Institutional Review Board

• Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research
  
  
• U.S. Department of Health Human Services (DHHS)
  • National Institutes of Health
  • Health Information Privacy
• Office for Human Research Protection
  
  • Title 45 CFR 46: Protection of Human Subjects
  • Policy and Guidance
  • IRB Guidebook
• Food and Drug Administration
  
  • A Guide to Informed Consent - Information Sheet
  • Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
  • Guidance for Drugs
  • Guidance for Medical Devices
  • Guidance for Humanitarian Device Exemption (HDE)
  • MedWatch: The FDA Safety Information and Adverse Event Reporting Program
  • Good Clinical Practice
  • International Conference on Harmonization (ICH) Guidance Documents
  • FDA Training and Education on-line courses