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What is an Institutional Review Board (IRB)?

Institutional Review Board (IRB) is a board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights, safety, and welfare of human subjects. The IRB should be established, operated, and function in conformance with 21 CFR 56. The term has the same meaning as "institutional review committee" in section 520(g) of the FD&C Act.