Food and Drug Administration

Links

View the Regulations
Comparison of the Common Rule and FDA Regulations

FDA’s regulations governing clinical trials are found at different parts of Title 21 of the Code of Federal Regulations. Use the link to search for 21 CFR Part 50 (Informed Consent) and 21 CFR Part 56 (Institutional Review Boards).Additional information can be found in 21 CFR Part 312 (Investigational New Drug Application) and 21 CFR Part 812 (Investigational Device Exemptions).

human subjects research