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Ethical Challenges

3. Principles, Codes, and Standards Today

The Nuremburg Code

  • The Nuremburg Code
  • The Declaration of Helsinki
  • The Belmont Report and The US Code of Federal Regulations: The Common Rule
  • The Council of International Organizations of Medical Science (CIOMS)
  • International Conference for Harmonization Guidelines for Good Clinical Practice (GCP)
  • Standards and Operational Guidance for Health Related Research

The Nuremburg Code, developed as a result of Nazi war crimes, was the first modern publication of ethical guidelines for experimentation with humans. It states an explicit requirement for voluntary consent of research subjects and spells out the elements of that consent. The code stipulates that the use of human participants is permissible (justified) so long as:

  • human subjects are necessary;
  • the results hold promise of benefit to society;
  • scientific basis and design are sound;
  • harms to humans are minimized or avoided;
  • risks are minimized;
  • experimenters are qualified;
  • voluntary withdrawal of subjects is allowed; and
  • the research will be terminated if research subjects are likely to be injured or harmed.