The Nuremberg Code
The next major advance in the ethics of human experimentation came as a result of the “Doctors Trial” at Nuremberg in 1946–7. In this the first, and most important, of the medical trials, 23 defendants were charged with: (1) The Common Design or Conspiracy; (2) War Crimes; (3) Crimes Against Humanity, and (for some of the defendants only); (4) Membership in a Criminal Organisation.9 Counts 2 and 3 were framed in relation to a catalogue of “experiments” performed on the inmates of concentration camps, and to a programme of euthanasia applied to various categories of psychiatric patients, children with congenital abnormalities, and others considered a burden on society.
Fifteen of the defendants in that first trial were found guilty and seven of them were hanged.10
The trial raised many issues not the least of which was the fact that no consent had been sought from the majority of the experimental subjects. An example of such consent as was sought was presented in the opening statement of the prosecution. One of the Gypsy women who volunteered to take part in the rewarming of the hypothermia experiment subjects at Dachau stated, “rather half a year in a brothel than half a year in a concentration camp.”9
As a result of the trial a 10 point code was established to govern the use of human subjects in biomedical research.11 The code was to have international standing.12 Its primary clause states that, “The voluntary consent of the human subject is absolutely essential”. It then expands on this to include the fact that the subject should be legally competent, should be able to exercise free choice, and should be fully informed. Two other clauses deal with the responsibility of the investigator to end the study if, “the experiment is likely to result in injury, disability, or death to the experimental subject”, and with the right of the subject to end the experiment. However, the code does allow that, “The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study”.
Consent was clearly not sought in the barbaric conditions of the concentration camps. Was it always sought in other parts of the world, or by those who drew up the code? The answer seems to be no. In the US during the second world war many experiments were conducted on prisoners and the inmates of mental institutions without great regard for the consent or the safety of the subjects (briefly summarised in Rothman13). The investigators in many cases considered that these were carefully designed studies tackling problems of national importance (mostly related to infectious diseases, which were to play a crucial part in the Pacific Theatre of operations). Consent and safety were not considered essential. Young men were being sent into battle: no one was seeking their consent. The inmates of prisons and mental institutions were considered to have a similar obligation in their country's hour of need. “Some people were ordered to face bullets and storm a hill; others were told to take an injection and test a vaccine”.13
One of the problems of the Nuremberg Code was the very fact that it was born of the horrors of the concentration camps: “It was a good code for barbarians but an unnecessary code for ordinary physician-scientists.”14 As a result it was often ignored.15 Henry Beecher, in 1966, searched various journals for examples of what he termed “unethical research”, which he thought did harm to the good name of American medicine. He found 50 examples of unethical research, only 22 of which were described in detail, and in only two was consent mentioned.16
Since the report of the Presidential Advisory Committee on Human Radiation Experiments it is clear that the US Government, through various departments, sponsored many experiments in the postwar period on the effects of radioactivity without obtaining consent.17 Many of these were clearly in breach of the Nuremberg Code in that they were performed without consent, they could be of no therapeutic benefit to the subjects or to society, and they exposed the subjects to harm.
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