NOTE: All research that is conducted, supported, or regulated by any US Government Agency under the Federal Policy (or Common Rule) for the Protection of Human Subjects is subject to certain uniform requirements regarding IRB membership, IRB review and approval criteria, IRB operations and record keeping, and informed consent. In addition to the information provided on this website, review that provided at the FDA Website.

Responsibilities of domestic IRBs and international IECs providing review and oversight of FDA-regulated research

1. The IRB should ensure that all human subject research that is regulated by the Food and Drug Administration (FDA), and for which the IRB provides review and oversight, complies with FDA regulations at Title 21 Code of Federal Regulations Parts 50 and 56 (21 CFR 50 and 56). FDA-regulated research in this case includes (a) clinical investigations overseen by domestic IRBs and regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act; (b) clinical investigations overseen by domestic IRBs that support applications for research or marketing permits for FDA-regulated products (such as drugs, biological products, devices, food additives, and color additives); and(c) clinical investigations overseen by foreign IRBs that are required to comply with 21 CFR Part 56.

2. Except for research exempted or waived under Sections 56.104 or 56.105 of the FDA regulations, all research for which the IRB is responsible should be reviewed, prospectively approved, and subject to continuing oversight by the IRB. The IRB should have the authority to approve, require modifications in, or disapprove the research for which it is responsible.

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