Skip Navigation
Search

Federal Regulations

Department of Health and Human Services (DHHS)/Office for Human Research Protections (OHRP)

Website:  http://www.hhs.gov/ohrp/
Regulations:  DHHS: 45 CFR Part 46 DHHS -- Protection of Human Subjects
Guidance:  http://www.hhs.gov/ohrp/policy/index.html#topics

Food and Drug Administration (FDA)

Website:  http://www.fda.gov/
Regulations:​

FDA: 21 CFR Part 50 FDA - Protection of Human Subjects

FDA: 21 CFR Part 54 FDA - Financial Disclosure by Investigators

FDA: 21 CFR Part 56 FDA - Institutional Review Boards

FDA: 21 CFR Part 312 FDA - Investigational New Drug Application

FDA: 21 CFR Part 812 FDA - Investigational Device Exemptions

Department of Defense

Website:  https://www.defense.gov/

In addition to the Common Rule, human subjects research supported by the DoD is subject to requirements and ethical standards outlined in the  Department of Defense Instruction 3216.02.

Office of Civil Rights (HIPAA: Privacy Law)

Website:  http://www.hhs.gov/ocr/hipaa/
Regulation:  http://www.hhs.gov/ocr/hipaa/finalreg.html