45 CFR 46 (Common Rule)

ARCHIVED 2026-05-01, DATE APPROXIMATE · VERSION 20260501_rev01 · COMPARED WITH 20250503_rev01

Full text changes — 20250503_rev01 to 20260501_rev01

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+The HHS regulations for the protection of human subjects in research at 45 CFR 46 include five subparts. Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects. The Common Rule, subpart A, was revised in recent years (the "2018 Requirements"). Subparts B, C, and D provide additional protections for certain populations in research. Subpart E provides requirements for institutional review board registration. Access the regulatory language using the links below.
+- - About HHS
+In general, research initiated before January 21, 2019 continues to comply with the pre-2018 Common Rule unless the institution chose to transition it to the revised Common Rule.
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+    - [Keeping Food Ingredients Safe](https://hhs.gov/about/news/2025/03/10/hhs-secretary-kennedy-directs-fda-explore-rulemaking-eliminate-pathway-companies-self-affirm-food-ingredients-safe.html)
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