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for the lack of a request for approval was that the project fell under the "line of duty" definition and was not subject to protocol approval.

Another example given by Taylor and Johnson pointed out that protocols were often submitted to test a class of drugs, rather than a specific drug at defined dosage levels. One project entitled, "Retention of Nerve Gas in the Human Respiratory Tract" was given only a cursory examination prior to approval, despite the fact that the specific nerve agents to be used were not listed in the proposal. By 1955, when research into psychochemicals began, approvals were still being given for general research types and not for specific protocols. In 1957, more potent nerve agents were being tested, but the protocols for this research were not sent for examination and approval on the justification that they were simply extensions of projects already approved years earlier. By 1959, Secretary of the Army Brucker gave blanket approval for all projects utilizing "non-lethal incapacitating agents," and the period between 1959 and 1975 was typified by great inconsistency in policy and practices relating to research with human volunteers. The situation became so bad, and the outcry from Congress, the press, and the citizenry so intense, that all research with human volunteers was suspended in 1975 by Acting Secretary of the Army Norman Augustine.

KEY ELEMENTS OF THE NUREMBERG CODE OF 1947

  1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved so as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the subject there should be made known to him the means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests with each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

  3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other



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