Draft Summary of History of Ethics Policies Relating to Human Radiation Experiments, DOD and AEC, 1942-1954

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TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff RE: Draft Summary of History of Ethics Policies Relating to Human Radiation Experiments, DOD and AEC, 1942-1954 The staff expects to learn a great deal more about the history of ethics policies relevant to human radiation experiments in the months ahead, but it is already possible to give an overview of what has been learned about the development of ethics policies concerning human radiation experiments fiom 1942 to 1954. This account of the history of ethics policies should be considered as a basis for comment. 1. The Consent Story Since at least the 1930's the Navy required approval by the Secretary of the Navy for human experiments, an early form of prior review, though it is not clear how often or how consistently this was practiced. (See Briefing Book #3, Tab H, Attachment D.) During World War II the Committee on Medical Research (which turned over most of its contracts to the National Institutes of Health after the war) stipulated fblly informed volunteers and consent forms. intended to do much the same sort of work as those called consent forms, as in the case of one fiom the Navy in 1943. (See this Briefing Book, Tab G, Attachment N.) Whatever the nomenclature, these forms often went as much to legal as to ethical concerns. Atomic Energy Commishon -- During this period there was no serious question in the minds of administrators and medical scientists that there were rules governing the ethics of the use of human subjects. Rather, the question was whether these rules should, or could, be specified. Within the AEC,for example, during 1947,alone there were shifhg notions about how much to require of a consent policy, fiom a relatively weak standard of assurance (letting researchers cert% consent), to a relatively strong one (requiring written consent fiom the subject and next of

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kin). (See Briefing Book #4, Tab L, Attachments K and L.) But, again, the idea that only informed volunteers should be used was prevalent. _jDepartment of Defense - As detailed in Briefing Book #4, following extensive internal debate in 1953, the Secretary of Defense issued the Nuremberg Code as a policy to govern DOD human experimentation. As noted above, the requirement of consent did not spring solely from Nuremberg; indeed, prior to the World War II Committee on Medical Research, Walter Reed had called for consent. Nonetheless, it should be noted that the 1953 code also followed a tradition, as shown by 1940's release forms, in which issues of liability, as well as consent, drove research During the months following the Wilson Memo in 1953, the Army worked hard to implement the new policy, requiring its laboratories to reevaluate their work in light of the new rules. The Army also required that its surgeon general give prior review of proposed experiments involving human subjects and, in light of this review, that the Army Secretary offer final approval Several proposals were rejected in this fashion in 1953, but, given the 1975 Army assessment of its chemical warfare program, it appears this system broke down after the initial enthusiasm. It is important to note that the Army stated that the consent standards set out in the Wilson Memo should apply to its contractors. (See this Briefing Book, Tab G, Attachment J.) It is not clear at this point how those standards were actually communicated to contractors or what kind of follow-up there was, if any. While it does not bear directly on the question of consent, documents show that consideration of risk was employed in determining whether or not to conduct human experiments. On at least two occasions radiation scientists were surveyed for their estimates of effects discernible in the human at various exposure levels, and both times the assessments varied wildly. This could not be reassuring to soldiers, sailors, and pilots, so more carefbl measures were among radiologists regarding critical exposure levels.) However, this posed an instance of the familiar ethical "catch-22": volunteers may not be exposed to a significant risk of serious harm, but unless the experiment is done the likelihood of such an occurrence cannot be known. In the case of isotope resekch the AEC's Subcommittee on Human Applications (of the Committee on Isotope Distribution) evidently considered risk and benefit as a critical factor in the allocation of isotopes for particular uses. (See Attachment 1.). By 1949 this subcommittee created what might have been the most detailed set of standards at the time. They established a committee reGew process for proposed uses, including both a central committee and one at each recipient institution, and a consent requirement. (See Attachment 1.)

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Similarly, in the continuing debate regarding the nuclear energy powered airplane (NEPA), the question of whether human research was needed to provide the basis for military standwds-or whether animal research would suffice--was debated. (See this Briefing Book, Tab G Staff Memorandum, Section 1 for further discussion of the NEPA human experimentation debate.) 3. Ambimitv over the Nuclear-Powered Aimlane "ExDeriments" Documents regarding human experimentation for NEPA raise, at least in retrospect, questions as to the meaning given to the word "experiments" when experiment policies and programs were discussed. For example, following extensive discussion within both the AEC and the DOD it was ostensibly decided not to proceed with human experiments for the nuclear powered airplane. Thus, a March, 1952 suqnary of a conference on "The Medical Aspects of Nuclear Powered Aircraft" recorded: "Human experimentation. This was not carried out, The same document proceeds shortly thereafter to record: The M.D.Anderson Hospital at Houston, Texas is making a study of human patients who have been exposed to various amounts of x-irradiation. The tests on humans involve coordination and psychomotor responses before and after Put side-by-side these two statements may represent a subtle distinction between the terms experiment and study, or a reference to two separate human experimentation projects. Regardless, the second quotation demonstrates that what we would call a human radiation experiment was carried out in connection with NEPA The Advisory Committee has asked the staff to address the question of how subjects were selected for experiments. Policy statements appear to put a premium on volunteer status. As yet we do not have a great deal of information on selection standards or procedures for specific populations, but the staff continues to collect material on these matters. (See for example this