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The SRA Symposium - College of Medicine

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Post-World War II<br />

As <strong>of</strong> 2001, according to Kubar, there were in excess <strong>of</strong> 250 guidelines, declarations, codes and other<br />

documents concerning bioethics. Between 1947 and 1998, 17 European countries and 15 Latin<br />

American countries adopted more than 74 codes or guidelines concerning medical ethics. <strong>The</strong>se<br />

are clearly outgrowths <strong>of</strong> the Nuremberg Trials and the medical experiments those trials exposed.<br />

Knowledge <strong>of</strong> experiments conducted by Nazi doctors on children, the mentally or physically<br />

handicapped, the elderly, and inmates <strong>of</strong> concentration camps caused horror and revulsion around<br />

the world. As a result <strong>of</strong> these atrocities and the Nuremberg trials, at which 23 Nazi doctors were<br />

tried for their medical experiments on concentration camp victims, the American doctors who<br />

had presided at the trials developed a ten-point code in 1947. <strong>The</strong> first, most basic and most discussed<br />

tenet <strong>of</strong> the code requires explicit consent from human subjects prior to participation. Risk<br />

and benefit are the subjects <strong>of</strong> the other nine items in the document. <strong>The</strong> Nuremberg Code is the<br />

basis for a majority <strong>of</strong> the subsequent ethical guidelines.<br />

Kious notes that, even with imperfections, this code provided guidelines where nothing had previously<br />

existed, certainly there was no international consensus on the ethics <strong>of</strong> human experimentation.<br />

But other issues require comment. Some populations that cannot give legal informed consent<br />

are unique and have research needs that can only be studied in individuals belonging to that<br />

group (children, the emotionally or psychologically impaired, the elderly). This code also requires<br />

experiments with significant risk (“death or disabling injury”) to be first tried on the experimenter.<br />

<strong>The</strong> requirement for animal experiments cannot work for conditions that have no animal model.<br />

Kious also points out that this code does not provide a definition <strong>of</strong> human experimentation, nor<br />

does it address the difference between therapeutic and nontherapeutic research.<br />

Evans and Beck note that this code had little impact at the time. In fact, most American and British<br />

researchers were <strong>of</strong> the opinion that it was not necessary, that the high motives and responsible<br />

nature <strong>of</strong> researchers obviated the need for such safeguards. <strong>The</strong> possibility <strong>of</strong> Nazi-type experiments<br />

occurring in a civilized society was dismissed out <strong>of</strong> hand. In 1953 the British Medical Research<br />

Council was the first to promulgate a statement on medical research ethics. This memorandum<br />

called for a signed informed consent statement and an oversight body to guide researchers.<br />

Parliament engaged the issue in 1955 after an experiment on the effects <strong>of</strong> two different penicillin<br />

concentrations in infants was performed without parental consent. Nothing came <strong>of</strong> the Parliamentary<br />

debate as the ministers did not consider it their duty to interfere with pr<strong>of</strong>essionals in the<br />

conduct <strong>of</strong> their responsibilities (Evans and Beck, 2002).<br />

Russia conducted its own version <strong>of</strong> the Nuremberg Trials in 1949 in Khabarovsk in which members<br />

<strong>of</strong> the Japanese military were indicted for “criminal and inhuman experimentation on live<br />

human beings, participated in the villainous killing <strong>of</strong> people by conducting cruel experiments on<br />

them, and were developing biological weapons for the mass destruction <strong>of</strong> peaceful populations”<br />

(Kubar, 2001).<br />

Public discussion on ethical standards occurred in Great Britain in 1964, concerned largely with<br />

treatments <strong>of</strong> direct benefit to the patient and procedures having no direct benefit to the subject.<br />

<strong>The</strong> use <strong>of</strong> controlled clinical trials also came in for comment, with general agreement that if the<br />

trial included two procedures, participants should be asked for their “cooperation.” It was also<br />

agreed that true consent was necessary if an experiment involved procedures <strong>of</strong> no direct benefit<br />

to the participants. Physician researchers, however, still resisted the concept <strong>of</strong> informed consent.<br />

<strong>The</strong> Royal college <strong>of</strong> Physicians published a 1967 report that questioned the advisability <strong>of</strong> giving<br />

patients a complete explanation <strong>of</strong> the experiment or even asking their consent. Physicians in the<br />

United States (in a 1975 report from the Department <strong>of</strong> Health and Social Security), clearly felt<br />

that requiring informed consent <strong>of</strong> everyone would hinder or prevent research and thought that<br />

2005 <strong>Symposium</strong> Proceedings Book 201

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