improve the efficiency of science by creating a new competitive market of processing, sumarizing and presenting textual information to scientists. This will ensure they learn about relevant discoveries sooner and avoid duplicating existing research needlessly etc. Best wishes, Tim Hubbard Head of Informatics PI, NIH ENCODE annotation scale up project Wellcome Trust Sanger Institute	Web Form
268	Town Hall Form Comments	03/12/2008 at 07:58:43 PM (898)	Emery	Sean	PhD	University of New South Wales, Australia	NSW	Australia	NIH-funded Investigator						Many groups conduct separate but parallel randomised clinical trials with similar interventions. Decisions regarding major changes to ongoing protocols following scheduled or unscheduled DSMB reviews or normal completion of studies can often exert profound effects on other studies. Often the safety and well being of participants in the parallel studies cannot be properly safegaurded if there asymmetric release of data. The sorts of detials required to understand the basis for changes to ongoing trials are not adequately addressed in NIAID press releases. There is an urgent need for timely release of pertinent data to other trial groups when major decisions are made regarding premature or scheduled termiantion of randomised clinical trials. Tissue repositories linked to informative clinical datasets generated during the conduct of prospective clinical research projects are an invaluable perhaps unique resource. They are under utilised - perhaps in large part because their existence is not adequately or effectively communicated. This clearly leads to enormous redundnacy and repetition. Mechanisms should be developed to ensure effective and efficient communication of tissue repositories (existence, inventories, mechanisms of access) arising from public sector funding to research groups.	Web Form
269	Town Hall Form Comments	03/12/2008 at 08:40:50 PM (765)	Roberts	Richard	Ph.D.	New England Biolabs	MA	US	NIH-funded Investigator						The move to mandate deposition of NIH-funded publications is long overdue. Our ability to conduct research depends completely on having complete access to the published work of other scientists. At present this is often not possible without spending a great deal of money. It has always seemed strange that the public, of whom I am a part, does not have free access to the results of the research that we have paid for through our taxes. Instead, as a research scientist I have to pay to publish my work, pay to read it and am expected to provide peer review for free. Even the one year period of restricted access is far too long in my opinion. Papers should be made available to the research community and the public immediately. It must also be made available in a form such that I can download it and search it using my own data mining software, not the rather limited options provided by a publisher.	Web Form
270	Town Hall Form Comments	03/12/2008 at 08:49:17 PM (258)	butcher	karyle	mls	libraries	or	US	Representative NIH Funding Recipient Organization						I support the NIH policy on open access to ensure that publicly funded research is made available to the research community and general public within 12 months from publication. The library community and others have in place or are putting in place processes which enable the researcher to deposit her/his information in a timely and efficient manner. Making this research available will have a great benefit on other aiding other researchers as well as providing the public with tools to make more informed health related decisions.	Web Form
271	Town Hall Form Comments	03/13/2008 at 07:13:22 AM (138)	Schmidt	Harald	MD/PhD	Monash University, Melbourne, Australia	VIC	Australia	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						The proposed NIH policy will help to advance free access and discussion of science. This will serve the public by redirecting the scientist's interest away from publicatiion as an output but rather focus on the real advancements and outcomes, such as relevance of work, translation into diagnostics and cures. A huge cost burden of subscribing to costly journals to read your own work and that of your colleagues would be removed. Innovative communication tools could be added, i.e. commenting, discussion and rating of papers post publication. Thus the individual paper and its finding rather than the journal where it is published would become the focus of attention. This will provide a much better and direct return for public investment in the NIH. Keeps the USA in step with other countries who have recently enacted similar polices. It also democratizes teaching and learning—by providing new resources for scientists to use in new and innovative ways.	Web Form
272	Town Hall Form Comments	03/13/2008 at 07:34:33 AM (514)	Barlow	Michelle	BA	Hidradenitis Suppurativa Foundation	CA	US	Patient or Representative of a Public Health Advocacy Organization						I believe open access is essential and only wish that it was less than 12 months.	Web Form
273	Town Hall Form Comments	03/13/2008 at 08:20:21 AM (132)	Fontaine-Terry	Patrick	JAD	Lay Public	MD	US	Other Member of the Public						Partially federal funded research that was released in a peer reviewed scientific journal should be available for open access no more that 12 months after original release. Open online access to scholarly scientific articles should be demanded and a new mechanism to require compliance should be adopted by the federal government. It is obvious to me as a lay person that the past agreements and compromises that NIH and the government have agreed to are insufficient and not be complied with by most of the journal publishers. As a taxpayer I fully expect that authors, publishers, and publishing conglomerates to abide by the open access agreements committed to over recent years. But unfortunately there remains a paucity of adherence and a shameful lack of sincere interest to permit access to dated articles. In some cases journals remain closed and require an access toll fee to retrieve full-text versions of correspondence, opinion pieces, and other federally funded primarily research for years and years beyond the original release date. It should not cost me or anyone $25, $45, $55 dollars to access a three year old article. Examples of proposed solutions that NIH could easily incorporate into the funding and grant making process: 1) Include in the application, scoring, and study section review process that the investigators have the option of pledging to open access publication. Commitment to open access publication by the authors could be a weighted scoring criteria for competitive review and funding. 2) NIH should survey and publish a Review of Compliance to open access and self-archiving of all the major scholarly scientific journals. 3) NIH should release a Score Card of scientific journals on the issue and adherence to open access after a specified closed subscription embargo. 4) NIH should craft a statement of Preferred Publication Strategy for any and all publicly funded researchers and institutions. 5) The NIH, as a matter of policy and the Director should make patently clear statements about the value and benefit of open access to all scholarly scientific articles.	Web Form
274	Town Hall Form Comments	03/13/2008 at 08:39:22 AM (798)	Rintamaki	Michelle	BA	Kids With Heart Natl Assn for Children's Heart Disorders, Inc	WI	US	Patient or Representative of a Public Health Advocacy Organization						I feel that this is a very positive move that would provide access to this information to many patients/ parents/ etc who would otherwise not have access to these results/ information. With our health care situation as it is, education is power but it is also necessary for us to advocate for our families. Access to this kind of information enables us to do this much more effectively. Please do not hesitate to contact me at 1-800-538-5390 or michelle@kidswithheart.org	Web Form
275	Town Hall Form Comments	03/13/2008 at 08:59:18 AM (909)	Patterson	Mark	PhD	Public Library of Science	CAMBS	UK	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						I would like to express strong support for the Public Access Policy of the NIH. The policy will ensure public access to around 80,000 original research article each year funded by the US taxpayer and will inspire similar policies at funding agencies around the world. Public access to research publications will accelerate research by allowing any scientist to read, use and build on the work of others. Deposition of the articles in PubMed Central will also allow better integration of research literature with the data that underpins research, bringing further benefits to the research process. Beyond the research community, the NIH policy will also enable any interested reader - physicians, educators, students, journalists, patients and so on - to access research literature, bringing further benefits for education and health. With the provision of an embargo of up to 12 months, the policy also balances the needs of publishers who rely on subscriptions to cover their costs.	Web Form
276	Town Hall Form Comments	03/13/2008 at 09:37:53 AM (594)	Ioannidis	John	MD, PhD	University of Ioannina School of Medicine and Tufts University School of Medicine	Epirus	Greece	Representative NIH Funding Recipient Organization						Any improvement in open access is likely to have a major impact in improving the yield and efficiency of scientific research in the US and at a global level. I would like to strongly support the NIH initiative for open access. Researchers, patients, and the general public would reap more of the benefits of the NIH investment in biomedical research.	Web Form
277	Town Hall Form Comments	03/13/2008 at 10:07:04 AM (743)	Genetti	Marianne	BS	In Need Of Diagnosis, Inc. (INOD)	FL	US	Patient or Representative of a Public Health Advocacy Organization						In Need Of Diagnosis, Inc. (INOD) is a non-profit which, in part, supports those who are ill with a medical problem that has eluded diagnosis. It is not unlikely that the problem has eluded diagnosis because the disorder is rare or, perhaps, becuase it is a disorder that has not yet been identified and named. In these cases especially, it is important that new research be made available to the public as soon as possible. We request NIH's support of open access to the results of NIH funded research. Thank you, Marianne Genetti, Exec.Dir., INOD	Web Form
278	Town Hall Form Comments	03/13/2008 at 10:08:43 AM (973)	Mabe	Michael	MA(Oxon)	International Association of STM Publishers	Oxfordshire	UK	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						STM continues to be concerned by the recent passage of legislation in the United States concerning the NIH mandate on deposit of peer reviewed manuscripts. The mandate neither provides compensation for the added-value of services that these manuscripts have received from publishers nor does it earmark funds to ensure the economic sustainability of the broad and systematic archiving this sort of project requires. It also undermines a key intellectual property right known as copyright – long a cornerstone used to foster creativity and innovation. STM believes that this legislation establishes an unfunded government mandate with an unknown impact on the advancement of science and puts at risk a system which has enabled more research to be available to more scientists in more countries than at any point in the history of science. Other governmental bodies, such as the European Commission, have recognized the unique role and extensive investments made by scientific publishers in the organization of peer review, the management of publication processes, the production, access, distribution, preservation and digitization of scientific knowledge. They have called for an evidence-based approach toward questions like the broad and systematic archiving of scientific manuscripts to ensure that the current system of scientific publishing is not destabilized without reason. Regrettably, neither the acknowledgement of the key role that publishers play in the advancement of science, nor the commitment toward an evidence-based approach, nor the funding to support this broad mandate seems present in the current U.S. legislation. STM publishers will, of course, comply with the laws of the nations in which they operate. At the same time, in order to fulfill their primary mission of maximizing the dissemination of knowledge through economically self-sustaining business models, they will continue a vigorous engagement with appropriate stakeholders on issues such as this where legislative change seems necessary or desirable.	Web Form
279	Town Hall Form Comments	03/13/2008 at 11:45:24 AM (964)	Chaitowitz	Simon	n/a	n/a	DC	US	Other Member of the Public						I support the free and open access of all medical studies to the public.	Web Form
280	Town Hall Form Comments	03/13/2008 at 12:17:37 PM (559)	Hadwiger	Jeff	PhD	Oklahoma State University	Oklahoma	US	NIH-funded Investigator						I'm in full support of this public access policy. As a researcher from a non-medical school university, I feel that this policy helps to level the playing field of research competition by making recent scientific information available to everyone. While realizing publishers need to turn a profit, I suggest the 12 month period be shortened to 3 months. Some publishers seem to do fine even with immediate release of the information. This can only speed up the progress of scientific research.	Web Form
281	Town Hall Form Comments	03/13/2008 at 12:48:06 PM (576)	Johnston	Lorraine	BS Life Sciences	US taxpayer	MD	US	Other Member of the Public						I and my fellow US taxpayers are entitled to free access to the medical studies published as a result of NIH-funded research.	Web Form
282	Town Hall Form Comments	03/13/2008 at 12:49:17 PM (972)	Beasley	Dale	BS	CRCFA	WA	US	Other Member of the Public						It seems only fair that publications funded with taxpayer dollars are accessable to the public at NO fee, especially if they are transmitted electronically. Dale Beasley, Member of ACOR list serve	Web Form
283	Town Hall Form Comments	03/13/2008 at 01:07:24 PM (638)	Hanson	Jaydee	M.A.	International Center for Technology Assessment	DC	US	Patient or Representative of a Public Health Advocacy Organization						As the Director for Human Genetics Policy at the International Center for Technology Assessment, I find it important to stay abreast of the latest research findings on human genetics. Much research in this area is funded through NIH grants. As a relatively small non-profit, the cost of scientific journals is huge. It is more frustrating when we are paying to get research that the US Government has paid for. In some cases, we have filed freedom of information requests to get access to the research. If the NIH made available research findings in a prompt manner, it would save us money and would likely save the NIH much staff time by not having to respond to as many freedom of information requests. The one-year delay in posting the research is unnecessary. These are rapidly moving fields; waiting a year is too long; please require posting on the NIH site as soon as the article is accepted for publication.	Web Form
284	Town Hall Form Comments	03/13/2008 at 01:08:46 PM (396)	Roberts	Diane		Citizen and taxpayer	CT	US	Other						I am in full support for NIH published results of medical research be available to citizens as soon as articles are published.	Web Form
285	Town Hall Form Comments	03/13/2008 at 01:11:09 PM (325)	Grundler	Clark	BA	Patient	Texas	US	Patient or Representative of a Public Health Advocacy Organization						I am dealing with my second cancer. At this time I believe it is important for me to be an informed patient, fully capable of participating in my treatment decisions. As such it is vital that I am current on published works concerning my disease. I also am on social security disability retirement as a result of the long term affects of radiation treatment for my first cancers. My income is $1,035 per month. I cannot afford to pay to read articles from medical jounrnals. NIH funding for research is public monies therefore the report results should be available to the public at no charge. Please pass this requirement. Clark Grundler	Web Form
286	Town Hall Form Comments	03/13/2008 at 01:11:29 PM (891)	Nowak	Joel	MA, MSW	Malecare, Inc.	New York	US	Patient or Representative of a Public Health Advocacy Organization						I am fully supportive of free open public access to all research that is derived from public funds. If research was paid for by public dollars then the results belong to the public. The public should not have to pay twice. Free and open access will enhance the advancement of basic science and health care.	Web Form
287	Town Hall Form Comments	03/13/2008 at 01:22:16 PM (603)	Monaco	Jo	MSLS	none	PA	US	Patient or Representative of a Public Health Advocacy Organization						Please do whatever possible to make access to cancer research available to those of us who are battling cancer. Informed patients are more likely to receive appropriate treatment. Also knowing as much as possible about our condition is a help in mentally coping with this disease.	Web Form
288	Town Hall Form Comments	03/13/2008 at 01:22:45 PM (321)	itri	cathy	BA	cancer patient	ct	US	Other Member of the Public						As a person who has to deal with three cancers, I need access to as much information as the NIH has through its various branches. Recently I tried to gain access to a possible trail using an experimental cancer drug and wanted further information but could not get it without cost. I have enough to deal with just paying for my medical so any savings is a plus. It's not right to ask the public to pay for what is already theirs . After all we pay for this accumulation of knowledge through our tax dollars. Please open up this vast storage of medical information at no cost. It will be a God sent to some many, many patients and their families. Thank you.	Web Form
289	Town Hall Form Comments	03/13/2008 at 01:30:08 PM (847)	Hammett	Carole	BA	Lung Cancer Alliance	CO	US	Patient or Representative of a Public Health Advocacy Organization						I support making it mandatory for articles resulting from NIH funded research to be placed in a repository at the National Library of Medicine and made available free of charge to the public.	Web Form
290	Town Hall Form Comments	03/13/2008 at 01:31:35 PM (564)	Larson	Richard	MD, PhD	University of New Mexico Health Sciences Center	New Mexico	US	Representative NIH Funding Recipient Organization						This policy clearly puts universities in a precarious position between publishers and NIH. Since it is unclear that publishers will change their policies, it may either decrease publication rates or put universities in a position of not being able to meet the requirements of this policy. I would hope that stop-gap measures could be put in place that do not penalize a university who is trying to comply but cannot due to intransient publisher policies.	Web Form
291	Town Hall Form Comments	03/13/2008 at 01:33:19 PM (684)	Thurman	Judy		Advocate: Men & Families dealing with Prostate Cancer	TN	US	Patient or Representative of a Public Health Advocacy Organization						I am in full support of the change in the NIH Public Access Policy. Citizens of the United States who pay taxes should not have to pay twice for access to potential life saving research. Free access is necessary to avoid the hardship patients experience when dealing with high charges for full text studies. I support the change.	Web Form
292	Town Hall Form Comments	03/13/2008 at 01:50:08 PM (465)	Evans	Michael	BA	None	FL	US	Patient or Representative of a Public Health Advocacy Organization						The Public Access Policy should ensure that the public has access to the published results of NIH funded research. People like myself with possibly terminal cancer could then take some control of educating ourselves as to what the latest research says about possible new strategies for combating our diseases. I believe this is a life and death issue and we the tax payer have funded these research projects. Let us have access to what we have paid for.	Web Form
293	Town Hall Form Comments	03/13/2008 at 02:05:36 PM (424)	tashman	eva	bs	none	ca	US	Patient or Representative of a Public Health Advocacy Organization						The public needs easy access to published reports of studies sponsored by the NIH. My husband who has a rare cancer could not have survived the past few years without educating ourselves and take front row seats in our cancer treatment. With more and easier information we can be effective advocates and actually help the doctors with our treatment. These are nationally funded research that needs to be available to everyone.	Web Form
294	Town Hall Form Comments	03/13/2008 at 02:06:56 PM (534)	Greenberg	Marvin	EECS	none	VA	US	Patient or Representative of a Public Health Advocacy Organization						I have extensively used available medical research as a patient and care giver to understand the pros and cons of different treatment approaches in the treatment of cancer, understanding the basis for different clinical trials, and generally getting more information from another one more during the difficult period when under a diagnosis of cancer. Having more reliable, reviewed research available, that was funded with public funds, is to the benefit of patients, researchers and the NIH.	Web Form
295	Town Hall Form Comments	03/13/2008 at 02:11:04 PM (763)	Margolis	Natalie	MS	ACOR	NY	US	Patient or Representative of a Public Health Advocacy Organization						As a breast cancer and NHL patient, I need to know what options are available to me for treatment.	Web Form
296	Town Hall Form Comments	03/13/2008 at 02:11:16 PM (927)	Miniken	Donald	A.S.	LUNG-NSCLC@LISTSERV.ACOR.ORG	WA	US	Patient or Representative of a Public Health Advocacy Organization						free access to the published results of medical research	Web Form
297	Town Hall Form Comments	03/13/2008 at 02:13:44 PM (226)	Van Gemert	Edward	MA	University of Wisconsin-Madison	Wisconsin	US	Representative NIH Funding Recipient Organization						The Libraries at the University of Wisconsin-Madison have taken a leading role, along with Legal Services, Research and Sponsored Programs, and the Research Deans, addressing the NIH Public Access Policy. Wisconsin receives approximately $500M in federally funded awards each year with about $250M coming from the NIH. It is therefore critical that we understand our obligations and provide reasonable methods for compliance for our authors, investigators, and PIs. The Library's NIH working group of the Scholarly Communication and Publishing Committee is busy with presentations across campus; alerting NIH investigators to the policy changes and offering assistance with copyright management, manuscript submission to PMC, and subsequent citation (PMCID) work. That demonstration of leadership has been greatly appreciated across campus. We know that we will encounter difficulties; with journals and publishers who will not initially agree to amended transfer agreements, but we believe that with time--that will change. We are confident that we can manage our obligations.	Web Form
298	Town Hall Form Comments	03/13/2008 at 02:44:24 PM (692)	Rixey Scott	Cynthia	JD, MLL	Brain Tumor Action Network	CO	US	Patient or Representative of a Public Health Advocacy Organization						I am a survivor of a right cavernous sinus meningioma for which I had gamma knife radiosurgery in December 1999. I am active on internet brain tumor support lists. My educational background includes a master in librarianship and I am a former reference librarian. I freqently post information about research articles related to brain tumors, and particularly meningiomas, which come to my attention through internet searches, as well as brain tumor research oriented websites. Also articles are brought to my attention by other internet brain tumor support group members. Generally, it is abstracts that are available. It is not unusual to there to be a request for a fee to view the full text of an article. On occasion I have recommended that members of the brain tumor community seek access to the article for which there is a fee through the interlibrary loan department of their local library. How much easier it would be to have access through the National Library of Medicine website. For brain tumor survivors, as well as for many disease specific patient groups, the information that comes from rigorous research can literally mean the difference between life and death. It is not unusual for patients to discuss the most recent reaserch results with their treating physicians to determine if they may be a candidate for a particular treatment. Our ability to access medical research articles online is one way in which we can have some semblance of control. "Knowledge is power" is more than a cliche to those whose lives are challenged by life threatening orphan diseases. Many of us want to be informed consumers and an active part of our treatment team. Additionatlly, directly or indirectly it is our dollars that support medical research. As patients it is unacceptable that we be denied access to potentially life saving research results for want of a fee. I fully support the NIH public access policy and would hope that articles are available online well in advance of the 12 month period after publication deadline. Thank you for your consideration.	Web Form
299	Town Hall Form Comments	03/13/2008 at 03:05:18 PM (511)	Scrivner	Libby		Leukemia	AL	US	Patient or Representative of a Public Health Advocacy Organization						I have leukemia and the articles are an invaluable resource for those of us trying to pursue the best choice of treatment and to better understand our disease. Please allow them to be free to the public.	Web Form
300	Town Hall Form Comments	03/13/2008 at 03:09:05 PM (653)	Hill	Emma	Ph.D.	Executive Editor, The Journal of Cell Biology, Rockefeller University Press	NY	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						I am the Executive Editor of The Journal of Cell Biology, published by The Rockefeller University Press (RUP). The RUP is a non-profit organization that publishes three highly respected scientific journals: The Journal of Cell Biology, The Journal of Experimental Medicine, and The Journal of General Physiology. As a university publisher, the RUP represents the middle of the road in the ongoing dialogue about public access to published data – firmly in between the advocates for complete open access and those publishers who hold most or all of their content behind access controls. The content of all three RUP journals is released on our own websites six months after the date of publication. More recently, we worked with the National Library of Medicine to post the full, final, copy edited, and formatted text of all of our content on PubMed Central to be made available to the public six months after publication. We thus already comply with the NIH Public Access Policy. Two of the RUP’s three journals have been free to the public, six months after the publication date, since January, 2001. Even though our content is only under access control for a short time period, our subscription revenues have continued to rise over the last seven years. The RUP is thus in the unique situation of demonstrating that it is financially feasible for publishers to permit the release of all of their content in accordance with the NIH Public Access Policy. At the RUP we strongly believe that scientific publishers have an obligation to release their content to the public, who provide much of the funding to generate that content and to buy subscriptions. In an ideal world, all publishers would fulfill and facilitate this obligation on their own. Although many publishers are doing so, there are still many who are not. We thus strongly support the NIH mandate for deposition of NIH-funded research in PubMed Central. I do not know of a single publisher that has publicly declared, in a forum available to their readers, opposition to the NIH mandate. This is probably because they fear alienating the readers on whom they depend for content and subscriptions. In contrast, many publishers have publicly declared support for the NIH mandate. Publishers who oppose this policy may present various arguments, but the bottom line is that they fear losing subscription revenue. In a sense they have a financial conflict of interest with respect to this debate that should be declared up front, just as we require authors and reviewers to do with regard to submitted manuscripts. With tax-payers money, the NIH funds the research. NIH funded researchers perform and review the research. And thus, the data from any resulting publications can and should be made available to the public. To this there should be no argument. We urge you to implement the mandate as soon as possible.	Web Form
301	Town Hall Form Comments	03/13/2008 at 03:24:09 PM (938)	Anderson	Rudy	MS	Academy for Educational Development	Virginia	US	Other Member of the Public						I am writing to encourage that the 12-month publication rule remain in effect. It allows much easier access to publicly funded research. In a time when government contractors are already seen as less than scrupulous to alter this rule to give publishers or others more time to make money on the articles and research would be giving in to profiting pressure of contractors.	Web Form
302	Town Hall Form Comments	03/13/2008 at 04:21:18 PM (839)	Worman	Michelle	LVN	www.bmtsupport.org	TX	US	Patient or Representative of a Public Health Advocacy Organization						The information needs to be made available to the taxpayers, as we funded the research. The patient has to be their own best advocate, and in order to do this, we need access to any and all information related to our condition.	Web Form
303	Town Hall Form Comments	03/13/2008 at 04:49:22 PM (626)	Stowell	Kyle		CFC International	UT	USA	Other Member of the Public						I am speaking as a father of a child with a rare genetic mutation. The problem I have with the current system of public access to studies is the cost. It is prohibitive for me to gain access to articles that have been written about my son's condition. I think 12 months is a reasonable time frame for a publisher to earn money on articles they publish. After that time, for studies funded by NIH, the publicly funded studies should be available for free to the public!	Web Form
304	Town Hall Form Comments	03/13/2008 at 05:21:46 PM (673)	Neddo	Barb	MSE	parent of a pediatric bone marrow transplant survivor	WI	US	Other Member of the Public						As a parent of a child with chronic myeloid leukemia (and later a bone marrow transplant survivor) it was absolutely essential for me to access fairly current medical research that applied to my son's conditions. Access to research allows patients and caregivers to make informed decisions. It also allows patients to identify specialists to contact or research centers to contact for further medical exploration.	Web Form
305	Town Hall Form Comments	03/13/2008 at 05:26:43 PM (601)	bayne	susie	NA	ACOR Member	IN	United States	Other Member of the Public						It is so very important that this mandate be approved for anyone and everyone who is facing or has ever faced serious medical issues. These are vital documents that promote the latest scientific studies and findings and they should not be held captive for only people with the financial means to have access to them. I think the 12 month rule is more than fair.	Web Form
306	Town Hall Form Comments	03/13/2008 at 05:34:54 PM (522)	Johnson	JQ	M.A.	University of Oregon	OR	US	Representative NIH Funding Recipient Organization						In my role as manager of a department that provides technology training and support for faculty, I have had several conversations with researchers who have been highly supportive of the public access policy. The general consensus is that (a) providing public access to government funded research is good public policy, that (b) the greater visibility that will come from being available in PMC will contribute to the impact of the individual articles, and that (c) the greater visibility will likely have a long-term positive impact on the prestige both of the individual researchers and, perhaps more interestingly, of the journals in which the articles are published. As one researcher (who is also the editor of a journal in the life sciences) noted, this is free advertising for the journals. She also expressed some puzzlement about why, especially given the huge success of Google and similar new models of information access, some academic publishers seem so resistant to innovation. There is, of course, some concern about implementation. Many authors are confused about what the terms of copyright transfer agreements allow, and about the potential for liability if they make an error. Some are concerned that the optional embargo period may imply very long delays from article acceptance to publication to eventual availability of public access. In medical research in particular, long delays may imply that members of the general public will still not have access to current research results that are crucial to informed medical decisions. On the other hand, I have heard very little concern about the actual mechanics of submitting final author manuscript to PMC.	Web Form
307	Town Hall Form Comments	03/13/2008 at 06:27:44 PM (173)	Shacklett	Barbara	PhD	University of California at Davis	CA	US	NIH-funded Investigator						The proposed NIH policy: Positively contributes to the advancement of science; Serves the public health by enabling discovery, speeding treatment and cures; Provides a direct return for public investment in the NIH; Keeps the USA in step with other countries who have recently enacted similar polices; Democratizes teaching and learning by providing new resources for scientists and teachers to use in new and innovative ways.	Web Form
308	Town Hall Form Comments	03/13/2008 at 06:49:12 PM (306)	Richardson	Jeanne	MS Library Service; MA Biochemistry	Arizona State Univeristy	AZ	US	Representative NIH Funding Recipient Organization						At Arizona State University (ASU), several Offices are collaborating to alert and assist NIH awardees at ASU in the timely deposit of NIH-funded peer-reviewed journal articles. In consultation with the Office of General Council (OGC), the ASU Libraries created a user guide (web page) that can be found at http://www.asu.edu/lib/scholcomm/nih.htm A printer friendly version of this help guide is located at: http://www.asu.edu/lib/scholcomm/Files/nih_print.pdf In consultation with the ASU Libraries, the Office for Research and Sponsored Projects Administration (ORSPA) sent out an e-mail to over 100 NIH Principal Investigators alerting them of the new mandatory NIH Public Access Policy. The ASU Libraries created an e-mail address where users may submit any NIH-related questions. Experts in the Libraries will promptly answer all queries and/or seek referrals as necessary. The ASU Libraries and ORSPA hosted group viewings and discussions of the webcast: Institutional Compliance with the NIH Public Access Policy. The ASU Libraries, Office of the Vice President for Research and Economic Affairs (OVPREA), ORSPA, and OGC are collectively branding the user guide, and remain committed to continue its collaboration and assistance to the ASU community.	Web Form
309	Town Hall Form Comments	03/13/2008 at 07:36:27 PM (247)	Thomas	Gail		Mother	Va	US	Other						My 26 y/o son currently has his second oligodendroglioma for which there is currently no known cure.Finding research,any information that may enable him to live the life God intended him to have should be available for all.I ask this for him and the 180,00 people who are diagnosed with primary brain tumors each year. They need every bit of knowledge and hope that is out there.	Web Form
310	Town Hall Form Comments	03/13/2008 at 08:19:32 PM (717)	Showers	Mac		Virginia Hospital Center Cancer Center	Virginia	US	Patient or Representative of a Public Health Advocacy Organization						As a prostate cancer survivor and PCa support Group facilitator for many years, I fully support the vital need for cancer patients to have free access to NIH-funded research studies. It is incumbent on all cancer survivors to educate themselves to the greatest extent possible on treatment choices, side effects, and new avenues of treatment resulting from current research. None of such information should be denied to patients, especially not at a price additional to taxpayer funds expended by the NIH. An educated survivor is the best patient. An educated patient is the most successful survivor.	Web Form
311	Town Hall Form Comments	03/13/2008 at 08:39:47 PM (459)	Garcia-Bunuel	Luis	MD	Retired	AZ	US	Patient or Representative of a Public Health Advocacy Organization						It is obscene to charge for publicly-funded, tax-payer-supported research, for report of research results. The present practices amount of abuse of public trust.	Web Form
312	Town Hall Form Comments	03/13/2008 at 08:40:06 PM (659)	Grant	Anne	N/A	N/A	NC	US	Patient or Representative of a Public Health Advocacy Organization						As a cancer survivor, who knows literally thousands of others either battling cancer currently or survivors like me, I know I can speak for all of us when I say that it's mandatory we have ready and free access to the intellectual material that we ourselves have funded through our taxes. We are our own best advocates for survival, given sufficient tools, and oftentimes financial hardship goes along with a cancer diagnosis. To not have access to the latest research findings is appalling.	Web Form
313	Town Hall Form Comments	03/13/2008 at 08:44:46 PM (941)	Feist	Patty	M.S.	ACOR	CO	US	Other Member of the Public						My son was in treatment for acute lymphoblastic leukemia, and I currently administrate an ACOR listserve for other parents currently on or off treatment for this type of childhood leukemia. As an educator at the Univ. of Colorado, I am able to read full text articles online. However, most parents researching treatment plans for this rare cancer are limited to the abstracts on PubMed. For full text, they must either travel to a medical library to view the articles, or pay a fee to see the online version. Why should they have to pay, when their tax dollars have paid for the research in the first place? I have experienced the difference between reading abstracts and reading the full text articles. Full text is so much better. We need public access to NIH-funded research articles to better participate in helping our doctors help our children beat this disease and to surmount the late effects caused by its treatment.	Web Form
314	Town Hall Form Comments	03/13/2008 at 09:05:34 PM (751)	Skovronek	Herbert	Ph. D.	retired	NJ	US	Patient or Representative of a Public Health Advocacy Organization						Sir: The US Taxpayer paid for the research, the public has a right to have the results readily available at no additional charge, not through a for-profit journal or one supporting a professional association. And, by "results available" I mean the full report or paper, not just an abstract or raw data. As a researcher, both for the government and for a contractor, I found that many funded studies never saw the light of day. That is wrong. Every government-funded study should be reported to the public, even if a total failure.	Web Form
315	Town Hall Form Comments	03/13/2008 at 09:08:56 PM (315)	Maack	Charles	AA	Us TOO Intl., Inc. Prostate Cancer Education and Support Network	KS	US	Patient or Representative of a Public Health Advocacy Organization						As an activist patient advocate regarding prostate cancer recognizing the necessity of access to any and all material relating to prostate cancer research and treatment, I encourage free and open access to the results of cancer, and in my case particularly prostate cancer, research records. Research is funded by taxpayer money to develop innovative treatment methods to conquer cancer. As such, research conclusions should be available for free, public access.	Web Form
316	Town Hall Form Comments	03/13/2008 at 09:13:02 PM (514)	Kienow	Paul	BS	US-Too	AZ	US	Patient or Representative of a Public Health Advocacy Organization						As one who is dealing with aggressive Prostate Cancer, I need to be current with possible cures and treatments. Often documents concerning the latest publicly funded research are not readily available to me. This policy would resolve that problem.	Web Form
317	Town Hall Form Comments	03/13/2008 at 09:22:49 PM (154)	Obermeier	Jeffrey	none	none	FL	US	Patient or Representative of a Public Health Advocacy Organization						In regard to the proposed rule change that will require study information to be made available to the public free of charge after 12 months I, as a taxpayer, strongly support this measure. Publcly funded studies are for the benefit of the public and paid for by the public therefore the public is entitled to the knowledge gained by their funding. As a taxpayer I feel we have the right to gain benefit from our tax dollars without having to purchase the same from any non government entity. Privat publications do not fund these research items, the taxpayer does. Give us access to what we already paid for.	Web Form
318	Town Hall Form Comments	03/13/2008 at 09:22:57 PM (499)	Balcombe	Jonathan	PhD	Physicians Committee for Responsible Medicine	DC	US	Patient or Representative of a Public Health Advocacy Organization						I welcome new legislation that would make it mandatory for articles resulting from NIH funded research to be made available (preferably online) free of charge to the public. Public access to taxpayer-funded published research should be a given. I have a professional interest in the NIH's work, and surely a considerable portion of the American population has a medical interest in same.	Web Form
319	Town Hall Form Comments	03/13/2008 at 09:27:16 PM (946)	Miller	Robert		Patient	AZ	US	Patient or Representative of a Public Health Advocacy Organization						Please allow the interested public free unrestricted access to research articles reated to NIH funded research. As a two time cancer survivor I know the importance of breaking research. Too many health professionals just do not have the time to keep up on the latest research and having this information empowers patients to help in their treatment. Thank you for the opportunity to comment on this inportant issue. Robert B. Miller	Web Form
320	Town Hall Form Comments	03/13/2008 at 09:39:14 PM (639)	Maloof	Edward	High School	Cancer Survivor	New Hampshire	US	Other						When I was diagnosed with Cancer, I was totally scared and uninformed. I relied on the NIH Web Site for information that helped me not only understand my disease, but also the treatments being suggested. Knowing which treatments were more appropriate than others and the consequential side effects, both long term and short, made my progress easier to understand. That information also provided my care-giver what was needed to assure her that the assistance she was providing was the best that could be given under the painful circumstances of chemo-theraphy. As a tax payer, I feel I have already paid for that access and I expect it to continue. I would like to think the Regulators give greater consideration to the patients who have to deal on a personal level than any group who would deny us that access.	Web Form
321	Town Hall Form Comments	03/13/2008 at 09:58:27 PM (391)	Easom	Colin	Master of Arts	None	AZ	United States	Other Member of the Public						I strongly support the move to provide free access to journal articles funded by the NIH within 12 months of publication. As the public are ultimately providing funding for this research it seems only fair that we should have access to it without having to subscribe to expensive research periodicals. Many of us face health issues in our lives that such articles have a bearing on, and often times doctors are so over worked that it takes patients own research to bring their doctors' attention to the latest findings. Please help us to help our medical teams take care of us and provide us access to NIH funded research free of charge. Thanks for your consideration.	Web Form
322	Town Hall Form Comments	03/13/2008 at 10:06:02 PM (734)	Lake	Howard	BA	recovering patient	FL	US	Other Member of the Public						As an activist patient-advocate of prostate cancer there is the necessity of access to any and all material relating to prostate cancer research and treatment. I regard free and open access to the results of all publicly funded cancer research as a given. As such, research conclusions should be available for free, public access. Anything less should be regarded as an abuse of the public trust.	Web Form
324	Town Hall Form Comments	03/13/2008 at 11:06:28 PM (616)	Nowlin	Jon	MSc	US Geological Survey (retired)	NV	US	Patient or Representative of a Public Health Advocacy Organization						I was diagnosed with prostate cancer in May 2006. Thus far I am fortunate in apparently having an early, small, probably indolent form of cancer. After considerable research, I am following "Active Surveillance", deferring immediate treatment while monitoring the stage of the cancer by several means. And, concurrently trying to stay up-to-date on research on treatment alternatives and outcomes. When first diagnosed, I was astounded to find that I had to pay to access current journal articles reporting the results of research funded with Federal funds-- i.e. my tax dollars. In a 35 + year career with the U.S. Geological Survey, one of the aspects of "Federal Science" that I appreciated was that all our information was made available at no cost to the public. As a cancer patient actively monitoring my cancer and trying to stay current on potential treatment alternatives, I find it unreasonable and unconscionable that I have to pay to obtain research results funded with my taxes. For patients such as myself, even a 12 month delay in access to research may be too long. There needs to be a public respository for current Federally-funded medical research that can be accessed with reasonable charges-- just enough to offset costs of maintaining the appropriate databases and servers. I will be following the results of the public access debate with great personal interest. Sincerely, Jon Nowlin	Web Form
325	Town Hall Form Comments	03/13/2008 at 11:21:05 PM (749)	Bolduc	Nancy		spouse of patient	MN	US	Other Member of the Public						I think there should be access to the public of records and research- this is funded by the taxpayer to begin with!	Web Form
326	Town Hall Form Comments	03/13/2008 at 11:51:07 PM (561)	Osterling	Ann	MA	Ann Osterling Therapy Associates	IL	US	Other						I have accessed many of the NIH-funded studies through Pub Med, wearing many different hats. As a speech-language pathologist in private practice, I have often needed research related to medical conditions of clients and evidence based information on assessment and intervention. I have also been a part of a University's research program that has been developing social skill groups for teens with autism spectrum disorders-it has been critical to have the latest research available to help in developing our program. On a personal level, I have referenced NIH funded studies to help my husband get through severe onset Rheumatoid Arthritis and then Hodgkins Lymphoma, my father find state of the art intervention at Loma Linda for his prostate cancer, my teenaged son's herniated disk and my own genetic predisposition to cholesterol problems. Having free internet access has empowered me as a patient, advocate, therapist and researcher. Thank you for ensuring this continues to be easily accessible and free of charge. Ann Osterling	Web Form
327	Town Hall Form Comments	03/14/2008 at 12:01:08 AM (814)	Demos	Nick	Masters of Social Work	Citizen of the United States of America	GA	US	Other						As a Lung Cancer survivor, it has been increasingly important and vital for patients to advocate for their life and treatment, and having knowledge of research is just as important for the patient as at anytime to promote understanding of new research in finding cures as to understanding how effective treatment is that is investigated by public monies. The Policy implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which states: SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law. The Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit journal articles that arise from NIH funds to the digital archive PubMed Central ( http://www.pubmedcentral.nih.gov/). The Policy requires that these articles be accessible to the public on PubMed Central to help advance science and improve human health.	Web Form
328	Town Hall Form Comments	03/14/2008 at 12:07:57 AM (664)	Bradie	Alice	BA	Lung Cancer Survivor	CO	US	Other Member of the Public						I was diagnosed in 2001 with Bronchioloalveolar Carcinoma. BAC is a relatively rare subtype of adenocarcinoma and is not well or widely understood; thus, treatment options are few and results are pretty much hit or miss. NIH, through our tax dollars, has funded significant research both directly and indirectly that may have bearing on my and other BACers' wellbeing. To deny almost immediate access to the fruits of those research dollars is unconscionable and immoral. Taxpayer funded research results should be considered part of the public domain as soon as possible; i.e., within 6 months of peer review, or earlier -- anything less constitutes a form of thievery.	Web Form
329	Town Hall Form Comments	03/14/2008 at 12:15:53 AM (834)	Soto	John		unaffiliated	CA	US	Other						As parents of a child with chronic myelogenous leukemia (CML) we need up-to-date technical information. This disease is so rare in children that only a handful of physicians are considered experts. Our first physician was a leukemia specialist, but our son was her only CML patient. We did considerable research to make sure that he son was provided with the best care. Ultimately it is up to the patient/caregiver to decide on a recommended course of treatment. We need the tools to do so, and access to current medical literature is crucial.	Web Form
330	Town Hall Form Comments	03/14/2008 at 12:16:20 AM (831)	Cain	Lois	MLIS	University of Hawaii, Hamilton Library (ret)	HI	US	Other Member of the Public						From a librarian viewpoint it is absolutely appalling that publicly funded research should not be published within 12 months free of charge for the benefit of the public that finances it. From a citizen viewpoint, my husband was diagnosed with leukemia in 2004 and it was imperative that we find the most up-to-date information on treatment immediately. Given that dread diseases are the major killers of American taxpayers, it is beyond appalling that current research results that we pay for should not be available as soon as it is published. Even a 12-month grace period is too long in my opinion. In health matters where current information is crucial, just weeks and hours can make the difference between life or death!	Web Form
331	Town Hall Form Comments	03/14/2008 at 12:38:12 AM (428)	Wilson	Mary Ann	BA	Neurofibromatosis, Inc.-Mid-Atlantic	MD	US	Patient or Representative of a Public Health Advocacy Organization						March 13, 2008 Neurofibromatosis, Inc.-Mid-Atlantic supports NIH requiring all NIH-funded investigators to submit to the National Library of Medicine their final, peer-reviewed manuscripts upon accceptance for publication be made publicly available no later than 12 months after the official date of publication.	Web Form
332	Town Hall Form Comments	03/14/2008 at 01:13:11 AM (690)	Smith	Bob	BS	Public	Ca	US	Other Member of the Public						As a cancer patient, I encourage free and open access to the results of cancer, and in my case particularly prostate cancer, research records. Research is funded by taxpayer money to develop innovative treatment methods to conquer cancer. As such, research conclusions should be available for free, public access.	Web Form
333	Town Hall Form Comments	03/14/2008 at 06:10:01 AM (329)	Wilkinson	Keith	MS	US Citizen	MO	US	Other Member of the Public						As a GBM (glio-blastoma multiforme) patient, an up-to 12 month delay in the ability to view research that may potentially extend my life is irrational. When first diagnosed, I was told the mean time of survival was 10 months. Time is not on my side. The quality of research results does not improve while sitting on a shelf in a dark room. The way to prove or improve them is through discussion and application.	Web Form
334	Town Hall Form Comments	03/14/2008 at 06:17:19 AM (942)	Jory	Dan		?	NY	US	Patient or Representative of a Public Health Advocacy Organization						I find it nessecary to have access to the results of the publicly funded trials. As a Cancer Patient I find it is nessecary to do our own research , and having public access to these publicly funded trials is a real help	Web Form
335	Town Hall Form Comments	03/14/2008 at 07:01:11 AM (135)	Weiss	Beth	Advocate	Patient Advocate	NY	US	Patient or Representative of a Public Health Advocacy Organization						It would be wonderful if the articles could reach the public at 6 months or sooner rather than 12 months or later. Many make life extending decisions based on the research that is being done and for some, 6 months may be all they have left. Thank you.	Web Form
336	Town Hall Form Comments	03/14/2008 at 07:44:02 AM (921)	Sullivan	Donna		US Taxpayer	IN	US	Other Member of the Public						As a member of a family with a hereditary genetic mutation for cancer I have spent years on the internet to find the latest and best information relevant to our cancers. This search often takes place when we are in the midst of making treatment decisions, or when dealing with an unusual side effect or problem. The frustration of being limited to an abstract after finally finding the information I'm seeking is terrible. It's also unfair since I don't have the means to pay an extra subscription fee. Isn't this research being done for us, the patients? Please. We need the benefit of this knowledge NOW.	Web Form
337	Town Hall Form Comments	03/14/2008 at 07:47:27 AM (820)	DeLia	Linda	MA	Association of periOperative Registered Nurses	CO	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Great idea! As a journal editor, I should be against this, but I believe that the results of research that has been funded by the American public. Twelve months after first publication seems perfectly fair to me.	Web Form
338	Town Hall Form Comments	03/14/2008 at 07:51:29 AM (855)	Edwards	Susan	MAT	Patient suffering from a Rare cancer Leimyosarcoma L-Sarcoma ilstserve	MA	US	Patient or Representative of a Public Health Advocacy Organization						Access to NIH funded research ought to be free. As a patient suffering from a rare cancer Leiomyosarcoma (LMS) w/limited treatments I need access to the research to make informed decisions about my care. Many of us are on reduced incomes as our disease interferes with our ability to work as we did when we were healthy. In addition, publicly funded research morally ought to be in the public domain. Please consider changing your policy of charging to even look at the research. Those of us suffering with cancer should not have not to also worry about how we are to fund our personal research as we battle this deadly disease.	Web Form
339	Town Hall Form Comments	03/14/2008 at 08:03:02 AM (715)	Nesse	Kristine	BA, MA	leiomyosarcoma patient	WA	US	Patient or Representative of a Public Health Advocacy Organization						I appreciate NIH's position on release of medical research information for free after 12 months. As a patient with rare cancer who tries to stay updated on pertinent studies, a 6 month policy would be even more beneficial. For those of us with aggressive disease, access to current research is critical as we attempt to plan toward and choose treatment options. Thank you.	Web Form
340	Town Hall Form Comments	03/14/2008 at 08:09:16 AM (733)	Bogle	Rick		Primate Freedom Project	WI	US	Other Member of the Public						Published scientific papers are essentially the public's only window into the activities taking place in labs conducting taxpayer-funded behavioral and biomedical research. Accessing this body of research can cost tens-of-thousands of dollars annually. This creates a signifcant barrier to the public's knowledge and understanding of experimental methods and procedures being used. Since the research is taxpayer-funded, it can hardly be argued that the public should not have free access to it. We should not have to pay for it twice.	Web Form
341	Town Hall Form Comments	03/14/2008 at 08:21:50 AM (168)	moon	Peter	PhD	Us Too Prostate cancer Group Leader Richmond Va	VA	United States	Patient or Representative of a Public Health Advocacy Organization						The transfer of information to patients and practioners is hinder by the additional road block of expensive access to articles that are supported by tax funded research. The patients are being taxed twice and their health suffers because it takes 10 to 15 years before new procedures proven by research are widely put into practice. Free access can shorten this time by removing one barrier to the process.	Web Form
342	Town Hall Form Comments	03/14/2008 at 08:27:30 AM (655)	matthews	lonnie	1.5 years college	Patient	Iowa	US	Patient or Representative of a Public Health Advocacy Organization						Please make it mandatory for articles resulting from NIH funded research to be placed in a repository at the National Library of Medicine and make them available free of charge to the public, no later than 12 months after they are published. Alowing us (patients) to be educated about our possible treatments is crucial to our staying alive.	Web Form
343	Town Hall Form Comments	03/14/2008 at 08:35:30 AM (793)	Brown	Thomas		US Citizen	NC	US	Other Member of the Public						Please make available to the public, in electronic form, results of any study funded by the public. The sooner the better. Thank you for your consideration.	Web Form
344	Town Hall Form Comments	03/14/2008 at 09:07:30 AM (740)	Garner	Linda	High Schoo, college	ACOR	MS	US	Patient or Representative of a Public Health Advocacy Organization						My husband has a rare disease, an orphan disease, and access to publicly fund articles are very helpful to us as we try to make educated decisions concerning his heath care. Our local doctors have never see a case of this disease, amyloidosis. Thank you.	Web Form
345	Town Hall Form Comments	03/14/2008 at 09:09:45 AM (824)	Oliver	Kathleen	MSLS, MPH	Johns Hopkins University Libraries Council	MD	US	Representative NIH Funding Recipient Organization						At Johns Hopkins University, the University Libraries Council strongly supports the NIH Public Access Policy.The new NIH reporting requirement will benefit Hopkins authors.The requirement provides an important opportunity to make published research funded by NIH and written by Hopkins authors accessible to all:the public, health care providers, educators and scientists, among others.This improved access will help advance science and, ultimately, improve human health.Deposit in PubMed Central ensures that research results will be preserved in a state-of- the-art digital repository.Free access within a 12 month period will maximize the visibility of Hopkins’research and ensure that researchers and students around the world will be able to read and build on Hopkins’ work,regardless of their ability to subscribe to the journal in which the research is published.Preliminary research suggests that articles freely available are cited more often and have a greater impact than articles locked away behind subscription walls. NIH public access will foster development of new research tools, open doors to new research avenues, and advance scientific discovery. At Johns Hopkins University, we have taken the following steps in response to the NIH Public Access Policy:1.Scheduled a meeting between the Dean of Libraries Winston Tabb, Nancy Roderer, Director of the Welch Medical Library and the Vice Provost for Research.The purpose of the meeting is to explore how the University and its Libraries can assist its authors in meeting the NIH mandate and support open access to the scholarly output of the University.We will present recommendations to the Provost on a University-wide publication agreement, the role of the University's repository, JScholarship,and the Harvard initiative.2.Created an FAQ on the NIH policy including an author's addendum and access to the SCAE to create their own addendum.The FAQ includes contact information for two members of the SCG, who will respond to questions from our authors. Liaisons will also assist their departments by directing them to information on the Policy.3.Advised our Vice Deans for Research in the Schools of Medicine, Public Health and Nursing of the FAQ; remain in close contact with the Office of the General Counsel sharing the Carroll White Paper and other relevant analysis of implications of the Policy for the University and its authors.4.The School of Medicine Vice Dean for Research sent two broadcast emails alerting faculty to their responsibilities under the new mandate directing authors to an FAQ on the NIH Policy.5.The School of Public Health and the School of Medicine will link to the resource from their research administration sites.6.The FAQ resides on a website for scholarly communication(openaccess.jhu.edu).7.Currently exploring with other institutions how we might develop an interface between our repository and PubMed Central in collaboration with other institutions and software developers.	Web Form
346	Town Hall Form Comments	03/14/2008 at 09:18:28 AM (717)	Hoffman	Ruth	MPH	Candlelighters Childhood Cancer Foundation	MD	US	Patient or Representative of a Public Health Advocacy Organization						As a mother of a two time cancer survivor (diagnosed at age 7 and 24), and Director of Candlelighters Childhood Cancer Foundation, I strongly advocate for free public access to full journal articles – i.e. the intellectual property that has been paid for through our tax dollars. It is imperative that patients and their families have access to research information so that they can make truly informed medical decisions. The current pay system to access full text articles creates an inequity in access to information. As Dr. von Eschenbach, former Director of the NCI said “Knowledge is Power.” The NIH has a responsibility to empower patients through access to the latest research findings.	Web Form
347	Town Hall Form Comments	03/14/2008 at 09:30:32 AM (441)	Marxen	Harry	BS/MBA	UsToo	VA	US	Other Member of the Public						The transfer of information to patients is hindered by the additional road block of expensive access to articles that are supported by funded research. Free access can shorten the time by removing the barriers to the process. Patients are being taxed twice and their health suffers because it takes years before new procedures by resarch are widley put into practice/	Web Form
348	Town Hall Form Comments	03/14/2008 at 09:50:22 AM (411)	Eisnor	Kristina	BA/MS	Dana Farber Cancer Institute/Children's Hospital Boston	MA	US	Patient or Representative of a Public Health Advocacy Organization						As the parent of a patient with a rare cancer, it has been very important to me to read the research available for my daughter's cancer. While many patients respond to traditional protocols and find their way through treatment, there are other patients that struggle. These patients that struggle are often asked to make unthinkable decisions about their care or their child's care. In this instance I believe it only right and humane to give that person access to the medical research that may help them make a more informed decision. Anything less is unacceptable.	Web Form
349	Town Hall Form Comments	03/14/2008 at 10:02:44 AM (776)	Gingrich	Franklin J.	BA	Citizen, Cancer Patient	VA	US	Patient or Representative of a Public Health Advocacy Organization						Please ensure that results of NIH-funded research are made available free of charge to the public as soon as possible after publication but, in no case, later than 12 months from that date. Cancer patients need to self-educate on their diseases and potential treatments, but the cost of doing so can be prohibitive. Patients and medical professionals should be entitled to the results of studies funded by our taxes. It is only right! Thank you.	Web Form
350	Town Hall Form Comments	03/14/2008 at 10:15:33 AM (587)	Amrine	Yvonne	JD	US Taxpayer	CA	United States	Patient or Representative of a Public Health Advocacy Organization						As a taxpayer and family member of a patient treated at NIH, it is important to me that these articles be accessible to the public on PubMed Central to help advance science and improve human health.	Web Form
351	Town Hall Form Comments	03/14/2008 at 10:21:45 AM (353)	Buyukmihci	Nedim	V.M.D.	University of California	TX	US	Other Member of the Public						Scientific papers published as a result of tax-payer funds (that is, funded through the NIH), should be available to all interested parties. Given that the tax-payer has paid for this research, without any meaningful input on the appropriateness of it, the papers should be available without further cost. Currently, there is no way for the average citizen to do this. The current PubMed system is almost useless because only an abstract is provided. Abstracts are not sufficient to discern the true nature or results of the work done.	Web Form
352	Town Hall Form Comments	03/14/2008 at 10:58:55 AM (575)	Jones	Edward C	Phd	Retired	MD	US	Patient or Representative of a Public Health Advocacy Organization						Dear Sir: I am a prostate cancer patient and spend a great deal of time counseling other prostate cancer patients, and giving lectures on the need to be screened for prostate cancer on a yearly bases. To be able to answer questions about prostate cancer I need to read the current journals and keep my self up to date. It is advantages to me to read the original articles and not a digested form done by someone else. Here in lies the difficulty, most charges for published articles are in the order of $25 or more and frequently I cannot tell from reading the abstract if it is the article that I really want. When I spend a day at a medical library I usually come home with copies of about 10 articles, and as you can see the cost mounts up if I have to pay a fee for them. I very much feel that should be a free public resource. Sincerely yours, Ed Jones	Web Form
353	Town Hall Form Comments	03/14/2008 at 10:59:03 AM (676)	Danaher	Kathryn	BA	Civil Society	CA	US	Other Member of the Public						I support my free access to the published results of medical research for which my tax dollars paid. Thank you.	Web Form
354	Town Hall Form Comments	03/14/2008 at 11:10:08 AM (635)	Corman	Stephen	MS	National Alliance of State Prostate Cancer Coalitions	Connecticut	US	Patient or Representative of a Public Health Advocacy Organization						As the moderator of a hospital based support group, the Secretary of a national prostate cancer advocacy organization, and a three time cancer survivor, I urge that public access be made to the full text of any and all reports arising from any studies that obtain federal funding. Many patients rely on such reports, especially those on governmental web sites, to assist in making treatment decisions. Those of us who are in a position to counsel such patients need that information even sooner. When we allocate public funds, it is not so that institutions and journals can make money. It is to fund helpful research. The results of such research should be freely made available to those whose tax dollars have helped fund that research.	Web Form
357	Town Hall Form Comments	03/14/2008 at 11:15:35 AM (859)	Stevens	Michele	Bachelor of Arts	Thyroid Cancer Survivor	WA	US	Other Member of the Public						Scientific papers published as a result of tax-payer funds (funded through the NIH), should be available to all interested parties. Given that the tax-payer has paid for this research, these papers should be available free-of-charge to anyone who wants to access them. I am a papillary thyroid cancer survivor and am an advocate for my own health, as I believe everyone should be. I've had to perform my own investigations to ensure I'm receiving the care that is necessary. Any information I can find is valuable and any research or articles/papers that have been paid for using tax-payer dollars should be avaiable to the public. The current PubMed system, although somewhat useful, would be much better utilized by people such as me if I could obtain the entire document versus just the abstract. I want to read all the nitty gritty, all the detail in these published papers. Viewing an abstract does not provide all the information that I want to see. I believe that everyone should have access to the published results of NIH funded research to ensure that the public can play their part in advancing science and improving human health. Although Sect. 218 states that all manuscripts should be made publicly available no later than 12 months after the official date of publications, I'd like to see the time-frame changed from 12 months to something more like 3 months. I don't understand why it should take 12 months to release these articles for public access. Thank you for your time and consideration.	Web Form
362	Town Hall Form Comments	03/14/2008 at 11:18:38 AM (740)	Hirtle	Peter	MA, MLS	Cornell University Llibrary	NY	US	Representative NIH Funding Recipient Organization						Some Cornell authors are concerned that their accepted manuscript, and not the published version of the paper, will be available through PMC. Their feeling is that the technical corrections, copy-editing, and formatting added by publishers would not itself be copyrightable and should not be afforded the kind of protections that original creative work is afforded. In all cases, the version of the paper as published should be accessible via PMC. You should require NIH researchers to secure permission to deposit the paper as published.	Web Form
365	Town Hall Form Comments	03/14/2008 at 11:46:26 AM (204)	Deutsch	Harry		member of the public	va	US	Other Member of the Public						The transfer of information to patients and practitioners is hinder by the additional road block of expensive access to articles that are supported by tax funded research. The patients are being taxed twice and their health suffers because it takes 10 to 15 years before new procedures proven by research are widely put into practice. Free access can shorten this time by removing one barrier to the process.	Web Form
366	Town Hall Form Comments	03/14/2008 at 12:01:25 PM (688)	Morrison	William	BA	Johns Hopkins Univ. Grad	NC	US	Other Member of the Public						Free access and avalibility to NIH related publications is in the best interest of all members of the AMERICAN PUBLIC, THE AMERICAN TAX PAYERS, THE MEDICAL PROFESSION AND THE PATIENT POPULATION. NIH has a duty to foster complete access to all documents without encumbrances (including profits for contract companies to convey requested documents). Certainly the public deserves no less and without extended delay.	Web Form
367	Town Hall Form Comments	03/14/2008 at 12:05:03 PM (351)	Hebert	Ann Marie	PhD	patient	CA	US	Patient or Representative of a Public Health Advocacy Organization						Please make available to the public articles published with NIH funding. It is a hardship for members of the public, who do not have subscriptions to science journals, to be shut out of this research. It is our lives at stake, and many of us have educated ourselves on our own disease and are at least partially able to read and assimilate technical journal articles in the area of our own health issues. It is important that we have access to current information and research on our disease.	Web Form
368	Town Hall Form Comments	03/14/2008 at 12:07:37 PM (964)	ODonnell	Mary	BS	Amyloidosis Foundation	MI	US	Patient or Representative of a Public Health Advocacy Organization						As a non-profit working to increase awareness of a rare disease, amyloidosis, it is imperative that any current up to date information be made available as soon as possible to allow us to help disseminate this information into the medical community. Especially information on diagnostics and treatments. Many publications allow free access after 6 months, and I would strongly urge the NIH to shorten the length to at least 6 months if not less.	Web Form
369	Town Hall Form Comments	03/14/2008 at 12:24:12 PM (947)	Bliok	Marilyn	M.S. Guidance & Counseling	Great Neck Public Schools as per diem teacher at this time	New York	US	Patient or Representative of a Public Health Advocacy Organization						Access to health information before it is filtered down to the general public, which may or may not happen, is important to those of us who have suffered and continue to experience terminal diseases. Amazingly, I am still alive after undergoing a Stage I LL lobectomy(no chemo) in 1994 and an UR lobectomy in stage IIIB or IIIA with chemo preceding in 2001. I need as much data as I can get to keep up with the most recent studies. I understand that what is considered best practice in one part of the USA and in other countries of the world is not standard. I am interested to know why and if any investigations have been made to determine what works best and for whom. I consider myself literate and can use a medical dictionary. Marilyn Bliok	Web Form
370	Town Hall Form Comments	03/14/2008 at 12:34:20 PM (317)	Franklin	Brinley	MLS, MBA	Vice Provost, University of Connecticut Libraries	CT	US	Representative NIH Funding Recipient Organization						At the University of Connecticut, the President and Provost have sent a message to all faculty informing them of the NIH Public Access Policy and its effective date. The Libraries are sponsoring a forum on the topic on March 26th and faculty have been encouraged to attend. The Libraries are working with the Office of Sponsored Programs to provide UConn faculty, and specifically NIH researchers, the information and resources they need to comply with the NIH Public Access Policy.	Web Form
371	Town Hall Form Comments	03/14/2008 at 12:34:57 PM (673)	Rusthoven	James	MD, MHSc (bioethics)	McMaster University	Ontario	Canada	Other						As a clinical researcher and student of bioethics, I think the public should have direct access to the results of studies which they help to fund. Patients now often come with information about therapies on websites which do not contain peer-reviewed study results but rather represent poorly conducted studies or no studies at all. It is time that they have access to high-quality studies which they can review and compare with those they find on various other websites. At very least, this will show that the medical community acknowledges that the public wants to be informed and that medical community is helping to educate the public. It is then up to the patient and her physician to interpret the studies in the context of that patient's situation.	Web Form
372	Town Hall Form Comments	03/14/2008 at 12:35:16 PM (935)	Goetsch	Lori	MLS	Kansas State University	KS	US	Representative NIH Funding Recipient Organization						As a Dean of Libraries at a research university, I support the NIH policy and am working with colleagues on campus to assure effective implementation. As a member of a family with many cancer survivors, I can also speak personally to the value of getting the latest research into the hands of the public as soon as possible. Knowledge is power when facing a life-threatening illness. Assuming that, at least for the moment, the embargo period will be for up to twelve months as the policy outlines, I encourage all NIH grantees to negotiate with publishers for shorter embargo periods. Exercise your rights as authors!	Web Form
373	Town Hall Form Comments	03/14/2008 at 12:48:17 PM (613)	dildine	james	MA, MA Information Science	Greater Western Library Alliance	UT	US	Other Member of the Public						The new requirements to post NIH funded research results in a timely manner will greatly expedite the availability of that critical information. In many cases, the availability of this information literally represents a matter of life or death. The early adoption of this policy may be difficult for some organizations to fully comply and it may be necessary to allow some case by case exceptions. Nevertheless, the short time line is representative of the urgency felt by many health care professionals, their clients, and researchers; and are reasonable given the critical nature of the information. I recently attend an all-day seminar of information specialists and the consensus of that group was that the new standards were much needed, and if anything could be more stringent. Its encouraging to see this policy being implemented.	Web Form
374	Town Hall Form Comments	03/14/2008 at 12:51:09 PM (610)	Schmiedge	Margot	RN	Kabuki Syndrome Network	Saskatchewan	Canada	Patient or Representative of a Public Health Advocacy Organization						I fully support access to information which has been made possible by NIH funding. As the director of a support group of a rare syndrome I know how difficult it is to access information without it costing an arm and a leg. That should not be. In today's world our medical system provides very fragmented care, each specialty only concerning themselves with their specialty. It has therefore fallen upon the shoulders of parents to coordinate and make sure that all aspects of their child's condition is being looked after. Today's parents NEED to be informed. Gone are the days where we can assume the medical field will inform us. I sincerely hope that information will become more readily accessible to them!	Web Form
375	Town Hall Form Comments	03/14/2008 at 12:51:51 PM (648)	Jerram	Peter	BA	The Public Library of Science	CA	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						I head The Public Library of Science (PLoS), a leading Open Access (OA) publisher of scientific literature. Over the past several years PLoS and other OA publishers have conclusively demonstrated the high impact of open access scientific publishing. PLoS Biology for example is now the number one general interest biology journal in the world and it’s not yet five years old. The NIH Public Access Policy will greatly expand the availability of the more than 80,000 articles that result each year from NIH funding. At the most fundamental level, of course, taxpayers have a right to see the results of research they have funded without paying an additional fee. But beyond basic rights, the policy’s impact will be far reaching and deeply felt. Two profound implications stand out. 1 Impact on Public Health. Currently, the general public does not have unrestricted access to rigorous, peer reviewed, high quality research. There are numberless examples of citizens seeking health information online, only to be denied the access for which they have essentially already paid. Similarly, due to the high cost of medical journals, many physicians can’t afford to keep up with the latest research in their own fields. And health policymakers, who formulate influential public policy, are likewise barred from reading the full text of the latest research. In all of these cases, people are forced to rely on abstracts alone, which are sorely inadequate as the basis for critical clinical and health policy decisions. In fact, there are several recent studies that suggest that abstracts often inaccurately represent the content of the research they purport to summarize. A recent editorial in no less an authority than The Lancet concluded that “abstracts are known to be fickle representations of an article.” 2 The Internet Unleashed. The internet has enormous power to not only disseminate information, but also to bring to bear computational tools to find, share and combine that information into virtual, interlinked libraries that will spark new ideas and spur scientific discovery. The Wellcome Trust, Great Britain’s largest private funder of medical research, has noted that “as the tools for mining become more sophisticated, we will see new knowledge being created by the linking of research papers that previously had not been seen as relevant to each other. For this to happen, however, papers must be held in an open access repository and not remain hidden behind publishers’ authentication systems.” The NIH’s seminal Open Access Policy will not only encourage others to follow suit with their own open access mandates, it will itself help unlock the power of scientific data and enable scientists to pioneer new kinds of computational research that can only occur in the open environment.	Web Form
376	Town Hall Form Comments	03/14/2008 at 01:16:17 PM (772)	Schottlaender	Brian	MLS	UC San Diego	CA	USA	Representative NIH Funding Recipient Organization						On April 7, the NIH Revised Policy on Enhancing Public Access to Archived Publications resulting from NIH-funded research will be implemented. This is a welcome and important change in public access policy that the UCSD Libraries and other libraries in the University of California system support. The UCSD Libraries are actively working with the Office of Research on our campus to inform our many NIH-funded researchers and to provide assistance in making a smooth transition to the new policy. As noted in a September letter to California’s senators from Wyatt Hume, UC Provost and Executive Vice President of Academic and Health Affairs, the new policy will maximize both the impact of research and the dissemination of new knowledge. The policy also appropriately recognizes and preserves the integrity of peer-reviewed journals, which play a vital role in the conduct of science, by providing a twelve-month embargo period that protects publishers’ subscription revenue. Equally important, the NIH Revised Policy on Enhancing Public Access to Archived Publications promises to achieve the goals of expanding the use of NIH research findings in the advancement of science and public health; enhancing the management of NIH's invaluable research portfolio; and providing for a timely, sustainable, and openly accessible archive of research results arising from the substantial investments of U.S. taxpayers. These NIH goals are strongly endorsed by University of California scientists and librarians, along with their academic colleagues throughout the nation. Brian E.C. Schottlaender University Librarian University of California, San Diego	Web Form
377	Town Hall Form Comments	03/14/2008 at 01:25:55 PM (439)	Estoff	Cindy	BSN	Leiomyosarcoma Patient	New York	US	Other Member of the Public						I have leiomyosarcoma. It is a very rare, aggressive and deadly cancer. Only 4 people in a million are diagnosed and very little is known about this disease. Publications regarding this cancer are crucial to our survival. Time is very precious to all of us no matter what medical condition we are dealing with. We need information as soon as it becomes available. Knowledge is a powerful tool...it helps us in our health care decision making...it helps us to take charge of our disease....we are entitled to be a part of the medical team. Please don't delay.	Web Form
378	Town Hall Form Comments	03/14/2008 at 01:33:04 PM (412)	Eaton	Elizabeth	PhD	Houston Academy of Medicine-Texas Medical Center Library	TX	US	Other						The Houston Academy of Medicine – Texas Medical Center Library in Houston, Texas wishes to express our deep appreciation for the efforts that NIH is taking to ensure an effective implementation of the updated Public Access Policy (NOT-OD-08-033). We have been supporting the Public Access Policy since its inception and are gratified to see the Policy take the form of a mandate. We are optimistic that this policy will speed the pace of discovery by expanding access to research findings supported with federal tax dollars in order to better advance science and improve health. The Library is partnering with research administrators and faculty at the many educational and clinical institutions in the Texas Medical Center to implement the policy by April 7, 2008. We have been recognized as leaders in addressing the issues surrounding the Public Access Policy and institutional repositories in general. This leadership role includes educating faculty about retaining more of their authorship rights when signing publication agreements with their publishers and encouraging faculty to retain rights for using their work in their teaching, for posting on their personal websites, or depositing to institutional repositories. This new mandated public access policy affects so many of our researchers and focuses increased attention on the issue of author rights. We believe this is a very positive and important outcome. We are developing methods to assist with the actual submission process. The NIH Submission System is easy to use once the author rights issues have been addressed, but when researchers need assistance, we are available to help. Many publishers have already worked to facilitate the implementation of the policy either by participating fully in PubMed Central or by submitting final manuscripts on behalf of the authors who wish to publish in their journals. These publishers are an important part of this process, and we look forward to an ever-expanding list of “fully compliant” journals that can ease the article submission process for our faculty. We recommend that NIH continue to actively seek out partnerships with publishers and work with other national associations to urge publishers to join the growing list of compliant journals. Thank you for your efforts to ensure a smooth implementation of the Public Access Policy. This policy will result in significant improvement in access to health information, in research collaboration, and in supporting educational programs in the health sciences. The Houston Academy of Medicine – Texas Medical Center Library is the library for Baylor College of Medicine and The University of Texas Health Science Center at Houston. You can learn more about us at http://resource.library.tmc.edu.	Web Form
379	Town Hall Form Comments	03/14/2008 at 01:37:32 PM (162)	Watson	Linda	MLS	Association of Academic Health Sciences Libraries	Washington	US	Representative NIH Funding Recipient Organization						I submit these comments on behalf of the Association of Academic Health Sciences Libraries (AAHSL), an organization of library directors of the 142 accredited and American and Canadian medical schools that belong to the Association of American Medical Colleges. AAHSL expresses its deep appreciation for the efforts that NIH is taking to ensure an effective implementation of the updated Public Access Policy (NOT-OD-08-033). We are optimistic that this policy will speed the pace of discovery by expanding access to research findings supported with federal tax dollars in order to better advance science and improve health. Our member libraries are recognized as leaders on our campuses in addressing policy issues related to authors rights. We have encouraged our faculty to retain rights to use their work in teaching, for posting on their personal websites, or depositing to institutional or subject repositories. This new policy directs increased attention to the issue of authors rights, a matter of high importance to the advancement of scholarship. Our libraries are partnering with research administrators and faculty on a number of activities to meet the April 7, 2008 implementation deadline. Many have taken steps to assist with the submission process. We are sharing “best practice” experiences with each other through our strong network, our website and a Toolkit. Our president is serving as a moderator for an online chat session on March 27 to discuss implementation strategies with libraries throughout the country. As preparation for the policy, AAHSL held a session at its annual meeting in November 2007 that included a presentation on authors rights. We are planning a session on the policy at the Medical Library Association annual meeting in May 2008 to continue the dialog with the larger medical library community. Special mention is due to those publishers who facilitate the public access policy implementation by either participating fully in PubMed Central already, or submitting final manuscripts on behalf of the their authors. We look forward to an ever-expanding list of “fully compliant” journals that can ease the article submission process for our faculty. We recommend that NIH actively seek out partnerships with other publishers and work with other national associations to urge publishers to join the growing list of compliant journals. And we urge NIH to continue its work to streamline the deposit system and the timely updating of its website. Thank you for your efforts to ensure a smooth implementation of the Public Access Policy. We believe the policy will result in a significant improvement in access to health information for our faculty, students and the academic medical centers that we serve. Our member libraries lend strong support to their institutions’ efforts to comply with the policy.	Web Form
380	Town Hall Form Comments	03/14/2008 at 01:40:27 PM (569)	Miller	Jonathan	MLS	Rollins College	FL	US	Other Member of the Public						I am the Library Director at a small private liberal arts college. We are not close to, or affiliated with, any large health science library. We have built a paper and online collection of journals that supports our undergraduate biology and health sciences program, but it is far from comprehensive. The NIH public access policy provides our students and faculty with much needed convenient access to a broad range of high quality health science research. This will not substitute for our local online and print journal collection but it does promise to expose our students to cutting edge research, thus improving their education, and ultimately the health care system in America.	Web Form
381	Town Hall Form Comments	03/14/2008 at 02:01:53 PM (225)	Salzberg	Steven	Ph.D.	University of Maryland	MD	US	NIH-funded Investigator						The proposed NIH policy requiring submission of all scientific papers supported by NIH funds is a truly wonderful step forward for science and for the public good. Open sharing of scientific knowledge is the foundation of all scientific progress. NIH and other government funding should be used to accelerate the progress of science as rapidly as possible, and this policy achieves that. It never made sense for scientists to sign over copyright to private publishers. We write the papers, we review the papers, we edit the papers, we even format them. The publisher's role has been reduced to a distribution channel, and the Internet now makes even that unnecessary. And the public pays for all of this. The public should have free, unfettered access to all the results of scientific research paid for by the public. Today, the Internet allows anyone to look up articles if they are publicly available - and the public is increasingly aware that many of these scientific articles affect them, especially research on human diseases. The open access policy will help make the public more aware of progress in treating a wide range of diseases, and it may save lives by steering people towards effective treatments and away from ineffective ones.	Web Form
382	Town Hall Form Comments	03/14/2008 at 02:10:21 PM (845)	Suber	Peter	Ph.D., J.D.	Earlham College, Yale Law School, SPARC, Public Knowledge	Maine	US	Other Member of the Public						My comment is more than 3,000 characters in length and I've mailed it to PublicAccessComments@NIH.gov.	Web Form
383	Town Hall Form Comments	03/14/2008 at 02:12:26 PM (559)	Phillipps	Richard	MPH, MSW	Adcare Hospital of Worcester	MA	US	Patient or Representative of a Public Health Advocacy Organization						I would like express my strong support for public access to published results of NIH funded research. Per article charges are a very high $25 to $50 in addition to the tax dollars I've already contributed to the research. I can not, and I hope you do not, accept arguments that you or I must subsidize journals or that the public needs to be "protected" from information. Public Health and Medical Social Work are my specialties. My experience and the literature clearly show that an informed public is a healthier public. Healthier citizens are the most effective and humane form of healthcare cost containment. That's one area in which not go backward. Thank you.	Web Form
384	Town Hall Form Comments	03/14/2008 at 02:37:46 PM (776)	Watson	Mark	MLIS	University of Oregon	Oregon	US	Representative NIH Funding Recipient Organization						The University of Oregon (UO), along with the UO Libraries, is committed to implementing the NIH policy. The Library is actively recruiting for a head of scholarly communications in part to provide the institutional resources to help make the policy a success. Substantial efforts will be on the parts of Library subject specialists (i.e., liaisons to the various departments)to make sure that faculty are aware of their obligations and opportunities. The Library is also committed to partnering with the Office of Research Services & Administration to provide faculty education and assistance. The NIH Access Policy propels very positive changes in the scholarly communications arena.	Web Form
385	Town Hall Form Comments	03/14/2008 at 02:52:25 PM (399)	Fauerbach	Ellen	MBA	retired	New York	US	Other Member of the Public						I am in favor of public access through PubMed Central of all NIH funded research.	Web Form
386	Town Hall Form Comments	03/14/2008 at 02:54:44 PM (414)	Peipert	Rosalie		Moderator Endometrial stromal sarcoma online support list on Yahoo	NJ	US	Patient or Representative of a Public Health Advocacy Organization						Please ensure that results of NIH-funded research are made available free of charge to the public as soon as possible after publication. 6 months would be more like it for people like me who have a rare type of cancer. Only .01% of us have uterine sarcoma. We need to know how to help ourselves it is critical to have information early rather than later. Cancer patients need to self-educate on their diseases and potential treatments, but the cost of doing so can be prohibitive. Patients and medical professionals should be entitled to the results of studies funded by our taxes. I believe knowledge is power. Help us educate our patients to know how to make educated decisions.	Web Form
387	Town Hall Form Comments	03/14/2008 at 03:04:24 PM (880)	Brady	Suzanne	BBS	Brady Marketing, Inc.	Georgia	US	Other Member of the Public						Please allow patients and their caregivers access to information regarding NIH projects which might prove helpful to us across the US. Since there are several ways of treating a patient for the same thing, it is so necessary to have available the information needed to give informed consent and to make a decision regarding possible alternatives for healthcare. As the wife of a stage 4 cancer patient with a rare disease, it is imperative that I understand as much as possible about the situation, know who the doctors are who specialize in our field of interest, and ultimately that we get the best, most up-to-date care available to us. Our stress levels rise and our income levels drop drastically as our loved ones face disease, even with good insurance! The fees charged now are exorbitant. And if these things are funded with government dollars, then shouldn't the public have access to what their tax dollars have provided? Thank you.	Web Form
388	Town Hall Form Comments	03/14/2008 at 03:17:00 PM (457)	bacot	angela	n/a	none	Ga	US	Other Member of the Public						My mother had amyloidosis for OVER a year without a correct diagnosis. Unfortunately she died prior to treatment due to the length of time it took to get the diagnosis. I believe that if more information had been accessible without the associated high cost we may have been in a better situation regarding her treatment and the outcome. Strongly believe that free access to publications should be made available and in a much shorter time frame than 12 months!!	Web Form
389	Town Hall Form Comments	03/14/2008 at 04:14:40 PM (847)	Graves	Diane	MLS	Trinity University	Texas	US	Representative NIH Funding Recipient Organization						This important legislation will provide access to information that previously has been unavailable to patients and physicians in rural areas (such as south Texas). It also will assist researchers at smaller institutions that do not support research libraries. I would like to see a shorter embargo period, as the content would be available in a more timely manner to all potential users, not just those who have access to medical research libraries.	Web Form
390	Town Hall Form Comments	03/14/2008 at 04:49:11 PM (380)	Martinez	Robin	BA	Association for Cancer Online Resources (ACOR)	CO	US	Patient or Representative of a Public Health Advocacy Organization						I am the widow of a kidney cancer patient. For over 10 years, I have worked online with caregivers and patients fighting renal cell carcinoma or transitional cell carcinoma of the renal pelvis and ureter. It is rare to find a person who even knows what those cancers are. The patients and caregivers are average citizens fighting to learn everything they can about advances that might give them a chance at life. If the proper information is available to them, these people can move from medical naivete to a high level of understanding in just a few weeks. I have seen it happen countless times on our mailing list where we discuss these cancers and treatments for them. But we need more! We need free access to research results so patients can get accurate information and up-to-date treatment in a field that is changing daily. Medical professionals also benefit from having research results freely available to the public. Highly-motivated patients and caregivers sieve out the most promising and important information and pass it along to professionals and others. Many oncologists have been able to use patient-provided research materials to everyone's benefit. Since we the public fund NIH research, it is only right that we all have access to the written results. Please make this life-saving resource available to all of us.	Web Form
391	Town Hall Form Comments	03/14/2008 at 04:51:41 PM (318)	Olsson	MiMi		http://health.groups.yahoo.com/group/MesenchymalChondrosarcoma/	MA	US	Patient or Representative of a Public Health Advocacy Organization						I spend approx 3 to 4 hrs a day researching articles for Sarcoma support groups. I scan PubMed, HemeOncLinx, etc. reading abstracts then contacting authors begging for free articles. The proactive parents and patients in my support groups have self-educated themselves with these articles and strive for the most up-to-date medical information and treatment options. These articles should be made available to everyone.	Web Form
392	Town Hall Form Comments	03/14/2008 at 05:09:25 PM (558)	Stockel	Eric		citizen	CA	United States	Other Member of the Public						I write to urge you to make available to the general public the results of research getting federal funding. There is simply no reason to hide from the public that which it has helped create. As someone who tries to assist those with lung cancer, I know that access to research articles can be difficult and expensive. Please make it easier.	Web Form
393	Town Hall Form Comments	03/14/2008 at 05:09:46 PM (465)	Heim	Erin	MS	Parent of child with cancer	CA	US	Other Member of the Public						I believe that free public access should be given to scientific articles online to interested parties.	Web Form
394	Town Hall Form Comments	03/15/2008 at 05:40:24 PM (909)	Scherrer	Wendy	B.S., MEd	Mantle Cell Lymphoma Survivor/Patient	WA	US	Patient or Representative of a Public Health Advocacy Organization						As a lymphoma patient in a rural area of northwest Washington State, I rely on websites carrying the latest scientific research findings on my rare of non-Hodgkins mantle cell lymphoma. I strongly belief that the Director of the National Institutes of Health shall require that all investigators funded by the NIH submit to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Research findings conducted with support from public monies should be made available to the public as soon as possible, so that patients, doctors, as well as cancer research organizations and organizations that support cancer patients can use the most current knowledge in the most timely way. Sharing information through electronic formats on the internet is an effective and cost-efficient method to empower all to solve our national health challenges. Knowledge is power. Empowering our communities through the more current knowledge from public-funded research is certainly the responsibility of the NIH.	Web Form
395	Town Hall Form Comments	03/15/2008 at 06:42:55 PM (987)	Faitek	Judy	MS	Hemophilia Association of San Diego	California	US	Patient or Representative of a Public Health Advocacy Organization						Please allow people who are sick access to journal articles without having to pay for them. People who are dealing with sickness have enough to worry about and pay for. Please allow us to research our diseases through these journal articles. Thank you.	Web Form
396	Town Hall Form Comments	03/15/2008 at 07:04:36 PM (593)	Ruane	Peter	MD	Private Practice	CA	US	Patient or Representative of a Public Health Advocacy Organization						I am in favor of the Public Access Policy that ensures that the public has access to the published results of NIH funded research. It requires that scentists to submit journal articles that arise from NIH funds to the digital archive PubMed Central. Specifically, currently the information that comes easily online to patients is through Pharma supported organizations ( Medscape, POZ, ViralED, Urotoday etc) and has an inherent bias.	Web Form
397	Town Hall Form Comments	03/15/2008 at 07:51:41 PM (193)	Odom	James	BS Elect. Eng.	Cancer Survivor	MO	US	Other						It is my belief that nothing but good can come of having free public access to results of public funded research. As a cancer survivor that is still under treatment, it is my observation that knowledge accessible to the patient at no cost can be very important in dealing with the disease, the medical profession, and deciding on treatment options.	Web Form
398	Town Hall Form Comments	03/15/2008 at 07:55:08 PM (291)	Greer	Lisa	J.D.	Parent of Medically Fragile Child w/ Rare Genetic condition .	California	US	Other Member of the Public						I am commenting in my capacity of as a taxpayer and the mother of a ten-year old little boy with the rare condition known as Kabuki Make-up Syndrome. Given the extent to which our son' genetic disease requires us to collaborate with his medical treatment team in rendering frequent and complex medical decisions, we are constantly seeking access to medical research data bases. However, as lay people who are unaffilliated with a university or other entity that maintains costly subscriptions to "for profit" medical research data bases, we are more often than not hamstrung in these efforts. From a policy perspective, it strikes me as nothing but beneficial to give the community of special needs parents/caregivers open access to the medical/scientific research that our tax dollars have funded. It will lead to better and more efficient decision-making by such individuals, and lead to a more transparent relationship between parents of chronically ill pediatric patients and the child's medical treatment team. It is important that parents such as us can, through self education, equalize the almost universal disparity of medical decision-making power that arises from a lay parents' inability to access data critical to render informed consent for proposed medical interventions.	Web Form
399	Town Hall Form Comments	03/15/2008 at 09:15:08 PM (114)	Freidus-Flagg	Alberta Joy	MA	US taxpayer	HI	United States	Other Member of the Public						Please support the recently-passed bill that will make it mandatory for articles resulting from NIH funded research to be placed in a repository at the National Library of Medicine and made available free of charge to the public, no later than 12 months after they are published. It is essential that this information be accessible.	Web Form
400	Town Hall Form Comments	03/15/2008 at 09:32:40 PM (182)	Meyer	Alan	M.S.	Cancer survivor	MD	US	Patient or Representative of a Public Health Advocacy Organization						When research has been paid for, or partially paid for, by public funds, it seems only right that the public be allowed to read the results of that research. I understand that private journal publishers wish to recover costs and make a profit by charging fees for journals, but the real scientific work, and the real expense of the research enterprise, is in the research itself, not the publishing. If the hard and expensive part of the research is paid for with public money, the results should be available to the public and should not be appropriated by the publishers. The proposal to allow private publishers the exclusive right to sell articles for one year after publication seems to me to offer reasonable protection for the publishers involved. The proposal does not completely disregard the publishers, but it does recognize that the public has a right to see the results that they paid to produce. I believe that there is also a compelling public interest in providing more and better access to medical research. The purpose of this research, and the reason that the government funds it, is to advance medical knowledge for the entire community. Providing free access to this research will benefit all of those who have the knowledge to read it. It will benefit private citizens, students, and doctors in the U.S. who have limited or no access to medical journals. It will also benefit large numbers of students, doctors, and researchers around the world who do not have the hard cash needed to pay for journal subscriptions.	Web Form
401	Town Hall Form Comments	03/15/2008 at 09:33:53 PM (438)	Peterson	John	BS	Medistem Laboratories, Inc.	MO	US	Patient or Representative of a Public Health Advocacy Organization						It is extremely important that new dat, publicatios, papers, results of NIH funded work be available to the public. 12 months seems a long time for protection but if that is the number, I support it. Please expedite the availability of this information. We patients often need it badly. Thanks. John Peterson	Web Form
402	Town Hall Form Comments	03/17/2008 at 01:29:46 PM (603)	Sugars	Stephanie	patient	Peutz-Jeghers Syndrome Online Support Group	CA	US	Patient or Representative of a Public Health Advocacy Organization						As a person living with a rare genetic disorder, Peutz-Jeghers syndrome (PJS), and a common cancer, metastatic breast, my survival has for years depended upon access to medical journal articles. Whether I’m seeking new doctors for second opinions, gathering information for my current doctors, investigating new treatments, keeping up on research or finding information for members of the PJS Online Support Group, access to medical journal articles is imperative. Over the past 25 years I’ve collected over 200 articles on PJS by traveling many miles to medical center libraries. While the photocopy/printout costs are reasonable – this is time consuming and taxing for someone who is seriously ill. The alternative, to print out articles from a computer, is prohibitively expensive. It’s difficult to judge the value of an article from a PubMed abstract. Spending a dollar or two for copy/print costs is one thing, spending over $30 is another. Public Access will help physicians as well as patients. Easy access to recent journal articles will help them keep up to date on research and treatment options – an invaluable aid whether treating patients with rare or common illnesses. Thank you for considering my comment, Stephanie Sugars	Web Form
404	Town Hall Form Comments	03/17/2008 at 01:37:17 PM (657)	Garrison	Ellen	Ph.D.	American Psychological Association	DC	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Underlying the new mandatory public access policy is a presumption that publishers will not incur significant financial hardship if up to 12 months is provided between the date of publication and the time the peer-reviewed manuscript will be made available to the public through PubMed Central. While this may be true for a handful of publishers, this hardly applies to the industry as a whole. For instance, the American Psychological Association is the largest publisher of behavioral science research and applications, with 37 of the premier scholarly journals in the field of psychology. The cutting-edge research that the association publishes is rarely obsolete within a year, and may have a shelf life of five to ten years. Moreover, only 15 percent of the eventual “lifetime” usage/downloads occurs within the first year after publication. So, it is imperative that adequate financial compensation be offered by NIH to offset the loss of income that the association and other publishers anticipate were all accepted, peer-reviewed manuscripts resulting from some degree of NIH support made publicly available within such a short period of time. When peer-reviewed manuscripts are made widely and freely available on line, the commercial value of the finished, published work is likely to be seriously undermined, with resulting declines in subscriptions and licensing agreements. The NIH policy does allow for the use of grant funds for the payment of publication fees for NIH-funded authors. Yet, it is not clear whether this refers to page charges or a more comprehensive fee per article payment. In this context, it should be noted that behavioral science publishers, unlike their colleagues who publish in the biomedical sciences, do not currently receive page charges for published articles, which can be quite substantial (e.g., as much as $850 per page), from authors through their designated grant funds. Thus, NIH needs to either set aside funds to make direct payment to publishers or to include publishing costs in behavioral and social science research grants (which NIH does not do at the present time). With respect to the first option, would it be possible for publishers to undertake direct licensing arrangements with NIH to deposit copyrighted work on behalf of authors? Would NIH be able to negotiate the terms of these licensing agreements like other non-government funding agencies have done, such as the Wellcome Trust and the Howard Hughes Medical Institute?	Web Form
406	Town Hall Form Comments	03/17/2008 at 01:42:12 PM (974)	Garrison	Ellen	Ph.D.	American Psychological Association	DC	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						NIH is to be commended for holding the March 20 public meeting and for the issuance of the upcoming Request for Information (RFI) later this month to provide the public with opportunities to comment on the new mandated public access policy and its implementation. Yet, even taken together, these actions do not substitute for a formal Notice and Comment Rulemaking, which NIH is still urged to pursue. Apparently, NIH considers its pending transformation of its current voluntary public access policy into a mandatory one as merely an interpretation of an existing policy that requires only the posting of a “revised” policy. However, this reflects a woeful miscalculation of the potential impact of this policy on our economy and international trade. Journals published by U.S. scientific, technical, and medical (STM) publishers represent about $3 billion in annual revenue, and North America-based STM publishers account for 45% of all peer-reviewed research papers published annually worldwide. The mandatory NIH public access policy would provide free, world-wide access to U.S. scientific research to countries who are competing with American business and industry, undermining the intent of the America Competes Act. Therefore, NIH would be well advised to proceed very carefully prior to implementing this new policy to ensure sufficient time to obtain and review input from key stakeholders. Such a deliberative approach would be in keeping with the guidance provided by the U.S. Senate in report language that accompanied the omnibus appropriations bill. Specifically, the Senate requested that NIH “seek the advice of journal publishers on the implementation of the mandate to ensure that publishers’ copyright protections are maintained.” Rather than take precipitous action, NIH should delay implementation of the public access policy for six months consistent with its own stated time frame to review comments arising from the RFI (i.e., March posting of RFI with 60-day comment period followed by 120 days for NIH to respond to comments and announce any amendments of the policy). It truly makes no sense and is highly questionable process-wise to seek informal input from the public at the end of March, implement the policy effective April 7, review the public comments, and then announce possible amendments to the policy six months later. Furthermore, if the policy were still to go into effect on April 7th, it should not apply to any grants issued before that date, counter to the current NIH guidelines that apply to NIH grants or cooperative agreements “active” in FY 2008 (which began on October 1, 2007). Otherwise, this policy would involve an unfair, retroactive imposition of grant terms and conditions that could extend back for years prior to the official April 7, 2008, implementation date.	Web Form
407	Town Hall Form Comments	03/17/2008 at 01:42:33 PM (416)	Goldberg	M		cancer survivor, past 10-year caregiver to parents with cancer, Parkinson's, strokes and dementia	NY	US	Other Member of the Public						To me it seems very simple: when _America_ pays for research, _America_ deserves to see the results. Period.	Web Form
408	Town Hall Form Comments	03/17/2008 at 01:48:39 PM (583)	Funk	Mark	MLS	President, Medical Library Association	New York	US	Other						The Medical Library Association(MLA) supports the NIH public access policy because researchers, students, educators, and the public will have improved access to the literature generated from federally funded scientific and medical research. The policy also will ensure that the information deposited into PubMed Central remains available for years to come. Both of these provisions are critical components in support of medical research and discovery, the development of new therapies and treatments, the delivery of high quality effective health care, and greater knowledge and understanding of health issues by the public. MLA is pleased that implementation of the newly revised policy is on schedule and is working with members of the medical library community to support implementation of the new policy. MLA is a nonprofit, educational organization with more than 4,500 health sciences information professional members worldwide. Founded in 1898, MLA provides lifelong educational opportunities, supports a knowledge base of health information research, and works with a global network of partners to promote the importance of quality information for improved health to the health care community and the public. Mark E.Funk,AHIP,President,Medical Library Association,Weill Cornell Medical College, Samuel J. Wood Library, NY, NY	Web Form
409	Town Hall Form Comments	03/14/2008 at 05:28:01 PM (582)	Kuta	Bob	Citizen	Child with Cancer	NE	US	Other Member of the Public						I believe that free public access should be given to scientific articles online to interested parties.	Web Form
410	Town Hall Form Comments	03/14/2008 at 05:37:10 PM (238)	Paskay	Licia	MS	Purpose Inc.	CA	US	Other Member of the Public						To whom it may concern, Please support the NIH Public Access Policy as there are so many peer-reviewed articles published every year and it is expensive for the general public or even non profit centers like mine to access the needed literature to stay current and educate and help the public. The proposal by NIH seems reasonable. Please support it. Sincerely, Licia C. Paskay, MS, CCC-SLP, COM	Web Form
411	Town Hall Form Comments	03/14/2008 at 05:41:04 PM (372)	TYACK	ELLEN	BA;MSW	PATIENT/CANCER SURVIVOR	NY	US	Patient or Representative of a Public Health Advocacy Organization						I am a two time cancer survivor: 2007 Uterine Carcinsarcoma Stage 3C and 2005 Papillary & Follicular Thyroid cancer Stage 1. I found it absolutely necessary to educate myself about both of my cancers, but especially about my aggressive and rare uterine cancer. By reading articles that I found myself or articles that were made available to me through members of my online group for uterine carcinosarcoma, I have learned alot about my disease and treatment options. My uterine cancer is so rare that there are oncologists in this country who have never treated a patient with this diagnosis. I think that it is imperative that a patient have free access to research articles so that she or he can be confident that treatment being proposed or given is the best choice. We will never become as knowledgeable as our doctors but having free access to research articles would help us to become better informed members of our own treatment teams. Let's face reality; many of us will do our research online. It is extremely important that accurate and up to date information is available to us from reliable, accountable sources. And if our tax dollars are funding that research, then we deserve to have free access to the results. Synopsis reveal so little that they are often of no use, and few of us cancer patients can afford paying for numerous articles. Thank you.	Web Form
412	Town Hall Form Comments	03/14/2008 at 05:42:35 PM (902)	Shapiro	Richard	JD	Amyloidosis Foundation	FL	US	Patient or Representative of a Public Health Advocacy Organization						I favor the proposal to make the full article available after one year. This is the model used by the medical Journal BLOOD. Apparently they make sufficient profits to have lasted decades and is a very prestigious Journal.	Web Form
413	Town Hall Form Comments	03/14/2008 at 05:51:13 PM (474)	Walters	G. Thomas		Cancer patient	CA	US	Patient or Representative of a Public Health Advocacy Organization						Any article for any study which used any amount of public, taxpayer money, should be available for viewing by the public for free. Expensive subscriptions or per/article fees should not be necessary to view findings of publicly financed studies. As a cancer survivor, I require access to this information. Not only have we paid taxes to support the research, but many of us have participated in the clinical trials on which these published articles report. We should not be expected to pay for access.	Web Form
414	Town Hall Form Comments	03/14/2008 at 06:09:18 PM (154)	Carstens	Mary		ACOR	Wisconsin	US	Patient or Representative of a Public Health Advocacy Organization						I support free public access to published results of NIH funded research. I am a kidney cancer survivor.	Web Form
415	Town Hall Form Comments	03/14/2008 at 06:18:16 PM (788)	obrien	j	Liberal Arts/Science	none	Maine	US	Patient or Representative of a Public Health Advocacy Organization						Collectively, into the research melting pot, the public spectrum donates organs, tissues and other pathology for research, without really knowing where it is going and who is doing research, It doesn't seem right that anyone can prosper in research for whatever initiative from our bodyparts without releasing access to "our collective" information results.	Web Form
416	Town Hall Form Comments	03/14/2008 at 06:25:58 PM (391)	Mansfield	Mark	BA, MA, MBA (in progress)	Indiana University student	IN	US	Patient or Representative of a Public Health Advocacy Organization						For those with orphan diseases (such as atypical cancers) NIH information can often be invaluable in the discovery of treatments on the cutting edge. Access to this taxpayer funded research should be the right of public.	Web Form
417	Town Hall Form Comments	03/14/2008 at 06:31:37 PM (347)	Clausen	Charles		Moderator, prostate cancer discussion list, Association of Cancer Online Resources	OR	US	Patient or Representative of a Public Health Advocacy Organization						Modern medicine has become exceedingly complex and expensive. Pressures of time during office visits make it difficult for clinicians to adequately inform patients about their medical conditions and their treatment options. Clinicians themselves have difficulty keeping up with the great volume of published research. Patients need access to medical journals in order to better inform themselves and be capable of participating meaningfully in discussing and deciding their treatment choices with their physicians. If citizens pay taxes for research, they should have free access to the published results.	Web Form
418	Town Hall Form Comments	03/14/2008 at 06:51:46 PM (901)	Shmulovich	Joseph	PhD	private	NJ	US	Other Member of the Public						I strongly support the Policy implementing Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) Patients have to have a free access to vital and timely info, if their government paid for the research. Joseph Shmulovich	Web Form
419	Town Hall Form Comments	03/14/2008 at 07:29:38 PM (834)	Merritt	Jean		US taxpayer	IN	US	Other Member of the Public						As the parent of a child who has survived AML, I can attest to the need and importance of access to as much information as possible to make informed choices on treatment options. I spent many hours searching for information to increase our understanding of his disease so we could ask the right questions. This is very important since I have found that doctors don't like to convey bad news, but will respond with needed information if you ask good questions. As much as you may want to just let the doctor handle things in the middle of the crisis, I found this only leads to delays and missed treatment opportunities.	Web Form
420	Town Hall Form Comments	03/14/2008 at 07:33:29 PM (242)	Wilkes	Chrisann	MS	ACOR	GA	US	Other Member of the Public						I'm in full support of this public access policy. We should have access to articles that result from tax-funded research.	Web Form
421	Town Hall Form Comments	03/14/2008 at 07:48:09 PM (116)	Kessler	Linda	Mom	All	CA	US	Patient or Representative of a Public Health Advocacy Organization						I am a single parent fighting for my son's life, already strapped financially and nickled and dimed as it is, with extra doctors appt's, parking fees,extra RX's, etc. This is a tremendous burden lifted from us if this is accessible without charge. Thanking you in adcance. Linda Kessler	Web Form
423	Town Hall Form Comments	03/14/2008 at 08:00:15 PM (404)	Guy	Connie		ACOR List Member	Ohio	US	Other Member of the Public						As a mother, advocate and soon to be RN, I feel it's imperative to have free access to medical journals.	Web Form
424	Town Hall Form Comments	03/14/2008 at 08:06:16 PM (837)	Bell	Virginia	2002 MA Government NMSU	Listserv member Esarc	LA	United States	Other						Research journal articles should be made available to the public at no cost - ever. My daughter died of Ewing's Sarcoma having survived for seven years after diagnosis. She twice received treatments her physicians had not seen because I had access to the information published by a list server for Ewing's Sarcoma patients, caregivers and loved ones. I am convinced that the treatments I read about online and brought to the doctors' attention extended her life and improved Katy's quality of life. In spite of medical insurance, my family was paupered by the illness and I could never have purchased access to the articles if they hadn't been made available free of charge by the list.	Web Form
425	Town Hall Form Comments	03/14/2008 at 08:13:51 PM (377)	Lee	Martin	BS BS AAS	Cancer Paitent	wa	US	Other Member of the Public						Personally 12 months is too long a wait. With the speed new research is coming up with new things to fight cancer, 4 or 5 months might be too long.	Web Form
426	Town Hall Form Comments	03/14/2008 at 08:28:34 PM (691)	Goodrich	Barbara	MSN	none	ia	US	Patient or Representative of a Public Health Advocacy Organization						As a renal cancer patient, I research all findings od my disease process. To make access to NIH research more open keeps patients and their families engaged in their life and ultimate outcome.	Web Form
427	Town Hall Form Comments	03/14/2008 at 09:16:10 PM (358)	Mawson	Kenneth		ACOR ListServe, CTCL patient	PA	US	Other Member of the Public						NIH medical research findings should be available for public review and reference purposes. These articles are most valuable when searching for any available information pertaining to a rare blood cancer, such as I have. This is one of the best resources for such information that I have found. To deny public access to the findings would be to deny someone access to a possible cure, or breakthrough treatment, for the type of condition they have.	Web Form
428	Town Hall Form Comments	03/14/2008 at 09:36:38 PM (607)	Orr	Scott	JD	PC survivor	MO	US	Other Member of the Public						I respectfully urge immediate access to all research articles of NIH without charge and hope this will be supported by all with ability to make it happen. Thank you for your listening to me. Scott Orr 573.489.6611	Web Form
429	Town Hall Form Comments	03/14/2008 at 09:56:05 PM (221)	Kasper	Michael	MBA	ACKC	pa	US	Patient or Representative of a Public Health Advocacy Organization						I am a survivor of Kidney Cancer who like ALL kidney cancer patients are seeking cures for our disease. Research and the information obtained from research is Vital for our ultimate survival. Please support the mandatory publication of articles resulting from NIH-funded research to be placed in a repository at the National Library of Medicine and made available free to the public. These articles should be available free of any fees to U.S. citizens. Please support this access to vital information!	Web Form
430	Town Hall Form Comments	03/14/2008 at 10:13:12 PM (545)	Eva	Norman		UStoo	VA	US	Other Member of the Public						The transfer of information to patients and practitioners is hindered by the additional road block of expensive access to articles that are supported by tax funded research. Patients are being taxed twice and their health suffers because it takes 10 to 15 years before new procedures proven by research are widely put into practice. Free access is needed to research to shorten this time by removing one of the barriers to the process and giving patients faster access what could be life saving new procedures.	Web Form
431	Town Hall Form Comments	03/14/2008 at 10:24:36 PM (985)	Eva	Nina		UStoo	VA	US	Other Member of the Public						The transfer of information to patients and practitioners is being hindered because of expensive access to articles that are supported by tax funded research. Why should patients be taxed twice and their health made to suffer because it takes 10 to 15 years before new research proven procedures are widely put into practice. Free access can shorten this time by making the information available much sooner and possibly providing a longer life for many patients.	Web Form
432	Town Hall Form Comments	03/14/2008 at 10:25:51 PM (441)	Quiriy	Christine	BA	ACOR	MA	US	Other Member of the Public						It is a hardship for non-professionals to get these articles. Taxpayers pay for this research. We should have free access to the written results.	Web Form
433	Town Hall Form Comments	03/14/2008 at 11:00:10 PM (379)	Zuckerman	Peggy	MS in Ed	kidney cancer association	CA	US	Patient or Representative of a Public Health Advocacy Organization						As a patient with a rare disease, kidney cancer, I am painfully aware how difficult it is for patients and DOCTORs to get the latest information from research. Since most physicians are overwhelmed trying to follow a broad range of information within their own areas, they are assisted when patients can initiate informed discussions. Patients who gain an education about their disease which is based on NIH studies will no doubt be more committed to their treatments. They also may be willing participate in clinical trials or genetic studies, all of which will have a general positive effect on the general public. Without such legitimate information, patients will be limited to less trustworthy sources. Please do make such information readily and freely available to the public. Peggy Zuckerman 2 El Portal Palos Verdes Estates, CA 90274	Web Form
434	Town Hall Form Comments	03/15/2008 at 12:40:26 AM (696)	Lehnert	Richard	BSEE, UC Berkeley	Patient with NHL (ALCL) at Kaiser Roseville and Stanford	CA	US	Patient or Representative of a Public Health Advocacy Organization						As a newly diagnosed patient with NHL (rare subtype ALCL) knowledge is my best weapon to fight this disease. I am being seen by doctors at 2 fine medical institutions, Kaiser, Roseville and Stanford Univ, Palo Alto. However these doctors do not have the time to answer all of me detailed questions and teach me what it took them many years to learn. And the technology and new developments are happening so quickly it is difficult for even these professionals to keep up with all of the latest information. I have embarked on a journey to fight my disease with the most potent weapon available and that is knowledge. Knowledge for myself and also to share with my doctors. Currently it is frustrating to read tantalizing abstracts of reports about the results of clinical trials and laboratory research that appears to show real promise, yet not be able to read the details of the study in order to evaluate the results of the work. I have been only in this quest for a few months and there have been numerous articles I have wanted to read completely. Yet the access seems to be at a high cost and primarily through institutional gateways. At the very least it seems to me that all such research and reports funded by NIH should be available to patients by request as the Journal "Blood" allows. It is a matter of life or death to me. Rich Lehnert BSEE, UC Berkeley Retired 916-390-2240 richlehnert@msn.com	Web Form
435	Town Hall Form Comments	03/15/2008 at 01:21:07 AM (638)	Ellis	Anne Marie	MA	US Citizen, caregiver to person's with lymphoma, lung and esophageal cancers, and member of ACOR	NH	US	Other Member of the Public						While I am glad that the concept within NOT-OD-08-057 is finally being moved on, i feel it falls way short of what is necessary. As rapidly as medicine advances all but the basic info in a publication may be obsolete within 12 months. If the public paid for the research i opine once published it should be public.	Web Form
436	Town Hall Form Comments	03/15/2008 at 02:40:15 AM (195)	Munroz	Elizabeth	MA	Sarcoma Alliance, Liddy Shriver Sarcoma Initiative, Chondrosarcoma Support Group	CA	US	Other Member of the Public						As a Sarcoma Group Facilitator it is imperative to have up-to-date information available to my patients with this very rare cancer. I have no funding resources to support purchasing information which would literally make a difference between life and death.	Web Form
437	Town Hall Form Comments	03/15/2008 at 05:20:30 AM (546)	Lawrence	Jennifer		Moderator, Asherman's International Support Group	NY	US	Patient or Representative of a Public Health Advocacy Organization						There is more and more literature being published each day regarding various medical conditions and it's becoming increasingly more difficult for health professionals to stay up to date on these studies. Because of this, I truly belief that that responsibility for learning about new and experimental procedures is falling on patients who might already be challenged by ever-increasing medical expenses and should not be further burdened by having to pay for medical research publications. By making these articles available to the public and allowing access for patients to do their own research, we will create a more educated, informed population who can serve as healthcare advocates for themselves and loved ones. It is critical that these articles be made available to the public so that we can all be aware of the most current information available.	Web Form
438	Town Hall Form Comments	03/15/2008 at 05:53:44 AM (832)	Anderson	Rosemary		Neurofibromatosis, Inc.	MI	US	Patient or Representative of a Public Health Advocacy Organization						On behalf of neurofibromatosis patients in West Michigan, I strongly encourage the publication and online public access of research results for all NIH-funded studies. So many lives depend on NF research; the NF community needs visible proof of the scientific community's commitment to understanding this disease and finding treatments and a cure.	Web Form
439	Town Hall Form Comments	03/15/2008 at 06:26:23 AM (856)	Baker	Shirley	MA, MA	Washington University	MO	US	Representative NIH Funding Recipient Organization						The transmission of knowledge is central to the mission of Washington University in St. Louis as is research and the creation of new knowledge. The underlying principle of the NIH Public Access Policy is to disseminate scientific knowledge generated by NIH funded research for the public good. We are confident that WU can meet its obligations to fulfill the requirements of the NIH Public Access Policy. Shirley K. Baker Vice Chancellor for Scholarly Resources Washington University	Web Form
440	Town Hall Form Comments	03/15/2008 at 07:42:05 AM (221)	Lykins	Charmian	BSN	George Mason University	VA	US	Patient or Representative of a Public Health Advocacy Organization						I am a parent of a two time leukemia survivor. I feel that access to peer reviewed medical literature (the full journal article as opposed to just the abstract) was invaluable in helping to decide on evidence based treatment that led to her current restored health. The type of leukemia my daughter had (ALL with MLL rearrangement) was rare enough for the treatment to be controversial. I needed to access current research to make an informed judgment on the options, risks, and experience of others. Fortunately for me, I am a member of a university and was able to access the articles through the university databases. Others may not have this option. Please let publicly funded research be available to the public. No one is more motivated to look for specific information than a patient or caregiver, and it is often this gathering of the available evidence that helps drive treatment decisions. Thank you.	Web Form
441	Town Hall Form Comments	03/15/2008 at 07:44:58 AM (291)	Westphal	Edward		none	NY	US	Other Member of the Public						All NIH funded research papers ought to be made readily available at no cost to the general public via the internet. Current system restricts dissemination due to restrictive cost structure. Remove cost and make available to public whose taxes have paid for the research to be conducted and could benefit from the results of the work done.	Web Form
442	Town Hall Form Comments	03/15/2008 at 08:58:06 AM (979)	Ottenbrite	Raphael	PhD	Virginia Commonwealth University	VA	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						I am in favor of the Public Access Policy that ensures that the public has access to the published results of NIH funded research. It requires that scentists to submit journal articles that arise from NIH funds to the digital archive PubMed Central	Web Form
443	Town Hall Form Comments	03/15/2008 at 09:23:26 AM (839)	baxter	richard	BS physics	retired from boeing	calif.	US	Other Member of the Public						All research funded partly or entirely by the government should be published and accessed by anyone for no cost.	Web Form
444	Town Hall Form Comments	03/15/2008 at 09:32:57 AM (983)	Jobe	John	PhD Physics	Jobe Consulting LLC	TX	US	Patient or Representative of a Public Health Advocacy Organization						We understand there is some resistance to free up access to archived articles and papers by those intent on protecting their rather lucrative revenue from expensive journal subscriptions. But for me, the issue is really simple: if we paid for it we should get to read it! And I also feel that 12 months is way too long to wait when such information could well be life-saving if made available ASAP. John Jobe PhD Atomic & Molecular Physics	Web Form
445	Town Hall Form Comments	03/15/2008 at 10:06:38 AM (856)	Hicks	Michael	Ph.D. Computer Science	University of Maryland, College Park	MD	US	Other Member of the Public						As a researcher and professor in computer science, I am a strong believer in the academic scientific process. The cornerstone of this process is publication, vetted by peer review. Without reading about the work of others in a timely fashion, we don't know where we stand, what is left to do, what is not understood. Research proceeds at a breakneck pace today, carried out by thousands of people worldwide. Timely publication makes keeping up with this work possible, and helps us all work together. Now imagine that all of this work is not just available to scientists in well-placed academic institutions that can afford to pay for it, but to anyone with an interest and an idea. We would multiply the potential for innovation tremendously. Anyone suitably motivated could learn something new and push the process. The few thousand scientists simply don't have time to do everything. But someone dying of cancer might find something that others missed, because of his situation. Such personal discovery is the kind of thing that made, and makes, America great. It's the American dream. In short, I fully support open publication. Innovation is driven by information, and innovation is the heart of America.	Web Form
446	Town Hall Form Comments	03/15/2008 at 10:42:44 AM (834)	miller	roberta		cancer survivor	wi	US	Patient or Representative of a Public Health Advocacy Organization						as a taxpayer, i should have free access to published research my tax dollars have funded (NIH funded research). as a cancer patient, i should not have to pay for access to valuable, government-funded information that may help me proactively partner with my healthcare professionals in an effort to save my life.	Web Form
447	Town Hall Form Comments	03/15/2008 at 10:48:15 AM (437)	Pedersen	Nikki	BA	tax payer	CA	US	Patient or Representative of a Public Health Advocacy Organization						As a tax payer and cancer survivor I believe NIH published data should be available for free: timely access to cutting-edge research can extend life or even save that life. I know first hand.	Web Form
448	Town Hall Form Comments	03/15/2008 at 10:55:32 AM (178)	Everett	Elyse	MSW	none	NY	US	Other Member of the Public						As a member of a NIH funded mental health research project from 1989 to 2003 I was frustrated by my lack of access to journal articles in the field that I was researching. Open access would be of great interest to me now as a mental health clinician in the community.	Web Form
449	Town Hall Form Comments	03/15/2008 at 11:00:06 AM (995)	Kochenderfer	Mary Anne	PhD	Medicine	MA	US	Other Member of the Public						As a medical researcher and a cancer survivor, I believe that providing the public with free online access to full text scientific journal articles would greatly increase general awareness and understanding of current medical research. Such access would also improve the research capabilities of those on limited budgets who are sometimes unable to pay to view all of the articles they might wish to see.	Web Form
450	Town Hall Form Comments	03/15/2008 at 11:03:30 AM (998)	vesel	mary	masters in communication disorders	patient and taxpayer	FL	US	Patient or Representative of a Public Health Advocacy Organization						1.I would like to have free access to research that would help in my continued struggle as a cancer survivor. Information that would help me to make more informed decisions in my treatment is critical. 2. As a speech pathologist research that would benefit my treatment of patient should be available. 3. As a tax payer I would want my money to support the free access of research that would help in the above situations.	Web Form
451	Town Hall Form Comments	03/15/2008 at 11:08:45 AM (649)	Hotez	Peter	MD, PhD	The George Washington Unviersity	DC	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						U.S. citizens have long funded research to which they had little to no access. The new NIH Public Access policy will provide the public access to research results, and will allow healthcare providers and researchers worldwide with access to these results with an eye toward improving healthcare and advancing science for everyone's benefit. This policy truly increases the ROI on NIH research in the sense that taxpayers don't pay twice--once for the research itself and once to access it.	Web Form
452	Town Hall Form Comments	03/15/2008 at 11:18:21 AM (284)	Baron	Caryl H.	BFA	Lung cancer caregiver, taxpayer	NM	US	Patient or Representative of a Public Health Advocacy Organization						It is vitally important that the taxpaying public have access to published, publicly funded information that may affect their health, wellbeing, even survival. Access to relevant information can aid in making difficult treatment decisions or evaluating new options. The technology is there. Let’s put it to good use in at least one aspect of health care. A patient or caregiver can devote more time, attention and interest to researching a particular subject than an overworked doctor who may be inundated with multiple problems to research and no time to do it. Or an article in one field may spur innovation in another, innovation that might not occur without access to information. Let us not impede progress by restricting access to knowledge.	Web Form
453	Town Hall Form Comments	03/15/2008 at 11:59:03 AM (345)	Evens	Leonard	PhD	Northwestern University	Illinois	US	Patient or Representative of a Public Health Advocacy Organization						I was treated for prostate cancer in 2000. At the time, I was very interested in looking at research on the subject. In fact, I found out from a literature search about the importance of PSA velocity and the threshold meriting a biopsy. This played an important role in the diagnosis of my PC since my primary care physician didn't normally look at PSAV. Since then I've followed the research on prostate cancer. As a retired university faculty member, I can with some difficulty get access to most such research but not all of it. Other prostate cancer survivors I've corresponded with have no such resources and are restricted to abstracts available through PUBMED/MEDLINE. I strongly support making all publicly funded research freely available to the public. Publishers may have an economic interest in restricting such use, but that should not weigh more heavily than the public's need to know the results of publicly funded research.	Web Form
454	Town Hall Form Comments	03/15/2008 at 11:59:37 AM (662)	Tkatcheva	Olga	MS	Sarcoma Alliance, cureasps	BC	Canada	Patient or Representative of a Public Health Advocacy Organization						I feel pretty strongly that we all should be able to view full text scientific journal articles online at no charge to improve information use.	Web Form
455	Town Hall Form Comments	03/15/2008 at 12:10:48 PM (455)	Kochenderfer	Mykel	Ph.D.	Massachusetts Institute of Technology	MA	US	Other Member of the Public						As a researcher, I am strongly in favor of making NIH funded articles publicly available. This will advance research and understanding.	Web Form
456	Town Hall Form Comments	03/15/2008 at 12:15:47 PM (752)	Mann	Trudie	MS	Caregiver	CA	US	Other Member of the Public						Since my hushand and I are taxpayers that support NIH research, I find it appalling that the public can only get access to recent cancer treatments for a fee. All that information should be released ASAP and therefore sooner than 12 months after it is published for the good of the patient and not for profit. I feel the relationship between the doctor and the patient is a trusted partnership. How can we as patients ask relevant questions about treatments when information is withheld from us unless we pay. I appeal to your humanitarian spirit that all helpful information by made available to everyone as soon as it is published. I want to know what treatments are viable and what ones are not before we commit to a treatment route. Time is one of our enemies...we need information as it becomes available...sooner, not later!	Web Form
457	Town Hall Form Comments	03/15/2008 at 12:33:30 PM (792)	Mallick	Indranil	MD	Tata Memorial Hospital	Maharashtra	India	Other						I believe that government funded projects should be accessible to all those who pay for it (taxpayers) and be available immediately on publication. If that is an infringement of copyright laws, then such research findings should only be published in journals that are open access.	Web Form
458	Town Hall Form Comments	03/15/2008 at 12:58:14 PM (854)	Dawes	Barbara	retired RN	patient	OK	US	Patient or Representative of a Public Health Advocacy Organization						As a stage IV Leiomyosarcoma patient, the public access to current studies and research could mean the difference between life and death. Six months rather than twelve would be better for all.	Web Form
459	Town Hall Form Comments	03/15/2008 at 01:42:11 PM (552)	Pam	Baker	BS/CPA	ACOR	IL	US	Patient or Representative of a Public Health Advocacy Organization						The research in lymphoma and specifically mantle cell lymphoma is expanding at an unbelievable pace. Acess to information for me may be the difference between life and death.	Web Form
460	Town Hall Form Comments	03/15/2008 at 01:59:24 PM (173)	Paley-Bain	Renee		NHL listserv	CT	US	Patient or Representative of a Public Health Advocacy Organization						For those of us who are living with cancer, it is essential that we be able to see the results of research work on new drugs. In some cases it may mean the difference between life or death. Please ensure that any federally funded research be made available at no charge to cancer patients and their families. Thank you.	Web Form
461	Town Hall Form Comments	03/15/2008 at 02:22:48 PM (887)	Feuerstein	Jennifer	BA	US citizen and taxpayer	NM	US	Other Member of the Public						As taxpayers, we should have free and unfettered access to the published results of government-funded research. The abstracts that are currently available through PubMed and other similar sites do not provide enough information, and access to the articles themselves is cost-prohibitive to the average citizen. I support making the full articles of all such published research available electronically for free.	Web Form
462	Town Hall Form Comments	03/15/2008 at 03:00:07 PM (107)	Roesler	Rod	MS	Prostate Cancer Survivor (5 years)	SD	US	Other Member of the Public						It seems reasonable that the results of research supported by public funds be made available to the public at no additional charge as soon as those results are available.	Web Form
463	Town Hall Form Comments	03/15/2008 at 03:43:22 PM (547)	Nordbrock	Terry	Master of Library Science	Candlelighters Childhood Cancer Foundation of Southern Arizona	AZ	US	Patient or Representative of a Public Health Advocacy Organization						We all should be able to view full text scientific journal articles online at no charge. All research funded by NIH that is published in scientific journals should be made available as full text articles online, with free access to the public. Taxpayers already paid for the research, and should receive easy access to the findings.	Web Form
464	Town Hall Form Comments	03/15/2008 at 05:03:31 PM (184)	kossove	doreen	md	leiomyosarcoma is a rare cancer	california	US	Patient or Representative of a Public Health Advocacy Organization						Please make public access to public funded NIC research available as soon as it is published.	Web Form
465	Town Hall Form Comments	03/15/2008 at 05:06:00 PM (621)	Macdonald	Bruce	BSEE	None	MI	US	Other Member of the Public						It's outrageous that information developed at public expense is handed over to private publishers for their profit. Ten years ago I was diagnosed with a rare autoimmune condition. It took me six months to find the NLM PubMed database, and then I could only view abstracts. It might help if the NIH/NLM would make it clear to the public that most hospitals have a medical library where full text articles can be obtained free or at nominal cost.	Web Form
466	Town Hall Form Comments	03/15/2008 at 09:39:06 PM (979)	Svatos	Jamie		Aunt to amazing 5 year old fighting a rare brain cancer	NE	US	Other						As a concerned family member of a young child with a rare and agressive brain tumor, I think all research funded by the NIH should be available online as full text articles at no charge.	Web Form
467	Town Hall Form Comments	03/15/2008 at 09:41:39 PM (829)	DICTOR	CARY	JD	NONE	CA	US	Other Member of the Public						I STRONGLY SUPPORT PUBLIC ACCESS TO HEALTH INFORMATION, AND ESP PUBLICLY FUNDED OR SUPPORTED RESEARCH.	Web Form
468	Town Hall Form Comments	03/15/2008 at 10:05:42 PM (308)	Feraru	Rob		patient	CA	US	Patient or Representative of a Public Health Advocacy Organization						Please make all the NIH funded research available in FULL FORM to the public as soon as possible after the research is published, but in no event later than 12 months. Our lives depend on it.	Web Form
469	Town Hall Form Comments	03/15/2008 at 10:20:06 PM (659)	Peckerman	Arnold	PhD	n/a	NJ	US	Other Member of the Public						It is wrong that the publishers have been allowed for so long to charge the public for articles generated by publicly-funded studies. It's a form of corporate welfare, plain and simple, and it's a high time for it to be stopped.	Web Form
470	Town Hall Form Comments	03/15/2008 at 10:20:27 PM (407)	Rowland	John		Leukemia patient	NC	US	Patient or Representative of a Public Health Advocacy Organization						Publicly funded research needs to be widely available within a reasonable time; that is the rationale for public funding research in the first place. Public funding is only appropriate for activities or research that will enhance the public welfare. In the case of medical research, restricting access is contrary to the purpose of the funding and will harm the patient population from whom in many cases the experimental subjects were drawn. It is entirely reasonable to assume that very few patients would volunteer for clinical trials if the result of those trials were to be withheld from them and their fellow patients. JR	Web Form
471	Town Hall Form Comments	03/15/2008 at 11:02:43 PM (458)	Grower	Colette	BSN	State of Alaska	Alaska	US	Other						The public is entitled to access to all information. We do not need big secrets in the Medical Profession.	Web Form
472	Town Hall Form Comments	03/15/2008 at 11:50:51 PM (741)	Klutenkamper	Mary Ann	BSN RN	patient	MN	US	Other						With the current cost, patients obtaining the literature they need to investigate the best treatments for their disease is truly a heartship. THe cost of copays and out of pocket expenses that medical treatments cost patients is beyond belief. Providing patients and their families with free access to published literature would greatly help the cancer patient in their fight against the disease. Patients need to be their own advocates today more then ever before and without being educated regarding treatment and outcomes is a great diservice to patients who often have to guide their care to continue the fight. Thank you, Mary Ann Klutenkamper survivor renal cell carcinoma 5/2001 survivor Lung cancer 11/2007	Web Form
473	Town Hall Form Comments	03/15/2008 at 11:59:38 PM (747)	Morford	Jean	BA	cancer patient	AZ	US	Patient or Representative of a Public Health Advocacy Organization						I sincerely hope that NIH funded articles will be offered to the public at no charge. It would help all cancer patients to be informed and educated about their illness. When I was diagnosed in 1991, it was extremely difficult to obtain first-hand information about my illness. In order to be responsible for making my own treatment decisions, it is extremely important that I be able to read articles myself. Due to my illness, my income has become very limited. I cannot afford to pay for information and I know that is true for many other patients. I appreciate all that anyone can do to help me make informed decisions. Thank you.	Web Form
474	Town Hall Form Comments	03/16/2008 at 12:28:03 AM (208)	Bishop	Pamela	AS	Lung Cancer Survivor	OH	United States	Patient or Representative of a Public Health Advocacy Organization						It is a hardship for non-professionals to get these articles. As taxpayers we pay for this research. Access should be free for the written results.	Web Form
475	Town Hall Form Comments	03/16/2008 at 06:47:02 AM (869)	Brown	Helen	Master of Laws	Caregiver to cancer patients	NSW	Australia	Other Member of the Public						US taxpayers should have free access to published research their tax dollars have funded (NIH funded research). Personally, as a past caregiver to 2 cancer patients, I benefited from accessing authoritative free of charge peer-reviewed, government-funded scientific that helped me partner with healthcare professionals so as to better care for my family members. Free access to high quality materiasl can only help this. As a lawyer in an Australian university workind directly with NIH-funded researchers I see every day the difficulties of managing the cost of access to information. Free access would help manage the costs of literature reviews that underpin every development in the area of health.	Web Form
476	Town Hall Form Comments	03/16/2008 at 07:10:51 AM (848)	Cooper	Vivian		Cancer Patient	NC	US	Patient or Representative of a Public Health Advocacy Organization						As one of hundreds of thousands of cancer patients in this country, I sincerely request that we not have to pay for access to valuable, government-funded information that may help us proactively partner with our healthcare professionals in an effort to save our lives.	Web Form
477	Town Hall Form Comments	03/16/2008 at 08:05:21 AM (780)	Malone	Frances		CLL Support Group	WA	US	Other						The Policy implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) The quickest possible free access to articles referring to research and new breakthroughs is of vital importance to those of us suffering from diseases for which there are no cure, or can carry with them unusual risks for other diseases. It was only because a physician friend was able to access articles which I couldn't that I learned that people diagnosed with Chronic Lymphocytic Leukemia are more prone to skin cancer. My personal physician never mentioned this because she said she wasn't aware of that fact. At my request she referred me to a dermatologist who found two cancerous moles. Even he was shocked because I am not fair skinned, have brown eyes and have lived most of my life in WA state where there is not an overabundance of sunshine. Members of the CLL ACOR group can tell numerous similar stories. Information regarding publicly funded research should be made available without charge as quickly as is reasonably possible.	Web Form
478	Town Hall Form Comments	03/16/2008 at 08:14:19 AM (261)	Prescott	Anne		mother to child with cancer	NY	US	Other Member of the Public						As a mother of a child with cancer I frequently searched for articles that might have provided cutting edge information only to find relevant abstracts and not be able to view articles. Journal access is critical to the lives of many and should not be based on ability to pay, especially when patients are in the middle of the finacial burden of medical care, and the emotional burden of survival. Isn't the purpose of research to supply answers? the people who are searching for these articles are the people who created a need for the research in the first place, the people who are funding this research, and the people who desparately need the answers offered. please help us. who knows if one of the articles i could not access would have helped my sweet girl?	Web Form
479	Town Hall Form Comments	03/16/2008 at 08:56:09 AM (209)	Layfield	Missy	PT, ATC	Patient Advocate/Parent of Childhood Cancer Survivor	IA	US	Other Member of the Public						The focus of publicly funded research should be public reporting of the results of that research, rather than journal publication. Why are our tax dollars providing the medical journals with exclusive access to research results? As a research oriented patient advocate, I struggle daily to access full articles, both new and old. I am not associated with a university, so I have to scramble and find someone who will provide the article to me. I would like to see a mandate that any research funded in full or part by NIH or any tax-funded entity, be required to provide a detailed research results article within 6 months of the completion of that research. There should be no waiting period while the journal decides to publish or not, and certainly no waiting period after journal publication. We as the funders of that research, should have access to it first.	Web Form
480	Town Hall Form Comments	03/16/2008 at 09:08:39 AM (531)	Sprague	Kim	MSW	Mother of child with cancer	CA	US	Patient or Representative of a Public Health Advocacy Organization						As the mother of a child with cancer, I have spent many hours researching treatment options. Most pediatric cancer protocols are experimental, and I believe we as parents should have access to research re: treatment and side effects. Personally, my son's treatment was changed, based on information I found doing research on pub med. That change is now the standard for children with his type of cancer, but he would not have received it if it werent for my access to articles. The costs of his treatment have nearly put our family in bankruptcy, I dont believe families facing such financial hardships for medical care should have the extra burden of paying for research articles. As a taxpaying citizen, I believe the pub med articles should all be available for free. thank you.	Web Form
481	Town Hall Form Comments	03/16/2008 at 09:11:15 AM (168)	Wessler	Neal		none	MO	US	Patient or Representative of a Public Health Advocacy Organization						Make them available immediately. Waiting for a year is just an arbitrary constraint that has no good justification - when it is potentially life saving information.	Web Form
482	Town Hall Form Comments	03/16/2008 at 09:25:52 AM (281)	Peress	Nancy		Prostate cancer online community	MI	United States	Other Member of the Public						Immediate public access is crucial for patient empowerment.	Web Form
483	Town Hall Form Comments	03/16/2008 at 09:30:36 AM (331)	Duffy	Robert		Private Individual	WA	US	Other Member of the Public						It is only fair and reasonable that research paid for with public funds should be available free to the general public. Having paid once for the research, individuals should not have to pay again via subscriptions or per-article fees to read the results of that research.	Web Form
484	Town Hall Form Comments	03/16/2008 at 09:33:36 AM (749)	Kagan	Ellen		cancer patient	NY	US	Patient or Representative of a Public Health Advocacy Organization						I believe all serious investigative results should be available to cancer patients as soon as it is available.The doctors are not always aware of what is available and unfortunately a great deal of responsibility falls on the sick patient to research new possible treatments. Denying or delaying this information is unjust.	Web Form
485	Town Hall Form Comments	03/16/2008 at 09:43:03 AM (728)	otterburn	hugh	B.Vet. Med.	self/prostyate cancer patient	Nc	US	Patient or Representative of a Public Health Advocacy Organization						I support free public access to the papers after 1 year Hugh	Web Form
486	Town Hall Form Comments	03/16/2008 at 09:47:05 AM (902)	Marsteller	Thomas	JD	None	TX	US	Patient or Representative of a Public Health Advocacy Organization						A dealy of 12 months before the public has free access to intellectual property rights in research funded by the US government is unreasonable. NIH is a publically funded institution and all intellectual property rights should vest in the US Government at the time the agreement funding the research is executed. Any deviation from this policy should be on a case by case basis and individally negotiated. The intellectual property rights policy of the NIH should be consistent with that of other US government contracting agencies and protect the rights of natural citizens. Any delay in full intellectual property rights received on behalf of the citizens on the US unjustly enriches the research entity. Permitting the entity receiving government funding to retain intellectual property rights is contrary to good business practices and I believe is not the norm in commercial, arms length transactions unless individually negotiated by the parties. Alternatively, NIH should advance or advocate for a change to the copyright laws of the US exempting intellectual property rights resulting from US government funded research. Again this policy would only impact government funded research and should be a quid pro quo for such funding. A researcher that does not agree to share their intellectual property rights has the alternative to seek private funding.	Web Form
487	Town Hall Form Comments	03/16/2008 at 09:58:55 AM (198)	Harris	David	B.S.	None	MD	US	Other Member of the Public						I am against any action that will make me pay "additional" money to access medical articles for which I have already made contributions in the form of taxes that went to grants, or charitable contributions that fostered many of these studies and reports. Approval to limit public access makes it appear that the government supports those who can afford to pay subscription services for information, instead of the population at large.	Web Form
488	Town Hall Form Comments	03/16/2008 at 10:13:50 AM (991)	Dickenson	Mary Alice	B.A.	None	NM	US	Patient or Representative of a Public Health Advocacy Organization						As the wife of a prostate cancer patient, I find that it is important for us to keep up with research being done in this field. The public should have the right to free access to the published articles as soon as they are published.	Web Form
489	Town Hall Form Comments	03/16/2008 at 10:20:40 AM (634)	Doherty	Tom	Ph.D.	self	DE	US	Other Member of the Public						Simple solution: We taxpayers who support the research should have free access to the published results within 30 days of publication date. We, who are also patients, have the largest stake in our own well being, and should not have to wait a year for the latest knowledge. How can we have an intellectual discussion with our physician if only one of us has access to the latest research. Free access can be accomplished from simply posting a link on the NIH site pointing to the latest research paper connected to each project. This would require the NIH grant recipient to by simply post a copies of their reports on a public accessible web site. Those researchers who don't accept this stipulation are free to apply for research grants elsewhere. Those who violate this stipulation should not be eligible to apply for further grants for one year after discovery of non-compliance with publishing policy. I prefer this penalty rather than prematurely ending the current research grant (assuming the research is meeting its original objectives), because often this is academic research where mainly graduate students academic careers would be adversely affected just because their professor did not ensure that grant requirements were fulfilled. It will take a few years to implement this policy, so NIH should be lenient in the initial stages, as some researchers are not web-savvy. Often there are many people in the organization, especially if it is a university, who are very web-savvy. It may take a few cases of enforcement a year after implementation of the guideline before everyone accepting funds gets the idea. ...Tom P.S. I have never applied for an NIH grant.	Web Form
490	Town Hall Form Comments	03/16/2008 at 10:25:18 AM (798)	Benjamin	Fred		Cancer Patient	AL	US	Patient or Representative of a Public Health Advocacy Organization						The public should have the right to view final reports on research that is paid for by public funds. even twelve months is too long to withhold information that I have paid for. All grants from NIH should come with the stipulation that final reports will be published for the public to view. If the researchers do not like the strictures placed on publishing, they can pay for it themselves or find other methods to pay the research. I have no problems with copyright restrictions placed on other uses of the material, but the public still has the right to view the reposrts.	Web Form
491	Town Hall Form Comments	03/16/2008 at 10:43:07 AM (142)	dolan	john	none	taxpayer	wa	US	Other Member of the Public						Why would the public (read taxpayers) not have access to the reasearch we have funded and payed for with taxes?????	Web Form
492	Town Hall Form Comments	03/16/2008 at 10:43:48 AM (469)	Himel	Justin	BSBA	ACOR	IL	US	Other Member of the Public						To put it briefly, the public should not have to pay twice for the information it's taxes have paidfor. Do the publications pay NIH for the right to initially publish? I DON'T THINK SO! 12 months is a long time to have exclusive rights to something that was free initially. I don't begrudge the publications that period to generate additional revenue but their primary income should be from subscriptions and advertising, not the exclusive right to public documents in perpetuity.	Web Form
493	Town Hall Form Comments	03/16/2008 at 10:47:24 AM (803)	Daggett	Richard		Polio Survivors Association	CA	United States	Patient or Representative of a Public Health Advocacy Organization						Access to research is vital to advocacy organizations. We must have the latest medical information available in order to adequately inform our clients.	Web Form
494	Town Hall Form Comments	03/16/2008 at 10:55:27 AM (518)	Simmons	Laurel	MS	Cancer Survivor	MA	US	Patient or Representative of a Public Health Advocacy Organization						More and more, patients and their loved ones with complex illnesses turn to PubMed for crucial diagnosis and treatment information, finding their way to the right facilty for the right life-saving care. This benefits both patients and families and the health care system, which is not desgined to bring the full range of medical opinion to bear on an individial patient. While not a perfect solution, anecdotal evidence is mounting: access to the literature can be life-saving for many patients. I strongly support releasing research findings to the people who paid for it. My life was saved by a clinical trial; I want as many as possible to have that same chance.	Web Form
495	Town Hall Form Comments	03/16/2008 at 10:56:25 AM (416)	Peterson	Carlton	MSEE	Retired	GA	US	Patient or Representative of a Public Health Advocacy Organization						I believe it is important that NIH funded reports on prostate cancer studies should be made available to the public. That should be of value both to men trying desperately to find a "better" treatment and to the surprisingly large number of doctors that seem to not understand the difference between treatments that work and those that are inferior.	Web Form
496	Town Hall Form Comments	03/16/2008 at 10:58:58 AM (643)	Byrd	Karen	BS	husband is dying of prostate cancer	CA	US	Other Member of the Public						Of course these journals should be made available to the public! Today, a patient needs to be their own advocate and information gatherer. All information relevant to our own health issues needs to be made readily available! Sometimes during a doctor appointment, we (the patient) have more information than our own physician!	Web Form
497	Town Hall Form Comments	03/16/2008 at 11:07:24 AM (949)	Self	Felicia	RN	Grandmother/legal guardian of child with Rhabdo.	AL	United States	Other						As a grandmother and legal guardian of my now 19 month old with a grandson with a rare cancer (Rhabdomyosarcoma), I have found it very beneficial to obtain info to make these very important decisions regarding his care and treatment. It is essential that we be able to obtain this info in a timely manner (3-6 months), this can be a matter of life and death. Since these are our tax dollars, we should not have to purchase this info, which may be an extreme hardship on many people. The cost/effect of cancer on families can and are devestating.Please help our loved ones. Thanks, Felicia Self	Web Form
498	Town Hall Form Comments	03/16/2008 at 11:18:53 AM (872)	Nyeholt	James	masters	patient	IL	US	Patient or Representative of a Public Health Advocacy Organization						As a cancer patient, and tax payer,I firmly support that all NIH funded research reports are made avaiable, at no charge, to the public who has supported this research.	Web Form
499	Town Hall Form Comments	03/16/2008 at 11:35:07 AM (738)	Becker	Sheldon	PhD	self	Colorado	US	Other Member of the Public						NIH-funded research is paid for by public money, i.e. the taxes the public pays, so the results of this research, in its entirety, should be made available to the public. We paid for it; it belongs to us.	Web Form
500	Town Hall Form Comments	03/16/2008 at 11:44:42 AM (949)	Glass	Harry	MBA	None	MD	US	Other Member of the Public						I believe that American taxpayers should be legally empowered with the right to read the results of NIH-funded research as soon as it is published. The public should not be discriminated against by delaying access until 12 months after publication. It is despicable that publishing organizations are able to influence and mold legislation to their liking while the public is left to nibble on the crumbs.	Web Form
501	Town Hall Form Comments	03/16/2008 at 11:53:36 AM (698)	YASENCHAK	PAUL		p2p	FL	US	Patient or Representative of a Public Health Advocacy Organization						Articles resulting from NIH funded research SHOULD be placed in a repository at the National Library of Medicine and made available free of charge to the public, no later than 12 months after they are published. We have already paid for this research through our taxes, we should not have to pay again to see the results of the previously paid for research.	Web Form
502	Town Hall Form Comments	03/16/2008 at 12:14:52 PM (847)	O'Neill	Chris	RN, DMin	None	OR	US	Patient or Representative of a Public Health Advocacy Organization						Along with clinical specialists, I am successfully managing a chronic disease diagnosed in 2000. I review scientific websites daily to keep up to date on research relevant to my condition. PubMed, Scirus and other specialized clinical websites are bookmarked so that I can easily check the most recent reports. I use the information in discussions with clinicians to revise my care plan as needed. Abstracts are often sufficient for the most relevant published articles. However, sometimes I require more detailed information about the subjects and research parameters, and only details from the full article suffice. On some occasions, the local state-funded university has the necessary journal. But, that is infrequent. I have to either purchase the article at $30 on average per article, or wait for a trip to the Oregon Health Sciences University where the journal article can be accessed and printed at a public access station. The public access is a genuine benefit for those who need the information from publicly funded research. However, the public access station is located 120 miles from my home. Given the increasingly rapid development of research results and the potential to assist in patient care planning, 12 months is excessively long to wait for information developed with public investments. No-cost public access to NIH funded research should be available electronically shortly after publication if not simultaneously. Thank you.	Web Form
503	Town Hall Form Comments	03/16/2008 at 12:30:21 PM (960)	Belverud	Tara	N/A	Patient Caregiver	MD	US	Other						We as American Taxpayers I believe should be able to recieve these studies free of charge. I strongly believe that because the facility is funded by our taxpayers dollars that we have already "paid" for these documents once and shouldn't be required to pay a second time.	Web Form
504	Town Hall Form Comments	03/16/2008 at 12:32:40 PM (121)	Rusnak	Stephanie	Ph.D. in Sociology	College of DuPage (presently on leave; family reasons)	IL	US	Patient or Representative of a Public Health Advocacy Organization						Do U.S. citizens want to encourage a split market system of health information resulting in one stratum of "haves" and another stratum of "have-nots"? It is outrageous for government-funded research to yield findings that are not readily available to the citizenry. Government-funded health-related empirical research findings need to be available to all those who seek such information as they engage in life-altering decision making.	Web Form
505	Town Hall Form Comments	03/16/2008 at 12:38:37 PM (134)	McCarl	Robert	Ph.D.	Boise State University	Idaho	US	Patient or Representative of a Public Health Advocacy Organization						Dear Sir or Madam: I am a sixty year old male who was diagnosed with prostate cancer last year. I am also a professor of sociology and a member of my university's IRB committee. I see daily the need for increased access to research by specialists in fields as wide ranging as history and genetics. Much of this research is funded either directly with federal dollars, or indirectly via subsidies and buyouts for research time at the university. As both a member of the research community and a patient I am acutely aware of the way in which research findings and even areas of inquiry affect people on a daily basis. Under the direction of my urologist, I sought information about research concerning watchful waiting for prostate cancer. I found both anecdotal and empirical evidence to support this approach within the international research record. In some cases, my ability to access journal articles online provided me with information and insights not yet accessible to my doctors. When you have cancer, you are constantly looking for answers. I do not suggest that every patient rely exclusively on the research record. However, I do believe that each patient must have access to up to date information and engage directly in his or her treatment. Federally funded research must be available to the citizen/patient in an understandable and useful format. Restricting research findings to professional outlets alone not only precludes patient education, it denies citizens the right to findings that were arrived at using taxpayer support. Thank you, Robert McCarl, Ph.D.	Web Form
506	Town Hall Form Comments	03/16/2008 at 12:56:00 PM (918)	Mongin	Stan	MME	PCa survivor	CT	US	Other Member of the Public						Please.	Web Form
507	Town Hall Form Comments	03/16/2008 at 01:07:32 PM (538)	Randlev	Peter	BSEE	Prostate Cancer survivor	New York	US	Patient or Representative of a Public Health Advocacy Organization						If public money paid for the work, the published output must be made available to the public without an additional fee..	Web Form
508	Town Hall Form Comments	03/16/2008 at 01:19:53 PM (107)	Harpham	Elizabethq	Associates	PCRI	PA	US	Other Member of the Public						I strongly advocate for research studies to be released within 30 days of completion. Members of our family have prostate cancer and access to research is maddeningly slow. The FDA is highly politicized and does not always make decisions purely in the patients' interest. The more informed the public is, the more we can push forward to overcome maddening bureaucratic obstacles.	Web Form
509	Town Hall Form Comments	03/16/2008 at 01:34:07 PM (618)	Richard	Paul		Prostate Cancer patient	MN	US	Other Member of the Public						The public which funds research should be entitled to immediate access when the results are published. With the rapid pace of new developments in medical research, it is imperative that we as patients stay well informed on the results of recent research. Even one year seems much too long to me.	Web Form
510	Town Hall Form Comments	03/16/2008 at 01:39:57 PM (605)	Sheridan	Wendy		ACOR; Bladder Cancer WebCafe	NJ	US	Patient or Representative of a Public Health Advocacy Organization						The many members of the e-health communities such as ACOR and other public cancer forums stand to benefit this important opportunity for change.	Web Form
511	Town Hall Form Comments	03/16/2008 at 01:42:18 PM (717)	Brassil	Eileen	BS	None	IL	US	Other Member of the Public						As a parent of a child with a rare syndrome, there is very little new information to be found anywhere except medical journal articles, in particular the subspecialty journals such as genetics, neurology, etc. I am willing to get out the medical dictionary and "translate" these articles on my own if only I could get a copy of them. Looking into a subscription for even one of these journals, I was told it was in the range of $10,000 a year. Why is the public virtually denied the opportunity to read published peer reviewed studies? Why is this so difficult for families with affected children? The doctors don't have time to look up the articles and send to the family but that is the route we are forced to take.	Web Form
512	Town Hall Form Comments	03/16/2008 at 01:45:29 PM (760)	Mills Jr	Frederick N		International Strategic Cancer Alliance	WA	US	Patient or Representative of a Public Health Advocacy Organization						I agree with the effort by NIH to make it mandatory for articles resulting from NIH funded research to be placed in a repository at the National Library of Medicine and made available free of charge to the public, no later than 12 months after they are published.	Web Form
513	Town Hall Form Comments	03/16/2008 at 01:48:26 PM (274)	Cottingham	Dave		Us TOO Prostate Cancer Support Group	NC	United States	Patient or Representative of a Public Health Advocacy Organization						Please don't reverse the decision to make NIH-funded research available for public viewing. It just might save a life. Most of us patients study our individual diseases (prostate cancer in my case) ad infinitum and new research can be vital.	Web Form
514	Town Hall Form Comments	03/16/2008 at 02:02:05 PM (515)	Cox	Michael		US Too Prostate Cancer	NY	US	Other Member of the Public						Please don't reverse the decision to make NIH-funded research available for public viewing. Most of us patients study our individual diseases (prostate cancer in my case) ad infinitum and new research can be vital. I know that when I was making my treatment decision I spent many hours on the PubMed web site because I found the information unbiased and presented with basis in science and investigation results. This was critical in allowing me to choose wisely.	Web Form
515	Town Hall Form Comments	03/16/2008 at 02:33:02 PM (624)	Williamson	Phil	BS	Public	OH	US	Other Member of the Public						The Policy implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) The submissions should be made public (on line) within 12 months.	Web Form
516	Town Hall Form Comments	03/16/2008 at 02:37:58 PM (831)	hamele	alice	BA	patient	MI	US	Patient or Representative of a Public Health Advocacy Organization						Whether cancer or other patient, caregiver, or simply citizen, publicly funded medical research should be made availabe without charge to all taxpayers.	Web Form
517	Town Hall Form Comments	03/16/2008 at 02:59:09 PM (645)	Nangle	Rosanne		Spouse of kidney cancer survivor	LA	US	Other Member of the Public						Our information, our bodies, our decision. We as taxpayers paid for this research to further our health and as such we own the knowledge/information gained through this research, it belongs to us no strings attached. It's ultimately our decision to choose what is best for our bodies and these research articles/information are rightfully ours to aid us in that quest.	Web Form
518	Town Hall Form Comments	03/16/2008 at 03:04:08 PM (770)	DePouw	Carol		Non Hodgkins Lymphoma survivor	MN	US	Other Member of the Public						As a cancer survivor, as well as a US taxpayer, I feel it is extremely important that we have access to NIH funded research results as soon as possible. Some patients do not have 12 months to wait for these results which may prolong their lives or even cure them.	Web Form
519	Town Hall Form Comments	03/16/2008 at 03:07:38 PM (323)	Bertolino	Chuck	B.S.Finance	CLL Patient	CA	US	Patient or Representative of a Public Health Advocacy Organization						I need treatment for a life threatening disease and need public access to NIH studies to make decisions regarding courses of treatment. Why have the studies if I can't get access to them?	Web Form
520	Town Hall Form Comments	03/16/2008 at 03:25:29 PM (232)	Shaw	Diana	JD	none	CA	US	Other Member of the Public						I am writing in support of the recently passed bill that will make it mandatory for articles resulting from NIH funded research to be placed in a repository at the National Library of Medicine and made available free of charge to the public no later than 12 months after they are published. As a cancer survivor, I try to keep apprised of the latest research and discoveries. To that end I am a member of a chat group. I can't do everything myself, and my group (the Bladder Cancer Web Cafe) has found that one or another person contributes to the whole of our knowledge by eacho of us reading & sharing accessible literature. On several occasions we have simply been unable to access research because the cost is prohibitive. So, for those of us who need the information the most, who want to be pro-active in our own healing, I hope that this bill becomes law.	Web Form
521	Town Hall Form Comments	03/16/2008 at 03:46:56 PM (730)	Price	Dean	MPA	none	CA	US	Other Member of the Public						It is important that reports resulting from NIH-funded research be released to the public. We have paid for such reports once by funding the NIH with our tax Dollars. We should not be asked to pay for them twice. Thank You !	Web Form
522	Town Hall Form Comments	03/16/2008 at 03:48:54 PM (907)	Piepmeier	Jerry	MA	Cancer Survivor	MO	US	Other Member of the Public						As a cancer survivor and a US taxpayer, I feel it is extremely important that we have access to NIH funded research results as soon as possible. Some patients do not have 12 months to wait for these results which may prolong their lives or even cure them.	Web Form
523	Town Hall Form Comments	03/16/2008 at 03:52:12 PM (522)	Richards	Kenneth	None	Stage IV Cancer Survivor	MI	United States	Other Member of the Public						For many of us, having to wait 12 months to see the information as a layman is a long time, but it is reasonable to expect that it is published and very very reasonable to make it accessible to the public. It's taxpayer money funded and as a taxpayer I would expect to be able to see what I'm paying for or how the grant money has been spent. Transparency is important to all of us and for all of us. If you don't want to make it public, don't ask for our money, and then I also get concerned that you maybe hiding something? Get the information out there sooner rather than later, it may help someone to live their normal expected life span.	Web Form
524	Town Hall Form Comments	03/16/2008 at 04:07:21 PM (660)	Mulliner	Kent	MA ; MLS	retired	OH	US	Patient or Representative of a Public Health Advocacy Organization						As a prostate cancer survivor and a citizen interested in my own health and the health of my peers, I feel that access to research is essential and a judicious use of tax dollars. I do not accept that publishers with little investment in the actual research should control access to the outcomes of research. I think that open access and commercial publishing are compatible (no one would contend that up-to-one-year delay in opening access significantly will impact sales of journals and articles in the science-technology-medicine fields. In fact many publishers currently provide such open access after one year through High Wire based at Stanford University.	Web Form
525	Town Hall Form Comments	03/16/2008 at 04:09:46 PM (382)	Granger	Pete	NA	NA	RI	US	Other						Currently, there are fundamental shortcomings in medical research. 1. Authors, in particular publicly funded researchers, are not mandatorily required to (a)express their conclusions in layman's language, and (b) explain the PRACTICAL medical significance of their findings (its context). 2. Whilst publishers should be free to list, collate and monopolize (copyright) their interpretive analysis/commentary on medical research, they should not be free to monopolize distribution of the raw content - unless they fund that research themselves. Appropriating/monopolizing raw, PUBLICLY funded research is a form of theft - particularly whilst there are free, public data distribution networks in place. 3. Publicly funded research is wasteful in the extreme because it is (a) not adequately expressed in laymen's terms (b) it is often not provided in any context (c) it is not adequately analysed and interpreted by another publicly funded umbrella organisation prior to publication (d) it is not adequately distributed to physicians in a manner akin to that of (say) drug companies. 4. Sponsored research that is favorable to the sponsor is published and vigorously promoted, whilst research that is unfavorable is selectively excluded from being published. 5. Very poor integration between US and non-US-based research in regards distribution of knowledge. All in all, the dissemination of medical research is hopelessly inadequate. The Internet is an ideal medium for this role, however it requires publishers and preferably Government agencies to collate, interpret and distribute the various data in an open-minded and progressive manner - with less of the pessimistic conservatism that currently prevails. Monopolization of raw content by publishers is just part of the problem. Removing the monopoly will force publishers to add REAL value to that content. Pete Granger	Web Form
526	Town Hall Form Comments	03/16/2008 at 04:22:13 PM (366)	Marcus	Syd	M.S.	Member of the Public	IL	US	Other Member of the Public						I would like the following policy to be implemented: The Policy implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which states: SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.	Web Form
527	Town Hall Form Comments	03/16/2008 at 04:26:25 PM (887)	Thomas	Karen		Patient, family member of patient and Developmental Specialist for Infants and Toddlers with Special Needs	WV	US	Other Member of the Public						I heartily agree that NIH funded research should be placed in a repository for public access. As the medical system becomes more complicated and as we learn more about various conditions and diseases-- It becomes vital that the patient learn to be an empowered advocate in their own care. Public information can open conversations between the patient and the doctor that may not have occurred before. Please help us take better care of ourselves and educate ourselves by making NIH funded research publicly available.	Web Form
528	Town Hall Form Comments	03/16/2008 at 04:56:11 PM (215)	Munsell	Kathie	BA,CBIST	Cancer survivor..public advocate	New York	US	Other						As a tax payer, RCC Survivor and medical professional I believe that all research papers funded by tax payers of this country be made available to the interested public free of charge. I find it difficult to believe that this move would affect the high priced professional journals that are currently available by subscription only to those who can financially afford to purchase them.	Web Form
529	Town Hall Form Comments	03/16/2008 at 05:09:01 PM (331)	Payton	Christiane	BA	care taker	OR	US	Other Member of the Public						As one of my mother's advocates and care takers (she has a stage 3C ovarian carcinosarcoma) I think it is very important the the public have access to the full text of all available medical studies. As a tax paying American, there should be no reason that I am not given the opportunity to educate myself to the fullest extent possible about the newest treatments for this rare and aggressive cancer.	Web Form
531	Town Hall Form Comments	03/16/2008 at 07:26:06 PM (439)	Ward	Rick	BA	Cancer survivor and advocate	TX	US	Patient or Representative of a Public Health Advocacy Organization						If possible, I encourage NIH to set as part of its policy to implement Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) a much shorter time frame than "up to 12 months" for free access to NIH funded research. As the funding party, NIH should be able to place conditions on the funding, such as free immediate availability of the full article when published. At present PubMed makes available only the abstracts while the publisher will provide the full article for a fee, so availability isn't at issue.	Web Form
532	Town Hall Form Comments	03/16/2008 at 07:29:33 PM (777)	Keating	Catherine	AB	US Taxpayer - lung cancer advocate	NY	US	Other Member of the Public						It's important to people who need only limited access to articles to be able to access them easily and free. Especially for non-academics who are desperately trying to learn as much as possible about their disease as quickly as possible. Cancer patients and their caregivers do not need full subscriptions, but nor do they need to jump through hoops to get a simple article. Please make it easy for those of us trying to make a difference.	Web Form
533	Town Hall Form Comments	03/16/2008 at 07:37:01 PM (228)	Mount	Steve	Ph.D.	University of Maryland	MD	US	Other						I would like to voice my support for public access, speaking as a scientist who frequently coauthors manuscripts with some NIH support. As a scientist, I share with the public an interest in making NIH funded research available to everyone with an interest in the work. I want people to be able to read my work!	Web Form
534	Town Hall Form Comments	03/16/2008 at 07:44:33 PM (819)	Keating	Julie	BA	Cancer Survivor	Connecticut	US	Other Member of the Public						Taxpayers should be allowed free and full access to NIH research. Information should be made available as soon as possible.	Web Form
535	Town Hall Form Comments	03/16/2008 at 08:05:32 PM (833)	Wilkinson	Kenneth	BA	Cancer Survivor	Virginia	US	Other						As a cancer patient with severe reactions to normal courses of treatment and the complication of a bleeding disorder, research on the internet has been critical to diagnosing the effects of my reactions and identifying ways treating them. The internet has been - in addition to having numerous consults - critical in identifying and evaluating alternate courses of treatment. NIH has been a great resource for me for treatment (as a patient) and research. Access to recent study results continues to be a major problem. Based on my past experiences, I am reluctant to merely submit to new courses of treatment - even after consulting with leading Dr's - with without researching them and gaining confidence in their efficacy - to include an in depth understanding of their side effects. My experience is that I find myself relying of studies conducted outside of the United States or having to evaluate treatment alternatives with dated material. Bottom-line: Public access to NIH funded studies will provide an important resource.	Web Form
536	Town Hall Form Comments	03/16/2008 at 08:10:38 PM (698)	Frankel	Carl	A.B. J.D.	Us TOO International	PA	US	Patient or Representative of a Public Health Advocacy Organization						I write as a prostate and oral cancer patient as well as the husband of a leukemia patient. In addition, in my capacity as an Us TOO Board member, I frequently serve as a source for information and support to my fellow prostate cancer patients. I regularly read the Pub Med abstracts relating to these diseases as well as other publications believing that a well informed patient is better able to deal with the difficult decisions we all have to make. It is clearly in our interest, in the interest of scientists and the public at large that access be granted access to the full articles reporting on taxpayer supported studies at the earliest possible date. What conceivable public purpose is served by withholding this information?	Web Form
537	Town Hall Form Comments	03/16/2008 at 08:15:57 PM (978)	Louis	Jennifer	BA	Candlelighters Childhood Cancer Foundation	TN	US	Other Member of the Public						As the NIH is supported by citizen's tax payments, all citizens should be able to view, at no charge, full text articles resulting from research that has been funded by the NIH .	Web Form
538	Town Hall Form Comments	03/16/2008 at 08:20:30 PM (351)	Andreae	Tiffany	Bachelor	Taxpayor - Cancer Advocate	IL	US	Other Member of the Public						Providing full access to full articles in a timely fashion would be an invaluable asset. For those of us working to help friends and family fight cancer, being able to contribute to the Doctors' research is a tremendous asset. We have made so many strides in our country that it is a shame not to openly and easily share the information. Thank you for your time and attention to this matter.	Web Form
539	Town Hall Form Comments	03/16/2008 at 08:30:20 PM (513)	Senecal	Eric	Bachelor of Arts	ACKC	KS	US	Other Member of the Public						I want to voice my strong opinion that indeed all medical reports on Trial results should be made free to the public. As a stage 4 RCC survivor I am constantly wanting more information on new treatment possibilities. Plus, I believe that since most of these trials occur with tax payer funds, the public should have access to that which their hard earned tax dollars have helped make possible.	Web Form
540	Town Hall Form Comments	03/16/2008 at 08:49:56 PM (634)	Wittenberg	Sidney	OD	Retired	CA	US	Other						Although currently retired, a have been a co-principal investigator on an NIH funded project. I heartily support the free use of the results of such work. The very purpose of the funding is the advancement of heath care. The latter is best accomplished by the ready accessibility of that information to all. It would be unconscionable to allow any limitation on the public’s access to it, especially when the public has paid for that research.	Web Form
541	Town Hall Form Comments	03/16/2008 at 08:52:39 PM (133)	Parker	Rod	BS, MBA	None	Kentucky	US	Patient or Representative of a Public Health Advocacy Organization						As a 54 year old prostate cancer survivor who has had an radical retropublic prostatectomy with 35 Tomo salvage radiation treatments with a Gleason score of (4+5). I also have been on over two years of Zoladex implants to keep my PCa at bay. I am constantly reading developing studies as at some time in the future my cancer will become independent of testosterone. I firmly believe that the NIH studies, which are financed by taxpayers monies, should be available to us when published, not after 12 months. Some of us are helping Physicians to be better educated and many patients actually read these studies before Physicians do.	Web Form
542	Town Hall Form Comments	03/16/2008 at 09:06:17 PM (415)	Jardine	Douglas/Sandy	Ph.D	consumers	AZ	US	Patient or Representative of a Public Health Advocacy Organization						Please urgently consider making medical articles available online and in libraries as soon after publication as possible. This needs to be done free of charge. We as consumers who are coping with life threatening illnesses need to have free and easy access to the latest information. This information is often not shared by our individual physicians. Our very lives depend on your making this accessible . Thank you. Respectfully, Douglas Jardine, Ph.D, MFT (prostate cancer survivor) Sandy Jardine, M.S. LPC (wife) We are both relationship therapists who counsel individuals and couples with life-threatening illnesses.	Web Form
543	Town Hall Form Comments	03/16/2008 at 09:36:54 PM (239)	Finkel	Muriel		Amyloidosis Support Groups Inc.	IL	US	Other						Knowledge is power. One cannot react without knowing what is going on, In the world of rare disease, it is vital that we know what and when things are happening. Time is not on our side. Thank you for this opportunity, Muriel Finkel President Amyloidosis Support Groups Inc. ASG www.amyloidosissupport.com Toll Free 866-404-7539 Organization Member of NORD www.rarediseases.org	Web Form
544	Town Hall Form Comments	03/16/2008 at 09:51:09 PM (449)	Goldsmith	Ronald	MSW, MA, MSEd	cancer survivor	NM	United States	Patient or Representative of a Public Health Advocacy Organization						It is critically important for cancer patients and survivors to have timely access to research findings. Only one journal dealing with leukemia (BLOOD) offers free access of articles by patients, on a request basis, otherwise there would be a $35 charge per article. I participated in a ECOG (Eastern Cooperative Oncology Group) clinical trial of fludarabine in 2001, spending over $5,000 above health insurance to participate. Yet, I cannot access the trial's findings, because apparently there is no requirement for publication. Clinical articles need to be available as soon as possible, not "up to 12 months." Informed patients need this information, as do their oncologists. Thank you for your consideration.	Web Form
545	Town Hall Form Comments	03/16/2008 at 09:58:02 PM (430)	Martin	Dan	Chemistry	USC/Norris	CA	US	Patient or Representative of a Public Health Advocacy Organization						Hi There, I appreciate the opportunity to provide my opinion on this important issue. As a cancer survivor who has done much research (that has hopefully led to my long-term survival), I can only repeat what others have said, namely, that public access to publicly funded cancer reserarch is the right thing to do. Please do it. Regards, Dan Martin	Web Form
546	Town Hall Form Comments	03/16/2008 at 10:42:04 PM (861)	W	H	Yes	Citizen	WA	US	Patient or Representative of a Public Health Advocacy Organization						NIH; Yes. I'd like to see complete public access to all NIH funded research articles and studies. I belive it's in the public interest. Thanks. HW	Web Form
547	Town Hall Form Comments	03/16/2008 at 10:57:13 PM (126)	thompson	jim	ba,jd	cancer patient	ca	US	Patient or Representative of a Public Health Advocacy Organization						It is insane that patients would be charged onerous per article sums for access to taxpayer funded medical activity. Online publishers, who have essentially zero cents incremental charge for an online reading, should not be allowed to plunder the public treasury in this fashion. Medical libraries are increasingly e-based. Hard copies of recent research are increasingly difficult to find. For the US government to aid in any way in the current ransom system is indefensible. 12 months is well too long. Government funded research should be available to the patient community immediately.	Web Form
549	Town Hall Form Comments	03/16/2008 at 11:14:22 PM (784)	Klopping	Ruth	n/a	n/a	Ca.	US	Other Member of the Public						As a cancer patient it is very vital to have free access to government funded health related studies.	Web Form
550	Town Hall Form Comments	03/16/2008 at 11:19:34 PM (872)	Barina	Charlene	BA, MPH (2009)	University of Washington, Peace Corps	Khovd	Mongolia	Other Member of the Public						The government's priority should be to protect its citizens' rights to live a free and healthy life. It also should be dedicated to serving the needs of the majority of its citizens. While most of the government does not necessarily operate in this manner, the NIH mandate is a positive step. Others have mentioned the fact that closing access to this research is in essence causing double payment for citizens. Additionally, the research that is funded by taxpayers has a very concrete benefit - it often relates to improving health. An educated society also tends to allow better decision-making, which in this case could save lives. Please continue to focus on citizens' rights and health by supporting this legislation.	Web Form
551	Town Hall Form Comments	03/16/2008 at 11:32:57 PM (917)	Driscoll	David	JD	None	CA	US	Patient or Representative of a Public Health Advocacy Organization						Articles resulting from NIH funded research should be available for public access, free of charge, no more than 12 months after publication. Those who oppose this change are apparently using self-serving motives to protect a free source of articles for their high subscription cost journals, or those which have exorbitant per article charges. The public has paid for these articles and to restrict access is patently an improper restraint on the public's right to know. The harm resulting from restricted timely access impacts directly on patient care and reflects poorly on the motives and dedication of our health care professionals.	Web Form
552	Town Hall Form Comments	03/16/2008 at 11:56:40 PM (456)	Burns	Charles		Private Citizen	NY	US	Other Member of the Public						Articles funded by the NIH should be placed in a repository of the NLM and made available to the public free of charge.	Web Form
553	Town Hall Form Comments	03/17/2008 at 12:20:20 AM (328)	Gardner	Sara	PhD	ACOR	OR	United States	Patient or Representative of a Public Health Advocacy Organization						As a taxpayer, who is funding NIH and its sponsored research, I very strongly feel that we should have access to the results of that research, whether publications or products (ie, drugs) at the lowest possible cost, if any. Companies should not make profits from government sponsored research...Of course they are entitled to received reimburshment for their costs, but not beyond that.	Web Form
554	Town Hall Form Comments	03/17/2008 at 12:25:16 AM (654)	Kelley	Brenda		Parent of a child with cancer	NM	US	Other Member of the Public						The parents, caregivers and family members of patients with cancer need and deserve to have access to publically-funded research, especially if there are studies which address concerns that the patient is experiencing but the oncologist may not have any experience in handling. The opportunity to reduce delays exists which may increase positive outcomes and improved experiences for patients and their caregivers and/or families.	Web Form
555	Town Hall Form Comments	03/17/2008 at 01:12:37 AM (205)	Bonser	Julia	MSSW	ACOR	AZ	US	Patient or Representative of a Public Health Advocacy Organization						I think it is vital to have the research papers available for free after they have been published. I tried to find research papers about Transitional Cell Carcinoma in the upper tract and kidneys. I was not able to read the papers I did find as the charge was $60 and up to get a full copy. I felt thwarted in my attempt to find treatment for my husbands bladder cancer that had spread to his kidneys. The support groups such as Bladder Cafe on ACOR and BCAN can only do so much to help patients with bladder cancer and we all need to be able to access current research in whatever illness is being researched.	Web Form
556	Town Hall Form Comments	03/17/2008 at 01:18:06 AM (408)	Taylor	A	n/a	Cancer Patient TRYING TO SURVIVE	California	US	Patient or Representative of a Public Health Advocacy Organization						Having to WAIT out months or years for the results of cancer studies to trickle down to 'patient level' adversely effects the window of survival for those of who are fighting for our lives in the battle against cancer. As things currently stand "WE" are the lowest realm of the information Totem Pole, despite the fact that "WE" have the MOST to lose. TIME is of the Essence in our ongoing struggle. WHY THE LEEWAY OF ONE FULL YEAR?? The published results should be FREELY ACCESSIBLE IMMEDIATELY!	Web Form
557	Town Hall Form Comments	03/17/2008 at 02:02:23 AM (743)	Bouley	Donald		ACOR	PA	US	Patient or Representative of a Public Health Advocacy Organization						How can anyone in good conscience want to keep information from people who are fighting for their lives?	Web Form
558	Town Hall Form Comments	03/17/2008 at 06:10:14 AM (389)	Click	Jennifer	JD	parent of a child with cancer	VA	US	Other Member of the Public						I believe research articles on all NIH-funded projects should be made available to the public free of charge w/in 12 months of publication. My daughter is a stage iv neuroblastoma patient. Because the survival statistics for stage iv nb are so poor, all patients are treated on clinical trials. As parents, we are asked to make treatment decisions with very little information, including information on treatments that may be available at other hospitals or cancer centers. Like many nb parents, I regularly read journal articles to try to gain a sense of which treatments are working, which aren't, which hold promise for the future. Because cancer in children is rare, and stage iv nb even rarer (about 350 cases/year in the US) parents' ability to research treatments can quite literally mean the difference between life and death. I am certain that had I stayed at our home hospital when my daughter was diagnosed 5 years ago, she would not be alive today. Please give parents access to the weapons they need to save their children's lives; give them access to full text of all articles reporting on NIH-funded research. Thank you.	Web Form
559	Town Hall Form Comments	03/17/2008 at 06:35:24 AM (719)	Quimby	Bruce	MS Materials Science	Prostate Cancer Survivor	AZ	US	Other Member of the Public						As a prostate cancer survivor I am interested in learning about any technical advance relevant to my condition. Much of the publications are blocked and prevent me from reading them. My doctors do not have time to read all the publications, so their knowledge does not advance in a timely manner. I would like to be able to bring relevant advances to their attention. Since I am a taxpayer, I would like to have access to the information we Americans have funded. Thank you, Bruce	Web Form
560	Town Hall Form Comments	03/17/2008 at 06:58:27 AM (480)	Dunn	Kathel	MSLS	NN/LM Middle Atlantic Region	NY	US	Other						I strongly support the NIH Public Access Policy and with its implementation, the greater availability of taxpayer-supported scientific research to researchers and members of the public. Scientific researchers, in particular, will benefit from the greater public accessibility of their work, and the subsequent ability to draw on the work of others to continue their own research. As the Associate Director of the National Network of Libraries of Medicine, Middle Atlantic Region, I am working in collaboration with one of our resource libraries in offering online courses in the NIH Public Access policy and demonstration of how the policy has been implemented at one library. The course will be available to librarians and researchers throughout four states: New York, New Jersey, Delaware and Pennsylvania. We will promote the availability of tutorials and training materials on the NIH Public Access site. Thank you for the opportunity to comment on the NIH Public Access policy.	Web Form
561	Town Hall Form Comments	03/17/2008 at 07:07:35 AM (846)	Salisbury	Paul	Ph.D	York College, City University of New York	NY	US	Other Member of the Public						The public needs open, user-friendly access to all NIH reports and publications. Information is the difference between life and death for so many cancer patients -- as well as all others with critical and serious, chronic diseases. It's the NIH budget but it is public tax dollars.	Web Form
562	Town Hall Form Comments	03/17/2008 at 07:22:15 AM (915)	Norkus	Barbara	RN	ACOR	IN	United States	Patient or Representative of a Public Health Advocacy Organization						As a cancer survivor member of two of ACOR's fine sites...Bladder Cancer Web Cafe and Colon Cancer,I am very interested in the free information that is provided to me through public access to Journal Articles. By having this available, it keeps me informed of the latest information so I can be a patient who is an asset in my medical care. Medical care costs are extreme...to add a fee for this valuable information is unreasonable in my estimation. Thank you for the opportunity to comment.	Web Form
563	Town Hall Form Comments	03/17/2008 at 07:36:38 AM (712)	Borcich	Holly		ACOR list	IL	US	Patient or Representative of a Public Health Advocacy Organization						As a patient afflicted with a disease for which there is limited treatment, I would state access to current articles may be pivotal in my survival. I do not believe in having access to those being limited by my ability to fork out as much as $60 per article. When you have exhausted known medical protocol it is likely a patient will bring info to the physician - for the love of God - make it available. Thank you.	Web Form
564	Town Hall Form Comments	03/17/2008 at 08:10:06 AM (495)	Abate	Laura	MSLS	The George Washington University	DC	US	Representative NIH Funding Recipient Organization						Access to information is crucial for healthcare providers and researchers both in the U.S. and worldwide. U.S. citizens have long funded research to which they had little to no access. The new NIH Public Access policy will provide the public access to research results, and will allow healthcare providers and researchers worldwide to access these results with an eye toward improving healthcare and advancing science for everyone's benefit.	Web Form
565	Town Hall Form Comments	03/17/2008 at 08:10:46 AM (303)	Toussaint	Patricia		NBlast	PA	US	Other Member of the Public						I think it would be extremely helpful to be able to view full text articles online at no charge. It is very frustrating to do research online and find articles on exactly what you are looking for, but to find that you need a subscription or pay a fee. I agree that all NIH funded research articles should be available at no charge. Thank you!	Web Form
566	Town Hall Form Comments	03/17/2008 at 08:16:25 AM (511)	Butler	Crilly	MA	Bladder Cancer Web Cafe	CA	US	Patient or Representative of a Public Health Advocacy Organization						The bulk of the revenue stream associated with these medical publications is realized within the first few months of their release. After that, the benefit to the public of providing this information to everyone for free would be astonishing. Please change your policy to permit this. For some of us, it may be a matter of life or death. Thank you!	Web Form
567	Town Hall Form Comments	03/17/2008 at 08:26:48 AM (554)	Kilburn	Wendy	BS in Psychology	Parent of cancer patient	Tx	United States	Patient or Representative of a Public Health Advocacy Organization						I would like to have free access to the results of cancer studies. My 2 year old son has leukemia, and it is important that I am aware of findings of studies that may help my son beat this. Paying for these results is difficult for those of us who are in the fight against cancer due to the high cost of medical care. We should not have to choose between finding the latest study results and buying medicines to save those that we love. Thank you for your time.	Web Form
568	Town Hall Form Comments	03/17/2008 at 08:29:33 AM (961)	Mono	Wendy		none	NY	US	Other Member of the Public						Taxpayer funded research should be available free of charge to the public.	Web Form
569	Town Hall Form Comments	03/17/2008 at 08:33:59 AM (565)	Smith	William	BA	Private Citizen	nc	US	Other Member of the Public						I want to confirm my support for the bill passed recently making it mandatory for articles published as a result of NIH funded research to be made available to the public through the National Liabrary of Medicine. It is only through a wider distribution path that patients, care-givers as well as the medical profession can gain the latest infomation on diseases/conditions that affect treatment whether it is for prophilactic, curative or maintenance of disease. My wife, diagnosed with Bronchoalveolar Adenocarcinoma, has brought information to her Oncologist - unknown to him- that affected our approach to the treatment of her diagnosis. It is vital, imperative that free access continue to be given NIH funded research. Bill Smith	Web Form
570	Town Hall Form Comments	03/17/2008 at 08:36:27 AM (587)	Sprouse	Gene	Ph.D.	American Physical Society	NY	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						The American Physical Society (APS) publishes articles primarily in basic physics, but does have some papers from scientists supported by NIH in the fields of biological physics. As a Society publisher, we are a not-for-profit organization that provides publishing services to the international community of physicists at very low cost. Our copyright statement has for many years allowed the specific form of open access that NIH is now mandating from every author. In our case, due at least in part to the long history, large size, and central position of APS journals in physics publication, our journals have so far remained strong, but we are particularly concerned that for smaller publishers and for some sub-disciplines the NIH mandate will be a significant problem, and for this reason, while supporting the goal of open access, we oppose the imposition of the mandate in its current form. We also worry that the NIH policy was implemented with essentially no opportunity for Society publishers such as APS, and other publishers to comment on its ramifications. Future unilateral steps by NIH and other government agencies could jeopardize the delicate balance between open access for authors and the financial support of publishers that provide important services to the scientific community, such as validation with high quality peer review, copy editing, and electronic composition and reference linking. The NIH policies appear to have targeted the practices of a few commercial publishers, but without adequate consideration of the consequences for not-for-profit publishers and other low cost publishers. We advocate a more collaborative process that includes input from all of the different stake-holders in the communication of science, so that we can preserve the scientific journals that have been the stalwarts of validation and preservation of science for centuries.	Web Form
571	Town Hall Form Comments	03/17/2008 at 08:38:29 AM (105)	Lastinger	Joseph	N/A	Self	TX	US	Other Member of the Public						As a parent of a child with cancer, I find it extremely frustrating that I cannot completely research my child's condition in order to better understand and to make good decisions for her. I cannot afford the thousands of dollars it would cost. I find it maddening when I cannot access an article that was essentially paid for already by me and the rest of our citizens that pay taxes. Government funded research is extraordinarily important. But tell your researchers that they don't have to publish in the NEJM, Science, or other journals that are fighting to make a buck here. PLEASE MAKE ALL ARTICLES RESULTING FROM NIH FUNDED RESEARCH AVAILABLE IMMEDIATELY AND ALSO MAKE IT MANDATORY THAT IT BE EASY FOR PARENTS OR PATIENTS DOING INTERNET RESEARCH TO FIND THE FREE VERSIONS RATHER THAN BE SUCKERED INTO PAYING. THANKS	Web Form
572	Town Hall Form Comments	03/17/2008 at 08:48:50 AM (203)	Hyman	Steven	MD, MA	Harvard University, Provost	MA	US	Representative NIH Funding Recipient Organization						The NIH Public Access Policy is an important and laudatory one. Harvard University supports the policy and its underlying ideals. The details of our own implementation of the requisite rights retention are still being worked out, and it will certainly require cooperation between grantees and publishers. Nonetheless, we believe any challenges that the policy presents can be surmounted, and applaud the NIH for its pursuit of the broadest access to scientific knowledge.	Web Form
573	Town Hall Form Comments	03/17/2008 at 09:02:19 AM (109)	Burke	Shanon		Parent of cancer survivor	FL	US	Other Member of the Public						As the mother of a pediatric cancer survivor, I often find myself in search of information regarding late effects of cancer treatment. This has only become a more focused field of study in recent years, so scientific journals are my primary source of information. Unfortunately, the fees they charge to access the full-text of these articles is prohibitive. To be of help to my child, I need access to information. It is unfair to charge a fee when my tax dollars are used to provide funds to said research. Sincerely, Shanon M. Burke	Web Form
574	Town Hall Form Comments	03/17/2008 at 09:03:17 AM (681)	Tignor	Lisa		mother of children with cancer and President of Candlelighters of the DC Metro Area	VA	US	Other Member of the Public						As a mother of two children who have battled cancer a total of 3 times in 7 years, I strongly urge you to allow taxpayers full access to taxpayer funded research. Although there is limited information available on the internet, it is often just an abstract or outdated research. Only with full access to the latest research can we make an informed decision on how best to proceed to save our child's life. That is the most difficult decision a parent can make.	Web Form
575	Town Hall Form Comments	03/17/2008 at 09:09:56 AM (336)	Reeves	Robert		Individual taxpayer	GA	US	Other Member of the Public						I strongly believe that free public access to NIH-funded cancer studies should be a requirement. Taxpayers pay for these studies, and we should not have to pay again to see the results of them.	Web Form
576	Town Hall Form Comments	03/17/2008 at 09:11:04 AM (895)	Ramsay	Wendy	BS	Bladder Cancer WebCafe; ACOR	WA	US	Other Member of the Public						To whom it may concern, My life is dependant upon up-to-date research for the treatment of metastatic bladder and upper urinary tract cancer. I am alive today in large part because of the information and research made available through ACOR and the Bladder Cancer WebCafe that I have brought to my doctors. I would like to see immediate public access to NIH research. Staying in front of a cancer that has made little treatment progress over the years demands a proactive patient, constant up-to-date research and the use of innovative treatment methods. We need and have a right to free access to all NIH research as soon as it is available. Thank you.	Web Form
577	Town Hall Form Comments	03/17/2008 at 09:20:53 AM (100)	Lowmaster	Kay	MSW	Us TOO International	PA	US	Patient or Representative of a Public Health Advocacy Organization						As the wife of a lung cancer survivor, the daughter of a woman who lost her battle with cancer, an oncology social worker, and a member of the Board of Directors of Us TOO International Prostate Cancer Education & Support Network, I know first-hand that today's patient must be his or her own advocate. Timely access to the latest research, in some cases, can literally mean the difference between life and death. Open access doesn't only benefit patients, however, but physicians and investigators as well. I fully support free public access to publicly funded research especially now in this Internet age when the cost of delivering that information is marginal.	Web Form
578	Town Hall Form Comments	03/17/2008 at 09:32:07 AM (238)	Fidoten	Robert	Ph.D.	UsTOO International	Pennsylvania	US	Patient or Representative of a Public Health Advocacy Organization						To be an informed patient is critical to the treatment and recovery process. Little if any detailed information is provided by the typical medical practice. It is essential that the NIH make its library collection easily and inexpensively available to our society. Please provide free access or veery low cost subscription access to all of the NIH's library files.	Web Form
579	Town Hall Form Comments	03/17/2008 at 09:33:25 AM (998)	McCauley	Jamie	N/a	Friend Of A Cancer Patient	WI	US	Other Member of the Public						Government funded studies should be FREE to everyone. For the government to be able to fund studies...that money comes from TAXES which each and every one of us pays in one form or another.	Web Form
580	Town Hall Form Comments	03/17/2008 at 09:34:41 AM (826)	Tarnowski	Marilyn	Ph.D.	Retired	Florida	US	Other Member of the Public						I am very much in favor of a bill was passed recently that will make it mandatory for articles resulting from NIH funded research to be placed in a repository at the National Library of Medicine and made available free of charge to the public, no later than 12 months after they are published. The opposition to this change among journal publishers is inappropriate for publically funded research, which SHOULD be made available to the public on a timely basis. I fully support the policy that implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which states: "SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law."	Web Form
581	Town Hall Form Comments	03/17/2008 at 09:36:41 AM (636)	Erwin	Nan	M.A.	Cancer Survivor	NJ	US	Other						I am very much in favor of a bill was passed recently that will make it mandatory for articles resulting from NIH funded research to be placed in a repository at the National Library of Medicine and made available free of charge to the public, no later than 12 months after they are published. The opposition to this change among journal publishers is inappropriate for publically funded research, which SHOULD be made available to the public on a timely basis. I fully support the policy that implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which states: "SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be madepublicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law."	Web Form
583	Town Hall Form Comments	03/17/2008 at 09:43:49 AM (511)	Mann	Mike	BS, MS	Bladder Cancer WebCafe; ACOR	FL	US	Patient or Representative of a Public Health Advocacy Organization						fully support the policy that implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which states: "SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be madepublicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law." Such information can be essential to people seeking information about illnesses that they have recently been diagnosed with. They often need the latest and most up to date research information to have a chance to save their lives.	Web Form
584	Town Hall Form Comments	03/17/2008 at 09:44:23 AM (384)	Smith	Katharine	B.A.	U.S. taxpayer and cancer advocate	CT	US	Other Member of the Public						The world of medicine is changing so quickly and patients need to and are expected to know so much about their own care. Information should be made available to the public, to those fighting cancer themselves or those helping a family member or friend. Time can make all the difference in life or death. Why not make it possible for more people to do research and figure out what might be best for themselves ot the person they are trying to help. Sharing knowledge and information in name of healing and helping makes a lot of sense. Please make these articles available for free to the general public. Thank you.	Web Form
586	Town Hall Form Comments	03/17/2008 at 09:57:07 AM (282)	Waldrop	Tony	PhD	University of North Carolina at Chapel Hill	NC	US	Representative NIH Funding Recipient Organization						Submitted jointly by the Provost, Vice Chancellor for Research and Campus Library Directors. We write in very strong support of the new NIH public access requirement and its implementation in April. This requirement will hasten the availability of biomedical research results from NIH grantees at UNC Chapel Hill and from leading scientists elsewhere. Because we have anticipated this legislation for some time, we are prepared to support and assist with its implementation at our institution. Deans, Associate Deans for Research, NIH funded researchers, and research administration staff have been informed of the new requirement and what assistance is available from UNC. Campus libraries have created a web site with helpful resources and scheduled classes and information sessions with faculty, deans and research administrators. We are requesting that our authors and principal investigators alert publishers of their intent to comply with the NIH policy at the time they submit their manuscripts, and to insert appropriate copyright language in their publishers’ agreements if it is needed when manuscripts are accepted for publication. Our internal grant processing systems have been altered to remind authors and principal investigators of the requirements of this policy.	Web Form
587	Town Hall Form Comments	03/17/2008 at 09:59:00 AM (495)	Naveira	Romina	MS Publishing, NYU	Association of American Publishers (Professional and Scholarly Division)	New York	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						NIH must agree to adopt and develop certain best practices to ensure that the public access policy meets and adheres to its stated objectives. 1. Since PMC will compete with publishers’ own websites as more PMC content overlaps with content on publishers’ sites, how will NIH maintain the primacy of the publishers’ websites and ensure that the manuscript on PMC does not displace or act as a substitute for the final published journal article, i.e., the authoritative version of record, which resides on a publisher’s site? Will NIH work with publishers to ensure that readers know and are directed to where the final published versions can be obtained? 2. Many publishers provide free access to authors’ manuscripts or final published articles twelve months after publication or even sooner. NIH does not consider this access compliant with the NIH policy. Would NIH consider including author manuscripts only in its administrative database and archive, while providing public access via display only through publisher sites? If not, what is the rationale for maintaining an unedited manuscript for public consumption if the final, authoritative version has been made available for free access on the publisher’s site? 3. What will NIH do in cases of noncompliance with its policy guidelines? What action will be taken when a grantee’s article is published, but NIH is not provided with the peer-reviewed manuscript? What actions will be taken against noncompliant grantees when they apply for future NIH grants? 4. How does NIH anticipate securing and sustaining a source of funding to maintain the database of articles that will accumulate over time, including costs to migrate to new platforms? Under the new policy, US taxpayers will be funding public access to science to any person anywhere in the world with Internet access. Has the NIH considered the ramifications of providing such international access, and how this might affect national security or other US government trade regulations? We look forward to the public meeting at NIH on March 20 and the upcoming RFI proceedings, but considering the far-reaching implications of the substantial change in the NIH public access policy, we urge HHS and NIH to do a full Notice and Comment Rulemaking. We believe that the public and the publishing community should be given an opportunity to comment on the content of the new policy before it goes into effect. We urge HHS and NIH to hold off on implementing the policy until after the Notice and Comment proceedings have been completed. We also look forward to a more formal process for working closely with NIH to implement the new public access policy.	Web Form
588	Town Hall Form Comments	03/17/2008 at 10:07:12 AM (580)	Gilbreath	Glenn	Ph.D.	Virginia Commonwealth University	VA	US	Patient or Representative of a Public Health Advocacy Organization						The transfer of information to patients and practitioners is hindered by the additional road block of expensive access to articles that are supported by tax funded research. The patients are being taxed twice and their health suffers because it takes 10 to 15 years before new procedures proven by research are widely put into practice. Free access can shorten this time by removing one barrier to the process.	Web Form
589	Town Hall Form Comments	03/17/2008 at 10:12:09 AM (187)	Abrishami	Lori	M.U.R.P.	Member of the public	CA	US	Other Member of the Public						All medical research and papers that have been funded by even one cent of taxpayer funds, either directly or indirectly, must be made available to all members of the public on the NIH website.	Web Form
590	Town Hall Form Comments	03/17/2008 at 10:27:38 AM (957)	Norkus	Dennis	Bach of Science	ACOR	IN	US	Patient or Representative of a Public Health Advocacy Organization						As a husband of a cancer survivor member of two of ACOR's web sites...Bladder Cancer Web Cafe and Colon Cancer, I am very interested in the free information that is available to me through public access to Journal Articles. By having this available, it keeps me informed of what is happening out in the world of cancer research so I as a care giver can asset the medical care available. Needless to say that all medical costs are extreme and to add another fee on top of this for valuable information would be another financial burden. Thank You.	Web Form
591	Town Hall Form Comments	03/17/2008 at 10:32:58 AM (982)	Kennison	Rebecca	M.A.	Columbia University	NY	US	Representative NIH Funding Recipient Organization						Columbia University welcomes the opportunity to implement the NIH Public Access Policy. We believe that the policy is consistent with the general educational and research objectives of the university and the broader research community and of the right of the public to access government-supported research. The NIH policy has also provided an important occasion for offices within the university to continue to collaborate and coordinate policy and procedures on the importance of managing our research output and ultimately making it more readily available to the public that has supported both the research and our researchers. We do have concerns about some of the challenges to implementation raised by the submission and compliance process as currently in place. Our authors, as is true throughout the academy, submit directly to journals without going through any university office, making tracking full and complete compliance difficult. Foremost among logistical concerns is with the required author approval of the XML-tagged version before the author can obtain a PMCID number. We look forward to working with NIH and the research community to resolving these challenges and developing an increasingly smooth process for implementation of this policy.	Web Form
592	Town Hall Form Comments	03/17/2008 at 10:44:17 AM (839)	Sherman	Cathy		Birt Hogg Dube Family Alliance	PA	US	Patient or Representative of a Public Health Advocacy Organization						For those with a rare syndrome or rare disease, using medical research becomes a way to educate themselves & their families. When they are seeing a doctor who has never seen the condition it becomes a way for the doctor to get information as well. This can make a tremendous impact in the treatment plan and in the success of that plan. Access to NIH funded research is invaluable in these situations - it's just not possible for the majority of patients and local doctors to get all the research when they have to pay for it. Free public access to NIH funded research is really important!	Web Form
593	Town Hall Form Comments	03/17/2008 at 10:52:58 AM (379)	Schafer	Dee		Cancer Survivor	NV	US	Patient or Representative of a Public Health Advocacy Organization						Many patients research extensively and take new treatment information to their doctors, which has the potential to save their lives. Publishers' profits should not take precedence over free access to valuable health research data, assuming the research wasn't done only for the the investigators' need to publish. The 12 month period is too long; New England Journal of Medicine is only 6 months.	Web Form
595	Town Hall Form Comments	03/17/2008 at 10:56:57 AM (391)	Terry	Sharon	MA	Genetic Alliance	DC	US	Patient or Representative of a Public Health Advocacy Organization						Genetic Alliance transforms health through genetics. We integrate individual, family, and community perspectives to improve health systems and services. We bring together diverse stakeholders to create novel partnership in advocacy. We promote individualized decision-making through increased access to information. We applaud the Congress in its wisdom for enacting the policy expressed in Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008and National Institutes of Health (NIH) for implementing this mandatory open access policy. Consumers must be empowered to make medical decisions about their health and that of their loved ones. Especially for those with rare diseases, the cutting edge research performed at NIH provides insight as to the nature of these conditions and can provide medical professionals with further insight on possible treatments and interventions. However, access to these vital research findings has been limited to the elite few who may have costly subscriptions to journals containing published research results. As a result, consumers have been forced to add to their suffering, beyond their disease and need for knowledge, to financial struggles as well, in an effort to access these findings. The consumer community was heartened with NIH’s voluntary policy two years ago to deposit research findings into a free, online database. However, less than 5% of individual researchers elected to submit their findings. As a result, public access to research findings was impeded. Quite obviously, this is not an area that will thrive with voluntary submission. The mandatory policy directed by Congress in recent fiscal year 2008 appropriations legislation is a necessary step to ensuring that NIH tracks its investments and corresponding results in federally funded research, has a complete archive of this research, and enhances public access to these assets. Genetic Alliance supports resource sharing, community commons and strengthening of the broad networks empowered by information. This is a strong step in a direction that will enable novel partnership to accelerate translation of biomedical research into better health. American taxpayers are entitled to open access. Widespread access to the information contained in these articles is an essential, inseparable component of our nation's investment in science.	Web Form
596	Town Hall Form Comments	03/17/2008 at 11:00:13 AM (686)	Ault	Harold	BA	Member of the Public	MD	US	Patient or Representative of a Public Health Advocacy Organization						As one diagnosed with bladder cancer I strongly urge Public Access be mandated so that I and others will be able to research any information that may have some influence on decisions for treatment.	Web Form
597	Town Hall Form Comments	03/17/2008 at 11:04:59 AM (966)	Terry	Sharon	MA	PXE International	DC	US	Patient or Representative of a Public Health Advocacy Organization						We applaud the Congress in its wisdom for enacting the policy expressed in Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008 and National Institutes of Health (NIH) for implementing this mandatory open access policy. Patients must be empowered to make medical decisions about their health and that of their loved ones. Especially for those with rare diseases, the cutting edge research performed at NIH provides insight as to the nature of these conditions and can provide medical professionals with further insight on possible treatments and interventions. However, access to these vital research findings has been limited to the elite few who may have costly subscriptions to journals containing published research results. As a result, patients have been forced to add to their suffering, beyond their disease and need for knowledge, to financial struggles as well, in an effort to access these findings. American taxpayers are entitled to open access. Widespread access to the information contained in these articles is an essential, inseparable component of our nation's investment in science. We recommend changing the period to 6 months and releasing articles thereafter.	Web Form
598	Town Hall Form Comments	03/17/2008 at 11:07:21 AM (502)	Petersen	Mike	BS	None	PA	US	Other Member of the Public						I was told by my sister that I should comment on this topic due to my personal experience. In a large bit of irony both my sister and I were involved in a great deal of personal research her for her son with lukemia and me with my wife and a diagnosed Brain tumor. In the course of research our concern was always finding relevant and recent Tf not up to the minute information on treatments and outcomes. this was seldom easy and often times very difficult. Anything, and I do mean anything that slows or stops the flow of information is impeding progress. On a personal level this is upsetting, on an emotional level it is devestating given to possible outcome of losing a loved one due to information not being available. Any small bit of information may be the key or shred of hope that could make the difference between life, death of major disability. To slow the process because of publication requirements or rights or any administrative requirements is an incredible shame. In the realm of information gathering , more is always better. Hope this helps. I have a lot more to say but this highlights my concerns.	Web Form
599	Town Hall Form Comments	03/17/2008 at 11:07:56 AM (930)	taylor	a a	- - - - -	bladder-cancer-cafe/listserv/acor.org group member	ca	US	Patient or Representative of a Public Health Advocacy Organization						cancer patients need immediate access to results in order to determine the best course for survival. since there are so many different forms of cancers, it is foolhardy to expect doctors to be up to date. we have to be our own advocate in order to survive. this is vitally important to patients who live in outlying areas far away from mainstream medical facilities. bottom line: cancer patients can't afford to wait a year or more to gain access to results that could impact the decisions we are currently faced with. due to the limited availablilty of current study results.... i would not have survived my bladder cancer battle without the knowledgeable support of the members of the awesome acor.org bladder cancer cafe. while I am exceedingly grateful to have found this group, it is a sad commentary that individuals cannot access study results that could very well end upsaving their life	Web Form
600	Town Hall Form Comments	03/17/2008 at 11:10:32 AM (698)	Ross	Susan	Ph.D.	The University of Southern Mississippi	MS	US	Patient or Representative of a Public Health Advocacy Organization						Public access for patients can make significant differences in survival -- as patients and physicians and other team members coordinate treatment. This is especially true in tough cases and rare cancer. I am fighting to survive both. When I click and get a "no access" message after finding a relevant study, I feel frustrated and angry (as if my fight for my life doesn't matter). I have paid taxes for 40 years and think I should have access to Govt. funded research reports. Please provide public access.	Web Form
601	Town Hall Form Comments	03/17/2008 at 11:15:05 AM (558)	Waldenfels	James	BA, MA	Prostate cancer survivor	VA	US	Patient or Representative of a Public Health Advocacy Organization						Open access to papers reporting research conducted in part with NIH funding will be helpful to survivors and should not be burdensome to subscription publications. Such access is particularly important to cancer community leaders and patients with advanced cases, like me. I have attended about a half dozen FDA hearings and have delivered oral statements at several. I have also attended four national conventions on prostate cancer, have been a Scientist-Survivor Program participant in 2005 and 2006 in the program sponsored by the American Association for Cancer Research, have been a consumer reviewer for peer reviews by the Prostate Cancer Research Program of the Congressionally Directed Medical Research Program in 2006 and 2007, and am a director of the Virginia Prostate Cancer Coalition. I am on the web and internet daily with other patients and caregivers. I make great use of PubMed, but I find that access to complete papers often adds great value to understanding and follow-up communication. Studying complete papers also enables survivors to participate meaningfully in current medical issues. Online access means I won't have to put off research until the next time I can fit in a trip to a medical library, and it will also be less time consuming. These are important benefits. Withholding access for a year, as proposed, should not be a significant hindrance to cancer community leaders like me, but it should preserve the subscription base for medical publishers. To me, that makes the proposal a win-win proposition. Providing access to the public as proposed will also have the important benefit of increasing the salience of Federally funded medical research. This is very important. As a prostate cancer community leader, I find that most survivors, let alone the general public, and most politicians have a grossly inadequate concept of the important role played by Federal funding. Among other benefits, having online access will let us quote and refer key parties directly to important research.	Web Form
602	Town Hall Form Comments	03/17/2008 at 11:23:43 AM (502)	Sprague	Stephen	none	patient advocate	New York	US	Patient or Representative of a Public Health Advocacy Organization						I was diagnosed with leukemia in 1995 at a time when access to information for patients was nearly impossible. Today, with the proliferation of the internet, info is plentiful, but often difficult to seperate fact from fiction. In an era when pro-active patients have a desire to know more, and the medical community is learning how to better deal with informed patients, the NIH's open access to credible information will make it easier for the patient community to become better informed and better able to make good decisions about treatment. As a grateful cord blood transplant recipient who found information the hard way, thank you for making this possible. Stephen R. Sprague Staten Island, NY	Web Form
603	Town Hall Form Comments	03/17/2008 at 11:32:03 AM (641)	Frydman	Gilles		ACOR: Association of Cancer Online Resources	NY	US	Patient or Representative of a Public Health Advocacy Organization						More and more research has demonstrated that higher levels of functional health literacy are associated with more knowledge about chronic or life threatening conditions, higher self-reported health status and lowered rates of hospitalization, likely resulting in lower health care expenditures. A nation subjected to ever increasing healthcare costs cannot ignore any longer the positive national financial impact of OA self-archiving as is required under the Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research. As is amply clear in so many of the comments made in the last few days, patients suffering from cancer and of rare diseases have already understood that knowledge is power. For those suffering from rare diseases, the higher the level of functional health literacy, the more they are able to truly partner with the few specialists in their condition and obtain optimal care. Access to full text peer-reviewed publications representing the current state-of-the-art knowledge can easily make the difference between life and death. That fact alone is sufficient to strongly support OA policies. We just hope that, after an initial period to pilot the implementation of the new policy, the next step will be a reduction of the 12-months period to a 6-months period and then to a 3-months period.	Web Form
604	Town Hall Form Comments	03/17/2008 at 11:40:35 AM (126)	Miller	Rush	Ph.D.	University of Pittsburgh	PA	US	Representative NIH Funding Recipient Organization						The University of Pittsburgh Libraries strongly support the new NIH public access requirement and its implementation in April, which will result in the wider distribution of results from biomedical research results, from the University of Pittsburgh and other leading universities. Researchers at the University of Pittsburgh receive grants in excess of $450 million from NIH last year and thus have a large stake in the outcome of this legislation. We are prepared to support and assist these scholars in meeting the requirements of the public access policy. The Health Sciences Library System has already held a number of special workshops for faculty with NIH grants in order to communicate directly with them about this new requirement and to provide direct assistance to them as needed to comply. They have also prepared a web site outlining the policy with useful information to ease compliance. The main University Library System is preparing to implement an institutional repository (much of which has been in place for several years) which will serve as an additional public outlet for researchers at the University. We have been coordinating these and other activities with the Vice Provost for Research. We are requesting that our authors and principal investigators alert publishers of their intent to comply with the NIH policy at the time they submit their manuscripts, and to insert appropriate copyright language in their publishers’ agreements if it is needed when manuscripts are accepted for publication. Our internal grant processing systems have been altered to remind authors and principal investigators of the requirements of this policy.	Web Form
606	Town Hall Form Comments	03/17/2008 at 11:46:53 AM (483)	Buys	Susan		Kabuki Syndrome Network	Ontario	Canada	Other Member of the Public						I am a parent of a child with a rare syndrome - Kabuki Syndrome. It is incredibly difficult to find any information on this syndrome, and it is very difficult to parent a child through all the passages of life without some help. The Kabuki Syndrome Network, an entirely volunteer group of parents, has been a lifesave for so many of us, providing information and advice as we face the many challenges of life with our children. So much of this information comes from medical articles that are available free of charge. We do not have the money to pay fees for these articles, but we are the people that need to see them the most. Please, please, go forward with this proposal to make all research articles that receive your funding available at no charge. You are doing such an incredible service to parents of disabled children everywhere. Thank you.	Web Form
607	Town Hall Form Comments	03/17/2008 at 11:48:22 AM (592)	Switzer	Al	BA, BEd	Prostate Cancer survivor	Ontario	Canada	Patient or Representative of a Public Health Advocacy Organization						I am a patient who takes ownership of my health care, and I need high quality access to health information. I think that publicly funded research should be readily available to the public, as that is where the ownership truly resides.	Web Form
608	Town Hall Form Comments	03/17/2008 at 11:50:28 AM (538)	Capaldo	Dr. Theodora	Ed.D	New England Anti-Vivisection Society	MA	US	Other Member of the Public						Affiliation: New England Anti-Vivisection Society (NEAVS), Boston, MA On behalf of our 25,000 members, NEAVS, a national animal protection organization, strongly supports the NIH Public Access Policy. As a not-for-profit organization, we have an on-going and important need for information regarding current research. Such information is necessary to fulfill program needs that are consistent with our mission -- a mission that is funded by our members' donations (the vast majority of whom are tax paying U.S. citizens). Having to pay for access to publications that result from biomedical research that was already paid for by public tax dollars is not only costly and a burden on our budget, but is an unfair double expense for our supporters. Further, the current process to access such information is not only costly but lengthy and cumbersome. To effectively do our work and maintain our fiduciary responsibility to our supporters, we need to be able to access publications even sooner than the current allowance of 12 months. Science moves quickly and obtaining current information is critical to fulfilling our mission. Additionally, we believe that through FOIA, the American public should have access to all information regarding animals in NIH funded research, even if such research is being done on animals housed in private institutions. The loophole that has allowed institutions that receive private and public funds to side step FOIA as well as state sunshine laws, has prevented proper monitoring, evaluation, or other critical thinking regarding what is and is not resulting from the billions of dollars of tax payer money that are spent each year on research. Further, the American public reluctantly supports animal research only when there are no alternatives, and only if they are assured humane treatment and freedom from pain and suffering. All Americans, including publicly supported not-for-profits who work on their behalf, should have free access to research publications. Thank you.	Web Form
610	Town Hall Form Comments	03/17/2008 at 11:51:54 AM (819)	VanDerBos	Trisha		Mother to Neuroblastoma Survivor	MI	US	Other Member of the Public						As a mother to a 4 year old high risk Neuroblastoma child, I urge you to allow public access to studies. Becoming more informed about treatment advances can only lead to better communication between doctor and patient and improved treatment and survival.	Web Form
612	Town Hall Form Comments	03/17/2008 at 11:54:16 AM (933)	Ross	Betsy	B.S.	Husband has rcc	RI	US	Other Member of the Public						The American public needs access to the NIH research. Patients can no longer completely depend on their doctors to provide them with all the necessary information. As taxpayers, we are paying for this research, and we have a right to the results. People are dying every day because they lack the information to make the correct decisions regarding their treatment. Please make this information available.	Web Form
613	Town Hall Form Comments	03/17/2008 at 11:58:21 AM (104)	Kelly	Patrick		John Wiley and Sons	NJ	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						We are encouraged that NIH is finally starting a dialogue with publishers, investigators, and representatives from scientific associations to ensure the success of this initiative. However, Wiley believes that NIH should adopt a more cautious and thoughtful approach, following through in its partnerships with scientific publishers in exploring through a formal process how to properly implement this new policy. Indeed, rushing implementation could carry with it the potential of causing irreparable harm to the integrity of science and to the very mission of NIH. The Senate has directed NIH "to seek and carefully take into account the advice of journal publishers on the implementation of this policy.” How exactly will NIH incorporate the concerns of publishers moving forward if the policy is already implemented?	Web Form
615	Town Hall Form Comments	03/17/2008 at 12:01:44 PM (663)	Myerson	Gary	M.A.	None	CA	US	Other Member of the Public						For those of us who are CA patients and have and ongoing interest in learning more and understanding better the various aspects of the disease it would be most helpful to have the research articles available to us without having to pay for them.	Web Form
616	Town Hall Form Comments	03/17/2008 at 12:02:13 PM (705)	Borrego	Stacey	Interpreter for the deaf	Kabuki Syndrome network	IL	US	Other						I am a parent of a child with a rare syndrome - Kabuki Syndrome. It is incredibly difficult to find any information on this syndrome, and it is very difficult to parent a child through all the passages of life without some help. The Kabuki Syndrome Network, an entirely volunteer group of parents, has been a lifesaver for so many of us, providing information and advice as we face the many challenges of life with our children. So much of this information comes from medical articles that are available free of charge. We do not have the money to pay fees for these articles, but we are the people that need to see them the most. Please, please, go forward with this proposal to make all research articles that receive your funding available at no charge. You are doing such an incredible service to parents of disabled children everywhere. Thank you. Stacey	Web Form
617	Town Hall Form Comments	03/17/2008 at 12:02:19 PM (555)	Furlong	Patricia	msn	Parent Project Muscular Dystrophy	OHIO	US	Patient or Representative of a Public Health Advocacy Organization						The level of access to NIH-funded research made possible by the new mandate will impact the disease process in novel ways, improving the ability of scientists to advance therapies and enabling patients and their advocates to participate more effectively. The advance is timely, much-needed, and – we anticipate – an indication of increasingly enhanced access in future	Web Form
618	Town Hall Form Comments	03/17/2008 at 12:07:58 PM (657)	Olsen	Evelyn	BS	Webcafe	CO	US	Other Member of the Public						It is critical, and long past time, for the NIH funded articles/publications be made available to the public at NO cost. Thank you for pursuing this matter. Sincerely, Evelyn Olsen	Web Form
619	Town Hall Form Comments	03/17/2008 at 12:08:19 PM (116)	Reid	Darcy		Mother	VA	US	Other						As the mother of a five-year-old child who died of a brain tumor, my duty to her was to keep her safe during treatment by making the most informed choices. This was made much more difficult, because 1) I needed easy access to publicly-funded research articles, and 2) Too much of the publicly-funded research was never published anywhere. I feel strongly that as a tax payer, this research we pay for should be there when the most catastrophic events happen in people's lives, and that if one receives public monies, there is an obligation for these research scientists to publish the results. Eight years later, none of the results from these clinical trials offered to my daughter, some of them out of NIH, have been published. How can anyone - younger doctors and new patients - benefit if they don't know the outcomes.	Web Form
620	Town Hall Form Comments	03/17/2008 at 12:17:06 PM (265)	Blake	Joni	PhD	Greater Western Library Alliance	MO	US	Other						I submit these comments on behalf of the Greater Western Library Alliance (GWLA), a consortium of 31 research libraries west of the Mississippi (www.gwla.org/library.html). Nearly all of our member institutions are substantial recipients of NIH funds. As an indicator of our overwhelming support for the Public Access Policy, we proactively held a symposium on March 10 on policy implementation and compliance. This meeting brought together librarians, medical school personnel, university research administrators and faculty to ensure that GWLA-member institutions were on schedule to meet the April 7th compliance deadline. The consensus of the symposium attendees: 1. GWLA-member libraries unanimously support this policy. 2. We are confident the policy will not harm the peer review process. 3. We believe the policy will increase the use and usefulness of the research conducted on our campuses. 4. We advocate for the shortest possible embargo period. 5. We urge NIH to keep the policy deadline firm at April 7, 2008. Administrators at GWLA-member institutions are working out the compliance workflows and communications infrastructure issues at each campus, and are confident they will be prepared for the deadline. 6. We urge the expansion of this policy beyond NIH to all federally-funded research. One faculty member in attendance said he “can’t wait until this policy applies to my discipline.”	Web Form
621	Town Hall Form Comments	03/17/2008 at 12:19:09 PM (799)	Stacey	Gary	Ph.D.	American Society of Plant Biologists	MD	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Dear Dr. Zerhouni: The American Society of Plant Biologists (ASPB) is a non-profit society of 5,000 scientists. ASPB publishes the two most frequently cited journals in plant science: Plant Physiology and The Plant Cell. ASPB is concerned that the published policy of the National Institutes of Health (NIH) on submissions to PubMed Central is not consistent with the provision on access passed by the Congress. The relevant provision of the law passed by Congress is found in Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008). This provision of the law states: SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law. Copyright law The law clearly states the importance of protecting publisher’s copyright ownership. The law says, “Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law." Implementation of the access policy is contingent upon this provision. It is not consistent with copyright law for NIH to mandate submission of copyright-protected articles to a federal publisher website, PubMed Central, without the agreement of publishers’ who hold copyright to the articles. NIH needs to revise its policy to remove mandatory submission of publisher’s articles to PubMed Central. Congress Addressed “Manuscripts” – not “Articles” Despite the reference to “manuscripts” in the law, NIH policy refers to scientists submitting “journal articles” to PubMed Central. NIH needs to amend its policy to include the language used by Congress in the Consolidated Appropriations Act. Congress clearly used the word “manuscripts” and at no time used the word “article.” The term “article” refers to the finished, completely edited document that is submitted for copyright. In comparison, a “manuscript” is not a fully edited document. The NIH Policy is out of compliance with the law by calling for submission of “articles” instead of “manuscripts.” This NIH Policy will threaten the viability of some publishers. Readers will soon learn they can read the publisher’s articles for free on PubMed Central instead of paying for them in a publishers’ subscription. Some readers will decide not to renew subscriptions, because they can read the articles for free on PubMed Central. Thank you for the opportunity to provide these comments. Please let us know if we could provide further information. Sincerely, Gary Stacey, Chair ASPB Committee on Public Affairs	Web Form
622	Town Hall Form Comments	03/17/2008 at 12:26:39 PM (765)	Bastian	Dawn	MA	Colorado State University	CO	US	Other						How does NIH intend to measure the impact of the new public access policy?	Web Form
623	Town Hall Form Comments	03/17/2008 at 12:39:26 PM (256)	Leonard	Thomas C.	Ph.D.	University of California, Berkeley	CA	US	Representative NIH Funding Recipient Organization						NIH Public Access Policy The Library of the University of California at Berkeley is strongly supportive of the NIH mandate as both good public policy and a research-friendly regulation. Berkeley-based research contributes to solving national and global health problems. And Berkeley libraries are a key conduit for information flows. To cite one example, our Public Health Library serves roughly 750 active users of health research, including California state government agencies such as the Department of Public Health, Department of Health Care Services, Department of Toxic Substances (Cal/EPA), and Office of Environmental Health Hazard Assessment (Cal/EPA). (On a personal note, the mission here is exemplified by the career of Berkeley’s distinguished Public Health graduate, Dr. Julie Louise Gerberding, Director of the Centers for Disease Control and Prevention.) Some 15,500 requests for materials are received per annum in the Public Health Library from researchers. Opening up access to even somewhat dated research from NIH-funded projects will aid immensely in the health-related study in the interest of public health that goes on at campus and government agencies in California. We see no problem in ensuring that our researchers with NIH funds meet the requirements of the new law. Modern librarians prize assignments to make scholarly communication more available in the society that funds research. The Library is currently working with our Sponsored Projects Office and Office of Research to ensure that all NIH grant recipients are aware of the new rules. As part of this coordinated strategy, the Library has developed an informational webpage with key dates and requirements at http://www.lib.berkeley.edu/scholarlycommunication/nih_mandate.html We also note that the University of California’s Office of President has issued a "Compliance Memo" to all UC campus research administration officers, including our Office of Sponsored Projects, outlining steps to be taken ensuring a consistent approach across the ten campuses of the University of California. Thomas C. Leonard University Librarian Professor in the Graduate School of Journalism University of California, Berkeley	Web Form
624	Town Hall Form Comments	03/17/2008 at 12:40:09 PM (978)	Gada	A	------------	Cancer Patient	CA	US	Patient or Representative of a Public Health Advocacy Organization						Cancer patients desperately need FREE access WHEN the results of government supported study results are published. It is sad that cancer patients are often the LAST ONES to be able to access results that could very well serve to save their lives. I daresay, those who are opposed to free access would very quickly change their minds if THEY were struggling with a life threatening cancer!	Web Form
626	Town Hall Form Comments	03/17/2008 at 12:46:13 PM (370)	Saatvedt	Benita	BS	Periodic Paralysis Association	OR	US	Patient or Representative of a Public Health Advocacy Organization						Please allow access to NIH funded research. I have studied Periodic Paralysis for over ten years. I cobbled together research from abstracts and thirty-year-old research. With a medical dictionary, Merck's manual, and a slew of other books, I learned to translate medical terminology into English. From my readings I've gleaned enough information to teach patients the importance of diet, exercise, and medical intervention. Familial Periodic Paralysis is often misdiagnosed and difficult to understand. Patients appear healthy until their muscles fail to contract and they become paralyzed. This paralysis attack can happen anywhere, at anytime, and can be quite dangerous. In the beginning there were three known variants of Familial Periodic Paralysis. Now researchers are working to identify many more variants and mutations. We need free access to NIH funded research because of the financial barrier that prevents ordinary people like me from reading important ion channel research. My reading and deciphering of abstracts and literature has helped hundreds of patients worldwide. All of my work as a patient advocate has been completely voluntary. With free access, it would allow more patients and their advocacy groups to help open communication with their doctors. It will allow more interaction between patient, doctor, and researcher. Patients and doctors would be better informed about the most recent research. Overworked healthcare worker currently do not have time to research each specific disorder their patients suffer from. Free access opens communication between the three most important groups: patient, research, and physician. Currently, the conduit of information from research group to physician is quite long. Allowing access to NIH funded research shortens that conduit from years to weeks. Please consider the disabled, hurting patients who will gain the most. Financial gain is not always the greatest reward. For me, personally, my research has kept me out of a wheelchair. I no longer use a cane. My last ER visit, via ambulance, was three years ago. I can keep up with my 11-year-old daughter. All of this happened because I was able to find answers hidden deep in NIH and MDA funded research.	Web Form
627	Town Hall Form Comments	03/17/2008 at 12:53:36 PM (265)	Balis	Philip	MS	US TOO	TX	US	Patient or Representative of a Public Health Advocacy Organization						As someone with prostate cancer I am coninually doing research. And, as a tax payer, I believe that the research that I do include all federal funded research. I want to be a smart consumer of health care. To do that I need access to all available research. Make it public!	Web Form
628	Town Hall Form Comments	03/17/2008 at 12:56:38 PM (184)	Polhemus	Craig	JD	Prader-Willi Syndrome Association (USA)	FL	US	Patient or Representative of a Public Health Advocacy Organization						On behalf of the Prader-Willi Syndrome Association (USA), I write in strong support of the Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research, published as NOT-OD-08-033 on January 11, 2008. The Prader-Willi Syndrome Association (USA) supported the legislation that became Division G, Title II, Section 218 of PL 110-161. As because Prader-Willi syndrome (PWS) is a rare disease, families of those with PWS have an avid need for relevant health information. NIH plays a significant part in funding the creation of such knowledge, and the Public Access Policy will therefore help thousands of families including those with PWS. Clearly it will be desirable for relevant journals to assume responsibility for submitting covered articles (or, ideally, all their articles regardless of source of funding) to PubMed Central to remove this burden from individual researchers. To the extent that NIH can ease the submission process or provide incentives to publishers to submit these articles directly, those would be positive additions to the current policy. Also, NIH should take steps to ensure that if publishers impose costs upon NIH-funded researchers to comply with this policy, these costs do not unduly diminish NIH or other funds available to researchers for their funded research. Craig ***************************************** Craig Polhemus Executive Director Prader-Willi Syndrome Association (USA) 8588 Potter Park Drive, Suite 500 Sarasota, FL 34238 Voice (800) 926-4797 ext. 720 Direct line (941) 487-6720 Fax (941) 312-0142 www.pwsausa.org cpolhemus@pwsausa.org *****************************************	Web Form
629	Town Hall Form Comments	03/17/2008 at 12:58:42 PM (925)	Clugston	Amy		Syndromes Without A Name USA	MI	US	Patient or Representative of a Public Health Advocacy Organization						I think public access will play an important role in the health of individuals who are experiencing undiagnosed situations. They need to educate themselves about the symptoms they are having, so that they can correctly describe their symptoms to their doctors. Often times when a person has a symptom of some disease or syndrome that they do not yet know the name of, they may leave out very important clues that may guide the doctor in making a correct diagnosis. If they inform their selves of diseases and syndromes, when they see some similarities they will likely feel more comfortable asking their doctors. This will happen because they will feel more capable of asking the right questions.	Web Form
630	Town Hall Form Comments	03/17/2008 at 01:23:18 PM (170)	Sparks	JoAnne	M.S.	Memorial Sloan-Kettering	NY	US	Representative NIH Funding Recipient Organization						As an information professional and library director, I strongly support the NIH Public Access Policy. The role of the modern librarian is to facilitate access to information for their constituents. The NIH mandate is in keeping with the mission of every librarian. The MSK Library is working closely with our Research Resources group to ensure effective communication, training and compliance at our institution.	Web Form
631	Town Hall Form Comments	03/17/2008 at 01:27:31 PM (177)	Ludwig	Deborah	MLIS	University of Kansas	KS	US	Representative NIH Funding Recipient Organization						At the University of Kansas, the office of Research and Graduate Studies and the KU Libraries are working together to ensure that our researchers understand the new NIH open access policy and will comply by depositing NIH-funded articles in PubMed Central. NIH research is publicly-funded and taxpayer-supported and yields important and timely scientific information. Open access will ensure that NIH-funded research is readily accessible to the research community, faculty, students, and the general public. Students and faculty will use PubMed Central to bolster their engagement in scientific learning. Researchers will continue to benefit from the peer review of their research and the prestige of journal publication while their research receives broader exposure to scholars and citizens alike. We support this important national initiative. William Sharp - Director, Research Integrity, Office of Research and Graduate Studies; Deborah Ludwig - Interim Assistant Dean, KU Libraries; Holly Mercer - Coordinator for Scholar Services, KU Libraries	Web Form
632	Town Hall Form Comments	03/17/2008 at 01:50:20 PM (678)	Joseph	Heather	MBA	Alliance for Taxpayer Access	DC	US	Other						The Alliance for Taxpayer Access (ATA) commends the National Institutes of Health (NIH) for moving forward with the timely implementation of its Public Access Policy. We strongly believe that it is the right of all citizens to have free and timely access to the results of our collective $28 billion annual investment in the critical biomedical research funded by the NIH. The Alliance -- a coalition of more than 80 research organizations, libraries, patient groups and consumer advocates -- believes that the NIH Public Access Policy will facilitate the ability of researchers, physicians, clinicians, health care professionals and other members of the public to access, share, and use the results of this research. Faster and wider sharing of NIH-funded research will enable scientists to build upon it more quickly, accelerating the pace of discovery and speeding the translation of this knowledge into public benefits. This will have a profound effect on the advancement of scientific research and the improvement of public health. The Alliance is pleased that the NIH has published implementation guidelines in a timely fashion, and our member organizations are actively working to raise awareness of the policy to ensure effective compliance within the communities we represent. Our organizations have also been developing and promoting mechanisms to help researchers prepare for manuscript deposit as well as to ensure they retain the necessary rights to comply with the policy, in accordance with current copyright law. We are particularly pleased to note the growing list of over 300 journals (listed on the PubMed Central Web site) that have indicated their willingness to support the policy by facilitating the deposit of manuscripts -- and, in some cases, final published articles -- on behalf of NIH-funded researchers. We believe the terms of the new NIH Public Access Policy reflect a reasonable balance of stakeholder interests with one exception: the Alliance urges the NIH to shorten the maximum time frame for this material to be embargoed from 12 months to six. A six-month embargo -- which has already been adopted by biomedical funders in Canada, the U.K., and the European Union -- better reflects the rapid pace of discovery in biomedical science and more effectively addresses the public’s pressing need for access to this publicly funded information.	Web Form
633	Town Hall Form Comments	03/17/2008 at 01:52:45 PM (599)	Ochs	John		American Chemical Society	DC	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						The American Chemical Society supports public access to the results of federally funded research but asserts that the implementation plan for the NIH Public Access Policy mandate does not abide with the law creating the mandate or with the sentiment and direction of the U.S. Congress. The NIH missed an opportunity to make its May 2005 voluntary public access policy a success by not proactively including scientific journal publishers as it developed its voluntary Public Access Policy. Consultation with publishers is critical in 2008 to prevent the agency from embarking on a similar collision course as it proceeds to implement the new mandate. Key to success will be NIH taking an active role, one based on openness and inclusiveness, to resolve the outstanding copyright and intellectual property issues that cut across a very broad and deep swath of the scientific journal publishing community. The ACS publishes annually approximately 4,000 articles that acknowledge NIH as a research funding source. Ever since NIH directed ACS to halt article deposition into PubMed Central in December 2005, ACS has tried unsuccessfully to resolve outstanding copyright and intellectual property issues with NIH. At present, ACS has more than 3,000 manuscripts awaiting deposition. During the 2005-2008 time period, NIH PubMed Central has accepted unauthorized postings of ACS copyrighted material, and repurposed and openly displayed such postings without adhering either to NIH’s own policy guidelines, or terms and conditions as set forth to NIH by ACS as rights holder. Issues of concern to ACS remain unresolved and will continue to be problematic and exacerbated under the new mandatory policy as outlined in NIH’s implementation plan issued on January 11, 2008. ACS hastens to point out that the vast majority, if not all, the Society’s copyright and intellectual property concerns could be resolved if NIH would abide the original intent of the Public Access policy and post without alteration or modification the unedited author versions of peer-reviewed manuscripts on PubMed Central—without any reformatting, repurposing or modification or any mirroring of content to third-party websites—and simply link back to the final published article as the authoritative version for readers on the Society’s own website. ACS commends the NIH for announcing a public comment process on its planned mandatory policy implementation through a Request For Information notice but questions the logic of proceeding with the announced implementation of the mandate on April 7, 2008 when the timeline for public comment submittal and the NIH’s response and possible amendment of the policy may not be complete until sometime in August 2008. ACS has submitted much more detailed comments for NIH’s consideration at its designated website -- PublicAccessComments@NIH.gov	Web Form
634	Town Hall Form Comments	03/17/2008 at 01:54:07 PM (950)	Lukowski	Linda	BS	Parent of child with Kabuki Syndrome	Illinois	USA	Other Member of the Public						I am the mother of a child with a rare syndrome, Kabuki Syndrome. It is incredibly difficult to find medical doctors and personnel who have up-to-date information on this syndrome, and it is very difficult to parent a child without some help. The Kabuki Syndrome Network is an entirely volunteer group of parents and has been a lifesaver for so many of us, providing information and advice as we face the many challenges of life with our children. Much of this information comes from medical articles that are available free of charge. We do not have the money to pay fees for these articles, but we are the people that need to see them the most. Please go forward with this proposal to make all research articles that receive your funding available at no charge. You are doing such an incredible service to parents of disabled children everywhere. Thank you. Linda Lukowski	Web Form
635	Town Hall Form Comments	03/17/2008 at 01:55:47 PM (245)	Albert	Karen	MLS	Chair, Medical Library Association Committee for Advocating Scholarly Communication	PA	US	Other						The NIH Public Access policy constitutes a noteworthy and positive step towards opening up access to the biomedical literature. While the mandate constitutes a significant compliance burden for researchers and their institutions, it also stands to confer long-term benefits on the conduct of research in general, and on individual researchers whose newly published work will likely gain visibility and citation impact. Patients will also benefit from broader access to the medical literature, which will accrue with time. These are points librarians can use to explain the reasons behind the mandate to their constituents. Some cancer center libraries have already taken action to create centralized support services for mandate compliance. As such, they post articles on behalf of their institution’s authors and provide additional support by interpreting copyright agreements and locating PMCID numbers. Other smaller research libraries are creating web pages of information and working with grants offices to ensure compliance. One concern is that a number of major publishers have not clearly indicated that their copyright agreements will allow authors to retain the right to comply with the mandate. Librarians and research administrators are consulting with legal counsel and approaching publisher representatives in order to ascertain the best approach to these situations. Also, the NIH Public Access FAQs do not address an exact deadline or specific number of days after publication acceptance that submission to PMC is expected to occur. It would be helpful to clarify this point and to provide FAQ information on how to post to the NIH Manuscript System on behalf of authors via an NCBI account. Finally, emailing the PMCID numbers to the author as well as the poster (librarian) following completion of the submission process would also help in retention of these numbers for future citing purposes in grant applications. Submitted by: Karen Albert, MLS, AHIP, Chair, Medical Library Association Committee for Advocating Scholarly Communication, and Library Services Director, Talbot Research Library, Fox Chase Cancer Center, Philadelphia	Web Form
636	Town Hall Form Comments	03/17/2008 at 02:07:14 PM (640)	FALCO	liz	RN	ROCK PSYCH CENTERR	NY	US	Patient or Representative of a Public Health Advocacy Organization						i WOULD LIKE TO SEE THE LEGISLATION ON RESEARCH DOCUMENTS BEING AVAILABLE AT NO COST WITHIN 12 MONTHS OF PUBLICATION BE PASSED.	Web Form
637	Town Hall Form Comments	03/17/2008 at 02:19:35 PM (514)	Greene	Karen	Ph.D.	Rockalnd Psychiatric Center	NY	US	Other Member of the Public						Research results, especially the outcome of those studies which were funded by public money, should be free and open to the public. It is not fair to pay for the research and then have to pay for the results, especially when the outcome or results of those studies may be critical to one's heal;th or wellbeing.	Web Form
638	Town Hall Form Comments	03/17/2008 at 02:20:53 PM (290)	Gaunt	Marianne	MLS	Rutgers University Libraries	New Jersey	US	Representative NIH Funding Recipient Organization						At Rutgers, the State University of New Jersey, the offices of the University Librarian, the Vice President for Research and Graduate and Professional Education, and University Counsel, have partnered to ensure compliance with the NIH Revised Policy on Enhancing Public Access to Archived Publications resulting from NIH-funded research. The University supports this new policy that will maximize both the impact of research and the development of new knowledge, and provide the U.S. taxpayers with direct access to the research results made possible by their substantial investments in the NIH. There are several ways in which the University is providing support to its NIH researchers to ensure compliance with the policy: Libraries will provide submissions to the NIH for Rutgers authors using the university’s institutional repository functionality; the Libraries, in collaboration with University Counsel, are providing copyright education and specific language that may be included in new copyright contracts; the Libraries are also assisting faculty and administrative assistants with information for those who have already signed copyright agreements and are unsure if they may have the rights to post in PubMed; the university’s copyright policy has language that encourages faculty to deposit their works in openly accessible archives; all deans in the sciences, current NIH grantees and their administrative assistants are being contacted to ensure that they are aware of the policy and how the university will support their compliance; websites for the Libraries and the Vice President for Research have coordinated information on the NIH policy and university support; library liaisons are contacting all faculty in the appropriate disciplines about the policy and will provide information and support; as part of ongoing procedures, the VP for Research and the Office of Research and Sponsored Programs will alert all new NIH grantees of the policy. The Libraries and the VP for Research are collaborating on a simple fact sheet that outlines various steps in the process and how the university supports their compliance.	Web Form
641	Town Hall Form Comments	03/17/2008 at 02:35:46 PM (619)	Wolpert	Ann		Massachusetts Institute of Technology (MIT)	MA	US	Representative NIH Funding Recipient Organization						MIT is pleased to have the opportunity to comment on the 2008 NIH Public Access Policy, as this policy manifests one of MIT’s most deeply held values and primary commitments – making research as widely available as possible. More open access to research directly supports MIT’s mission to “generate, disseminate, and preserve knowledge, and to work with others to bring this knowledge to bear on the world's great challenges.” MIT’s longstanding commitment to the principle underlying the Public Access policy is expressed in its open access innovations: the widely adopted models of OpenCourseWare and DSpace, as well as many other projects such as MIT World, TechTV, and OpenWetWare. MIT is therefore committed to complying with the new policy not only for legal reasons, but because it expresses a key component of MIT’s fundamental mission. Although implementing the policy will create short term challenges for MIT and its investigators, we do not view those challenges as a reason to delay implementation. In the short term, without a broader, institutional approach in place, compliance necessarily falls to individual authors who will need to ensure they retain sufficient rights to comply with the terms of their research funding. There is a tension inherent in this situation, which will at times leave authors and their institutions struggling with the need to execute hundreds of individual appropriate legal contracts with publishers in order to achieve compliance. MIT’s approach to implementation assumes that over time, all players in the scholarly communication chain – research institutions, authors, funding agencies, and publishers – will need to work together to find efficient procedures and policies so that publicly funded research is shared as widely as possible, for the benefit of taxpayers and the betterment of society. CONTINUED IN PARTS TWO AND THREE	Web Form
642	Town Hall Form Comments	03/17/2008 at 02:36:09 PM (558)	Keener	Molly	MLIS	Wake Forest University Health Sciences	NC	US	Representative NIH Funding Recipient Organization						On behalf of the Wake Forest University Scholarly Communications Committee, I am writing to voice our strong support for the full and timely implementation of the revised NIH Public Access Policy. Anticipating that the voluntary policy would eventually be strengthened to a mandate, in mid-2007 the WFU Libraries created a cross-campus, University-wide committee of librarians and faculty to address scholarly communications issues at Wake Forest, and begin laying the foundation for successful support of the NIH Public Access Policy. In preparation for the April 7 and May 25 implementation dates, the Libraries have been working with the Office of Research (WFU Health Sciences, Bowman Gray Campus) and Office of Research and Sponsored Programs (WFU, Reynolda Campus) to educate faculty researchers and research administration staff on the steps necessary to ensure compliance, specifically advocating the joint use of cover letters and copyright contract addenda to retain rights necessary for compliance. The Coy C. Carpenter Medical Library has featured articles and announcements about the policy in its quarterly newsletter and weblog, will offer scheduled classes on the policy throughout the spring and summer, and maintains a resources webpage on the NIH Public Access Policy (http://www.wfubmc.edu/library/nih). The Z. Smith Reynolds Library recently hosted a scholarly communications workshop, organized by the Committee, for staff from all three WFU Libraries to provide education on scholarly communications issues and author rights management, and to discuss strategies being developed by the Committee to address issues important to the University community, of which the NIH Public Access Policy is a key priority. As an institution that last year received 53% of all extramural research funding from the NIH, and with a Health Sciences division that received close to 70% of its total funding from the NIH during the past five fiscal years, we are dedicated to ensuring successful compliance by all WFU investigators as a means of guaranteeing that the vital research being conducted by our scholars continues unimpeded and is disseminated as broadly as possible. Molly Keener, Chair - Scholarly Communications Committee, Wake Forest University	Web Form
643	Town Hall Form Comments	03/17/2008 at 02:46:44 PM (905)	Stoltz	Melissa	BA	Public/Parent of child with cancer	TX	US	Other Member of the Public						As a parent of a child with cancer as well as someone who struggles with my own medical issues, current knowledge on treatment, outcomes, etc. is *extremely* important in order to make informed decisions about treatment and clarify knowledge about the health issues in question. Being able to read about the research provides me with a better picture of available treatment or of ways of handling the various effects, allowing me to ask more specific questions and make decisions based on wider knowledge. The information/questions I ask can and has resulted in better treatment and support for my daughter. The current practice of requiring a subscription or charging a fee for each article quickly goes beyond my ability to pay.	Web Form
644	Town Hall Form Comments	03/17/2008 at 02:47:50 PM (777)	Persily; Karen Butter	Gail	MLIS	University of California San Francisco, Library	CA	US	Representative NIH Funding Recipient Organization						These comments are submitted on behalf of the Library of the University of California San Francisco (UCSF). UCSF ranks among the top 10 NIH-funded institutions in the country with a strong mission of advancing health worldwide. We applaud the new NIH Public Access Policy and believe it will make a tremendous contribution to the advancement of science by leveraging the public investment in NIH to improve public health and providing new resources for scientists to use in new and innovative ways. At the UCSF Library, we have been engaged in efforts to educate our researchers about options for increasing access to their scholarly work through publication in open access journals and managing their copyrights to enable self-archiving in PubMed Central and the UC repository, eScholarship. For the past several years, many of our faculty have taken an interest in the issues of scientific publishing. At UCSF, we have been able to build upon existing initiatives in the area of scholarly communication in order to assist our campus with responding to the new NIH policy. We have coordinated communication with the campus office of contracts and grants to notify our researchers about the policy. The Library put up an informational website and questions regarding copyright compliance are being directed to our staff. Members of our faculty senate committees have identified an interest in understanding the copyright policies of the top journals where our researchers publish. We are in the process of developing a list of journals and determining their policies. The list of PMC participating journals provided by NIH is extremely helpful. However, faculty also want an easy way to know about the other publishers who will submit to PMC on behalf of authors. At the University of California, a letter signed by the Executive Director, Office of Technology Transfer and Research Administration, University of California, Office of the President is being sent to publishers notifying them that UC faculty will be posting their articles to PubMed Central. We are instructing investigators to enclose this letter with any articles submitted to publishers for possible publication or to append it to any copyright agreement with publishers. This letter significantly facilitates the process of compliance for our researchers. Our researchers are expected to handle their compliance with the mandate using their own staff and resources. The Library would also like to commend NIH for developing thorough and useful instructions and training materials. In particular, the slide presentations explaining the policy are very useful, as well as the tutorials that explain how to use the manuscript submissions system. As UCSF researchers begin the process of complying with the mandate, we will gain more knowledge about the effectiveness of the FAQ and other help materials provided by NIH. We will forward any comments for improvements at that time.	Web Form
645	Town Hall Form Comments	03/17/2008 at 02:51:38 PM (121)	Ferullo	Donna	MLS, JD	Purdue University	IN	US	Representative NIH Funding Recipient Organization						At Purdue University, we strongly believe in and support the concept of the NIH Public Access policy. The Libraries, the Office of the Vice President for Research, and the University Copyright Office are collaborating on structuring the implementation of the new policy. To date, notification of the policy and timelines is being sent to all faculty who have NIH funding: information on the process has been posted to the Purdue University Scholarly Communication web site; and informational sessions for faculty have been arranged in the coming weeks. There are some concerns that contracts between publisher and author might not, at least initially , fully integrate the language necessary to deposit the work with PMC. We also anticipate that as with any new policy more questions will arise as will suggestions for changes and improvements once the system is fully in place and has been operational for a period of time.	Web Form
646	Town Hall Form Comments	03/17/2008 at 02:51:43 PM (281)	Giesecke	Joan	D.P.A.	University of Nebraska-Lincoln	NE	US	Representative NIH Funding Recipient Organization						The University Libraries at the University of Nebraska-Lincoln, working with the Office of Research, UNL are very supportive of the NIH public access requirment. The University Libraries have established a system with the Director of Research Compliance using the university grant management system, and the university institutional repository system to assist researchers, and ensure that publications based on NIH funded projects will be deposited easily in PubMed. The reporting requirement is not a burden to the faculty, will ensure that results of funded research are available world wide, and will ultimately improve human health. Using the already established onine systems at UNL, faculty have easy access to the information they need to submit manuscripts to journals, to ensure copyright is handled properly, and for the Libraries to assist with the deposit of accepted manuscripts into PubMed and also into our institutional repository.	Web Form
647	Town Hall Form Comments	03/17/2008 at 03:00:04 PM (515)	burke	april	J.D.	Association of Independent Research Institutes	D.C.	US	Representative NIH Funding Recipient Organization						The Association of Independent Research Institutes (AIRI) is a nationwide association of nearly 90 non-profit independent research institutes that conduct peer-reviewed basic, translational, and applied research in the biomedical and behavioral sciences. As recipients of approximately 11 percent of NIH extramural research grant funding, AIRI is pleased to offer comments concerning implementation of the NIH Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research, which was mandated by Congress in the FY 2008 Consolidated Appropriations Act. Non-profit independent research institutes are stand-alone academic-style centers that offer scientists a focused research environment to conduct innovative science. Therefore, despite the fact that AIRI member researchers may not have an institutional repository to assist authors with depositing their manuscripts into PubMed Central, we stand ready, willing and able to comply with the requirement. Our Board has not expressed any concerns with this policy and actually believes that this requirement may enhance overall support for science once the public is able to view first hand the benefits that result from federally funded research. AIRI applauds NIH for undertaking the effort to implement the intent of Congress, and we believe the requirements are clear, easy to follow and do not constitute an excessive burden on our researchers or research institutes. We also enthusiastically support making our research available to all who can benefit from it. We thank you for the opportunity to express our views. We hope that you will continue to look upon AIRI as a resource on this and other issues. Should you require additional information, please do not hesitate to contact me at (405) 271-7410 (Chip-Morgan@omrf.ouhsc.edu) or Jon Retzlaff in the AIRI Washington office at (202) 289-7475 (jretzlaff@lewis-burke.com).	Web Form
648	Town Hall Form Comments	03/17/2008 at 03:03:15 PM (413)	Hoffman	Maggie		Project DOCC - Delivery of Chronic Care	NY	US	Patient or Representative of a Public Health Advocacy Organization						Public Access to publicly-funded research findings, articles, summaries, and analyses is critically important. Just as critical is the timeliness of access. Individuals, their doctors, and their family members depend on evidence-based clinical medicine as well as indicators from bench research Advocacy organizations work in partnership with medical providers to refine treatment and research guidelines that in turn are disseminated to individuals and their local physicians; they deserve complete information in a timely manner. There should be no more than a six month lag between journal publication and public access.	Web Form
649	Town Hall Form Comments	03/17/2008 at 03:13:45 PM (248)	samuels	barb		Cancer Patient	nj	US	Other Member of the Public						II feel to to our benefit to have the information available on a free basis to the public. Knowledge is power and the physicians etc can hellp interpret if necessary.	Web Form
650	Town Hall Form Comments	03/17/2008 at 03:25:04 PM (888)	Strong	Gary		UCLA University Librarian	CA	US	Representative NIH Funding Recipient Organization						On behalf of the UCLA Library, one of the top ten research libraries in the U.S., I write in support of the NIH open-access policy, which will make peer-reviewed, published research funded by the NIH freely available to the public through PubMed within twelve months of its publication date. The policy supports the mission of the UCLA Library in many ways. It provides broader access to and dissemination and preservation of scholarly research, both that conducted at UCLA and elsewhere. This enhances the free flow of information, which has untold benefits such as stimulating further ground-breaking research and giving the public access to articles about research and treatment options that may save lives. It respects the important role played by peer-reviewed journals, while at the same time making research conducted at UCLA – a public university supported by both U.S. and California tax dollars – freely available to the public whose tax dollars pay for that research. I strongly encourage you to keep the policy as it is currently written. It clearly supports Article I of the U.S. Constitution – "The Congress shall have Power…To promote the Progress of Science and the useful Arts..." – which established the purpose of copyright under U.S. law as to promote learning and the creation of knowledge. Thank you for your consideration.	Web Form
652	Town Hall Form Comments	03/17/2008 at 03:29:16 PM (951)	Banik	Naren	PhD	Medical University of South Carolina	SC	US	NIH-funded Investigator						1. Mark some applications “not recommended for resubmission.” The researcher does not agree with this recommendation because it would allow for novel applications to be rejected if they did not follow common beliefs concerning certain topics. While the Pioneer Award is aimed at recognizing higher-risk proposals, the researcher feels that grants could be rejected if they explored ideas that were out of the realm of current perceptions about disease/injury states or because the idea was tested without success in other models. 2. Amend applications considered as “new” – omitting rebuttals of criticism. The reviewer supports this recommendation. 3. Rate all applications by specific criteria and rank to reduce ambiguity. The reviewer supports this recommendation. 4. Shorter applications with focus on impact and innovation, less on methods and preliminary results. The reviewer supports the recommendation that less focus should be on methods that are standard in research and can be referenced in published literature. However, novel methods and altered disease models should be discussed if the information necessary to conduct the experiments is not available in published literature. The researcher also feels that focus should be kept on preliminary data that begins to support a hypothesis. However, large sample sizes and statistically significant data may not be necessary for all data presented. Also, addressing each specific aim in preliminary data should not be a requirement since many subsequent experimental designs may depend on the results from the previous specific aims. 5. Require at least 20% of effort to go to grant, to limit investigators with multiple grants. The reviewer supports this recommendation. 6. Consider separate review for new investigators. The reviewer supports this recommendation and would like to suggest that R21 grant proposals also be reviewed in separate study sections since the current protocol lumps R21 grants and R01 grants together in a single review process, which inadvertently creates a situation where the R21 is being compared to R01 grants.	Web Form
655	Town Hall Form Comments	03/17/2008 at 03:33:12 PM (725)	Mortali	Jill		Harvard Medical School	MA	US	Representative NIH Funding Recipient Organization						1. What about situations where we are junior authors on papers in which the senior author is not a Harvard faculty member? 2.What do I do about publishers that charge authors to make NIH funded manuscripts publicly accessible via PubMedCentral? 3. What do I do about the considerable staff time required to upload my publications to PubMedCentral? 4. Why does the list of journals which automatically upload to PubMedCentral not include many of the journals (Health Care Policy) that faculty members routinely submit to?	Web Form
656	Town Hall Form Comments	03/17/2008 at 03:33:53 PM (137)	English	Dr. Ray	PhD	Chair, SPARC Steering Committee, Azariah Smith Root Director of Libraries, Oberlin College	OH	US	Representative NIH Funding Recipient Organization						Many SPARC institutions have also been actively working to build awareness of the policy and its requirements, and to create mechanisms to smooth the compliance process. Member campus libraries have established online resources with up-to-date information and guidance on compliance; a number of campuses have convened meetings to provide researchers with further support; and some campuses have used e-mail, newsletters, and online grants management systems to ensure that researchers know about the policy and its requirements in a timely manner. Many SPARC members have established robust author rights management campaigns. These are now being deployed to specifically address questions related to the NIH policy and how authors may comply. Many universities are also providing explicit language to their authors to ensure proper copyright compliance. (See: http://www.mclibrary.duke.edu/nihpolicy for just one of many examples.) While these libraries are playing central roles in facilitating communication and compliance programs, they are by no means acting alone. On many campuses, these efforts have involved close collaboration among librarians, researchers, research administrators, and university counsel. SPARC’s members view the NIH policy as a welcome opportunity to work in concert with their campus colleagues and contribute directly to the mission of the institution – to promote and advance knowledge. SPARC commends the National Institutes of Health for issuing implementation guidelines in a timely manner and for being consistently responsive to queries about the process from our member organizations. SPARC applauds the National Institutes of Health for advancing this important policy, which will provide a rich and innovative suite of new resources – as well as access to critical biomedical research findings – to researchers on our campuses and beyond. Prompt implementation of this policy will accelerate the pace of research and discovery, fuel innovation, and serve the public good. SPARC looks forward to continuing to work with both its member libraries and the broader American academic community to ensure the policy’s success. [Part 2 of 2]	Web Form
657	Town Hall Form Comments	03/17/2008 at 03:34:41 PM (469)	Eaton	Nancy L.	M.L.S.	The Pennsylvania State University	PA	US	Representative NIH Funding Recipient Organization						Submitted jointly by the Dean of University Libraries and Scholarly Communications and the Vice President for Research on behalf of Penn State, we write in strong support of the new NIH public access requirement. We believe that this provision will assist in the dissemination of research and will aide in the creation of new research. At Penn State, the responsibility for submission will remain with the PI, though we are actively preparing PI's and faculty to be ready to comply via publicity, an information website, training, and a copyright release addendum.	Web Form
658	Town Hall Form Comments	03/17/2008 at 03:35:55 PM (633)	Todaro	Julie	D.L.S.	Association of College and Research Libraries	IL	US	Other						The Association of College and Research Libraries (ACRL), a division of the American Library Association (ALA), represents more than 13,000 academic and research librarians and interested individuals. ACRL has long supported the National Institutes of Health’s Public Access Policy, believing that ensuring public access to the fruits of publicly-funded research is a logical, feasible, and widely beneficial goal. Given increasing evidence that the cost of validating, packaging, and disseminating research results can be met through a variety of business models that complement public access, it is clear to ACRL that the NIH Policy will provide a public benefit and accelerate the advancement of knowledge. It is entirely in keeping with the missions of colleges and universities and their libraries. We are pleased that legislation was passed to make this policy mandatory. To help our members and their institutions with implementing the NIH Policy, ACRL is providing education, networking, and tools around the NIH Public Access Policy itself and the related issue of maximizing the use and impact of research and scholarship. For example: 1. Convening a live chat in late March so librarians can discuss how institutions are implementing the NIH Public Access Policy and how libraries could leverage this opportunity on campus. 2. Developed a short video, together with the Association of Research Libraries (ARL) and the Scholarly Publishing and Academic Resources Coalition (SPARC), to help librarians effectively engage disciplinary faculty and researchers on maximizing the use and impact of their scholarship. 3. Presented special joint one hour Webcasts for librarians, together with ARL and SPARC, called “Understanding Author Rights.” 4. Co-sponsoring with SPARC a regular twice yearly forum at the meetings of the ALA with topics including federal policy for public access and author control of copyrights. 5. Publishing a regular column in College and Research Libraries News on topics related to the changing system of scholarly communication, including federal policy and copyright. In summary, ACRL applauds the NIH on the Public Access Policy and is taking steps to support our members as they work within their institutions to implement this policy effectively. Sincerely, Julie B. Todaro President, ACRL	Web Form
659	Town Hall Form Comments	03/17/2008 at 03:46:21 PM (924)	Stoddart	Joan	MALS	University of Utah	UT	US	NIH-funded Investigator						I am pleased that the NIH submission mandate has finally become reality. As a librarian, PI of NIH funded contract and as a member of the public I fully support open access to NIH funded research. Our library can only afford a fraction of the journals we need and we are supposed to support clinical, educational and research needs in the entire state. Thank you for your efforts in this regard.	Web Form
660	Town Hall Form Comments	03/17/2008 at 03:47:53 PM (808)	Diamond	Jane	MPH	American College of Rheumatology	GA	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Thank you for the opportunity to comment. The American College of Rheumatology publishes two monthly peer-reviewed journals. The College has several concerns about the new policy, related to deposition of articles before they have been vetted by the copyeditors, the procedure for holding articles, and when the clock starts running. While peer reviewers vet the scientific merit of journal articles, they do not identify every subtle error in the data. This is done at the copyediting stage, after articles are accepted. In virtually every article in our journals, such errors are identified by the copyeditors. Frequently, the errors appear in the Results section and, if not corrected, may lead to misinterpretation of some of the study findings. The copyeditors identify errors by spotting inconsistencies in data presented in one part of an article versus another and rectify them with the author prior to the article’s publication. Such errors occur in articles accepted by all journals, even those authored by the most seasoned and respected investigators. NIH is now requiring that articles be deposited in PubMed Central immediately upon acceptance, i.e., prior to correction of errors in data. The ACR is pleased that although the policy requires that an article be deposited at this stage, the author may stipulate that it not be made open-access until a year after publication, at which time the article initially deposited will be replaced by the published version. The ACR already allows open access to every article in its journals one year after publication. Many other journals follow this same policy. Given the new policy requiring deposition of NIH-funded articles in PubMed Central upon acceptance, there are some procedural issues that seem unclear at this time: • Who will have access to the article in the uncopyedited form? If no one, why does NIH need it to be deposited in this form? • What will be the mechanism by which the author can direct NIH to make only the final published version available for open access? • How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal? Journals add considerable value to published papers by performing peer review; over 98% of papers eventually published undergo revision to improve the validity of the published product, benefiting future researchers as well as patients. The expense and effort of this process is supported entirely by the journals and not by NIH. Many investigators do not seem to be aware of this new policy, despite the fact that NIH plans to put it into effect April 7. Does NIH have a process to handle the questions that will arise from authors and journals? What will the repercussions be for investigators and journals who do not follow the process? The ACR urges NIH to delay this deadline so that authors and publications can adequately prepare for the deadline and these procedural questions may be adequately addressed.	Web Form
661	Town Hall Form Comments	03/17/2008 at 03:48:28 PM (927)	Dylla	H. Frederick	PhD	American Institute of Physics	MD	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Although the intent of public access policy is laudable, the issues underlying the implementation of this policy are economic and legal. Who pays for the value added after an author submits his/her manuscript to a publisher or institutional online platform? Should institutional platforms--like PMC--be using government funds to reproduce what is already effectively supplied by the private sector? Publishers (both for-profit and nonprofit)invest considerable resources in the editorial and production processes that underly high quality journals. They result in high quality articles that have been peer reviewed, copyedited, and properly referenced to the world’s scientific literature. The articles are then made available in online versions on highly reliable, digital platforms with evolving features. They are also published and distributed in print versions – the only form accepted by some archivists and librarians as archival. Publishers provide this added value to the submitted manuscripts and are compensated for this service under several business models. The models typically involve the reader paying (through institutional or individual subscriptions) or the author paying (by open access fees or page charges) or a combination of these. If the NIH public access policy is implemented without real engagement of the publishing community, the viability of the journal publishing enterprise—a significant asset to the scientific community and valuable means of distribution to the international scientific community—could be adversely affected. A critical concern is the value of copyright. NIH has put the onus of respecting the copyright onto the author. But publishers are willing to provide to authors and the NIH simple and streamlined methods of depositing the final, as-published versions of their manuscripts into PMC. In return, they ask that proper links to the publisher’s version should be included in PMC. We also ask that NIH makes it clear that payment of open access fees by authors are not only an allowable grant expense, but that funds are specifically provided for such publication. NIH is exceeding its legal mandate by distributing copies of the PMC version to websites hosted outside the U.S. and licensing re-use of the submitted materials by third parties. By authorizing the hosting of the PMC database outside of the U.S. and permitting third parties to obtain copies of the PMC database, NIH has greatly exceeded the provisions of the legislation. The emotional genesis of the NIH public access policy is well known: the discontent of NIH and institutional libraries with certain high-cost, biomedical journals. It is important that the well-recognized benefits of the majority of journals should not be jeopardized because of the discontent with a segment of high-priced medical journals.	Web Form
662	Town Hall Form Comments	03/17/2008 at 03:50:44 PM (865)	Olsen	Ben	BA	patient	CO	US	Other Member of the Public						Please give us FREE ACCESS to published results of government funded cancer studies....It will eliminate the current time-consuming need to drive to the nearest medical library and search the journals, and enable us to make better decisions as to diagnosis and treatment options. Thank you, Ben Olsen	Web Form
663	Town Hall Form Comments	03/17/2008 at 03:51:30 PM (368)	Lougee	Wendy	MLS	University of Minnesota Libraries	MN	US	Representative NIH Funding Recipient Organization						The University of Minnesota Libraries and the Office of Vice President for Research write to support the efforts that NIH is taking to ensure an effective implementation of the updated Public Access Policy (NOT-OD-08-033). We believe that this policy will speed the pace of discovery by expanding access to research findings supported with federal tax dollars in order to better advance science and improve health. The NIH public access policy directs welcomed attention to the issue of authors rights. Our University encourages faculty and students to exercise their interests in ownership and use of their copyrighted works in a manner that provides the greatest possible scholarly and public access to their work. We have worked over the past year on a number of initiatives to support this goal including conducting an educational campaign on authors rights http://www.lib.umn.edu/scholcom/au-rights.phtml. The University of Minnesota, as a member of the Committee on Institutional Cooperation (Big 10 schools plus Chicago) has endorsed an “addendum to publication agreements” for faculty to use with their publishers to retain rights for use of their work in their teaching, for posting on their personal websites, or depositing to institutional or subject repositories, such as PubMed Central. At the University of Minnesota, the University Libraries have partnered with the Office of the Vice President for Research to implement the policy by April 7, 2008. We have created a website to centralize all information and institutional advisories about the policy http://www.lib.umn.edu/scholcom/NIHaccess.phtml; met with faculty and administrative committees to discuss the policy and plan its implementation; prepared to assist authors with the submission process; developed plans to provide effective notice to Principal Investigators about their responsibilities; drafted a letter to publishers from the Vice President for Research for use by authors in the first submission of a manuscript that informs publishers of University of Minnesota intent to comply with the NIH policy and requests their support in permitting deposit of manuscripts; and, finally, we have shared best practice experiences with colleagues at other institutions. We urge the NIH to work with all stakeholders to reduce the administrative burden of compliance on institutions and authors, and to streamline the process wherever possible. Work to influence additional publishers to participate as “fully compliant” partners. Consider providing a master list of journals and their policies to guide author choice, and incorporate those lists into the NIH submission system. Thank you for your efforts to ensure a smooth implementation of the Public Access Policy. We think the policy will result in a significant improvement in access to health information that will benefit both our university and the publics it serves.	Web Form
665	Town Hall Form Comments	03/17/2008 at 03:54:52 PM (339)	Childs	John	PhD	Optical Society of America	DC	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						The Optical Society of America has made major strides forward within the worldwide Open Access movement. Our number-one-ranked Optics Express is one of the two oldest open access journals in the physical sciences. In addition, OSA offers an array of other open access alternatives. We are a “Leading Edge” member of SPARC (the Scholarly Publishing and Academic Resources Coalition), and OSA representatives have spoken on behalf of open access at any array of international conferences. Even with this unsurpassed record of commitment to open access, we nevertheless rely on our traditional journals to supply core financial support to our many other services to our community, which include significant efforts in science education for K-12 students and outreach to minority programs in science on all grade levels. As important, OSA’s journals offer common ground for our highly unified sector of physics. OSA is small by the standards of the large “general” scientific societies, which makes our journals all the more valuable in sharing research. No other publisher—commercial or nonprofit—is as dedicated to publishing peer-reviewed research in optics, and the loss of any of our journals would damage the free flow of information in one of the oldest branches of physics. Throughout OSA’s 90-year history, optical scientists have time and again broken new ground by bridging the apparent gap between traditional optics and other scientific fields. Authors in our journals have been responsible for the technology behind lasers, fiber optics, Polaroid photography, and an array of other breakthroughs with impact throughout the physical sciences. Most recently, we have allied ourselves with well-respected scientists in biomedicine to explore the many ways that optics can offer significant advances in medical imaging. Our efforts in consolidating research in fields like biomedical optics need careful nurturing. We are not certain that NIH has fully weighed the repercussions of mandated open access within small, highly respected scientific societies. We’re aware that our “big sisters” in physics and chemistry have clearly voiced their concerns in this matter. Yet as we hope we have made clear above, societies like OSA operate at even less margin than organizations that are household names. Our delicate margin and promising alliances for cross-disciplinary research may be impaired by NIH’s recent open access policy. We would very much like to state our case more fully as part of NIH’s decision-making policy. We agree with AIP, APS and others that a more “open access” rulemaking process would be helpful to all concerned—public, government, and scientific societies. We at OSA support more freely available research in our field, but we feel, along with AIP and APS, that scientists and the public would be better served by a process developed jointly by NIH and scientific society publishers.	Web Form
666	Town Hall Form Comments	03/17/2008 at 03:54:58 PM (149)	Ogburn	Joyce	MSLS, MA	University of Utah, University Librarian	UT	US	Representative NIH Funding Recipient Organization						The University of Utah supports the NIH Public Access Policy. We believe that it is essential to disseminate the results of critical research as widely as possible to spur additional research and innovation, improve treatment of diseases, and increase human understanding, as well as supporting patients and their families in making informed decisions. The NIH Public Access Policy will ensure that NIH funded research results remain broadly available for future use, not just the present, through a publicly supported repository. Having access to its own funded research will improve NIH's accountability and strengthen programs by making it easier to analyze investments in research and corresponding results. University of Utah researchers publish cutting-edge medical research, much of it funded by NIH. Our research will earn greater returns if it can be read and used by medical practitioners and researchers everywhere. Pubmed Central complements our institutional repository that contains research articles and other sholarly works from many disciplines. We are actively working on compliance and welcome the opportunity to contribute our research to Pubmed Central. The Eccles Health Sciences Library has established a web site to assist our researchers and the Office of Sponsored Programs is organizing compliance activities.	Web Form
667	Town Hall Form Comments	03/17/2008 at 03:56:34 PM (899)	Fox	Christopher	DMD, DMSc	International Association for Dental Research	VA	US	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						The International Association for Dental Research and the American Association for Dental Research are two 501c3 not-for-profit associations who publish the Journal of Dental Research. In the previous comment box we described the potential effects on small professional societies who self-publish. In this comment box, we propose a solution. To address these concerns, we believe that the NIH should undertake a formal Administrative Procedure Act Rulemaking. A Rulemaking would provide the public and all interested stakeholders with a formal mechanism for comment with adequate lead times and a formal procedure for NIH to address the concerns. All publishers, from the corporate publishing houses to the small professional societies, have questions not addressed in the NIH Frequently Asked Questions section of the NIH Public Access Website. Significant copyright concerns remain. To implement a policy by issuing a Notice just sixteen days after being signed into law, then seeking public input with an open meeting just eighteen days prior to the implementation date (with one week to prepare), will never be used as a case study in effective public policy with open communication from all stakeholders. Should the NIH undertake a Rulemaking, the final NIH Public Access Policy, taking into serious consideration comments from all stakeholders, would be greatly improved for the betterment of science, clinicians and the public.	Web Form
668	Town Hall Form Comments	03/17/2008 at 03:57:22 PM (478)	Courant	Paul	PhD	University of Michigan	MI	USA	Representative NIH Funding Recipient Organization						These comments are submitted on behalf of the University of Michigan Library. The University Library strongly supports the "NIH Revised Policy on Enhancing Public Access to Archived Publications Resulting From NIH Funded Research" (the NIH Public Access Policy). The University of Michigan is home to hundreds of researchers who receive funding from the NIH, and the University Library provides many kinds of support to those researchers. We are collaborating with external groups such as the Association for Research Libraries (ARL), and with other departments at the University of Michigan to ensure effective compliance with the revised Public Access Policy. We at the University of Michigan believe that ARL's comments accurately reflect the beliefs of its membership and the interests of research universities. ARL points out that the U.S. Government funds research with the expectation that new ideas and discoveries from the research will further scientific discovery, stimulate the economy, and improve the lives and welfare of Americans. When American taxpayers are funding research, it makes perfect sense that they should also have free, unfettered access to the fruits of that research. The access required by the revised NIH Public Access Policy will advance science, enhance U.S. competitiveness, and promote the public good, and the University of Michigan Library strongly supports its prompt implementation.	Web Form
669	Town Hall Form Comments	03/17/2008 at 03:57:38 PM (994)	Russell	Brad	MS	Pediatric Cancer Advocate	Connecticut	US	Patient or Representative of a Public Health Advocacy Organization						I am in full support of the policy to have NIH funded studies freely accessible. However, from the time a study is complete, it may be another 6 months to a year to have the study published. Therefore, waiting another 12 months to make that study freely accessible limits the timeliness of the information, especially for patients diagnosed with diseases where conventional treatment approaches have mixed results. In its present form, I believe the Policy is somewhat limited in its approach. While access to published studies is very important to many, access to NIH funded study protocols is equally important. Important for two reasons: first, unlike a published study which may detail research conducted as much as two years previously, NIH funded studies currently underway detail cutting edge research. Unfortunately, unless enrolled in the particular study, obtaining a trial protocol is not an easy task. Second, NIH funded studies typically build off of the published literature and, in doing so the written trial/study protocols provide an excellent summary of the research conducted to date and how the current study will advance the understanding of a treatment process. This is the kind of information extremely important for those seeking potential solutions that support, or go beyond, conventional approaches. While the NIH ponders the issue of making published studies freely accessible, as an interim measure I suggest the NIH make the study protocols from all NIH funded clinical trials accessible so those in need of alternative solutions will have the ability to obtain this information. To quote Margret Fuller, “If you have knowledge, let others light their candles at it”. Please, let us light our candles.	Web Form
670	Town Hall Form Comments	03/17/2008 at 05:09:23 PM (244)	Lowery	Bertha	?	Sister of a cancer patient	CA	US	Other						Although I am not as good at writing profound comments as are most of the entries posted here. I feel compelled to BEG you to make these studies available for FREE... I've watched my sister's frustrating efforts to obtain vital information to survive her bladder cancer.... and how hard it is for her to find it in our tiny little communitity! PLEASE keep the 'little people who are fighting for their lives' in mind as you address this subject! WHEN the researchers publsh their results, I see NO REASON to delay making the results AVAILABLE to the public! A few months MAY SEEM INSIGNIFIC to those who do NOT have cancer... HOWEVER a few months delay can be deadly to cancer patients. Thank You Bertha	Web Form
671	Town Hall Form Comments	3/14/2008 11:08 PM	Heitzman	Joanne				USA	Other						ase, please seriously consider making available to the public all the published results of BIH research in six months. Anything longer is too long to wait. Sometimes it is a matter of life and death and patients need to have access to this information as soon as possible. Your interest and consideration will be greatly appreciated	E-mail
672	Town Hall Form Comments	3/17/2008 5:00 PM	Phimister	James	Ph.D.	Elsevier	PA	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						1600 John F. Kennedy Blvd Philadelphia, PA 19103 March 17, 2008 Elsevier gratefully acknowledges the opportunity to contribute to the NIH meeting on Public Access and the opportunity to contribute to the NIH’s Public Access Policy Request for Information. Elsevier has an unqualified commitment to encouraging wide access to authoritative, peer-reviewed scientific, technical and medical research and continually tests new approaches to access and dissemination of research to meet the evolving needs of the diverse communities we serve. Due to the far-reaching implications of the NIH’s new Public Access Policy on grantees, authors, institutions and publishers, we urge the NIH to expand its consultative process and conduct a Notice and Comment Rulemaking as defined by the Administrative Procedures Act. We believe the public should be given an opportunity to comment on the new policy before it goes into effect. Indeed, in 2005, when the NIH introduced the voluntary Public Access Policy, the NIH stated: “We believe that the voluntary nature of the final policy is preferable to a ‘one size fits all’ requirement, as it permits sufficient flexibility to accommodate the needs of different stakeholders.” The significant departure from this position warrants a formal consultation with stakeholders. HHS should follow the Administrative Procedures Act and stay the effective date of the mandate until a full Notice and Comment Rulemaking is completed. We urge the NIH to ensure that the implementation of the policy will respect the basic principles embodied in copyright and not undermine those rights that provide incentives for publishers to invest in peer-review, publishing and the communication of scientific and medical research. Without sufficient consideration the mandatory Public Access Policy could have unintended and undesirable consequences. Rulemaking will ensure critical questions are addressed: A. PubMed Central (PMC) content overlaps with publisher content and PMC may compete with publisher websites. How will the NIH ensure that content on PMC will not displace the definitive published version, and what actions are the NIH undertaking to ensure that PMC does not undermine the viability of journals whose economic stability varies widely? B. Will the NIH share bibliographic usage information so that publishers can quantify the degree to which PMC is competing with publisher websites and resulting in loss of publisher website traffic? C. Revenue sources for publishers, including subscriptions, ‘one-off’ transactional sales, commercial redistribution rights, and online ad or classified display could be compromised threatening a publisher’s ability to cover costs or make new investments. How will the NIH ensure the policy will not negatively impact commercial, nonprofit and society publishers and will the NIH compensate publishers for the added-value of services that publishers provide? D. Many manuscripts currently appear on PMC in contravention to publisher policies. How will the NIH ensure individuals post the correct manuscript version to PMC to be publicly available at the correct time, as consistent with publisher policies? E. Third parties could commercially exploit content that appears on PMC without the consent of the publisher. How will the NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished and resold? F. In the NIH’s processing of manuscripts, manuscripts that appear on PMC may differ from the definitive version hosted by the publisher. How will the NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? For the past three years, Elsevier has sought to work collaboratively with the NIH in its implementation of the voluntary Public Access Policy. Elsevier has proactively identified authors who report NIH-funded research, deposited their manuscripts to PMC and actively monitored policy compliance. However, we consider the change to a mandatory policy a very significant step. It should not be done hastily. There is a fundamental difference between the government working with researchers and the publishing community to achieve common goals, and the government asserting rights to copyrighted content. In conclusion, we see STM publishing as a system that has developed over many years and is core to the continuing success of the research community. We are keen to sustain quality and balance in its continuing evolution. We wish to work collaboratively with all key players, particularly the NIH, to demonstrate leadership in optimizing this evolution, to address the issues we raise and to develop viable solutions that will benefit everyone. A rulemaking is an important and necessary step to continue to optimize this evolution. Sincerely, James Phimister, Ph.D. Elsevier 2	E-mail
673	Town Hall Form Comments	3/17/2008 4:36 PM	Binder	Steven	Ph.D.	IEEE Publications	NJ	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						17 March 2008 Elias A. Zerhourni, MD, Director National Institutes of Health 9000 Rockville Pike Bethesda, MD 20892 Via: Email to http://PublicAccessComments@nih.gov Subj: NIH Notice on Public Meeting: Seeking Comments on the Implementation of the NIH Public Access Policy, NOT-OD-08-057 (7 March 2008) Dear Dr. Zerhourni: On behalf of the IEEE, we are writing in response to the announced implementation plans for the NIH Revised Policy on Public Access. As one of the world’s leading not-for-profit scholarly publishers, the IEEE wishes to express concern that 1. The implementation of NIH Public Access pursuant to recent legislation embodied in the Consolidated Appropriations Act of 2008 (Public Law 110-161) appears to be proceeding with greater haste than is in the best interest of the public, and 2. The NIH should give serious consideration to enlisting experienced scholarly publishers to help implement Public Access Policy in a way that will provide maximum benefit to the public, and that 3. The NIH may not be fully aware of what we believe are important principles governing scholarly publishing. (See http://www.ieee.org/web/publications/rights/PublishingPrinciples.html). As you recall, the Senate committee report (110-107) associated with the FY08 LHHS Appropriations Act directed NIH to seek publisher input to ensure that publishers’ copyright protections are maintained under this new policy. The request for comments via web-based questionnaires and a brief public meeting to be held less than two weeks from the proposed roll-out of NIH’s public access policy does not seem to adequately comply with this Senate directive. The IEEE is concerned that, in NIH’s haste to move forward, it has not considered the full implication of the plan and we do not believe that speed to implementation is in the best interests of the public or publishers. We urge NIH to consider a number of alternatives that do not compete with publishers’ interests and that protect the copyright of publishers and their authors. With this in mind, we recommend that NIH consider the following: 1. A proposal to use services of experienced scholarly publishers, in lieu of developing a separate and costly repository of NIH-fund research. This could include a simple link from Pub Med Central to the publisher’s final version of the published manuscript. 2. The SCOAP3 model (Sponsoring Consortium for Open Access Publishing in Particle Physics) for supporting NIH-funded research. This would assume that NIH would reimburse publishers for the cost of making NIH-funded research publicly available, in lieu of author payment. IEEE recently expressed an interest in working with CERN and the SCOAP3 group to experiment in this area. The Institute of Electrical and Electronics Engineers, Inc. 445 Hoes Lane ● Piscataway, NJ 08854-4141, USA ● Phone +1 732 981 0060 ● Fax +1 732 981 0027 ● www.ieee.org The Institute of Electrical and Electronics Engineers, Inc. 445 Hoes Lane ● Piscataway, NJ 08854-4141, USA ● Phone +1 732 981 0060 ● Fax +1 732 981 0027 ● www.ieee.org IEEE’s core purpose is to foster technological innovation and excellence for the benefit of humanity. The IEEE is also committed to providing access to scholarly and professional publications in a convenient, timely, and affordable manner. Late in 2007, the IEEE developed a set of “Principles of Scholarly Publishing” that we believe is important to carry out our publishing mission successfully. In principle, IEEE is supportive of alternative publishing models, like public access, as long as there is a business model to sustain these activities. Among the publishing principles IEEE has adopted are: • Society benefits from an objective and intellectually free scholarly publishing environment that is unfettered by censorship or bias based on personal, commercial, or governmental agenda. • In order to perpetuate itself, scholarly publishing requires financial support from self-sustaining business models. • Copyright and intellectual property rights of authors and publishers must be protected in any publishing activity, including those that involve government-mandated policies on access to government sponsored research. We hope the NIH will respect the IEEE Principles Scholarly Publication as it implements the new public access policy, and again, we urge all parties to the discussion to read our entire set of principles at http://www.ieee.org/web/publications/rights/PublishingPrinciples.html. We hope you will give some consideration to these points and that the HHS and NIH will provide for a full Notice and Comment Rulemaking, rather than this brief request for information, in order to provide ample opportunity to provide comment on this important implementation. Sincerely, John Baillieul Vice President, Publication Services and Products Anthony Durniak Staff Executive, IEEE Publications	E-mail
675	Town Hall Form Comments	3/17/2008 4:56 PM	Martin	Frank	Ph.D.	American Physiological Society	MD	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						The American Physiological Society 9650 Rockville Pike Bethesda, MD 20814-3991 March 17, 2008 NIH Public Access Staff National Institutes of Health Transmitted via email to PublicAccessComments@nih.gov RE: NIH Notice of Public Meeting: Seeking Comments on Implementation of the NIH Public Access Policy NOT-OD-08-057 (March 7, 2008) To the National Institutes of Health: These comments are submitted on behalf of the American Physiological Society (APS). In addition to its views on the policy implications of the NIH proposal, the APS is submitting a legal analysis jointly commissioned by the APS and the American Association of Immunologists (AAI). The legal analysis was originally submitted November 16, 2004, in response to NOTOD- 04-64 (September 3, 2004) and is being resubmitted at this time. In NOT-OD-05-022 (February 3, 2005), NIH dismissed several issues raised in our legal analysis by stating that the points were not relevant since the May 2, 2005 Public Access Plan was voluntary. With the release of NOT-OD-08-057, the NIH Public Access Policy is no longer voluntary, which now makes certain legal issues raised in the earlier analysis germane. The APS/AAI legal analysis may be found as Attachment A. Request for a Rulemaking On March 7, 2008, NIH announced that it would conduct a public meeting on March 20, 2008, to discuss the agency’s implementation of the Revised Policy. That notice also announced that NIH would publish a Request for Information (RFI) in the Federal Register during the month of March, and that NIH would respond to comments within 120 days after the close of a 60-day comment period. However, that notice states that the Revised Policy will nevertheless go into effect on April 7, 2008. APS is pleased that NIH has chosen to solicit the public’s views regarding the important issues raised by the Revised Policy and looks forward to participating in that process. We believe, however, that NIH’s “regulate first, ask questions later” approach not only violates the letter of the Administrative Procedure Act (APA), but that it also violates the spirit of that statute. The APA requires that regulated entities and the public be given an opportunity to comment on the content of a regulation before it goes into effect, absent emergency circumstances -- an exception that is not relevant here. The APS believes that NIH is obliged to engage in notice and comment rule-making since the courts have held that the failure to engage in notice-andPage 1 of 53 comment rulemaking cannot be cured by an agency’s acceptance of comments after the effective date of a legislative rule such as the Revised Policy. In other words, permitting the submission of views after the effective date of the policy is no substitute for the right of interested persons to make their views known to the agency in time to influence the rulemaking process in a meaningful way. Consequently, the APS respectfully requests that HHS and NIH stay the effective date of the Revised Policy and grant the rulemaking petition that was submitted to HHS on January 11, 2008 as soon as possible. The NIH apparently recognized that it might have to comply with the APA in 2005. NOT-OD05- 022 stated: The Policy does not require investigators to do anything other than what the current rules require. While funding recipients may follow the Policy to fulfill some of their existing reporting requirements they need not do so and may continue to provide hard copies of publications. Inasmuch as the April 2008 policy now mandates deposit of manuscripts, this removes any flexibility in terms of how to comply. Thus, it is our view that as a mandatory requirement, the proposed policy is a rule-making which means that APA notice and comment and other procedural requirements for final agency actions must be followed. Recommendations The APS supports the principle of public access to science but believes that the NIH plan is not the right approach because it is not a collaborative endeavor. The implementation of this policy will come at great cost to the NIH, the research community and the American taxpayer. It will also cause disproportionate harm to not-for-profit societies that publish high-quality journals containing a significant amount of NIH-funded research. This group includes many publishers who have been at the forefront of providing free public access from journal websites within 12 months after publication. The APS believes that NIH could have achieved greater success 3 years ago had it enhanced the existing MedLine/PubMed web site to enable full text searches of articles on the journals’ own websites. Such searches would yield links to finished articles on those websites rather than access to manuscripts as PMC now provides. A number of publishers were interested in this approach, which would have led to the development of a comprehensive search engine that would do for biomedical research what search engines such as Google and Yahoo do for the web as a whole. The APS urges NIH to revisit this approach because it has a number of advantages to all parties. For NIH, this arrangement would make it possible to search the text of all biomedical research articles and not just the 10% that are based on NIH-funded research. Journals, and especially high-quality journals that publish a significant proportion of NIH-funded research, would still be able to determine their own access policies within a 12-month window and based upon their own cost recovery requirements. Finally, and perhaps most importantly, instead of access to manuscripts, this would make it possible to locate the final copy-edited articles of record presented in context with links to related materials such as commentaries and corrections. Page 2 of Specific Problems with the New Policy 1. Incorrect terminology The policy implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which states: SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law. The Public Access Frequently Asked Questions (FAQs) posted on January 11, 2008, has created confusion because it used the wrong terminology. In numerous places the document refers to journal articles rather than final peer-reviewed manuscripts as stated in the legislation. Specific instances where this occurs may be found in the answers to question 1 under General Information and questions #1 – 7 under Scope of the Policy. The confusion caused by multiple references to journal articles may encourage investigators to submit final published article to PubMed Central in violation of revised copyright agreements made in good faith by publishers such as the APS that grant NIH funded authors the right to make their accepted manuscripts publicly accessible through PMC 12 months after publication. NIH clearly knows the difference between final peer-reviewed manuscript and the final published article as evidenced by the FAQ response provided under C (“How to Comply With the Policy - #5. What is the difference between a final peer-reviewed manuscript and a final published article?”). All improper references to journal articles should be replaced immediately with correct references to final peer reviewed manuscripts. Moreover, NIH should draw attention to the correction and monitor information being disseminated by third parties to ensure that the misconception is not perpetuated. 2. Scope of the Policy The language in Section 218, PL 110-161 suggests that NIH-funded investigators must deposit every accepted manuscript into PMC whether or not the actual research reported in a given manuscript was supported by NIH. This is a significant issue for investigators who might receive funds from multiple sources including private sources. There is an implied threat that failure to do so might jeopardize future requests for NIH grant support. This requirement vastly expands NIH “ownership” of its grantees’ work. The 2005 NIH policy focused solely on the research funded by NIH. NIH must clarify the scope of the policy to ensure that investigators know with certainty which research manuscripts they must submit. Moreover, it should provide justification for its expansive claim to its grantees’ works. The 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” This was consistent with statements Dr. Zerhouni made during an October 2004 Page 3 of 53 meeting with publishers. During that meeting, Dr. Zerhouni encouraged publishers to maintain the subscription base of their journals by publishing reviews and other non-research materials. The inclusion of reviews under the 2008 mandatory policy breaks Dr. Zerhouni’s promise to publishers and will undermine the economic viability of these same society journals. The 2008 policy also threatens to exacerbate problems caused by NLM’s flawed implementation of the 2005 policy. The policy that went into effect on May 2, 2005 clearly stated that it “focused on final peer-reviewed manuscripts and publications that result from research supported, in whole or in part, with direct costs from NIH.” However, NLM failed to create a system that would screen out submissions that fell outside the scope of the policy. As a result, publishers had no choice but to police the site themselves and request removal of non-compliant articles one-by one in order to defend their legitimate copyright interests in those items. Under the 2005 voluntary Policy, investigators only submitted 4% of the NIH-funded manuscripts, with publishers submitting another 20-25% of the eligible manuscripts. Under a mandatory Policy, the volume of investigator submitted manuscripts will increase dramatically and so will the burden on publishers to make sure that authors comply with the terms of their copyright agreements. It is critically important for NIH to work with publishers to modify the NIH manuscript submission site to ensure that only manuscripts eligible for submission may be uploaded. As a publisher, the APS is prepared to work with NIH to address these issues. Another reason why non-compliant uploads may be expected to increase is confusion caused by NIH’s failure to make a consistent distinction between peer-reviewed manuscripts and articles in its FAQ. It is therefore all the more urgent that NIH modify its submission site to prevent the upload of non-compliant articles. Absent such action, it is difficult for publishers to believe that the NIH has any meaningful interest in protecting publishers’ copyright. Publishers have asked NIH to help protect publishers’ copyrights by creating a database of journal embargo periods as a means of assisting authors to comply. The request was denied because NIH did not want to influence the submission decisions of their investigators. There is a great tradition in scientific publishing that it is unethical for the funding agencies to influence where and how an article was published. However, NIH has now created a list of journals (http://publicaccess.nih.gov/submit_process_journals.htm) that submit articles directly to PubMed Central on behalf of authors. By providing the list, NIH may be perceived as encouraging authors to publish in a small subset of journals that have established a favorable relationship with the agency. NLM’s Mission The preservation of the biomedical literature is a responsibility mandated in NLM’s authorizing legislation, found at 42 U.S.C. 286(b)(1). While the NLM has done an excellent job of preserving the printed biomedical research literature going back to 1836, it has not devised a suitable plan to do so for digital content. The APS and other publishers have urged NIH to exercise its responsibility to preserve digital journal content in collaboration with journal publishers. Many publishers whose content will be subject to the new policy previously offered Page 4 of 53 to work with NLM to preserve the digital record by depositing the entire content of their journals for use within the NLM. NLM rejected this offer. Instead, the current plan will only preserve articles funded by the NIH, which comprise just 10% of the total biomedical literature. Many publishers have expressed a willingness to work with NLM on digital preservation and would deposit both NIH and non-NIH funded content to create a digital archive that would fulfill many of the goals of the NIH Public Access Plan. The viability of the archive could be assured through its use on the NIH campus and within the NLM with the understanding that public access would be provided via a link to the publisher’s online journal. In so doing, NIH would be able to preserve the scientific literature, maintain an archive for portfolio management, have the ability to search the entire scientific literature, and direct the public to free access available from the publishers. The maintenance of a complete archive by NLM would enable NIH to utilize it to set its research priorities, something that cannot be done with an archive that contains only 10% of the biomedical literature. The APS as a scientific publisher The American Physiological Society is a not-for-profit scholarly association founded in 1887 to promote the advancement of physiology. Today the Society has nearly 11,000 members who are scientists involved in physiological research and the teaching of physiology. APS members hold positions at colleges, universities, and medical schools and in industry, government, and independent research institutions. In the fulfillment of its mission, the Society publishes peer-reviewed journals; sponsors scientific meetings and conferences; and provides professional development opportunities for its members as well as educational and mentoring programs to identify, encourage, and train future physiologists. For its efforts in the latter areas, the APS was awarded the 2003 Presidential Award for Excellence in Science, Mathematics, and Engineering Mentoring. The Society publishes 14 journals that provide venues where research findings are validated through peer review and disseminated to other scientists. In 2007, 8,710 manuscripts were submitted to APS journals for peer review, and 4,642 of those manuscripts were ultimately published. The Society’s oldest journal is the American Journal of Physiology, which was founded in 1898, and its newest journal is Physiological Genomics, which was founded in 1999. Thank you for considering the comments we have submitted on behalf of the American Physiological Society. Sincerely, A A Hannah V. Carey, Ph.D. Martin Frank, Ph.D. President, American Physiological Society Executive Director, APS Enclosure Page 5 of 53	E-mail
676	Town Hall Form Comments	3/17/2008 4:25 PM	Smith	Kevin	J.D.	Duke University	NC	USA	Representative NIH Funding Recipient Organization						Duke University has consistently supported public access to the output of federal funded research. In 2006 our Provost was among a large group of high-level university administrators who signed letters supporting the Federal Research Public Access Act. Throughout the past year our library administration has worked with the Association of Research Libraries to encourage and support the National Institutes of Health in its efforts to make the voluntary program of deposit into PubMed Central of funded research articles a requirement of the funding. The Director of our Medical Center Library has also been very active in supporting this initiative. As the deadline to begin mandatory submission nears, Duke has engaged in planning for compliance that includes the Libraries, the offices for research support, the Vice Provost for Research and the Vice Dean of Clinical Research in the Medical School. A memo signed by the appropriate administrators outlining our initial plan for compliance with the mandate was sent to University researchers during the last week of February 2008 and to Medical Center researchers early in March. As Duke understands the new requirement, there are three elements to institutional and authorial compliance. First, authors must retain sufficient intellectual property rights, when they agree to publication terms, to be able to grant to the NIH a license to deposit the article in question into PMC and to make it available to the public within one year of publication. Second, the relatively simply online deposit must be accomplished, including, in many cases, verification by the lead author of the final PMC version of the article prior to public availability. Third, researchers will need to be able to document their compliance in progress reports, renewal applications and requests for new funding by providing PMC reference numbers for previous works. Our approach to each of these compliance steps is outlined below. The copyright issue is certainly the most complex. It is Duke’s strong hope and expectation that the NIH will continue to work with major STM publishers, and, indeed, with small journal publishers as well, to increase the number of journals that deposit NIH- funded research directly with PMC so that authors, whose primary concern is to advance scientific knowledge and for whom ongoing concern about copyright is a distraction from that work, will be relieved of the task. . It is likely that Duke would also support a decision by the NIH to assert its “government purpose” license in funded research articles to allow PMC deposit without the need to negotiate a second set of licensing terms. Until such time as these steps taken, however, Duke has developed a procedure to ensure that our researchers are able to grant the license to NIH that will be necessary for deposit. First, we have written and circulated to faculty a cover letter, signed by our research administrators, which each author is asked to include when s/he first submits to a potential publisher an article that results from funded research. That letter serves, first, to give any potential publisher of the article advance notice that the work is subject to the mandate. Second, the letter stresses our hope that the publisher will either accomplish PMC deposit on behalf of the author or, at least, will include explicit language by which authors will retain the right to comply with the NIH deposit requirement. Finally, the letter informs publishers that Duke authors will, if they have any doubt about their ability to grant the necessary license to NIH, attach an addendum to a final publication agreement retaining that right, and make their signature subject to that additional term of the contract. Again, it is our hope that this addendum will be necessary only very seldom, but we believe it will be necessary in some cases to ensure that Duke and its authors are able to comply without creating inconsistent contractual obligations. The second step in copyright compliance, obviously, is to provide the suggested addenda to faculty authors. At Duke we have chosen simply to use the language suggested by NIH that explicitly retains a right for PMC deposit. While we recognize that many institutions will want to use this opportunity to encourage authors to retain rights for a broader range of public access deposit opportunities, we chose this more conservative route for a couple of reasons. First, faculty policy at Duke is that authors retain their copyright in all of their scholarly works, and any institutional action that appears to compromise that retention will require careful discussion. The short time frame for NIH compliance suggests that a conservative approach, with the intention of using this opportunity to begin a broader conversation, is appropriate. Second, by using this very specific language, authors will have before them a model of the rights retention clause we hope will already be found in their publication contracts. By putting such a model in their hands, we hope it will be easier for them to determine whether the addendum is necessary. The materials sent to faculty do also include an offer to have the Scholarly Communications Officer, who is a librarian and a lawyer, review publication contracts whenever an author feels that would be useful. For the next stage of compliance – the actual mechanics of compliance – we are also taking a double approach in order to increase the likelihood of compliance. From what we have learned thus far, it seems that the mechanics of deposit will be somewhat easier if the researchers perform this step themselves. In order to make this easier, a group of librarians, from both the Medical Center and the University Libraries, will be trained in the deposit functions and will offer to faculty their assistance in completing the deposit process. Because some researchers will, inevitably, not wish to do this themselves, the Medical Center Library is also setting up a service by which they will oversee deposit for the small group that we expect to prefer this alternative. Finally, the Libraries will be prepared to help researchers locate the PMC reference numbers they will need to include in subsequent documentation filed with NIH. This is consistent with the Libraries’ usual role; librarians are always prepared to assist faculty in making the most efficient use possible of all online resources. In both of these last steps especially, the University Libraries and the offices of sponsored research will work together closely to ensure that, wherever authors turn for assistance, they are given accurate and consistent information and directed to those who can help them comply with the public access requirements as efficiently as possible. Duke has established a sensible and workable policy and procedure for complying with the NIH public access mandate. As noted above, the best thing that the NIH can do to assist us with compliance is to encourage publishers to participate directly in depositing their content into PubMed Central within the statutory period so that both the public interest and the needs of researchers will be better served.	E-mail
677	Town Hall Meeting Form	3/17/2008 4:03 PM	Dylla	Frederick		American Institute of Physics	MD	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						H.FrederickDylla,ExecutiveDirectorandCEOOnePhysicsEllipseMarch17,2008CollegePark,MD20740-3843TheHonorableEliasZerhouniTel.301-209-3131Fax301-209-3133DirectorTheNationalInstitutesofHealthE-mail:dylla@aip.orgBethesda,MD20892http://www.aip.orgSubject:CommentfromtheAmericanInstituteofPhysics(AIP)ontheImplementationoftheNIHPublicAccessPolicyDearDr.Zerhouni:TheAmericanInstituteofPhysics(AIP)isconcernedabouttheimplementationoftheNIHPublicAccessPolicy.AIP,anumbrellaorganizationfortenphysics-relatedsocietiesrepresenting130,000scientists,engineersandeducatorsisanonprofitpublisherofsciencejournals.AIPhasbeenfullycompliant1withtheNIH’spublicaccessonavoluntarybasis.Thiswasthecasebeforethe2007legislatedmandateandwillcontinuetobesoasoutlinedintheJanuary2008RevisedNIHPolicy.Nevertheless,wearegreatlyapprehensiveabouttheNIH’simplementationofthepolicyanditslikelyharmtotheintegrityandviabilityofpeer-reviewedscientificpublishing.WhileAIPandmanypublishersembracethelaudablelegislativegoalofpublicaccesstothepublishedresultsofNIH-fundedresearch,wetakeissuewithNIH’simplementationofthepolicy.ThecurrentandproposedNIHimplementationwillcompromisetheintegrityandusefulnessofthescientificrecordbypresentingresearchersandtheublicwithmultipleversionsofthesamearticle.Furthermore,NIH’simplementationofteninvolvesreprocessingpublishedresults,alteringformandsometimessubstance,resultinginthecreationofonlinepublicationsthatcompetewithjournalsofscholarlypublishers.AIPisalsoconcernedthatNIH,inthespiritofglobalpublicaccess,willdistributecopiestoWebsiteshostedoutsidetheUnitedStatesandlicensere-useofthesubmittedmaterialstothirdparties.MemberSocieties:Inadditiontoourdeepconcernaboutthenegativeimpactontheintegrityandviabilityofpeer-AmericanPhysicalSocietyreviewedscientificpublishingduetoNIH’sreprocessingandrepurposingofarticlespostedforOpticalSocietyofAmeriapublicaccess,therearesignificanteconomicandintellectualpropertyconsiderations.ThevalueofAcousticalSocietyofAmericacreatingapeer-reviewedarticleforNIHtopostentailssignificantcosts.WhowillpayfortheTheSocietyofRheologyvalueaddedtoaresearcharticleafteranauthorsubmitshis/hermanuscripttoapublisher?Uptothepresenttime,theanswertothisquestionhasbeenthescientificpublisher.ScientificpublishersAmericanAssociationofPhysicsTeachers(bothfor-profitandnonprofit)investconsiderableresourcesinthepeerreview,editorial,AmericanCrystallographicproduction,distributionandarchivalprocessesthatunderpinqualityjournals.InexchangeforthisAssociationaddedvalue,publishersarecompensatedunderavarietyofstandardandinnovativebusinessAmericanAstronomicalSocietymodels.Themodelstypicallyinvolvea)thereaderpaying(throughinstitutionalorindividualAmericanAssociationofsubscriptions)orb)theauthorpaying(byopenaccessfeesorpagecharges)orc)third-partyPhysicistsinMedicinepayments(forexampleadvertisingorsubsidies)ord)acombinationofallofthese.AVSTheScienceandTechnologySocietyAmericanGeophysicalUnion1AIPexplicitlyallowsauthorstodeposittheirarticlestoPubMedCentralwithfulOtherMemberOrganizations:authorizationtomakethearticlespubliclyavailableafteratwelve-monthwaitingperiod.SigmaPiSigmaPhysicsAuthorsmayalsochoosetopublishtheirarticlesbeforethetwelve-monthperiodhasHonorSocietyexpiredbypayingAIP’s“AuthorSelect”openaccessfee.AIPalsoofferstomaketheSocietyofPhysicsStudentsdeposittoNIHonbehalfoftheauthor,therebyensuringthat“therecordofscience”isCorporateAssociatesnotdistortedbyhavingmultipleversionsofthefinal,publishedarticle. Somehow the economic loss from the NIH taking of the publisher-paid, peer-reviewed articles, and, if used, the desirable NIH posting of a copy of the version of record article, needs to be compensated. NIH should make it very clear that author payment of publication fees for NIH posted articles are not only an allowable grant expense, but that funds are specifically provided for such publication. NIH should budget for such publication fees. AIP, as well as Congress, are concerned about how NIH will respect the vital intellectual property rights inherent in the copyright publishers obtain from authors. While NIH has been very careful to-date to put the onus of respecting copyright onto the author, a likely result may be to undermine the ability of authors to transfer the needed rights to a publisher. But AIP is willing to provide the NIH (and authors) simple and streamlined methods of depositing the final, copyrighted, peer-reviewed and as-published version of articles. In return, AIP asks that NIH provide proper links to the published version of record and facilitate the payment of author fees. For NIH to effectively implement the policy, NIH should address both the needs of the public for access and the continuing need for a vibrant scientific publishing enterprise. NIH should engage with scientific publishers and follow the full rulemaking process that the federal government has put in place for implementing new rules that have significant impact on the private sector. Without careful review, comment, negotiation, and implementation of NIH’s public access policy, some well-established and respected scientific journals might be so strained by government competition that publishers will be forced to cease or restrict their publication. Presumably, this is not NIH’s purpose. Sincerely, H. Frederick Dylla	E-mail
678	Town Hall Meeting Form	3/17/2008 3:21 PM	Jacobs	Madeleine		American Chemical Society	DC	USA	Patient or Representative of a Public Health Advocacy Organization						American Chemical Society 1155 SIXTEENTH STREET, N.W. WASHINGTON, D.C. 20036 Phone (202) 872-6310 Madeleine Jacobs Executive Director & CEO January 11, 2008 The Honorable Elias Zerhouni Director National Institutes of Health Bethesda, Maryland 20892 Dear Dr. Zerhouni: Now that the enactment of the Consolidated Appropriations Act of 2008 (PL 110-497) has changed the current NIH voluntary public access policy into a mandatory policy, I would like to suggest that NIH utilize an inclusive process, such as the rule-making process of the federal Administrative Procedures Act, to guarantee the widest range of views and inputs are heard, considered and evaluated before the new mandatory policy is implemented. As you know, the publishing community is deeply concerned that this new mandatory policy, if not carefully implemented, may result in conflicts with copyright law and intellectual property rights. These potential conflicts could interfere with scientific peer review of journal articles and adversely impact the sustainability of scientific journals. In enacting Section 218, Congress was aware that flawed implementation of a mandatory public access policy could create serious problems for the scientific publishing community which is why it included the statutory proviso directing “That NIH shall implement the public access policy in a manner consistent with copyright law.” Senate Report 110-107 further directs NIH to take the following course of action when implementing the new mandatory policy. The Report reads, in part: “…The Committee highly encourages collaborations with journal publishers that would enable them to deposit manuscripts on behalf of the funded investigator, if all parties agree. The committee directs the NIH to seek and carefully take into account the advice of journal publishers on the implementation of this policy. In particular, the Committee directs the NIH to ensure that publishers’ copyright protections are maintained…” The Honorable Elias Zerhouni 2 January 11, 2008 Given the statutory and legislative language on this matter, we trust that NIH will provide the publishing community with an opportunity for “notice and public comment” when devising rules implementing the mandatory policy. As this new policy would, in our view, be a major undertaking that will have a significant impact on publishers, I urge you to utilize the rulemaking procedures under the Administrative Procedures Act (APA) that have guided federal activities for over 60 years. Following the APA would assure that all stakeholders have an opportunity to provide input into the process. As you know, NIH followed an APA-like process when it published its proposed voluntary public access policy on September 17, 2004, in the Federal Register and provided the public an opportunity to offer comments on the proposal. NIH noted in publishing its final policy in the February 9, 2005 Federal Register that it was not required to follow the APA because of the voluntary nature of the policy, but did so in order to obtain public comment on the proposed policy. NIH noted that it received over 6,000 public comments. The public comments received on the proposed public access policy were quite thoughtful and provided value to the process as NIH modified its proposal and increased the timeframe for manuscript deposition into PubMed Central from 6 to 12 months citing the need to “ensure that peer review of scientific articles is preserved.” It would only seem logical and fair that since the mandate policy will carry with it the full enforceability of federal law that it should be subject to the APA process, which would allow comment from all concerned parties to ensure that it is implemented fairly and comports with the Congressional intent of complying fully with copyright law. If, for some reason, NIH does not follow the APA process, could you please advise me as to how you plan to involve the publishing community in implementing the mandatory public access policy to address issues such as copyright protection and scientific peer review? Sincerely, Madeleine Jacobs Cc: Brian Crawford, President, ACS Publications Division	E-mail
679	Town Hall Meeting Form	3/17/2008 3:21 PM	Smorodin	David		American Chemical Society	DC	USA	Patient or Representative of a Public Health Advocacy Organization						Comments of The American Chemical Society On the Mandatory NIH Public Access Policy Implementation Plan Announced January 11, 2008 March 17, 2008 Overview and Context of ACS’ Comments on the Implementation of the Mandatory Policy The American Chemical Society supports public access to the results of federally funded research but asserts that the implementation plan for the NIH Public Access Policy mandate does not abide with the law creating the mandate or with the sentiment and direction of the U.S. Congress, particularly as outlined in the Senate Appropriations Committee report that directed NIH to work with scientific journal publishers in implementing the new policy mandate. The NIH missed an opportunity to make its May 2005 voluntary public access policy a success by not proactively including scientific journal publishers as it developed its procedures and policies for the deposit of manuscripts reporting on NIH-funded research into PubMed Central. Consultation with publishers is critical in 2008 to prevent the agency from embarking on a similar collision course as it proceeds to implement the new mandate. Key to success will be NIH taking an active role, one based on openness and inclusiveness, to resolve the outstanding copyright and intellectual property issues that cut across a very broad and deep swath of the scientific journal publishing community. The ACS publishes annually approximately 4,000 articles that acknowledge NIH as a research funding source. ACS has tried to resolve outstanding copyright and intellectual property issues with NIH in connection with the Society’s efforts to deposit manuscripts directly with NIH PubMed Central on behalf of ACS authors who have elected to “opt in” to have the Society do so on their behalf. Despite ACS’ efforts, the NIH instructed ACS in December 2005 to suspend article deposition into PubMed Central; that prohibition has prevented the Society from depositing more than 3,000 manuscripts on behalf of ACS authors. During the 2005-2008 time period, NIH PubMed Central has accepted unauthorized postings of ACS copyrighted material, and repurposed and openly displayed such postings without adhering either to NIH’s own policy guidelines, or terms and conditions as set forth to NIH by ACS as rights holder. Issues of concern to ACS remain unresolved and will continue to be problematic and exacerbated under the new mandatory policy as outlined in NIH’s implementation plan issued on January 11, 2008. ACS hastens to point out that the vast majority, if not all, the Society’s copyright and intellectual property concerns could be resolved if NIH would abide the original intent of the Public Access policy and post without alteration or modification the unedited author versions of peer-reviewed manuscripts on PubMed Central—without any reformatting, repurposing or modification or any mirroring of content to third-party websites—and simply link back to the final published article as the authoritative version for readers on the Society’s own website. ACS Comments – NIH Mandatory Public Access Policy 2 ACS commends the NIH for announcing a public comment process on its planned mandatory policy implementation through a Request For Information notice to be published in the Federal Register, but questions the logic of proceeding with the announced implementation of the mandate on April 7, 2008 when the timeline for public comment submittal and the NIH’s response and possible amendment of the policy may not be complete until sometime in August 2008. ACS and Scholarly Publishing The American Chemical Society (ACS) is the world's largest scientific society with more than 160,000 members. We care deeply about the advancement of scholars and scholarship and pursue these goals through advocacy, publishing, conferences, information resources and professional development efforts. We have been doing so ever since publishing our first journal – The Journal of the American Chemical Society – in 1879. Our 36 peer-reviewed scientific journals are distributed globally in print and electronic media and showcase the world’s finest research in chemistry and related sciences. Articles that appear in our journals are widely regarded having received recognition of excellence and the visibility that content in ACS journals receives not only helps scholars achieve new scientific breakthroughs but also leads to practical applications that directly benefit human health and welfare and the world’s economy. Collectively our peer-reviewed journals form an informal but widely recognized hierarchy used by funding bodies and the academic community itself to assess research quality, impact, and priority—key factors used to allocate funding resources, evaluate levels of personal achievement, and determine professional advancement. We believe that it is in the public interest to foster this beneficial publishing activity and toward that end we invest heavily in staff and technology resources required to be successful in this endeavor. Copyright creates the opportunity for us to do this by sustaining our publishing enterprise. This is why, we trust, Congress has directed NIH to implement its Public Access Policy in a manner consistent with copyright law and respect for its underlying principles and why the Senate Appropriations Committee, in Report 110-107, directed NIH to “seek and carefully take into account the advice of journal publishers on the implementation of this policy” and “to ensure that publishers’ copyright protections are maintained”. We also believe that Congress considers, as we do, that the integrity of intellectual property is an essential criterion for the advancement of science as well as for innovation and creative activity. For all of these reasons we welcome the opportunity to comment on NIH’s interpretation of the mandate given to it by Congress and the implementation of its Public Access Policy. Our comments (attached) are organized into the following categories: • General Comments and Concerns, and • Specific Comments Relative to Copyright and Intellectual Property ACS Comments – NIH Mandatory Public Access Policy 3 General Comments and Concerns The American Chemical Society (ACS) expresses concern that NIH has not abided the law creating the new mandatory public access policy as stipulated in Division G, Title II, Section 218 of Public Law 110-161 (the Consolidated Appropriations Act of 2007) In enacting Section 218, ACS believes that Congress was aware that flawed implementation of a mandatory public access policy could create serious problems for the scientific publishing community which is why it included the statutory proviso directing “That NIH shall implement the public access policy in a manner consistent with copyright law.” In its implementation plan published on the NIH website on January 11, 2008, NIH placed the burden of ensuring copyright compliance on the individual researcher or institution, a directive that ACS asserts does not comport with the Congressional intent or guidance. Shortly after P.L. 110-161 was enacted, ACS submitted a letter (attached) to NIH Director Zerhouni wherein we proposed a constructive path forward for implementation of the new mandatory policy in consultation with publishers as rights holders. That letter, sent several hours before NIH posted its implementation plan, asked that NIH seek broad input into the formulation of its implementation plan, and recommended the appropriate method to do this is through the rulemaking procedures under the Administrative Procedures Act (APA), an Act that has guided federal regulatory activities for over 60 years. Following the APA would assure that all stakeholders have an opportunity to provide input into the implementation process and the oversight of NIH’s administration of the policy. ACS asserts that following the APA would be consistent with Senate Committee Report 110-107 which conveyed with P.L. 110-161. The report directed NIH to take the following course of action when implementing the new mandatory policy. The Report reads, in part: “…The Committee highly encourages collaborations with journal publishers that would enable them to deposit manuscripts on behalf of the funded investigator, if all parties agree. The committee directs the NIH to seek and carefully take into account the advice of journal publishers on the implementation of this policy. In particular, the Committee directs the NIH to ensure that publishers’ copyright protections are maintained…” Following an APA process would also be consistent with the approach NIH followed when it published its proposed voluntary public access policy on September 17, 2004, in the Federal Register and the public was invited to offer comment. NIH noted in publishing its final voluntary policy in the February 9, 2005 Federal Register that it was not required to follow the APA because of the voluntary nature of the policy, but had done so in order to obtain public comment on the proposed policy. NIH noted that it received over 6,000 public comments at that time. The public comments received were quite thoughtful and provided value to the process, as NIH modified its original proposal and increased the timeframe for manuscript deposition into PubMed Central from 6 to 12 months, citing the need to “ensure that peer review of scientific articles is preserved.” ACS Comments – NIH Mandatory Public Access Policy 4 It would only seem logical and fair that since the policy is now mandatory, and carries with it full enforceability of federal law that its implementation should now be subject to the APA process. That process would allow comment from all concerned parties to ensure the policy is implemented fairly and comports with the Congressional intent of complying fully with the protections that rights holders are afforded under copyright. It is hard to see how NIH’s implementation announcement on January 11, 2008 – 16 days after enactment – followed either the statutory language or the above referenced Senate Committee report language. ACS is unaware of any scientific journal publishers that were consulted in this 16 day window. In fact, as of the date of these comments, ACS has yet to receive a reply to the letter it sent more than two months ago that brought these concerns to the attention of the NIH Director. In announcing this public meeting on March 7, 2008, NIH has outlined its plans to publish a Request for Information (RFI) notice in the Federal Register asking for comments about the new mandatory Public Access policy and the effectiveness of the Policy’s implementation. According to NIH, the RFI notice will appear sometime in the month of March and will solicit comments for a period of 60 days. The RFI also states that NIH will respond to comments and announce any amendments to its policy within 120 days of the end of the comment period. Given that comments submitted under this process will not be received until May, and that NIH’s response to those comments may not be published until August—and yet NIH plans to implement its Public Access Policy in April—leads ACS to question what good can be gained by implementing a policy on April 7, 2008 only to possibly amend it later in the same year? ACS is unaware of any other federal mandate being implemented in such a disjointed fashion. A policy as important as this should be initiated only after a period of public comment and those comments have been carefully weighed and considered and any amendments found necessary have been made. ACS believes that an APA process would best abide the Congressional intent in both that statute and committee report. Specific Comments and Concerns Relative to Copyright and Intellectual Property Since 2005, ACS has made voluntary and good-faith efforts to facilitate the deposit of NIH-funded research into PubMed Central in a manner consistent with the Society’s interests in copyright. We have been prevented from doing so by NIH-generated intellectual property and process-related roadblocks that remain unaddressed by the agency to this day. We are concerned that such problems will remain unaddressed, and may even be exacerbated under the new mandatory policy. By way of example, ACS has in excess of 3,000 unedited peer-reviewed author manuscripts pending deposit with PubMed Central, as a consequence of NIH’s having refused to accept such deposits from ACS. NIH has rejected ACS’ right, as copyright holder, to establish reasonable safeguards on use of this material. ACS Comments – NIH Mandatory Public Access Policy 5 Instead, NIH has sought to appropriate copyright for itself - reformatting and altering submitted author manuscripts; “repurposing” deposited manuscripts in connection with their display in PubMed Central; and expatriating versions of that repository to countries elsewhere around the globe. In our view, implementing the Public Access Policy in a manner consistent with copyright law, and the intent of that aspect of its Congressional mandate, would mean that: A. NIH would respect the integrity of the copyrighted content it receives and ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles are undertaken only when consistent with copyright. Not only are there no mechanisms in place to do this, but also the range of uses outlined in NIH’s terms and conditions for manuscript deposit take substantial liberty with content to create unauthorized derivative works. ACS questions how NIH can proceed in this manner, as doing so would seem to disregard the intent of Congress. B. NIH would respect ACS’ right, as the copyright holder, to stipulate what it will or will not allow related to third-party use of its works. Instead, NIH has rejected ACS terms and conditions, designed to protect the integrity of the scientific record and, without permission or consultation, has linked content to a variety of online resources (or seeks the latitude to do so). For example, nothing in NIH’s implementation guidelines explicitly prohibits the licensing, selling, or distributing of links or access to content deposited within the PubMed Central database. C. NIH would acknowledge and support ACS as the copyright holder in the works deposited. Instead, the NIH website directs users to information which we assert undermines ACS’ copyright. In some cases, ACS’ copyright notice is not displayed or NIH’s site links to its own copyright information rather than that of ACS as rights holder. D. NIH would respect the trademarks and branding of the ACS. Not only has there been no affirmation of these markers of quality, but all too often branding information is missing − potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain. E. NIH would take steps to ensure copyright compliance for material deposited into PubMed Central. No mechanisms to do this are in place, even for content that that has been erroneously deposited by authors without authorization, or that does not fall within the scope of the NIH Policy, and thus should not have been made publicly available. This causes potential economic harm to ACS as publisher. F. NIH would provide a mechanism to incorporate the concerns of publishers as the policy evolves over time. No mechanisms to do this are in place or have been proposed − indeed, the implementation guidelines in connection with the mandated Public Access Policy was announced almost immediately after enactment of P.L. 110-161, without consultation with publishers, even as the NIH proceeded to inform other stakeholders. ACS Comments – NIH Mandatory Public Access Policy 6 G. NIH would respect ACS’ right, as copyright holder, to decide how its content will be disseminated. Instead, NIH, without permission or consultation, has made arrangements to mirror ACS content deposited on its site. A mirror site for PubMed Central has been established in the United Kingdom, and our understanding is that other mirror sites are planned or proposed to be located internationally. This raises important questions and concerns regarding copyright protections that would prevail in such circumstances for content located outside the borders of the U.S. We question also how such international mirror sites serve the needs of the U.S. taxpayer and the intended purpose of the NIH Public Access Policy as directed by Congress. H. NIH would support the integrity of the scientific record. Instead, NIH has declined to use a link to the final published article at a specified URL on the ACS’ own website as an alternative to the deposit and display of the unedited author’s version on PubMed Central. Furthermore, NIH has also chosen to use its own system of article identification (PubMed Identifiers) rather than adopt the widely- accepted Digital Object Identifier (DOI) as a means of identifying authoritative material and associating it with the rights holder of record. This adds to reader confusion as to the definitive version of the article, and by diverting web traffic from ACS’ final published article, poses economic harm in the process. It is unclear to us how NIH will manage and maintain such an identifier system, or the value that this system adds on behalf of the taxpayer. I. NIH would seek only the deposit of final, peer-reviewed manuscripts upon acceptance for publication. Instead, under the scope of the policy NIH allows, and even encourages, the deposit by authors of the final published version − without any provision for distinguishing the two versions, or for compensation in recognition of this federal taking of the publisher’s investment in the peer-reviewed version of the manuscript. In so doing, NIH is placing authors in potential conflict with publishers and their copyright or other publishing policies, or (at worst) steering authors to favor journals with policies consistent with a particular business model. ACS questions whether the intent of Congress was to enable NIH to engage in this interference with the private sector and authors’ to assign and transfer their copyrights in an unfettered manner. In addition to the issues summarized above, we note that the NIH has not implemented its current voluntary Public Access Policy in a manner consistent with its own self-created guidelines. For example, articles, including those from ACS, falling outside the NIH Public Access Policy implementation date of May, 2005 have been posted on the PubMed Central repository. Those and other posted articles are made openly available that should have been embargoed for 12 months. Final published articles in journal formal and with content copyrighted by ACS have been converted into NIH’s XML format and posted regardless of publication date. One of our own journal editors has expressed surprise that PubMed Central includes open access to articles he published prior to the policy implementation date − articles that were posted by others without his knowledge. These experiences indicate that NIH lacks adequate control over the posting of manuscripts on its own website. This must be addressed. ACS Comments – NIH Mandatory Public Access Policy 7 Mindful of these unaddressed implementation problems that affect protections provided under copyright, ACS is concerned that the new mandatory NIH Public Access Policy leaves key policy and implementation questions unaddressed, such as: 1. By what process will NIH establish criteria to ensure that publishers’ copyright protections are maintained? Why has NIH refused to engage in a notice and comment rulemaking that would help to assure publishers that such protections can be put in place? 2. By what process will NIH seek and take into account the advice of journal publishers in determining if it is implementing its Public Access Policy in a manner consistent with protections under copyright law, and the spirit of NIH’s Congressional mandate? 3. If deposited content will be “mirrored” to other sites outside the U.S., what process will be entailed for the establishment of such sites, and how would national and international copyright considerations be addressed to protect rights holders? 4. What limitations, if any, would be imposed on PubMed Central as an “aggregator” of content from sources such as HHMI, Wellcome Trust, other U.S. government agencies, etc? 5. Will NIH negotiate terms and conditions with publishers for the use of NIH grant funds to enable the deposit of copyrighted works on behalf of authors? Will NIH make such payment directly to publishers on behalf of its grantee authors? 6. How will NIH identify grant funds allowable to be used for the payment of publication fees? Will supplemental funds be made available to support author compliance with the mandate? 7. What steps will NIH take if it is found that its Public Access Policy is harming publishers? 8. Why has NIH refused to work with publishers to gather and share PubMed Central usage statistics on copyrighted content? Should this information not be considered as in the public domain, as it is funded with taxpayer monies? Why should articles be freely available, but information about the usage of those same articles be hidden? 9. How will NIH ensure that articles on PubMed Central meet ACS requirements, such as the access-control period, and that the policy actually applies to the articles that it is posting? 10. How will NIH prevent piracy of the articles from PubMed Central? At present, publishers are not protected from systematic downloading that could occur from the NIH website; pirates also could disseminate paper copies of article content, and undermine publishers’ economic interests. What will happen if piracy is discovered as a result of downloading of content from PubMed Central? ACS Comments – NIH Mandatory Public Access Policy 8 11. What provisions will be made to evaluate whether the policy is effective in achieving its intended purpose of promoting public access by US taxpayers to NIH-funded research? As announced, the policy makes no mention of mechanisms for oversight of NIH’s implementation efforts, to ensure that the policy’s scope and operational costs are contained. What “sunset” provisions will be made so that the policy mandate may be amended or phased out if it proves to be ineffective, too costly to maintain, or too disruptive to the peer-reviewed scientific publications on which ultimately it relies? Regardless of the questions and serious nature of the issues raised above, we choose not to believe that NIH is willfully disregarding copyright law and Congressional intent in the implementation of its Public Access Policy. However, ongoing consultation with publishers such as ACS is needed to ensure that NIH does not misapply its Congressional mandate and do irreparable harm to the very fabric of scholarly publishing that supports scientific research and our nation’s competitiveness. ACS is willing and able to work with NIH and other key stakeholders to establish the kind of productive ongoing dialog that we feel will truly maximize the sustainable dissemination and discoverability of knowledge in chemistry and the allied sciences, and fulfill the intended purpose of the Congressional mandate in serving the public interest. Thank you for this opportunity to share the views of the American Chemical Society with you. If you have any questions, please feel free to contact: Submitted By: David Smorodin Assistant General Counsel American Chemical Society 1155 Sixteenth Street, NW Washington, DC 20036 Telephone - 202-872-4510 E-Mail - d_smorodin@acs.org. .	E-mail
680	Town Hall Meeting Form	3/14/2008 3:06 PM	Suber	Peter		SPARC			Patient or Representative of a Public Health Advocacy Organization						The new NIH public access policy serves the public interest and is long overdue. I oppose attempts by the publishing lobby to delay its implementation. Congress asked for a mandatory policy in 2004, but the NIH adopted a voluntary policy instead. The compliance rate for the voluntary policy ranged from 4% to 15%, and failed to meet the objectives of Congress and the agency. It's no exaggeration to say that we've waited more than three years for the strengthened policy to take effect and exert its beneficial effects on medical research and healthcare. Further delay would further delay those benefits. The policy has been thoroughly vetted. The NIH released its first draft policy for a 60 day period of public comments, ending on November 2, 2004, and later extended the period by two weeks. The agency received more than 6,000 comments, which Director Elias Zerhouni described as "overwhelmingly supportive." In addition, the NIH held multiple meetings with stakeholders, including publishers. The bill to strengthen the policy (Consolidated Appropriations Act of 2008) was subject to amendment on six occasions from June to October 2007. Senator James Inhofe actually filed two amendments in October, one to weaken the language on the NIH and one to delete it, but withdrew them both when he couldn't drum up enough support. The NIH provision was subject to amendment again in December 2007, after the Bush veto, when Congress had to cut provisions to make the bill acceptable to the President. Publishers are mistaken to say that the policy violates copyright. Indeed, the policy uses a simple, effective method to avoid any question of copyright infringement. When NIH grantees publish articles based on NIH-funded research, they must now retain the right to comply with the public access policy, even if they transfer all their other rights to publishers. As a result, public access by the NIH is expressly authorized by the copyright holders. The only aspect of the policy I would change is the permissible 12 month embargo between publication in a peer-reviewed journal and public access through PubMed Central. I would reduce this to six months, the period used in similar policies from the Arthritis Research Campaign (UK), British Heart Foundation, Canadian Breast Cancer Research Alliance, Canadian Institutes of Health Research, European Research Council, Cancer Research UK, Chief Scientist Office of the Scottish Executive Health Department, Department of Health (UK), Fund to Promote Scientific Research (Austria), Genome Canada, Howard Hughes Medical Institute, Joint Information Systems Committee (UK), and the Wellcome Trust (UK). Any delay is a compromise with the public interest, and delays are more harmful in medicine than in any other field. The public access policy is badly needed to insure that the large volume of high-quality medical research produced by the NIH is made available to everyone who can make use of it: researchers whose universities cannot afford access to the full range of biomedical journals, practicing physicians without university or large-hospital affiliations, non-profit disease advocacy organizations, and patients and their families. It's not true that all who need access already have it. The best evidence that free online access to peer-reviewed research meets a large unmet need is that open-access articles are cited 50-250% more often than non-open-access articles published in the same issues of the same journals. Sincerely, Peter Suber Senior Researcher, SPARC Visiting Fellow, Information Society Project, Yale Law School Research Professor of Philosophy, Earlham College Open Access Project Director, Public Knowledge	E-mail
681	Town Hall Meeting Form	3/14/2008 3:37 PM	Gross	Lauren	J.D.	The American Association of Immunologists	MD	USA	Patient or Representative of a Public Health Advocacy Organization						President Olivera J. Finn, Ph.D. Vice President Arthur Weiss, M.D., Ph.D. Past President Lewis L. Lanier, Ph.D. Secretary-Treasurer Steven J. Burakoff, M.D. Councillors Betty A. Diamond, M.D. Jeffrey A. Frelinger, Ph.D. Leslie J. Berg, Ph.D. Gail A. Bishop, Ph.D. Executive Director M. Michele Hogan, Ph.D. The AMERICAN ASSOCIATION OF IMMUNOLOGISTS Comments of The American Association of Immunologists Regarding the Implementation of the NIH Public Access Policy Notice Number: NOT-OD-08-057 March 14, 2008 The American Association of Immunologists (AAI), a professional association of more than 6,500 research scientists and physicians dedicated to understanding the immune system, and the publisher of The Journal of Immunology (“The JI”), the world’s most cited immunology journal, respectfully submits the following comments regarding the implementation of the National Institutes of Health’s (NIH) Public Access Policy. AAI has strong concerns about the implementation of the NIH Public Access Policy. The Policy, as enacted by the Consolidated Appropriations Act of 2008 (P.L. 110-161), requires that “all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.” AAI continues to believe that the NIH Public Access Policy will duplicate, at great cost to NIH and to taxpayers, publication services which are already provided cost-effectively and well by the private sector. The private sector, including not-for-profit scientific societies, already publishes - and makes publicly available - thousands of scientific journals that report cutting-edge research funded by both NIH and other public and private entities. Rather than creating a new government bureaucracy, a particular burden in this era of severe budget constraints, NIH should partner with these publishers to develop a plan that enhances public access while also addressing publishers’ key concerns, which include ensuring journals’ continued ability to provide high quality, independent peer review of NIH-supported research. AAI is also concerned that the information that NIH has provided to investigators and institutions mischaracterizes the plain language of the federal law. The Consolidated Appropriations Act of 2008 (P.L. 110-161) requires “(t)hat the NIH implement the public access policy in a manner consistent with copyright law.” And yet, in its Notice and Revised Policy Statement dated January 11, 2008 (NOT-OD-08-033), NIH shifts what is clearly its legislative responsibility to ensure (i.e., that the Policy respects publishers’ copyright rights) to institutions and investigators: “Institutions and investigators are 9650 ROCKVILLE PIKE, BETHESDA, MARYLAND 20814-3994 PHONE: 301-634-7178 * FAX: 301-634-7887 E-MAIL: INFOAAI@AAI.ORG * WEB: WWW.AAI.ORG responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy.” This is clearly creating concern and confusion among investigators and institutions and must be addressed in a way that eases compliance for authors while respecting publishers’ rights. AAI has significant concerns about the legality of NIH’s implementation plans. As AAI pointed out in a legal brief commissioned by AAI and the American Physiological Association (APS) in 2004 when NIH proposed a mandatory program (see AAI’s position and the full legal brief at http://www.aai.org/News_Board/CommentsNIHPublicAccess.pdf), the following questions, among others, must be addressed before any implementation plan is adopted: • whether NIH has complied with the Freedom of Information Act (and has considered its impact on patent applications); • whether NIH has complied with the provisions of the Administrative Procedures Act and whether the notice provided to the public under this Act, and the opportunity for public comment, has been satisfied; • whether NIH has complied with OMB Circular A-76; and • whether NIH has complied with the Regulatory Flexibility Act and the Paperwork Reduction Act. Even if NIH addresses the above concerns, AAI needs additional information regarding NIH’s implementation plans in order to be able to submit thoughtful comments in response to NIH’s upcoming Request for Information (RFI) on the NIH Public Access Policy (see NOT-OD-08-057). Therefore, AAI respectfully requests that NIH respond to the following questions before the RFI is published: 1. What are the total funds that were expended on implementing the voluntary NIH Public Access Policy (May 2, 2005 – January 11, 2008)? 2. What is the cost anticipated for implementation of the mandatory NIH Public Access Policy in FY 2009? 3. How much of the cost anticipated for implementation in FY 2009 will be a one-time implementation cost, and how much will be an annual implementation cost? 4. In responding to the above 3 questions, please report the costs incurred by the National Library of Medicine (NLM) as well as the various NIH Institutes, Centers, and Offices involved, including: a) the number of FTEs and contracted services used to accommodate this initiative; b) the cost of personnel and administrative services for this program (including associated space for infrastructure and personnel); c) time spent directly on the promotion, management, enforcement and assessment of this program to/by NIH grantees and the public; and d) all costs associated with network infrastructure improvements including but not limited to bandwidth capabilities, server capacity, and equipment. 5. What steps is NIH taking to ensure that it posts only articles that comply with a particular publisher’s embargo period? 6. Who will be responsible if the publisher’s embargo period (and therefore the publisher’s copyright rights) is violated? 7. Who will ensure that NIH complies with a publisher’s copyright rights once a manuscript is submitted (i.e., who will make sure that NIH does not transfer a manuscript to any other entity/repository without permission from the publisher)? 8. Who within NIH/the various Institutes will be responsible for determining whether a grantee is in compliance? (Institute directors, Program officers, etc.?) 9. What will be the penalties for non-compliance by a grantee? Will it matter if the non-compliance is intentional or inadvertent? 10. Why won’t NIH accept the “Linking Proposal” offered to NIH in 2005 by fifty-seven not-for-profit scientific publishers, which would provide seamless links on PubMed Central to the journals’ websites, enable readers to access the full text of any article funded by NIH (and in many instances, the full text of all articles published in the journal, irrespective of funding source)? This proposal has the following advantages: a) it provides the public with free access to all published articles funded by the NIH b) it provides access to the final, copy-edited articles c) it is cost effective, since the NIH would not have to create a new repository, educate grantees about compliance and copyright, or monitor for compliance d) it addresses publishers’ copyright concerns e) it satisfies the new law f) it complies with copyright law by ensuring that an article cannot be posted before the journals’ embargo period is over • In subsequent conversations with NIH about this Linking Proposal, publishers offered to consider ways to satisfy NIH’s need for a repository of all NIH-funded works, i.e. to help NIH populate a “dark archive” for internal NIH use only.	E-mail
682	Town Hall Meeting Form	3/14/2008 4:08 PM	Kosden	Laura		American Dental Association	IL	USA	Patient or Representative of a Public Health Advocacy Organization						AMERICAN DENTAL ASSOCIATION Concerns Regarding Implementation of Public Access Policy On Behalf of The Journal of the American Dental Association Public Comments to NIH March 14, 2008 The American Dental Association (ADA), America’s leading advocate for oral health, supports the goal of providing important health information to the public. With that goal in mind, the ADA established its own public access policy several years ago for The Journal of the American Dental Association. That policy calls for an embargo period of 1 year after publication before a published article can be released to the public. The Association also supports the NIH Public Access Policy, provided that the policy is implemented with the necessary rules in place to protect the public, the journal authors, as well as the publisher’s intellectual property rights and financial investment. Therefore, the ADA is urging the NIH to delay the policy’s implementation until public comments are heard and an official rulemaking process is established. It is the ADA’s strong belief that the lack of open rulemaking to guide the implementation of this policy, combined with the impossibly tight deadline, has created numerous unresolved problems that we have identified below and that require further clarification: 1. COMPLIANCE DEADLINE. The NIH has imposed a deadline of April 7 for authors to comply with this Public Access Mandate. This deadline is nearly impossible to meet. Although the NIH has taken the position that the responsibility for complying is up to the funded author, the agency ignores the role that publishers must play in this process. Foremost, publishers must provide a service to their authors to ensure that they have a clear understanding of the government’s policy and how it affects their submissions to a peer-reviewed journal. On any new significant policy change, publishers must take numerous steps to inform authors about the new requirements. This includes revising the publisher’s author guidelines and copyright transfer forms in addition to announcing the policy change through its publications, its Web site, and other means. Such announcements would reinforce the publisher’s embargo period and intellectual property rights. 2. COPYRIGHT CONTROL. Considering that Congress passed the public access legislation on the condition that the NIH implement its Public Access Policy “in a manner consistent with copyright law,” it is unclear what process the NIH has established to protect a publisher’s copyright on articles deposited with PMC—particularly in view of the global reach of the Internet. Piracy, either intentional or otherwise, is a serious concern for publishers, especially if a deposited manuscript is out of the publisher’s control because it has been posted on another Web site. It is not sufficient for the NIH to simply refer inquirers to the publisher. 3. DISCLAIMER AND COPYRIGHT STATEMENT. In view of the concern noted above, the ADA is requesting that all deposited manuscripts contain the publisher’s copyright statement as well as a disclaimer stating that the manuscript is the author’s submission, that it may contain errors because it is not the final edited version of the manuscript, and that the reader therefore should be directed to the publisher’s Web site for the definitive published manuscript. Otherwise, the public will not have the correct and final version of the published manuscript. 4. NOTIFICATION OF PUBLICATION DATE. It is unclear how the NIH intends to ensure that it is complying with publishers’ embargo policies before posting accepted manuscripts. According to NIH policy, the agency will honor a publisher’s embargo period before releasing a manuscript to the public. However, there is no mechanism in place for notifying the NIH about the publication date and who is responsible for doing so. At the time an author’s manuscript has been accepted for publication, the publication date generally is not known. 5. MULTIPLE ACCEPTED VERSIONS OF THE SAME MANUSCRIPT. The Public Access Policy as stated lends itself to the possibility of an author posting, inadvertently, multiple versions of the same accepted manuscript: edited and unedited. As the NIH may be aware, a number of publishers have had to police the NIH deposits because of the need to remove several different versions of the same manuscript; many of these manuscripts have been released before the close of the publisher’s embargo period. This does not appear to be a benefit to the public. During the copyediting process following acceptance, the title of a manuscript may change along with its content. It is not clear how the NIH will track the same manuscript, if at all, to ensure that multiple versions of the manuscript are not being disseminated to the public. 6. LINK TO PUBLISHER’S WEB SITE. It also is unclear to the ADA why the NIH will not simply link to a publisher’s Web site for the final, correct published version of a manuscript. There is no rationale for maintaining an unedited manuscript if the final version has been made available in public access on a publisher’s Web site. At a minimum, the NIH should provide a link within the author’s manuscript to the publisher’s Web site for the final published version. 7. PUBLICATION COSTS. A publisher’s costs for establishing an effective, peer-review editing and publication process far exceed those of an author’s grant. Therefore, the NIH should be subsidizing these costs to create an environment in which the publisher and author may continue to “publish, or otherwise perish.” Furthermore, if not enforced properly, the NIH policy as briefly stated will have a measurable and adverse impact on a publisher’s subscription income that helps to subsidize publication. 8. FUNDED MANUSCRIPTS. The briefly stated NIH policy does not clarify which funded manuscript must be deposited with PMC. For example: If an author who receives some NIH funding as part of his or her salary and produces an article that is not specifically NIH supported, does this article need to be deposited with PMC? 9. NIH INFRASTRUCTURE AND OVERSIGHT CAPACITY. The ADA is concerned that the NIH may not have the technical capability or substantial resources to suddenly accept tens of thousands of author deposits. This problem may lead to the lack of proper oversight by the NIH to ensure that only one version of a manuscript is posted on PMC. 10. QUICK RESPONSE MECHANISM. Because of a lack of clarity within the NIH policy—and its own Q&A on the NIH Web site—it is important that a quick response mechanism be established to answer author and publisher questions. For example: a) How long will it take to respond to a specific, deadline-driven inquiry from either the author or publisher? b) Can the NIH establish a help desk with a published phone number for a rapid response to inquiries? Thank you for your consideration of the ADA’s concerns. _________________________________ Submitted by Ms. Laura A. Kosden Managing Vice President and Publisher Publishing Division American Dental Association 211 East Chicago Avenue Chicago, 60611 312-440-2790 kosdenl@ada.org	E-mail
683	Town Hall Meeting Form	3/13/2008 11:52 AM	Reinhard	Robert		Community Advisory Board Member	CA	USA	Patient or Representative of a Public Health Advocacy Organization						Robert Reinhard 425 Market Street, 32nd floor San Francisco, CA 94105 March 13, 2008 Dr. Neil M. Thakur, Ph.D. Special Assistant to the NIH Deputy Director for Extramural Research Building 1, Room 134 Bethesda, MD 20892 PublicAccessComments@NIH.gov RE: NOT-OD-08-057 - Notice of Public Meeting: Seeking Comments on Implementation of the NIH Public Access Policy 1 To the NIH and Dr. Thakur: Please accept these comments on the NIH invitation to meet on March 20, 2008 to discuss implementation of the NIH Access Policy. I have followed development of the policy since its origination in 2004 efforts and have commented previously to NIH in my capacity representing participants in NIH funded research to treat and prevent HIV infection. I am a member of related community advisory boards within the NIH networks and in advocacy organizations. Of course, I welcome the significant development that Congress has mandated to convert the previously voluntary effort into a binding requirement for deposit into PUBMED Central of articles for publication The previous voluntary system proved to be ineffectual without sufficient yield or dissemination of vital knowledge for this publicly funded work.. The precise scope of current implementation issues requiring a meeting is unclear because the provisions of P.L. 110-161 (2008) are straightforward. Indeed, it is only a few short weeks until the April 7, 2008 start date that NIH has explained is the date after which submitted articles must comply with the new law. The public assumes and relies on the fact that the current policy will remain in effect continuously without any suspension during the period when further public comments are collected. I understand that some parties continue to object to these developments or may seek to weaken the effectiveness of a robust and dedicated effort to make materials available in public access. However, the research community, advocates for research participants, universities funded by NIH and a tide of international peer organizations all unite to conclude that the policy should be strengthened even further. Among only the latest of those common efforts are the European Research Council “Scientific Council Guidelines for Open Access.”2 These ERC efforts, those of the UK Research Councils, the Canadian 1 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-057.html 2 http://erc.europa.eu/pdf/ScC_Guidelines_Open_Access_revised_Dec07_FINAL.pdf December 17, 2007 2 Institutes of Health Research, the European Research Advisory Board and many others demonstrate the NIH must take steps to associate itself with the best practice for national public grant institutions or risk a deterioration of its international parity for advancement of biomedical science. The consensus of these efforts is to require public repository deposit or public access availability as soon as possible but no later than 6 months after publication in a fee-based journal. Therefore, if NIH is considering any implementation changes, the strongest evidence and best practice policy would be to shorten the time for deposit under current NIH policy. There is no doubt that P.L. 110-161 provides ample authority for NIH to make this change and join the international community in establishing a workable knowledge dissemination program. Because NIH will engage in further comment collection after March 20, 2008, please consider these comments preliminary. I request that on March 20, 2008 and after NIH dedicate its implementation efforts towards revising the current policy to: require deposit or public access as soon as possible but no later than 6 months after publicationI look forward to the results of the upcoming meeting, and provide publication funding support to grantees so that they may choose publication options permitting immediate open access in journals that publish full text articles for immediate free viewing online. I can be reached at 415/268-7469 or rjreinhard@gmail.com if you have any questions. Sincerely, Robert Reinhard Community Advisory Board Member	E-mail
684	Town Hall Meeting Form	3/12/2008 5:53 PM	Rossner	Mike	Ph.D.	Rockefeller University Press	NY	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						February 26, 2008 The Honorable Tevi Troy Deputy Secretary Department of Health and Human Services 200 Independence Avenue, SW Washington, DC 20201 Mr. Secretary: I am the Executive Director of The Rockefeller University Press, a non-profit organization that publishes three scientific journals. I am writing to take issue with a letter sent to you on January 11, 2008 by Martin Frank of the DC Principles Organization and Allan Adler of the Association of American Publishers (AAP). That letter is an attempt to stall the implementation of the mandatory NIH public access policy, under which authors will be required to post publications resulting from NIH-funded research on PubMed Central. Dr. Frank and Mr. Adler note that many of their “member organizations… strongly opposed enactment of the controversial mandatory NIH public access policy as part of the FY2008 omnibus appropriations legislation”. As far as I know, not a single publisher has publicly declared opposition to this policy. In fact, several publishers, including ourselves, have publicly declared that they do not support the AAP’s lobbying efforts against this policy (see references below). All of these publishers are members of the AAP. The authors of the January 11th letter request a public notice and comment rulemaking on the mandatory policy. They contend that the policy is materially different from the previous policy, which requested but did not require that scientists deposit publications resulting from NIH-funded research in the PubMed Central database. I respectfully disagree. The issues with which the authors of that letter are concerned – the effects on scientific research publishing and protection of copyright – have already been commented upon at length in the context of the previous policy. All scientific publishers understand several truths: 1) that their content is generated in large part through federally funded research, 2) that the peer review process is carried out in large part by federally funded individuals, and 3) that a significant portion of their subscription revenue is obtained from government funded institutions. Many publishers believe they have an obligation to give something back to the public that has provided those funds, and they make their online content free after a short delay under subscription control. However, a few large, highly profitable publishers have refused to do this, and have thus forced the NIH into the position of mandating deposition of NIH-funded research publications in PubMed Central to make them available to the public. I strongly support this mandate, and I urge you to implement it as soon as possible, without the unnecessary delay of further public comment. Yours sincerely, Mike Rossner, Ph.D. Executive Director The Rockefeller University Press rossner@rockefeller.edu Cc: NIH Director, Elias A. Zerhouni, M.D. Senator Arlen Specter (R-Pa.) Martin Frank, Ph.D. Allan Adler References: 1. Rossner, M. (2007) Bending the truth with a PRISM. J. Cell Biol. 179:177–8. http://www.jcb.org/cgi/content/full/179/2/177 2. Suber, P. (2007) Oxford UP distances itself from PRISM. Open Access News September 6, 2007. http://www.earlham.edu/~peters/fos/2007/09/oxford-up-distances-itself-from-prism.html 3. Suber, P. (2007) MIT Press dissociates itself from PRISM. Open Access News October 4, 2007. http://www.earlham.edu/~peters/fos/2007/10/mit-press-dissociates-itself-from-prism.html 4. Howard, J. (2007). Publishers' PR Tactic Angers University Presses and Open-Access Advocates. The Chronicle of Higher Education 54:A13. http://chronicle.com/weekly/v54/i04/04a01301.htm	E-mail
685	Town Hall Meeting Form	3/13/2008 1:13 PM	Adler	Prudence	M.A., M.L.S.	Association of Research Libraries	DC	USA	Patient or Representative of a Public Health Advocacy Organization						These comments are submitted on behalf of the Association of Research Libraries (ARL). ARL is a nonprofit organization of 123 research libraries in North America. ARL strongly supports the "NIH Revised Policy on Enhancing Public Access to Archived Publications Resulting From NIH Funded Research" (hereafter the NIH Public Access Policy). ARL members include many university libraries that support researchers on campuses who receive NIH funding. As a consequence, many ARL libraries are collaborating with others within their institution to ensure effective compliance with the revised Public Access Policy. The U.S. Government funds research with the expectation that new ideas and discoveries from the research will further scientific discovery, stimulate the economy, and improve the lives and welfare of Americans. These strategies, such as the revised NIH Public Access Policy, advance science, enhance U.S. competitiveness, improve access to the fruits of our collective investment, and provide better accountability of our Nation's research investments. For these reasons, ARL is a strong supporter of the NIH Public Access Policy. ARL and its member libraries are actively engaging in a number of activities to assist institutions and their researchers in complying with the NIH Public Access Policy thus maximizing its benefits for researchers and research institutions as well as the public. ARL has developed tools and resources for the research and education community and for institutions to assist in developing and/or modifying existing policies and practices in order to comply with the NIH Public Access Policy. It is important to note that although the change in the NIH Public Access Policy is relatively recent, ARL and its members have been focused on copyright management and access issues for some time. For example, helping authors of works make informed decisions about these issues has been a priority for research libraries for many years. As a recent survey of ARL member libraries demonstrates, libraries are providing and promoting tools that allow authors to deposit their works in disciplinary repositories like PubMed Central and also their own institutional repositories. Please see: http://www.arl.org/sc/copyright/author-rights-resources.shtml and http://www.arl.org/bm~doc/spec299book.pdf.zip . The resources that ARL developed since the announcement of the revised Public Access Policy include the following. First, ARL hosted a small group of library directors and chief research officers with staff from NIH, a copyright expert and representatives from higher education associations to explore the implications of the mandatory NIH Public Access Policy. The group identified strategies that research universities and their national associations could pursue to support campus investigators in complying with the new deposit requirement. These strategies were shared with the ARL community. Following up on that session, ARL published the "NIH Public Access Policy: Guide for Research Universities." (http://www.arl.org/sc/implement/nih/guide/index.shtml) This Guide complements the NIH resources devoted to the Public Access Policy and includes links to many examples of resources created by research institutions. Third, ARL released a joint white paper with SPARC and Science Commons that explored new institutional policies that address copyright management issues that may be needed to comply with the NIH Public Access Policy. The paper analyses a set of options that institutions can use to ensure that the rights needed for articles to be made available in PubMed Central are reserved. (http://www.arl.org/pp/access/accessfunded/nihaccess.shtml) More recently, on March 7, 2008, ARL co-sponsored with the National Association of State Universities and Land Grant Colleges (NASULGC), a webcast entitled, " Institutional Compliance with the NIH Public Access Policy: Ensuring Deposit Rights." (http://www.arl.org/sc/implement/nih/webcast/) This webcast reached over 1,000 participants and focused on retaining deposit rights for compliance and helping institutions and investigators be successful in responding to the NIH Public Access Policy. All of these resources and communication strategies are designed to accelerate the readiness of institutions and their researchers to successfully comply with the NIH policy.	E-mail
686	Town Hall Meeting Form	3/17/2008 2:02 PM	Saad	Diane		Wiley-Blackwell John Wiley & Sons	NJ		Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						III River Street Hoboken, NJ 07030-5774 www.wiley.com WILEY TEL 201.748.6000 FAX 201.748.6088 JohrL Wilev & Sons, Inc. , etlJ lJj\!7cr.<..,' \'inc/ !~07 March 17,2008 Elias A. Zerhouni, M.D., Director National Institutes of Health ()OOO Rockville Pike Bethesda, MD 20892 Transmitted via email to PublicAccess@nih.gov RE: NIH Notice on Public Meeting: Seeking Comments on the Implementation of the NIH Public Access Policy NOT-OD-08-057 (March 7, 2008) Dear Dr. Zerhouni: I am writing on behalf of John Wiley and Sons to express important practical concerns related to Ihe implementation of the "NIH Revised Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research." Our biomedical division Wiley-Blackwell is one of the world's foremost academic and professional publishers with a combined list of more than 1,400 scholarly peer-reviewed journals. We are also the world's largest society publisher, working with 700 societies that represent close to 1,000,000 members globally. While Wiley supports the concept of "public access" to government-funded research, we believe that the NIIH mandatory policy must be implemented in a way that maximizes its effectiveness to the public and the scientific research community, ensures protection of copyright and protects our business and employees. To achieve this objective, it will be critical for NIH to work closely with publishers. Specifically, Wiley looks forward to working with NIH to address the following concerns: • Formal Consultative Mechanism Between NIH and Publishers. We are encouraged that NIH is finally starting a dialogue with publishers, investigators, and representatives from scientific associations to ensure the success of this initiative. However, Wiley believes that NIH should adopt a more cautious and thoughtful approach, following through in its partnerships with scientific publishers in exploring through a formal process how to properly implement this new policy. Indeed, rushing implementation could carry with it the potential of causing irreparable harm to the integrity of science and to the very mission of NIH. The Senate has directed NIH "to seek and carefully take into account the advice of journal publishers on the implementation of this policy." How exactly will NIH incorporate the concerns of publishers moving forward if the policy is already implemented? • Business Impact and Compensation. The public indisputably benefits from new cures and innovative discoveries generated by scientists who access and build upon the research described in first-class articles published and disseminated via advanced infonnation systems supported by the substantial investments of publishers. Peer review represents a significant investment by publishers like Wiley, and neither originates with licensor-authors nor is it the product 0f NIH funding. Yet under the new policy, NIH insists on appropriating the final, peer-reviewed manuscript. Publishers recoup the expense of peer review, production, and distribution by several means, including commercial sales both domestically and abroad. As a result, when copyrighted articles are freely available online, their commercial value is significantly eroded. How will you ensure that the policy will protect publishers' copyrighted assets and maintain the commercial value ofthe copyrighted manuscripts? How will you ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles do not undermine the rights and value-added provided by publishers like Wiley? How will you ensure that the articles on PMC maintain the publishers' branding, and any corresponding disclaimers and notices? • Cost and management. The mandatory public access policy will not change the cost of scientific publishing, but will shift the burden of that cost away from scientific publishers and onto authors and the funding agency. At what cost? Why is simply linking to publishers' web sites, rather than mandatory deposition at PubMed Central, not acceptable? It would certainly be a more efficient, less costly way to achieve the desired increased access. The policy provides for publisher deposit of final published articles on behalf of authors, and includes allowance for the use of grant funds in the payment of publication fees levied on NIH-funded authors. Will NIH be empowered to negotiate such licensing terms, including payment, on a publisher··by-publisher basis, as certain non-government funding agencies have done? John Wiley and Sons is eager to work with NIH to enhance public accessibility of scientific research results and address these specific concerns. We hope to find ways to do so while continuing to protect the publishing enterprise that has nurtured and served the scientific research community. Respectfully, \~.~ \ \" \\ ~\\\ ..I ~~~ \ .~\ \~ Patrick J. K~IY, Ph.D. \ .fournals Publishing Director, Li fe Sciences, Americas Wiley-Blackwell .fohn Wiley & Sons, Inc. III River Street, 8-02 Hoboken,N.f 07030-5774 Email: pkelly@wiley.com Tel.: 201-1'48-6689 Cell: 201-349-7123 Fax: 201-748-8888 Signed in Nlr. Kelly's absence by Diane Saad, Executive Assistant 2	E-mail
687	Town Hall Meeting Form	3/17/2008 1:12 PM	Wolpert	Ann		MIT	MA	USA	Representative NIH Funding Recipient Organization						MIT is pleased to have the opportunity to comment on the 2008 NIH Public Access Policy, as this policy manifests one of MIT’s most deeply held values and primary commitments – making research as widely available as possible. More open access to research directly supports MIT’s mission to “generate, disseminate, and preserve knowledge, and to work with others to bring this knowledge to bear on the world's great challenges.” MIT’s longstanding commitment to the principle underlying the Public Access policy is expressed in its open access innovations: the widely adopted models of OpenCourseWare and DSpace, as well as many other projects such as MIT World, TechTV, and OpenWetWare. MIT is therefore committed to complying with the new policy not only for legal reasons, but because it expresses a key component of MIT’s fundamental mission. Although implementing the policy will create short term challenges for MIT and its investigators, we do not view those challenges as a reason to delay implementation. In the short term, without a broader, institutional approach in place, compliance necessarily falls to individual authors who will need to ensure they retain sufficient rights to comply with the terms of their research funding. There is a tension inherent in this situation, which will at times leave authors and their institutions struggling with the need to execute hundreds of individual appropriate legal contracts with publishers in order to achieve compliance. MIT’s approach to implementation assumes that over time, all players in the scholarly communication chain – research institutions, authors, funding agencies, and publishers – will need to work together to find efficient procedures and policies so that publicly funded research is shared as widely as possible, for the benefit of taxpayers and the betterment of society. In implementing the new policy, then, MIT has identified a short term strategy and intends to work diligently toward a longer term strategy. For the short term, we’ve created a team to develop a communication plan and specific documentation for MIT authors, making them aware of the new policy and its requirements. The team includes representatives from the Office of Sponsored Programs, the General Counsel’s Office, the Libraries, the Vice President for Research, the Chair of the faculty, and Biology Department faculty. Our team has focused so far on written communications and face-to-face discussions meant to convey the basic requirements of the policy and to inform authors of what resources MIT has to assist them in compliance. The documents we’ve prepared include a web page to guide authors in complying with the policy, a draft journal submission letter, and a draft one-page overview of the key aspects of the policy. We have begun drafting a letter to be sent to each NIH Principal Investigator, and an article for the faculty newsletter is in the planning stages. We are prepared to handle the inquiries we expect as of the April 7 implementation date, since MIT already makes available to its authors an amendment to publisher agreements that was developed in support of voluntary deposit in PubMed Central. MIT additionally supports authors in compliance through a staff position in the Libraries devoted to supporting authors in retaining rights to their work. Over the longer term, we are beginning to discuss possible institutional efforts that could potentially reduce the burden on individual authors in complying with the policy. We look forward to partnering with publishers, NIH, and others in devising structural changes that will successfully support this policy’s goal of more open access to research.	E-mail
688	Town Hall Meeting Form	3/17/2008 12:05 PM	Naveira	Romina		Association of American Publishers (PSP Division)	NY	USA	Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Association of American Publishers 71 Fifth Avenue New York, NY 10003-3004 Tel (212) 255-0200 Fax: (212) 255-7007 www.publishers.orgwww.pspcentral.org aap Professional & Scholarly Publishing (PSP) Division Executive Council 2007-2008 March 17, 2008Michael Hays, Chair McGraw-Hill F. Hill Slowinski, Vice Chair Elias A. Zerhouni, M.D., Director American Society of Clinical Oncology National Institutes of Health Matthew Cahill Wolters Kluwer Health 9000 Rockville Pike Bethesda, MD 20892 Glen Campbell Elsevier, Inc. Transmitted via email to PublicAccess@nih.gov Brian D. Crawford American Chemical Society RE: NIH Notice on Public Meeting: Seeking Comments on the Implementation of the NIH Public Access Policy William Curtis Springer Science + Business Media NOT-OD-08-057 (March 7, 2008) Maureen DeRosa American Academy of Pediatrics Dear Dr. Zerhouni: H. Frederick Dylla American Institute of Physics John A. Jenkins CQ Press Patrick Kelly John Wiley & Sons, Inc. Thane Kerner Silverchair Science+Communications, Inc Christopher Lynch New England Journal of Medicine Alison Mudditt SAGE Publications Niko Pfund Oxford University Press James Pringle ISI Thomson Scientific Lynne Rienner Lynne Rienner Publishers Fran Zappulla IEEE Marc Brodsky PSP/IFLA Representative AAP/PSP Staff Sara Firestone Director, PSP Division Allan Adler Vice President for Legal & Government Affairs Romina Naveira Project Manager, PSP Division We are writing on behalf of the Professional and Scholarly Publishing Division (PSP) of the Association of American Publishers (AAP) to relay important practical concerns that have been expressed by many of our members regarding implementation of the “NIH Revised Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research.” These members of the PSP publish the vast majority of materials produced and used by scholars and professionals in science, medicine, technology, business, law, and the humanities, and they employ tens of thousands across the United States. While the PSP supports the principle of public access to science, we have significant concerns about aspects of the NIH public access policy’s implementation that we believe may have unintended negative consequences for all stakeholders in the scientific research community, including the broader public. We note that many of our concerns as scholarly publishers stem from the manner in which NIH and staff responsible for PubMed Central have implemented the public access policy, by taking liberties with copyrighted content in a fashion that competes with the activities of independent publishers and that undermines their rights in copyright. Specifically, by reprocessing and enriching manuscript submissions and expropriating publishers’ value-added investments in peer-reviewed content, NIH is creating enhanced, derivative publications that go beyond the congressional mandate of posting researchers’ documents that report on the results of federally funded research. Rather than just posting what it receives, be it an author’s version (after peer review) or a publisher’s submission (in a PDF or other fixed format), NIH has embarked upon XML-reformatting and tagging procedures to create alternative versions of published works that, when made freely available, substitute for the definitive articles in which publishers have already invested. In effect, NIH is entering the publishing business (and enabling other international mirror locations of its database to do so as well) by creating these enhanced derivative versions. As a result, the integrity of the scientific literature is compromised. 2 Below we have grouped our comments by topic and included relevant questions, focusing on the (A) importance of consultation with publishers as to the effective implementation of the new public access policy; (B) need for real safeguards to ensure meaningful protection of publisher copyright as Congress intends; and (C) development of best practices to ensure that the public access policy meets its stated objectives. A. Consultation with Publishers: NIH must ensure that there is a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to attaining a balanced implementation of the policy that achieves the public access objectives without negative impact on peer review publishing. The Senate committee report (110-107) to the FY08 LHHS Appropriations bill directed NIH to seek publisher input to ensure that publishers’ copyright protections are maintained under the new policy. 1. How has the policy that NIH announced on January 11, 2008, only weeks after the legislation was signed into law, incorporated publisher input, and how will NIH incorporate the concerns of publishers as it moves forward? 2. We would like to work with NIH toward an effective and fair implementation of this policy. We propose that a task force or advisory group, co-chaired by NIH and publisher-designated representatives, be vested with the requisite authority and responsibility to propose procedures for implementation of the policy mandate. 3. In the NIH Notice of Jan 11, NIH notes that “institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy.” Why would NIH place grantees in the position of negotiating with publishers in the complex world of copyright law? Why not reach agreements with publishers regarding payment for their journal articles, so as to remove from authors the administrative or financial burden of compliance with the policy? 4. The policy will have a negative impact on publishers, many of whom are small professional societies, because with their copyrighted material freely available on PubMed Central, subscription or other article-related revenues may well decline. What is NIH’s plan to track possible harm to publishers, especially small societies? If harm is found, how does NIH plan to remedy it? Does NIH understand the basis for publishers’ concern about such possible harm and its impact on publishers’ willingness to invest in promoting the integrity and widespread availability of the scientific literature? 5. What are NIH expectations of its grantees with regard to ensuring that PMC postings of material will not diminish the rights that are acquired by publishers in that material, the value of the publishers’ added contributions, and the interests of authors? 6. Will NIH provide publishers with detailed and robust PMC usage statistics that will enable them to assess the impact of PMC usage on their subscriptions? It is not clear from current NIH policies and procedures how publishers may obtain detailed and robust PMC usage statistics that will enable them to assess the impact of PMC usage on their own web traffic and subscription or other article-related income. B. Proper Protection of Copyright: NIH must develop specific safeguards to ensure that day-to-day implementation of the public access policy respects the basic principles embodied in copyright and not undermine these rights that provide incentives for publishers to invest in the peer-reviewing, publishing, distribution, and archiving of scientific articles. 1. How will NIH ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking, or otherwise changing the articles do not undermine the rights, added value and interests referred to above? 2. How will the policy protect against distribution of copyrighted materials to other sites around the world besides PubMed Central? 3. How will NIH address possible objections or concerns from copyright owners who do not assent to the public posting of their material on PubMed Central and its related international sites, or who have concerns about the enforcement of copyright located on and delivered from those sites? 4. Publishers recoup the expense of peer review, production, and distribution by several means, including commercial sales. When copyrighted articles are freely available online, their commercial value can be eroded. How will NIH ensure that the policy will protect publishers’ intellectual property assets, retaining the commercial value of the copyrighted articles? 5. Recognizing publishers' copyright and investments in peer review and publishing, does NIH plan to supplement its grant funds to sponsor public access to the manuscripts? If yes, how will such funds be identified in the grant, and what has NIH budgeted per year for such incremental costs? 6. How will NIH ensure that the articles on PubMed Central meet with publisher requirements, such as the access-control period, and that the policy actually applies to the articles that NIH is posting? 7. How will NIH prevent piracy of the articles from PubMed? Will NIH monitor for mass downloading of posted articles by single users? How will NIH work with publishers in the event that copyrighted articles are pirated from PubMed Central? If NIH finds that articles have been subject to piracy, how will NIH notify the publisher and provide any information NIH may have about the infringer? Will NIH provide for review and revision of the public access policy if piracy occurs from PubMed Central or the other international repositories connected with PMC? 8. How will NIH ensure that the articles on PMC maintain the publisher’s branding, and if applicable, the corresponding disclaimers and notices so that publishers can preserve their brand assets and manage their liability appropriately? C. Good Faith Implementation: NIH must agree to adopt and develop certain best practices to ensure that the public access policy meets and adheres to its stated objectives. 1. Since PMC will compete with publishers’ own websites as more PMC content overlaps with content on publishers’ sites, how will NIH maintain the primacy of the publishers’ websites and ensure that the manuscript on PMC does not displace or act as a substitute for the final published journal article, i.e., the authoritative version of record, which resides on a publisher’s site? Will NIH work with publishers to ensure that readers know and are directed to where the final published versions can be obtained? 2. Many publishers provide free access to authors’ manuscripts or final published articles twelve months after publication or even sooner. NIH does not consider this access compliant with the NIH 3 policy. Would NIH consider including author manuscripts only in its administrative database and archive, while providing public access via display only through publisher sites? If not, what is the rationale for maintaining an unedited manuscript for public consumption if the final, authoritative version has been made available for free access on the publisher’s site? 3. What will NIH do in cases of noncompliance with its policy guidelines? What action will be taken when a grantee’s article is published, but NIH is not provided with the peer-reviewed manuscript? What actions will be taken against noncompliant grantees when they apply for future NIH grants? 4. How does NIH anticipate securing and sustaining a source of funding to maintain the database of articles that will accumulate over time, including costs to migrate to new platforms? Under the new policy, US taxpayers will be funding public access to science to any person anywhere in the world with Internet access. Has the NIH considered the ramifications of providing such international access, and how this might affect national security or other US government trade regulations? We look forward to the public meeting at NIH on March 20 and the upcoming RFI proceedings, but considering the far-reaching implications of the substantial change in the NIH public access policy, we urge HHS and NIH to do a full Notice and Comment Rulemaking. We believe that the public and the publishing community should be given an opportunity to comment on the content of the new policy before it goes into effect. We urge HHS and NIH to hold off on implementing the policy until after the Notice and Comment proceedings have been completed. We also look forward to a more formal process for working closely with NIH to implement the new public access policy. Thank you for the opportunity to communicate our views. Sincerely yours, Michael Hays, Chair F. Hill Slowinski, Vice-Chair Executive Council, Professional and Scholarly Publishing Division Association of American Publishers (AAP/PSP) 4	E-mail
689	Town Hall Meeting	3/10/2008 10:00 AM	Ochs	Jack		American Chemical Society			Patient or Representative of a Public Health Advocacy Organization						Good morning, I’m Jack Ochs and I’m here to speak on behalf of the American Chemical Society. We’re grateful for the opportunity to comment on the implementation of the public access policy. Although we hold the view that this meeting and the RFI that’s been announced by the NIH are a step in the right direction, they are no substitute for the formal notice and comment rulemaking that’s required by the Administrative Procedures Act. And we believe that the NIH should not only postpone the implementation but also the formulation of its revised policy until this process can be undertaken. It’s also clear to us that no single meeting, however long, will be able to resolve the many issues and questions that surround the NIH’s implementation of its revised policy; there are too many to go in this 5-minute period but they are detailed in the written comments submitted by ACS and other publishers. Because we don’t have time to go into it, we do think that it’s essential that the NIH establish a formal and ongoing consultation with publishers to safeguard the integrity of the scientific record to implement the policy, the NIH’s policy, in a manner consistent with copyright law and to fulfill the intended purpose of Congress when it directed NIH to work with publishers in implementing the new policy. We think that NIH missed an opportunity to make its voluntary policy a success by not proactively including publishers as it developed that policy, and we feel that consultations with publishers are even more critical today to resolve a number of copyright and implementation issues that the agency faces. We can speak from our own organizational experience about some of these issues. We publish approximately 4,000 articles a year that acknowledge the NIH as a funding source. And we’ve been trying since 2005 to resolve copyright and intellectual property issues with the agency in connection with our efforts to deposit those articles on behalf of our authors who asked us to do so. Despite our efforts, we’ve been told by NIH to suspend our article deposits, and that prohibition has prevented us from depositing more than 3,000 articles on behalf of our authors. During this same period, PubMed Central has accepted unauthorized postings of our copyrighted material, and repurposed and openly displayed those materials, and not following either its own guidelines or the legitimate terms and conditions that we as the copyright holders have set to protect the integrity of the scientific record. Our issues and concerns remain unresolved to this day. And we can only feel that the mandatory policy will do nothing to help this situation and may in fact exacerbate it. We’d like to point out that the vast majority, if not all of our copyright concerns, could be resolved by the NIH if they would abide by the original intent of the public access policy and post unaltered final author versions of peer-reviewed manuscripts on PubMed Central without reformatting, repurposing, modifying or mirroring on third party web sites, and accept the offer made by many publishers, including the ACS, to link to the final authoritative version of record on publisher web sites. We are aware that there are some people that have the opinion that publishers have been slow to take advantage of the opportunities created by the web to enhance the scientific literature but nothing could be further from the truth. Publishers are experimenting with data mining and visualization tools, semantic web applications, on-line navigation aids, flexible display, free access to the recent archive of published articles and web 2.0 applications as well as 11 supporting the development of international standards to enhance the scientific literature, web sites, and maximize the discoverability of science in general. Thanks to publisher efforts, global access to scientific information for investigators at institutions like the NIH are easy and widespread. And researchers are now one of the very few online communities that spends more time analyzing and reviewing content than actually finding it. More than any other industry that we are aware of, publishers have embraced the internet and our investments and licensing options have made more content available in more ways to more people than at any time in history. And that includes the NIH. Copyright is one of the main tools that has made this possible. Regardless of the nature of the issues that have been raised here and will be raised here this morning and have been raised in the written comments, we choose not to believe that the NIH is willfully disregarding copyright and the intent of Congress. We stand ready to work with the agency to establish the kind of ongoing productive dialogue that we feel is in the public interest. Thank you.	In Person
690	Town Hall Meeting	3/10/2008 10:00 AM	Fox	Christopher		American Association for Dental Research			Patient or Representative of a Public Health Advocacy Organization						Good afternoon, colleagues. Thank you, Dr. Zerhouni, for this opportunity to provide public comments on the implementation of NIH public access policy. I'm Dr. Christopher Fox, Executive Director of the International Association for Dental Research and the American Association for Dental Research. We are two 501(c)(3) not-for-profit associations based in Alexandria, Virginia. We publish the Journal of Dental Research, the number 1 dental publication in terms of scientific impact factor. While an international publication, most years we have about 30% of published articles with some NIH-funding, although it has been as high as 57%. So the implementation of this NIH public access policy will certainly have an impact on our Journal. Here is the antiquated print version of this month's Journal of Dental Research for those of you who remember print, but we are also online through the High Wire Press platform from Stanford University and have also digitized our entire journal content back to Volume 1, Issue 1, published in March of 1919. By publishing online with High Wire Press, we are part of the largest repository of high impact peer review articles in the world with over 1 thousand journals and over 4.5 million articles. By partnering with High Wire, although we are a small association, we are also able to offer to our readers, all the linking services to references, similar articles and our journal as well as the ISI web of science, links to Google scholar and links to PubMed and downloads to Citation managers and a variety of formats. Real 21st century technology. The Journal of Dental Research fully supports open access as a signatory of the Washington, D.C. Principles of Open Access. All of our content is free of access controls no matter the funding source 12 months after publication. Scientists, dental practitioners, students and the public can access all of our content from March 1919 to March of 2007, 87 years of oral, dental and craniofacial science. And by being part of High Wire, the Journal of Dental Research is part of the largest archive of free full tech science in the world, with over 1.8 million free full-tech articles. 12 While we support open access, we strongly object to NIH’s interpretation and planned implementation of the mandatory language contained in the Consolidated Appropriations Act of 2008. Specifically and most importantly we do not believe that NIH has adequately addressed Congress’ proviso that “NIH shall implement the open access policy in a manner consistent with copyright law”. For a small professional association, we have invested significant resources to establish an effective peer review system, to develop in-house copyediting and production systems to launch our journal online in 2002, and to digitize all our volumes back to 1919. The only way for the association to recoup this investment, not make a profit, just recoup this investment, is retain the copyrighted materials and to offer individual and institutional subscriptions. Once a significant proportion of our copyrighted journal content in the form of accepted manuscripts is available free on PubMed Central and possibly onto PubMed Central international, we forecast the decline in our subscriptions which will undermine and threaten the sustained viability of the number 1 journal in the dental sciences. Furthermore, the IDR and ADR as publishers of the Journal of Dental Research, we are more than willing to provide PubMed Central with a link to our site with a final authoritative version of the published article within the same embargo period. Yet the proposed implementation of the public access policy would retain the earlier non-authoritative version of the accepted manuscript on the PubMed Central site. If this is about public access, surely the interest of the public is better served by having access to the final authoritative publications rather than to an unedited manuscript. To address these concerns, we believe that the NIH should undertake a formal administrative procedure and rulemaking, and a rulemaking would provide the public and all interested stakeholders with a formal mechanism for comment with adequate lead times and a formal procedure for NIH to address the concerns. All publishers from the corporate publishing houses to small societies like ours have questions not addressed in the frequently asked questions section of the public access website. Significant copyright concerns remain. While we appreciate this opportunity we don't believe that seeking public input with an open meeting just 18 days prior to the implementation date with one week to prepare is sufficient to address all of our concerns. I certainly have additional concerns that I don't have time to discuss in this allotted 5 minutes. Should the NIH undertake a rulemaking and carefully consider the comments from all stakeholders, the final NIH public access policy would be greatly improved for the betterment of science, clinicians, and the public. Thank you for your time.	In Person
691	Town Hall Meeting	3/10/2008 10:00 AM	Dean	Donna		Association of the Independent Research Institutions			Patient or Representative of a Public Health Advocacy Organization						Good morning. I'm Donna J. Dean speaking today for the Association of the Independent Research Institutions. Dr. Zerhouni, Dr. Kington, and Dr. Ruiz Bravo, we appreciate the opportunity to provide our comments on the NIH revised policy on enhancing public access to archived publications resulting from NIH-funded research. The Association of Independent Research Institutes (AIRI) is a nationwide association of nearly 90 nonprofit independent research institutes that conduct peer-reviewed, basic 13 translational and applied research in the biomedical and behavioral sciences. AIRI institutes are recipient of approximately 11% of NIH extramural research grant funding, and we are pleased we have the opportunity to articulate our position today. Nonprofit research institutes, independent research institutes are stand alone, academic style centers that offer scientists a focused research environment to conduct innovative science. Therefore, despite the fact that ARIE member researchers may not have an institutional repository to assist authors with depositing their manuscripts into PubMed Central, we stand ready, willing and able to comply with the requirement. Our board has not expressed any concerns with the policy and actually believes that this requirement may enhance overall support for science once the public is able to view firsthand the benefits that result from federally funded research in a more timely and open way. AIRI applauds the National Institutes of Health for undertaking the effort to implement the intent of Congress and we believe the requirements are clear, easy to follow, and do not constitute an excessive burden on our researchers or our research institutes. We also enthusiastically support making our research available to all who can benefit from it since it is federal tax dollars from the public. We thank you for the opportunity to express our views today. And we hope that you will continue to look upon the Association of Independent Research Institutes as a resource on this and other issues as NIH moves forward with the next implementation step. Thank you for the opportunity to respond.	In Person
692	Town Hall Meeting	3/10/2008 10:00 AM	Taylor	Crispin		American Society of Plant Biologists			Patient or Representative of a Public Health Advocacy Organization						Good morning, everyone. Thank you very much for your time; it’s a pleasure to be here. My name is Crispin Taylor from the American Society of Plant Biologists. I want to make 3 points, if I can. I'm going to tell you that the mandatory policy is unnecessary and flawed. I think that it inhibits small publisher innovation and it's a fundamental departure from the voluntary policy. I also will make a plea for NIH cooperation and constructive engagement with publishers and for a full public comment rulemaking. So ASPB is a small professional society. We have 5,000 members. Even so, we manage to publish two of the top 3 journals in plant biology. By impact factor they are very well represented and regarded worldwide. The content of both of those journals is posted on PubMed Central in its entirety in one of the mechanisms that Dr. Lipman described earlier. It is also hosted on the journal sites that we own at High Wire Press. Entire annual budget for the Society is less than many NIH grants. We are a nonprofit and our annual operating income pays for the entire activities of the Society including the innovations that we do make in publishing. Nonprofit or not, publishers have made hundreds of millions of dollars in investments in putting their peer review process online and their journals online. Through High Wire, as you’ve heard, ASPB journals are part of an archive of 4.7 million articles from hundreds of publishers. 1.9 million of those are already freely available right now. They are fully interlinked. They are indexed by Google and they’re connected already to many other databases of biological information. So, the mandatory deposit policy is duplicating efforts by publishers already and is 14 unnecessary in that regard. These efforts by publishers are self motivated. Nobody told us to do this. We want to do this because it's part of our mission. I also dispute the need for a central monolithic repository regarding articles to link to all sorts of other things. On today’s internet, it's all about discoverability and as I said, the journal content on our own site is already easily discoverable. It's richly interlinked and it's connected to all sorts of other information resources. One of my biggest bug-bearers with this mandatory policy has to do with publisher innovation. And ASPB, like many other small publishers, has indeed welcomed and embraced this new world of online publishing and we worked hard to find ways to innovate that don't greatly impact our bottom line. This implement now, figure out the details later approach that the NIH is prescribing right here, I think it violates the letter and the spirit of the law passed by Congress. I think it will divert money from the primary mission of funding research into human health. We don't know how much. And for ASPB, this sort of Damocles’ that’s hanging over us, this threat that the literature will be made open access by fear, is stifling out our facility to implement our own innovations and to do research on our own. As I mentioned, ASPB deposits the full text of our articles in PubMed Central. We have been doing this for years. We felt it was important for reasons to preserve the literature to have a second archive in addition to the one that we pay for at High Wire Press. We felt it would be an opportunity to reach new audiences, either public audiences or audiences in different fields of science that may not be familiar with our work in the journals, which is very important, of course, in this era of interdisciplinary science. The NIH also very generously and graciously funded conversion of content pre-internet from both of our journals and created an entire archive for us and it was a very constructive engagement at that the time. Since then, however, NIH has not, in my opinion, worked cooperatively or constructively with ASPB which I think is a missed opportunity. We don't have access to usage data that would allow us to determine whether or not we are indeed reaching the new audiences through this partnership. And therefore we have no capacity to determine whether or not our goals are being met. The NIH has also sought to take the content that we deposited with them under license and distribute it around the world, although they didn't actually do that. And my sitting in on public access working groups and PMC advisory committee meetings, I have to say that the NIH has been dismissive of publisher motivations, our expertise, our perspective and willingness and desire to cooperate and help. So, I would argue that robust and respectful engagement with publishers whose content NIH seeks to take in this mandatory policy is essential. And like others, I would argue that a full comment and rulemaking is necessary before implementation. And that the voluntary switch to mandatory policy is a fundamental change. Thank you for your time.	In Person
693	Town Hall Meeting	3/10/2008 10:00 AM	Case	Kathy		Cancer Survivor			Patient or Representative of a Public Health Advocacy Organization						I'd like to say I'm not here under false pretenses. I figured you would have heard enough from publishers so I'm here as a cancer survivor to speak about the issue of insufficient public access to the information. I'm one of 10 million cancer survivors in this country. I'm also a heart attack survivor. My life was saved by well informed doctors who knew what they were doing. During both of my illnesses, I had access to 15 anything I wanted in the literature through the NCI, through heart associations; I was not ill-informed in spite of the fact that people have to pay for subscriptions. I don't believe the cure for cancer is hidden in the literature and just being kept from us by greedy publishers. Many of you know I have been a publisher for 40 years. I'm about to retire. I don't accept the judgment that we have failed. I don't accept the judgment that the librarians have failed. Our doctors are the best in the world. They save our lives every day. They saved my life. The Congress made a ruling based on a notion that there is insufficient public access to the literature because a handful of people convinced them of that. The rest of us were silent. There weren't 10 million cancer survivors there saying that. There weren't people like me. I wish I had gone there and spoken to them instead of taking the role of a publisher, who has worked her whole life to get information out to the public there. So … there is a lot of heat, a lot of emotion around this but there is not a lot of truth around it. Our role as publishers and scientists and whatever we are, has been to improve healthcare and it has worked. So why are we allowing the negative PR that somehow all you librarians, all you publishers and the government have failed? I'd like to see the energy. I'm not even following my notes anymore, amazingly enough…I'd like to see the energy put into this, put into the fact that research is what saves lives. Why aren't we out there advocating for not having a research budget slashed, which is what's happening. Why aren't we out there? Doctors save lives. 47 million people in this country don't have access to doctors, don't have access to healthcare, that's where we need to be putting our energy. We have all this brouhaha based on a myth that lives are being lost, and this is what the Congress bought. I'm not talking about the National Library of Medicine or the National Institutes of Health. I'm talking about the Congress believes. That a few people went to them and said, we are dying because we can't get a hold of an article from the "New England Journal of Medicine ". That's pretty much hooey. You can find whatever you want on the internet. And you can also ask your doctor. In that sense maybe we’ve succeeded because as we have a well educated medical cadre. Why don't we put our information, I mean our energy to work, dealing with where the real problems are with getting advances in research, not spending more on bombers than we spend on medical research. And it’s very disturbing…I'm a taxpayer. I'm a citizen. I'm about to retire. So I'll be a retiree. I won't be a publisher. So I guess I won't be the bad guy anymore. Maybe I can be a survivor and speak from that point of view. But this is very disturbing, disheartening to those of us who spent all of our lives trying to improve the access to medical information; in fact trying to improve healthcare in general. Most of us, whether you're in the for-profit or not-for-profit, really believe we have a mission. Some of those missions make money, some of them don't. I published 3 journals that didn't make any money but they had a mission behind them. So my concern is the judgment is now that we have failed in our ability to get out medical information. That's what the Congress said with this ruling. And that is now the role of the U.S. government to get that information out. I would argue that we shouldn't accept that. We should put some of our energies into where the real problems are, which is what saves lives is not the medical literature. What saves lives is the research behind the medical literature. And that is where we should be putting the combined energy and resources of everyone in this room. Thank you.	In Person
694	Town Hall Meeting	3/10/2008 10:00 AM	Franks	Martin		American Physiological Society			Patient or Representative of a Public Health Advocacy Organization						My name is Martin Frank. I'm a taxpayer. I'm a patient and an Executive Director of the American Physiological Society, founded in 1887 and publishing The Science of Physiology since 1888. I'm the coordinator of the DC Principal Coalition, a coalition of 70 not-for-profit publishers who make their content freely available after a interval determined by their business and publishing models. The APS, along with many of the coalition members, utilize the services of Stanford University’s press, High Wire Press, to publish a content of our journals on-line. High Wire Press hosts the largest repository of high impact peer-reviewed context with over 1100 journals, 4.7 million full text articles from over 140 scholarly publishers. High Wire hosted publishers have collectively made over 1.8 million articles available for free. We are here today to talk about the efforts of NIH to duplicate the efforts of High Wire Press to create a repository of a small fraction of the content resident on their site. The content specifically derived from research funded by NIH or approximately 80,000 articles annually. Not-for-profit publishers question the need to utilize scarce research dollars in order for the NIH to become a publisher of that research. As Dr. Zerhouni indicated to me yesterday, we are having today's public access discussion solely because the scientific literature is available on-line and is more readily accessible to the public. While true, the scientific literature is available only because of the millions of dollars invested by publishers to publish their content on-line. Public access advocates tell us that the taxpayer paid for it. Therefore the public should have it for free. That is untrue. The taxpayer may have supported in whole or in part the research that appears in the articles, but the publication process is paid for by consumers just as consumers pay for the loaf of bread produced from the taxpayer subsidized wheat. The 4,000 articles published annually by the APS costs the society approximately 12 million dollars annually. The appropriation of the content by NIH is being done in a way that might limit the publisher's ability to recover these costs. We are here also because according to NIH, the voluntary submission policy has been a failure. Only 4% of the 80,000 eligible articles were submitted by the NIH-funded author investigators. What NIH and others failed to indicate is that publishers have deposited another 20% of the eligible articles. Publishers have repeatedly offered to work with NIH to facilitate the deposit of the NIH-funded articles but NIH is unwilling to negotiate with publishers in good faith. During the summer of 2006, I met with NIH as part of a delegation representing 56 society publishers responsible for the publication of over 15,000 NIH-funded articles. We were offering to deposit the final published articles on behalf of our authors under the NIH portfolio agreement. Those negotiations broke down because NIH told us that their international agreements to create international PMC repositories were more important than the taxpayer access to NIH-funded content. Publishers also offered to work with the National Library of Medicine to fulfill its mission, preservation of the biomedical literature. By offering to provide them with the full text of our on-line journals just as it had been done previously with print journals. Not only would the NLM be able to host the NIH-funded research, but they also received 17 the research articles arising from support provided by all funding agencies. Instead of trying to work with publishers to fulfill its mandate, NLM rejected the offers as unworkable. In reality, working together, we could have made it succeed. Instead, we now have a plan that will only provide the public with access to 10% of the literature funded by NIH. Can we truly advance science and find cures for disease by only accessing 1 in10 articles? As a patient, I want access to every research article and it appears that right now the best way to gain access to both NIH and non-NIH-funded research is to access that content through High Wire Press. For the NIH public access to succeed, NIH must agree to work constructively with publishers. Even with mandatory deposit, author investigators will not deposit their peer review manuscripts. They do not want to be burdened with bureaucratic requirements. We believe NIH must not regulate first and ask questions later. It must undergo Administrative Procedures Act discovery before implementing the plan. We urge NIH to create a better plan by listening to the community, working with publishers before implementing the mandatory deposit aspect of the public access plan. Thank you.	In Person
695	Town Hall Meeting	3/10/2008 10:00 AM	Phimister	James		Elsevier			Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Good morning. Elsevier appreciates the opportunity to contribute to the NIH meeting on public access. Elsevier has an unqualified commitment to the growth, quality and efficiency of peer review publications and to widening access to scientific and medical research. Each year we spend hundreds of millions of dollars to collate, review, edit, correct, produce and disseminate nearly 300,000 articles in over 2000 trusted specialized peer review journals. We have also invested over half billion dollars in electronic digitization, hosting and distribution of over 8 million articles, dramatically increasing effectiveness and efficiency of researchers and practitioners. For the past 3 years, we have sought to work collaboratively with the NIH on implementation of the voluntary public access policy. We proactively identified authors who report NIH-funded research, deposit their manuscripts to PubMed Central and actively monitor policy compliance. We calculate Elsevier’s contributions and increased current deposit rates to PubMed Central to over 30% of articles reporting NIH research. However, we consider the move to mandatory policy to be a very significant change. It should not be done hastily. There is a fundamental difference between the government working with researchers and the publishing community to achieve common goals and the government asserting rights to copyrighted content and competing directly with scholarly publishers. Due to the far-reaching implications of the NIH’s new public access policy on grantees, authors, institutions and publishers, we urge the NIH to expand the consultative process and conduct a notice and comment rule making as defined by law. Indeed, in 2005, when the NIH introduced the voluntary public access policy, the NIH stated: We believe that the voluntary nature of the final policy is preferable to one-size-fits-all requirement as it permits sufficient flexibility to accommodate the needs of different stakeholders. Significant departure from this position warrants a formal consultation with stakeholders. The Department of Health and Human Services should follow the Administrative Procedure Act and stay the effective date of the mandate until a 18 full notice and comment rulemaking is completed. We urge the NIH to ensure the implementation of the policy and respect the basic principals embodied and copyrighted and not undermine those rates that provide incentives for publishers to invest in peer review, publishing and the communication of scientific and medical research. Without sufficient consideration, the mandatory public access policy left unintended and undesirable consequence. It is therefore important that we address critical questions. How will the NIH ensure that PubMed Central does not compete with publisher websites? That traffic is not diverted to PubMed Central and that content on PubMed Central will not displace the definitive published version? What actions are the NIH taking to ensure that PubMed Central does not undermine the viability of journals whose economic stability varies widely? How will the NIH ensure policy will not negatively impact commercial, nonprofit and the society publishers and will the NIH compensate publishers for the added value of services that publishers provide? Third parties could commercially exploit the content that appears on PubMed Central without the consent of the publisher. How will the NIH prevent copyrighted material available on PubMed Central from being altered, pirated, made into derivative works, redisplayed, republished and resold? Many manuscripts that currently appear on PubMed Central are in contravention to publisher policies. How will the NIH ensure individuals post the correct manuscript version to PubMed Central to be publicly available at the correct time as consistent with publisher policy? In the NIH’s processing of manuscripts, manuscripts that appear on PubMed Central may differ from the definitive version hosted by the publisher. How will the NIH ensure that researchers are not mislead as to the accuracy and validity of the manuscripts on PubMed Central? In conclusion, we see scientific and medical publishing as a system that has developed over many years and is core to the continuing success of the research community. As the publishing system evolves, we must sustain quality and balance. We wish to work collaboratively with all key players, particularly the NIH, to demonstrate leadership in this evolution, to address the issues we raise, and to develop viable solutions that will benefit everyone. A rulemaking is a critical and necessary step. Thank you for the opportunity to contribute to this meeting.	In Person
696	Town Hall Meeting	3/10/2008 10:00 AM	Dylla	Fred		American Institute of Physics			Patient or Representative of a Public Health Advocacy Organization						Thank you, Dr. Zerhouni and others to from NIH to give us the opportunity to make some comments this morning. My name is Fred Dylla. I'm the Executive Director of the American Institute of Physics. This is an umbrella organization of 10 member societies and 23 affiliated societies that represent 135,000 physical scientists. And you might think that we don't have much of an oar in the water when dealing with medicine and biomedicine, but your distinguished director is a very credible radiologist and prior to Dr. Zerhouni's directorship, we had Harold Varmus who noted to Congress and the public and the medical community that physicists are valuable to medicine. We developed MRI. We invented the x-ray. A high-energy physicist invented the web to share large amounts of data. And physicists we are perfectly happy and willing to share all of this 19 for the worldwide good. Our society members are all for increased access and open access, public access, all these words get confused. They have various definitions. We support the goal. But…and it was very good for us to hear this morning from Dr. Zerhouni in his remarks that this policy is moving towards presenting information to the public, to scientists, for wider public access. And with respect to copyright law, and he does not want to harm the peer review process of the publishers which aggravate and provide this information, that’s very good to hear. But it's the implementation that concerns us at the American Institute of Physics and our member societies and our publishers, as you have already heard from this morning. When you ask the public or Congress about the fact that NIH is paying for a certain amount of research, it should be made available, of course they’ll say yes. The survey we heard about this morning, 66% said yes, they want public access. If you ask anybody, if they want something for free, they are going to say yes. Unfortunately the public, members of Congress, most of them, and many of our authors do not understand the economics of journal publishing. Journal publishing has been around for 3 centuries and it's gone through a tremendous transformation in the last decade, thanks to the physicists providing the worldwide web as a very interactive way of presenting information. The American Institute of Physics hosts 300,000 pages from over 100 journals on our own platform. And since we introduced that, our access has gone up by an order of magnitude. But we risk damaging the entire journal process. We risk damaging the value of scientific societies and we risk damaging science if we don't very carefully migrate our economic models to open access models. I'm a big fan of NIH. It's the largest funder of science in the country. And I'm very distressed as a citizen and as a scientist that the budget for NIH has been flat over the last 5 years. I'm also distressed in my new job. I have only had this job for a year. I was an active scientist for 3 decades before that. I'm distressed that I see NIH spending its good money duplicating what scientific publishers do both profit and nonprofit. This gets very technical. You heard this morning talk from David Lipman this morning, the entire bottom half of a slide is duplicating what publishers do to have interactive database…documents have to be referenced with a digital number. NIH has duplicated what publishers have done en mass with that. They have to have an interactive database; you have to have a very complicated cross-referencing scheme. All the publishers that work together in an organization called Cross-Ref that allows that to happen. And NIH should not be spending its precious funds to duplicate those things. My final remark has to do with the fact that the public confuses public access to research with the public translation of science. I have a degree from MIT in biophysics and I can't read a state-of-the-art journal in cancer research. What we do in our society is take some of the money that we have for publications and provide translations of that science that the public can understand. I don't want to see that damaged. Thank you very much.	In Person
697	Town Hall Meeting	3/10/2008 10:00 AM	Hogan	Michelle		American Association of Immunologists			Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Thank you for this opportunity to speak. I'm Michelle Hogan, I’m the Executive Director of the American Association of Immunologists, which is a professional association representing 6,500 research scientists and physicians dedicated to understanding the immune system. We publish the Journal of Immunology, the world’s most cited immunology journal and one of the top ranked journals in the ISI. It publishes over…we publish over 15,000 text pages a year and we are part of the High Wire Press at Stanford. We respectfully submit the following comments and these are in brief some of the comments. AAI continues to believe the NIH public access policy will duplicate at great cost to the NIH and to taxpayers publication services which are already provided cost effectively and well by the private sector. The private sector including not-for-profit scientific societies already publishes and makes publicly available thousands of scientific journals that report cutting-edge research funded by both NIH and other public and private entities rather than creating a new government bureaucracy, a particular burden in this era of severe budget constraints. NIH should partner to develop a plan that enhances public access but addresses the publishers’ key concerns, of which we’ve heard of many today, and also ensuring journals’ ability to provide high quality independent peer review of NIH supported research assuring to the public and the to NIH that in which they are investing. AAI has strong concerns about the implementation of this policy. In our submitted comments we have noted a number of the issues which include legal and procedural concerns that the NIH must address prior to issuing the RFI. But even if NIH addresses these concerns, we need additional information in order to submit thoughtful comments in response to the RFI. Therefore, AAI respectfully request that NIH publicly respond to the following questions before the RFI is published. One, what are the total funds that were expended on implementing the voluntary public access policy starting May 2, 2005 to January 11, 2008? We’ve never seen that number. What is the cost anticipated for implementation of the mandatory NIH public access policy in FY 2009, including one time costs as well as annual reoccurring costs? In responding to the above questions, we ask NIH to report specific costs included in the NLM as well as various NIH institutes, centers and offices which will undoubtedly be involved. We have provided these specific costs in our written comments but they include items such as the number of FTEs and contracted services used to accommodate this initiative. What steps is NIH taking to ensure that it posts only articles that comply with a particular publisher’s embargo policy? We have certainly had this violated for us and have a full-time FTE just looking this over to have them taken down. Who will ensure the NIH complies with the publisher's copyright rights once a manuscript is submitted? That is, who will make sure the NIH does not transfer a manuscript to any other entity or repository without permission from the publisher? Who within NIH and the various institutes will be responsible for determining whether a grantee is in compliance? Is it institute directors, is it program officers? How will this process be carried out and who is responsible? And in fairness to our members, what will the penalties be for noncompliance specifically? What is the evaluation plan for the public access effort and when will it be assessed? How can NIH move forward with this 21 implementation plan when NIH will not be responding to the RFI until September 30, 2008? And finally and specifically we would like to know why the NIH will not accept the linking proposal offered in 2005, described by Marty Frank, by 56 not-for-profit scientific publishers. It would enable the journal’s website to be available seamlessly on PubMed Central and enable readers full text … the access to full text articles funded by NIH and most instances all articles irrespective of the funding. This proposal has the following advantages and provides public with free access, provides the final published articles. It’s cost effective since the NIH would not have to recreate and continue supporting a new repository, educate grantees’ compliance and copyright and monitor for copyright and compliance. It addresses publishers’ copyright concerns and upholds embargo periods. It satisfies new laws. And finally in discussions with the NIH and the linking proposal we offered to satisfy NIH’s need for a repository of NIH-funded works with a dark archive for internal purposes only. Thank you for your time and attention.	In Person
698	Town Hall Meeting	3/10/2008 10:00 AM	Garrison	Ellen		American Psychological Association			Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Thank you for the opportunity to comment on behalf of the American Psychological Association, APA, regarding the new mandatory NIH public access policy. I am Dr. Ellen Garrison, Senior Policy Advisor to our CEO, Dr. Norman Anderson, and I'm accompanied today by Susan Harris, APA’s Senior Director for Journals. APA is the largest scientific and professional organization representing psychology in the United States, and the world's largest association of psychologists with 148,000 researchers, educators, clinicians, consultants and students. APA is also the largest publisher of behavioral science research with 37 of the premier scholarly journals in the field of psychology. Given that the 6 leading causes of death in the U.S. are behaviorally determined, it is clear that psychological science has a critical role to play in improving the health of our nation. Accordingly, APA strongly supports efforts to enhance public access to scientific publications but has serious problems about the new public access policy as related to copyright, compensation, scope of coverage, and date of implementation. Underlying this new policy is the faulty presumption that publishers will not experience significant financial hardship due to the 12 month lag between data publication and posting of the peer-reviewed manuscript on PubMed Central. While this may be true for a handful of publishers, it hardly applies to the industry as a whole and certainly not to our association. This is due to the fact that the cutting edge research that we publish is rarely obsolete within a year, and may have a shelf life of 5 to10 years. Moreover, only 15% of the eventual lifetime usage of our journal articles in the form of downloads occurs within the first year after publication. About one-third of the articles in 9 of our journals resulted in whole or in part from NIH grant support. Our authors reflect the wide diversity and the behavioral and social sciences field including new investigators. Our overriding concern is that when peer-reviewed manuscripts are made widely and freely available online, the commercial value of the finished public work is likely to be seriously diminished while resulting declines in subscriptions and licensing 22 agreements. This loss of income is likely to lead to less scientific publishing, and thereby less public access to research. According to the statute, it is the responsibility of NIH, not the institutions or investigators as NIH contends, to “implement the public access policy in a manner consistent with copyright law”. In clear violation of copyright principles, publishers for the first time ever are essentially being made to forego their copyright interests without just compensation for their investment. It is critical to realize that publishers add immense value through such functions as editorial selection, peer review, copy editing and design production. The public access policy must not have a negative impact on publishers both in this country and internationally nor on U.S. business or industry that would undermine our high quality of research. The policy by its very nature compromises a quality of scientific publishing by ultimately making available two versions of scientific papers. How does NIH propose to ensure that the postings in PubMed Central will not adversely affect the copyright interests of publishers, the value that they add to research and the interests of the public in maintaining the quality of scientific publish? In certain aspects, NIH would be well-advised to scale back the reach of its policy, specifically the policy should only apply to scholarly work fully funded by NIH. So as not interfere with the interests of other funding sources and to empirical research, not literature review. And lastly, NIH should not hold investigators and their institutions responsible for the submission of manuscripts that arise directly from the research that they did not author or coauthor. NIH is to be commended for holding this open meeting and for issuing a request for information (RFI) later this month. Yet even taken together, these actions do not substitute for a formal notice and comment rulemaking which NIH is still urged to pursue. Rather than take precipitous action, NIH should delay implementation of its policy to allow time for the consideration of today's comments and those arising from the RFI and should not apply the policy to any grants issued before its effective date. In keeping with the Senate report language, it is also critical that NIH meaningfully engage publishers in the implementation and evaluation of its new public access policy. Thank you once again for this opportunity to comment.	In Person
699	Town Hall Meeting	3/10/2008 10:00 AM	Blum	Carol		Council on Government Relations			Patient or Representative of a Public Health Advocacy Organization						Good afternoon. I'm Dr. Carol Blum, Director of Research Compliance and Administration at the Council on Governmental Relations, or COGR, an association of more than 175 research universities, their affiliated academic medical centers and research institutes. As an association, COGR concerns itself with the influence of federal regulations, policies and practices on the performance of research conducted at its member institutions. COGRs’ members are aware of the statute and the implementing National Institutes of Health policy on enhancing public access and are working to assist their investigators in meeting the statute and policy requirements. Because the mandatory requirement is applicable only to articles funded by grants, contracts or cooperative agreements with current active support, grants funded since October 1, 2007, and contracts awarded after April 7, 2008, we have time to inform and insist our 23 investigators in meeting this shared obligation. We can focus first on those researchers with continuing funding whose research may be sufficiently advanced to have results to report. As new awards are made, we will provide notification and support as needed to assist our investigators. Public reports of the policy have given rise to some confusion and we appreciate the resources NIH has made available, notably the frequently asked questions to clarify the applicability of the policy and how grantees and their investigators meet their obligations. We would note that the policy needs further clarification to reflect the relationship between NIH-funding described in the FAQ, and the acceptance for publication, the criteria described in the policy. Normally, institutions do not join the relationship between authors and journals. As educational institutions, universities seek to balance scholars’ rights as authors with our fundamental mission to promote the free exchange of ideas and research results and we urge our faculty to publish their scientific and technical research. In accordance with this academic tradition, most institutions do not claim ownership to pedagogical, scholarly or artistic works regardless of their form of expression. However, as the grantee, a research institution is obligated to meet the terms and conditions of all its agreements. As such, institutions must act to ensure compliance with the statute and NIH requirement. Where publishers’ practices would restrict required access to research results, we will remind our investigators to retain their rights individually to provide a copy of the final peer-reviewed manuscript that has been accepted for publication to PubMed Central under current copyright law provisions. We appreciate that NIH is providing an example of language that can be used in copyright agreements to meet this obligation. Some of the burden of meeting this statutory requirement would be eased if more journals would collaborate with NIH and the research community in meeting these statutory obligations. Recognizing the requirement, we hope the publishers will modify standard copyright agreements to include a provision that acknowledges the author retains the right to provide a copy of the final peer-reviewed manuscript to NIH and to make the article available in PubMed Central. Alternatively, journals could agree to deposit the final published manuscript in PubMed Central. In this case, a significant portion of the burden on the grantee institution and its investigators is relieved. There are currently over 250 journals and 60 open access publications submitting directly to PubMed Central. This assistance from NIH and these journals to secure agreements is particularly important since many manuscript submission and copyright authorization procedures are electronic and do not offer the authors an opportunity to adapt the publisher's submission procedures to meet the NIH policy. The consequence to investigators who inadvertently fail to reserve their rights to submit are not clear and should be addressed by NIH. We are equally concerned for investigators, particularly junior investigators, whose career advancement may be jeopardized if some journals refuse to accept the reservation of rights or the investigator lacks access to sufficient resources to pay the price for public access. As NIH creates programs to encourage and support new investigators, it needs to address the challenges of publishing results of that research that may fall particularly hard on these new scientists. The research institutions intend to meet their obligations and responsibilities under the statutory requirements as 24 implemented by the policy. And we appreciate the opportunity to make these observations and comments today.	In Person
700	Town Hall Meeting	3/10/2008 10:00 AM	Adler	Ellen		Association of American Public Schools			Patient or Representative of a Public Health Advocacy Organization						and Government Affairs for the Association of American Publishers. But that was good because it demonstrates that even the NIH is not infallible. Which I think is very important point for why we are all here today. We submitted formal comments to the NIH in which we discussed the problems that we’ve had in obtaining meaningful consultation with NIH for the journal publishing community. We outlined some of the specific concerns we have about protection of publishing rights including copyright, and we also talk about a number of issues raised about good faith implementation. So I want to summarize for you in a sort of a broad fashion why it is that publishing is so concerned about what the NIH is doing. The concerns of scholarly publishers stem mainly from the manner in which NIH and its staff responsible for PubMed Central have implemented this public access policy, both when it was a voluntary policy and now when it has become mandatory. Briefly, they have taken liberties with copyright content in a fashion that simply competes with the activities of independent publishers and that undermines the rights of those publishers including copyright. Specifically, by reprocessing and enriching manuscript submissions and expropriating publisher's value added investments in peer-reviewed content, NIH is creating enhanced derivative publications that go beyond the explicit congressional mandate of posting researchers’ documents that report on the results of federally funded research. Let me say that again. They are going beyond the explicit congressional mandate of posting researchers’ documents that report on the results of federally funded research. What you have seen demonstrated in the presentations by NIH officials are the processing and reformatting and repurposing of the materials that are submitted to them by the researchers is not at all required by the mandate that Congress enacted in the Consolidated Appropriations Act. It is simply the way that NIH has chosen to implement that policy. And in doing so, they have doggedly disregarded proposed alternative ways in which this could be done coming from the publishing community which knows a thing or two about publishing. Rather than just posting, what it receives, whether it’s an author's version after peer review or a publisher's submission in a PDF or other fixed format, NIH has embarked upon XML based, reformatting and tagging procedures to create alternative versions of published works that when made freely available will substitute for the definitive articles in which publishers have already made substantial investments. And therefore, in effect, there is no question in the minds of the publishing community that NIH is itself entering the publishing business, and more to the point, enabling other international entities to enter the publishing business with the same material through mirror locations of its database. And they will do so by creating enhanced derivative versions of the materials that they receive. 25 So, the question we come with today primarily is what does NIH have to fear in conducting a notice and comment rulemaking consistent with the Administrative Procedures Act? You heard from NIH, their willingness to receive input from the public, that’s why they are conducting this meeting, that’s why they are going to announce their request for information. But that's not an indication NIH is willing to respond to the input that it receives. And that is where the Administrative Procedures Act becomes very important. Over 60 years ago it was an acted by Congress to ensure generally that the agencies of the federal government in imposing regulatory policy do so in a manner that is rational rather than arbitrary and consistent rather than abusive of their authority under the law. It requires that the agencies not simply request and solicit public input, but also that the agencies respond to that input and particularly in responding to that input, do so in a way that justifies and explains the nature of their regulatory policies and demonstrates that those policies are in fact necessary and reasonable. So why is the NIH afraid to conduct an APA rulemaking in this area? Could it be because they don't want to engage in that justification? They have to engage in that justification because the law requires it. We hope that the APA rulemaking will in fact take place because there are a number of important issues that need to be aired and need to be discussed in broader terms in greater detail that can be discussed in a forum such as this one. For example, this government imposed rule and mandatory license may well be equivalent to exceptions to copyright that would contravene fundamental obligations of the United States under treaties such as the Bern Convention and Trips Trade Agreement, and therefore may be directly counterproductive to this country's intellectual property law advocacy abroad in the global marketplace. We hope that ultimately there will be an APA rulemaking and that the NIH will not only solicit comments but will also itself comment in a meaningful way on what it is doing. Thank you.	In Person
701	Town Hall Meeting	3/10/2008 10:00 AM	Kelly	Patrick		John Wiley and Sons, Incorporated			Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Hello. I'm Pat Kelly. I'm a publishing director within Wiley Blackwell, which is a Division of John Wiley and Sons. Wiley Blackwell is one of the world’s foremost academic and professional publishers with a combined list of more than 1400 journal titles. We are also the world's largest society publisher. More than half of those titles we don't own. We publish on behalf of scholarly, medical and professional societies. The 700 or so societies have more than a million members worldwide. As stakeholders in the research community that have invested billions of dollars to advance science to peer review and editorial production distribution and archival processes, publishers will be significantly affected by the implementation of this new public access mandate. What Wiley and many other publishers want is for NIH public access policy to be implemented in a way that maximizes its effectiveness to the public and scientific research community, ensures protection of copyright, and protects our and our employees and our society partners’ interests. What we don't want is a regulate first and ask questions later approach that harms more than it helps. 26 The key to ensuring for us, that the public access policy meets its stated objectives and is effectively implemented, is for NIH to work closely with publishers and other stakeholders in the scientific research community to seek their detailed input through a full notice and comment rulemaking under the Administrative Procedures Act before the implementation of the policy. The public had a similar opportunity in 2005 when the voluntary public access policy was first announced and it should have that opportunity again, as directed by Congress. Wiley supports enhancing public access to government funded research, and we look forward to partnering with NIH to get this policy right. We have a number of concerns in various areas but I thought I would just highlight a couple in the area of protection of copyright that bother us particularly. In our view, implementing the public access policy in a manner consistent with copyright law and the intent of its congressional mandate would mean that NIH would respect the integrity of the copyrighted content it receives and ensure that any revisions to copyrighted material, such as reformatting, enhancing, linking or otherwise changing the articles are undertaken only when consistent with copyright. We also have significant concerns related to how NIH will safeguard against domestic and international piracy of deposited manuscripts. NIH seems to assume that only U.S. copyright law is pertinent to the worldwide posting of articles by PubMed Central, yet the application of foreign copyright laws to the worldwide mirroring or downloading by PMC would have to be analyzed in far greater detail and in respect to the law of each country where such activity may occur. On a practical level, that makes publisher's final peer review manuscripts vulnerable, both to the interpretation of foreign government's and to international piracy of U.S. government funded research. Peer review represents a significant investment by publishers like us and many others and neither originates with license or authors nor is the product of NIH-funding. Yet under this new policy, NIH insists on appropriating the final peer-reviewed manuscript. Publishers recoup the expense of peer review production and distribution by several means including commercial sales both domestically and overseas. As a result, when copyrighted articles are freely available online their commercial value in our view is significantly diminished. When peer-reviewed manuscripts are made widely and freely available online, the commercial value of the finished, published work is eroded significantly with resulting declines in subscriptions and licensing agreements. This global effect will seriously harm publishers of all sorts but especially many of the smaller society publishers that we represent here today and whose journal titles we publish. Scientific, technical, and medical publishers employ some 30,000 people in North America alone with perhaps an equal number indirectly supported. How will those publishers be compensated for the economic loss that results from the NIH taking of the publisher paid peer-reviewed articles? NIH could undertake direct licensing arrangements with publishers to deposit copyrighted work on behalf of authors. It would be the simplest and cleanest way to do business, to ensure compliance with the public access policy agreements with publishers regarding payments for their journal articles, removes the administrative and financial burden of compliance with the policy from authors. The new NIH mandatory public access policy places heavy undue burden on institutions and investigators to uphold the copyright provision of the statute while the private sector is equipped now to help implement this policy effectively. 27 So, in conclusion, and on behalf of Wiley Blackwell, I want to thank NIH for the public meeting and the upcoming RIF proceedings. But considering the far-reaching implications of the substantial change in the NIH public access policy, we urge NIH to do a full APA notice and comment rulemaking. Publishers look forward to working with NIH to enhance public accessibility of scientific research results. We hope to find ways to do so while continuing to protect the publishing enterprise that has nurtured and served the scientific community. Thank you.	In Person
702	Town Hall Meeting	3/10/2008 10:00 AM	Adler	Prudence		Association of Research Libraries			Patient or Representative of a Public Health Advocacy Organization						Good morning. I'm Pru Adler with the Association of Research Libraries. ARL’s very pleased to present comments on the revised NIH public access policy. ARL strongly supports the policy and commends NIH for soliciting comments while moving ahead in a timely manner with this critically important congressionally approved policy. Most ARL libraries support researchers who receive NIH-funding, thus are collaborating with others to ensure effective compliance with a policy. As is abundantly clear by the numerous comments filed by ARL members, there is strong support for the revised policy because it is integrally tied to the mission of higher education. As Dr. Zerhouni noted earlier, since the policy was first introduced in 2004, there has been extensive public comment, legislative consideration, review by an NIH appointed working group that included publishers, and many meetings with effective parties and NIH as we saw this morning. Now is the time to work collaboratively to ensure that implementation is successful as public access to federally funded research, furthers scientific discovery, enhances U.S. competition and importantly improves the health of Americans. ARL and its members are actively engaging in a number of activities to assist institutions and their researchers in complying with the NIH policy. Steps taken today demonstrate that institutions believe that the compliance is achievable. This is due in part because research libraries focused on copyright management and access issues well before the NIH policy surfaced. This involves helping authors make informed decisions to exercise their interests and their institutions’ interest in the ownership and use of copyrighted works and to do so in a manner that promotes the greatest possible scholarship and public use of their work. This includes promoting tools that allows authors to deposit their works in disciplinary repositories such as PubMed Central and in their own institutional repositories. The resources and communications strategies that we have designed and developed are designed to accelerate the readiness of institutions and the researchers to comply with the NIH policy. Now with regard to possible changes that we were asked to consider, we encouraged NIH to reconsider the embargo period of 12 months, and once again solicit comments on a 6 month embargo as was originally proposed. As is widely understood, even with a 6 month embargo period, research libraries will not cancel journal subscriptions. Publishers, therefore, are not at risk from this revised policy or from a shortened embargo period. Thank you.	In Person
703	Town Hall Meeting	3/10/2008 10:00 AM	Hill	Emma		JCB Rockefeller University Press			Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Hi. First of all, thanks very much for the opportunity to present our comments here today. It’s very much appreciated. I'm Emma Hill, I’m the Executive Editor of the Journal of Cell Biology, which is published by the Rockefeller University Press. The Press is a nonprofit organization, which you may guess is linked to Rockefeller University. We publish 3 well respected scientific journals—the Journal of Cell Biology, the Journal of Experimental Medicine, and the Journal of General Physiology. I speak for all three journals and the Press as a whole today. As a university publisher, we represent the middle of the road in the ongoing dialogue about public access to published data. Somewhere in between, the advocates to complete open access, and publishers who hold most or all of their content behind access controls. We applaud the NIH for their efforts to move forward with this policy which we wholeheartedly endorse. The content of all 3 Rockefeller University Press journals is released on our own websites 6 months after the date of publication. More recently we worked with the National Library of Medicine to post the full final, copyedited and formatted text of all of our content on PubMed Central which is made available to the public 6 months after publication. With us we are ready to comply with the NIH public access policy. We estimate that this only costs us approximately 6 dollars per paper, which is not a significant cost. We do not charge the author. We see multiple copies and important digital archiving of our content in a public database as a completely positive aspect and in no way is this in competition to our own journals’ websites. Greater availability of our content equates with enhanced visibility of our journals. Two of the Rockefeller University Press' 3 journals have been freely available to the public 6 months after the publication date since January 2001. Even though our content is only under access control for this short period of 6 months, our subscription revenues have continued to rise over the last 7 years. The Rockefeller University Press is in a unique situation of demonstrating that it is financially feasible for publishers to permit the release of all their content in accordance with the NIH public access policy. At the Press, we strongly believe that scientific publishers have an obligation to release their content to the public to provide much of the funding to generate that content and to buy subscriptions. In an ideal world, all publishers would fulfill and facilitate this obligation on their own. Although many publishers are already doing so, there are still many who are not. Some may see this as duplication of effort by the NIH. I think this is wrong and that this is the NIH protecting their own interests and making sure they have ongoing access to the research that they funded with taxpayers’ monies and also as a counter against the possibility of any publishers, especially those small and society publishers who may sadly eventually disappear. Their content will then be maintained within the PubMed Central archives. Publishers who oppose this policy may present various arguments but the bottom line is possibly they lose …they fear losing subscription revenue. In a sense, their stakeholders are a conflict of interest with respect to this debate which should be declared upfront just 29 as we also review as to …excuse me…just as publishers do with authors and reviewers in regards to their submitted manuscripts. If some people wish to demand financial accountability from the NIH, then we should also demand the same from many concerned stakeholder publishers. With taxpayers’ monies, the NIH funds the research. NIH-funded research performs and reviews any research and thus the data from any resulting publications can and should be made available to the public. To this I don't think there should be any argument. We believe that publishers can and should facilitate the implementation of this policy and see no need for any further comment period. We thus strongly support the NIH public access policy and urge you to implement this mandate as soon as possible. Thank you once again for the opportunity to talk and present our comments.	In Person
704	Town Hall Meeting	3/10/2008 10:00 AM	Terry	Sharon		Genetic Alliance			Patient or Representative of a Public Health Advocacy Organization						Thank you. I'm the President and CEO of Genetic Alliance. Genetic Alliance transforms health through genetics. We accomplish this by integrating improving individual family and community perspectives to improve health systems and by bringing together diverse stakeholders to create novel partnerships and promote individualized decision making through increased access to information. Our network includes over 650 disease specific advocacy organizations and hundreds of partnerships with universities, companies, government agencies and policy organizations. The network is an open space for thousands of shared resources, hundreds of creative tools and dozens of dynamic programs. We applaud the Congress for enacting this policy and NIH for implementing it. We are pleased by this action but we are also acutely aware of the profound urgency inherent in a society that requires accelerated translation of basic science to meaningful clinical interventions. All information, the raw materials of making sense of disease and mitigating its effects should be immediately available. We also ask the NIH go a step farther and make submissions of articles mandatory at 6 months as a compromise to immediate access. We live in an age of an over abundance of information. Information is not a scarce commodity anymore. Material that is 12 years old is old. It is unconscionable that scientific information is not immediately available to everyone. While publishers argue that they create value around raw information, we would argue that scientists funded with federal dollars and also stewards of the public trust infuse these articles with value. There is no doubt that publishers add value and the value proposition around this body of knowledge should be 30 paid for. But not the research results themselves. It is the duty of NIH as the primary funder of biomedical research to facilitate sunshine on the data and to bring these articles into the public commons as quickly as possible. Information critical to health and biomedical research should no longer be held hostage by arcane publishing practices. It is time for publishers, both private and academic, to redesign their business models in response to a new age of information, sharing a stronger sense of the scientific commons. The myriad of solutions proposed and in use simply formulate the walls of silos, only a central repository will allow robust, annotated meta analysis. We have seen business paradigms for all sorts of publishing industries evolve as information aggregation changes. It is time for this industry to evolve as well. Public access to scientific information is critical. It is the bedrock of our current system of discovery and the catalyst to build on science. Scholars and educators will find riches of new data and studies to use in classrooms. Researchers across disciplines will have new opportunities for collaboration as they engage this treasure of publicly funded knowledge and the work of all authors will be cited more frequently. Public access to the biomedical literature funded by NIH will yield untold benefits for medical research and discovery of treatments. I also stand here today as the mother of Elizabeth and Ian Terry, two kids with a genetic disease. It's rare. It’s not well understood and there is no treatment. We are facing an uphill battle, a future of blindness for the two of them and thousands more with this disease. Another 6,000 or so genetic diseases burden more than 25 million Americans. When I began speaking about public access, I tried to carefully counter all of the arguments which we have heard today. My thinking has evolved. While I once thought we should move forward carefully and try to ease into these paradigm shifts, I think now, years later, we have evidence that the public banking of the genome, journals that have 3 month embargoes and less and then open access and the commons of information are thriving. I have also during this period watched thousands of people in our community die in these years and the time for waiting is over. Let's do it. Let's not spend any more of our precious time debating on this, commenting on this. We live on the promise and inestimable value of publicly funded science. Obstacles to translating basic science into practice abound. But gated access is an artificial obstacle. Remove barriers to information immediately, open access to publicly funded research without delay. We’ve got a great deal of work to do and we need the tools now.	In Person
705	Town Hall Meeting	3/10/2008 10:00 AM	Jerram	Peter		Public Library of Science			Patient or Representative of a Public Health Advocacy Organization						Hi, I'm Peter Jerram, I’m Chief Executive of the Public Library of Science, or PLoS for short. We are a leading open access publisher of scientific literature. And I'd like to thank the NIH for the opportunity to speak today and to share our views. Over the past several years, we and other open access publishers have conclusively demonstrated the high impact of open access scientific publishing. PLoS Biology, for example, is now the number 1 general interest biology journal in the world. PLoS has been in de facto compliance with the NIH policy since day 1 since all of our articles are already sent to the PubMed Central archive. And since we already grant copyright to our authors, we 31 have no concerns over this aspect of the policy. The policy itself in fact will greatly expand the availability of the more than 60,000 articles that result each year from NIH-funding. At the most fundamental level of the course, the taxpayers have the right to see the results of the research that they have funded without paying an additional fee. But beyond basic rights, the policy’s impact will be far reaching and deeply felt. Two profound implications stand out. First, the impact on public health. Currently the public generally does not have access, unrestricted access to, rigorous peer-reviewed high quality research. There are numerous examples of citizens seeking health information on-line only to be denied the access for which they have essentially already paid. Similarly due to high cost of medical journals, many physicians can't afford to keep up with the latest research in their own fields. And health policymakers who formulate influential public policy are likewise barred from reading the full text to avoid this research. In all of these cases, most people are forced to rely on abstracts alone which are sorely inadequate as the basis for critical, clinical and health policy decisions. In fact, there are several recent studies that suggest that abstracts often inaccurately represent the content of the research they purport to summarize. A recent editorial and no less authority than the Lancet concluded that, “abstracts are known to be fickle representations of an article.” Secondly, the internet has enormous power not only to disseminate information but also to bring to bear computational tools to find, share and combine that information into virtual interlinked libraries that will spark new ideas and spur scientific discovery. The Wellcome trust, Great Britain's largest private funder of medical research, has noted that, as the tools for mining become more sophisticated, we will see new knowledge being created by the linking of research papers that previously not been seen as relevant to each other. For this to happen, however, papers must be held in an open access repository and not remain hidden behind publishers’ authentication systems. We, as scientific publishers, support the NIH’s open access policy. Over the past 4 years, we’ve taken the time to comment on the policy and have had ample opportunity to make our thoughts known. The policy will not only encourage others to follow suit with their own open access mandates, it will itself help unlock the power of scientific data and enable scientists to pioneer new kinds of computational research that can only occur in the open environment. Thank you.	In Person
706	Town Hall Meeting	3/10/2008 10:00 AM	Kennison	Rebecca		Columbia University			Representative NIH Funding Recipient Organization						Columbia University welcomes the opportunity to implement the NIH public access policy. We believe that the policy is consistent with educational and research objectives of the university, and of the right of the public to access government supported research. The NIH policy has also provided an important occasion for offices within the university to continue to collaborate and coordinate policy and procedures on the importance of managing our research output and ultimately making it more readily available to the public that has supported both the research and our researchers. In conjunction with the institutions around the country, Columbia University is taking steps to implement the NIH policy in full by the stated dates of April 7 and May 25, 2008. To 32 that end, Columbia has done the following: coordinated efforts between the office of research and the libraries; developed local implementation policies and procedures; drafted guidance documents and forms for submission of articles to journals and for agreements between authors and publishers; begun development of educational programs and tutorials for faculty members and other researchers and authors; created an original website of materials and information related to the policy. We do have concerns about some of the challenges to implementation raised by the submission and compliance processes currently in place. Many of those concerns have been raised by other institutions grappling with the same issues. Our authors, as is true, throughout the Academy, submit directly to journals without going through any university office making tracking full and complete compliance difficult. There are also several logistical concerns, that the person submitting is required to enter into the NIHMS as part of the submission process the date the paper is to be published but since submission is upon acceptance, that date is almost assuredly not known at that time; that the designated PI is required to approve the XML tagged version of the submitted manuscript before the PI can obtain a PMC ID number and the compliance in this step may be difficult to ensure; that the mechanism in place for correcting errors that might be discovered within the submitted paper once it has been approved is unclear; that authors may face long delays in obtaining PMC ID numbers for those publishing in a journal that submits the final published paper to PMC as the time from acceptance to publication can sometimes be quite lengthy. That said, we are committed to working with NIH to develop and refine an increasingly smooth process for implementation of this policy. Implementing a new policy is never simple but we believe that Columbia University will be on schedule for implementation and we are motivated in large part by our support for the objectives of this important new policy. Thank you very much for this opportunity to comment.	In Person
707	Town Hall Meeting	3/10/2008 10:00 AM	Oliver	Kate		Johns Hopkins			Representative NIH Funding Recipient Organization						Good afternoon. I am Kate Oliver. And I serve as Chair of the Scholarly Communications Group at Johns Hopkins University. Our group is a part of the University Libraries Council. I also serve as Associate Director of the Welsh Medical Library and as a member, as a staff member of that library, our library is part of the Association of Academic Health Science Libraries. The Johns Hopkins University Library Councils strongly support the NIH public access policy. The requirement provides an important opportunity to make published research funded by NIH and written by Hopkins authors accessible to all…the public, healthcare providers, educators, and scientists, among others. This improved access will help advance science and ultimately improve human health. Deposit in PubMed Central ensures that research results will be preserved in a state-of-the-art digital repository. Free access within a 12 month period will maximize the visibility of Hopkins research and ensure that researchers and students around the world will be able to read and build on Hopkins work, regardless of their ability to subscribe to the journal in which the journal is published … the article is published or research is published. Preliminary research suggests that articles freely available are cited more often and have greater impact than 33 those articles that are locked away behind subscription walls. NIH public access will foster development of new research tools, open doors to new research initiatives, and advance scientific discovery. At Johns Hopkins, we have taken the following steps to respond to the NIH public access policy. We have scheduled a meeting between the Dean of Libraries, the Director of the Welsh Medical Library and the Vice Provost for Research. The purpose of the meeting is to explore how the university and its libraries can assist its authors in meeting the NIH mandate and support open access to scholarly output from the university. We will present recommendations to the Provost on a university-wide publication agreement, the role of the university's repository, J Scholarship, and the Harvard initiative. We have created an FAQ on the NIH policy including an authors’ addendum. Library liaisons will assist Hopkins authors by directing them to the information on the policy and assisting them in the submission process. We have advised our vice deans for research in School of Medicine, School of Public Health and School of Nursing on the FAQ that we’ve developed. And we remain in close contact with the Office of the General Counsel sharing the Carol White Paper and other relevant analysis of implications of the policy for the university and its authors. The School of Medicine Vice Dean for Research sent two broadcast e-mails alerting them to their responsibilities under the new mandate. And the second e-mail directed authors to the FAQ that we had developed. Both the School of Public Health and the School of Medicine will be placing a link to the FAQ assisting authors on the Office of Research Administration site. And this FAQ resides in a scholarly communications website that was developed by the university: openaccess.jhu.edu. Finally, we are currently exploring how we might develop an interface between our repository and PubMed Central in collaboration with other institutions and software developers. These institutions include members of the Association of Research Libraries, and the Association of Academic Health Science Libraries. Thank you for the opportunity to comment.	In Person
708	Town Hall Meeting	3/10/2008 10:00 AM	Diamond	Jane		American College of Rheumatology			Representative NIH Funding Recipient Organization						Thank you for the opportunity to comment. I represent the American College of Rheumatology. We publish two monthly peer review journals that are the leading journals in our field. We have a number of concerns about the NIH policy, many of which are similar to the ones I'm going to say are the ones that you’ve heard before. We are fully in favor of the concept of open access to articles 12 months after publication backed as was mentioned by other publishers here. All of our articles, not just NIH-funded articles, are currently made open access on our own journals website 12 months after publication. We do have some concerns about the process, though, as it is proposed, one of the greatest of which has to do with the deposition of articles at the moment of acceptance before they’ve been fully vetted. Peer reviewers vet the scientific merit of journal articles but they do not identify subtle errors in the data. This is done at the copyediting stage after articles have been accepted. In virtually every article in our journals, such errors are identified. Frequently errors appear in the results section and if not corrected could lead to misinterpretation of 34 some of the study findings which, if left, would be detrimental to patients and future researchers. Copyeditors identify errors by spotting inconsistencies in data presented in one section of an article versus another section and rectify them with the author prior to final publication of the article. These types of errors occur in articles accepted by all journals, even articles authored by the most seasoned and respected investigators. NIH policy requires that articles be deposited at PubMed Central immediately upon acceptance prior to correction of these errors. Open access is proposed one year after publication and is open access to the final version at which time those articles would have been corrected, but our question is, who will have access to the articles in the form in which they are initially deposited? And if no one will have such access, we wonder why they need to be deposited in this form. We also had questions similar to something that was raised by a speaker just a few minutes ago about how the author is to know when his or her article is to be published so he can indicate that upon deposition of the article because that is not something that the authors definitely know at the time an article is accepted. Also, I'd like to reiterate that journals do add considerable value to published papers by performing peer review. Over 98% of papers eventually published undergo revisions to improve the validity of the published product benefiting future researchers as well as patients. The expense and effort of this process is supported entirely by the journals. We like to know if it will be possible that at the time the final published version is made open access, if that could be done only by a link to the journal site. This would lessen the negative effect on the journal’s ability to continue with this vital contribution. Finally, I'd like to point out that many investigators do not seem to be aware of the new policy despite the fact that NIH plans to put it into effect very soon, April 7. The ACR urges NIH to delay this deadline so that authors and publications can adequately prepare for it, and the procedural questions can be adequately addressed. Thank you for the opportunity to comment.	In Person
709	Town Hall Meeting	3/10/2008 10:00 AM	Joseph	Heather		SPARC			Publisher (including Commercial Organizations, Professional Societies and Journal Editors)						Thank you. I'm Heather Joseph, I’m representing SPARC, the Scholarly Publishing and Academic Resources Coalition. We are very pleased that the revised NIH public access policy is moving towards a timely implementation. We strongly believe that effective immediate implementation of this policy will enhance researchers’ ability to access, share and use the results of the critical biomedical research funded by this agency. As an organization of more than 220 academic and research libraries, serving both public and private universities and colleges across the United States, SPARC is committed to the promotion of policies that expand the dissemination of research results, reduce barriers to the use of those results, and leverage the network digital environment in an efficient and cost effective manner. We believe that the NIH public access policy provides an important opportunity to further these aims. SPARC has been strongly supportive of this policy since it was first proposed back in 2004. The breadth of support for this policy was clear to us from the reaction of the American public in the first request for comments published in the Federal Register in September of 2004 when the vast majority of the more than 6,000 individuals and 35 organizations who responded did so in support of the policy. We have been actively involved in the numerous public discussions and debates that have taken place here at NIH, in the U.S. Congress, over the past 3 years as the policy has worked its way visibly and transparently through the legislative process. We participated in dozens of meetings devoted to discussion of this policy convened by interested policymakers, universities, libraries, publishers and other stakeholder organizations. We have been very pleased to see this issue receive prominent coverage year in and year out in national and international media outlets ranging from the "Washington Post" to the Wall Street Journal to the NBC Nightly News. This long and thorough and very public vetting process culminating in the passage of the policy by both houses of Congress and ultimately with the signature of the President, strengthened our commitment to see this policy through to its successful implementation. Now that the policy has been signed into law, our focus has been on creating programs to ensure the effective enactment of the policy so that its benefits can begin to accrue to the public. We are pleased to see that most other stakeholder groups are also putting their resources into these efforts rather than into costly and unnecessary campaigns designed to delay this crucial policy. Our efforts at SPARC have centered around raising awareness of the policy on our campuses, facilitating the deposited manuscripts into PubMed Central, and ensuring that authors understand the rights that they, as the original holders of their copyrighted manuscript, need to retain in order to comply with the policy legally. This third element remains particularly important as a small but vocal number of publishers continue to make the misleading and incorrect assertion that this policy will somehow put authors into conflict with copyright law. We are very pleased to see by contrast the growing number of publishers who see that this simply is not the case and whose publication policies encourage and facilitate compliance with the policy. The several hundred journals listed on the PubMed Central website who fall into this category, underscored that many in this stakeholder group understand that no conflict with copyright exists and that deposit of an author’s manuscript in PubMed Central complements rather than conflicts with publication of a final article in a journal. To help provide clarity on this issue, SPARC and its partners recently published a widely distributed white paper outlining 6 options for copyright management strategies that can be adopted to guarantee that researchers and their institutions effectively meet the policy’s requirement for compliance with current copyright law. While our member libraries are certainly playing a central role in facilitating compliance with this policy, they are no means acting alone. On many campuses, these efforts involve close collaborations among librarians, researchers, research administrators, and university legal counsel. SPARC’s members view the NIH policy as a welcomed opportunity to work in concert with their campus colleagues and to contribute directly to the mission of higher education, the promotion and advancement of knowledge. SPARC commends the NIH for issuing clear implementation guidelines in a very timely manner and for being consistently responsive to queries about the implementation process from our member organizations. We applaud the NIH, Dr. Zerhouni, the U.S. Congress and the President for advancing this important policy which will provide a rich and innovative sweep of new resources as well as access to critical biomedical research findings to researchers on campuses and beyond. Prompt implementation of this policy will accelerate the pace of 36 research and discovery, fuel innovation, and serve the public good. Thank you for the chance to comment today.	In Person
710	Town Hall Meeting	3/10/2008 10:00 AM	Carlson	David		Southern Illinois University, Carbondale Campus			Representative NIH Funding Recipient Organization						I’d appreciate more NIH-funding into the froggy-throat syndrome first, so I apologize for the voice. Thank you for the opportunity to speak with you today. My name is David Carlson and I'm Dean of the Library at Southern Illinois University, Carbondale. I made a special trip to Washington today to attend this meeting and express my enthusiastic support for the deposit of NIH-funded articles into the PubMed Central database. In 5 minutes I cannot give a full accounting of the reasons for the wide support that this policy has by the library and research community generally. The changes occurring as a result of the transition from print to digital are complex and strategic. These changes strike deep at the heart of traditional library processes and procedures. However, libraries are not idle. We are focusing our energies not on the elements of what we may be losing but on the opportunities of what can be gained with these changes. Libraries are exploring and experimenting with new models and modes of preservation, distribution, service, that preserve the important and successful elements of a print bound system but integrate and combine them with the exciting opportunities of a digital network environment. I cannot stand here today and say this that particular requirement for article deposit will be a linchpin of a new information distribution environment. But we are confident that it represents the right direction and we applaud NIH in this change to change research distribution as we adapt and change to the new opportunities of digital networking. It's important that I take one minute of my precious 5 to speak to the critical importance of peer review. Libraries value peer review. We recognize that the peer review process is a critical element of the research infrastructure that must be preserved. Peer review insures that the information we provide is reliable and vetted to the best of our ability and present state of research and knowledge. We see no threat to peer review from this change by NIH. This article deposit requirement is not about a change to the quality of information but about a broadening of access to information and that distinction is vital. Library concerns about the article deposit requirement are much different than some of the other comments you’ve heard today. We want to see this change be successful and we stand ready to work with NIH and our researchers on campus to make it successful. However, I hope that you would consider two changes that we believe would improve the value and impact of the deposit requirement. First, we believe that the lag time of one year for deposit of articles is excessive and longer than necessary. The information in medical research has long-lasting value but its market value in the information marketplace is immediate and rampant. Libraries favor a shorter embargo period than one year. We would urge an embargo period closer to 3 months after publication and certainly no more than 6 months. We believe that this would still preserve the market value of research information which is critical to the publishing community. But even if this were not the case, NIH has already paid for the 37 information gained from the research and as an agency of government expending public funds, we believe the primary obligation is not to the publisher's bottom line but the welfare and support of the public good. Secondly, we would encourage NIH to strengthen its enforcement mechanisms for the deposit requirement. While the deposit of articles is a requirement, we believe that the current procedures do not have adequate enforcement. Minimally, we believe that noncompliance with the article deposit requirement should be in an element in the evaluation of future grant applications by researchers. Thank you for the opportunity to speak with you today and thank you for this change which in my judgment represents an important and progressive step in our pursuit of research system in a digital network environment that balances quality and excellence of content with access that is fair, equitable, and an appropriate use of public funds. Thank you.	In Person
711	Town Hall Meeting	3/10/2008 10:00 AM	White	Patrick		Association of American Universities			Patient or Representative of a Public Health Advocacy Organization						Good afternoon. I think today marks the official beginning of spring. So, let's sit in a windowless room and talk about public access. If I don't get more laughter, I'm going to run through 45 PowerPoint slides. I'm Pat White. I’m with the Association of American Universities. We are an association that includes 60 leading public and private U.S. research institutions. Our association focuses on issues important to research intensive universities, such as funding for research and scholarship, science policy issues, and graduate education. The goals of university research are the discovery, creation and dissemination of new knowledge for the benefit of society. AAU, on behalf of its member university presidents and chancellors, has repeatedly endorsed NIH’s efforts to implement public access. Most recently as the FY08 House Labor Appropriation Act was about to be debated on the House floor last summer, AAU president Robert M. Birdall wrote to Subcommittee Chairman David Obey endorsing what became the policy we are discussing today. Today, I speak on behalf of AAU and urging prompt adoption of the resulting NIH policy on enhancing public access to archived publications resulting from NIH-funded research. Our member institutions, several of whom have testified here today, have responded to the issuance of this policy by developing their own policies and procedures to alert, educate and assist faculty in complying with the new requirements. They have circulated specific instructions to faculty and administrators to ease adoption to the new requirements. Generally speaking, our administrators appreciate the effort and thought that NIH has put into setting up this somewhat complex exercise of complying with the new requirements. Our principal concern with the change from voluntary to mandatory submission to PubMed Central is the requirement that authors of works subject to the new policy must obtain permission from the publication before submitting it to PubMed Central. Should a journal refuse permission to place an author’s accepted manuscript in PubMed Central, the author would face the untenable and highly frustrating course of having to withdrawal the manuscript from publication in that journal and submit it elsewhere. We seek NIH's help in negotiating a blanket agreement with publishers that will greatly ease the transaction cost currently that is currently borne by the individual 38 author and by extension his or her institution, and indeed, by the publisher. What is needed is a modified standard copyright agreement acknowledging that the author retains the right to provide a copy of the final manuscript to NIH and post the article on PubMed Central within 12 months of publication by a given journal. We request that NIH encourage publishers declare on a blanket basis that they will permit authors to place into PubMed Central any manuscript they accept for publication on or after April 7, 2008 if the manuscript arose from any direct funding from an NIH grant or cooperative agreement. Active in FY 08 or beyond. We understand the concerns that some publishers have had about the implications of PubMed Central for their publishing operations. We also understand and appreciate the efforts of the publishing community has already made in adapting to the new scholarly publishing environment, and the significant opportunities and challenges that NIH's new policy, and indeed the new world of electronic publishing, are bringing to all participants in the scholarly communications system. But we all must recognize, however, that public access to the published results of all NIH-funded research is now the law and urge publishers to negotiate in good faith so as to make the transition as straightforward and easy as possible. We believe a blanket license will best serve the interest of authors, publishers and NIH. In closing, let me reaffirm AAU’s strong support for the new NIH policy by quoting from our 2005 endorsement of NIH's then voluntary public access proposal. AAU strongly supports efforts to achieve the widest possible dissemination of the results of federally funded research and the association commends the NIH for its proposal to increase public access to published results of NIH-funded research. Making research results freely available to the public after those results are published should not only benefit the public through expanded access to information, but should benefit scientists and advance science through wider dissemination of new knowledge. NIH's policy on enhancing public access to archived publications resulting from NIH-funded research will promote the goal of sharing as broadly as possible the new knowledge made possible by the American people’s investment in university research. Thanks for the opportunity.	In Person
712	Town Hall Meeting	3/10/2008 10:00 AM	Gobstein	Howard		NASULGC, Public University Association			Patient or Representative of a Public Health Advocacy Organization						Good afternoon. My voice also is doing some funny things, David. I'm Howard Gobstein, Vice President of NASULGC, that’s how that’s pronounced, a public university association. The National Association of State Universities and Land Grant Colleges is the nation's oldest higher education association. Dedicated to supporting excellence in teaching, research and public service, NASULGC has been at the forefront of education, leadership nationally, for more than 120 years. NASULGC encompass more than 218 members consisting of public research universities and land grant colleges in all 50 states, the U.S. territories, and the District of Columbia, as well as 18 historically public black institutions and 29 public higher education systems. Faculty at NASULGC institutions undertake a very significant share of NIH supported research and award the dominant share of PhDs across the sciences and engineering. NASULGC serves as the 39 convener for many executive officers of our institutions, including the Presidents and Chancellors and Provosts, and one of my responsibilities is to work with our Counselor of Research Policy in graduate education consisting of research Vice-Presidents and graduate Deans. Thank you for this opportunity to offer comments on the implementation of the revised NIH public access policy. I'm here to voice support for these policies in which to make several points. One, the NIH proposed deposit procedure clearly implements the intent of Congress expressed in last year’s appropriation bill and the procedures NIH specifies for meeting the requirements are clear, easy to follow and do not constitute an excessive burden on researchers or universities. NASULGC has shared the NIH proposed implementation steps with our 218 institutions by sending it both to our Provosts and Vice-Presidents of research. We also have cosponsored a webinar with the Association of Research Libraries during with they have full opportunity to be briefed on implementation. And our institutions have not brought us any serious concerns about the implementation or request to have it delayed. Three, it seems to us scholarship may suffer if the PubMed Central deposit requirement is delayed. Not every scholar has access to every scientific journal. The deposit requirement is intended to ensure that this is not the case for NIH-funded work. While we cannot measure the loss to research productivity from this lack of access, it is potentially large. Faculty researchers at small universities and especially at poorly funded minority serving institutions potentially may make very large impacts on science if they have full access to the literature. Delaying deposit delays their opportunity to do so and society's opportunity to benefit from their work. Four, support for science is enhanced when the public sees benefit from that science. Many members of the public, as we’ve heard already today, are interested in the findings that arise from NIH research. Their access to this work will be considerably enhanced when it is all available through PubMed Central, and delay keeps this material from them for a longer period of time as well. Five, our institutions feel an obligation to make the research available to all who can benefit from it, particularly to those in developing nations of the world who need access to our research findings but who cannot begin to afford to buy that access. Deposited through PubMed Central solves this research problem and brings the world this knowledge. Finally, we look forward to working with NIH, ARL, other university and science associations to ensure that implementation of these policies proceeds smoothly with minimal difficulties. I thank you very much.	In Person