The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services on Oct. 25, 2024, issued nonsubstantive amendments to subparts B, C and D of 45 CFR Part 46, which provide additional protections for specified vulnerable populations participating in research studies.
The Final Rule immediately implements technical changes to align the protections for pregnant women, human fetuses and neonates, prisoners and children in subparts B, C and D with the Common Rule (Subpart A of 45 CFR Part 46, as amended in 2017 and 2018, the "2018 Requirements")1 and to the "pre-2018 Requirements" that apply to research approved under such pre-2018 Common Rule Requirements.
Regulatory Updates
Notably, the updates:
- add language to specify references to the 2018 Common Rule Requirements and the pre-2018 Common Rule Requirements
- add language to clarify the meaning of "2018 Requirement" and "pre-2018 Requirements"
- Modify language to reflect the additional exemptions allowed by 46.104(b) of the 2018 Requirements
- Correct technical errors
Foonote
1. The Common Rule, as amended (a) on January 19, 2017 (82 fed Reg 7149), (b) on January 22, 2018 (83 Fed Reg 2885), and (c) June 19, 2018 (83 Fed Reg 28497), is referred to as the "2018 requirements." The version of the common Rule prior to these amendments is referred to as the "pre-2018 Requirements."
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