Common Rule (45 CFR Part 46) and IRB Oversight

What this entry covers

45 CFR Part 46 is the HHS regulation for the protection of human subjects in research. Subpart A, the Common Rule, sets requirements for institutional review boards (IRBs), informed consent and assurances of compliance, and has been adopted by many federal departments and agencies; Subparts B, C and D add protections for pregnant women, fetuses and neonates, prisoners, and children, and Subpart E covers IRB registration. HHS’s Office for Human Research Protections (OHRP) approves assurances and accepts IRB registrations under it, while FDA-regulated clinical investigations follow FDA’s parallel rules at 21 CFR Parts 50 and 56.

MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid. It is not legal advice and is not a substitute for the official text.

Official documentation

• Primary official source: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
• Regulation text (eCFR): https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46

Recent changes

• 2026-06-03: ICH adopted Annex 2 of the E6(R3) Good Clinical Practice guideline at Step 4. ICH
• 2025-01-06: ICH adopted the E6(R3) Good Clinical Practice guideline (Principles and Annex 1) at Step 4. ICH
• 2024-10-24: HHS published non-substantive amendments to Subparts B, C and D of 45 CFR Part 46 so they conform to the 2018 Common Rule, effective the same day (89 FR 84822). Federal Register

How to use this index entry

1. Open the official link above (or the agency home if the deep link drifts).
2. Confirm edition / revision date against your program scope.
3. Map applicability by sector and jurisdiction listed in the metadata.
4. Follow related frameworks only after checking their own official sources.

Disclaimers

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