Creighton University

Ethical Codes Governing Human Subjects Research

• Belmont Report - Ethical principles and guidelines for the protection of human subjects of research
• Nuremberg Code - Directives for human experimentation
• Declaration of Helsinki - Biomedical research recommendations

Federal Regulations

• Code of Federal Regulations (CFR)
  • Title 21 CFR Part 50 (FDA)
  • Title 21 CFR Part 56 (FDA)
  • Title 45 CFR Part 46 (DHHS)
• Federal Register

Web Resources

• Department of Education - Protection of human subjects in research
• Department of Health and Human Services (DHHS)
• Food and Drug Administration (FDA)
  • FDA - Guidance for institutional review boards and clinical investigators
• International Ethical Guidelines for Biomedical Research Involving Human Subjects of the
  Council for International Organizations of Medical Sciences (CIOMS)
• National Institutes of Health (NIH) Bioethics resources
• Office for Human Research Protections (OHRP)
  • OHRP - Policy Guidance
  • OHRP - IRBs and Assurances
• Office of Research Integrity (ORI)