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P30 Center Core Grant Guidelines

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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
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 renewal (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 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 (October 2010, http://grants.nih.gov/grants/policy/nihgps_2010/index.htm), 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 individual trainees supported by Institutional National Research Service Awards (T32) is allowable, with NICHD approval.
  • 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.

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

  • For P30 applications, page limits are as follows:
    • Specific Aims for Overall P30                                          1 page
    • Overview of the Program Project (for overall P30)      12 pages
    • Core Descriptions (each Core)                                      12 pages
    • Research Project Descriptions (each project)            1 page
    • New Program Development Projects (each project)  6 pages
  • For Resubmission or Revision applications, also include the following:
    • Introduction (required for a resubmission or revision application)
    • For overall P30                                                                   1 page
    • For each Core Unit                                                            1 page
    • For each New Program Development Project             1 page

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 renewal (competing continuation) Center grant application, the proposed research plan must be described in sufficient detail, comparable to R03 research grant applications, 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. Revision (formerly competing 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 renewal 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, or on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html.

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), renewal (Type 2), and revision (Type 3) applications.

Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040-MSC 7710
Bethesda MD 20892-7710
Bethesda MD 20817 (for express/courier service)

For NICHD planning, it is important that two additional copies of the application and all copies of the appendices are sent under separate cover directly to the NICHD Scientific Review Branch (SRB):

Sherry Dupere, Ph.D.
Director, Scientific Review Branch (SRB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)

Receipt dates for new or renewal applications are specified in the relevant RFA.

Receipt dates for revision applications are January 25, May 25, and September 25..

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), renewal (Type 2), and revision applications (Type 3).

Competing applications (new and renewal) 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 renewal 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 Scientific Review Branch (SRB), 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 eight subcommittees: (1) the Biobehavioral and Behavioral Sciences Subcommittee; (2) the Developmental Biology Subcommittee; (3) the Function, Integration and Rehabilitation Sciences Subcommittee; (4) the Health, Behavior and Context Subcommittee; (5) the Obstetrics and Maternal-Fetal Biology Subcommittee; (6) the Pediatrics Subcommittee; (7) the Population Sciences Subcommittee; and (8) the Reproduction, Andrology and Gynecology Subcommittee. Each subcommittee includes approximately 10-18 scientists and is staffed by a Scientific Review Officer (SRO) and an Extramural Support Assistant (ESA). 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 SRO, 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 SRO, 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 an impact/priority score, and receive a second level review by the National Advisory Child Health and Human Development Council.

Scientific Review Group Evaluation

At its scheduled meeting, the SRG considers the full application with each application 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.

In evaluating each project and Core, the SRG will use the following 9-point scale and descriptor terms to assess scientific and technical merit:

Impact Score Descriptor
High Impact 1 Exceptional
2 Outstanding
3 Excellent
Moderate Impact 4 Very Good
5 Good
6

Satisfactory

Low Impact 7 Fair
8 Marginal
9 Poor

Non-numeric score options: NR = Not Recommended for Further Consideration, DF = Deffered, AB = Abstention, CF = Conflict, NP = Not Present, ND = Not Discussed

Reviewers are encouraged to use the full range.

NIH policy states that members of a Scientific Review Group (SRG) will score an application as presented in its entirety, and Scientific Review Officers will be responsible for enforcing compliance with the policy. Under no circumstance may members of an SRG or the SRG as a whole:

  • modify their final overall impact scores for an application based on the assumption that a portion of the work proposed and/or budget requested will be deleted or modified according to the SRG's recommendations.

  • recommend reducing the complexity of an application and score on the basis of the more meritorious components.

  • provide a numerical overall impact score for an application if the SRG votes that a portion of the application be Not Recommended for Further Consideration (NRFC). However, an SRG may vote to streamline a component of a multi-component application or deem a component Unsatisfactory, and vote a numerical overall impact score for the entire application, taking that component into consideration.

Not Recommended for Further Consideration. An application may be designated Not Recommended for Further Consideration (NRFC) by the Scientific Review Group if it lacks significant and substantial merit; presents serious ethical problems in the protection of human subjects from research risks; or presents serious ethical problems in the use of vertebrate animals, biohazards, and/or select agents. Applications designated as NRFC do not proceed to the second level of peer review (National Advisory Council/Board) because they cannot be funded.

Core units which are found to lack significant and substantial scientific and technical merit may be given the rating "Not Discussed" (ND), which is applied to applications or components falling in the lower half of the distribution of impact/priority scores.

  • 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 non-NSF, funded projects also will be evaluated for scientific merit (no descriptor will be assigned).
  • For the overall program, reviewers will assign an impact/priority score 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 impact/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 "Not Discussed" (ND). In assigning impact/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 SRO 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 written comments of the reviewers.

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 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. Renewal 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 Revision Applications(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 SRB 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 P30 revision applications are January 25, May 25, and September 25.

Review of Non-Competing Renewal 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

    This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

    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 Renewal 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.

  6. RESOURCES

    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

  1. SPECIFIC AIMS FOR OVERALL P30 CENTER (1 Page)

    • Follow theinstructions in the PHS 398 Application Guide

  2. OVERVIEW OF P30 CENTER

    The Overview shall not exceed 12 pages in total.

    • History, Purpose, and Objectives of the Center; Discuss the philosophy and objectives of the Center and general plans for the proposed grant period. For an existing Center, the history information can be shortened to emphasize information that confirms the Center's past success in realizing its objectives.
    • 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.
    • Cost-Effectiveness and Quality Control:  Describe procedures used to lower costs and assure quality of Center administrative and research activities.
    • Progress Report Overview (If applicable): For renewal applications, a general progress report should be included as described in the PHS 398 Instructions.  A more detailed progress report for each core may be included in the Core Descriptions below.
    • Accomplishments of Center not previously cited:
      • Use of administrative funds by Center Director for activities such as consultant services, scientific seminars, renovations, or travel.
      • Training activities external to the center (not including the P30 core grant that contributes to the center environment): Previous trainees, preceptors, present positions; Current trainees, preceptors, research topics.
      • Investigators attracted to the field by this center core grant and its facilities: New investigators; Visiting investigators.
      • Impact on institution and community.
      • Role of center in facilitating research, assisting young investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research.
      • Other

  3. CORE DESCRIPTIONS

    For each Core Unit, include a single cover page listing the title of the Core, the name of the Core Director, and names of any other investigators (with titles and affiliations).  Identify each proposed Core unit by a letter (A, B, C…) and a title (Administrative Core, Molecular/Cellular Core, etc.).

    The description of each core is limited to 12 pages.  Limitations on the total number of cores per application will be specified in the relevant RFA.

    1.  Administrative Core Unit
    • Objective
    • Organizational Chart
    • Staffing:  Description of key professional and support staff functions
    • Resources:  Description of space and physical resources
    • Services Provided:  Description of current and projected services to other Core units and research projects, as well as the process for prioritizing requests for use of Core facilities by the various research projects;
    • Cost effectiveness and plans for quality control
    • Progress Report:  For competing renewal applications, include a description of progress during the past funding period, including services performed, new technologies developed, changes in protocols or Core administration, and any other significant developments.
    2.  Research Core Units
    • Objective
    • Staffing:  Brief description of scientific, technical, as well as support staff functions
    • Resources: Description of space and physical resources
    • Administration:  Description of overall management of the research Core unit
    • Justification:  Description of services provided and their bearing on productivity and quality, as well as documentation of cost-effectiveness and quality control
    • Utilization of Core:  Provide a summary of projected usage of Core services (e.g., assays performed, animals supplied, etc.) by affiliated research projects.
    • Cost effectiveness and plans for quality control
    • Progress Report:  For renewal (competing continuation) applications, include a description of progress during the past funding period, including services performed, new technologies developed, changes in protocols or core administration, and any other significant developments.
    • Human Subjects:  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.

  4. 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. These projects should be listed in numerical order. The following information is to be given for each research project that is currently funded or pending award (status = "to be paid" in eRA Commons or IMPACII).

    Do not exceed one page per project.
    • Principal Investigator and percent effort
    • Title of project
    • Source of support (including complete designation and grant number, such as 5 P01 HG 12345 (P.I. - Smith), Project III (P.I.- Jones)
    • Indication of funding status (funded or pending)
    • Period of support
    • Budget:
      • Total first year or current 12-month budget  
      • Total project period
    • Brief description of project
    • Relevance of the project to P30 center mission as specified in the FOA
    • Core(s) to be accessed with brief justification statement

  5. NEW PROGRAM DEVELOPMENT PROJECTS (Optional) 
    For each New Program Development Project, include a single cover page listing the title of the project and the name of the investigators (with titles and affiliations).  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 description of each New Program Development project is limited to 6 pages, and should include the following information:  
    • Abstract
    • Specific Aims
    • Background and Significance
    • Progress Report/Preliminary Studies
    • Research Design and Methods
    • Core(s) to be accessed with brief justification statement
    • Human Subjects (including consideration of policies on inclusion of women, minorities and their subgroups, and children) and Vertebrate Animals
    • Literature Cited

  6. PROGRESS REPORT PUBLICATION LIST (For competing renewal applications only) 
    • List publications prepared during current grant period (or the past five-year period) which report results of research supported by the grant.

  7. USE OF CORES IN PRIOR PROJECT PERIOD (For competing renewal applications only)
    • Provide a summary of usage of each core by research projects over the past year, presented in a table or other format.   Include the name of the project investigator, title of project, funding source, grant number, project period, and percent usage of each core by the project.

  8. LETTERS OF ASSURANCE/AGREEMENT
    • Any arrangements for collaborative and cooperative endeavors or subcontracts should be highlighted. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

APPENDIX II
GUIDELINES FOR REVIEWER'S COMMENTS AND REVIEW CRITERIA

Critique templates are provided that match different types of NIH grant applications. Assigned reviewers/discussants should download from the Internet Assisted Review (IAR) system a separate template for each application, with information fields prefilled with specific information about that application. Enter your comments directly on the template and upload the document to IAR when completed. Enter your overall impact/priority score and scores for each of the standard review criteria (significance, investigators, innovation, approach, environment) into IAR. Also record your score for each of the review criteria on the template in the box above your critique. Do not record your overall impact/priority score on the critique template. All of the text that you enter will become part of the summary statement, and the criterion scores will be available to the applicant, but not your overall score. The template provides space to list bulleted strengths and weaknesses for each review criterion. You can list as many strengths and weaknesses as you wish, but please limit your comments to no more than half a page for each of the core criteria, and keep your comments in other sections as brief as possible. If appropriate for the application, you may list strengths for some criteria and no weaknesses. In addition, please indicate the magnitude of each strength or weakness, e.g., major, moderate, or minor.

Although not part of your critique, if you are a primary reviewer it is helpful to prepare a brief summary of the application introducing and describing it to the panel to guide the discussion.

Each reviewer has been assigned to prepare written comments on one or more component projects or core units and/or the overall center grant application (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 (in bullet format), providing appropriate examples, rather than attempting to enumerate every strength and weakness or discuss every experiment proposed.

The following are general instructions for preparing your written reports:

  • The Overall Description section of the summary statement will be prepared by NICHD staff using the applicant's description.
  • 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 entered into the Internet Assisted Review (IAR) system prior to the meeting. Modifications and additions reflecting changes in your opinion following discussions during the review committee meeting may be entered into IAR during the designated Edit phase. You may wish to bring hard copies of your reviews with you to the review meeting. If you have difficulty entering your critiques in IAR, you may wish to fax or email your reviews to the Scientific Review Officer (SRO). The SRO will provide specific instructions for the IAR system or the use of email to submit reviews.

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

As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For P30 applications, peer review of scientific and technical merit focuses on: (1) review of the individual Core units; (2) review of the New Program Development Projects (if applicable); and (3) review of the P30 program as an integrated collection of projects and Cores oriented around a set of research themes, and the overall merit of the program. Review criteria for these elements are listed in the sections below.

For each project or core component to which you are assigned, please prepare a Critique and other required sections, and address administrative considerations as necessary using the template provided.

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 summary statement.

Your essentially unedited, verbatim comments will be incorporated into the summary statement.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the overall P30 Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Significance. Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Integration of the Overall P30 Center

A major emphasis in evaluating the P30 Center is the integration or "centeredness" of the overall program. The P30 Center will be evaluated as an integrated collection of cores and research projects oriented around a set of research themes. The review will evaluate the following:

  • Does the program function as a true "Center" rather than a collection of unrelated support services with the sum of the parts being greater than the individual components?
  • Is there coordination and integration between the proposed Cores that reflects a cohesive research support program?
  • Is there value added by having the proposed Cores comprise a Center that allows the Center to leverage additional resources that would not have been possible without an integrated P30 structure?

The review will also evaluate the following:

  • Does the program involve the participation of a suitable number of responsible, experienced investigators with adequate time commitment for the cores and Center to succeed?
  • Does the Center Director have leadership ability and scientific stature, an ability to meet the program's demands of time and effort, and an ability to promote the Center mission among participants?
  • Is the Center able to provide adequate infrastructure to support novel approaches to research and has it anticipated current and future needs of the research community?
  • Are the scope, breadth, and overall quality of the Center's program, the core units, and the research projects adequate?
  • Is the program multidisciplinary in scope and does it have the ability to coordinate the research projects and core units?
  • Are the 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 well delineated and appropriate?
  • Is the administrative and organizational structure conducive to attaining the objective of the proposed program?
  • If New Program Development Projects are proposed, are the research projects consistent with the goals of the Center, the program, and likely to lead to independent or additional funding for the investigator? Is the institutional commitment to the requirements of the program adequate?
  • Is the 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 sufficient and conducive for the project?
  • Is there adequate justification for adding or deleting new Research Projects and/or Cores?

Has adequate progress been made since the previous competitive review (renewal applications only)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment and, if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession, use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Review Criteria for Core Unit Components

Reviewers will assign an impact/priority score based on the assessment of each Core unit in terms of the following review criteria. Separate criterion scores will not be assigned for Cores.

For each individual Core, the review will evaluate the following:

  • Qualifications, experience, and commitment of the Core Director and other Core personnel;
  • The quality of the services provided;
  • The cost effectiveness and quality control of the Core;
  • The utility of the Core to the program;
  • Progress during the past funding period (if applicable), including services performed, new technologies developed, changes in protocols or Core administration, and any other significant developments.

For the Administrative Core, the review will also evaluate the following:

  • The Core Director's experience in research administration;
  • The appropriateness of administrative structures and day-to-day management of the program;
  • T he decision-making process within the proposed center for the evaluation of research productivity, allocation of funds, and management of resources;
  • The process for prioritizing use of Core facilities by the various research projects;
  • The process for selecting additional New Program Development Projects (if applicable);
  • The mechanisms proposed for regular communication and coordination among investigators in the program;
  • The plan for program evaluation, including the use of any internal or external advisory groups;
  • Progress during the past funding period (if applicable), including services performed, new technologies developed, changes in protocols or Core administration, and any other significant developments.

Review Criteria for New Program Development Projects (if applicable)

Reviewers will assign an impact/priority score based on the likelihood of each new program development project to develop new areas of research, or to facilitate the development of newly trained investigators or investigators new to the program of research.

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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Last Updated Date: 11/30/2012
Last Reviewed Date: 11/30/2012

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