Institutional Review Board (IRB)

The IRB is the US counterpart to an EU ethics committee. A significant risk device study needs both IRB approval and an FDA-approved IDE, while a non-significant risk study needs only IRB approval.

Institutional Review Board (IRB) means any 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 and welfare of the human subjects. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act.

21 CFR, 56.102