Regulatory Links

Federal Regulations

• Office for Human Research Protections (OHRP)
• Protection of Human Subjects (45 CFR 46)
• U.S. Food and Drug Administration
• Protection of Human Subjects (21 CFR 50)
• Financial Disclosure by Clinical Investigators (21 CFR 54)
• Institutional Review Boards (21 CFR 56)
• Investigational New Drug Application (21 CFR 312)
• Investigational Device Exemptions (21 CFR 812)

Federal Guidelines

• National Institutes of Health
• 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
• Office for Civil Rights (OCR)
• National Standards to Protect the Privacy of Personal Health Information (HIPAA)
• Secretary's Advisory Committee on Human Research Protections

Ethical Codes

• Belmont Report
• World Medical Association Declaration of Helsinki