IRB

An Institutional Review Board (IRB) is an ethics committee that reviews, approves, and monitors research involving human participants to protect their rights and welfare. In the United States, IRBs operate under two principal regulatory frameworks: 21 CFR Part 56 for FDA-regulated research (drugs, devices, biologics) and 45 CFR Part 46, the "Common Rule," for federally supported research across 20+ agencies. Both trace their ethical foundation to the 1979 Belmont Report, which articulated the core principles of respect for persons, beneficence, and justice (HHS Office for Human Research Protections). Cannabis research carries additional layers because cannabis remains a Schedule I substance under the Controlled Substances Act: IRBs typically require confirmation of a DEA Schedule I researcher registration, an approved source of study drug (historically NIDA/University of Mississippi, now also DEA-registered bulk manufacturers), and, for interventional studies, an FDA IND. These added requirements extend review timelines substantially compared with Schedule II–V research. → See also: Placebo-controlled, Double-blind.