Belmont report

California Law: Protection of Human Subjects in Medical Experimentation Act

FDA: Food and Drug Administration

• Informed Consent (guidance)
• 21 CFR Part 50 - Protection of Human Subjects
• 21 CFR Part 56 - Institutional Review Boards
• 21 CFR Part 312 - Investigational New Drug Applications (INDs)
• 21 CFR Part 812 - Investigational Device Exemptions (IDEs)
• Information Sheet Guidances for IRBs, Investigators and Sponsors
  • Significant Risk and Nonsignificant Risk Medical Device Studies
• IRB Frequently Asked Questions
• Clinical Trials and Human Subject Protections - Guidance, resources, good clinical practices (GCPs)
  
  

OHRP: Office of Human Research Protections

• Title 45 CFR 46: Protection of Human Subjects
• Policy guidance and documents
• Inclusion of Children - Policy Implementation (NIH)
• Certificates of Confidentiality
• International Compilation of Human Research Protections - listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations
• OHRP Frequently Asked Questions

 

VA: Department of Veterans Affairs

• Office of Research & Development (ORD) Programs
• 38 CFR Part 16
• VA Handbooks website including:
  • VHA Handbook 1200.05 - Requirements for the Protection of Human Subjects in Research
  • VHA Handbook 1058.01 - Research Compliance Reporting Requirements
• VHA Publications

International Research

• International Compilation of Human Research Protections (OHRP) - listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations