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F
Summary of the Department of the Army Report

by James R. Taylor and William Johnson

USE OF VOLUNTEERS IN CHEMICAL AGENT RESEARCH (1975)

This report was the result of a request to the Inspector General and Auditor General of the Department of the Army (DoA) by the Secretary of the Army to research the use and treatment of human volunteers in chemical agent research. The request was prompted by congressional inquiries, during 1975 and 1976, by the Senate Select Committee on Intelligence Activities and joint hearings by the Senate's Labor and Public Welfare Committee and the Judiciary Committee, individual Members of Congress, private citizens, and the press regarding the use of human volunteers in testing of hallucinogenic substances in DoA chemical warfare research. Although the report focused largely on psychochemical testing programs and on testing programs from approximately 1950 to 1975, it also related certain specific aspects of the history of chemical warfare research in regards to treatment of human volunteers and general attitudes toward and compliance with the Nuremberg Codes of 1947. The major conclusion of these authors was that the secrecy, applied to the projects, to the overall research program, and even to the official guidelines governing use of human volunteers, left

Summarized from: Taylor JR, Johnson WN. 1975. Research Report Concerning the Use of Volunteers in Chemical Agent Research. DAIG-IN 21-75. Washington, DC: Department of the Army, Office of the Inspector General and Auditor General.



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Veterans at Risk: The Health Effects of Mustard Gas and Lewisite F Summary of the Department of the Army Report by James R. Taylor and William Johnson USE OF VOLUNTEERS IN CHEMICAL AGENT RESEARCH (1975) This report was the result of a request to the Inspector General and Auditor General of the Department of the Army (DoA) by the Secretary of the Army to research the use and treatment of human volunteers in chemical agent research. The request was prompted by congressional inquiries, during 1975 and 1976, by the Senate Select Committee on Intelligence Activities and joint hearings by the Senate's Labor and Public Welfare Committee and the Judiciary Committee, individual Members of Congress, private citizens, and the press regarding the use of human volunteers in testing of hallucinogenic substances in DoA chemical warfare research. Although the report focused largely on psychochemical testing programs and on testing programs from approximately 1950 to 1975, it also related certain specific aspects of the history of chemical warfare research in regards to treatment of human volunteers and general attitudes toward and compliance with the Nuremberg Codes of 1947. The major conclusion of these authors was that the secrecy, applied to the projects, to the overall research program, and even to the official guidelines governing use of human volunteers, left Summarized from: Taylor JR, Johnson WN. 1975. Research Report Concerning the Use of Volunteers in Chemical Agent Research. DAIG-IN 21-75. Washington, DC: Department of the Army, Office of the Inspector General and Auditor General.

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Veterans at Risk: The Health Effects of Mustard Gas and Lewisite ample room for misinterpretation, lack of knowledge about, and outright disregard for established policies and guidelines. The June 1942 request for human volunteers to the Secretary of War, and its subsequent approval, gave authority to the War Department to use human volunteers in the World War II sulfur mustard and Lewisite testing programs. The approval of this request became the basis on which such authority was retained by the Army and the Chemical Warfare Service to use human volunteers in all other World War II and later testing programs up to the mid 1950s. In July 1950, research was placed under the control of the Army by the Organization of the Army Act. Despite the establishment in 1947 of the Nuremberg Codes regarding the appropriate use and treatment of human subjects in research, Taylor and Johnson reported that no documentation could be found about whether the Army was explicitly bound by the Codes. By 1952, the Armed Forces Medical Policy Council filed a request to use human subjects and suggested that the Nuremberg Codes be used as guidelines. The possible guidelines were discussed at a meeting at Edgewood Arsenal in March 1953. Recommendations were made at the conference that distinctions be made between hazardous and nonhazardous test situations so that nonhazardous procedures/tests would not require approval of the human-use research protocols. The examples given for nonhazardous situations were training exercises in which men, equipped with gas masks, went through gas chambers filled with high concentrations of sulfur mustard. A further proposal was that any human-use codes based on the Nuremberg Codes should only apply to biological warfare testing, not to chemical or radiological testing. This proposal was rejected. Formalized guidelines were finally issued in June 1953 in a Chief of Staff Memo (MM 385). These guidelines represented an official adoption of the Nuremberg Codes (although somewhat modified) and were meant to apply to all types of chemical, radiological, and biological warfare testing. Further, they required all projects to be approved by the Secretary of the Army. However, no detailed descriptions of what types of experiments required this approval were included, and the report authors argue later that this was a "loophole" that permitted "selective compliance" with the guidelines. For example, in August 1953 seven research projects were sent for approval, one on vesicants and other agents, one on phosgene, and five on nerve agents. Not sent for approval was a research project labelled a ''local field exercise" at Fort McClellan, Alabama (Operation TOP HAT). This operation involved use of Chemical Corps personnel in tests of decontamination methods for biological warfare agents, sulfur mustard, and nerve gases. These personnel were not informed and were not volunteers. The justification

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Veterans at Risk: The Health Effects of Mustard Gas and Lewisite 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 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. 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. 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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Veterans at Risk: The Health Effects of Mustard Gas and Lewisite problems under study that the anticipated results will justify the performance of the experiment. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians will also serve as subjects. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even the remote possibilities of injury, disability or death. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill, and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the subject.