U.S. Office for Human Research Protections

• Protection of Human Subjects — 45 CFR 46
• The Belmont Report
• The Nuremberg Code
• Institutional Review Board Guidebook
• World Medical Association Declaration of Helsinki
• Compilation of National Policies

U.S. Food and Drug Administration

• Protection of Human Subjects — 21 CFR 50
• Institutional Review Boards — 21 CFR 56
• Investigational New Drug Application — 21 CFR 312
• Investigational Device Exemptions — 21 CFR 812
• FDA Guidance

National Institutes of Health

• Office of Biotechnology Activities
• NIH Registry of Clinical Trials
• Certificates of Confidentiality

U.S. Department of Health and Human Services — Office of Civil Rights

• The Health Insurance Portability and Accountability Act of 1996 (HIPAA)