An Institutional Review Board (IRB) is an independent committee that reviews and oversees research involving human participants in the United States.
IRBs evaluate riskñbenefit balance, informed consent content, participant protections, and study procedures before enrollment begins and throughout the study via continuing oversight. They operate under 45 CFR 46 and, when FDA-regulated, under 21 CFR Parts 50 and 56. IRB review helps ensure participant rights, safety, and welfare are prioritized while supporting ethically sound study design. Ongoing IRB oversight also addresses amendments, safety updates, noncompliance, and unanticipated problems.