Links

Federal Regulations and Guidances

• NIH
• FDA
• Guidances from the Office of Human Research Protections, DHHS
• Office of Human Research Protections
• HIPAA
• OHRP Compliance Activities: Common Findings and Guidance
• Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators, Food and Drug Administration

Ethical codes

• The Belmont Report
• The Nuremberg Code
• Declaration of Helsinki
• International Conference on Harmonisation

Other Resources

• Clinical Research Times Newsletter
• Clinical and Translational Science Institute (CTSI)
• FDA, “Gender Studies in Product Development: Scientific Issues and Approaches”
• National Cancer Institute, Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials
• Office of Research Integrity
• National Institutes of Health, Bioethics Resources on the Web
• AAMC Research Compliance Resources