Code of Federal Regulations
TITLE 45
PUBLIC WELFARE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 46
PROTECTION OF HUMAN SUBJECTS
| 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 |
Food and Drug Administration Regulations
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials
Federal Policy for the Protection of Human Subjects (“Common Rule”)
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html