Regulations & Ethical Guides


Ethical Codes

  • Nuremburg Code: Directives for Human Experimentation
  • World Medical Association: Declaration of Helsinki
  • 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

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:  Protection of Human Subjects

Federal Laws and Regulations

  • Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
  • (FERPA) Family Educational Rights & Privacy Act

Other Guidance and Resources

  

Last Updated: 1/13/2014