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Pertain only to applications submitted in response to Requests For Applications (RFAs)
Effective July 1999
Table of Contents
These Research Program Project Guidelines (hereafter termed "Guidelines") from the Agency for Health Care Policy and Research (AHCPR) are effective immediately for all applications for Research Program Project (P01) Grants. At this time, the Research Program Project Grant constitutes an extramural research mechanism supported by the AHCPR only through Requests for Applications (RFAs), announced in the NIH Guide for Grants and Contracts. The P01 is a particularly effective and potentially highly productive grant mechanism, especially in areas where interdisciplinary collaboration and specialized core resources are needed to achieve a larger objective than can be supported through the traditional research project grant (R01).
Preparing, submitting, and reviewing a competitive research program project grant application require a substantial investment of effort by applicants, applicant organizations, AHCPR staff, and peer reviewers. To maximize the potential of this effort, prospective applicants are strongly encouraged to discuss their ideas with relevant AHCPR program staff prior to the submission of a formal application. Relevant program staff are listed in the published RFA.
After submission of the application to the National Institutes of Health, Center for Scientific Review (CSR), staff in AHCPR's Scientific Review Division (SRD) will be responsible for all phases of communication while the application is under review. The AHCPR Project Officer assigned to the application will become the next point of contact for questions and inquiries after the initial stages of review are complete, i.e., after conclusion of the initial peer review.
AHCPR requires that P01 applications be prepared according to the instructions contained in this publication and in the relevant RFAs that will provide additional specific instructions and review criteria. These Guidelines reflect updated information required for use with the Application for a Public Health Service Grant, PHS 398, as well as the latest changes in policies governing the submission, review, and award of P01s by AHCPR. Applications may be submitted on the 4/98 version of the Form 398 (available from most institutional offices of sponsored research or the AHCPR contractor named in the RFA and at http://grants.nih.gov/grants/forms.htm). Applications submitted on other than the 4/98 version of the application kit or not adhering to the instructions for preparation contained in this publication may be returned without review. State and local government applicants may use PHS 5161-1, application for Federal Assistance (5/96) and should follow those requirements for copy submission.
Of special note for applications involving human subjects is the requirement for defining and documenting the populations used in the study. Expected subject accruals must be presented in tabular form for each proposed study involving human subjects.
Reviewers will rate the P01 application as a whole, using the traditional adjectival merit ratings (or priority scores; see Section G of this document, Review Committee Meetings). This practice serves to place emphasis on assessing the scientific merit of proposed projects in the context of the scientific environment of the total research program project. AHCPR expects that the research program project grant should be a cohesive, synergistic research effort focused on a central theme. Peer reviewers will assess applications in accordance with this expectation.
In assigning a single numerical score for the overall program project, reviewers will consider the likelihood that the proposed research will have a substantial impact on the scientific field under study. Since a single, numerical priority score is assigned to the program as a whole, applicants should keep in mind that inclusion of projects of lower quality or having only peripheral relationship to the central theme will have a negative impact on the overall evaluation. AHCPR recommends, therefore, that research program project applications include no more than six individual research projects. Applicants desiring to conduct more than six individual research projects should consider preparation and submission of individual R01 grant applications.
AHCPR continues to participate in the Presidential initiative to reinvent the Federal Government. Policies and procedures relating to all application preparation, review, and award activities will be undergoing continuing review and evolution. Applicants are strongly encouraged, therefore, to make certain to obtain the latest policy and procedure information prior to preparing any research program project application. Updated information is available from sources indicated in relevant RFAs soliciting P01s, from AHCPR's Web site, and from:
The Office of Research Review, Education, and Policy
The P01 is a mechanism for the support of an integrated, multi-project research program involving a number of independent investigators who share knowledge and common resources. This type of grant has a well-defined central research focus involving several disciplines or several aspects of one discipline. The individual projects are interrelated and synergistic; hence, they result in a greater contribution to program goals than if each project were pursued separately. Interrelationships among projects are specified in the relevant RFA.
These Guidelines provide: definitions, background, and review criteria for AHCPR research program project grants; instructions for the preparation of research program project grant applications; and a description of the peer review process used for the evaluation of research program project grant applications.
Research Program Project Grant (P01)—An assistance award for the support of a broadly based multi-disciplinary research program that has a well-defined central research focus or objective. The P01 grant supports a minimum of three (3) scientifically meritorious interrelated projects that contribute to the program objective; during no budget period of the proposed project may less than three projects be approved for funding. It may also include support for common supporting resources (cores) required for the conduct of the component research projects. Interrelationships between component projects are expected to result in a greater contribution to the program goals than if each project were pursued separately.
P0l—The activity code that identifies a research program project application or grant.
R01—The activity code that identifies an individual, regular research project application or grant.
Principal Investigator—The one person designated by, and responsible to, the applicant/awardee institution for the scientific and administrative direction and proper conduct of all aspects of the program project.
Project Leader/Core Director—The investigator responsible for the scientific direction and conduct of an individual research project or core component of a program project.
Scientific Review Administrator (SRA)—The AHCPR staff member responsible for the organization, management, and documentation of the initial review process for applications.
Program Officer/Project Officer—The AHCPR staff member responsible for the development of initiatives and for the scientific management of research programs sponsored by AHCPR. The Project Officer serves as the focal point for all science-related activities associated with the negotiation, award, and administration of grants.
Grants Management Specialist—The AHCPR official who serves as the focal point for all fiscal and business-related activities associated with the negotiation, award, and administration of grants.
Project or Research Project—A research component of the program project application with a separate detailed budget.
Core—A separately budgeted component of the program project that provides essential facilities or services to two or more of the proposed research projects.
Summary Statement—The official record of the evaluation and recommendations of the Initial Review Group (IRG).
The research program project grant is intended solely for the support of multi-disciplinary or multifaceted research programs which have a strong central theme. This unique grant mechanism builds on the leadership of the Principal Investigator and on the interaction of the participating investigators to integrate the individual projects in a way that accelerates the acquisition of knowledge beyond that expected from the same projects conducted separately, without the benefit of combined leadership or a common theme. Individual investigators apply their specialized research capabilities to social science research projects, clinical research projects, health services research projects, or combinations of such projects as they relate to the focused, central theme of the overall program project. The research program project grant offers a special way to achieve an economy of effort through the sharing of personnel, facilities, equipment, data, ideas, and concepts.
There are several features that distinguish research program project grants from other assistance mechanisms. Each individual project within a program project is similar to the traditional research grant application in the sense that each is reviewed for scientific merit. However, a component project is evaluated within the context of the special collaborative interrelationships and environment required for a program project. A research program project grant may contain one or more core component(s), each with a separate budget, for administrative or research support services that are required for and shared solely within this particular research program project. There is no allowance for unspecified developmental research funds (seed money) in research program project grants.
Further, a research program project application should include a sufficient number of scientifically meritorious projects to promote an effective collaborative effort among the participating investigators. To be eligible for an award, a research program project must consist at all times of a minimum of three scientifically meritorious projects. (RFAs will provide more specific details regarding minimum and maximum allowable numbers of individual research projects.) A research program project grant should not be so large that it exceeds the scientific and administrative leadership capability of the Principal Investigator or that it loses a tight focus or desired synergy. In addition, in the peer review process, components deemed non-competitive are considered in the peer review evaluation of the Principal Investigator's scientific judgment and program administration skills.
Applicants should realize that, the more components there are to a program, the greater the likelihood that some segments will be of lower quality. Thus, as size of the research project increases, there is a risk that overall quality of the application may be adversely affected. Given the anticipated level of intensity of competition, the inclusion of projects of lower quality or having only peripheral relationships to the central theme will have a negative impact on the overall evaluation. The maximum number of research projects recommended for any given research project program, therefore, is six. Investigators considering research programs with a larger number of projects should consider submission of separate R01 applications. Plans to submit applications with more than six projects should be discussed with the appropriate AHCPR Program Officer. Please note that division of projects into subprojects in order to designate additional key investigators or to fragment the experimental approach is not permitted.
The Principal Investigator of the research program project grant must be an established scientist with a strong record of accomplishment, who is substantially committed to, and exercises the responsibility for the scientific leadership, integration, and administration of the entire program project. Also, the component projects should be directed by investigators who are experienced in the conduct of independent research and whose backgrounds and interests relate sufficiently to one another to allow for integrated group pursuit of the proposed program project goals and objectives.
Peer review emphasizes a synthesis of two major aspects of the program project application: 1) review of the overall program as an integrated research effort focused on a central theme; and 2) review of the merit of individual research projects and core components in the context and environment of the proposed program. In arriving at an overall score for the research program project, reviewers will consider the likelihood that the proposed research will have a substantial impact on the scientific field.
A. Review Criteria for the Overall Program
Significance: The significance of the program overall and its potential to advance scientific knowledge in the field.
Approach: The adequacy and quality of the experimental approaches proposed in the projects and the overall design of the program project.
Innovation: The degree to which the overall program applies novel concepts and innovative approaches.
Investigators: The qualifications of the Principal Investigator and the program leadership.
Environment: Scientific, organizational and administrative environment.
B. Program as an Integrated Effort
C. Review Criteria for Individual Projects
Significance: Does this study address an important problem? If the aims of the project are achieved, how will scientific knowledge be advanced? What will be the effect of the study on the concepts or methods that drive this field?
Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
Investigator(s): Is the Project Leader appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Project Leader and other researchers (if any)?
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?
Protection of Human Subjects: The adequacy of the proposed protection for humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed.
Representation of Racial/Ethnic Minority Subjects and Gender and Inclusion of Children: The adequacy of plans to include both genders, racial/ethnic minorities, and children as appropriate for the goals of the research. Extent to which applicant provides plans for the recruitment and retention of subjects.
Appropriateness of the proposed project budget and duration.
Note: Synergy and thematic relatedness between the projects and cores and the significance of the project for the program as a whole will be described and evaluated under "Program as an Integrated Effort."
D. Review Criteria for Core(s)
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows AHCPR staff to estimate the potential review workload and to avoid conflict of interest in the review.
A. Contents of the Letter of Intent
The letter of intent need include only:
B. Address for Submission
Letters of intent should be sent to the addressee(s) listed in the relevant RFA.
Additional Communications With AHCPR Staff
Potential applicants have often found it useful to establish additional communications with relevant AHCPR staff prior to submission of an application. Refer to the specific RFA for the names of designated AHCPR program staff.
Specific issues which might be discussed include:
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