General instructions relevant for the preparation of the program project grant application are contained in the Grant Application Form PHS 398. Please note that the instructions provided are designed primarily for regular research project (R0l) applications. All page references given below refer to the instructions in the bound version of the Form PHS 398. Research program project applications require additional information as outlined below. Clear and concise organization of the application is essential (i.e., a Table of Contents, headings, subheadings, limited repetition rather than extensive referencing to other areas of the application, clearly readable type, etc.). Such features promote the review and assessment of the application. Please note that page limitations will appear in individual RFAs; applicants should follow these closely for the overall program project, each individual project, and cores.
A. Face Page (PHS 398 Form Page AA; Instructions for PHS 398)
Type "RESEARCH PROGRAM PROJECT" in the top left-hand corner of the face page immediately above the words "GRANT APPLICATION." Complete all items on the face page of the application as in a traditional research grant application. This is page 1 of the application; all succeeding pages should be numbered consecutively.
B. Description, Performance Sites, and Key Personnel (PHS 398 Form Page 2-BB and Continuation Pages; Instructions for PHS 398)
State concisely the overall goals of the entire program project and clearly state the contribution of each component to the overall theme and goals. In the section labeled Performance Sites, list the applicant institution and all other sites where work described in the research plan will be conducted. Key personnel for the entire program project, including consultants and consortium collaborators, if any, should be listed alphabetically. To aid in the review of the application, include information concerning the distribution of effort of key personnel on each project and core. This could be presented in a tabular form such as that shown in Appendix A: Sample Structure for Table of Professional Effort.
C. Table of Contents (PHS 398 Research Grant Table of Contents Form Page 3-CC; Instructions for PHS 398)
The application is reviewed as a whole as well as project by project; therefore, prepare a detailed Table of Contents that enables reviewers to find specific information readily. Identify projects by number, title, and responsible investigator. Identify cores by letter, title, and responsible investigator. A Sample Structure for Research Program Project Application is included at the end of these Guidelines as an example of how to order and format the application (Appendix B).
D. Detailed Budget for Initial Budget Period (PHS 398 Form Page 4-DD; Instructions for PHS 398)
Applicants should follow closely the PHS 398 Instructions regarding preparing the total research program project budget. Budgetary information is also required for each component project and core. Specify and justify personnel effort for each participating investigator even if no salary support is requested.
Note: Ignore instructions pertaining to modular grant applications.
Present a detailed composite budget for all requested support for the first year, using page 4 of the PHS 398 application form. If collaborative efforts or "purchased services" involving other institutions or organizations are anticipated, itemize all costs associated with such third-party participation, including any applicable indirect costs, on a separate budget page and enter the total under the "Consortium/Contracted Costs" direct costs budget category. For details, refer to Guidelines for Establishing and Operating Consortium Grants (Center for Scientific Review, 6701 Rockledge Drive, Room 6095, Bethesda, Maryland 20892-7910; telephone 301-435-0714).
E. Budget for Entire Proposed Period of Support (PHS 398 Form Page 5-EE; Instructions for PHS 398)
Present a composite summary budget for all years of requested support for the overall program project by category, i.e., personnel, equipment, supplies, etc. Pay particular attention to the specific instructions for justifying budget requests, as cost containment policies encourage the deletion of unreasonable or unjustified expenditures. All increases for future years, whether standard cost of living or projected special requirements, should be stated explicitly and clearly justified.
F. Biographical Sketch (PHS 398 Form Page 6-FF; Instructions for PHS 398)
Biographical sketches must not exceed two pages. Therefore, cite only the most relevant publications. Place all biographical sketches in alphabetical order (by participant last name) immediately after the pages for the budget. Do not repeat biographical sketches in each project or core. Biographical sketches are required for all professional personnel participating in individual projects and cores and for all consultants. Include all biographical sketches in the application, not in an appendix. Indicate the specific role of the participant, for example, Project Leader or Core Director, in section designated "Role on Project."
G. Other Support (There is NO form page; Instructions for PHS 398)
Information should be provided for each participating investigator following the sample format shown on Form page 7-GG. Comment on the extent of financial and/or scientific overlap of any of these grants or contracts with the proposed research program project, how time and effort would be redistributed, and what support would be relinquished if the research program project grant were awarded. It is the policy of AHCPR that meritorious projects reviewed as part of the research program project be funded as part of the program project even though other funding (e.g., in the form of an R01 grant) may be available.
H. Program Narrative: Overall Program Project (PHS 398 Continuation Pages; pay attention to page limitations in individual RFAs)
The narrative for the program project should explicitly provide the required information in the order noted below.
I. Individual Research Projects (Research Plan, Instructions for PHS 398)
Refer to RFA for relevant page limitations. Describe each project in sufficient detail to enable experts in other disciplines to follow the main thrust of the project. Do not present separate "subprojects." All projects are to have a single theme, Project Leader, and budget.
J. Cores (PHS 398 Continuation Pages; Instructions for PHS 398)
The cores of a program project may include relevant clinical facilities, equipment, data, and services which will be shared by multiple projects of the research program project grant. A core may also include support for administration, such as the costs of fiscal and business management, consultant, secretarial and clinical services associated with the program project unless these items are included in the institution's indirect cost rate.
K. Checklist for overall application (Use Form Page II; Instructions for PHS 398)
Self-explanatory.
A. Application Submission
Application receipt dates are given in the relevant RFA.
B. Mail the original and designated numbers of copies of the complete application in accordance with instructions in the relevant RFA, using the label included in the application kit.
The RFA label available in the 4/98 revision of Application Form 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review.
A. Policies
AHCPR is committed to the conduct of fair, objective, thorough peer review of grant applications submitted by the scientific community.
The Scientific Review Division (SRD), in the Office of Research Review, Education, and Policy (ORREP), is organizationally independent from the AHCPR program units. The SRD has responsibility for, and autonomy in, the conduct of initial review activities.
The conduct of peer review by a traditional Initial Review Group (IRG) or Special Emphasis Panel (SEP) shall be in all particulars consistent with, and subject to, AHCPR and PHS committee practices and policies.
Review staff are responsible for managing the scientific and technical review of P0l applications, including the selection of reviewers, management of IRGs and SEPs, and the documentation of reviewers' findings and recommendations.
The responsibility for communications by AHCPR staff with applicant investigators changes during the various phases of the application process. Prior to submission of the application, AHCPR program staff are appropriate contacts. Subsequent to submission and assignment of the application, and until initial review has been completed, all contacts should be made through the AHCPR SRA. Following the initial peer review, program staff again become the focal point for communications with the applicant.
Every effort is made to avoid both the fact and appearance of conflict of interest in obtaining advice concerning program project applications. In addition, the confidentiality of both the review materials and deliberations is maintained. Under no circumstances should there be direct contact between applicants and reviewers; instead, any questions or concerns should be brought to the attention of appropriate AHCPR staff as indicated above.
In order to maintain the integrity of the peer review process in its focus on scientific merit, current pay lines and funding policies are not discussed during peer review.
B. Application Receipt and Referral
Research program project applications, like all other PHS grant applications, are received and initially processed by the National Institutes of Health (NIH) Center for Scientific Review (CSR). The application is assigned to an AHCPR program area and to an AHCPR SRA who manages the review.
C. Administrative Review
Upon receipt of an application, the SRA reviews it for conformance to AHCPR Guidelines and discusses concerns with the Program Officer. If the application fails to comply, it will be returned to the applicant without further consideration.
D. Communications with the Principal Investigator
If additional significant findings are obtained in the interval between submission and review of the application, the Principal Investigator should contact the SRA for advice about submitting such findings for review. To allow sufficient time for adequate peer review, this information is not accepted later than four weeks prior to the review meeting, except in unusual circumstances. Major changes in scope or documentation cannot be readily assimilated in the review process.
Submission of additional materials beyond the original application should be kept to a minimum.
Sections that follow address communications with the Principal Investigator concerning the selection of reviewers.
E. Communications with AHCPR Staff
Shortly after receipt of the application, the SRA contacts appropriate AHCPR program staff and other individuals for supplemental information and recommendations for prospective reviewers where appropriate.
Program and/or grants management staff discuss with the SRA any unusual features of the application which might require additional material for reviewers or any special problems that they anticipate in the review of the application.
All review-related communications with actual or potential reviewers are through the SRA.
F. Selection of Reviewers
The size and composition of each review panel are determined by the number and particular details of the application/s to be reviewed. It is the responsibility of the SRA to make these determinations based upon a thorough review of the application/s and suggestions from program staff.
In identifying prospective qualified reviewers, the SRA takes full advantage of the many resources available, including existing name files of experienced reviewers, lists of grantees and contractors, computerized databases, and consultation with program and review staff and recognized authorities in the scientific community. The SRA, as well as program staff, will identify reviewers who, because of collaboration, affiliation, or bias, should be excluded from the review panel. It is inappropriate for applicants to suggest names of prospective reviewers; however, SRAs will accept suggestions of particular expertise that may be appropriate for review of a given application.
The chairperson of the review panel is a senior investigator experienced in the review of complex multi-disciplinary applications and is generally knowledgeable in the scientific areas to be reviewed. The review panel membership reflects a balance in terms of experience, expertise, and specialty so as to afford peer review of the separate components as well as the overall program project. A consultant experienced in management and fiscal administration may be needed when large research program project applications are reviewed. In most cases, this consultant does not vote on the scientific merit of the components or assign a priority score for the application.
The SRA may contact the Principal Investigator to discuss the specific disciplines or specialty areas of expertise which the Principal Investigator feels are required to review the application properly. However, as noted above, names of potential reviewers are not directly or indirectly solicited from the Principal Investigator.
G. Review Committee Meetings
Although the specific format for each review depends on the application, the SRA, as the AHCPR official responsible for managing the review, ensures that the review is conducted in accordance with PHS and AHCPR policies.
As the manager of the review process, the SRA serves as the resource for the IRG or SEP with respect to AHCPR review policies, guidelines, rules, regulations, options available, procedures, etc. The AHCPR Program Officer serves as a resource, as needed, concerning the history and development of the program, changes in program direction, and other relevant program matters.
The SRA discusses review procedures and criteria, the need for a well-documented review, and the functions of the AHCPR staff. The SRA also presents an explanation of conflicts of interest, implications of the Privacy Act, the need for confidentiality of the proceedings, the necessity of addressing protection of human subjects and gender and minority representation in study populations, inclusion of children in research, and other policy and logistic matters. In accordance with the review criteria presented in these Guidelines, the SEP evaluates each component of the program project.
Reviewers' recommendations will center on the following options: voting an adjectival descriptor for components having significant and substantial merit; or voting non-competitive which means that the proposed research, as submitted, is not recommended for funding.
If a component is deemed to have significant and substantial merit, each reviewer rates the potential impact of the project on the field according to the adjectival scale adopted by the NIH (see below). Adjectival descriptors are assigned to meritorious cores as well as research projects. Reviewers critically examine the requested budget for each component and recommend a budget appropriate for the activities. A merit rating for "Program as an Integrated Effort" is also obtained.
After review of all of the components and program as an integrated effort, the reviewers discuss and evaluate the overall research program project in terms of the specific criteria provided in these Guidelines. Reviewers consider only the meritorious projects and cores of the program (excluding any components not recommended for funding) in voting a priority score. In addition, an individual research project that is not recommended for funding does not contribute toward the minimum project requirement for the application under the RFA. If the number of scientifically meritorious projects of a P01 applications is less than the minimum requirement stated in the RFA, the application will not be scored and cannot be funded under the RFA. Components of the P01 that are deemed non-competitive will not be considered in the evaluation of the overall program. Nevertheless, inclusion of components which are of poor quality or are unrelated to the program project will be considered as evidence of a deficiency in judgment on the part of the Principal Investigator. It should be noted that reviewers do not have the option of selecting only the better components of the program in order to improve the overall score. Again, a vote in the form of an adjectival descriptor (or for non-competitive) is taken, and a period of support is recommended. Then, each reviewer privately assigns a priority score as a measure of the potential impact of the program project on the scientific field using the current NIH rating scale and priority score ranges:
Outstanding: 1.0—1.5
Excellent: 1.5—2.0
Very Good: 2.0—2.5
Good: 2.5—3.5
Acceptable: 3.5—5.0
The findings and recommendations of the reviewers are summarized in a written report which conveys the evaluation of the program project. This summary statement is transmitted to the Principal Investigator, AHCPR official file, and to the appropriate AHCPR staff. AHCPR program staff will send a copy to the Principal Investigator as soon as the final document is available.
Following review, scored applications are considered for funding by AHCPR program staff and the AHCPR Administrator. When an award is made, it is the policy of AHCPR that meritorious projects reviewed as part of the program project be funded as part of the program project even though other funding may be available. Under no circumstances is duplicate funding awarded.
AHCPR program staff may administratively delete funding or reduce the duration of support for components of program projects that are judged by peer review to be less meritorious and/or non-essential to the conduct of the program project.
The award and administration of program projects are subject to the same policies and procedures as other research grants. These policies and cost principles are set forth in the current PHS Grants Policy Statement, other AHCPR issuances, and Federal legislation and regulations.
Name/Role (e.g., Project Leader 1) Core A, Core B,...Project 1, Project 2,...Total Name/Role (Project Leader 2) Core A, Core B,...Project 1, Project 2,...Total Name/Role (e.g., Core Director A) Core A, Core B,...Project 1, Project 2,...Total Name/Role (Core Director B) Core A, Core B,...Project 1, Project 2,...Total Investigator Smith Core A, Core B,...Project 1, Project 2,...Total Investigator Brown Core A, Core B,...Project 1, Project 2,...Total
[First lines should be reserved for Project Leaders and Core Directors; names of other investigators should follow thereafter; percent effort for the entire P01 is listed in the Total column.]
Section I—Face Page, Table of Contents, Detailed Program Project Budget for First 12-Month Period, Budget Estimate for Each Year of Program Project, Summary of All Other Sources of Support, Biographical Sketches
Section II—Overall Program Project, Goals, Theme of the Program Project, Research Plan,
Progress Report/Preliminary Studies, Institutional Environment and Resources, Organization and Administrative Structure, Literature Cited (with complete titles and authors)
Adhere to page limitations given in relevant RFA.
Individual Research Project 1 (Title, Project Leader)—Title Page, Description of Research, Plan/List of Key Personnel, Detailed Budget for First 12-Month Period, Budget Estimate for Each Year of Requested Support, Resources and Environment, Research Plan, (Gender and Minority Inclusion), (Human Subjects), (Vertebrate Animals), Literature Cited (with complete titles and authors), Consortium/Contractual Arrangements, Consultants and Collaborators
Adhere to page limitations given in relevant RFA.
Individual Research Project 2 (Title, Project leader)—Title Page, . . ., . . ., Consultants and Collaborators
Adhere to page limitations given in relevant RFA.
Core Component A (Title, Core Director)—Cover Page, Description of Core, Budget for the First 12-Month Period, Budget Estimate for Each Year of Requested Support, Role and Justification for the Core Component,...
Adhere to page limitations given in relevant RFA.
Core Component B (Title, Core Director)—Cover Page, Description of Core,...Role and Justification for the Core Component,...
Adhere to page limitations given in relevant RFA.
Check List
Core A: Administration Project, Project 1, Project 2,...Total (100%) Core B: Data Purchase and Processing Project, Project 1, Project 2,...Total (100%)
Project 1: American Indian or Alaskan Native Female, Male, Unknown, Total Asian or Pacific Islander Female, Male, Unknown, Total Black, not of Hispanic Origin Female, Male, Unknown, Total Hispanic Female, Male, Unknown, Total White, not of Hispanic Origin Female, Male, Unknown, Total Other or Unknown Female, Male, Unknown, Total Total Female, Male, Unknown, Total Project 2: . . .
Current as of July 1999
Internet Citation:
AHCPR Guidelines for the Research Program Project Grant (P01). July 1999. Agency for Health Care Policy and Research, Rockville, MD. http://www.ahrq.gov/fund/guiderpg.htm
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