External Resources

Department of Health and Human Services

• The Belmont Report
• Research That May Be Reviewed Through an Expedited Procedure
• Statutory Basis for 45 CFR 46
• Title 45 Code of Federal Regulations Part 46 Protection of Human Subject

Food and Drug Administration (FDA)

• 21 CFR 50 – Protection of Human Subjects (PDF)
• 21 CFR 54 – Financial Disclosure by Clinical Investigators (PDF)
• 21 CFR 56 – Institutional Review Boards (PDF)
• 21 CFR 312 – Investigational New Drug (IND) Applications (PDF)
• 21 CFR 812 – Investigational Device Exemptions (IDEs) (PDF)
• FDA Center for Devices and Radiological Health
• FDA Forms – Devices
• FDA Forms – Drugs
• FDA ICH E6: Good Clinical Practice: Consolidated Guidance
• FDA Information Sheets

National Institutes of Health (NIH)

• National Human Genome Research Institute
• Office of Grants and Contracts

Office for Human Subject Research Protection (OHRP)

• IRB Guidebook
• OHRP Compliance Oversight Procedures
• OHRP Guidance (listed by topic)

Clinical Trials

• ClinicalTrials.gov
• FAQ about ClinicalTrials.gov
• Clinicaltrials.gov registration requirements fact sheet (PDF)

Other Sites of Interest

• American Society of Bioethics and Humanities
• Applied Research Ethics National Association (ARENA)
• AAMC Clinical Research Compliance & Human Subjects Protection
• Medical College of Wisconsin IRB Discussion Forum
• National Bioethics Advisory Commission (NBAC)
• Public Responsibility in Medicine and Research