U.S. Department of Health and Human Services
- Compilation of Guidances on the EU General Data Protection Directive (GDPR)
- DHHS Regulations
- DHHS Policy and Guidance
- ORI (Office of Research Integrity)
- Belmont Report
- Investigator Manual (Appendix A-1: Additional Requirements, DHHS-Regulated Research)
U.S. Food and Drug Administration
- FDA Regulations
- Clinical Trials Guidance Documents
- Investigator Manual (Appendix A-2: Additional Requirements, FDA-Regulated Research)
International Conference on Harmonisation - Good Clinical Practice
- ICH-GCP Website
- Good Clinical Practice standards
- Investigator Manual (Appendix A-3: Additional Requirements, Clinical Trials (ICHGCP)
Veterans Administration
- VAMHCS Collaborative Studies Checklist
- VA — Maryland Research and Development
- VA — Current ORD Policy Documents
- VA Regulations - Human Subjects Protections
- Office of Research Oversight (ORO) - Veterans Health Administration
- Investigator Manual (Appendix A7: Additional Requirements, VA Research)
Department of Defense (DoD)
- DoD Directive (DoDD) 3216.02 — Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
- Department of the Navy (DON) — Human Research Protection Program
Other Resources
- NIH (National Institutes of Health)
- NIH Certificates of Confidentiality (CoC)
- AAHRPP — Association for the Accreditation of Human Research Protections Programs
- ACRP — Association of Clinical Research Professionals
- AAMC Research Compliance Resources
- Barnett Educational Services
- PRIM&R
- The Hastings Center
- SOCRA — Society of Clinical Research Associates
- Center for Clinical Trials
- General Clinical Research Center
- Certificates of Confidentiality
- Bioethics Resources