Federal Policies on Human Subjects Research

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

Guidance:

• General
• Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
• Good Clinical Practice

Office of Civil Rights (HIPAA: Privacy Law)
Website: http://www.hhs.gov/ocr/hipaa/
Regulation: http://www.hhs.gov/ocr/hipaa/finalreg.html
Guidance (Research-related): 

• HIPAA Privacy Rule, Information for Researchers
• Clinical Research and the Privacy Rule

SBU Policies
RESEARCH INVOLVING HUMAN SUBJECTS P 202R