21 CFR Part 56 - Institutional Review Boards

What it says

Part 56 sets the standards for institutional review boards that review clinical investigations regulated by FDA. It covers IRB membership, functions and operations, criteria for approval of research, review of ongoing studies at least once a year, records the IRB must keep, and administrative actions for noncompliance.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• An IRB must review and approve a study before it starts, and continue to review it at appropriate intervals.
• Written procedures define how the board operates, handles changes, and reports problems.
• Records such as minutes, protocols, consent forms and correspondence have to be kept for the required period.

What FDA inspectors look for

• Whether the IRB has written procedures and follows them.
• Whether continuing review was done on time.
• Whether minutes and records show required quorum and reasoning.

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