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1 About Peer Review

Learn about the review of human subjects during the peer review process. Applicants can get a better idea of what peer reviewers look for in the application and Protection of Human Subjects section. Peer Reviewers can find guidance for reviewing the human subjects research plan.

3 Peer Review For Peer Reviewers

NIH Peer Review Site

The core values of peer review drive the NIH to seek the highest level of ethical standards, and form the foundation for the laws, regulations, and policies that govern the NIH peer review process. NIH policy is intended to promote a process whereby grant applications submitted to the NIH are evaluated on the basis of a process that is fair, equitable, timely, and free of bias. 

Peer Review Guidelines for the Review of the Human Subjects Section

This guide is to assist applicants in preparing the Protection of Human Subjects section for submission to the NIH, and to assist reviewers in evaluating the Protection of Human Subjects section of grant applications and cooperative agreements. It provides an overview of the requirements, applicant and reviewer responsibilities, a checklist, and detailed instructions for the review of human subjects in NIH applications.

3 Peer Review About the Peer Review Process

About the Peer Review Process

The core values of peer review drive the NIH to seek the highest level of ethical standards, and form the foundation for the laws, regulations, and policies that govern the NIH peer review process. NIH policy is intended to promote a process whereby grant applications submitted to the NIH are evaluated on the basis of a process that is fair, equitable, timely, and free of bias.

The first level of review is carried out by a Scientific Review Group (SRG) composed primarily of non-federal scientists who have expertise in relevant scientific disciplines and current research areas. The second level of review is performed by Institute and Center (IC) National Advisory Councils or Boards. Councils are composed of both scientific and public representatives chosen for their expertise, interest, or activity in matters related to health and disease. Only applications that are recommended for approval by both the SRG and the Advisory Council may be recommended for funding. Final funding decisions are made by the IC Directors.

For applications that propose the involvement of human subjects, Federal regulations (45 CFR 46.120) require that the information provided in the application (Protection of Human Subjects section or other sections of the application) must be evaluated with reference to the following four criteria: (1) Risk To Subjects; (2) Adequacy Of Protection Against Risks; (3) Potential Benefits Of The Proposed Research To The Subjects And Others; (4) Importance Of The Knowledge To Be Gained. This evaluation is independent of any other group who will review the research.

For more information see NIH Peer Review (PDF).

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