45 CFR Part 46 - PROTECTION OF HUMAN SUBJECTS
- Subpart A - Basic HHS Policy for Protection of Human Research Subjects (§§ 46.101 - 46.124)
- Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (§§ 46.201 - 46.207)
- Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects (§§ 46.301 - 46.306)
- Subpart D - Additional Protections for Children Involved as Subjects in Research (§§ 46.401 - 46.409)
- Subpart E - Registration of Institutional Review Boards (§§ 46.501 - 46.505)
Link to an amendment published at 82 FR 7273, Jan. 19, 2017.
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, copayment and coinsurance, in the Medicaid program. For further information see 47 FR 9208, Mar. 4, 1982.