# Protection of Human Research Subjects
> **US Department of Health and Human Services** · Final Rule. · Published 2001-11-13 · Effective 2001-12-13 · 66 FR 56775
## Document
- **Document number:** 01-28440
- **Category:** other
- **Sub-agency:** US Department of Health and Human Services
- **Federal Register citation:** 66 FR 56775
- **CFR reference:** 45 CFR 46
- **Publication date:** 2001-11-13
- **Effective date:** 2001-12-13
## Abstract

The Department of Health and Human Services (DHHS) is withdrawing Subpart B of its human subjects protection regulations published on January 17, 2001 and is issuing this replacement rule. These regulations provide additional protections for pregnant women and human fetuses involved in research. The final rule continues the special protections for pregnant women and human fetuses that have existed since 1975 and makes limited changes in terminology referring to neonates, clarifies provisions for paternal consent when research is conducted involving fetuses, clarifies language that applies to research on newborns of uncertain viability, and corrects technical errors.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2001/11/13/01-28440/protection-of-human-research-subjects)
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