Table of Contents

Introduction
Definition and Philosophy
Scope, Size, and Budget
Applying for a Program Project Grant
Pre-submission
Application Preparation and Submission
Application Receipt and Review Dates
Procedures for Review of Competing and Non-Competing Applications
Review of New Applications
Review Criteria
Review of Competing Continuation (Renewal) Applications
Review of Applications for Competitive Supplements
Review of Revised Applications
Review of Non-Competing Continuation Applications
Other Considerations
Appendix I: Format for NICHD P01 Grant Applications
Table I: All Current and Pending Research Support of Professional Personnel (Sample Format)
Table II: Quantitative Use of Core Units by Component Research Projects (Sample Format)
Appendix II: Guidelines for Reviewers' Comments

Introduction

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) uses the program project (P01) grant mechanism to support research on reproductive, developmental, behavioral/social, and rehabilitative processes that determine the health or that optimize the functioning of newborns, infants, children, adults, families, and populations.

The purpose of the P01 mechanism is to encourage multidisciplinary approaches to the investigation of complex problems relevant to NlCHD's mission and to facilitate economy of effort, space, and equipment. NICHD believes that the collaborative research effort of a program project accelerates the acquisition of knowledge more effectively than does a simple aggregate of research projects without thematic integration.

This document provides information on NIH and NICHD policies and procedures for P01 grants, including: (I) definition, philosophy, and distinguishing features; (II) scope, size, and budget; (III) procedures for applying for a P01 grant; and (IV) procedures for reviewing P01 applications.

Definition and Philosophy

The program project grant is an institutional award made in the name of a program director for the support of a broadly based, long-term, multidisciplinary research program that has a well-defined central theme, research focus, or objective. The grant funds at least three interrelated projects and, often, core resources that support at least three projects at all times. Interrelationships and synergism among component research projects should result in greater scientific contributions than if each project were supported through a separate mechanism. The grant is based on the concept that projects closely related to a central theme can be conducted more effectively and efficiently through a coordinated, collaborative, multidisciplinary approach.

The P01 research effort is facilitated by the sharing of ideas, data, and specialized resources, such as equipment, services, and clinical facilities. Clearly, an essential requirement is a central theme toward which the total scientific effort is directed and to which each component project relates. Although the component projects must have scientific merit individually, they also must complement one another and support the program's overall theme. Thus, the program's overall scientific merit should be greater than the sum of its parts. In keeping with the philosophy of traditional investigator-initiated research, the applicant should define the integrating theme and develop approaches to accomplish the proposed research objectives. The P01 may involve, for example, a disease process encompassing both clinical and basic science elements; a unifying concept of biological control; a problem common to related diseases; behavioral aspects of a medical condition; or population processes and problems.

Component research projects should be conducted by experienced scientists who have a variety of disciplinary and specialty backgrounds. They must be willing to interact with each other so that new scientific information may be freely exchanged and effectively applied by others in the program. The program director should be an established scientist with demonstrated administrative capabilities.

Regular meetings of participating investigators who share and evaluate results and new ideas are essential to the consolidation of the research projects into a cohesive program. An internal advisory committee, selected from among the participating investigators, can be effective in assisting the program director in making scientific and administrative decisions. The judicious use of an external advisory committee, composed of consultants from outside the program, can be helpful in providing independent program evaluation and guidance. Applicants are strongly encouraged to consider incorporating all three methods of communication in their programs.

Distinguishing features of a program project are as follows:

• There must be a unifying, well-defined goal or central research theme to which each component project relates and contributes scientifically, thereby producing a synergistic environment that allows each research effort to share the creative strengths of the other projects.
• The program involves interrelated research projects and collaborating investigators, yielding results beyond those achievable if each project were carried out separately.
• Component projects may be supported by technically competent and efficient core units to enhance the research efforts.
• Each component research project must independently have significant and substantial scientific merit, as assessed by peer review, and must complement the other research projects in the program.
• The program director must possess recognized scientific and administrative competence, show a substantial commitment of effort to the program, and exercise leadership in maintaining program quality.
• Program projects require the participation of established investigators in several disciplines or investigators with special expertise in several areas of one discipline. All principal investigators must contribute to, and share in, the responsibilities of fulfilling the program objectives.

To constitute a program project, at least three component projects must be rated by peer review to be of high scientific merit. Core facilities, if requested, need to support at least three component projects at all times.

Scope, Size, and Budget

P01 size should be thoughtfully considered. The program must comprise a sufficient number of scientifically meritorious research projects (at least three) to permit an effective collaborative effort among the participating investigators. On the other hand, research efforts should not be so diverse and diffuse in scope as to hinder productive collaboration. In such instances, consideration should be given to submitting individual R01 research project grant applications. P01s that are too large may inhibit communication and interaction among collaborators and, as a result, become less effective.

NICHD has instituted the following funding caps, effective for all applications submitted for the October 1, 1998 receipt date, and thereafter. Applications requesting funding levels beyond those listed here will not be accepted for review:

NOTE: For the purpose of funding caps, the calculation of total direct costs may exclude all facilities and administrative (indirect) costs, including those indirect costs associated with subcontracts.

• For all unsolicited Type 1 applications, the first-year cap is $750,000 direct costs, with a cumulative cap of $4,000,000 direct costs over the 5-year award period.
• For all unsolicited Type 2 (renewal) applications, the first-year direct cost cap is either $750,000 or the amount representing an increase of 20% over the direct costs awarded in the last non-competing (Type 5) year, whichever is greater. There is, in addition, a cumulative cap of $5,000,000 direct costs over the 5-year award period.
• In addition, unsolicited P01 applications must also comply with the NICHD Large Grants Policy, as described at http://www.nichd.nih.gov/funding/policies/large_grants.cfm
• Caps for program project grant applications solicited through a Request for Applications (RFA) or Program Announcement (PA) will be specified in the relevant RFA/PA.

Rules for allowable costs are set forth in the NIH Grants Policy Statement and in the NIH Guide for Grants and Contracts, unless otherwise stated in the Notice of Grant Award. Under these guidelines, the program director may exercise flexibility to meet unexpected requirements by rebudgeting or requesting approval to rebudget among budget categories within the total cost of a project (as shown on the Notice of Grant Award).

Applying for a Program Project Grant

Pre-submission

The prospective program director should communicate with NICHD program staff before submitting an application. Early communication will assist NICHD staff in determining whether the proposal is responsive to the NICHD research mission and whether it meets P01 criteria, including criteria for requested funding levels. Communication will also enable the potential applicant to benefit from consultation with NICHD staff.

Early contact with NICHD staff is strongly recommended; applications that do not meet NIH or Institute guidelines for program project grants, including funding caps, will not be accepted for review. Any exceptions to standard NICHD practice must be approved for submission in advance; such applications must be submitted with a cover letter to the Director, Division of Scientific Review, NICHD, identifying the program staff member agreeing to accept assignment of the application to NICHD.

NICHD staff will advise applicants on the preparation of a complete and well-developed application. Communication will focus on such issues as the need for thematic integration of all component projects, the proper format, established review guidelines, and the importance or relevance to NICHD program areas.

Communication with NICHD may be initially by telephone, E-mail, or letter, and should provide the following information:

• Applicant qualifications, including key collaborators;
• the P01 central theme and objectives;
• a brief description of each component project and core unit, including component investigators, and a statement of how each project will contribute to the overall P01 goal; and
• an estimate of the annual budget and the number of years of support requested for the total program project and for each component project and core.

When NICHD solicits the submission of P01 applications in a specific area, this need will be conveyed to the scientific community through a Request for Applications (RFA) or Program Announcement (PA), which will be published in the NIH Guide for Grants and Contracts.

Depending on the application's subject matter, communications should be directed to relevant program staff or:

Director, Center for Developmental Biology and Perinatal Medicine (CDBPM), NICHD
Executive Building, Room 4A05
6100 Executive Boulevard, MSC 7510
Bethesda MD 20892-7510
Telephone: (301) 496-8535
E-mail: hansonj@exchange.nih.gov

or

Director, Center for Population Research (CPR), NICHD
Executive Building, Room 8B07
6100 Executive Boulevard, MSC 7510
Bethesda MD 20892-7510
Telephone: (301) 496-1101
E-mail: haseltif@exchange.nih.gov

or

Director, Center for Research for Mothers and Children (CRMC), NICHD
Executive Building, Room 4B05
6100 Executive Boulevard, MSC 7510
Bethesda MD 20892-7510
Telephone: (301) 496-5097
E-mail: willouga@mail.nih.gov

or

Director, National Center for Medical Rehabilitation Research (NCMRR), NICHD
Executive Building, Room 2A03
6100 Executive Boulevard, MSC 7510
Bethesda MD 20892-7510
Telephone: (301) 402-2242
E-mail: weinricm@mail.nih.gov

In response to this communication, NICHD staff may initiate detailed discussions with the potential applicant. A decision to encourage submission does not imply prior approval or a commitment to fund. NICHD program and grants management staff may be contacted for administrative guidance. However, they will not become directly involved in developing the application, or in providing feedback on scientific aspects of the application.

Application Preparation and Submission

Program project grant applications are to be submitted using the most recent revision of the PHS 398 Grant Application form. These forms are available at most institutional offices of sponsored research, but also can be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone: 301-435-0714, or E-mail: grantsinfo@nih.gov.

Because this form is designed primarily for the traditional R01 application, several sections outlined in the 398 Instructions will need to be modified and expanded to provide the additional information required for a P01. To ensure that the essential information is provided in a systematic fashion that will facilitate scientific review, all applications should be submitted in a format such as that outlined in Appendix I. Because the P01 application requests funds for direct research support, each project must be presented in as much detail (within PHS-398 page limitations) as if it were a request for an R01.

With the exception of non-competing (Type 5) applications, all P01 applications are submitted to the NIH Center for Scientific Review (CSR). These include new (Type 1), renewal (Type 2), and revision (Type 3) applications.

Submit a signed, typewritten original of the application, including the Checklist, and three 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

Via express/courier services:

Bethesda MD 20817

For Institute planning, it is important that two additional copies of the application and appendices are sent under separate cover directly to the NICHD Division of Scientific Review (DSR). As noted above, any application differing from standard NICHD practice must be accompanied by a letter identifying the NICHD staff member agreeing to accept assignment of the application to the Institute:

Director, Division of Scientific Review, NICHD
Executive Building, Room 5B01
6100 Executive Boulevard, MSC 7510
Bethesda MD 20892-7510

Via express/courier services:

6100 Executive Boulevard, Room 5B01
Rockville MD 20852

Application Receipt and Review Dates

The standard NIH receipt dates for competing grant applications may be found at http://grants1.nih.gov/grants/funding/submissionschedule.htm.

Unless otherwise specified in an RFA, receipt and review dates for all P01 grant applications are as follows:

These deadlines are applicable to all new, resubmission, and revised P01 applications. Applications received too late for one cycle of review will be held for the next review cycle. Applications must be complete to be considered timely. For example, late submissions of component research projects will not be accepted.

Procedures for Review of Competing and Non-Competing Applications

Initial peer review of P01 applications for scientific and technical merit is carried out by a Scientific Review Group (SRG) managed by the NICHD Division of Scientific Review, either a subcommittee of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Initial Review Group (NICHD IRG) or a Special Emphasis Panel (SEP). The NICHD IRG consists of seven subcommittees: (1) the Biobehavioral and Behavioral Sciences Subcommittee; (2) the Developmental Biology Subcommittee; (3) the Function, Integration and Rehabilitation Sciences Subcommittee; (4) the Obstetrics and Maternal-Fetal Biology Subcommittee; (5) the Pediatrics Subcommittee; (6) the Population Sciences Subcommittee; and (7) the Reproduction, Andrology and Gynecology Subcommittee. When a subcommittee member is named in an application, the application is assigned to another NICHD subcommittee or to a special review by a Special Emphasis Panel.

Review of New Applications

From the time that an application is submitted until its review is completed, communications must be directed to the DSR Scientific Review Administrator (SRA) or other DSR staff rather than to program staff. However, during the review process, NICHD grants management staff may be in direct communication with the applicant for budgetary and other fiscal and administrative information, as necessary.

Upon receipt in NICHD, an administrative review of the application is performed by the SRA, program staff, and grants management staff to ensure conformance with NIH/NICHD guidelines as well as relevance to NICHD program interests. If the application is not in compliance, it is returned to the applicant without review.

1.      Preliminary Review of Applications to Determine Competitiveness

A process may be implemented for preliminary evaluation of applications by peer reviewers to determine whether or not the applications are likely to be competitive for funding. Only those applications deemed competitive will be subjected to an in-depth review. Reviewers' written critiques of non-competitive applications will be provided to the applicants.

2.      Site Visits

A site visit is not a prerequisite for consideration of any application by an NICHD review committee. A site visit may be considered in the review of a new, Type 1 or Type 2 application. Site visits will not be conducted for most revised applications. However, if a revision represents a substantial modification of the original application, a site visit may be considered. The applicant should not rely on a site visit to supplement or improve an incompletely written application.

If a site visit is planned, the program director will be contacted by the SRA.

If a site visit is not planned, other forms of review may be arranged prior to SRG review. These could include a teleconference, with or without participation of the applicant investigators. The program director will be contacted by the SRA if such arrangements are planned.

3.     Committee Review

The review committee considers the full application at its scheduled meeting. Each application is considered independently. If a site visit took place, the site-visit chairperson is usually responsible for presenting the site-visit report.

Following a thorough discussion, the review committee may 1) assign a priority score to the application and to individual projects/cores; 2) decide that one or more individual projects/cores and/or the overall application lack significant and substantial merit and should not be recommended for further consideration; or 3) defer a decision regarding the application pending the receipt of additional information and/or a site visit.

Review Criteria

Peer review of scientific and technical merit focuses on three areas: (1) review of the individual component projects; (2) review of the individual cores; and (3) review of the program as an integrated effort and the overall merit of the program. (The full scope of reviewer considerations is described in Appendix II.)

In their considerations, the review committee also will be guided by the following directives:

• A five-year total project period is encouraged, but is not mandatory. The minimum total project period is three years.
• Unless the applicant has requested a shorter duration, component research projects/core units must be recommended for at least three years.
• There must be at least three component research projects at all times during the grant period.
• Each core unit must serve as a resource for at least three research projects at all times during the grant period.

The reviewers will assign a priority score to each research project and each core unit that is deemed to have significant and substantial scientific merit, indicating their assessment of the degree of scientific and technical merit based on the criteria outlined in Appendix II:

The numbers in parentheses refer to corresponding ranges for priority scores. Reviewers are encouraged to use the full range. Research projects or core units that are found to lack significant and substantial scientific and technical merit will not be recommended for further consideration (NRFC). The NRFC designation is distinct from the designation "Unscored," used in the streamlined review process and applied to applications falling in the lower half of distribution of priority scores. The streamlined review process is not used by NICHD in the review of P01 applications.

For individual projects, reviewers will assign a priority score or recommend no further consideration based on the assessment of each project independently, in terms of the specified review criteria for individual projects (Appendix II).

For individual cores, reviewers will assign a priority score or descriptor term, as appropriate, or recommend no further consideration, based on the assessment of each core independently in terms of the specified review criteria for individual cores (Appendix II).

For the overall program, reviewers will assign a priority score or recommend no further consideration based on assessment of the entire application, in terms of the review criteria specified for the overall program (Appendix II). The resulting priority score for the overall program project will reflect reviewers' assessment of the scientific and technical merit of the proposed program project. The assessment will take into consideration all proposed projects and cores, including any with poor ratings or a NRFC recommendation.

Each committee member privately assigns a numerical rating (between 1.0 and 5.0) to each project and scientific core, and to the application as a whole, based on his/her judgment of the applicable review criteria. In doing so, reviewers will be guided by the same criteria as described in Appendix II.

After the committee has acted, the SRA will prepare a summary statement, following the format outlined in Appendix II. The summary statement will indicate the committee's recommendations, including the priority score for those applications recommended for further consideration, recommended first-year budget figures, priority scores for individual projects recommended for further consideration, recommendations for each core, and, for each project year, narrative descriptions of any recommended budget changes. The text will present reviewers' unedited comments on the scientific merit of each project and core, and on the overall program. A copy of the summary statement will be sent to the program director.

5.    Advisory Council Review

Second-level review is provided by the National Advisory Child Health and Human Development Council. The Council votes concurrence or non-concurrence with the recommendations of the scientific review group (SRG) as described in the summary statement. In the event of non-concurrence, the application may be returned to the DSR for additional information or another review. The Council does not evaluate the scientific and technical merit of applications, but makes recommendations on matters pertaining to program relevance and the adequacy of the initial review.

Review of Competing Continuation (Renewal) Applications

NICHD support for a program project may not exceed five-year intervals. The grantee institution must submit a competing continuation (Type 2) application to request support beyond the current project period. Plans to submit a Type 2 application should be discussed with NICHD staff. Any significant increase in budget over the current level of support must be justified and NICHD policy regarding caps on funding (see above) must be observed.

Unless a recompetition is announced in an RFA, grantees are requested to submit Type 2 applications 11 to 14 months before the scheduled termination date of the current period of support. Earlier submission is discouraged.

The receipt dates for competing continuation (renewal) applications are January 25, May 24, and September 25.

Review of Revision Applications (formerly called Competitive Supplements)

The submission of revision applications to P01 grants (Type 3) must be approved by NICHD program staff prior to acceptance for evaluation by a DSR review committee. Any program project supplement that would result in a total award that exceeds the relevant funding cap is not allowed. In addition, multiple component supplements submitted as one composite application are not allowed. Instead, each request for supplementing a component project or core should be submitted as a separate application.

The receipt dates for revision applications to P01 grants are January 25, May 24, and September 25.

Review of Resubmission Applications (formerly called Revised Applications)

Resubmission applications generally are reviewed by an NICHD SRG without site visit or applicant interview. In certain cases, the modifications to the original application may be significant enough (e.g., new investigators and/or new projects) to warrant a site visit. Determination of the need for a site visit in such cases will be made by DSR, in consultation with program staff.

The receipt dates for resubmission P01 applications are January 25, May 24, and September 25.

Review of Non-Competing Continuation Applications

After award, NICHD staff evaluate the program project on a yearly basis or more frequently, as necessary. The program director is encouraged to consult with staff regarding scientific or administrative issues, as appropriate.

The program director must submit annually an "Application for Continuation Grant" (Form PHS-2590) at least two months before the end of the grant year. This application (Type 5) should be prepared in accordance with the instructions provided with Form PHS-2590. In addition to a composite budget, detailed budgets should be prepared for each research component and for each core unit. The information requested in Appendix B of Form PHS-2590 may be displayed using sample formats shown in Tables I and II (Appendix I). A progress report should be submitted following the format and instructions contained in Form PHS-2590. In addition to the overall progress report for the program project, individual progress reports are required for each scientific project and core, not to exceed two pages per project or core. The Type 5 application is sent directly to NICHD's Grants Management Branch.

Because of the size and complexity, program project grants are monitored closely. If the quality of performance or status of a particular component of the program is in question, a staff field visit may be conducted. If problems are identified, staff may recommend that funding of a component of the program project be disallowed or be contingent upon peer review.

Other Considerations

Changes in Personnel

Institutions must notify NICHD staff immediately if a program director or principal investigator of a component research project or core unit plans to leave the institution or can no longer fill the day-to-day role prescribed in the grant award. The notification should include a proposal for disposition of the funds involved, either by discontinuing the relevant portion or by appointing a new individual.

If the institution plans to appoint a new principal investigator for a component research project or core unit, a letter of justification, co-signed by the responsible university official, and a curriculum vitae must be submitted to the Grants Management Branch, NICHD. The request will be reviewed by the program official and grants management staff and, if the qualifications of the proposed replacement are acceptable to the NICHD, the appointment will be authorized.

A change in the overall program director must be approved by the appropriate NICHD program official, grants management specialist, and center director.

Changes in Projects

An award authorizes expenditure of funds only for component research projects and core units reviewed through the competitive peer-review process. The addition of a new component research project or core unit requires competitive review of a supplemental application.

Transfer

Program project grants are not transferrable to other institutions. However, administrative actions such as organization name change, successor in interest, or mergers are usually acceptable.

Foreign Institutions

Program project grants to foreign institutions are not allowable.

Scientific/Administrative Overlap

Potential overlap of P01 subprojects with other current and/or pending applications must be addressed in the Other Support sections of the PHS 398 application, and should include plans for adjustment, as necessary. The simultaneous submission of an R01 and a P01 application for support of the same project is discouraged.

Notice of Grant Award

Conduct of the program project must comply with the terms and conditions as stated in Sections III and IV of the Notice of Grant Award.

APPENDIX I

FORMAT FOR NICHD P01 GRANT APPLICATIONS

Applications are submitted on Grant Application Form PHS-398 (most recent revision). All requested information should be provided in addition to the information indicated below.

In lieu of the Table of Contents outline presented on page 3 of Form PHS-398, a table of contents listing all of the major sections described in these guidelines should be prepared and paginated to enable reviewers to readily find specific information.

The Table of Contents will contain the headings outlined below in Section l--Specific Instructions, Section 2--Research Plan, and Section 3--Appendix. The following guidelines provide directions for preparing each page. Major areas to be listed and paginated in the Table of Contents are underlined.

SECTION I -- SPECIFIC INSTRUCTIONS

2. FACE PAGE

   Complete all items on the application's face page. This is page 1; number succeeding pages consecutively.

   On Line 2, please enter "NICHD P01 PROGRAM".

3. ABSTRACT OF RESEARCH PLAN

   On page 2, describe briefly the proposed research program, indicate the research emphasis of the component research projects, and identify the purpose of the proposed core units.

   List all key personnel engaged on the project. Use continuation pages as necessary, numbering consecutively.

4. TABLE OF CONTENTS

   Prepare the Table of Contents as noted above. The major areas to be listed are underlined in these instructions.

5. BUDGET ESTIMATES

   Prepare a series of composite budget tables for the P01 grant as requested below. A detailed budget is required for each component research project and each core unit.
    

   1. Composite Budget

      Use page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of Form PHS-398 to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment," etc., give the amount requested for each component research project and each core unit, with subtotals.

      If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.

      Use page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of Form PHS-398 to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual component research project and core unit budgets.

   2. Individual Component Research Projects and Core Budgets
       
   1. First year (use Page 4 of the PHS-398 for each)
   2. Total project period Years 2-5 (use Page 5 of the PHS-398 for each)

      Budget Justifications and Explanations: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For additional years of support requested, justify any significant increases or decreases in any category over the first 12-month budget period. Identify such changes with asterisks against the appropriate amounts. If a recurring annual increase in personnel or other costs is anticipated, give the percentage; however, current NIH practice limits escalation to 3%. In addition, for COMPETING CONTINUATION applications, justify any significant increases in any category over the current level of support.

      PLEASE NOTE: Consortium budgets (if applicable) should be presented as described in A, including budget for the entire proposed project period. Total direct and indirect costs of sub-awardee are to be shown under Consortium/Contractual costs on the individual component budget and a detailed sub-awardee budget is to be placed following the appropriate project/core budget.

6. SUMMARY OF OTHER SUPPORT

   Information for all current and pending research support of key personnel should be presented in tabular form (such as shown in the example presented in Table 1). Please indicate by an asterisk, research support that overlaps with projects proposed in the subject P01 application. For all key personnel named on page 2, except consultants, beginning with the program director and, thereafter, in alphabetical order, list separately: (1) current support; and (2) applications pending review and/or funding.

7. BIOGRAPHICAL SKETCH

   Biographical sketches are required for all key personnel participating in the component research projects and core units, corresponding to personnel listed on page 2. Begin with program director and thereafter, in alphabetical order, submit biographical sketches as described in the Instructions for Form PHS-398. Do not exceed four pages for each person.

8. RESOURCES

   Complete the "Resources" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

SECTION II- RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II.

Identify each component research project and each core unit by title. Assign each component research project a Roman numeral (I, II, III) and assign each core unit a capital letter (A, B, C) that reflects the order in which the research projects and core units are presented.

For each component research project and core unit, provide the name of the responsible investigator, and biographical sketches for personnel not identified previously.

2. INTRODUCTORY OVERVIEW
   
   1. History and Purpose of the Program.

      Discuss the program's objectives and general plans for the proposed grant period, including research grant history with yearly funding level.

   2. Administration, Organization, and Operation.

      Include information on the support and commitment of the parent institution for the program, the authority of the program director, the use of advisory committees, and space assignment. Describe organizational framework and provide an organizational chart.

   3. Publications.

      List publications prepared during current grant period (or the past five-year period) which report results of research supported by the grant.

   4. Assurances and Collaborative Agreements.

      Any arrangements for collaborative and cooperative endeavors or subcontracting should be highlighted. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a PHS-398 face page or other documentation, signed by the off-site institutional officials, must be submitted with the application.

3. RESEARCH PROGRAM

   Discuss the proposed research program, highlighting its central theme. List by title and investigator's name the component research projects and core units, showing the relationship between the projects and the core units and their relationship to the central theme.

4. RESEARCH PROJECT DESCRIPTIONS

   Identify each project by a Roman numeral (I, II, III...) and a title.

   A full description of each project is to be provided following the format presented in Form PHS-398. Include the following:

   Introductory Information

   1. Begin the presentation of each component research project on a separate page. Indicate:
      • Title of Project
      • Principal Investigator, title, affiliation
      • Other investigators, titles, affiliations
   2. Abstract of Research Plan (use page 2 of Form PHS-398)
       

   Research Project Plan (Do not exceed 25 pages for Sections A-D)

   Discuss the purpose and nature of the project and its relevance to the program's overall theme. Elaborate on:

   1. Specific Aims
   2. Background and Significance
   3. Preliminary studies and progress to date, if applicable. Indicate the research project's use of core units services, including why needed and the advantages and cost effectiveness of core unit usage for the project.
   4. Research Design and Methods
   5. Human Subjects (including gender and minority representation, and participation of children)
   6. Vertebrate Animals
   7. Literature Cited
   8. Consultants
   9. Collaborative Arrangements (include pertinent letters of assurance and collaboration). For off-site projects, justification should be provided for the project's location, and plans for interaction and cooperation with the other components of the program should be addressed.
   
   
5. CORE DESCRIPTIONS

   Identify each proposed core unit by a letter (A, B, C...) and a title (Administrative, Molecular/Cellular...). For each proposed core, address cost effectiveness and plans for quality control, as appropriate.
    

   Introduction

   Discuss each core's overall objectives; present the organizational framework or chart; highlight the decision-making process for use of core services and plans for quality control; and identify the proposed core units by title.

   Complete a summary table for the first year of the proposed grant by showing the quantitative use (percent) of each core unit by the component research projects presented in a format such as that suggested in Table II.

   Administrative Core Unit

   • Objective
   • Organizational chart (if appropriate)
   • Staffing (Professional and Support)
   • Resources: provide description of space and physical resources
   • Services Provided (current and projected use): describe services to other core units and research projects

   Overview of Each Research Core Unit

   • Objective
   • Staffing (Professional and Support)
   • Resources: provide description of space and physical resources
   •  Administration
   • Justification: describe services provided with their bearing on productivity and quality
   • Usage: Indicate past and/or current usage (e.g., assays performed, animals supplied, etc.) and list projects proposed for core usage

TABLE I

ALL CURRENT AND PENDING RESEARCH SUPPORT
OF PROFESSIONAL PERSONNEL
(SAMPLE FORMAT)

*Overlaps with proposed PO1 projects.

TABLE II
QUANTITATIVE USE OF CORE UNITS BY COMPONENT RESEARCH PROJECTS
(SAMPLE FORMAT)

APPENDIX II
GUIDELINES FOR REVIEWERS COMMENTS

Each reviewer has been assigned to prepare written comments on one or more component projects and/or core units and/or the overall program project critique (see Tentative Assignment List). All reviewers should prepare their written comments in advance of the review meeting according to the format presented below. You are encouraged to be concise in your comments, and to focus on the main strengths and weaknesses of the application, providing appropriate examples, rather than attempting to enumerate every strength and weakness or discuss every experiment proposed. Suggested approximate page lengths for each section are indicated in the instructions that follow.

The following are general instructions for preparing your written reports:
 

1. The Overall Description section of the site visit report/summary statement will be prepared by NICHD staff using the applicant's description. Component Project/Core Descriptions are optional but, if written, they should be very brief.
2. Except for the section on PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR, separate Investigator sections are not needed; evaluative comments about the individual project/core investigators should be included in the Critique under the "Investigators" review criterion.
3. The first time any discipline-specific or unusual abbreviation is used, spell out the full word(s) to which it applies.
4. Although your specific assignments are identified on the Tentative Assignment List, you may submit additional comments about any aspect of the application. 
5. Your review comments should be typewritten double-spaced to facilitate modifications and additions reflecting changes in your opinion following discussions during the review committee meeting. Please bring hard copies of your reviews with you to the site visit/review meeting or fax or E-mail your reviews to the Scientific Review Administrator (SRA) prior to teleconference calls. 
6. Please submit your reviews on a formatted diskette, as provided. Save each project/core review as a separate file. Use only standard keyboard characters in your review; please do NOT use any Greek letters, special fonts (i.e., italics or bold), or special formatting in your review, since these are incompatible with the process that staff must use to upload the final summary statement into the NIH mainframe computer. Please put your name on the diskette, and identify the computer type (IBM or Macintosh) and the word processing program/version used.

The SRA will provide specific instructions for the use of E-mail to submit reviews.

SUMMARY STATEMENT COMPONENTS

RESUME: This section is intended to provide a brief overview of the proposed program project and the reviewers' final evaluation and recommendation of the application as a whole. The Resume should consist of a brief summary of the program's central theme and major components (one or two sentences). This should be followed by two or three sentences indicating the scientific disciplines involved, the number of projects and core units proposed, and the level of merit of each of the components (for site visit reports, the level of merit is expressed as a descriptor; for summary statements, the individual component scores should be reported). Finally, the general quality of the program project should be summarized, including the main strengths and weaknesses, the adequacy of the program leadership, and synergy among the projects. The section should conclude with the committee's recommendation, including any recommended changes in budget and/or duration. For site visit reports only, the recommendation will be expressed as a descriptor.

BACKGROUND: The Background section is needed only for revised or competing continuation applications. It should be brief and contain only those points regarding the history of the program or of the application which are relevant to the current review (e.g., changes in scientific direction, staffing, etc.).

OVERALL DESCRIPTION: You do not need to prepare an Overall Description.

PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR: In one paragraph, evaluate the strengths and weaknesses of the Program Director (PD) as a scientist and as director of the proposed program of research. For competing continuations, also evaluate the PD's performance in this role during the previous funding period. DO NOT include descriptive, biographical information unless required for the evaluation of merit.
 
REVIEWS OF INDIVIDUAL PROJECTS AND CORES

For each project or core component to which you are assigned, please prepare a double-spaced draft of the Critique and other required sections, and address administrative considerations as necessary.

During the course of the review, reviewers have the responsibility to incorporate new information from the applicants and to modify their written comments as needed to reflect their final opinions after discussion. The opinions and written reports of all reviewers are valued and will contribute to the final site visit report/summary statement which is usually compiled by the primary reviewer.

Your unedited, verbatim comments will be incorporated into the site visit report/summary statement.

INDIVIDUAL RESEARCH PROJECTS

Description: (Optional; if written, confine to 2-3 sentences) Succinctly summarize the main goals of the project. Significant changes from the originally stated goals, as reflected in late arriving material or applicant presentations during a site visit, should be summarized.

Critique: (Up to 2-3 pages, depending on the complexity of the project) The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In your written review, you should comment on the following aspects of each project in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.

Address each of the following five review criteria under separate subheadings, considering progress and/or preliminary data and, for amended applications, changes made to the application in response to the previous critique, as appropriate under each criterion:

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?

Approach: Are the conceptual framework, design (including composition of study population), 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?

Investigators: Is the principal investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? DO NOT INCLUDE descriptive biographical information unless important to the evaluation of merit.

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? DO NOT INCLUDE description of available facilities or equipment unless important to the evaluation of merit.

(NOTE: Although the Environment for each project includes the other components of the Program Project as a whole, insofar as possible, evaluate the merit of each project individually. Synergy among the projects and cores should be addressed in the "Overall Critique" described below.)

Overall Evaluation: (One paragraph) Summarize the main strengths and weaknesses of the project in terms of the five review criteria. Recommend a score reflecting the overall impact that the project could have on the field, weighting the review criteria as you feel appropriate for each project. The emphasis or weight placed on each criterion may vary from one project to another, depending on the nature of the project and its particular strengths. Note that the project does not need to be strong in all categories to be judged likely to have a major scientific impact and, thus, have high merit. 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.

Other Considerations:

For detailed information on evaluating the following sections, see NIH policy and guidance for review of applications proposing use of human subjects, available at http://grants.nih.gov/grants/peer/hs_review_inst.pdf

Gender and Minorities in Clinical Research: Unless compelling justification is provided, studies involving human subjects must include appropriate representation of women and minorities. Plans to address this issue should be evaluated in a separate note at the end of the relevant project. Determine whether the research is a Phase III Clinical Trial and whether the minority and gender characteristics of the sample are scientifically acceptable and consistent with the aims of the project. Following discussion by the site visit team/review committee, each project (and the overall application) must ultimately be assigned a gender code and a minority code, according to the following categories:
 

Evaluate whether the gender and minority characteristics of the sample are scientifically acceptable (A) or unacceptable (U) and consistent with the aims of the project. If you rate the sample as unacceptable, consider this feature a weakness or deficiency in the design of the project, address the deficiencies under the Approach criterion, and factor it into the overall merit rating of the project. (Further information and instructions on the assignment of gender and minority codes are provided in a separate handout).

Participation of Children: Evaluate the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. If you rate the plans for inclusion or the justification for exclusion unacceptable (U), consider this a weakness or deficiency in the design of the project and factor it into the overall merit rating of the project.

Following discussion by the site visit team/review committee, each project (and the overall application) must ultimately be assigned a three-character code, according to the following categories:

For any of these categories, the plan may be rated Acceptable (A) or Unacceptable (U). (Further information and instructions on the assignment of codes for participation of children are provided separately.)

Human Subjects: If Exemptions Claimed, express any comments or concerns about the appropriateness of the exemption(s) claimed (e.g., for Exemption 4, is it clear that the information will be recorded by the investigator so that subjects cannot be identified directly or indirectly?) If No Exemptions Claimed, express any comments or concerns about the appropriateness of the responses to the four required points, especially whether the risks to subjects are reasonable in relation to the anticipated benefits to the subjects and in relation to the importance of the knowledge that reasonably may be expected to result from the research. This section is not required if there are no comments or concerns.

Animal Welfare: Express any comments or concerns about the appropriateness of the responses to the five required points, especially whether the procedures will be limited to those that are unavoidable in the conduct of scientifically sound research. This section is not required if there are no comments or concerns.

Biohazards: Note any materials or procedures that are potentially hazardous to research personnel and/or the environment and indicate whether the protection proposed will be adequate.

Budget: Evaluate direct costs only. For all years, determine whether all items of the budget are appropriate and justified for the work proposed. The narrative should include all recommended changes for the first and subsequent years, with detailed rationale for each specific change recommended. For supplemental applications, comment on the requested budget in relation to the parent grant. This section is not needed if no changes are recommended.

Recommendation: Indicate the final recommendation for the project (level of scientific merit /not recommended for further consideration). Site visit teams making recommendations to a parent committee will use descriptor terms. Scores will be assigned at the review committee meeting.

Minority Report: A minority report will be required for a project, core, or the final recommendation for the overall program project whenever two or more reviewers vote in opposition to a motion which is passed. The Chairperson will assign a member of the minority to write the report.

Administrative Considerations

These comments are useful to NICHD, but should not influence your score. They will be included as Administrative Notes in the summary statement.

1. Overlap:
   Identify any apparent scientific or budgetary overlap with active or pending support.

   NOTE: POTENTIAL OVERLAP WILL BE DEALT WITH ADMINISTRATIVELY. REVIEWERS SHOULD NOT ADJUST THE BUDGET OR THE MERIT EVALUATION TO ADDRESS THE PERCEIVED OVERLAP.

2. Foreign Component Project:
   If the component project is to be carried out at a foreign institution, comment on any special talents, resources, populations, or environmental conditions that are not readily available in the United States or that provide augmentation to existing U.S. resources. In addition, indicate whether similar research is being performed in the U.S. and whether there is a need for such additional research. These factors do not apply to projects at U.S. institutions containing a significant foreign component.

CORE UNITS

Description: (Optional; if written, confine to 2-3 sentences) Briefly summarize the major functions of the core. Summarize any significant changes from originally stated goals as reflected in late arriving material or applicant presentations during a site visit.

Critique: (1-2 pages, as appropriate for the complexity of the Core)

Each core unit must provide facilities or services for at least three research projects in the program at all times during the grant period. The Critique should address:

• Qualifications, experience, and commitment of the core director and other core personnel.
• The quality of services provided.
• The cost effectiveness and quality control of the core.
• The utility of the core to the program.
• For the Administrative Core, the following issues should also be addressed:
• The core director's experience in research administration.
• The decision-making process within the proposed program project for the evaluation of research productivity, allocation of funds, and management of the resources.
• The plan for program project evaluation, including the use of any internal and external advisory groups.

Reviewers should also prepare Budget and Overall Evaluation sections for each assigned Core Component, and address Overlap, Human Subjects, Animal Welfare, Hazardous Conditions, Participation of Children, and Gender and Minority issues, as appropriate.

A Recommendation should also be prepared. Please note that Core Units should not receive a numerical score unless there is substantial scientific content to evaluate.

OVERALL CRITIQUE: (Limit to 2-4 pages; prepared by Chairperson or Designated Reviewer)

The Overall Critique should convey the overall level of quality of the program project and should contain the following sections:

1. First, the Overall Critique should address the program as an integrated effort. This section should briefly describe and evaluate:
   
   
   • The coordination, interrelationships, cohesiveness, and synergy among the meritorious research projects and core components as they relate to the common theme of the program project;
   • The advantages of conducting the proposed research as a program rather than through separate research efforts;
   • The mechanisms proposed for regular communication and coordination among investigators in the program, and;
   • The appropriateness of administrative structures and day-to-day management of the program.
     
     
2. Second, the Overall Critique should address the overall merit of the program. Although individual subheadings are not required, use the following review criteria as a framework for the this section of the Overall Critique: 

Significance of the program overall and its potential to advance scientific knowledge in the field.

Approach: Adequacy and quality of the experimental approaches proposed in the projects and the overall design of the program project.

Innovation: Degree to which the overall program applies novel concepts and innovative approaches, represents novel collaborations, etc.

Investigators: Qualifications of the Principal Investigator, the program leadership, and individual project and core directors.

Environment: Scientific, organizational/institutional, and administrative environment of the program.
 

Each of these aspects should be addressed and considered in assigning the overall merit rating for the application as a whole, weighting them as appropriate for each program project application. Note that the application as a whole (as well as each individual project) does not need to be strong in all categories to be judged likely to have a major scientific impact and, thus, deserving of a high merit rating.

INCLUSION OF WOMEN AND MINORITIES: Provide a brief summary of the reasons for the codes assigned to the overall application. The application cannot be assigned codes that are more acceptable than the least acceptable codes assigned to any project or core.

PARTICIPATION OF CHILDREN: Provide a brief summary of the reasons for the code assigned to the overall application. The application cannot be assigned a code that is more acceptable than the least acceptable code assigned to any project or core.