Table of Contents

Introduction
The U19 Funding Mechanism
Eligibility Requirements
Allowable Budgetary Items and Supportable Activities
Application Preparation
Application Submission
Review Procedures
      Overview
      Review of New Applications
      Preliminary Review of Applications
      Site Visits
      Scientific Review Group Evaluation
      Advisory Council Review
      Review of Competing Continuation (Renewal) Applications (Type 2)
      Review of Applications for Competitive Supplements (Type 3)
      Review of Non-Competing Continuation Applications (Type 5)
Other Considerations
      Meetings of Program Directors
      Changes in Personnel
      Changes in Projects
Appendix I - Format for NICHD Cooperative Research Program Project (U19) Applications
Core Usage Table - 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 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) or Letter of Invitation (LOI). Applicants are encouraged to consult with appropriate NICHD staff, listed in the relevant RFA or LOI, 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 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 or LOI; unsolicited applications for new or competing continuation 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.

Eligibility Requirements

In addition to meeting the standard eligibility criteria for research grants specified in the National Institutes of Health Grants Policy Statement ( March 2001, http://grants.nih.gov/grants/policy/nihgps_2001/), a 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.

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 or LOI 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 or LOI, 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 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 or LOI prior to preparing an application. Specific application guidelines may be outlined in the RFA or LOI.

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, 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 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 or LOI.

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), competing continuation (Type 2), and supplemental (Type 3) applications.

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

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

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

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

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

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

Applications must be received by CSR on or before the due date specified in the RFA or LOI. 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), competing continuation applications (Type 2), and supplemental applications (Type 3).

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

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

A 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 Division of Scientific Review (DSR), either a subcommittee of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Initial Review Group (NICHD IRG) or a Special Emphasis Panel (SEP). The NICHD IRG consists of seven subcommittees: (1) the Biobehavioral and Behavioral Sciences Subcommittee; (2) the Developmental Biology Subcommittee; (3) the Function, Integration and Rehabilitation Sciences Subcommittee; (4) the Obstetrics and Maternal-Fetal Biology Subcommittee; (5) the Pediatrics Subcommittee; (6) the Population Sciences Subcommittee; and (7) the Reproduction, Andrology and Gynecology Subcommittee. Each subcommittee includes approximately 10-18 scientists and is staffed by a Scientific Review Administrator (SRA) and a Grants Technical Assistant (GTA). 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 or LOI 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 SRA 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 SRA, Program Staff, and Grants Management Staff for conformance to NIH policy and NICHD guidelines, responsiveness to the RFA or LOI, 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 or LOI, 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 a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council.

Site Visits

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

The plans for site visits in the review of a particular U19 program may be addressed in the relevant RFA or LOI. Final decisions about whether or not a site visit will be held are made by DSR. If a site visit is planned, the Program Director will be contacted by the SRA managing the review and detailed site visit procedures will be provided.

Scientific Review Group Evaluation

At its scheduled meeting, the SRG considers the full application and, if a site visit has taken place, the site-visit report. Each application 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 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 or LOI.

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.
  
  
• Research projects or core units that are found to lack significant and substantial scientific and technical merit will not be recommended for further consideration (NRFC).
  
  
• For individual projects, reviewers will assign a 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/LOI).
  
  
• For individual cores, reviewers will assign a descriptor term 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/LOI). The Administrative Core will either be recommended favorably or not recommended, with no descriptor.
  
  
• In evaluating each core, the SRG will use the following descriptor terms to express its assessment of each core's level of scientific and technical merit:
  
  

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

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

Research projects or core units that are found to lack significant and substantial scientific and technical merit will not be recommended for further consideration (NRFC). The NRFC designation is distinct from the designation "Unscored", used in the streamlined review process and applied to applications falling in the lower half of distribution of priority scores. The streamlined review process is not used by NICHD in the review of U19 applications.

• 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 Program (see Appendix II and relevant RFA/LOI). The resulting priority score for the overall U19 application will reflect reviewers' assessment of the scientific and technical merit of the proposed Program. This assessment must take into consideration all proposed projects and cores, including any with poor ratings or a NRFC recommendation. In assigning priority scores and descriptors, reviewers will be guided by the criteria detailed in Appendix II and in the relevant RFA/LOI.
  
  
• After the review committee has acted, the SRA will prepare a summary statement. The summary statement will indicate the overall SRG recommendation, critiques and recommendations for each proposed project and core, and recommended budgets. All critiques are the verbatim comments of the reviewers. A copy of the summary statement is sent to the Program Director.

Advisory Council Review

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

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

NICHD support for a 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 or LOI. Plans to submit a Type 2 application should be discussed with NICHD Staff listed in the RFA or LOI. 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 or LOI 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 or LOI.

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 Applications for Competitive Supplements (Type 3)

The submission of all applications for competitive supplements to U19 awards (Type 3) must be approved by NICHD Program Staff prior to acceptance for evaluation by an NICHD scientific review group. Any Program supplement that potentially results in a total award that exceeds the funding cap specified in the original RFA or LOI is not allowed. In addition, multiple component supplements submitted as one composite application will not be accepted. Instead, each request for supplementing a component project or core should be submitted as a separate application.

The receipt dates for applications for U19 competitive supplements are February 1, June 1, and October 1.

Review of Non-Competing Continuation Applications (Type 5)

After award, NICHD Staff will evaluate the 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 5/01) 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 or LOI.

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 or LOI.

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 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 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.

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 or LOI 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) or Letter of Invitation (LOI) 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 PROJECTPERIOD ," 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 Competing Continuation applications, justify any significant increases in any category over the current level of support.
         
         
5. BIOGRAPHICAL SKETCH
   
   

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

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

   1. History, Purpose, and Objectives of the 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 competing continuation applications, during the current award 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 Type 2 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 or LOI, 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 25 pages for Sections a-d):

   Discuss the purpose and nature of the project and its relevance to the application's overall theme. Address the following:

   1. Specific Aims
      
      
   2. Background and Significance
      
      
   3. Preliminary Studies /Progress Report (for competing continuations), if applicable. Describe the research project's use of core unit services, including need for the services, and the advantages and cost effectiveness of core unit usage for the project.
      
      
   4. Research Design and Methods. For research involving human subjects, this section must address the inclusion of women, minorities and their subgroups, and children as research subjects, following relevant policy announcements (see RFA or LOI for references).
      
      
   5. Human Subjects Research
      
      
   6. Vertebrate Animals
      
      
   7. Literature Cited
      
      
   8. Collaborative arrangements, including pertinent letters of assurance and intent.
      
      
   9. Consultants
      
      
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 or LOI, the page limitations for each section provided in the PHS 398 instructions are to be used.

   1. Overall Introduction (Do not exceed 3 pages, excluding the summary table)
      
      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 award by showing the quantitative use (percent) of each core unit by the component research projects, presented in a format such as that suggested in the Core Usage Table, 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:
      
      
   2. 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 competing continuations)
         
         
      5. Services Provided: Describe current and projected services to other core units and research projects, and the Program as a whole
         
         
   3. Research Core Units
      
      
      1. Objective
         
         
      2. Staffing: Brief description of scientific, technical, as well as support staff functions
         
         
      3. 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 competing continuations)
         
         
      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 the Core Usage Table
         
         
      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 or LOI for references)
         
         
5. ACCOMPLISHMENTS OF PROGRAM NOT PREVIOUSLY CITED
   
   
   1. Results of completed research projects not previously included (competing continuation only).
      
      
   2. Use of administrative funds by Program Director for activities such as consultant services, scientific seminars, renovations, or travel (competing continuation only).
      
      
   3. Investigators attracted to the field by this Cooperative Research Program Project and its facilities:
      
      
      1. New investigators
         
         
      2. Visiting investigators
         
         
   4. Impact on institution and community
      
      
   5. Role of the U19 award in facilitating research, assisting new investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research.
      
      
   6. Other
      
      
6. CHECKLIST - As required in Form PHS 398

SECTION III - APPENDIX

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

APPENDIX II

GUIDELINES FOR REVIEWERS' COMMENTS AND REVIEW CRITERIA

Each reviewer has been assigned to prepare written comments on one or more component projects or core units and/or the overall Cooperative Program Project 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, 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.

• The Overall Description section of the summary statement will be prepared by NICHD staff using the applicant's description.
  
  
• Except for the section on PROGRAM DIRECTOR, separate Investigator sections are not needed; evaluative comments about the individual project/core investigators should be included in the Critique under the "Investigators" review criterion.
  
  
• The first time any discipline-specific or unusual abbreviation is used, spell out the full word(s) to which it applies.
  
  
• Although your specific assignments are identified on the Tentative Assignment List, you may submit additional comments about any aspect of the application.
  
  
• Please consider evaluation criteria that may be specified in the relevant RFA or LOI that must be addressed in addition to the standard criteria specified below.
  
  
• Your review comments should be typewritten double-spaced to facilitate modifications and additions reflecting changes in your opinion following discussions during the review committee meeting. Please bring hard copies of your reviews with you to the review meeting (or site visit if performed) or fax or E-mail your reviews to the Scientific Review Administrator (SRA) prior to teleconference calls.
  
  
• Please submit your reviews on a formatted diskette unless otherwise instructed by the SRA. Save each project/core review as a separate file. Use only standard keyboard characters in your review; please do NOT use any Greek letters, special fonts (i.e., italics or bold), or special formatting in your review, since these are incompatible with the process that staff must use to upload the final summary statement into the NIH mainframe computer. Please put your name on the diskette, and identify the computer type (IBM or Macintosh) and the word processing program/version used.
  
  
• The SRA will provide specific instructions for the use of E-mail to submit reviews.
  

SUMMARY STATEMENT COMPONENTS

RESUME: You do not need to prepare a Resume.

BACKGROUND: The Background section is needed only for revised or competing continuation applications. It should be brief and contain only those points regarding the history of the Program or of the application that are relevant to the current review (e.g., changes in scientific direction, staffing, etc.).

OVERALL DESCRIPTION: You do not need to prepare an Overall Description.

PROGRAM DIRECTOR: In one paragraph, evaluate the strengths and weaknesses of the Program Director as a scientist and as director of the proposed Program. For competing continuation applications, also evaluate the Program Director's performance in this role during the previous funding period. DO NOT include descriptive, biographical information unless required for the evaluation of merit.

REVIEWS OF INDIVIDUAL PROJECTS AND CORES

For each project or core component to which you are assigned, please prepare a double-spaced draft of the Critique and other required sections, and address administrative considerations as necessary.

During the course of the review, reviewers have the responsibility to incorporate new information from the applicants and to modify their written comments as needed to reflect their final opinions after discussion. The opinions and written reports of all reviewers will contribute to the final summary statement.

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

INDIVIDUAL RESEARCH PROJECTS

Description (Provided by applicant)

Critique (Up to 2-3 pages, depending on the complexity of the project): The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In your written review, you should comment on the following aspects of each project in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.

Address each of the following five review criteria under separate subheadings, considering progress (for competing continuation applications) and/or preliminary data and, for amended applications, changes made to the application in response to the previous critique, as appropriate under each criterion:

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

Approach: Are the conceptual framework, design (including composition of study population), methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigators: Is the Principal Investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? DO NOT INCLUDE descriptive biographical information unless important to the evaluation of merit.

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? DO NOT INCLUDE description of available facilities or equipment unless important to the evaluation of merit.

(NOTE: Although the Environment for each project includes the other components of the Program as a whole, insofar as possible, evaluate the merit of each project individually. Synergy among the projects and cores should be addressed in the "Overall Critique" described below.)

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

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.

Other Considerations:

For detailed information on evaluating the following sections, see NIH policy and guidance for review of applications proposing use of human subjects, available at http://grants.nih.gov/grants/peer/hs_review_inst.pdf.

Protection of Human Subjects from Research Risk

Data and Safety Monitoring Plan

Plan for Inclusion of Women

Plan for Inclusion of Minorities

Plan for Inclusion of Children

Please also include comments, as appropriate, with respect to the following:

Animal Welfare: Express any comments or concerns about the appropriateness of the responses to the five required points, especially whether the procedures will be limited to those that are unavoidable in the conduct of scientifically sound research. This section is not required if there are no comments or concerns.

Biohazards: Note any materials or procedures that are potentially hazardous to research personnel and/or the environment and indicate whether the protection proposed will be adequate.

Budget: Evaluate direct costs only. For all years, determine whether all items of the budget are appropriate and justified for the work proposed. The narrative should include all recommended changes for the first and subsequent years, with detailed rationale for each specific change recommended. For supplemental applications, comment on the requested budget in relation to the parent award. This section is not required if no changes are recommended.

Recommendation: Indicate the final recommendation for the project (level of scientific merit /not recommended for further consideration).

Minority Report: A minority report will be required for a project, core, or the final recommendation for the overall 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.

Foreign Component Project: If the component project is to be carried out at a foreign institution, comment on any special talents, resources, populations, or environmental conditions that are not readily available in the United States or that provide augmentation to existing U.S. resources. In addition, indicate whether similar research is being performed in the U.S. and whether there is a need for such additional research.

These factors do not apply to projects at U.S. institutions containing a significant foreign component.

CORE UNITS

Description (Provided by applicant)

Critique (1-2 pages, as appropriate for the complexity of the core): Each core unit must provide facilities or services for at least three research projects in the Program at all times during the award period.

The Critique for all cores should address:

• Qualifications, experience, and commitment of the core director and other core personnel;
  
  
• The quality of services provided;
  
  
• The cost effectiveness and quality control of the core;
  
  
• The utility of the core to the Program;
  
  
• Appropriateness of the use of core services by the budgeted 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 Program for the evaluation of research productivity, allocation of funds, and management of the resources;
  
  
• The plan for Program evaluation, including the use of any internal and external advisory groups.
  
  

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

Reviewers also should prepare an Overall Evaluation section for each assigned core component, and address Budget, , Human Subjects, Animal Welfare, and Biohazards, , as appropriate.

A Recommendation also should be prepared. Please note that Core Units should receive a descriptor, except for the Administrative Core.

OVERALL CRITIQUE (Limit to 2-4 pages; prepared by Chairperson or designated reviewer): The Overall Critique should convey the overall level of merit of the U19 application and should contain the following sections:

1. The Program 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 Program;
     
     
   • The multidisciplinary scope of the proposed 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 Program; and
     
     
   • The appropriateness of administrative structures and day-to-day management of the Program, 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 Program overall and its potential to advance scientific knowledge in the field.
   
   Approach: Adequacy and quality of the experimental approaches proposed in the projects and the overall design of the Program.
   
   Innovation: Degree to which the overall program applies novel concepts and innovative approaches, represents novel collaborations, etc.
   
   Investigators: Qualifications of the Program Director, the Program leadership, and individual project and core directors.
   
   Environment: Scientific, organizational/institutional, and administrative environment of the program, including institutional commitment to the Program.
   
   
3. The Program 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 or LOI.
     
     
   • For new applications, plans for participation in joint cooperative efforts of the Network of U19s, as described in the relevant RFA or LOI.
     
     
   • For competing continuation applications, comment on specific examples of cooperative interaction with other Programs and/or NICHD.
     
     

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

Protection of Human Subjects from Research Risk

Data and Safety Monitoring Plan

Plan for Inclusion of Women

Plan for Inclusion of Minorities

Plan for Inclusion of Children