Additional 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
• 21 CFR 54- Financial Disclosure by Clinical Investigators
• 21 CFR 56 - Institutional Review Boards
• 21 CFR 312 - Investigational New Drug (IND) Applications
• 21 CFR 812 - Investigational Device Exemptions (IDE's)
• FDA Center for Devices and Radiological Health
• FDA Forms - Devices
• FDA Forms - Drugs
• ICH GCP Consolidated Guidelines,5/9/97
• FDA ICH Good Clinical Practice Consolidated Guidelines
• 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)
• OHRP LISTSERV

Clinical Trails

• 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 Research
• AAMC Research Compliance Resources
• Medical College of Wisconsin IRB Discussion Forum
• National Bioethics Advisory Commission (NBAC)
• Public Responsibility in Medicine and Research