What US 45 CFR Part 46: Protection of Human Subjects (Common Rule) requires
US 45 CFR Part 46 (the Common Rule) establishes the principal federal regulation for the protection of human subjects in research conducted or supported by 15+ federal departments and agencies. Subpart A (the basic policy adopted by Common Rule signatories) covers Institutional Review Board (IRB) review and approval criteria, informed consent requirements, exemption categories (8 categories in revised 2018 Rule), expedited review procedures, and continuing review. Subparts B C D provide additional protections for pregnant women fetuses and neonates (Subpart B) prisoners (Subpart C) and children (Subpart D). Subpart E covers Registration of IRBs. The 2018 Revised Common Rule introduced single IRB review for multi-site studies broad consent for storage of identifiable biospecimens and new exemption categories.
Pillar: Education & Research · Authority: US HHS OHRP · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46
SHA-256 integrity: debeadcae1fb1ed45039f82025da77be8672ec01e7c11ee4613dea602c23be3d
Primary Citations — 5 traced to source
- US 45 CFR Protection of Human Subjects
- US 45 CFR § 46.102 Definitions
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