Final Rule Amending Subparts B, C, and D of 45 CFR Part 46 for Conformity to the Revised Common Rule

The Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) announces the publication of a final rule that includes non-substantive amendments to HHS’s regulations for the protection of human subjects at 45 CFR part 46. This final rule amends subparts B, C, and D, which provide additional protections for certain populations in research. Administrative changes needed to be made to these subparts to ensure that subparts B, C, and D align with the 2018 revision to subpart A, known as the Common Rule, which provides a robust set of protections for research subjects. For example, this final rule updates regulatory citations that were renumbered in the revised Common Rule and adds new language based on the transition provisions in the revised Common Rule. This final rule also includes other non-substantive technical changes to ensure conformity between the Common Rule and subparts B, C, and D of 45 CFR part 46.

There are no substantive amendments included in this final rule, which is effective upon publication. Institutions may choose to update their materials accordingly.

This final rule can be viewed online here:
https://www.federalregister.gov/documents/2024/10/24/2024-24399/department-of-health-and-human-services-policy-for-the-protection-of-human-research-subjects-update