Federal Regulations

Office for Human Research Protections (OHRP)

45 CFR 46 - Protection of Human Subjects

U.S. Food and Drug Administration (FDA)

• 21 CFR 50 - Protection of Human Subjects
• 21 CFR 54 - Financial Disclosure by Clinical Investigators
• 21 CFR 56 - Institutional Review Boards
• 21 CFR 312 - Investigational New Drug Application
• 21 CFR 812 - Investigational Device Exemptions

Federal Guidelines

National Institutes of Health (NIH)

• Guidelines on Women and Minorities
• Inclusion of Women and Minorities as Participants in Research Involving Human Subjects - Policy Implementation Page
• Inclusion of Children Policy Implementation
• Research Involving Individuals with Questionable Capacity to Consent: Points to Consider

U.S. Department of Health & Humans Services (HHS) - Office for Civil Rights (OCR)

• HIPAA - National Standards to Protect the Privacy of Personal Health Information

Federal Advisory Committee on Human Subjects Research

• Secretary's Advisory Committee on Human Research Protections (SACHRP)

Ethical Codes

• Belmont Report
• World Medical Association Declaration of Helsinki