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U54 Cooperative Specialized Research Center Grant Guidelines

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Table of Contents

Introduction
The U54 Funding Mechanism
Eligibility Requirements
Application Preparation
Application Submission
Review Procedures
Overview
       Review of New Applications
       Review of Renewal Applications
       Review of Applications for Revision Applications
       Review of Non-Competing Continuation Applications
Other Considerations
       Meetings of Center Directors
       Changes in Personnel
       Changes in Projects
Appendix I - Format for NICHD Cooperative Specialized Research Center (U54) Grant Applications
       Table I - All Current and Pending Research Support of Professional Personnel
       Table II - Quantitative Use of Core Units by Component Research Projects
Appendix II - Guidelines for Reviewers' Comments and Review Criteria

Introduction

This document provides information on policies and procedures relevant to NICHD Cooperative Specialized Research Center (U54) Grants, and is intended for both applicants and peer reviewers.

The 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 Cooperative Specialized Research Center (U54) mechanism.

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 U54 Centers program may have special requirements that go beyond these general guidelines. These requirements are described in the originating Request for Applications (RFA). Applicants are encouraged to consult with appropriate NICHD staff, listed in the relevant RFA, to become familiar with these additional, program-specific requirements.

The U54 Funding Mechanism

The U54 is a cooperative agreement, an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activities.

The U54 is an institutional award, made in the name of a Center Director (i.e., the Principal Investigator) for the support of a large, interrelated research program, focused on a specific problem or theme. It is awarded competitively, initially for up to five years, and may be renewed for five-year periods if renewal applications are solicited. The grant provides support for both research projects and the core support services used by those projects.

NICHD U54 grants are funded only in response to a specific RFA; unsolicited applications for new or renewal U54 grants will not be accepted.

In general, 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_2010/), a U54 grant application must have a strong, well-established research base. The proposed research program must include three or more related, integrated, and high-quality research projects that provide a multi-disciplinary, yet unified, approach to the problems to be investigated.
Scientific personnel and institutional resources capable of providing a strong research base in the field specified must be available. A strong institutional commitment also must be demonstrated. The commitment may take the form of faculty appointments for investigators, purchase of research equipment, or assignment of research space to facilitate collaborative research and interdisciplinary interaction.

Allowable Budgetary Items and Supportable Activities

Allowable costs in NIH grants are governed by rules set forth in the National Institutes of Health Grants Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise stated in the relevant RFA and/or the Notice of Grant Award. Under these rules, the Center Director of a U54 Center may exercise flexibility to meet unexpected Center requirements by rebudgeting or requesting approval to rebudget among budget categories, within the total direct cost budget of a project or core unit (as shown on the Notice of Grant Award).

The following NICHD guidelines also affect the allowable costs.

Items fundable under an NICHD U54 grant include:

  • Direct support of individual research projects.
  • Core facilities used by these research projects.
  • Salaries and support for a limited number of administrative and clerical personnel, such as the Center Director, Center Administrator, secretaries, and clerical support staff. The criteria defined under revised OMB Circular A-21 will be used by NICHD staff to determine allowabilty 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.
    • At the discretion of the NICHD Center Program, and as described in the relevant RFA, travel to one Center Directors' Meeting and/or Steering Committee Meeting annually to confer with other NICHD Center Directors, center participants, and Administrators or to visit other Center facilities pursuant to the administration of the Center.
    • Travel of Center Director and other investigators to scientific meetings.
    • Travel of technical staff for training that would enhance the quality of the research projects supported by the U54 grant.
    • Seminars or meetings designed to promote interdisciplinary interaction, education, or Center cohesiveness.
    • Consultants providing specific scientific and/or technical support to Center projects or cores.
    • Costs related to internal program advisory committee meetings.

Items not fundable under an NICHD U54 grant include:

  • Salary and support for central institutional administrative personnel usually paid from institutional F&A charges, such as budget officers, grants assistants, and building maintenance personnel.
  • Salary and support for administrative activities such as public relations, or health or educational services unrelated to the research carried out under the grant.

Application Preparation

Applications for new or renewal NICHD U54 grants will be accepted for review only if they are submitted in response to an NICHD RFA.

Interested prospective applicants are strongly encouraged to consult with the NICHD Program Staff identified in the RFA prior to preparing an application. Specific application guidelines may be outlined in the RFA.

U54 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 U54. To ensure that essential information is provided in a systematic fashion, all applications should be submitted in a format such as that outlined in Appendix I. Because the U54 application requests funds for direct research support, each project must be presented in as much detail as if it were a request for an R01, within PHS 398 page limitations, or other limitations specified in the relevant RFA.

See Appendix I  for detailed application instructions.

Application Submission

With the exception of non-competing (Type 5) applications, all U54 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 appendices are sent under separate cover directly to the NICHD Scientific Review Branch (SRB):

Director, Scientific Review Branch (SRB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda MD 20892-7510
Rockville MD 20852 (for express/courier service)

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

The 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 U54 applications are submitted by an institution, in the name of a Center Director, to the CSR. These include new applications (Type 1), renewal applications (Type 2), and revision applications (Type 3).

Competing applications (new, renewal, and revision) 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 U54 application is judged both for the scientific merit of the research and for its relevance to the Institute's program priorities. Initial peer review of U54 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 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 Officer (SRO) and a Grants Technical Assistant (GTA). U54 applications will be reviewed either by one of the standing subcommittees or by a SEP, as appropriate. U54 applications may not be reviewed by a subcommittee which has as a member an applicant investigator.

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 the 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's Grants Management Staff may be in direct communication with the applicant for budgetary and fiscal information.

Review of New Applications

Upon receipt in the 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, and relevance to NICHD program interests. If the application fails to comply with NIH policy and guidelines or is determined to be nonresponsive to the RFA, it will be returned to the applicant without further consideration

Preliminary Review of Applications

A process may be implemented for preliminary evaluation of applications by peer reviewers to determine whether or not the applications are likely to be competitive for funding in the context of all applications submitted in response to the RFA. Only the most meritorious applications will be subjected to an in-depth review.

Scientific Review Group Evaluation

At its scheduled meeting, the SRG considers the full application, which is considered independently. Peer review of scientific and technical merit focuses on three areas: (1) review of the individual component projects; (2) review of the individual cores; and (3) review of the Center as an integrated effort and the overall merit of the Center. (The full scope of reviewer considerations is described in Apendix II. These criteria may be enhanced by additional criteria outlined in the relevant RFA.)

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

  • A total project period of no more than five years is required.
  • Unless the applicant has requested a shorter duration, component research projects/core units must be recommended for at least three years.
  • There must be at least three component research projects at all times during the five-year grant period.
  • Each core unit must serve as a resource for at least three research projects at all times during the five-year grant period.

In evaluating each project and core, the SRG will use the following descriptor terms to express its assessment of each project/core's level of 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 = Deferred, 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.

Before the review meeting, assigned reviewers/discussants determine a separate score for each of the core review criteria and a score for the overall impact. The impact score should reflect a reviewer's evaluation of the overall impact that the project/core is likely to have on the research field(s) involved, rather than a weighted average applied to scores given to each criterion. 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. Reviewers will not assign individual scores to the following factors: protection of human subjects; inclusion of women, minorities, and children; vertebrate animal welfare; adequacy and appropriateness of resubmission applications; progress made for renewal applications; appropriateness of the proposed expansion of scope for revision applications; and protections from biohazards. However, reviewers will consider the adequacy of the information provided for each of these factors in assigning their overall impact scores. Reviewers will not assign individual scores to the following factors and will not consider them in assigning their overall impact scores: budget and duration of the project; select agent research; applications from foreign organizations; and resource sharing plans. Reviewer comments on these items will be considered in making funding decisions.

If specified in the relevant RFA, all applications may undergo an initial selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.  Such applications identified in this selection process will be given a rating of "Not Discussed" (ND).

Research projects or core units that 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.

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

For individual cores, reviewers will assign a priority score or descriptor term, as appropriate, or recommend no further consideration, based on the assessment of each core independently in terms of the specified review criteria for individual cores (see Appendix II and relevant RFA). The Administrative Core will either be recommended favorably or not recommended, with no descriptor.

For the overall program, reviewers will assign a priority score or recommend no further consideration based on assessment of the entire application, in terms of the review criteria specified for the overall center (see Appendix II and relevant RFA). The resulting priority score for the overall U54 Center grant 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. Each committee member privately assigns a numerical rating (between 1.0 and 5.0) to each project and scientific core, and to the application as a whole, based on his/her judgment of the applicable review criteria. In doing so, reviewers will be guided by the 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 recommendation and, for each project year, the requested and the recommended budgets. The text will contain a Resume of the overall Center program and each of its projects/cores with the review committee's recommendations. This is followed by an evaluation of the Center Director and summary descriptions and critiques of the scientific merit of the individual research projects and core units, including all budgetary requests, and a critique of the overall Center program, according to the specified review criteria. 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 RenewalApplications

NICHD support for a Center may not exceed five years without submission and peer review of a renewal application. The grantee institution must submit a Type 2 application to request support beyond the current project period. A renewal application may be submitted only in response to an RFA. Plans to submit a Type 2 application should be discussed with NICHD Staff listed in the 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 second-level review by the Institute's Advisory Council.

Receipt and review dates are specified in the RFA.

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

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

Review of Resubmitted Applications (formerly Revised Applications)

Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html  and NOT-OD-09-016.

Review of Revision Applications (formerly Competitive Supplements)

The submission of all revision applications to U54 grants (Type 3) must be approved by NICHD Program Staff prior to acceptance for evaluation by an NICHD scientific review group. Any Center supplement that potentially results in a total award that exceeds the funding cap specified in the original RFA is not allowed. In addition, multiple component supplements submitted as one composite application will not be accepted. Instead, each request for supplementing a component project or core should be submitted as a separate application.

The receipt dates for U54 revision applications are January 25, May 25 and September 25.

Review of Non-Competing Continuation Applications

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

The Center Director must submit annually an "Application for Continuation Grant" (Form PHS 2590) at least two months before the end of the grant year. PHS 2590 may be obtained on the Internet at http://grants.nih.gov/grants/funding/2590/2590.htm. The application (Type 5) should be prepared in accordance with the instructions provided with Form PHS 2590. In addition to a composite budget, detailed budgets should be prepared for each research component and for each core unit.

Because of their size and complexity, center grants are monitored closely. If the quality of performance or status of a particular component of the program is in doubt, a staff field visit may be conducted. If serious problems are found, NICHD staff or the governing body of the cooperative centers network may recommend that funding of a component of the Center's program be disallowed or be contingent upon peer review. Detailed Terms and Conditions of Award for each Specialized Cooperative Research Centers program are specified in the relevant RFA.

Other Considerations

Meetings of Center Directors, Investigators, and Administrators

Because the U54 Centers programs are cooperative in nature, it is likely that Center Directors and other Center participants will be expected to attend a number of meetings over the course of the funding period. Specific meeting requirements for each program are specified in the relevant RFA.

Changes in Personnel

A change in the Center Director of a U54 grant must be approved by the NICHD program official for the relevant NICHD Centers program. Institutions are required to notify the Grants Management Branch, NICHD, if a Center Director or project/core leader 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 Center Director or as a project/core leader, a letter of justification for the appointment, co-signed by the responsible university official, and a curriculum vitae must be submitted to the NICHD. The request is reviewed by Program Staff and, if the qualifications of the proposed replacement are acceptable to the NICHD, the appointment will be authorized.

Changes in Projects

Award of an NICHD Center grant authorizes expenditure of funds only for those component research projects and core units reviewed and recommended through the competitive peer review process. A proposal by a Center Director to add a new research project or core unit to the Center requires competitive review.

APPENDIX I
FORMAT FOR NICHD COOPERATIVE SPECIALIZED RESEARCH CENTER (U54) 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. Please note that the relevant RFA also may contain specialized formatting requirements.

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

The Table of Contents should contain the types of information suggested below.

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

SECTION I - GENERAL INFORMATION

  1. FACE PAGE

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

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

  2. DESCRIPTION AND PERSONNEL

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

    List key scientific and technical personnel participating in the Specialized Cooperative Research Center. Use continuation pages as necessary, numbering consecutively.

  3. TABLE OF CONTENTS

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

  4. BUDGET ESTIMATES

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

    1. Composite Budget

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

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

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

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

        Consortium Budgets (if applicable) should be presented as described in Item 1

        (Composite Budget), including a budget for the entire proposed project period. Total Direct and F & A costs of sub-awardees are to be shown under "CONSORTIUM/CONTRACTUAL COSTS" on individual research project or core budgets and a detailed consortium budget is to be inserted following the appropriate research project or core budgets.

        Budget Justifications: Describe the specific functions of key scientific and technical personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For future years of support requested, justify any significant increases in any category over the first 12-month budget period. Identify such significant increases with asterisks against the appropriate amounts. If a recurring annual increase in "PERSONNEL" or "OTHER EXPENSES" is anticipated, give the percentage. However, current NIH practice limits escalation to 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 research projects and core units as listed in the PHS 398 instructions.
    Beginning with the Center Director, and following in alphabetical order, submit biographical sketches as described in the PHS-398. Do not exceed four pages for each person.

  6. SUMMARY OF OTHER SUPPORT
    Information regarding active and pending research support of all key scientific and technical personnel named on Form Page 2 (except consultants) should be presented in a format such as that suggested in Table I, below, beginning with Center Director and listed thereafter in alphabetical order. Identify other support in the following categories:
    1. Current Active Support; and
    2. Applications Pending Review or Funding.
      This table is in lieu of the "OTHER SUPPORT" Form Page in PHS 398.

  7. RESOURCES

    Complete the "RESOURCES" section on Form Page 8 of the PHS 398 for the overall Center. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. Use continuation pages as needed.

SECTION II - DESCRIPTION OF RESEARCH PROGRAM

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

  1. INTRODUCTORY OVERVIEW

    Applicants are encouraged to present a concise and succinct overview (12 page limit).

    1. History, Purpose, and Objectives of the Center. Discuss the philosophy and objectives of the Center and general plans for the proposed grant period. Discuss the composite research program, highlighting its central theme. List by title and investigator the component research projects and core units, showing the interrelationship between the research projects and the core units and their relationship to the central theme.

    2. Administration, Organization, and Operation of the Center. Include information on the support and commitment of the parent institution for the Center, the authority of the Center Director, the use of advisory committees, and the method of determining core access and space assignment. Describe organizational framework and provide an organizational chart.

    3. Publications. List relevant publications prepared during the past five-year period or, for renewal applications, during the current grant period (see PROGRESS REPORT, below).

    4. Assurances and Collaborative Agreements. Any arrangements for collaborative and cooperative endeavors or subcontracting should be highlighted. Letters of Intent to Collaborate and Letters of Agreement from consultants should be referenced here and included at the end of the appropriate research project or core unit. (This is usually covered under each research project and core.)

  2. PROGRESS REPORT

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

  3. RESEARCH PROJECT DESCRIPTION

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

    For each component research project, a full description is to be provided following the format presented in Form PHS 398. Unless stated otherwise in these guidelines or in the relevant RFA, the page limitations for each section provided in the PHS 398 instructions are to be used. The Research Strategy section of regular R01-type projects is limited to 12 pages. The Research Strategy section of optional pilot projects is limited to 6 pages. The Introduction section for each project is limited to one page. The Specific Aims section for each project is also limited to one page. The Introduction and Specific Aims sections do not count against the page limitations for the Research Strategy sections of each project. Begin the presentation of each component research project on a separate page. For each project, include the following information:

    1. Introductory Information

      1. Indicate:

        • Project Title

        • Project Principal Investigator, title, location

        • Other investigators, consultants, and collaborators, titles (Associate Professor, Postdoctoral Fellow, student)

      2. Abstract of Research Plan (use Form Page 2 of PHS 398)
    2. Research Project Plan

      Discuss the purpose and nature of the project and its relevance to the application's overall theme. Address the following:
      1. Introduction (for resubmission and revision projects only) (one page limit)
      2. Specific Aims (one page limit)
      3. Research Strategy (12 page limit; 6 page limit for optional pilot projects): to include (a) Significance, (b) Innovation, and (c) Approach
      4. Inclusion Enrollment Report (renewal or revision applications only).
      5. Bibliography and References Cited/Progress Report Publication List (Renewal applications only)
      6. Protection of Human Subjects
      7. Inclusion of Women and Minorities
      8. Targeted/Planned Enrollment Table
      9. Inclusion of Children
      10. Vertebrate Animals
      11. Select Agent Research
      12. Multiple PD/PI Leadership Plan
      13. Consortium/Contractual Arrangements
      14. Letters of Support (e.g., consultants)
      15. Resource Sharing Plan
  4. CORE DESCRIPTIONS

    Identify each proposed core unit by a letter (A, B, C...) and a title (Administrative, Molecular/Cellular...).

    For each core unit, a full description is to be provided following the format presented below. Unless stated otherwise in these guidelines or the relevant RFA, each core unit is limited to 6 pages.

    Overall Introduction

    Identify the proposed core units by title; briefly summarize the overall objectives of each core unit; present the organizational framework or chart; highlight the decision-making process for use of core unit services described; and present plans for quality control.

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

    Begin the presentation of each core unit on a separate page. For each proposed core, address cost effectiveness and plans for quality control, as appropriate. For each core, include the following information:

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

SECTION III - APPENDIX

Include materials as appropriate (see PHS 398)

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

TABLE I

ALL CURRENT AND PENDING RESEARCH SUPPORT

OF PROFESSIONAL PERSONNEL

(SAMPLE FORMAT)

Investigator
Full Grant Number
Source of Funds

Title of Project

Total Project
Period & Amount
(Direct Costs)

Current Project
Period & Amount
(Direct Costs)

% of Effort

ROE, R.A. (P.I.)        
Current:
5 RO1 HD 00000-03 (NIH)

Saccharin and Reproduction

8/1/99 - 7/31/04 $167,254

8/1/00 - 7/31/01 $56,628

30%

1 R01 AI 00000-04 (NIH)

Cell Surface Antigens

2/1/99 - 1/31/03 $190,000

2/1/00 - 1/31/01 $84,000

20%

Pending:
1 R0 1DA 00000-01* (NIH)

Drugs and Male Sterility

2/1/99 - 1/3/02 $34,132

2/1/00 - 1/31/01
$34,132

10%

BAND, J.H. (P.I.)        

Current:
5 R01 CA 00000-02 (NIH)

Amino Acid Requirementof Chick Embryos

etc.

etc.

etc.

Pending: None

       

CONWAY, O. (P.I.)

       

Current: RCH-00-000 (NSF)

Role of Androgens in Embryonic Growth

etc.

etc.

etc.

Pending: None

       

*Overlaps with proposed U54 projects.

 

TABLE II

QUANTITATIVE USE OF CORE UNITS BY COMPONENT RESEARCH PROJECTS

(SAMPLE FORMAT)

 

 

PROJECT CORE UNIT
Investigator Number Abbreviated Title Animal Facility Amino Acid Analysis Data Analysis, etc.

ROE

I

Drugs & Male Sterility

20%

10%

5%

BAND

II

Genetics of Reproduction

20%

5%

20%

CONWAY

III

Cell Motility

5%

5%

25%

SMITH

IV

Immunocontraception

40%

5%

5%

 

 

Etc.

Etc.

Etc.

Etc.





TOTAL

100%

100%

100%

APPENDIX II

GUIDELINES FOR REVIEWERS' COMMENTS AND REVIEW CRITERIA

Critique templates are provided that match different types of NIH grant applications. Assigned reviewers/discussants should download from IAR 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 score and scores for each of the core 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 score on the critique template. All of the text that you enter will become part of the summary statement, and the criteria 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.

SUMMARY STATEMENT COMPONENTS

REVIEWS OF INDIVIDUAL PROJECTS AND CORES

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.

INDIVIDUAL RESEARCH PROJECTS

The following instructions apply to the U54 Template.

1. 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?

2. Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators (see definitions below), 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?

New Investigator: An NIH research grant Program Director/Principal Investigator (PD/PI) who has not yet competed successfully for a substantial, competing NIH research grant is considered a New Investigator. For example, a PD/PI who has previously received a competing NIH R01 research grant is no longer considered a New Investigator. However, a PD/PI who has received a Small Grant (R03) or an Exploratory/Developmental Research Grant Award (R21) retains his or her status as a New Investigator. A complete definition of a New Investigator along with a list of NIH grants that do not disqualify a PD/PI from being considered a New Investigator can be found at http://grants.nih.gov/archive/grants/new_investigators/index.htm.

Early Stage Investigator (ESI): An individual who is classified as a New or First-Time Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) is considered an Early Stage Investigator (ESI).
Extension of ESI Eligibility: The 10 year period after completion of the terminal degree or residency may be extended to accommodate special circumstances including various medical concerns, disability, pressing family care responsibilities, or active duty military service. Guidelines for requesting and considering such requests are being developed and will be announced.

3. 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?

4. 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?

5. 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?

6. Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), please 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.

7. Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), please consider the progress made in the last funding period.

8. Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), please 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 please consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

9. 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 (for more information see  http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html), please 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, please evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

10. Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, please evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

For gender, minority and children coding, indicate the subjects proposed in the application and whether the involvement of these subjects is acceptable ("A") or unacceptable ("U"). For example: Gender 1A; Minority 2A; Children 3U. Please use the following codes:

Gender: 1. Both; 2. Women only; 3. Men only; 4. Unknown composition Minority: 1. Minorities and non-minorities; 2. Minorities only; 3. Non-minorities only; 4. Composition unknown; 5. Foreign Children: 1. Children and adults; 2. Children only; 3. Adults only; 4. Composition unknown

(Note: A child is defined as an individual under the age of 21 years. For additional information on the inclusion of children see: http://grants.nih.gov/grants/funding/children/children.htm)

11. Vertebrate Animals. Please 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.

12. 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.

13. Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved. Please consider all 12 of the criteria above (as appropriate for the application) in determining the overall score. Your critique should indicate the most significant strengths and weaknesses.

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

Overall Evaluation : (One paragraph) Summarize the main strengths and weaknesses of the project in terms of the review criteria. Recommend a descriptor term 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.

Recommendation : Indicate the final recommendation for the project (level of scientific merit ).

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

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

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

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

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

CORE UNITS

The Critique for all cores should address:

  • Qualifications, experience, and commitment of the core director and other core personnel;
  • The quality of services provided;
  • The cost effectiveness and quality control of the core;
  • The utility of the core to the center;
  • Appropriateness of the use of core services by the budgeted center projects and, if applicable, by external projects;
  • If applicable, adequacy of plans for charge back and priority management procedures for core units offering services to external projects.

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

  • The core director's experience in research administration;
  • The decision-making process within the proposed center for the evaluation of research productivity, allocation of funds, and management of the resources;
  • The plan for center evaluation, including the use of any internal and external advisory groups.

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

Reviewers also should prepare an Overall Evaluation section for each assigned core component, and address Budget, Overlap, Human Subjects, Animal Welfare, Biohazards, Participation of Children, and Gender and Minority issues, as appropriate.

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

REVIEW OF OVERALL PROGRAM

An overall critique is prepared by either the Chairperson or the designated reviewer. The Overall Critique should convey the overall level of merit of the center grant application and should contain the following sections:

  1. The Center as an Integrated Effort . This section should briefly describe and evaluate:
    • The coordination, interrelationships, cohesiveness, and synergy among the research projects and core components as they relate to the common theme of the center;
    • The multidisciplinary scope of the center's research program;
    • The advantages of conducting the proposed research as a program rather than through separate research efforts;
    • The mechanisms proposed for regular communication and coordination among investigators in the center; and
    • The appropriateness of administrative structures and day-to-day management of the center, including arrangements for internal quality control of ongoing research.
  2. The Overall Merit of the Program . Include comments on the progress made during the previous funding period for competing continuation applications.

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

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

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

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

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

    Environment: Scientific, organizational/institutional, and administrative environment of the program, including institutional commitment to the center.
  3. The Center as a Participant in a Cooperative Effort. Include comments on performance during the previous funding period for competing continuation applications.

    • Willingness and ability to adhere to the Terms and Conditions of Award stated in the relevant RFA.
    • For new applications, plans for participation in joint cooperative efforts of the Centers Program, as described in the relevant RFA.
    • For renewal applications, comment on specific examples of cooperative interaction with other Centers and/or NICHD.

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

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

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

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

Related Resources

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