- Federal Register: 21CFR312: Investigational New Drug Applications Title 21, Chapter FDA, Part 312
- Federal Register: 21CFR812: Investigational Device Exemptions Title 21, Chapter FDA, Part 812
- 45 CFR Part 46: Pre 2018 Code of Federal Regulations- Public Welfare: Protection of Human Subjects (Common Rule)
- 45 CFR Part 46: 2018 Code of Federal Regulations- Public Welfare: Protection of Human Subjects (Common Rule)
- 21 CFR Part 50: Protection of Human Subjects
- 21 CFR Part 56: Institutional Review Boards
- 32 CFR Part 219: National Defense: Office of the Secretary of Defense
- 28 CFR Part 512: Department of Justice : Research with Prisoners within the Bureau of Prisons
- 45 CFR Part 164: HIPAA Regulations-- Standards for Privacy of Individually Identifiable Health Information; Security Standards for the Protection of Electronic Protected Health Information (HIPAA Privacy and Security Rules)
Guidance
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research, The Belmont Report (April 18, 1979) - World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
- OHRP Determination Letters
- FDA (Food and Drug Administration) IRB Information Sheets-policy statement and guidance documents
- FDA International Conference on Harmonization, Guidance on General Considerations for Clinical Trials, 62 Federal Register 66113 (December 17, 1997).
- International Conference on Harmonisation (ICH), Good Clinical Practice Guidelines
- The Nuremburg Code
- Department of Defense Directive Number 3216.02