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The Nuremberg Code was created after World War II, following the Nuremberg Trials, with the goal of protecting human rights and patients in clinical research. During World War II, extensive human experimentation was conducted by the Nazis (National Socialists) in Germany. These experimentations were exposed during the Nuremberg Trials of 1947 and resulted in a code of ethics, which set “standards to which physicians must conform when carrying out experiments on human subjects.” The code of ethics was called for, taking into account that several of the accused in the “Doctors’ Trials” presented arguments that their medical experimentations differed little from those conducted by others in the United States and elsewhere, prior to World War II.

One such example brought up by the trial defendants was the Stateville Penitentiary malaria experiments that took place in Illinois in the United States. The nominated medical adviser to the Nuremberg Trials, Andrew Ivy, had firsthand knowledge of these experiments. The defendants furthermore argued that there was no law differentiating between what is and is not allowed, and therefore they had committed no legal crime. Based on this, six main points defining what is and is not legitimate medical research were presented to the Counsel for War Crimes by Leo Alexander. The results of the trial itself reiterated these points and included the addition of four more points in the verdict in a section titled “Permissible Medical Experimentation.”

Key roles in the analysis of the ideas and shaping of medical research ethics, born from the trials, were played by American neuropsychiatrist Leo Alexander, German psychiatrist Werner Leibbrand, and American physiologist/medical historian Andrew Ivy. Ivy is recorded as stating during the trials that there is “no justification in killing five people in order to save the lives of five hundred” and citing the Hippocratic moral maxim in that “what refers to the Hippocratic oath is that he must have respect for life and the human rights of his experimental patient.” Together, the 10 points became the basis of the 10 principles of the Nuremberg Code, although no specific findings from the trials were included.

The principles called for informed consent, absence of coercion, well-thought-out and planned scientific experimentation, and benefits to the participants in the clinical research. In general, it was argued that the ethics of human experimentation should be in conformation with the ethics of the medical profession and the Hippocratic oath, but that more was necessary to protect human subjects participating in clinical research, hence bringing forth the Nuremberg Code of ethics.

The 10 principles of the Nuremberg Code were adapted and expanded upon in the Declaration of Helsinki. While the Nuremberg Code protects the human rights of clinical research subjects, the Declaration of Helsinki focuses on the obligations of the physicians to the participants. Probably the most important of these is that participation by the human subject in experimentation must be by voluntary consent (changed in the Declaration of Helsinki to also include consent by the legal guardian when the subject is legally incapacitated). The Nuremberg Code was pivotal in changing what constitutes good and ethical conduct of clinical research.