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

 

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