Data / Federal rules / 2024-24399

Department of Health and Human Services Policy for the Protection of Human Research Subjects: Update to the Additional Protections for Specific Populations

The Health and Human Services Department published this final rule in the Federal Register on October 24, 2024. It took effect on October 24, 2024.

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What the agency says

In this final rule, the Department of Health and Human Services (HHS) is amending its regulations that govern the protection of human subjects for conformity with 2018 revisions made to the Federal policy for protection of human research subjects (the "Common Rule"), as well as to maintain consistency with the prior version of the Common Rule for research that remains subject to those requirements. Amendments include updating citations that were renumbered, adding updated descriptions of the applicability of exemptions, and correcting a technical error. No substantive amendments are included in this final rule.

Key facts

Document number: 2024-24399
Type: Final rule
Action: Final rule
Agency: Health and Human Services Department
Published: October 24, 2024
Takes effect: October 24, 2024
Dates: This final rule is effective October 24, 2024.
Regulation ID (RIN): 0937-AA09
Code of Federal Regulations: 45 CFR 46
Topics: Human research subjects; Reporting and recordkeeping requirements; Research
Significant: Yes, under Executive Order 12866
Pages: 6

The document on federalregister.gov PDF

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Everything from the Health and Human Services Department · Rules on human research subjects · Rules on reporting and recordkeeping requirements · Rules on research · Published in October 2024

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.