Federal Regulations and Guidance:
OHRP:
- Office for Human Research Protections
- Human Subjects Regulations Decision Charts
- Institutional Review Board Guidebook
- Protection of Human Subjects: 45 CFR 46
FDA:
- Food and Drug Administration
- Human Subject Protection (Informed Consent): 21 CFR Part 50
- IRB Regulations: 21 CFR 56
- Information Sheets: Guidance for IRBs, Clinical Investigators, and Sponsors
- Investigational New Drug Application: 21 CFR Part 312
- Investigational Device Exemptions: 21 CFR Part 812
Ethical Principles and 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:
