Department of Health & Human Services

1. Title 45 CFR 46 Public Welfare: Protection of Human Subjects

Food and Drug Administration – Department of Health & Human Services

1. Title 21 CFR 11 Food and Drugs: Electronic Records; Electronic Signature
2. Title 21 CFR 54 Food and Drugs: Financial Disclosure by Clinical Investigators
3. Title 21 CFR 50 Food and Drugs: Protection of Human Subjects
4. Title 21 CFR 56 Food and Drugs: Institutional Review Boards
5. Good Clinical Practice: Consolidated Guidance

Human Subjects Information

1. Belmont Report 
2. U.S. Department of Health and Human Services
3. U.S. Office for Human Research Protections (OHRP)
4. U. S. Food and Drug Administration
5. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)