Code of Federal Regulations
Title 45, Public Welfare
Department of Health and Human Services
Part 46 - Protection of Human Subjects
Revised June 23, 2005.
Effective June 23, 2005.
- Basic HHS Policy for Protection of Human Research Subjects
- Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
- Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
- Additional Protections for Children Involved as Subjects in Research
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a)
Editorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the Social Security Act, which test the use of cost—sharing, such as deductibles, co-payment and coinsurance, in the Medicaid program. For further information, see 47 FR 9208, Mar. 4, 1982.
Note: As revised, Subpart A of the HHS regulations incorporates the Federal Policy for the Protection of Human Subjects (56 FR 28003). Subpart D of the HHS regulations has been amended at Section 46.401(b) to reference the revised Subpart A.
The Federal Policy for the Protection of Human Subjects is also codified at:
- 7 CFR Part 1c - Department of Agriculture
- 10 CFR Part 745 - Department of Energy
- 14 CFR Part 1230 - National Aeronautics and Space Administration
- 15 CFR Part 37 - Department of Commerce
- 16 CFR Part 1028 - Consumer Product Safety Commission
- 22 CFR Part 225 - International Development Cooperation Agency, Agency for International Development
- 24 CFR Part 60 - Department of Housing and Urban Development
- 28 CFR Part 46 - Department of Justice
- 32 CFR Part 219 - Department of Defense
- 34 CFR Part 97 - Department of Education
- 38 CFR Part 16 - Department of Veterans Affairs
- 40 CFR Part 26 - Environmental protection Agency
- 45 CFR Part 690 - National Science Foundation
- 49 CFR Part 11 - Department of Transportation