FDA Regulations

Below are the regulations that relate to human subjects research and their direct links.

• Electronic Records; Electronic Signatures (21 CFR 11)
• Protection of Human Subjects (21 CFR 50)
• Financial Disclosure by Clinical Investigators (21 CFR 54)
• Institutional Review Boards (21 CFR 56)
• Investigational New Drug Application (21 CFR 312)
• Investigational Device Exemptions (21 CFR 812)
• Protection of Human Subjects (45 CFR 46)
  • Subpart A Basic HHS Policy for Protection of Human Research Subjects
  • Subpart B Additional Protections for Pregnant Women, Human Fetuses and
    Neonates Involved in Research
  • Subpart C Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects  
  • Subpart D Additional Protections for Children Involved as Subjects in Research
• The Privacy Rule (45 CFR 160 & 45 CFR 164)