Program Project (P01) Guidelines

These instructions supplement and do not replace the Public Health Service Grant Application (PHS Form 398) instructions at: http://grants.nih.gov/grants/funding/phs398/phs398.html. Applicants are encouraged to check PHS Form 398 periodically because the instructions are updated frequently.

Sample Format

Preapplication

Applicants should discuss potential P01s with program staff prior to submission to determine whether the proposed research meets a programmatic need in NIA's priority areas of interest. In addition, NIH policy requires potential applicants to discuss and obtain approval from program staff before submitting an application if the requested budget will exceed $500,000 in direct costs (see Detailed Budget for Initial Budget Period in the PHS Form 398 instructions) at least 6 weeks prior to submission.

Eligibility 

• Applications from domestic nonprofit institutions are eligible to apply. Applications from foreign institutions are not eligible, but individual projects within the P01 are acceptable.
• To be eligible for an award, a P01 must have a minimum of three fundable research projects each grant year, including one for the principal investigator (PI). Cores do not satisfy this requirement. 
• Cores must be justified in terms of the P01's needs. A core must serve more than one project. Each P01 must have an administrative core.
• Competing continuation applications must include progress reports that discuss research and core component accomplishments during the previous award period, regardless of whether the components are included in the renewal application. 
• Once a P01 has been awarded, competing supplements to expand the scope of awarded grants will be considered, but may not extend beyond the timeframe of the parent P01. A supplemental application will not be accepted until after the parent P01 application has been awarded.

Submission Dates 

All P01 applications—new, competing renewals, amended and supplements—are due the first receipt date of the cycle:

• February 1
• June 1
• October 1

When submitting the application, send the original and three copies to the Center for Scientific Review (see PHS Form 398 for address). Send two copies of the application and six copies of the appendix materials to:

Chief, Scientific Review Office
National Institute on Aging
National Institutes of Health
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, MD 20814

Page Limitations 

The page limits cited in the PHS Form 398 instructions apply to each research project. Cores are limited to 10 pages for Sections A–D. Provide an introduction—not exceeding 10 pages—of the P01 as a whole. Page limitations are strictly inforced in the interest of fairness to all applicants.

Amended Applications

An introduction—not exceeding three pages—for the P01 as a whole and one page for each core that describes responses to criticisms and issues raised in the summary statement is required. The changes in the Research Plan must be clearly marked by bracketing, indenting, or changing of typography, unless the changes are so extensive that they include most of the text. This exception should be explained in the Introduction. Changes should not be underlined or shaded. 

Supplemental Applications 

An introduction—not exceeding three pages—providing information relevant to the nature of the supplement and how it will influence the specific aims, research design, and methods of the current grant is required. Any budget changes for the remainder of the project period of the current grant should be discussed in the Budget Justification section. Amended supplements should include another introduction describing responses to the previous review.

Organization of the Application

Follow the instructions of the PHS Form 398, with the following additions:

Section 1: Information for the Entire Application

Table of Contents

1. Use the sample format provided as Attachment 1 of these instructions, rather than Form Page 3, "Table of Contents" from PHS Form 398; PHS Form 398 applies only to applications of single projects.
2. Number all pages consecutively. Because the first page of the application is the Title Page, begin the next page with the numeral "2." Do not use lettered numbers (e.g., 2A, 2B, etc.).

 Appendices

1. Identify appendix material by the PI's name, core or project name and number, and core or project leader’s name. Do not insert appendices in the body of the application. 
2. Refer to restrictions on any material that may be included in appendices as outlined in the PHS Form 398 instructions. 
3. Send appendix materials to the Chief, SRO, NIA.

Budgets

1. Insert a table describing the "Consolidated Direct Costs for First Year of Requested Support," as shown in Attachment 3.
2. Insert budgets for the first 12 months and for the entire proposed period for the overall program. List detailed budgets for individual research projects and cores with the corresponding project or core.
3. Justify all items carefully according to the PHS Form 398 form instructions. A complete budget for a consortium project is to be developed and identified as such. The period of support may not exceed 5 years.

Biographical Sketches

1. Follow the PHS Form 398 instructions. 
2. Include sketches for all key personnel and list them in alphabetical order, but list the PI's/program director's biographical sketch first.
3. Insert a completed Table II to aid in the review of the application. See sample, Attachment 4: Distribution of Professional Effort (Percent) on This Application."

Section 2: Summary Research Plan for Entire Application

Introduction to the Application (Specific Aims)

1. Summarize the research focus and long-term goals of the overall program. 
2. Include the major approaches and studies involved in the application. 
3. Discuss the relation of the program to other activities in the applicant's institution (e.g., other relevant research projects) and the extent of institutional, departmental, and interdepartmental cooperation. 
4. Describe the administrative relationships of the proposed program to the institution.
5. Include issues relating to institutional commitment and settings.
6. Describe the mechanisms that will ensure the coherence of the project and maintain a multidisciplinary focus. 
7. Summarize the major resources available to the entire research program and the environment in which it will be conducted.

If this is a revised or supplemental application, include information relevant to the overall program. The introduction should contain sufficient information from the original grant application to allow evaluation of the proposed supplement in relation to the goals of the original application and how it will integrate with goals of the parent application. 

Background and Significance

Self-explanatory.

Preliminary Studies/Progress Report

1. Provide a summary of accomplishments, publications, and any problems encountered with fulfilling the original specific aims for competing renewal and supplemental grant applications.
2. Include a report covering expansion or contraction of the currently funded program, if applicable.
3. Include an adequate progress report will result in deferral of the application.
4. Justify any changes in research emphasis and level of requested funds, and discuss progress for all funded elements in the previous period, regardless if they will be continued in the new application (this applies to competing renewal applications). 

Human Subjects

1. Describe the general principles and policies that will apply to human subjects. 
2. List the components of the application that involve human subjects and page numbers for the relevant human subjects sections.

See PHS Form 398 instructions. 

Women and Minorities

1. Describe the composition of the human subjects and the proactive plan to recruit women and minorities.
2. List the page numbers for the relevant Women and Minorities sections.

See PHS Form 398 instructions. 

Vertebrate Animals

1. Describe the general principles and policies that will apply to vertebrate animals. 
2. List the components in the application that involve vertebrate animals and page numbers for the relevant Vertebrate Animal sections.

See PHS Form 398 instructions. 

Consortium/Contractual Arrangements

1. List all performance sites—including the applicant institution and the collaborating institutions—on page 2 of the P01 application.

See "Detailed Budget Initial Period" of PHS Form 398 instructions. 

Consultants

1. Summarize this information for all components of the program, and indicate the consultants by name.
2. Include biographical sketches and signed letters of agreement to serve. For new applications, advisory committee members should not be recruited until after the review is complete, but include criteria to select advisors. 
3. Identify advisors/consultants—and their respective institutions—currently employed or with whom prospective employment has already been discussed.

Use of Cores by Projects

1. Insert a completed Table III (see sample, Attachment 5: “Percent use of Each Core by Each Project First Year”).

Section 3: Research Plans for Individual Projects and Cores  

1. Present information for each component project and core according to the Table of Contents. 
2. List the cores first, identifying multiple cores by consecutive letters (Core A, Core B, etc.) and titles (Administrative Core, Laboratory Animal Core, etc.). 
3. List individual research projects in the application after the cores, and identify them with consecutive Arabic numbers (Project 1, Project 2, etc.). 
4. Continue numbering components according to the system used in the previous application for competing continuation and supplemental applications (e.g., a project included in the previous application and is continuing should have the same number as in that application). 
5. Number the new project in sequence if a project is eliminated and another one is added.
6. Write the title within a maximum of 56 spaces.
7. Include the project leader’s name at the upper right-hand corner of each page under the PI's name.
8. Prepare each core or project as a separate section beginning on a new page of the application, and begin each with a title page (use the format of sample Attachment 2, not the face page of PHS Form 398) and a detailed first year and summary budget for all years. Number the pages consecutively. 

Review Criteria

Evaluation by the initial review group will be based primarily on the following criteria: 

• The scientific merit of the program as a whole.
• The scientific merit of each individual project; each project should be supportable on its own merit. 
• The significance of the overall program goals and a well-defined central research focus.
• The coherence and multidisciplinary or multifaceted scope of the program, the coordination and interrelationships among the individual projects and cores, and their relationship to the central focus of the overall program.
• The qualifications, experience, and commitment of the investigators for the individual research projects or cores and their contribution to the research effort, including their ability to devote adequate time and effort. It is expected that the project leader will commit a substantial amount of time and effort to the research.
• Accomplishments of the research to date (for renewal and supplemental grant applications).
• The intellectual and physical environment in which the research will be conducted, including the availability of space, equipment, and research subjects, if applicable, and the potential for interaction with scientists from other laboratories and institutions.
• The appropriateness of the administrative and organizational structure to attain the research aims. 
• Arrangements for internal quality control of the research, allocation of funds, day-to-day management, internal communications and cooperation among the investigators, including those involving contractual agreements, etc. 
• The institutional strength, stability, and commitment to research and to the proposed research program, including fiscal responsibility and management capability to help the PI and staff comply with PHS policy.
• The appropriateness of the period of support and budget requested in relation to the proposed activities. 
• Protection of human subjects, gender, and minority recruitment into clinical studies, adequate care and use of vertebrate animals, and biohazard issues. 

The review group will use the above criteria for an evaluation score for each research project and core that has significant and substantial merit and a priority score for the overall program, unless it is not recommended for further consideration. The PI's inclusion of marginal projects in an application may affect reviewers’ assessment of the overall merit of the proposed program. Therefore, the application should include only projects with individual significance, substantial merit, and contribution to the merit of the overall proposed program.