AHCPR Guidelines for the Research Program Project Grant (P01)

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Special Instructions for Preparation of Research Program Project (P01) Applications

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.

Goals: Present the general problem area to be studied, the overall long-term objectives of the research described in this application, and any hypotheses to be tested.
Theme: A program project is a confederation of interrelated research projects. It is important to establish the programmatic theme in this section and to address the issue of the integration of components, demonstrating how each individual component benefits from and contributes to the overall program project. A diagram illustrating the effective interactions between components may be helpful to reviewers.
Research Plan: This section delineates the research addressed by the program as a whole and explains the strategic approach to the problem, briefly mentioning each project as it relates to the overall program project. Descriptions of prior collaborative efforts among investigators in the group, as well as the sequence of events leading to and supporting the current application, may also be included in this section. It is important to discuss the advantages expected from a group effort, e.g., how the projects are mutually reinforcing, how collectively they further the goals of the proposed research, etc.
Preliminary Studies: This section should focus on research already underway and current accomplishments of the investigators applicable to the proposed program project. More detailed preliminary reports are included separately under each individual project. Items to be included may include: (1) a summary of major accomplishments attributed to the participating investigators that relate to the overall theme of the program project; (2) a list of all publications and manuscripts accepted for publication already produced by the interaction(s) of the participating investigators.
Institutional Environment and Resources: Briefly describe the institutional environment and resources that are relevant to effective implementation of the program project. This may include statements about relevant clinical and laboratory facilities, participating and affiliated units, subject population, geographic distribution of space, and personnel, consultative resources, data and data processing resources, etc.
Organization and Administrative Structure: Several kinds of information are required in this section:
1. Describe in detail, and by diagram, the chain of authority for decision making and administration, beginning at the level of Principal Investigator. Include names of investigators responsible for individual components (Project Leaders) and describe how the projects are planned, coordinated, and evaluated. If internal or external advisory groups are to be used, list the membership and describe the role of each.
2. List in a separate table all consultants and their institutional affiliations, both paid and unpaid.
3. Describe relationships between the program project and other research, academic, and administrative units of the institution (such as centers, institutes, departments) and the central administration.
Literature Cited: List complete literature citations at the end of the program narrative. Each should include names of all authors, full title, name of book or journal, volume, pages, and year of publication.

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.

Title Page (PHS 398 Continuation Page; NOT page AA, FACE PAGE). Clearly denote the project number, the title of the project, and Project Leader.
Description/List of Key Personnel (PHS 398 Form Page 2-BB). The title of "Principal Investigator" is reserved for the director of the overall application. The directors of individual projects should be designated as "Project Leaders," and directors of cores should be designated as "Core Directors."
Omit Table of Contents.
Detailed Budget (PHS 398 Form Pages 4-DD and 5-EE; Instructions for PHS 398). A detailed budget is required for the first year and the budget summary for each additional year. The budget justifications are to be explicit, including those for any increases or changes for future years. In projecting the future year needs for each project, the applicant should keep in mind that the P01 must maintain the required minimum number of projects (3, unless as specified otherwise in the RFA) in each year of the life of the research program project.
Omit Biographical Sketches and Other Support because these are included elsewhere in the application.
Resources (PHS 398 Form Page HH). Follow instructions on the form. List only those specific to the individual projects.
Research Plan:
1. Project Aspects—Include Sections a-d (Instructions for PHS 398, Pages 15-17). Refer to RFA for relevant page limitations.
2. Program Aspects—(This item is NOT included in Instructions for PHS 398.) Describe in this section the relevance of the project to the primary theme of the program and the collaborations with investigators within the program project. Limited to one page.
Gender and Minority Inclusion (Instructions for PHS 398). Each project or core involving Human Subjects as described in the Instructions must include information in tabular form as shown in Appendix D. A table must be prepared for each study involving human subjects.
Human Subjects (Instructions for PHS 398, Item e). Applicants must provide clear evidence of full protection and monitoring of human subjects.
Literature Cited (PHS 398 Continuation Pages; Instructions for PHS 398). List complete literature citations specific to the project at the end of the project narrative. Each citation must include the names of all authors, full title, name of book or journal, volume, pages, and year of publication.
Consortium/Contractual Arrangements (PHS 398 Continuation Pages; Instructions for PHS 398, Item h). Self-explanatory.
Consultants (PHS 398 Continuation Pages; Instructions for PHS 398, Item i). List consultants specific to this project but external to the program project. For each consultant, include a letter of support detailing the nature and extent of participation (e.g., number of hours or days of consultation to be provided).
Do not include a checklist for each project.
Appendix (Form PHS 398; Instructions, Item 10). Appendices should be clearly identified by project number and investigator. Two types of appendices exist:
1. Sets of supplementary graphs, diagrams, tables, photographs, and charts directly pertinent to the application may be submitted as appendix material. Keep such material to a minimum; if the information in appendix material is essential to an evaluation of a project or of the application, incorporate it in the application. The appendix is not to be used to circumvent the page limitations in the application. Normally only the assigned reviewers for an application receive the appendix material. Submit appendix materials in accordance with instructions
2. No more than 10 publications and manuscripts accepted for publication that are specific for each project may be submitted as appendix material.

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.

Using a Form PHS 398 Continuation Page, denote "Core Component" and the Core Director's name. If there is to be more than one core component, prepare a separate section for each core (i.e., Core Component A, Core Component B, etc.).
For each core component, follow the specific instructions for the individual Research Project, Item I, of these Special Instructions, except that in place of Item I. 7., Research Plan, describe the role of the core component as a resource to the program project as a whole. Clearly present the facilities, resources, services, and professional skills that the core component provides.
To aid in the review, it is suggested that a table showing the estimated or actual proportional use of this core component by each project be included in the application (See Appendix C: Sample Structure for Table of Scientific Core Research Resources). Justify this core component by discussing ways in which these centralized services improve quality control, produce an economy of effort, and/or save overall costs compared to their inclusion as part of each project in the program project.

K. Checklist for overall application (Use Form Page II; Instructions for PHS 398)

Self-explanatory.

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Application Submission

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.

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Review Procedures

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

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Summary Statement

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.

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Award

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.

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Appendix A: Sample Structure for Table of Professional Effort (%)

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.]

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Appendix B: Sample Structure for Research Program Project Application

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)