Belmont report

Office of Human Research Protections (OHRP)

• Title 45 CFR 46: Protection of Human Subjects
• Policy guidance and documents
• Inclusion of Children Policy Implementation
• Certificates of Confidentiality
• International Compilation of Human Research Protections - listing laws, regulations, and guidelines on human subjects research in 101 countries, and standards from international and regional organizations
• OHRP Frequently Asked Questions

Food and Drug Administration (FDA)

• FDA Informed Consent
• 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 (pdf)
• FDA Frequently Asked Questions
• Running Clinical Trials - Guidance, information sheets from FDA Office of GCP

California Law (Statutes)

California Protection of Human Subjects in Medical Experimentation Act

Department of Veterans Affairs (VA)

• Veterans Health Administration (VHA) - Research 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 Forms, Publications & Records Management

International Research

• International Compilation of Human Research Protections (OHRP) - listing laws, regulations, and guidelines on human subjects research in 101 countries, and standards from international and regional organizations