An institutional review board (IRB) is the institutional entity charged with providing ethical and regulatory oversight of research involving human subjects, typically at the site of the research study. NIH does not require IRB approval before NIH peer review of proposed research; however, the appropriate IRB approval(s) must be in place to implement the research protocol. This review must be conducted by an IRB approved by the HHS Office of Human Subjects Protection; this can include approval by a single or central IRB in the case of multisite studies. Both local and single IRBs must follow the same Federal regulations about human subjects protections provided in 45 CFR 46, Subpart A and 21 CFR Part 50 (for studies that must also meet Food Drug Administration requirements). IRBs also ensure compliance with relevant local and State regulations.

Each IRB follows its own operational policies. Contact your local IRB to learn how it can work with you to help protect human subjects in your clinical research. IRB staff may be able to offer recommendations on writing the protocol, consent forms, and other documents and on the appropriate training to provide your research staff.

NIH Single Institutional Review Board Policy

NIH Single IRB policy affects multi-site studies involving non-exempt human subjects research funded by NIH and applies to grant applications with due dates on or after January 25, 2018, and R&D contracts in response to solicitations issued on or after January 25, 2018.