Which regulation part primarily governs Institutional Review Board operations?

• A. 21 CFR Part 33
• B. 21 CFR Part 56
• C. 21 CFR Part 312
• D. 21 CFR Part 11

Answer: (B)

Institutional Review Board operations are governed primarily by 21 CFR Part 56, which lays out the IRB’s authority, membership, and procedures, including how they review and approve research involving human subjects, conduct continuing review, and ensure proper informed consent and record-keeping. This regulation directly addresses how IRBs function, their responsibilities, and the safeguards required to protect participants throughout a study. Other parts of the CFR cover related aspects of FDA-regulated research—such as electronic records and signatures, and the management of investigational drugs and trials—but they do not establish the core rules for how IRBs operate.