What US 21 CFR Part 56: Institutional Review Boards requires
US 21 CFR Part 56 sets requirements for IRB membership, functions, operations, review of research, recordkeeping, and IRB-related submissions and approvals for FDA-regulated clinical investigations. The regulation covers IRB composition including non-affiliated and non-scientific members, expedited review categories, criteria for approval (risk minimisation, equitable selection, informed consent, data monitoring, privacy), continuing review at intervals appropriate to risk, suspension or termination, and FDA registration of IRBs. Compliance is verified during FDA bioresearch monitoring inspections.
Pillar: Pharmaceuticals & Life Sciences · Authority: US Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56
SHA-256 integrity: 27083ed6a8d18611c8bc2acdf92750ce3b1518cf87689c9c5a38d9a305d2697f
Primary Citations — 5 traced to source
- Title 21 Code of Federal Regulations Part 56 Institutional Review Boards
- Title 21 Code of Federal Regulations Part 50 Protection of Human Subjects
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/us-21-cfr-part-56-institutional-review-boards.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/us-21-cfr-part-56-institutional-review-boards.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/us-21-cfr-part-56-institutional-review-boards
- Back to registry: Browse all 10,090 compliance nodes