Federal Policies

Federal Regulatory Offices

• 45 CFR Part 46-Protection of Human Subjects
   
• 21 CFR Part 56-FDA Institutional Review Board      

• Office for Human Research Protections
   
• Food and Drug Administration

Ethical Principles

Clinical Guides

• Belmont Report
   
• Declaration of Helsinki
   
• Nuremberg Code

• ICH Guideline for Good Clinical Practice