The HHS Regulations – Protection of Human Subjects

Document titled with text: Code of Federal Regulations, Title 45, Public Welfare, Department of Health and Human Services, Part 46, Protection of Human Subjects.

The ethical principles for research involving human subjects described in the Belmont Report are codified in the Code of Federal Regulations, 45 CFR 46. The NIH follows all Subparts of the HHS regulations:

Subpart A – Basic HHS Policy for Protection of Human Research Subjects

Subpart B – Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

Subpart D – Additional Protections for Children Involved as Subjects in Research

Subpart E – Registration of Institutional Review Boards (effective July 14, 2009)