Helpful links
OHRP Links
- OHRP Home - Office of Human Research Protections
- Human Participants Regulations Decision Charts
- Protection of Human Participants: 45 CFR 46
FDA Links
- FDA Home - Food and Drug Administration
- Human Participant Protection (Informed Consent): 21 CFR Part 50
- Information Sheets: Guidance for IRBs, Clinical Investigators, and Sponsors
- IDE - Investigational Device Exemptions: 21 CFR Part 812
- Investigational New Drug Application: 21 CFR Part 312
- IRB Regulations: 21 CFR 56
Ethical Principles & Codes
- American Society for Bioethics & Humanities (ASBH)
- Belmont Report
- Declaration of Helsinki (World Medical Association)
- NIH Bioethics Resources on the Web
- Nuremberg Code
- National Bioethics Advisory Commission (NBAC)
- Public Responsibility in Medicine and Research (PRIM&R)
- The President's Council on Bioethics
Good Clinical Practices
- Good Clinical Practice in FDA-Regulated Clinical Trials
- Good Clinical Practice Contacts
- ICH E6: Good Clinical Practice: Consolidated Guidance
- Medical Devices (Device Advice)
HIPAA - Privacy Rule
- IRBs and the HIPAA Privacy Rule (NIH)
- NIH Guidance on Protecting Personal Health Information in Research (NIH)
- NIH Guidance on Research Repositories, Databases, and the Privacy Rule (NIH)
- NIH Guidance on Clinical Research and the HIPAA Privacy Rule
Veteran Affairs Administration
- VA Website
- VA Office of Regulation Policy and Management
- Research Office at the VA Medical Center 313-576-3430
National Institutes of Health
- NIH Issues Policy Change to Certificates of Confidentiality (effective Oct. 1, 2017) (.doc)
- Good Clinical Practice Training for all NIH-funded Clinical Investigators and Clinical Trial Staff (.doc)
Department of Defense
Guide for Department of Defense Researchers using Military Health System Data
Department of Energy
Department of Education
Department of Justice
Environmental Protection Agency
Office of Biorepositories and Biospecimen Research