Table of Contents

Introduction
The P50 Funding Mechanism
Eligibility Requirements
Allowable Budgetary Items and Supportable Activities
Application Preparation
Application Submission
Review Procedures
Overview
Review of New Applications
Review of Competing Continuation (Renewal) Applications
Review of Applications for Competitive Supplements
Review of Non-Competing Continuation Applications
Other Considerations
Meetings of Center Directors
Changes in Personnel
Changes in Projects
Appendix I - Format for NICHD Specialized Research Center (P50) Grant Applications
Table I - All Current and Pending Research Support of Professional Personnel
Table II - Quantitative Use of Core Units by Component Research Projects
Appendix II - Guidelines for Reviewers’ Comments and Review Criteria

Introduction

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides funding for a limited number of research centers in several specific areas of the NICHD mission. The centers are broadly based investigative endeavors, encompassing research of a biological, biomedical, behavioral, social science, demographic, and/or epidemiological nature. They are supported through several National Institutes of Health (NIH) center grant mechanisms, including the Specialized Research Center (P50) Grant.

These centers are a national resource. They form networks that foster communication, innovation, and high-quality research in a particular area of science. They also provide a stimulating, multidisciplinary environment that attracts both established and promising new investigators. As a participant in a center network, each center works closely with NICHD staff to carry out its objectives in a manner consistent with Institute goals and mission.

This document provides information on NIH/NICHD policies and procedures relevant to NICHD Specialized Research Center (P50) Grants, and is intended for both applicants and peer reviewers.

It is important to note that each NICHD P50 Centers program may have special requirements that go beyond these general guidelines. These requirements are described in the originating Request for Applications (RFA). Applicants are encouraged to consult with appropriate NICHD staff, listed in the relevant RFA, to become familiar with these additional, program-specific requirements.

The P50 Funding Mechanism

The Specialized Research Center Grant (P50) is an institutional award, made in the name of a Center Director (i.e., the Principal Investigator), for the support of a large, interrelated research program, focused on a specific problem. It is awarded competitively, initially for not less than five years, and may be renewed for five-year periods. A P50 grant provides support for both research projects and the core support services used by those projects. The activities included in the supported research comprise a multidisciplinary approach to the biological, biomedical, behavioral, demographic, social, and/or epidemiological problems characterizing a specific research area.

NICHD P50 center grants are funded only in response to a specific RFA; unsolicited applications for new or competing continuation P50 grants will not be accepted.

NICHD will not support more than one center grant in a given department or specialty unit, regardless of the grant mechanism (i.e., P30, P50, U54, etc.).

Eligibility Requirements

In addition to meeting the standard eligibility criteria for research grants specified in the National Institutes of Health Grants Policy Statement (March 2001, http://grants.nih.gov/grants/policy/nihgps_2001/, a P50 grant application must have a strong, well-established research base. The proposed research program must include three or more related, integrated, and high-quality research projects that provide a multi-disciplinary, yet unified, approach to the problems to be investigated.

Scientific personnel and institutional resources capable of providing a strong research base in the field specified must be available. A strong institutional commitment also must be demonstrated. The commitment may take the form of faculty appointments for investigators, purchase of research equipment, or assignment of research space to facilitate collaborative research and interdisciplinary interaction.

Allowable Budgetary Items and Supportable Activities

Allowable costs in NIH grants are governed by rules set forth in the National Institutes of Health Grants Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise stated in the relevant RFA and/or the Notice of Grant Award. Under these rules, the Center Director of a P50 center may exercise flexibility to meet unexpected center requirements by rebudgeting or requesting approval to rebudget among budget categories, within the total direct cost budget of a project or core unit (as shown on the Notice of Grant Award).

The following NICHD guidelines also affect cost allowability.

Items fundable under an NICHD P50 grant include:

• Direct support of individual research projects.

• Core facilities used by these research projects.

• Salaries and support for a limited number of administrative and clerical personnel, such as the Center Director, Center Administrator, secretaries, and clerical support staff. The criteria defined under revised OMB Circular A-21 will be used by NICHD staff to determine allowability of direct charging of administrative and clerical support staff.

• Administrative support services, including supplies, duplication, telephone, and maintenance contracts for equipment when not covered by institutional Facilities and Administrative (overhead) charges.

• At the discretion of the NICHD Center Program, and as described in the relevant RFA, travel to one Center Directors' and Administrators' meeting annually to confer with other NICHD Center Directors and Administrators or to visit other center facilities pursuant to the administration of the center.

• Travel of Center Director and other investigators to scientific meetings.

• Travel of technical staff for training that would enhance the quality of the research projects supported by the P50 grant.

• Seminars or meetings designed to promote interdisciplinary interaction, education, or center cohesiveness.

• Consultants providing specific scientific and/or technical support to center projects or cores.

• Costs related to internal program advisory committee meetings.

Items not fundable under an NICHD P50 grant include:

• Salary and support for central institutional administrative personnel usually paid from institutional Facilities and Administrative (overhead) charges, such as budget officers, grants assistants, and building maintenance personnel.

• Salary and support for administrative activities such as public relations, or health or educational services unrelated to the research carried out under the grant.
  
  

Application Preparation

Applications for a new or competing continuation NICHD P50 grant will be accepted for review only if they are submitted in response to an NICHD RFA. Interested prospective applicants are encouraged to consult with NICHD program staff identified in the RFA prior to preparing an application. Specific application guidelines may be outlined in the RFA.

P50 center 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, on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the 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 need to be modified and expanded to provide the additional information required for a P50. To ensure that essential information is provided in a systematic fashion, all applications should be submitted in a format such as that outlined in Appendix I. Because the P50 application requests funds for direct research support, each project must be presented in as much detail as if it were a request for an R01, within PHS 398 page limitations.

See Appendix I for detailed application instructions.

Application Submission

With the exception of non-competing (Type 5) applications, all P50 applications are submitted to the NIH Center for Scientific Review (CSR). These include new (Type 1), competing continuation (Type 2), and supplemental (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 NICHD 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).

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

The receipt dates for new or competing continuation applications are specified in the relevant RFA.

The receipt dates for supplemental applications are February 1, June 1, and October 1.

Applications must be received by CSR on or before the due date specified in the RFA. Late applications will not be accepted. In addition, applications must be complete to be considered timely.

Review Procedures

Overview

All competing P50 applications are submitted by an institution, in the name of a Center Director, to the CSR. These include new applications (Type 1), competing continuation applications (Type 2), and supplemental applications (Type 3).

Competing applications (new and continuation) are assigned to a scientific review group for evaluation of scientific and technical merit. The National Advisory Child Health and Human Development Council provides a second-level review.

Non-competing continuation applications (Type 5), submitted annually after funding, are reviewed by NICHD staff.

A P50 application is judged both for the scientific merit of the research and for its relevance to the Institute's program priorities. Initial peer review of P50 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. Each subcommittee includes approximately 10-18 scientists and is staffed by a Scientific Review Administrator (SRA) and a Grants Technical Assistant (GTA). P50 applications will be reviewed either by one of the standing subcommittees or by a SEP, as appropriate. P50 applications may not be reviewed by a subcommittee which has as a member an applicant investigator or collaborator.

All applications submitted in response to an RFA will be reviewed together by a single review group.

From the time an application is submitted to NIH until review is completed, all communications from the applicant should be directed to the assigned SRA, rather than to program staff. During the review process, NICHD grants management staff may be in direct communication with the applicant for budgetary and fiscal information.

Review of New Applications

Upon receipt in NICHD, an administrative review of the application is performed by the SRA, program staff, and grants management staff for conformance to NIH policy and NICHD guidelines, responsiveness to the RFA, and relevance to NICHD program interests. If the application fails to comply with NIH policy and guidelines or is determined to be nonresponsive to the RFA, it is returned to the applicant without further consideration.

The SRA may send the application to selected members of the Institute's initial review committee for their evaluation to determine if a site visit is needed. A site visit is not a prerequisite, however, for consideration of an application by an NICHD review committee.

1. Preliminary Review of Applications

   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 in the context of the applications submitted in response to the RFA. Only those applications deemed competitive will be subjected to an in-depth review. Reviewers also may be asked to carry out a preliminary review to determine which applications require a site visit prior to SRG review.

2. Site Visits

   A site visit is not a prerequisite for consideration of any application by an NICHD review committee. Although a site visit may be considered, site visits will not be conducted for most applications. The applicant should not rely on a site visit to supplement or improve an incompletely written application.

   The plans for site visits in the review of a particular P50 Center may be addressed in the relevant RFA. Final decisions about whether or not a site visit will be held are made by DSR. If a site visit is planned, the Center Director will be contacted by the SRA managing the review and detailed site visit procedures will be provided.

3. Scientific Review Group Evaluation

   The SRG considers the full application and, if a site visit has taken place, the site-visit report at its scheduled meeting. Each application is considered independently. If there has been a site visit, 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; or 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.

   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 center as an integrated effort and the overall merit of the center. (The full scope of reviewer considerations is described in Appendix II. These criteria may be enhanced by additional criteria outlined in the relevant RFA.)

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

   • A five-year total project period is required.
   • 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 five-year grant period.
   • Each core unit must serve as a resource for at least three research projects at all times during the five-year 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 one of the following descriptor terms indicating its assessment of the degree of scientific and technical merit based on the criteria outlined in Appendix II and in the RFA, if applicable:

   
   
   

   Outstanding	(1.0 - 1.5)
   Excellent	(1.5 - 2.0)
   Very Good	(2.0 - 3.0)
   Good	(3.0 - 4.0)
   Acceptable	(4.0 - 5.0)
   Not Recommended for Further Consideration	(NRFC)

   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 the distribution of priority scores. The streamlined review process is not used by NICHD in the review of P50 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 and relevant RFA).

   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 and relevant RFA). The administrative core will either be recommended favorably or not recommended, with no descriptor.

   For the overall program, reviewers will assign a priority score or recommend no further consideration based on assessment of the entire application (including all proposed projects and cores, including any not recommended for further consideration), in terms of the review criteria specified for the overall center (Appendix II and relevant RFA). The resulting priority score for the overall P50 center grant application will reflect reviewers' assessment of the scientific and technical merit of the proposed center. 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 detailed in Appendix II and in the relevant RFA.

   After the review committee has acted, the SRA will prepare a summary statement. The summary statement will indicate the recommendation, the priority score for those applications recommended for further consideration, and, for each project year, the requested and the recommended budgets. The text will contain a resume of the application and the recommendations. This is followed by a summary description and critiques of the scientific merit of the program and its research projects and core units, including all budgetary requests; a commentary on the qualifications of the Principal Investigators and other key professional personnel; an evaluation of the environment and facilities; the strengths and weaknesses of the application, including the research projects and core units; and the SRG's recommendations, including priority scores assigned to individual projects and cores. A copy of the summary statement is sent to the Center Director.

4. Advisory Council Review

   A second-level review of applications submitted in response to an RFA is provided by the National Advisory Child Health and Human Development Council. The Council votes concurrence or non-concurrence with the recommendations of the SRG as described in the summary statement, including the priority score. The Council does not evaluate the scientific and technical merit of applications, but focuses on matters pertaining to budget, program relevance, and the adequacy of the initial review. After Council consideration, applications in response to an RFA are forwarded to the Institute Director for funding decisions.

Review of Competing Continuation (Renewal) Applications

NICHD support for a center may not exceed five years without submission and peer review of a competing application. The grantee institution must submit a competing continuation application (Type 2) to request support beyond the current project period. Submission of a competing continuation application may only be in response to an RFA. Plans to submit a Type 2 application should be discussed with NICHD staff listed in the RFA. Competing continuation applications are reviewed in the same manner as new applications, including administrative review by NICHD program staff for conformance to NIH policy, RFA requirements, and program relevance, evaluation by an NICHD SRG, and a second-level review by the Institute's Advisory Council. Receipt and review dates are specified in the RFA.

In the application, any significant increase in budget over the current level of support must be justified.

In addition to the review criteria applied to new applications, reviewers will evaluate the progress made by a center in the previous funding period, with emphasis on the achievement of specific aims outlined in the previously funded application.

Review of Applications for Competitive Supplements

The submission of all applications for competitive supplements to P50 grants (Type 3) must be approved by NICHD program staff prior to acceptance for evaluation by a DSR scientific review group. Any center supplement that potentially results in a total award that exceeds the funding cap specified in the original RFA is not allowed. In addition, multiple component supplements submitted as one composite application will not be accepted. Instead, each request for supplementing a component project or core should be submitted as a separate application.

The receipt dates for applications for P50 competitive supplements are February 1, June 1, and October 1.

Review of Non-Competing Continuation Applications

After award, NICHD staff will evaluate the center program on a yearly basis or more frequently, as necessary. The Center Director should feel free to consult with staff regarding scientific or administrative issues, as appropriate.

The Center Director must submit annually an "Application for Continuation Grant" (Form PHS 2590) at least two months before the end of the grant year. PHS 2590 may be obtained on the Internet at http://grants.nih.gov/grants/funding/2590/2590.htm. The 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.

Because of their size and complexity, center grants are monitored closely. If the quality of performance or status of a particular component of the program is in doubt, a staff field visit may be conducted. If serious problems are found, NICHD staff may recommend that funding of a component of the center's program be disallowed or be contingent upon peer review.

Other Considerations

Meetings of Center Directors

To promote the sharing of common concerns and research opportunities within the network of each type of NICHD center program, the Center Directors of a centers program may meet annually. The meetings include reports on research of special interest, and discussions of research and administrative problems.

Changes in Personnel

A change in the Center Director of a P50 grant must be approved by the NICHD program official for the relevant NICHD centers program. Institutions are required to notify the Grants Management Branch, NICHD, if a Center Director or Principal Investigator of a research project or core unit plans to relinquish his/her day-to-day functions prescribed in the grant award. The notification should include a proposed plan from the institution for disposing of or transferring the funds involved, either by discontinuing the relevant portion of the grant or by appointing a new individual.

If a new individual is to be appointed as Principal Investigator for a research project or core unit supported by the NICHD center grant, a letter of justification for the appointment, co-signed by the responsible university official, and a curriculum vitae must be submitted to NICHD. The request is reviewed by program staff and, if the qualifications of the proposed replacement are acceptable to NICHD, the appointment will be authorized.

Changes in Projects

Award of an NICHD center grant authorizes expenditure of funds only for those component research projects and core units reviewed and approved through the competitive peer review process. The addition of a new research project or core unit to the center requires competitive review.

APPENDIX I

FORMAT FOR NICHD SPECIALIZED RESEARCH CENTER (P50) GRANT APPLICATIONS

Applications are submitted on Form PHS 398 (http://grants.nih.gov/grants/funding/phs398/phs398.html). All instructions and guidelines accompanying the PHS 398 are to be followed, with the exception of the sections modified by the specific instructions described below:

In lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a table of contents should be prepared listing all of the major sections described below and paginated to enable reviewers to find specific information readily.

The Table of Contents should contain the types of information suggested below: Section I - General Information, Section II - Research Plan, and Section III - Appendix. The following guidelines will provide directions and descriptions for preparing each section. Major areas to be listed and paginated in the Table of Contents are underlined.

SECTION I - GENERAL INFORMATION

1. FACE PAGE

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

   On line 2, enter the appropriate Request for Applications (RFA) number and title, and mark the YES box.

2. DESCRIPTION AND PERSONNEL

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

   List key scientific and technical personnel participating in the specialized research center. Use continuation pages as necessary, numbering consecutively.

3. TABLE OF CONTENTS

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

4. BUDGET ESTIMATES

   Prepare a series of composite budget tables for the Specialized Research Center Grant as requested below. A separate detailed budget is required for each research project and for each core unit.

   1. Composite Budget

      Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of the PHS 398 to present the total direct cost budget for all requested support for the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc., list the amount requested for each research project and for each core unit.

      If consortium arrangements have been made involving other institutions or organizations, include total costs [(direct and Facilities and Administrative (F & A)] associated with such third party participation in the "CONSORTIUM/CONTRACTUAL COSTS" category. Costs for purchased services should be itemized under "OTHER EXPENSES."

      Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of the PHS 398 to prepare a budget, by category, that provides direct cost totals for each year of requested support.

   2. Individual Project and Core Budgets
      1. First year (use Form Page 4 of PHS 398 for each)
      2. Total project period (use Form Page 5 of PHS 398 for each)

   Consortium Budgets (if applicable) should be presented as described in Item 1 (Composite Budget), including budget for the entire proposed project period. Total Direct and F & A costs of sub-awardee are to be shown under "CONSORTIUM/CONTRACTUAL COSTS" on individual research project or core budget and a detailed consortium budget is to be inserted following the appropriate research project or core budget.

   Budget Justifications: Describe the specific functions of key scientific and technical personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For future years of support requested, justify any significant increases in any category over the first 12-month budget period. Identify such significant increases with asterisks against the appropriate amounts. If a recurring annual increase in "PERSONNEL" or "OTHER EXPENSES" is anticipated, give the percentage. However, current NIH practice limits escalation to 3 percent. In addition, for Competing Continuation applications, justify any significant increases in any category over the current level of support.

5. BIOGRAPHICAL SKETCH

   Biographical sketches are required for all key scientific and technical personnel participating in the research projects and core units as listed on Form Page 2.

   Beginning with the Center Director, and following in alphabetical order, submit biographical sketches as described in the "Instruction Sheet for Form PHS-398." Do not exceed four pages for each person.

6. SUMMARY OF OTHER SUPPORT

   Information regarding active and pending research support of all key scientific and technical personnel named on Form Page 2 (except consultants) should be presented in a format such as that suggested in Table I, below, beginning with Center Director and listed thereafter in alphabetical order. Identify other support in the following categories:

   1. Current Active Support; and
   2. Applications Pending Review or Funding.

   This table is in lieu of the "OTHER SUPPORT" Form Page in PHS 398.

7. RESOURCES

   Complete the "RESOURCES" section on Form Page 8 of PHS 398 for the overall center. 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. Use continuation pages as needed.

SECTION II - RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II. Identify each research project or core unit by title, and assign each research project a number (I, II, III) and each core unit a capital letter (A,B,C) that reflects the order in which the research projects and core units are presented in the application research plan. For each research project and core unit, provide the name of the Principal Investigator or Core Director, and biographical sketches for personnel not identified previously.

1. INTRODUCTORY OVERVIEW

   Although there is no page limitation for this section, applicants are encouraged to present a concise and succinct overview.

   1. History, Purpose, and Objectives of the Center. Discuss the philosophy and objectives of the center and general plans for the proposed grant period.
   2. Administration, Organization, and Operation of the Center. Include information on the support and commitment of the parent institution for the center, the authority of the Center Director, the use of advisory committees, and the method of determining core access and space assignment. Describe organizational framework and provide an organizational chart.
   3. Publications. List publications prepared during the past five-year period or, for competing continuation applications, during the current grant period.
   4. Assurances and Collaborative Agreements. Any arrangements for collaborative and cooperative endeavors or subcontracting should be highlighted. Letters of Intent to Collaborate and Letters of Agreement from consultants should be referenced here and included at the end of the appropriate research project or core unit.
   
   
2. PROGRESS REPORT - as required in Form PHS 398.
   
   
3. RESEARCH PROJECT DESCRIPTION

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

   For each component research project, a full description of the project is to be provided following the format presented in Form PHS 398. Include the following information:

   1. Introductory Information
      1. Begin the presentation of each component research project on a separate page. Indicate:
         • Project Title
         • Principal Investigator, title, location
         • Other investigators, consultants, and collaborators, titles (associate professor, postdoctoral fellow, student), location
      2. Abstract of Research Plan (use Form Page 2 of PHS 398)
         
   2. 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 application's overall theme. Address the following:

      1. Specific Aims
      2. Significance
      3. Preliminary Studies and/or progress to date (for competing continuations), if applicable. Describe the research project's use of core unit services, including need for the services, and the advantages and cost effectiveness of core unit usage for the project.
      4. Research Design and Methods. For research involving human subjects, this section must address the inclusion of women, minorities and their subgroups, and children as research subjects, following relevant policy announcements (see RFA for references).
      5. Human Subjects
      6. Vertebrate Animals
      7. Consultants
      8. Collaborative arrangements, including pertinent letters of assurance and intent.
      9. Literature Cited
         
         
4. 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.

   1. Introduction

      Discuss the overall objectives of each core unit; present the organizational framework or chart; highlight the decision-making process for use of core unit services described; present 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, below.

   2. Administrative Core Unit
      1. Objective
      2. Organizational Chart
      3. Staffing: Description of key professional and support staff functions
      4. Resources: Description of space and physical resources
      5. Services Provided: Describe current and projected services to other core units and research projects, and the center as a whole.
      
      
   3. Research Core Units
      1. Objective
      2. Staffing: Brief description of scientific, technical, as well as support staff functions.
      3. Resources: Description of space and physical resources.
      4. Administration: Description of overall management of the research core unit.
      5. Justification: Description of services provided and their bearing on productivity and quality, as well as documentation of cost-effectiveness and quality control.
      6. Utilization: Indicate past and/or current usage (e.g., assays performed, animals supplied, etc.) and list projects proposed for core usage, identified by full title, such as displayed in sample format shown in Table II.
      7. If core service involves human subjects (e.g., recruitment; screening), discuss the inclusion of women, minorities and their subgroups, and children as research subjects, following relevant policy announcements (see RFA for references).
      
      
5. ACCOMPLISHMENTS OF CENTER NOT PREVIOUSLY CITED
   1. Results of completed research projects not previously included (competing continuation only).
   2. Use of administrative funds by Center Director for activities such as consultant services, scientific seminars, renovations, or travel (competing continuation only).
   3. Training activities in the center:
      1. Previous trainees, preceptors, present positions
      2. Current trainees, preceptors, research topics
   4. Investigators attracted to the field by this specialized research center grant and its facilities:
      1. New investigators
      2. Visiting investigators
   5. Impact on institution and community
   6. Role of center in facilitating research, assisting young investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research.
   7. Other
   
   
6. CHECKLIST - As required in Form PHS 398

SECTION III - APPENDIX

Include materials as appropriate (see PHS 398)

The following tables provide sample formats for the requested Other Support and Core Usage information:

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

*Overlaps with proposed P50 projects.

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

APPENDIX II
GUIDELINES FOR REVIEWERS’ COMMENTS AND REVIEW CRITERIA

Each reviewer has been assigned to prepare written comments on one or more component projects and/or core units and/or the overall center grant application 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:

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.

Except for the section on CENTER 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.

The first time any discipline-specific or unusual abbreviation is used, spell out the full word(s) to which it applies.

Although your specific assignments are identified on the Tentative Assignment List, you may submit additional comments about any aspect of the application. 

Please consider evaluation criteria that may be specified in the relevant RFA that must be addressed in addition to the standard criteria specified below.

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. 

Please submit your reviews on a formatted diskette, as provided, unless otherwise instructed by the SRA. 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 center program and the reviewers' final evaluation and recommendation of the application as a whole. The Resume should consist of a brief summary of the application'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 center grant application should be summarized, including the main strengths and weaknesses, the adequacy of the center 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 center or of the application that 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.

CENTER DIRECTOR: In one paragraph, evaluate the strengths and weaknesses of the Center Director as a scientist and as director of the proposed center. For competing continuation applications, also evaluate the Center Director’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 that is usually compiled by the primary reviewer for a component.

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

INDIVIDUAL RESEARCH PROJECTS

Description (Optional; if written, limit 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 (for competing continuation applications) 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 center 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.)

RFA-Specific Criteria: Address any additional evaluation criteria for individual projects specified in the relevant RFA.

Overall Evaluation: (One paragraph) Summarize the main strengths and weaknesses of the project in terms of the 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.

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 document).

Participation of Children: Evaluate the adequacy of plans for inclusion of children as appropriate for the scientific goals of the research, or the adequacy of the 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 required 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 center grant application 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.

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 PERCEIVED OVERLAP.  

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, limit 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 center at all times during the grant period.

The Critique for all cores 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 center;

For the Administrative Core, the following issues also should be addressed:

• The core director's experience in research administration;

• The decision-making process within the proposed center for the evaluation of research productivity, allocation of funds, and management of the resources;  

• The plan for center evaluation, including the use of any internal and external advisory groups.

RFA-Specific Criteria: Address any additional evaluation criteria for cores specified in the relevant RFA.

Reviewers also should 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 also should 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 merit of the center grant application and should contain the following sections:

First, the Overall Critique should address the center as an integrated effort. This section should briefly describe and evaluate:

• The coordination, interrelationships, cohesiveness, and synergy among the research projects and core components as they relate to the common theme of the center;

• The multidisciplinary scope of the center’s research program;  

• 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 center; and  

• The appropriateness of administrative structures and day-to-day management of the center, including arrangements for internal quality control of ongoing research.

Second, the Overall Critique should address the overall merit of the program, including comments on the progress made during the previous funding period for competing continuation applications.

Although individual subheadings are not required, use the following review criteria as a framework for this section of the Overall Critique: 

Significance of the center’s 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 center.

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

Investigators: Qualifications of the Center Director, the center leadership, and individual project and core directors.

Environment: Scientific, organizational/institutional, and administrative environment of the program, including institutional commitment to the center.

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 center grant 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.

RFA-Specific Criteria: Address any additional evaluation criteria for the overall program specified in the relevant RFA.

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.