An Institutional Review Board (IRB) — also called an Independent Ethics Committee — is a federally registered body that reviews human-subjects research before it begins and monitors it while it is underway.
What an IRB does
- Reviews protocols, informed consent forms, and recruitment materials
- Determines the appropriate level of review (exempt, expedited, or full board)
- Approves, requires modifications to, or disapproves studies
- Conducts continuing review of ongoing research
Regulatory basis
IRBs operate under 45 CFR 46 (the Common Rule) for federally funded research and 21 CFR 50/56 for FDA-regulated studies. An IRB must be registered with OHRP (IORG/IRB numbers) and, for FDA studies, follow FDA registration requirements.