Institutional Review Boards (IRBs)
The US regulation governing the composition, functions, and operations of Institutional Review Boards (IRBs) that review FDA-regulated clinical investigations to protect the rights and welfare of human subjects.
IRBs reviewing FDA-regulated research, and the sponsors/investigators relying on IRB review. Complements 21 CFR Part 50 (informed consent).
- 01IRB review and approval before initiation and at intervals appropriate to risk
- 02Documented written procedures for initial and continuing review
- 03Records retained for at least 3 years after completion of the research
Aligned with the revised Common Rule single-IRB expectations for cooperative research.
21 CFR Part 56: frequently asked questions
Quick answers to common questions about 21 CFR Part 56.
What is 21 CFR Part 56?
21 CFR Part 56 — Institutional Review Boards (IRBs) — is a regulation issued by the Food and Drug Administration (United States). The US regulation governing the composition, functions, and operations of Institutional Review Boards (IRBs) that review FDA-regulated clinical investigations to protect the rights and welfare of human subjects.
Who does 21 CFR Part 56 apply to?
IRBs reviewing FDA-regulated research, and the sponsors/investigators relying on IRB review. Complements 21 CFR Part 50 (informed consent).
What are the key requirements of 21 CFR Part 56?
FDA 21 CFR Part 56 requires, among other things: IRB review and approval before initiation and at intervals appropriate to risk; Documented written procedures for initial and continuing review; Records retained for at least 3 years after completion of the research.
When was 21 CFR Part 56 last updated?
The current version of 21 CFR Part 56 dates from January 2024. Aligned with the revised Common Rule single-IRB expectations for cooperative research.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When 21 CFR Part 56 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.