Regulations & Ethical Guidelines

Ethical Codes

  • Nuremberg Code: Directives for human experimentation
  • World Medical Association: Declaration of Helsinki 1964
  • The Belmont Report
    • Ethical Principles and Guidelines for the Protection of Human Subjects of Research
      • Respect for Persons: Treat all persons as autonomous agents 

      • Beneficence: The benefits of the research outweigh the risks to participants 

      • Justice: Distribution of risks and benefits in a population

Henry K. Beecher M.D. "Ethics and Clinical Research" New England Journal of Medicine June 1966, Special Article

Code of Federal Regulations

  • 45 CFR 46: Protection of Human Subjects
    Subpart A: (The Common Rule) Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection on Human Research Subjects)
    • Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
    • Subpart C: Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
    • Subpart D: Additional DHHS Protections for Children Involved as Subjects in Research
    • 21 CFR 50: Food and Drug Administration; Guidance for IRB's and Clinical Investigators

Federal Laws and Regulations

Other Guidance and Resources


Training for AUM researchers for compliance to human subjects research regulations may be obtained through the CITI (Collaborative Institutional Training Initiative) at