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.
What this does not cover
stated in the document's own scope- Governs the review board and its operations, not informed consent itself, which is set out in 21 CFR Part 50.
- Covers ethical review, not the design or conduct of the investigation, which for drugs is governed by 21 CFR Part 312 and for devices by Part 812.
- Applies to FDA-regulated research; boards reviewing only federally funded non-FDA research operate under the corresponding provisions of the HHS Common Rule (45 CFR 46).
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 56 is the US regulation governing Institutional Review Boards — the committees that review FDA-regulated clinical investigations to protect the rights and welfare of human subjects. It requires IRB review and approval before covered research begins and as it continues, and it sets the board’s composition, its functions and operating procedures, the criteria it must apply to approve research, and its recordkeeping. It provides for expedited review of minimal-risk research and of minor changes, and it sets out the administrative actions FDA can take against an IRB or institution for non-compliance, including disqualification.
Scope & applicability
IRBs reviewing FDA-regulated research, and the sponsors/investigators relying on IRB review. Complements 21 CFR Part 50 (informed consent).
Legal basis & how it acquires force
Part 56 is a binding regulation in Title 21 CFR, issued under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, which authorise FDA to require review of clinical investigations to safeguard human subjects. IRB approval is a legal precondition for conducting FDA-regulated research: an investigation subject to Part 56 may not proceed without it. Its requirements are coordinated with the HHS Common Rule (45 CFR 46), whose IRB provisions closely parallel Part 56 so a single board can operate under both frameworks.
Document structure
| Part | Covers |
|---|---|
| Subpart A | General provisions — scope, definitions, and the circumstances requiring IRB review |
| Subpart B — §56.107 | IRB membership: the required composition, diversity of members, and conflict-of-interest limits |
| Subpart C — §56.108–§56.111 | IRB functions and operations, review of research, expedited review procedures, and the criteria for approval |
| Subpart C — §56.113, §56.115 | Suspension or termination of approval and the records an IRB must prepare and retain |
| Subpart E | Administrative actions for non-compliance, including lesser sanctions and disqualification of an IRB or institution |
Key requirements
- 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
Implementation tips
- Reconcile IRB approval dates against site activation and each protocol/consent amendment
- Verify quorum and voting records exist for the approvals your trial relies on
Revision notes
Aligned with the revised Common Rule single-IRB expectations for cooperative research.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 56 is coordinated with the IRB provisions of the HHS Common Rule (45 CFR 46), so an IRB can review studies under both the FDA and HHS frameworks against consistent membership, procedure, and approval standards. Together with the informed-consent requirements of 21 CFR Part 50 it forms the US human-subject protection scheme that gives regulatory effect to the ethical-review principles of the Declaration of Helsinki and ICH E6.
21 CFR Part 56: frequently asked questions
Quick answers to common questions about 21 CFR Part 56.
What must an IRB do under 21 CFR Part 56?
Review and approve FDA-regulated clinical research before it begins and at intervals thereafter, applying the approval criteria in §56.111, and maintain the membership, procedures, and records the regulation specifies to protect subjects’ rights and welfare.
Can one IRB operate under both FDA and HHS rules?
Yes. Part 56 is coordinated with the IRB provisions of the HHS Common Rule (45 CFR 46), and their membership, procedure, and approval requirements closely parallel each other, so a single board can review studies under both frameworks.
How do Parts 50 and 56 fit together?
Part 56 governs the review board; Part 50 governs informed consent. Together they make up the FDA human-subject protection framework, alongside the study-conduct rules in Parts 312 and 812.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.