A board or committee that an institution designates to review and approve biomedical research involving human subjects, including clinical trials for investigational new drug applications (INDs) and investigational device exemption (IDEs). The Institutional Review Board's (IRB) primary purpose is to safeguard the human subjects' rights and welfare. (21 C.F.R. § 56.102(g).)

Before approving proposed research involving a human subject, the IRB must determine that the research requires informed consent to be sought from each prospective subject or the subject's legally authorized representative under 45 C.F.R. § 46.116 and 21 C.F.R. §§ 50.1 to 50.56.

The Food and Drug Administration regulates the IRB's functions, operations, records, reports, registration, and membership. The IRB must register with the FDA if they review clinical trials for INDs or IDEs, or for research or marketing of FDA-regulated products (21 C.F.R.§ 56.106(a)). The IRB must register with the Department of Health and Human Services, Office of Human Research Protections (OHRP) if they will review clinical research supported by federal agencies (45 C.F.R.§ 46.501).

The IRB should consist of at least five members with diverse backgrounds who can review and evaluate the proposed research's scientific and medical aspects, and ethics. The IRB must have at least one member:

(45 C.F.R. 46.107(b) and 21 C.F.R. § 56.107.)