• FDA Guidance FAQs on Form 1572, Updated, May 2010
  
  
• Protection of Human Research Subjects [45 CFR 46] (DHHS)
  
  
• Office of Human Research Protections
  
  
• Protecting Human Research Subjects: IRB Guidebook
  
  
• Office of Health Affairs - U.S. Food and Drug Administration (FDA)
  
  
• IRB Operations and Clinical Investigation Requirements
  
  
• Protection of Human Subjects (FDA)
  
  
• Frequently Asked Questions: Protection of Human Subjects (FDA)
  
  
• IRB [21 CFR 56]
  
  
• Investigational New Drug Application - Information for Clinical Investigators
  
  
• National Cancer Institute - Recommendations from NCI's Informed Consent Working Group
  
  
• Good Clinical Practice - International Conference on Harmonisation (ICH): Consolidated Guidance
  
  
• ICH Efficacy Guidelines
  
  
• Good Clinical Practice (ICH) - Summary of Investigator Responsibilities (pdf file)
  
  
• Privacy Protection for Research Subjects