ORGAN SYSTEMS BRANCH
OFFICE OF CENTERS, TRAINING, AND RESOURCES
OFFICE OF DEPUTY DIRECTOR FOR EXTRAMURAL SCIENCES
NATIONAL CANCER INSTITUTE
June 2001
Introduction
Specialized Programs of Research Excellence (SPOREs) were conceived and implemented by the National Cancer Institute (NCI) through a special $20 million appropriation from Congress in Fiscal Year 1992. SPOREs evolved from the original NCI Organ Site Programs, which were organ-specific but without translational research focus, established shortly after the National Cancer Act of 1971. SPOREs represented a strategic response to the rapid expansion of information about cancer being developed through basic research using model systems. At that time, there was no funding mechanism designed exclusively to focus on translational research that would take a systematic approach to exploring which basic research discoveries were potentially the most likely to have an impact on human cancers. In order to address this need, the SPORE Program was initiated by the NCI as an experiment to promote interactions between basic scientists and applied scientists and provide them with the flexibility to rapidly test new approaches to the prevention, early detection, diagnosis and treatment of human cancer.
When the SPORE program was initiated in FY92, Request for Applications (RFAs) were issued that resulted in the funding of four breast cancer SPOREs, two prostate cancer SPOREs and two lung cancer SPOREs. The objective of the SPORE program was and is to encourage a wide range of scientific approaches focused on translational research (see the SPORE definition of translation below). Of particular importance was choosing a grant mechanism (i.e., the P50) that has all of the features necessary to enable SPOREs as translational research instruments. These P50 grants are designed so that every research project is inherently translational: specialized infrastructures are established to support translational research; scientists work as teams rather than as independent investigators; scientists have the flexibility to start and stop research projects without additional peer review; scientists have flexible funds to develop pilot projects and test new technologies in collaboration with scientists in or outside of their institutions; and SPOREs combine their resources to ask questions that no one institution could address alone.
The first P50 SPORE grants were funded for three rather than five years in order to ensure that the translational research concept was working; as the experiment proved more promising, all applicants were allowed to request five years of support. Using the RFA process, the SPORE Program evolved to include five sites: breast, prostate, lung, gastrointestinal and ovary. However, by limiting the submission of SPORE applications to every five years in response to RFAs, the Program was relatively “closed” and unable to capitalize on investigator-initiated scientific opportunities. In addition, the Program was not open to all cancer sites. These issues were discussed with NCI advisory groups. In particular, the NCI Board of Scientific Advisors suggested that the initial results of the SPORE Program were very promising and, although it favored additional evaluation with time, it saw no reason to restrict the expansion of the SPORE Program. As a result, in 1999 the NCI approved restructuring the SPORE program from one that was RFA-driven to one that was investigator-initiated, utilizing a program announcement (PA) open to grant applications for all types of cancers on a scheduled competitive basis.
Funding of SPORE Grants
Grant Mechanism
Basis of Funding
Planning Grants
Expanded Authorities
Support of this program is through the specialized center grant (P50) mechanism employed by the National Institutes of Health. Applicants are responsible for the planning, direction, and execution of the proposed SPORE program. Awards can be made for up to five years and will be administered under NIH grants policy as stated in the NIH Grants Policy Statement.
Applications will be awarded on a competitive basis. The following will be considered in making decisions: quality of the application as determined by peer review, availability of funds, and programmatic priorities.
While applicants cannot apply directly for planning grants (P20s), under special circumstances, the NCI may consider funding a P50 SPORE application at a reduced level for up to two years using the P20 grant mechanism. Circumstances leading to the funding of a P20 rather than a P50 include: (1) the research projects in the SPORE application have high scientific merit but other essential components of the application require further development; (2) the peer review criticisms can be readily addressed within two years; and/or (3) the application meets important NCI program objectives (e.g., the organ site to be studied is under-represented).
Both NCI P50 and P20 grants may be administered by the awardee under Expanded Authorities which can be viewed at: http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#expandauth. The expanded authorities allow additional flexibility to take advantage of research opportunities as they arise throughout the term of the grant. Under the expanded authorities, NIH has waived the requirement for its approval of specified actions under certain awards and has provided the authorities to grantees to take such actions without NIH prior approval. These actions include the carryover of unobligated funds and extensions of the project period without additional funds.
Eligibility and Required Components
Eligibility
(b) Minimum Research Base
(c) Cancer Patient Population
(d) Budget Limitation
Statement of Institutional Commitment
Intellectual Property Rights
Research Projects
Each proposed research project must meet the definition of translational research as described in Section I.B above. Investigators who are not certain about whether their project fits this definition are advised to consult with NCI staff.
Each proposed research project must be designed to test the relevance and/or potential importance of the research to human cancer within the five-year term of the grant (e.g., validation of a new screening mechanism or diagnostic test, early phase therapeutic trial, analysis of human tissues such as tumor or blood samples). Basic research projects, such as those employing animal models or cell lines, qualify as translational only if a human application is included in the specific aims of the research. A project(s) proposed in a competitive renewal application may focus solely upon the human application or laboratory effort if it marks the final stage of an ongoing translational SPORE study. Applicants are encouraged to contact the Organ Systems Branch (see INQUIRIES below) if they have any questions concerning this essential requirement.
Each proposed research project must be led by co-(principal) investigators in biological science and applied sciences who commit adequate percent efforts and who use their combined conceptual and experimental skills in designing and implementing the project. It should be evident from this collaboration that translational research objectives will be accelerated such that it will be possible to test the relevance of the underlying hypotheses or to generate new hypotheses relevant to human disease. It is not necessary that the co-investigators commit equal effort to the project. There are NO exceptions to this requirement.
At least ONE research project must focus on early detection, screening, prevention, and/or population science research. (Note that at least one scored project in this category will be required for award, see REVIEW CONSIDERATIONS, Section G.1. below.) If the application is funded, a project with this research focus must be maintained throughout the entire term of the grant.
A minimum of four research projects are required representing a balance and diversity of translational research objectives (e.g., screening, prevention, diagnosis, treatment). Applications with a specific theme (e.g., gene therapy in prostate cancer) are discouraged. (Note that four projects scored by the peer review group will be required for award, see REVIEW CONSIDERATIONS, Sections G.1. and G.5. below.)
A plan must be proposed for evaluating the scientific progress and translational potential of all projects and replacing them as necessary. During the period of award, replacement projects will be reviewed by the grantee institution and NCI program staff, but will not undergo additional peer review. Competing renewal applications will be evaluated based on their track record for fostering significant translational research during the prior grant period.
Research projects involving HUMAN SUBJECTS must include women, children, and members of minority groups and their subpopulations unless a clear and compelling rationale establishes inclusion is inappropriate with respect to the health of the subjects, the purpose of the research, or another extenuating circumstance. Applicants are required to address this issue in developing a research design appropriate to the scientific objectives of their study. Instructions for responding to this issue are provided at: http://grants.nih.gov/grants/funding/phs398/section_3.html#humans and http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. Recruitment plans, as well as Gender and Minority Inclusion Reports must be included for each project/ resource that involves human subjects.
Only early (Phase I and Phase II) clinical trials may be supported by the SPORE mechanism. A plan for a clinical trial must include provisions for rigorous data management, quality assurance, and safety monitoring. These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy of the NCI for Data Safety Monitoring of Clinical Trials see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. Applicants should provide evidence that they will utilize Data and Safety Monitoring systems in place at their institution. A general description of the data and safety monitoring plans should be included in the application (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html). This description should explain the rules and procedures for detecting, monitoring, and reporting any adverse drug reaction or event during a clinical trial. A copy of the trial protocol, along with informed consent forms, are also required if the trial is already underway or is anticipated to begin soon after an award is made. If the trial will be performed during the latter part of the grant term, submission of these items to NCI program staff is required prior to the initiation of the trial.
Shared Resources (or Cores)
Each SPORE must have a dedicated component for collecting and distributing human cancer site-specific tissue. The tissues may be frozen or archived paraffin blocks, slides, or fluids such as serum, plasma, urine, or sputum samples. This should be a true tissue resource that can be used to generate and test translational hypotheses, rather than a small collection of heterogeneous samples. The tissue core should also include the essential pathological, clinical and family history information needed for conducting a wide range of translational research. Appropriate informatics capability for tracking, as well as linkage to clinical and follow-up data sets, should be demonstrated.
Additional shared resources (e.g., administrative, clinical, statistical, animal) may also be proposed that are supportive of one or more of the research projects of the SPORE.
Developmental Research Program
Career Development Program
Annual SPORE Workshop
Other Provisions
Once a SPORE is funded, the Principal Investigator of the SPORE should become a senior leader in the Cancer Center. The Principal Investigator of the SPORE may or may not be the Cancer Center Director.
Lines of authority should be clearly indicated such that the SPORE is an integral part of the Cancer Center but does not interfere with the P30 chain of authority. A letter of commitment which delineates these organizational relationships is required. This letter must be signed by the proposed Principal Investigator of the SPORE, as well as the Cancer Center Director.
The applicant should discuss how the SPORE will interact synergistically with existing P30 programs in order to maximize both SPORE and Cancer Center research objectives. While the SPORE is expected to become an integral element within the NCI-designated Cancer Center, a distinct institutional commitment to the SPORE must still be maintained throughout the term of the SPORE grant (see Section E.2. above).
The resources (or cores) within the SPORE should not duplicate any available facility already in place and supported by another granting mechanism (e.g., P30, P01, U01, U10, DOD, etc.). Applicants can, however, use SPORE funds to augment pre-existing Cancer Center resources in order to direct these activities towards more effectively fulfilling the requirements of the SPORE. This is especially true of the SPORE tissue resource, which should be designed to prioritize the needs of SPORE investigators over those of others. The SPORE should also utilize the IRB, Data and Safety Monitoring Board(s), as well as clinical resources available throughout the Cancer Center whenever possible.
Applications must meet all of the following eligibility criteria [items 1(a)-(d)] as well as contain the required components of a SPORE listed in items 2-9 below. Applications that are not responsive to these requirements will be returned to the applicant by NCI program staff and will not undergo scientific peer review.
(a) Institutional
Applications may be submitted by domestic for-profit and non-profit organizations, either public or private, including universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators.
In order for a SPORE application to be accepted by NCI, the application must include four or more independent investigators who currently serve as principal investigators (or project leaders) on peer-reviewed research grants (e.g., R01, P01, U01, U10, ACS, DOD, or equivalent) directly related to the cancer(s) being investigated. The applicant is encouraged to provide a separate list of these grants or, alternatively, can highlight them on Other Support pages.
Each SPORE must document access to a substantial patient population in the cancer-site focus of the application and provide reasonable assurance that the patients and tissues needed for translational research are readily available. If the appropriate patient population is not available to the applicant institution, a consortium agreement may be established with a different institution to provide adequate access to clinical specimens (tissue) and patients at another site.
By NCI policy, all competing SPOREs are subject to both direct cost and total cost budget caps, which currently are $1.75 million and $2.75 million, respectively. In complying with the direct cost cap of $1.75 million, the indirect costs related to subcontracts to other institutions or organizations do not apply toward the direct cost cap. However, these consortium indirect costs must be included in the total cost which, overall, may not exceed the $2.75 million cap. Applications with requests exceeding these financial limits will be returned to the applicant without peer review. In non-competing years, applications can exceed these caps as a result of standard (yearly) cost-of-living increases or as a result of special supplements approved by the NCI. For more information about the cap in any given year, applicants must contact the Organ Systems Branch using the telephone number, fax number or e-mail address listed under INQUIRIES below.
An institution considering applying for a SPORE should demonstrate a commitment to the SPORE's stability and success by incorporating the SPORE high within its institutional priorities. The application must provide a statement of commitment that includes a plan addressing how the institutional commitment will be established and sustained, how the institution will maintain accountability for promoting scientific excellence, and how the SPORE research effort will be given a high priority within the institution relative to other research efforts. The institutional commitment may be in the form of support for recruitment of scientific talent, provision of discretionary resources to the SPORE Director, assignment of specialized research space, cost sharing of resources, or other ways proposed by the applicant institution. A letter from the Dean or Cancer Center Director should be attached confirming this commitment. In the case of a SPORE that involves a consortium arrangement between two or more institutions, the institution that submits the P50 application must receive a formal written agreement(s) from the other participant organization(s). This agreement should clearly delineate the institutional commitment of the participating organization(s) (in the ways outlined above) to the SPORE program.
The institution should provide a written assurance that it will protect the intellectual property rights of the SPORE investigators and their collaborators and under no circumstances engage in formal/legal agreements with commercial sources (e.g., pharmaceutical companies) that would compromise the ability of SPORE investigators to have unhampered access to institutional resources in SPORE-related research or participate fully in collaborations with any other researchers. The statement of commitment should also include a written assurance that in its interactions with commercial entities under sponsored research agreements, the SPORE will comply with the requirements of the Bayh-Dole Act and NIH funding agreements while upholding basic principles of academic freedom. Sponsored research agreements with commercial entities should be entered into by the SPORE only upon due consideration of the points outlined in "Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and
Contracts (Federal Register, Vol. 59, No. 215, Tuesday, November 8, 1994, pp. 55674-55679)", a copy of which can be viewed at: http://ott.od.nih.gov/NewPages/text-com.htm. The statement of commitment should also include a written assurance that the SPORE will manage its interactions with third parties so that they do not restrict the SPORE's ability to receive and disseminate biomedical research materials from and to the scientific community. Likewise, letters should be supplied by any relevant third parties confirming their adherence to these policies.
Research projects may be conducted solely through the parent institution, or through collaborative associations that have been developed or are planned with other SPOREs or with other investigators in the biomedical research community. However, all SPOREs must meet the following requirements:
The NIH now also requires that all investigators proposing research involving human subjects are educated on the protection of human research participants. This policy was effective as of October 1, 2000 and was published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000) which is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
This resource should benefit the specific research activities of the SPORE, as well as the research activities of other scientists within and outside the parent institution who are concentrating on translational research issues. A plan must be proposed for prioritizing distribution of tissues to SPORE scientists and others based on the merit of translational cancer research projects.
Every SPORE must allocate a significant effort to support pilot projects that take maximum advantage of new research opportunities. Such projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE environment. The SPORE application should propose an institutional review process for funding pilot projects that generate feasibility data and have the most promising translational research potential. These funds are intended to remain flexible and to support studies of a limited duration, e.g., two years or less. The expectation is that successful feasibility studies will replace full projects that are not progressing satisfactorily with regard to translational research objectives within the SPORE (see above). New applicants may supply a short description (1-2 page(s) maximum) of eligible projects as examples. Renewal applicants should supply their track record of funding pilot projects, ongoing pilot projects, and short descriptions of other potentially eligible projects.
A Developmental Research Program, as a required element of a SPORE, must be maintained throughout the entire term of the grant.
The SPORE must demonstrate a consistent and significant commitment to a career development program in translational cancer research. This may focus on advanced post-doctoral candidates, junior faculty, or established investigators who wish to develop or refocus their careers on translational research. SPORE career development programs are not intended for predoctoral candidates.
An appropriate portion of the total SPORE budget should be dedicated to this program and support the salary and research costs of candidates with outstanding potential. Each candidate should have a mentor(s) and devote a significant percentage of his/her effort to translational research. The description of this program should include the policies, criteria, and processes for selecting candidates, including special efforts to recruit qualified women and minorities. The plan should include the number and types of positions (e.g., advanced post-docs, junior faculty, established investigators) that will be made available, the criteria for eligibility and selection of candidates, and a description of the selection process. New applicants should provide a list and short description of potential candidates, as well as the names and research activities of mentors. Renewal applicants should provide this in addition to the track record of candidates supported on the SPORE.
A Career Development Program, as a required element of a SPORE, must be maintained throughout the entire term of the grant.
SPORE investigators will be expected to participate in an annual workshop organized by the Organ Systems Branch of the NCI to share positive and negative results with other SPOREs, share materials, assess progress, identify new research opportunities, as well as establish interactions, research priorities, and collaborations that will maximize the impact of the research on reducing incidence and mortality, and improving survival. Travel funds for the Principal Investigator and selected SPORE investigators and collaborators may be budgeted for this purpose. In conjunction with the workshop, SPORE Directors will be required to attend an administrative and planning meeting with program staff from the NCI.
If a SPORE application originates from an institution that is supported by an NCI Cancer Center Grant (P30), the following items should also be addressed (generally within the Program Description).
Submission Requirements and Receipt Dates Pre-application Consultation (Strongly Recommended)
A brief description of the background and proposed responsibilities of the SPORE Director and key senior leaders of the SPORE.
A diagram showing the proposed reporting, programmatic, and advisory structure of the SPORE and how it relates to the structure of the institution as a whole.
A brief description of the proposed translational research projects, along with their specific aims and the names of project leaders.
Estimated budgets for each component (i.e., full projects, resources, developmental/career programs) of the anticipated SPORE application.
A list of active peer-reviewed research grants, cooperative agreements, and contracts that form the research base of the scientific leaders of the SPORE.
Letter of Intent
The letter of intent should to be sent to the following address:
Organ Systems Branch
Application Procedures
Division of Extramural Outreach and Information Resources
Copies of the SPORE guidelines and program announcements are available at the following URL addresses, respectively: http://spores.nci.nih.gov and
http://grants.nih.gov/grants/guide/index.html. Instructions in these documents must be followed in preparing a SPORE application. On line 2 of the face page of the application form, the applicant should provide the Program Announcement (PA) number, the title “SPORE in (Organ) Cancer”, and check the YES box.
At the time of submission, the original signed application, including the checklist, should be sent along with three copies (without appendices) to:
Center for Scientific Review
Two additional copies of the application and five copies of any appendices must also be sent to:
Ms. Toby Friedberg
The copies to the Center for Scientific Review (CSR) and the Division of Extramural Activities (DEA) should be sent at the same time to assure that the NCI will be able to review the application along with others submitted for the same receipt date. The applicant is encouraged to keep documentation of their mailing date(s) rather than contact the CSR or DEA for confirmation of receipt. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Applications must meet all eligibility requirements as described above and must address all programmatic requirements (see ELIGIBILITY AND REQUIRED COMPONENTS, above) in these guidelines.
Application Receipt Dates
Receipt dates for cancer sites will be announced each year with a formal program announcement in the NIH Guide http://grants.nih.gov/grants/guide/index.html). The tentative receipt dates for organ sites during this transition period are as follows:
February 1, 2001: Skin, Prostate
February 1, 2002: Breast, GYN
February 1, 2003: Skin, Ovary
February 1, 2004: Breast, Ovary, GYN
February 1, 2005: Breast, Skin, Ovary, GYN
Applications for a given organ site will be accepted only on the specified receipt date. Incomplete applications will be returned without peer-review (see ELIGIBILITY AND REQUIRED COMPONENTS, above). For competing renewal applications, consultation with NCI program staff is encouraged to ensure adherence to the organ-specific submission schedule and avoid gaps in funding.
Inclusion of Women, Minorities, and Children in Research Involving Human Subjects
It is also the policy of the NIH to include children (i.e., individuals under the age of 21) in all human subjects research conducted or supported by the NIH, unless there are scientific or ethical reasons to exclude them. This policy applies to all initial (Type 1) applications submitted for receipt after October 1, 1998. All investigators proposing research involving human subjects should read the “NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects” that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
As part of the scientific and technical merit evaluation of the research plan, reviewers are instructed to consider the adequacy of the plan for including women, minorities, and children. Omission of this information (including reasons for exclusion) can have a negative impact on the priority score of a specific project and/or the overall application. In preparing these sections of the application, investigators are encouraged to follow the additional instructions provided under Section E.4.f. above.
URLS in NIH Grant Applications or Appendices
Required Education in the Protection of Human Research Participants
The Office of Management (OMB) Circular A-110
NCI program staff strongly encourages each prospective applicant to schedule a pre-application consultation. The consultation should be scheduled four to six months in advance of the due date for submission and is intended to help the applicant (along with one or more of his/her intended co-investigators) understand the SPORE Program and discuss strategies for preparing a competitive application. NCI staff will clarify the intent of the guidelines, discuss funding trends, discuss potential alternative SPORE organizational structures and allowable resources, and describe the peer-review process. The applicant can define which issues would be most helpful to discuss and then work with NCI program staff to decide what information is most appropriate to provide. The following are examples of items that help NCI program staff understand the plans of applicants:
Although it is not required and does not enter into the review of an application, all prospective applicants are requested to submit a letter of intent at least 60 days prior to the receipt date for the application. The letter of intent should include a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. This letter allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. Furthermore, NCI staff can make sure applicants are fully aware of all applicable NIH and NCI policies, meet eligibility requirements and understand the peer review process before the application is submitted.
OCTR, ODDES, NCI
6116 Executive Blvd.
Suite 7013, MSC 8347
Bethesda, MD 20892
The NIH application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Application forms and guidelines are available through: http://grants.nih.gov/grants/funding/phs398/phs398.html, most institutional offices of sponsored research, or from:
National Institutes of Health
6701 Rockledge Drive, Suite 6095
Bethesda, MD 20892-7910
Ph. (301) 435-0714
FAX (301) 480-0525
E-mail: grantsinfo@nih.gov
National Institutes of Health
6701 Rockledge Drive
Room 1040, MSC 7710
Bethesda, MD 20892-7710
(use 20817 zip code for express service)
Ph. (301) 435-0715
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109
Rockville, MD 20852 (if hand or express delivered)
Bethesda, MD 20892-8329 (if using US Postal Service)
Due to the logistical problems that would be created by simultaneously accepting and reviewing grant applications for all cancer sites, the NCI has implemented a transition plan that will move the program towards one receipt date per organ site per year by the year 2005.
June 1, 2001: Gastrointestinal (upper/lower GI, pancreatic, and spleen cancers), Prostate
October 1, 2001: Lymphoma, Brain, Head and Neck, Prostate
June 1, 2002: Lung, Myeloma, Leukemia (acute, chronic)
October 1, 2002: Prostate, Genitourinary
June 1, 2003: Gastrointestinal, Leukemia (acute, chronic)
October 1, 2003: Lymphoma, Brain, Head and Neck
June 1, 2004: Lung, Gastrointestinal, Myeloma
October 1, 2004: Prostate, Genitourinary, Leukemia (acute, chronic)
June 1, 2005: Lung, Myeloma, Gastrointestinal
October 1, 2005: Prostate, Genitourinary, Brain, Head and Neck, Leukemia, Lymphoma
All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site.
Investigators proposing research involving human subjects are now required to demonstrate that they have been trained in the protection of human research participants according to the policy published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA (PA) in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Inquiries
For further clarification of the different topics contained in the present guidelines, individuals may contact the Organ Systems Branch by e-mail (nciosb-r@mail.nih.gov), phone (301-496-8528), or fax (301-402-5319).
Introduction
These instructions are supplemental to those provided with the Form PHS 2590 (rev. 4/98), “Application for Continuation of a Grant,” which is required each year in order to receive continuing support. In general, you should follow the “Information and Instructions for Using Form PHS 2590 to Apply for Continuation of a Grant Award.” To avoid a gap in funding, non-competing continuation applications should be received 60 days prior to the anniversary date of the award. Please note that non-competing SPORE applications are not eligible for the streamlined non-competing award process (SNAP). Additional guidance important in the preparation of a SPORE continuation application is provided below.