Federal Regulations

Common Rule

• Department of Health and Human Services Office for Human Research Protections
• 45 CFR Part 46  Protection of Human Subjects
  • Subpart A Basic Policy
  • Subpart B Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
  • Subpart C Additional Protections for Prisoners
  • Subpart D Additional Protections for Children
• Exempt Categories
• Expedited Categories
• Guidance on the Involvement of Prisoners in Research (OHRP)
• HHS OHRP Institutional Review Board (IRB) Guidebook
• OHRP International Issues
• Summary of Basic Protections for Participants in Human Research (OHRP)

FDA

• U.S. Food and Drug Administration
  • 21 CFR Part 11 Electronic Records; Electronic Signatures
  • 21 CFR Part 50 Protection of Human Subjects
  • 21 CFR Part 54 Financial Disclosure by Clinical Investigators
  • 21 CFR Part 56 Institutional Review Boards
  • 21 CFR Part 312 Investigational New Drug Application
  • 21 CFR Part 314 Applications for FDA Approval to Market a New Drug
  • 21 CFR Part 812 Investigational Device Exemptions
  • 21 CFR Part 814 Premarket Approval of Medical Devices
  • 21 CFR Part 820 Quality System Regulation, Subpart C-design Controls
  • Good Manufacturing Process March 6, 2000 FDA Letter

Other

• Regulations.gov

Last updated: 8/2/08