45 CFR 46 (Common Rule)
ARCHIVED 2024-08-01, DATE APPROXIMATE · VERSION 20240801_rev01 · COMPARED WITH 20230510_rev01
Full text changes — 20230510_rev01 to 20240801_rev01
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| 1 | The HHS regulations for the protection of human subjects in research at 45CFR 46 include five subparts. Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for IRB registration. The Common Rule, subpart A, was revised in recent years. Access the regulatory language for all of the subparts using the links below. In addition, OHRP provides an annotated version of the Common Rule that highlights changes between the pre-2018 and 2018 versions of the Common Rule. | |
| 1 | ## Disclaimer Policy: Links with this icon () mean that you are leaving the HHS website. | |
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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. | |
| 3 | - The Department of Health and Human Services (HHS) cannot guarantee the accuracy of a non-federal website. | |
| 4 | - Linking to a non-federal website does not mean that HHS or its employees endorse the sponsors, information, or products presented on the website. HHS links outside of itself to provide you with further information. | |
| 5 | - You will be bound by the destination website's privacy policy and/or terms of service when you follow the link. | |
| 6 | - HHS is not responsible for Section 508 compliance (accessibility) on private websites. | |
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| 8 | For more information on HHS's web notification policies, see [Website Disclaimers](https://hhs.gov/disclaimer.html). |