Table of Contents

Introduction
The P30 Funding Mechanism
Eligibility Requirements
Allowable Budgetary Items and Supportable Activities

Application Preparation
Application Submission
Review Procedures

Other Considerations

Appendix I - Format for NICHD Center Core (P30) Grant Applications
Table I - All Current and Pending Research Support of Professional Personnel (Sample Format)
Table II - Quantitative Use (Percent) Of Core Units By Research Projects (Sample Format)
Appendix II – P30 Review Criteria

Introduction

This document provides information on policies and procedures relevant to NICHD P30 Center Core Grants, and is intended for both applicants and peer reviewers.

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 Center Core (P30) 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 missions.

It is important to note that each NICHD P30 Center program may have unique 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 P30 Funding Mechanism

The Center Core Grant (P30) is an institutional award, made in the name of a Center Director, for the support of centralized resources and facilities shared by investigators with existing research projects and a multidisciplinary approach to a joint research effort. It is awarded competitively, initially for not less than five years, and may be renewed for five-year periods. Although no funds are provided for the direct support of research projects (except for New Program Development projects), the Center Core Grant helps to integrate existing projects in a specialized area of research or within a central theme. By making resources accessible, this support is designed to enhance quality, facilitate productivity, encourage interdisciplinary collaboration, and promote cost-effectiveness of R01, P01, and other externally supported research projects. NICHD P30 Center grants are funded only in response to a specific RFA; unsolicited applications for new or competing continuation P30 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 P30 application must have a strong, well-established research base. The research base must consist of an adequate number of specific research projects which must be (1) relevant to the mission of NICHD's Center programs; (2) of a quality acceptable to NICHD; and (3) funded when the P30 award (initial or renewal) begins.

In demonstrating its research base, the application must have a minimum number of externally (non-university) funded research projects that will use Center facilities. This minimum number will be specified in the RFA announcement. (Individual research components of a P01 program project may be counted as separate projects to qualify a Center or core.)

At least three cores are required for each year of a funded P30 grant.

Each core unit must:

• provide essential facilities or services for at least three federally funded research projects, at least one of which is NIH-funded. Additional requirements may be specified in the RFA;

• have satisfactory quality-control systems documented for its services or facilities;

• be cost-effective, i.e., the centralization should result in a lower cost than would be incurred if the same facilities or services were supported by the individual research grant budgets; and

• increase the quality and productivity of research projects receiving core support.

The following additional requirements apply:

• In general, contract-supported projects may not be counted to qualify a core. In cases where the funding agency primarily uses the contract mechanism to support investigator-initiated projects rather than the grant/assistance mechanism, the aforementioned restrictions may not apply. In any case, NICHD staff should be consulted. Use of core facilities by projects funded by research and development contracts will be evaluated on an individual basis. Any use of core facilities by contracts must be paid for in full from contract funds, not from NICHD Center Core Grant funds.

• Use of core facilities by projects located at other institutions generally is not allowable. NICHD prior approval is required for any rare exception granted as a waiver of this policy.

• Use of core facilities by Institutional National Research Service Awards (T32) is not allowable.

• The cost-effectiveness of the core units must be demonstrated in the application. Mechanisms such as fee-for-service, in-kind, or other means are acceptable.

Scientific personnel and institutional resources capable of providing a strong research base in the field specified must be available. There also must be a strong institutional commitment. 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. Scientists may have access to the Center's centralized facilities and participate in its activities while retaining independent control of their respective research projects. However, all activities using NICHD Center funds must be relevant to the mission of NICHD's Center programs.

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 director of a P30 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 core unit (as shown on the Notice of Grant Award).

The following NICHD guidelines also affect cost allowability.

Items fundable under an NICHD P30 grant include:

Administrative Core Unit

• 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 (F&A) charges;

• Travel to one Center Directors' meeting annually to discuss scientific advances in the Centers and promote scientific interaction among the Centers; and

• At the discretion of the relevant 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 or to visit other Center facilities pursuant to the administration of the Center.

Research-Related Core Units

• Salaries and support for core staff;

• Supplies (including animals);

• Scientific equipment;

• Computer facilities and services;

• Travel of technical or administrative staff for technical training that would enhance the quality of core unit operation or travel required to maintain the operation of a core unit;

• Minor renovation or alteration of existing facilities; and

• Consultant services. 

New Program Development Projects

• Funds may be requested to provide initial support of new research projects relevant to the center's goals. Plans for seeking subsequent grant support through other funding mechanisms or sources should be indicated. (NICHD encourages these alternatives as a first option.)

• Support for individual New Program Development projects is limited to a two-year period. Funding may not exceed 10 percent of the center grant's total annual direct costs awarded, inclusive of the portion budgeted for New Program Development projects, or $50,000 per year, whichever amount is smaller. With NICHD staff approval, the period of support may be extended one additional year.

• When support for a New Program Development project is requested in a new or competing continuation Center grant application, the proposed research plan must be described in sufficient detail, comparable to a regular research grant application (R01), to permit evaluation of the project through the competitive peer review process.

• Funds for a New Program Development project may also be requested during the Center grant support period, with funds made available through rebudgeting. Because prior approval must be obtained for support of a New Program Development project, the project must be described in sufficient detail to permit evaluation by NICHD staff or through the peer review process. Supplemental applications (Type 3) requesting additional funds for a New Program Development project are discouraged. Any such applications should be discussed with NICHD staff before submission.

• If New Program Development is approved for an initial two-year period, funds will be included each year for the full five years. Funds in Years 03-05 will be contingent upon review and approval of additional projects by NICHD staff. Funding levels for Years 03-05 will be based on the approved level in Years 01 and 02.

Other Research Projects

Support of unfunded research projects by core units generally is not allowable, except in rare situations, and requires approval by NICHD staff.

Other Costs

• Costs related to dissemination of research results to the scientific community and lay public;

• Costs related to seminars or meetings designed to promote interdisciplinary interaction, education, or center cohesiveness; and

• Costs related to advisory committee meetings.

Items not fundable under an NICHD P30 grant include:

• Direct support of individual research projects (except New Program Development projects);

• Salary and support for central institutional administrative personnel usually paid from institutional F&A charges, such as budget officers, grant assistants, and building maintenance personnel;

• Salary and support for administrative activities such as public relations, health or educational services unrelated to the research; and

• Travel of investigators, other than the Center Director, to scientific meetings.

Application Preparation

Applications for new or competing continuation NICHD P30 grants 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.

P30 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 P30. 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.

See Appendix I for detailed application instructions.

Application Submission

With the exception of non-competing (Type 5) applications, all P30 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
Bethesda MD 20817 (for express/courier service)

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
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda MD 20892-7510
Rockville MD 20852 (for express/courier service)

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 P30 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 P30 application is judged both for the scientific merit of the research and cores and for its relevance to the Institute's program priorities. Initial peer review of P30 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). P30 applications may not be reviewed by a subcommittee which has as a member an applicant investigator or collaborator.

As a rule, 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, as well as for its relevance to NICHD program interests. If the application fails to comply with NIH policy and guidelines or determined to be nonresponsive to the RFA, it is returned to the applicant without further consideration. Research projects proposed for core use that are of questionable relevance or are not thematically related may be administratively deleted.

Preliminary Review of Applications

As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council.

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 P30 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.

Scientific Review Group Evaluation

At its scheduled meeting, 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.

Peer review of scientific and technical merit focuses on three areas: (1) review of each core unit; (2) review of the research projects requesting access to the core units; and (3) review of the overall 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 will also be guided by the following directives:

• A five-year total project period is required.
  
  
• Core units may be recommended for a minimum of three years. This would not preclude requests for support of core units for less than three years. However, a minimum of three core units is required in each of the five years of the Center grant.
  
  
• The site-visit team will assign to each core unit that is deemed to have significant and substantial scientific and technical merit one of the following descriptor terms, indicating its assessment of the adequacy of the core unit (including the Administrative Core) based on the criteria outlined in Appendix II and in the relevant RFA, if applicable:
  
  

In evaluating each core, the SRG will use the following descriptor terms to express its assessment of each core's level of scientific and technical merit:

The numbers in parentheses refer to corresponding ranges for priority scores. Reviewers are encouraged to use the full range.

Core units which 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 P30 applications.

• The reviewers will assign to all research projects proposed for core use one of the following two statements: (1) "RECOMMENDED FOR CORE USE," or (2) "NOT RECOMMENDED FOR CORE USE."

• New Program Development projects will be evaluated for scientific and technical merit and assigned one of the descriptor terms identified above if found to have significant and substantial scientific merit.

• Non-NIH, and -NSF, funded projects also will be evaluated for scientific merit (no descriptor will be assigned). The site-visit team will then determine whether these projects are appropriate for access to core support.

• 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 Center (see Appendix II and relevant RFA). The resulting priority score for the overall P30 Center application will reflect reviewers' assessment of the scientific and technical merit of the proposed Center. This assessment must take into consideration all proposed projects and cores, including any with poor ratings or a NRFC recommendation. In assigning priority scores and descriptors, reviewers will be guided by the 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 overall SRG recommendation, critiques and recommendations for each proposed project and core, and recommended budgets. All critiques are the verbatim comments of the reviewers. A copy of the summary statement is sent to the Center Director.

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. 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, recommendations are forwarded to the Institute Director for funding decisions.

Review of Competing Continuation (Renewal) Applications (Type 2)

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 Type 2 application to request support beyond the current project period. This must be in response to an 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.

If budgetary limitations are not specified in the RFA, 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 (Type 3)

The submission of all applications for supplements to P30 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 would exceed the funding cap specified in the original RFA is not allowed. In addition, multiple component supplements submitted as one composite application are discouraged. Instead, each request for supplementing a Center component should be submitted as a separate application.

The receipt dates for applications for P30 competitive supplements are February 1, June 1, and October 1.

Review of Non-Competing Continuation Applications (Type 5)

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 core unit and for each New Program Development project. Any new project that is proposed for use of core facilities, but which was not reviewed previously, must be described in detail to allow NICHD Program Staff to evaluate the project for its program relevance and scientific appropriateness for core use. All projects funded from external sources are reviewed for relevance and appropriateness for core use.

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 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 P30 grant must be approved by the director of the relevant NICHD Center program. Institutions are required to notify the Grants Management Branch, NICHD, if a Center Director or principal investigator of a core unit or a New Program Development project 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 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 Core Grant authorizes expenditure of funds only for those core units and New Program Development projects reviewed and approved through the competitive peer review process. The addition of a new core unit to the Center requires competitive review.

NICHD staff may give administrative approval to Center requests to add a project or to transfer support to a different core, if such a change requires minimal or no additional funds.  

Core Usage by Outside Institutions

Use of P30 facilities by projects located at organizations other than the grantee institution is generally not allowed. Exceptions will be evaluated on an individual, case-by-case basis by NICHD staff. Justifications for exceptions must adequately address the planned use of the core and demonstrate collaboration between the external projects and the Center's internal research projects.

APPENDIX I

FORMAT FOR NICHD CENTER CORE (P30)

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 which will be served by the proposed Center grant and the proposed cores.

   List key scientific and technical personnel participating in the Center Core Grant (including principal investigators of projects accessing cores). 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 Center Core Grant as requested below. A separate detailed budget is required for each core unit and each New Program Development project.

   1. Composite Budget

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

      If consortium arrangements have been made involving other institutions or organizations, include total costs (direct and 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 totals for each year of requested support.

   2. Individual Core and New Program Development Budgets
      
      
      1. First year (use Form Page 4 of the 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 core budget and a detailed consortium budget is to be inserted following the appropriate core budget.
         
         
      2. Total project period (use Form Page 5 of the PHS-398 for each)

         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 additional 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 three 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 core units and New Program Development projects as listed on Form Page 2, including principal investigators of projects accessing cores.

   Beginning with Center Director, and following in alphabetical order, submit biographical sketches as described in the "Instruction Sheet for Form PHS-398," using the sample format on the Biographical Sketch Format Page. Do not exceed four pages for each person. It is not necessary to describe other research support in the Biographical Sketch.

6. SUMMARY TABLE OF CENTER RESEARCH SUPPORT

   Present a summary table of current research support such as shown below:

   Total Center Funds	Total from NICHD Core Grant	Total Other NICHD	Total Other NIH	Total Other Sources
   $4,839,621	$330,387	$937,000	$2,756,975	$814,809
   (100%)	(6.8%)	(19.4%)	(57.0%)	(16.8%)

   
   
7. SUMMARY OF INDIVIDUAL RESEARCH 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.

   Place an asterisk next to those projects proposed to access cores.

8. RESOURCES

   Follow the sample format and instructions on the Resources Format Page when completing information on resources available 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 Center. 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 core unit by title, and assign each core unit a capital letter (A,B,C) that reflects the order in which the core units are presented in the application research plan. For each core unit, provide the name of the 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 or user committees, and the method of determining core access and space assignment. Describe organizational framework and provide an organizational chart.
      
      
   3. Center Publications. List publications prepared during the past five-year period or, for competing continuations, 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 core unit.
      
      
   5. Cost-Effectiveness and Quality Control. Describe procedures used to lower costs and assure quality of Center administrative and research activities.
      
      
   6. Quantitative Use Table. A summary table should be submitted for the first year of the proposed Center grant, showing quantitative use (percent) of each core by research projects, presented in a format such as that suggested in Table II, below.
      
      
   
   
2. PROGRESS REPORT - as required in PHS 398.
   
   

   For Type 2 applications, a progress report should be included, as described in the PHS 398 Instructions.

3. CORE DESCRIPTION
   
   

   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. 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:  Description of current and projected services to other core units and research projects
         
         
      
      
   2. Research Core Units
      
      
   3. 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).
         
         
   
   
4. NEW PROGRAM DEVELOPMENT PROJECTS
   
   

   New Program Development projects will be peer reviewed for scientific and technical merit, as well as for the appropriateness of the projects' use of core services. These projects must be described in sufficient detail to permit evaluation through the competitive, peer-review process. The following sections should be included in the presentation of each New Program Development project proposed.

   1. Abstract
      
      
   2. Specific Aims
      
      
   3. Background and Significance
      
      
   4. Progress Report/Preliminary Studies
      
      
   5. Research Design and Methods
      
      
   6. Human Subjects (including consideration of policies on inclusion of women, minorities and their subgroups, and children) and Vertebrate Animals
      
      
   7. Literature Cited
      
      
   
   
5. RESEARCH PROJECTS PROPOSED FOR CORE USAGE
   
   

   Research projects proposed for core usage will be evaluated with respect to the appropriateness of the projects' use of core services. The scientific and technical merit of projects funded by NIH and NSF generally will not be assessed because such projects already have been peer reviewed. These projects should be listed in numerical order. The following information is to be given for each funded and pending research project from NIH and NSF proposed for core usage. Do not exceed one page.

   1. Principal Investigator and percent effort
      
      
   2. Title of project
      
      
   3. Source of support (including complete designation and grant number, such as 5 P01 HG 12345 (P.I. - Smith), Project III (P.I.- Jones)
      
      
   4. Period of support
      
      
   5. Budget:
      
      
      1. Total first year or current 12-month budget; and
         
         
      2. Total project period
         
         
      
      
   6. Brief description of project
      
      
   7. Relevance of the project to center mission as specified in the RFA
      
      
   8. Core units to be accessed with brief justification statement
      
      
   9. Indication of funding status (funded or pending)
      
      
   
   

   All projects with funding sources other than NIH and NSF, as well as New Program Development projects, will be peer reviewed for scientific and technical merit as well as for the appropriateness of the projects' use of core services. These projects must be described in sufficient detail to permit evaluation through the competitive, peer-review process.

6. 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 external to the center (not including the P30 core grant that contributes to the center environment):
      
      
   4. 1. Previous trainees, preceptors, present positions
         
         
      2. Current trainees, preceptors, research topics
         
         
         
   5. Investigators attracted to the field by this center core grant and its facilities:
      
      
      1. New investigators
         
         
      2. Visiting investigators
         
         
   6. Impact on institution and community
      
      
   7. Role of center in facilitating research, assisting young investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research
      
      
   8. Other
      
   
   
7. CHECKLIST - As required in PHS 398.
   
   
   
   

SECTION III – APPENDIX

Include materials as appropriate (see PHS 398)

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

TABLE I

ALL CURRENT AND PENDING RESEARCH SUPPORT OF PROFESSIONAL PERSONNEL

(SAMPLE FORMAT)

* Accessing cores.

TABLE II

QUANTITATIVE USE (PERCENT) OF CORE UNITS BY RESEARCH PROJECTS

(SAMPLE FORMAT)

APPENDIX II

P30 REVIEW CRITERIA

In addition to the criteria listed below, evaluation criteria specified in the relevant RFA will be considered by reviewers.

REVIEW CRITERIA FOR CORES

• Technical merit and justification of each core unit.

• Evidence of cost-effectiveness and documentation of quality control of core units.

Note:  : In the demonstration of cost-effectiveness, certain clearly definable services, such as computer time, may be appropriate for fee-for-services consideration. Other services, such as tissue culture preparation, may be better suited to in-kind consideration in exchange for supplies. Less clearly defined core facilities such as administrative support may not be readily adaptable to such systems; their cost-effectiveness can be demonstrated with other procedures that are acceptable to the NICHD, although detailed documentation of usage logs and balance sheets is not required. Potential program income, however, should be described.

• The extent to which core units contribute to greater cooperation among center investigators.

• The scientific appropriateness of the research projects' use of core services. 

• Qualifications, experience, and commitment to the center mission of the investigators responsible for the core unit and their ability to devote the required time and effort to the program.

• Accomplishments and progress to date of the core units, particularly for competing continuation and supplemental applications.

• Appropriateness of the budget request for the core unit, including consideration of overall administrative costs.

• As appropriate, the adequacy of the means proposed for protecting against risks to human subjects, animals, and/or the environment.

• As appropriate, the adequacy of representation of both genders, minorities and their subgroups, and children in study populations.

Further specification of review criteria may be presented in the relevant RFA.

REVIEW CRITERIA FOR RESEARCH PROJECTS

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 the 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.

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.

REVIEW CRITERIA FOR OVERALL CENTER APPLICATION

• Significance of the research program to the mission of the relevant NICHD center program.

• Scope, breadth, and overall quality of the Center's program, the core units, and the research projects.

• Multidisciplinary scope of the program and the ability to coordinate the research projects and core units.

• Participation of a suitable number of responsible, experienced investigators.

• Leadership ability and scientific stature of the Center Director, his/her ability to meet the program's demands of time and effort, and his/her ability to promote the Center mission among participants.

• Academic and physical environment as it bears on research subjects, space, and equipment, and on the potential for interaction with scientists from other departments and institutions.

• Arrangements for internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements, internal communication, and cooperation among the investigators in the program.

• Presence of an administrative and organizational structure conducive to attaining the objective of the proposed program.

• Institutional commitment to the requirements of the program.

• In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following:

• The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects also will be evaluated.

• The reasonableness of the proposed budget and duration in relation to the proposed research.

• The adequacy of the proposed protection for humans, animals, and/or the environment to the extent they may be adversely affected by the activities proposed in the application.

Reviewers also will examine the provisions for the protection of human subjects and the safety of the research environment.

Last updated: 07/2003