45 CFR 46 (Common Rule)
ARCHIVED 2025-05-03, DATE APPROXIMATE · VERSION 20250503_rev01 · COMPARED WITH 20240801_rev01
Full text changes — 20240801_rev01 to 20250503_rev01
COLOUR MARKS THE SEVERITY OF A FLAGGED CLAUSE · + AND − MARK ADDED AND REMOVED
| 1 | ## Disclaimer Policy: Links with this icon () mean that you are leaving the HHS website. | |
| 1 | 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. | |
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| 3 | 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. |