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

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?

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.

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.

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.

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.

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.

• 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.

See response to Q4 for expansion.

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) Ensure that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements 2) For publishers who submit manuscripts directly into PubMed Central, ensure that articles will not be accepted from individuals or entities other than the publisher 3) 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 Central 4) 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 Central 6) Ensure that the Policy is, and continues to be implemented in a manner consistent with copyright law

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.

Finally, it would be helpful if the NIH grant application form/e-submission included a field requiring citation to all previously required PubMed Central deposits as part of ensuring that an application was complete.

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.

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.

It would be helpful if NIH would work with academic institutions on coordinated manuscript deposit between PubMed Central and institutional repositories.

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.

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.

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.

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.

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).

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) Undue Burden on Authors and Institutions

According 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 Changes

As 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 Protections

Also, 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.

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 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

A policy without consequences for noncompliance (reward for compliance) is useless.

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.

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.

1)Ensure that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements 2)For publishers who submit manuscripts directly into PubMed Central, ensure that articles will not be accepted from individuals or entities other than the publisher 3)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 Central 4)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 Central 6)Ensure that the Policy is, and continues to be implemented in a manner consistent with copyright law