Regulations and Resources

Federal Regulations & Guidelines

DHHS Office of Human Research Protections (OHRP)
45 CFR 46 – Protection of Human Subjects (the “Common Rule”)
Frequently Asked Questions
OHRP Policy & Guidance Index

U.S. Food and Drug Administration (FDA)
21 CFR 50 – Protection of Human Subjects (Informed Consent)
21 CFR 56 – Institutional Review Boards
21 CFR 312 – Investigational New Drug Application
21 CFR 812 – Investigational Device Exemptions
21 CFR 814 Subpart H – Humanitarian Use Devices

Information Sheets for IRBs, Investigators, and Sponsors
Clinical Trials and Human Subject Protection
Medical Device Comprehensive Regulatory Assistance

National Institutes of Health (NIH)
Grants Policy & Compliance
Certificates of Confidentiality

Other Regulations

Health Insurance Portability and Accountability Act (HIPAA)
Family Educational Rights and Privacy Act (FERPA)
National Science Foundation (NSF)

International Research

OHRP International Research Guidance Page

Ethical Codes

Belmont Report
World Medical Association Declaration of Helsinki