initial review, responsibilities, CSR, center for scientific review, DRR, Division of Receipt and Referral, SRO, scientific review officer, peer review, overall impact, scored review criteria, additional review criteria, additional review considerations

2.4.1 Initial Review

2.4.1.1 Responsibilities

The Division of Receipt and Referral (DRR) within the CSR receives all competing grant applications submitted to NIH.

CSR centrally reviews the application for completeness and responsiveness to the NOFO, as applicable, conducts the initial technical review for scientific merit and prepares the summary statements.

CSR Referral Officers, who are senior health scientist administrators with both research and scientific review experience, assign each application to one or more ICs for potential funding and to a specific study section for initial review of the scientific merit of the application. These assignments are made on the basis of the application's contents and referral guidelines.

CSR's study sections are organized into Review Branches by scientific discipline or current research areas and are managed by health scientist administrators functioning as SROs. Generally, study sections are chartered groups composed of formally appointed members serving multiyear terms, to which the SRO Scientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h). often adds temporary members or other additional reviewers. Ad hoc Special Emphasis Panels (SEPs) are formed to review applications that cannot be reviewed by a standing review group or study section because they require special expertise or involve other special circumstances.

SRGs, whether study sections or SEPs, are primarily composed of non-federal scientists who have expertise in relevant scientific disciplines and are actively engaged in research. NIH's conflict-of-interest and confidentiality of information requirements for reviewers are intended to promote an unbiased review process by minimizing even the appearance of a conflict of interest and by restricting the use of privileged application information.

Applicants are notified by e-mail that their application has been received and that they can find information about the application's SRO Scientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h)., SRG, and IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. assignments in eRA Commons. At this time, applicants may request reconsideration of the SRG and IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. assignment. Applicants also are notified by e-mail to check eRA Commons for any change in the application's SRG or IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. assignment, as well as a change in Council date. Once the assignment process is completed, the SRO Scientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h)., not the PO, is the primary contact for communication with the applicant until the summary statement is released. An applicant organization may withdraw an application from consideration at any time during the review process. A request to withdraw an application must be signed by the PD/PI and an AOR, and submitted to the SRO Scientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h)..

In preparation for the initial review, SROs review applications to determine whether they are complete and conform to administrative requirements. For each reviewable application, they then assign (from among the standing and temporary members) at least three reviewers to write a critique of the application, provide initial scores, and to be prepared to discuss the application in detail.

Following the initial review, the SRO Scientific Review Officer: The NIH official who serves as the designated Federal official having legal responsibility for managing the peer review meeting, the procedures for evaluating the applications assigned to the SRG and the determinations and management of conflicts of interest, as noted in 42 CFR 52(h). prepares a summary statement for most applications reviewed. The summary statement includes the reviewers' written comments, and, for scored applications, a summary of the discussion, and an overall impact score. Summary statements are then provided to the IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.'s Advisory Councils, the PD(s)/PI(s), and applicant institution's Authorized Organization Representative The individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. This individual is equivalent to the signing official in the eRA Commons, i.e., holds the SO Role..

2.4.1.2 Overall Impact

Reviewers assess overall impact in the determination of scientific and technical merit; overall impact is defined based on the different types of applications. When considering applications for research grants and cooperative agreements, reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the five scored review criteria, and additional review criteria (as applicable for the project proposed). These criteria are evaluated and scored in accordance with the applicable peer review framework (standard or Simplified Review Framework (SRF.)

NIH utilizes SRF for the peer review of the majority of competing research project grants (applications under the following activity codes: R01, R03, R15, R16, R21, R33, R34, R36, R61, RC1, RC2, RC4, RF1, RL1, RL2, U01, U34, U3R, UA5, UC1, UC2, UC4, UF1, UG3, UH2, UH3, UH5, (including the following phased awards: R21/R33, UH2/UH3, UG3/UH3, R61/R33).

All other research project grant applications utilize the standard peer review criteria.

2.4.1.3 Standard Scored Review Criteria (Non SRF-applicable activity codes)

The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, enhance health, and reduce illness and disability. For research grant applications, and most other types of applications, reviewers evaluate the overall impact of the proposed project based on five regulatory criteria: Significance, Investigator(s), Innovation, Approach, and Environment.

For non SRF-applicable activity codes, reviewers will consider each of the five criteria below in the determination of scientific and technical merit, and determine a separate score for each. An application does not need to be strong in all categories to be evaluated likely to have a major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

  • Significance
  • Investigator(s)
  • Innovation
  • Approach
  • Environment

The NOFO should be consulted for additional information describing each of the scored review criteria.

2.4.1.4 Standard Additional Review Criteria (Non SRF-applicable activity codes)

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

  • Protections for Human Subjects
  • Inclusion of Human Subjects, Policies
  • Vertebrate Animals
  • Biohazards
  • Resubmission /Renewal / Revision Applications

The NOFO should be consulted for additional information describing each of the relevant additional review criteria.

2.4.1.5 Standard Additional Review Considerations (Non SRF-applicable activity codes)

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

  • Provision of Family Care Facilities (for Conference Grant Applications)
  • Select Agent Research
  • Resource Sharing Plans
  • Authentication of Key Biological and/or Chemical Resources
  • Budget and Period of Support

The NOFO should be consulted for additional information describing each of the relevant additional review considerations.

Although these review criteria are intended for use primarily with investigator-initiated research project grant applications (e.g., R24 and P01), including those in response to PAs, to the extent reasonable, the criteria also will form the basis of the review of solicited applications and research related activities. However, for some activities (e.g., construction grants and research project grants subject to the Simplified Review Framework), the use of these criteria may not be feasible. Applications also may be reviewed against other pertinent factors as stated in NOFOs.

2.4.1.6 Simplified Review Framework (SRF)

Due to the inherent complexity of the peer review process, NIH utilizes the Simplified Review Framework (SRF) for the peer review of the majority of competing research project grants (applications under the following activity codes: R01, R03, R15, R16, R21, R33, R34, R36, R61, RC1, RC2, RC4, RF1, RL1, RL2, U01, U34, U3R, UA5, UC1, UC2, UC4, UF1, UG3, UH2, UH3, UH5, (including the following phased awards: R21/R33, UH2/UH3, UG3/UH3, R61/R33). The SRF enables peer reviewers to better focus on the central questions necessary to assess the scientific and technical merit of a proposed research project: the importance of the proposed research, whether the proposed research methods are rigorous and feasible, and whether the investigators and institution have the expertise and resources necessary to carry out the project as proposed. Additionally, the use of the SRF aids NIH in mitigating the effect of reputational bias by refocusing the evaluation of the investigator/environment to within the context of the proposed and research and also reduces burden on the reviewer by shifting policy compliance activities to NIH staff.

SRF Review Criteria

The SRF reorganizes the five regulatory criteria into three factors as listed below. Each factor is evaluated by the Reviewer in the determination of scientific merit, and in providing an overall impact score. Factors 1 and 2 will each receive a separate criterion score; Factor 3 will be evaluated for sufficiency. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Factor 1. Importance of the Research (scored 1-9):

  • Significance
  • Innovation

Factor 2. Rigor and Feasibility (Scored 1-9)

  • Approach (also includes Inclusion and Clinical Trial Study Timeline)

Factor 3. Expertise and Resources (considered in overall impact: no individual score provided)

  • Investigator(s), Environment
    • Evaluated as 'appropriate' or 'gaps identified'
    • Reviewer is required to provide further explanation, if gaps are defined.

SRF Additional Review Criteria (can affect overall impact score)

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items:

  • Protections for Human Subjects
  • Vertebrate Animals
  • Biohazards
  • Resubmission / Renewal / Revision Applications

The NOFO should be consulted for additional information describing each of the relevant additional review criteria.

SRF Additional Review Considerations (No effect on overall impact score)

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

  • Authentication of Key Biological and/or Chemical Resources

  • Budget and Period of Support