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U19 Cooperative Research Program Project Guidelines

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Table of Contents

Introduction
The U19 Funding Mechanism
Eligibility Requirements
Allowable Budgetary Items and Supportable Activities
Application Preparation
Application Submission
Review Procedures
Other Considerations
Appendix I - Format for NICHD Cooperative Research Program Project (U19) Applications
Appendix II - Guidelines for Reviewers' Comments and Review Criteria

Introduction

This document provides information on policies and procedures relevant to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Cooperative Research Program Project (U19) Awards, and is intended for both applicants and peer reviewers.

It is important to note that each NICHD U19 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 U19 Funding Mechanism

The purpose of the U19 mechanism is to encourage multidisciplinary approaches to the investigation of complex problems relevant to NlCHD's mission and to facilitate economy of effort, space, and equipment. NICHD believes that the collaborative research effort of a program project accelerates the acquisition of knowledge more effectively than does a simple aggregate of research projects without thematic integration. The U19 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 U19 is an institutional award, made in the name of a Program 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 not less than five years, and may be renewed for five-year periods if renewal (competing continuation) applications are solicited. The award provides support for both research projects and the core support services used by those projects.

NICHD U19 awards are funded only in response to a specific RFA; unsolicited applications for new or renewal U19 awards will not be accepted.
Distinguishing features of a Cooperative Research Program Project are as follows:

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

To constitute a program project, at least three component projects must be rated by peer review to be of high scientific merit. Core facilities, if requested, need to support at least three component projects at all times. It is expected that, except under exceptional circumstances that will require advanced approval by NICHD, U19s supported by the NICHD will have a specific life-span of 1-2 funding cycles.

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 U19 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.

Application Page Limits and Instructions

Page limits for the following sections of NICHD U19 applications: (1) Introductory Overview; (2) Research Program; (3) Research Project Descriptions; (4) Cores; and (5) Introductions for Resubmission Applications are presented in the following table:

NICHD U19 Section Page Limits
OVERVIEW OF THE PROGRAM PROJECT (for overall U19) 12
RESEARCH PROJECT DESCRIPTIONS (for each subproject)  
Research Project Cover Page 1
Abstract 1
Specific Aims for the subproject 1
Research Strategy for the subproject 12
CORE (for each core)  
Core Unit Cover Page 1
Abstract 1
Core Unit Structure, Administration & services 6


Resubmission Applications (A1s):
Introduction
Page Limite
Overall U19 1
Each subproject 1
Each core 1

For additional information on the recent changes in NIH grant application guidelines, please consult the following authoritative sources:

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 Program Director of a U19 Program may exercise flexibility to meet unexpected Program 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).

Items fundable under an NICHD U19 award 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 Program Director, Program 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.
  • At the discretion of the NICHD Program, and as described in the relevant RFA, travel to one Program Directors' and Administrators' meeting annually to confer with other NICHD Program Directors and Administrators or to visit other Program facilities pursuant to the administration of the Program .
  • Travel of Program 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 U19 award.
  • Seminars or meetings designed to promote interdisciplinary interaction, education, or Program cohesiveness.
  • Consultants providing specific scientific and/or technical support to Program projects or cores.
  • Costs related to internal program advisory committee meetings.

Items not fundable under an NICHD U19 award 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 award.

Application Preparation

Applications for new or renewal (competing continuation) NICHD U19 awards will be accepted for review only if they are submitted in response to an NICHD RFA or LOI.

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.

U19 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 U19. 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 U19 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 U19 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):

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)

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 U19 applications are submitted by an institution, in the name of a Program 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 U19 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 U19 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). U19 applications will be reviewed either by one of the standing subcommittees or by a SEP, as appropriate. U19 applications may not be reviewed by a subcommittee that has an applicant investigator as a member.

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

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 the individual component projects; (2) review of the individual cores; and (3) review of the Program as an integrated effort and the overall merit of the Program. The full scope of reviewer considerations is described in Appendix II. These criteria may be enhanced by additional criteria outlined in the relevant RFA.

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

  • A five-year total project period is required.
  • Unless the applicant has requested a shorter duration, component research projects/core units must be recommended for at least three years.
  • There must be at least three component research projects at all times during the five-year award 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 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 = 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.

If specified in the relevant RFA, all applications may undergo a 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 an impact/priority score or rating of "Not Discussed" (ND) based on the assessment of each project independently, in terms of the specified review criteria for individual projects ( Appendix II and relevant RFA).

For individual cores, reviewers will assign an impact/priority score or descriptor term, as appropriate, or a rating of "Not Discussed" (ND), based on the assessment of each core independently in terms of the specified review criteria for individual cores ( Appendix II and relevant RFA). The administrative core will either be recommended favorably or not recommended, with no descriptor.

For the overall program, reviewers will assign an impact/priority score based on assessment of the entire application (including all proposed projects and cores, and including any given a rating of "Not Discussed" (ND), in terms of the review criteria specified for the overall U19 Program ( Appendix II and relevant RFA). The resulting impact/priority score for the overall U19 grant application will reflect reviewers' assessment of the scientific and technical merit of the proposed program project.

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 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 (Competing Continuation) Applications (Type 2)

NICHD support for a U19 may not exceed five years without submission and peer review of a competing application. The awardee institution must submit a Type 2 application to request support beyond the current project period. A competing continuation 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. Competing continuation applications are reviewed in the same manner as new applications, including administrative review by NICHD Program Staff for conformance to NIH policy, RFA requirements, and program relevance; evaluation by an NICHD SRG; and second-level review by the Institute's Advisory Council.

Receipt and review dates are specified in the RFA.

Any significant increase in budget over the current level of support must be justified in the application.

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

Review of Revision (Competitive Supplements) applications (Type 3)

Applicants are urged to discuss the submission of all revision applications for U19 grants (Type 3) with NICHD program staff prior to submission. Any Program 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 U19 revision applications are January 25, May 25, and September 25.

Review of Non-Competing Continuation Applications (Type 5)

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

The Program Director must submit annually a "Non-Competing Grant Progress Report" (Form PHS 2590, updated 6/09) 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, U19 awards 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 Program network may recommend that funding of a component of the Program be disallowed or be contingent upon peer review. Detailed Terms and Conditions of Award for each Cooperative Research Program Project program are specified in the relevant RFA.

Other Considerations

Meetings of Program Directors, Investigators, and Administrators

Because the U19 Programs are cooperative in nature, it is likely that Program Directors and other Program 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 Program Director of a U19 award must be approved by the relevant NICHD program official. Institutions are required to notify the Grants Management Branch, NICHD, if a Program Director or project/core leader plans to relinquish his/her day-to-day functions prescribed in the 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 award or by appointing a new individual.

If a new individual is to be appointed as Program 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  Grants Management Branch, 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.

A change in the overall PD or PDs must be approved by the appropriate NICHD program official and grants management specialist.

Changes in Projects

Award of an NICHD Cooperative Research Program Project 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 Program Director to add a new research project or core unit to the Program requires competitive review of a revision application (formerly called a competing supplement).

Transfer

Cooperative Research Program Projects are not transferable to other institutions. However, administrative actions such as organization name change, successor in interest, or mergers are usually acceptable.

Foreign Institutions

Cooperative Research Program Project grants to foreign institutions are not allowable, but foreign subprojects are allowed.

Scientific/Administrative Overlap

Potential overlap of U19 subprojects with other current and/or pending applications must be addressed in the Other Support sections of the PHS 398 application, and should include plans for adjustment, as necessary. The simultaneous submission of an R01 and a U19 application for support of the same project is discouraged.

Notice of Grant Award

Conduct of the Cooperative Research Program Project must comply with the terms and conditions as stated in Sections III and IV of the Notice of Grant Award.

APPENDIX I
FORMAT FOR NICHD COOPERATIVE RESEARCH PROGRAM PROJECT (U19) APPLICATIONS

Applications must be submitted on the most recent version of 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 the event of an discrepancy between the instructions below and those in the relevant published Funding Opportunity Announcement (FOA), the FOA instructions should be used. 

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 Cooperative Research Program Project. 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 Cooperative Research Program Project 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.
      2. 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."
      3. 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 on Form Page 2.

    Beginning with the Program Director, and following in alphabetical order, submit biographical sketches as described in the "Instructions for Form PHS 398," using the sample format on the Biographical Sketch Format Page . Do not exceed three pages for each person.

  6. RESOURCES

    Follow the sample format and instructions on the Resources Format Page when completing information on resources available for the project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. Use continuation pages as needed.

SECTION II - RESEARCH PLAN

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

  1. OVERVIEW of U19 PROGRAM PROJECT

    The Overview shall not exceed 12 pages in total.

    1. History, Purpose, and Objectives of the Program. Discuss the philosophy and objectives of the Program and general plans for the proposed award 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 Program. Include information on the support and commitment of the parent institution for the Program, the authority of the Program Director, the use of advisory committees, and 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 award period.
    4. Assurances and Collaborative Agreements. Any arrangements for collaborative and cooperative endeavors or subcontracting should be highlighted. Include Letters of Intent to Collaborate and Letters of Agreement from consultants. For projects to be conducted off-site, i.e., at an institution other than the applicant institution, a PHS 398 face page or other documentation, signed by the off-site institutional officials, must be submitted with the application.
    5. For renewal applications, a general progress report should be included as described in the PHS 398 instructions. This should include results of completed research projects; use of administrative funds by Program Director for activities such as consultant services, scientific seminars, renovations, or travel; investigators attracted to the field by this Cooperative Research Program Project and its facilities; new investigators; visiting investigators; impact on institution and community; role of the U19 award in facilitating research, assisting new investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research.
  2. 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. 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)

    Research Project Plan (Do not exceed 12 pages for the Research Strategy plus 1 page for Specific Aims):

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

    1. Specific Aims
    2. Preliminary studies and progress to date, if applicable. Indicate the research project's use of Core unit services, including why needed and the advantages and cost effectiveness of Core unit usage for the project.
    3. Research Strategy, including Significance, Innovation and Approach
    4. Investigators
    5. Environment
    6. Human Subjects (including gender and minority representation, and participation of children)
    7. Vertebrate Animals
    8. Literature Cited
    9. Consultants
    10. Collaborative Arrangements (include pertinent letters of assurance and collaboration). For off-site projects, justification should be provided for the project's location, and plans for interaction and cooperation with the other components of the program should be addressed.
  3. 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, the page limitations for each section provided in the PHS 398 instructions are to be used.

    Introduction
    Discuss each Core's overall objectives; present the organizational framework or chart; highlight the decision-making process for use of Core services and plans for quality control; and identify the proposed Core units by title. Include an Abstract that identifies and describes the purpose of the proposed Core units.

    Administrative Core Unit

    • Objective
    • Organizational chart (if appropriate)
    • Staffing (Professional and Support)
    • Resources: provide description of space and physical resources
    • Accomplishments: List accomplishments and services provided during previous funding period (for renewal applications)
    • Services Provided (current and projected use): describe services to other Core units and research projects and the Program as a whole

    Research Core Units

    • Objective
    • Staffing (Professional and Support): Brief description of scientific, technical, as well as support staff functions
    • Resources: provide description of space and physical resources
    • Administration:  Description of overall management of the research core unit
    • Justification: describe services provided with their bearing on productivity and quality, as well as documentation of cost-effectiveness and quality control
    • Usage: Indicate past and/or current usage (e.g., assays performed, animals supplied, etc.) and list projects proposed for Core usage
    • If core service involves human subjects (e.g., recruitment; screening), discuss the inclusion of women, minorities and their subgroups, and children as research subjects

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 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 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/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 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.

The review process will start with the evaluation of all individual components of the U19 program project, starting with the individual Research Projects and followed by individual Core components.  The overall U19 application will be evaluated in terms of how well it demonstrates an integrated research effort focused on a central theme.  The relationship and contributions of each Research Project and Core to the overall theme of the U19 will be discussed and evaluated.  Reviewers will assign an overall impact/priority score based on their assessment of the scientific and technical merit of the overall U19 application.  This assessment will take into consideration all proposed Research Projects and Cores, including any with poor scores or ratings of "Not Discussed" (ND).

Review Criteria for Individual Research Project Components

The following standard review criteria will be used for the evaluation of the individual Research Project components: 

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate criterion 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? 

Review Criteria for Core Unit Components

Reviewers will assign an impact/priority score based on the assessment of each Core unit independently in terms of the specified review criteria for Cores. Separate criterion scores will not be assigned for Cores.  The following review criteria will be used for the evaluation of the individual Core units. 
For all Cores, 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.

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

  • The Core Director's experience in research administration;
  • The decision-making process within the proposed U19 program for the evaluation of research productivity, allocation of funds, and management of resources;
  • The plan for program project evaluation, including the use of any internal or external advisory groups.

Review Criteria for Overall U19 Program Project

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the U19 program project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable). 

Scored Review Criteria - Overall

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate criterion 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 program address an important problem or a critical barrier to progress in the field?  If the aims of the program 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 program?  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 program?  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 program 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 program proposed?  Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Additional Review Criteria – Overall

As applicable for the program 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.

Program as an Integrated Effort

  • The coordination, interrelationships, cohesiveness, and synergy among the Research Projects and Cores as they relate to the common theme of the program project;
  • The advantages of conducting the proposed research as a program project rather than through independent research projects;
  • The mechanisms proposed for regular communication and coordination among investigators in the program;
  • The appropriateness of administrative structures and day-to-day management of the program.

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

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

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

  • Has adequate progress been made in Research Projects and Cores since the previous competitive review?
  • Were the previous specific aims accomplished, and are the proposed research goals logical extensions of work during the current funding period?
  • Has scientific synergy occurred, as indicated by joint publications and new collaborative aims and/or projects?
  • Is there adequate justification for adding or deleting new Research Projects and/or Cores?

Revision Applications.   When reviewing a Revision application (formerly called a competing supplement application), 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 

As applicable for the project proposed, reviewers will address 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.

Select Agents 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 ( http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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.​​

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

Related Resources

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