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The term Nuremberg Code refers to the set of standards for conducting research with human subjects that was developed in 1947 at the end of World War II, in the trial of 23 Nazi doctors and scientists in Nuremberg, Germany, for war crimes that included medical experiments on persons designated as non-German nationals. The trial of individual Nazi leaders by the Nuremberg War Crimes Tribunal, the supranational institution charged with determining justice in the transition to democracy, set a vital precedent for international jurisprudence.

The Nuremberg Code was designed to protect the autonomy and rights of human subjects in medical research, as compared with the Hippocratic Oath applied in the therapeutic, paternalistic patient-physician relationship. It is recognized as initiating the modern international human rights movement during social construction of ethical codes, with the Universal Declaration of Human Rights in 1954. Human subjects abuse by Nazi physicians occurred despite German guidelines for protection in experimentation, as noted by Michael Branigan and Judith Boss. Because the international use of prisoners in research had grown during World War II, the Code required that children, prisoners, and patients in mental institutions were not to be used as subjects in experiments. However, it was reinterpreted to expand medical research in the Declaration of Helsinki by the World Medical Association in 1964.

The legal judgment in the Nuremberg trial by a panel of American and European physicians and scientists contained 10 moral, ethical, and legal requirements to guide researchers in experiments with human subjects. These requirements are as follows: (1) voluntary informed consent based on legal capacity and without coercion is essential; (2) research should be designed to produce results for the good of society that are not obtainable by other means; (3) human subjects research should be based on prior animal research; (4) physical and mental suffering must be avoided; (5) no research should be conducted for which death or disabling injury is anticipated; (6) risks should be justified by anticipated humanitarian benefits; (7) precautions and facilities should be provided to protect research subjects against potential injury, disability, or death; (8) research should only be conducted by qualified scientists; (9) the subject should be able to end the study during the research; (10) the scientist should be able to end the research at any stage if potential for injury, disability, or death of the subject is recognized.

Impact on Human Subjects Research

At the time the Nuremberg Code was formulated, many viewed it as created in response to Nazi medical experimentation and without legal authority in the United States and Europe. Some American scientists considered the guidelines implicit in their human subjects research, applying to nontherapeutic research in wartime. The informed consent requirement was later incorporated into biomedical research, and physicians continued to be guided by the Hippocratic Oath for clinical research.

Reinterpretation of the Nuremberg Code in the Declaration of Helsinki for medical research modified requirements for informed consent and subject recruitment, particularly in pediatrics, psychiatry, and research with prisoners. Therapeutic research was distinguished from nontherapeutic research, and therapeutic privilege was legitimated in the patient-physician relationship.

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