Historical perspectives and their significant impact on the development of ethical standards governing research using human participants

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Experiments on treating exposure to chemical-warfare agents were ongoing throughout the war years. Prisoners were forced to drink poisoned water and breather noxious gases. Some were shot with cyanide-tipped bullets or given cyanide capsules. A mortality rate of 25% was typical.

“The Nazi Doctors Trial,” was held from December 9, 1946 to August 8, 1947. The 23 defendants (including 20 physicians) were charged with murder, torture and other atrocities committed in the name of medical science. When the trial was over, 15 of the 23 defendants were found guilty. Seven were sentenced to death. Although the trial was called “The Trial of the Century,” it would probably have been forgotten except for the fact that the judgment included a set of standards known as the Nuremberg Code. The Code, was the ‘ethical yardstick’ by which the defendants had been measured and guilt determined. The ‘Modern’ era of human research protections is routinely dated from the promulgation of the Nuremberg Code. The Code stated that: informed consent of volunteers must be obtained without coercion; human experiments should be based upon prior animal experimentation; anticipated scientific results should justify the experiment; only qualified scientists should conduct medical research; physical and mental suffering and injury should be avoided; and there should be no expectation of death or disabling injury from the experiment.

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