SUPPORT OF NIGMS PROGRAM PROJECT GRANTS Release Date: July 9, 2001 PA NUMBER: PA-01-116 (Reissued as PA-07-030) National Institute of General Medical Sciences PURPOSE The program project grant mechanism is designed to support research in which the funding of several interdependent projects as a group offers significant scientific advantages over support of these same projects as individual regular research grants. The purpose of this announcement is to update and clarify the policy of the National Institute of General Medical Sciences (NIGMS) regarding program project grants and to announce new limits on budgets relevant to future submissions of applications. NIGMS supports research in the broad areas of its Divisions: Cell Biology and Biophysics, Genetics and Developmental Biology, and Pharmacology, Physiology, and Biological Chemistry. Program project grants are investigator-initiated, but are restricted to areas of special interest to the individual divisions within NIGMS (see http://www.nigms.nih.gov/about_nigms/about.html for scientific areas of interests). Potential applicants are strongly encouraged to contact the NIGMS program staff listed at the end of this announcement for guidance about the areas appropriate for program project grant applications and the preparation of the application itself. Potential applicants must obtain prior approval for the submission of applications that intend to request in excess of $500,000 (direct costs) in any project year, in accordance with NIH policy (http://grants.nih.gov/grants/guide/notice-files/not98-030.html). NIGMS will not accept applications for which prior approval has not been obtained. For areas not supported by NIGMS, potential applicants are encouraged to contact staff in other Institutes. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This Program Announcement (PA), Support of NIGMS Program Project Grants, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or 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. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) P01 award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years. RESEARCH OBJECTIVES The program project mechanism is designed to support research in which the funding of several interdependent projects as a group offers significant scientific advantages over support of these same projects as individual regular research grants. Successful program projects generally bring together scientists in diverse fields, who would not otherwise collaborate, to apply complementary approaches to work on an important well-defined problem. Since it is not unusual for principal investigators of individual research grants to share techniques, information, and methods, it is not sufficient that the projects are unified by a common theme. In this regard the burden of proof is on the principal investigator, and on each individual project leader, to demonstrate in the written application that the program would be much less effective if parceled out as a set of independent research grants. In addition, the program project can facilitate the support of essential shared core facilities, e.g., major equipment, although the need of a group of investigators for a major piece of equipment or a core facility does not in itself justify a program project grant. Administrative cores, except in special, well-justified circumstances, will not be allowed. Further, it is expected that successful program projects will establish effective collaborations, particularly in emerging areas of research, that extend beyond the life of the program project grant itself. Hence, a program project generally has a finite lifetime. Normally, a program project consists of three to five individual interdependent projects from different investigators. The scientist designated by the applicant institution as the principal investigator bears responsibility for the overall scientific leadership and fiscal management of the program project grant. It is expected that each of the collaborating scientists responsible for the individual projects will be independent investigators. Investigators from more than one department, administrative unit, or institution (through a subcontract mechanism) are commonly included. The program project grant is not intended to be a vehicle for departmental support, nor is the research support of a single senior investigator and several postdoctoral and research associate- level scientists appropriate under this mechanism. In addition, the program project and each individual project must represent a significant effort on the part of the participating scientists and be distinct from their other funded efforts. If individuals have substantial support in areas closely related to the program project, their support should be folded into the program project. If their support cannot be folded in, they may participate as associate members. Associate members have full use of, for example, core facilities, and contribute to the overall collegiality of the project, but derive no financial support from it. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates 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 following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the NIH policy on education in the protection of human research participants now required for all investigators, which is 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. A continuing education program in the protection of human participants in research is now available online at http://cme.nci.nih.gov/. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT 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 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. URLS IN NIH GRANT APPLICATIONS OR APPENDICES 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. APPLICATION PROCEDURES For applications seeking initial funding in FY 2002, there is an upper limit of $5,500,000 direct costs (exclusive of subcontractual indirect costs) for the entire five year project period that may be requested in a competing program project grant application to the National Institute of General Medical Sciences. If fewer than five years are requested, the limit is prorated accordingly. Applications that exceed this limit will be returned without review. For program project grants that would be initially funded in the following fiscal years, the limits for direct costs are: FY 2002 $5,500,000 FY 2003 $5,650,000 FY 2004 $5,800,000 FY 2005 $5,950,000 FY 2006 $6,100,000 Under certain circumstances, with the concurrence of NIGMS, staff additional funds may be requested and provided for major pieces of equipment. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. The receipt dates for new, revised, supplemental, and renewal program project grant applications are February 1, June 1, and October 1. The earliest possible award dates will be approximately nine months after the receipt date. Applications received too late for one cycle of review will be held for the next. The program project grant application should be structured as a series of separate but interrelated project proposals. The following format should be used: Overall Proposal An introductory section must contain justification for the program project grant mechanism and describe those goals that are not readily attainable through individual research project grants. This section should include: the face page, an abstract, a description of the objectives of the program as a whole, which describes the relationship of the individual research projects to the entire program project, and the special benefits to be achieved by funding as a program project grant rather than as a series of individual research grants, a list of participating personnel, the consolidated budget for the program project grant (summarizing budgets for the component parts and core), a description of facilities available, including major instruments and special program resources, administrative arrangements for overall scientific leadership, quality control, and management of the program project grant, and a separate, overall listing of the proposed percent effort on the program project grant and actual and pending research support from all sources for each participating investigator (including percent effort devoted to each project). This section must also detail the relationship of existing support to the proposed program project and describe planned modifications to that support in the event of funding, for example, folding in support for related funded research. Component Projects Each individual project of a program project grant should represent both an independent and an interdependent research effort, and should be prepared in the format of an individual research grant application. The cover page, abstract, budget pages, biographical information, a detailed description of the research to be conducted, and any justification for human and animal experimentation, if applicable, should be included as noted below. The special benefits associated with being part of the program project must also be addressed. If support of core resources is requested, a separate component describing and justifying these should be included. The page limits for individual R01 research grant applications applies to the individual projects. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS The initial review of program project grant applications for scientific merit is conducted by either the Center for Scientific Review or the NIGMS Office of Scientific Review, depending on the subject. Subsequent to the initial review, program project grant applications are reviewed by the National Advisory General Medical Sciences Council. The applicant should not assume that a site visit or applicant interview will accompany the review of a program project grant application. Therefore, the application must be sufficiently complete so that it can be reviewed without a site visit. The individual projects within a program project grant, as well as the program project grant as a whole, must meet the same standards of scientific merit as those required of regular research project grants. The scientific merit of the entire program project grant application, as well as its coherence as a program, will be assessed on the basis of the criteria outlined below. Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project as a whole? What are the advantages of the program project mechanism over a collection of regular research grants (R01s)? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the proposed program project grant employ novel concepts, approaches or method? Are the overall aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the principal investigator appropriately trained and well suited to carry out this work and provide the leadership necessary to ensure success of the entire program? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition, the scientific merit of each individual project will be assessed and a priority score assigned. This assessment will be based on the scientific merit of the individual project based on the published criteria for regular research grants (http://grants.nih.gov/grants/guide/notice-files/not97-010.html), taking into account the additional strength the project gains from interactions with other components of the proposed program project grant and its potential importance to the success of the total effort. In this context, it may be the case that an individual project may be highly meritorious in the context of the entire program project, but not make sense as a stand-alone research grant. AWARD CRITERIA For those applications assigned to NIGMS, final review and recommendations by the National Advisory General Medical Sciences Council and NIGMS program staff will take into account the scientific merit of both the individual projects and the program project as a whole and the relevance of the project to the interests and mission of NIGMS. It is possible that funding for some of the individual projects or core components favorably recommended by the initial review group may be deleted by NIGMS staff prior to award of a grant, based on the scientific merit of these components or the lack of coherence with the rest of the program project. In judging the appropriateness of the application to the mission of the programs within NIGMS, Council and staff will consider the budgetary situation at the time of funding. In addition, the total support of the principal investigator, the group of investigators as a whole, or any individual investigator will be considered in funding the entire program project or any part thereof. INQUIRIES For further information, applicants are urged to contact the NIGMS program staff listed below: Cell Biology and Biophysics: Dr. James Cassatt NIGMS Natcher Building, Rm. 2AS.19C Bethesda, MD 20892-6200 (301) 594-0828 cassattj@nigms.nih.gov Genetics and Developmental Biology: Dr. Judith H. Greenberg NIGMS Natcher Building, Rm. 2AS.25 Bethesda, MD 20892-6200 (301) 594-0943 greenbej@nigms.nih.gov Pharmacology, Physiology and Biological Chemistry Dr. Michael Rogers NIGMS Natcher Building, Rm. 2AS.49C Bethesda, MD 20892-6200 (301) 594-3827 rogersm@nigms.nih.gov For general information, applicants should contact: Dr. Ann A. Hagan NIGMS Natcher Building, Rm. 2AN.24G Bethesda, MD 20892-6200 (301) 594-3910 hagana@nigms.nih.gov For fiscal matters, applicants should contact: Mr. Joe Ellis NIGMS Natcher Building, Rm. 2AN.32C Bethesda, MD 20892-6200 (301) 594-5135 ellisj@nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.862, 93.821, and 93.859. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, and portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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