Army Inspector General Report on LSD Volunteers

Informed Consent

The "Wilson Memorandum," the Chief of Staff Memorandum 385, and The Surgeon General principles all provided that the human subject "should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision."

All available evidence indicated that with one exception, which will be discussed under the chapter on intelligence testing, only volunteer subjects were used for the chemical drug or agent experiments by Army investigators. Moreover, the great majority of the volunteers signed formal volunteer agreements, prior to participation in experiments. These facts were made abundantly clear through formal testimony of former Medical Research Laboratory Commanders and investigators, review of official reports (cited elsewhere in this report), review of available volunteer records, interview of former volunteers, and informal discussions with Medical Laboratory employees. Thus, the question was not whether the subjects volunteered, but whether they were provided sufficient information to permit an enlightened decision. Several factors were apparently weighed by the medical investigators in an evaluation of the depth of knowledge made available to the volunteer. These factors were: security requirements surrounding the experimental agent or testing procedure; invalidation of the objectivity of the test results through suggestion of what was expected of the volunteer under the influence of the drug/agent (placebo effect); depth of available knowledge and personal convictions of the investigator regarding effects of the experimental compound; and a judgment of what information would be of value to the volunteer subject in making his decision. This is not to say that these factors, when reviewed in respect to present knowledge, were valid considerations, but, rather, it is to point out that there was apparent concern at the time the experiments were conducted.

The first of these factors was a concern which was reflected in the initial draft participation agreement, and which stated: "I certify that I have been familiarized with the nature of the experiment and the agents to be used, commensurate with security requirements." Although this phrase was not found in the approved edition of the volunteer agreement, neither was a reference to disclosure of the agent. Thus, the approved agreement removed the mandatory requirement for the investigator to disclose the actual agent or to determine the security classification of the drug/agent and match it against the security clearance of the volunteer. It is difficult to imagine an investigator withholding the identification of the experimental agent from the volunteer because it was highly classified, and there was no evidence found of this happening. On the other hand, if a medical investigator simply apprised the volunteer subject that he was about to receive an experimental agent called EA 1476 or EA 1729 or LSD or any other Laboratory related nomenclature, this would appear to be nothing more than paying "lip service" to the requirement. Therefore, disclosure of the agent name or withholding it might not have been material to the volunteer's decision process at the time of the experiment. However, it would seem appropriate that the volunteer should have been provided, sometime during the volunteer period, the medical name of the drug in the event of future adverse reactions.

Concern for the objectivity of the experiment was reflected in the Army Regulation (AR 70-25), 31 July 1974, governing the use of volunteers as subjects of research. It provided that: "He will be told as much of the nature, duration, and purpose of the experiment, the method and means by which it is to be conducted, and the inconveniences and hazards to be expected, as will not invalidate the results." If that statement extracted from the context of the regulation appears bland and inconsistent with the intent of informed consent, such does not appear to have been the intent. Rather, the purpose was to illuminate that the objectivity of test results was a concern of the medical investigator. The 1962 edition of the regulation contained a similar caution. No evidence was found which would indicate that any investigator allowed the volunteer to accept greater risks to his health or well-being simply for the sake of more objective test results.

Finally, there is the question of how much of his own knowledge and possible contrary opinions did the investigator have to relate to the volunteer. Evidence reviewed during the research effort indicated that the medical research personnel employed at the Chemical Corps Medical Research Laboratories were among the most knowledgeable in their field and that they were kept abreast of related research findings by civilian investigators. Nevertheless, there were no records located which would corroborate or establish that the investigators presented all the medical evidence available to the volunteer. Nor could it be determined that what was reported as evidence by one investigator was accepted as such by another. The problem of voluntary consent was not peculiar to the Army; it was common to all medical investigators.

In June 1966 Dr. Henry K. Beecher, of Harvard Medical School, a long-time consultant to the Army Surgeon General, addressed the problem of consent in a special article for the New England Journal of Medicine, in which he wrote: "All so-called codes are based on the assumption that meaningful or informed consent is readily available for the asking, . . . this is very often not the case. Consent in any fully informed sense may not be obtainable. Nevertheless, it remains a goal toward which one must strive for sociological, ethical and clear-cut legal reasons. There is no choice in the matter. If suitably approached, patients will accede, on the basis of trust, to any request their physician may make. At the same time, every experienced investigator knows that patients will often submit to inconvenience and some discomfort, if they do not last very long, but the usual patient will never agree to jeopardize seriously his health or his life for the sake of science." His article continued: "In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator."

On 28 June 1966 Dr. Beecher's article was relayed to Edgewood [a word or two illegible in the source] and Development Command. He urged the Commander at Edgewood to be alert to the requirement for informed voluntary consent on the part of each volunteer subject. One month later the Edgewood Arsenal Commander responded. He reported that a copy of the Beecher article had been furnished to all professional personnel at the Medical Research Laboratories. Moreover, he stated that "all volunteer test subjects, after a thorough indoctrination and briefing on the program in which they are participating, sign a volunteer participation agreement in triplicate. Such procedure has been reviewed and approved from the legal standpoint by representatives of the JAG." His reply implied that the agreement signed by the subject was used for the protection of the doctors and the Army in general and not specifically as a means of communicating the hazards of an experiment to the potential volunteer, which was apparently the function of the briefing that reportedly preceded the signing of the agreement. However, documents regarding recruiting procedures and some volunteer records indicated that in most cases the agreement was signed prior to arrival at Edgewood Arsenal, or on the first day after arrival. In either case, it was usually signed before the subject was selected for a specific agent test. Therefore, it was not likely that meaningful information regarding all hazards to his health were provided the volunteer prior to his signing the participation agreement.

[The paragraph continues onto the next page of the report, which is not included in this excerpt.]

Finding: informed consent was not obtained in the Intelligence Corps LSD tests

(U) The exact number of volunteers used in these tests could not be determined. However, evaluation of testimony, travel orders, and reports indicated that 30 to 35 different volunteers were used, some of whom may not have received a drug but performed a technical service such as operation of a polygraph machine. Moreover, it was not possible to determine the number of times the volunteers (individually or collectively) received LSD. Some volunteers may have received 20 or more doses of LSD over the period of nearly two years covering both phases of the tests.

(U) The evidence clearly established that the volunteers did not render their "informed consent" prior to the first occasion they received LSD. Moreover, there was a deliberate effort to deny them any information that would permit them to make a knowledgeable evaluation of the hazards involved in their participation. The failure to inform the volunteer of even the fact that they would receive a drug must be shared by both the Intelligence Board, as initiator of the tests, and the Medical Research Laboratories, as the medical investigators. However, it must be noted that following the initial surreptitious administration of the drug, the volunteers were provided a full explanation of the drug properties and a briefing on the remainder of the project. There was no indication that any subject withdrew his consent or declined to return for subsequent ingestions of LSD.

(U) One witness testified that he was asked to volunteer in such a manner that he believed his refusal to participate would have placed him in disfavor with his immediate superior. However, other Intelligence Corps volunteers testified that no pressure was exerted to cause them to volunteer, nor were they placed in a position that made participation appear to be their military duty. The project officer testified that several prospects he approached declined to participate and their disinterest was not mentioned to anyone. That is not to say that pressures were not brought to bear on certain subjects, rather, that the majority of the evidence indicated the subjects were highly dedicated Intelligence Corps officers and enlisted men who entered the program and remained in it because they believed they were making an important contribution to the Corps and perhaps to national defense.