Conclusion

Chapter 1: The Department of Defense: Consent is Formalized

The most famous example of the early use of subject consent in the military took place at the turn of the century. Walter Reed's successful research on yellow fever, the mosquito-borne disease that bedeviled Panama Canal construction efforts, employed healthy subjects who signed forms indicating their agreement. Whether the practice was required by the Army or self-imposed by Reed is unknown. In 1925 an Army regulation to promote infectious disease research noted that "volunteers" should be used in "experimental" research.[43]

The Navy also provided early requirements for human subject research. In 1932, the secretary of the Navy granted permission for the conduct of an experiment involving divers on condition that the subjects were "informed volunteers."[44] In 1943 the secretary of the Navy also required that all investigators seeking to conduct research with service personnel obtain prior approval from the secretary.[45]

As we have noted in the Introduction, during World War II, federally funded biomedical research related to the war effort (outside the Manhattan Project) was coordinated by the Committee on Medical Research (CMR) of the Office of Scientific Research and Development, which was part of the Executive Office of the President. The CMR supported a program of human research, during which the question of the rules for the conduct of human research was addressed. In 1942 a University of Rochester researcher, seeking to "work out a human experiment on the chemical prophylaxis of gonorrhea," asked the CMR for "an opinion that such human experimentation is desirable."[46] In an October 9, 1942, response, the CMR's chairman offered the following general statement, which was endorsed by the full committee:

[H]uman experimentation is not only desirable, but necessary in the study of many of the problems of war medicine which confront us. When any risks are involved, volunteers only should be utilized as subjects, and these only after the risks have been fully explained and after signed statements have been obtained which shall prove that the volunteer offered his services with full knowledge and that claims for damage will be waived. An accurate record should be kept of the terms in which the risks involved were described.[47]

In spite of the CMR's statement in response to this researcher's query, it supported other experiments that involved subjects whose capacity to give valid consent to participation was doubtful, including institutionalized people with cognitive disabilities.[48]

During the war, the Navy used consent forms in wartime experiments using prisoners and conscientious objectors, as a proposal for research on an influenza vaccine with prisoners at San Quentin in 1943 shows.[49] The form used in this case indicates that the subject is "acting freely and voluntarily without any coercion on the part of any person whomever."[50] To be sure, the forms located by the Advisory Committee were called "waiver" or "release" rather than "consent" forms. Thus, the attestation to voluntary participation was punctuated by the release of experimenters from liability. However, at a time when free young men were routinely conscripted into the military, the requirement that subjects, including prisoners and conscientious objectors, must be volunteers seems remarkable.

In sharp contrast with these procedures, the Navy, too, sometimes functioned in a manner inconsistent with a voluntary consent policy for healthy subjects. Surviving subjects have reported that harmful mustard gas experiments on naval personnel at the Naval Research Laboratory in Washington, D.C., during World War II failed to adequately inform subjects and seem to have involved manipulation or coercion of "volunteers."[51] The lack of medical follow-up on the subjects of these experiments was sharply criticized in a 1993 report by the Institute of Medicine of the National Academy of Sciences.[52]

The NEPA Debate on the Ethics of Prisoner Experiments

Robert Stone, the recipient of the November 1947 letter in which AEC General Manager Wilson called for "informed consent," emerged as the primary proponent of human experiments. In a January 1950 discussion paper, he focused on the "ethics of human experimentation."[53] After a recitation of a tradition that included Walter Reed's experience and the historical use of prisoners and medical students as research subjects, Stone cited requirements that had been publicized by the American Medical Association in 1946. These rules provided that subjects must give voluntary consent, that animal experimentation must precede human experimentation, and that human experiments should be "performed under proper medical protection and management."[54] (See chapter 2.) Stone argued that it would be possible to conduct NEPA-related experiments with prisoners in compliance with all three of these requirements.

Stone's proposal generated considerable discussion among DOD and AEC experts and officials. In April 1950, the DOD's Joint Panel on the Medical Aspects of Atomic Warfare endorsed the use of prisoners of "true volunteer status" as meeting "the requirements of accepted American standards for the use of human subjects for research purposes."[55]

However, AEC officials were less than enthusiastic. "Doesn't the prisoner proposal," ACBM Chairman Alan Gregg asked a military official in the course of one discussion, "fall in the category of cruel and unusual punishment?"[56] "Not," the official replied, "if they would carry out the work as they proposed. . . . It would be on an absolutely voluntary basis, and under every safety precaution that could be built up around it . . . it didn't strike me as being cruel and unusual." To which Shields Warren retorted: "It's not very long since we got through trying Germans for doing exactly the same thing."[57]

In December 1950 the AEC convened a panel to discuss what was known about potential radiation effects on service personnel and whether human research was needed. Joseph Hamilton, Robert Stone's colleague at the University of California, was unable to attend the meeting, and in his regrets he offered his thoughts on the matter. In a letter to Shields Warren, he noted that the proposal to use prisoner volunteers "would have a little of the Buchenwald touch" and reported that he had no "very constructive ideas as to where one would turn for such volunteers should this plan be put into effect."[58] He suggested using large primates, even though, from a purely scientific viewpoint, the data collected would not be as useful as data from humans.[59]

Apparently Stone lost the debate. A decision was made not to conduct experiments with prisoners or other healthy subjects in connection with the NEPA project. However, as will be discussed in more detail in chapter 8, the military contracted with a private hospital to study patients who were being irradiated for cancer treatment, in the hopes of answering the same kinds of questions that would have been addressed if NEPA research with prisoners had gone forward.

Congress Provides for DOD Contractor Indemnification in the Case of Injury

In the late 1940s, some university researchers expressed concern that they were not adequately protected from liability in the case of injury or death of their prisoner-subjects. The ensuing dialogue provides a window on the role of the written releases and the understanding of the rules governing human subject research. In response to a researcher's request to be reimbursed by the Army for a disability policy for the subjects, the Army lawyers replied that the Army could not provide indemnification in the absence of clear congressional authority. Army legal advisers recommended that the researcher "protect himself, the State of New Jersey [the research locale], and the Government by means of the usual waiver."[61]

In a February 1948 letter, the AEB director, John R. Paul, explained that the "world situation" had placed the rules for human experimentation up for grabs.[62]

At this stage in the world situation one should proceed cautiously, until standards are set by what ever body is in 'authority.' I am not sure just what the rules are but I understand that . . . some type of vigilance committee has laid down certain principles about volunteers in order to protect this country from the criticisms brought up in Germany during the Nuremberg trials. . . . During the war we more or less made our own policies on this, but I am not sure that this is possible today. . . .[63]

The allusion to a "vigilance committee" is unclear. It may be a reference to a committee established by the governor of Illinois to examine the use of prisoners as research subjects in that state and chaired by Andrew Ivy, the principal expert witness for the prosecution at the Nuremberg Medical Trial (see chapter 2). Given the date of the letter, February 18, 1948, it seems likely that Paul had just skimmed through his new copy of the Journal of the American Medical Association--the report of Ivy's committee was published in the February 14, 1948, issue.[64]

In April 1948, an AEB official made it plain to the researchers that the fact that state authorities or the prison warden gave permission for the experiment should be of little comfort to them. In case of a lawsuit, responsibility "would devolve entirely upon the individual experimenter."[65] Only Congress could provide a solution, but it would be a "dangerous course" to raise the matter publicly. "I have," the AEB official wrote,

given considerable thought to the matter of whether it would be advisable to approach individuals or groups in Congress with the idea of having laws passed relating to payment of compensation for disability or release of the experimenter from liability. I am afraid that this would be a dangerous course, and that it might in fact injure clinical investigations generally. There is a very real possibility that unfavorable publicity would quickly result.[66]

It appears that the relief sought by researchers was provided by Congress in 1952, however, under the umbrella of a law that provided indemnification for DOD research and development activities as a whole. In October 1952, following the death of a prisoner-subject in an AFEB-sponsored hepatitis study[67] and questions raised by the Army Chemical Corps about release forms for "human 'guinea pigs,'"[68] the AFEB administrator queried the DOD Legal Office about a recently passed federal law. The law provided authority for the military to indemnify contractors for risks undertaken in "research and development situations." Did the new law "afford relief to the immediate dependents of . . . prison volunteers when as [a] result of these experiments they should die[?]"[69] The answer was yes, but only by providing relief to the researchers first. "From the wording of the law, and from . . . the legislative history," the Legal Office replied, "it is a direct indemnification to the contractor and not to the individual human guinea pig."[70]

Thus, what appears to have been the first Cold War congressional enactment to deal with human subjects of research addressed the government's obligation to its contractors, not the government's and its researchers' obligations to the subjects. Moreover, the record indicates that a more direct approach was not sought by the DOD because of concerns about public relations. At the same time Congress was acting, however, the DOD itself was secretly debating a new policy for human experiments.

The Secretary of Defense Issues the Nuremberg Code in Top Secret

From 1950 to 1953 discussions about human research and human research policy were held in several high-level DOD panels, including the Armed Forces Medical Policy Council (AFMPC), the Committee on Medical Sciences (CMS), and the Joint Panel on the Medical Aspects of Atomic Warfare. These groups were headed by civilian researchers, and, in at least the latter two cases, included representatives of the AEC, CIA, NIH, VA, and Public Health Service.

At its September 8, 1952, meeting, the AFMPC heard a presentation from the chief of preventive medicine of the Army Surgeon General's Office on the topic of biological warfare research:

It was pointed out that the research had reached a point beyond which essential data could not be obtained unless human volunteers were utilized for such experimentation. . . . Following detailed discussion, it was unanimously agreed that the use of human volunteers in this type of research be approved.[72]

At its October 13, 1952, meeting the AFMPC again took up the question of human experimentation. "It was resolved," the chairman wrote to the secretary of defense, "that the ten rules promulgated at the Nuremberg trials be adopted as the guiding principles to be followed. An eleventh rule [barring experiments with prisoners of war] was added by the legal advisor to the Council, Mr. Stephen S. Jackson."[73]

DOD attorney Jackson evidently was responsible for the inclusion of the Nuremberg Code in the AFMPC's proposed policy. In an October 13, 1952, memo to the chairman of the AFMPC, Jackson

recommended: that the attached principles and conditions for human experimentation, which were laid down by the Tribunal in the Nuremberg Trials, be adopted instead of those previously submitted by me.[74]

As an addendum to the Nuremberg Code, Jackson proposed a requirement that "consent be expressed in writing before at least one witness." This recommendation followed from the suggestion of Anna Rosenberg, assistant secretary of defense for manpower and personnel, who was an expert on labor relations.[75]

The Nuremberg Code

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 as to enable him to make an understanding and enlightened decision. The latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and 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 rest upon 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 problem under study that the anticipated results will justify the performance of the experiment.

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. 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 also serve as subjects.

6. 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.

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8. 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.

9. 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.

10. 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 experimental subject.

A letter written by the administrator of the Armed Forces Epidemiological Board documents Mr. Jackson's role and motivation:

It was on Mr. Jackson's insistence that the 'Nuremberg Principles' were used in toto in the document, since he stated, these already had international judicial sanction, and to modify them would open us to severe criticism along the line--"see they use only that which suits them."[76]

Thus, the DOD's counsel cited the 1947 Nuremberg military tribunal ruling as establishing an international legal precedent to which American researchers should be held.

It appears that in succeeding months the AFMPC proposal was received unenthusiastically by other DOD committees that reviewed it. In a November 12, 1952, memorandum, the executive director of the Committee on Medical Sciences pointed out that "human experimentation has been carried on for many years." He contended that

to issue a policy statement on human experimentation at this time would probably do the cause more harm than good; for such a statement would have to be "watered down" to suit the capabilities of the average investigator.[77]

"Human experimentation," the CMS executive director asserted, "has, in years past, and is at present governed by an unwritten code of ethics," which is "administered informally by fellow workers in the field [and] is considered to be satisfactory. . . . To commit to writing a policy on human experimentation would focus unnecessary attention on the legal aspects of the subject."[78]

Notwithstanding the reservations of the CMS and others,[79] the Nuremberg Code proposal had the support of President Truman's secretary of defense, Robert A. Lovett.[80] However, the secretary's aide, George V. Underwood, wrote in January 1953, "Since consequences of this policy will fall upon Mr. Wilson [President Eisenhower's nominee for secretary of defense, Charles Wilson], it might be wise to pass to him as a unanimous recommendation from the 'alumni.'"[81]

In a January 13, 1953, memorandum for the new secretary, the AFMPC "strongly recommended that a policy be established for the use of human volunteers (military and civilian employees) in experimental research at Armed Forces facilities." The policy would render the research "subject to the principles and conditions laid down as a result of the Nuremberg trials."[82]

The Wilson Memorandum

Memorandum for the Secretary of the Army

Secretary of the Navy

Secretary of the Air Force

Subject: Use of Human Volunteers in Experimental Research

1. Based upon a recommendation of the Armed Forces Medical Policy Council, that human subjects be employed, under recognized safeguards, as the only feasible means for realistic evaluation and/or development of effective preventive measures of defense against atomic, biological or chemical agents, the policy set forth below will govern the use of human volunteers by the Department of Defense in experimental research in the fields of atomic, biological and/or chemical warfare.

2. By reason of the basic medical responsibility in connection with the development of defense of all types against atomic, biological and/or chemical warfare agents, Armed Services personnel and/or civilians on duty at installations engaged in such research shall be permitted to actively participate in all phases of the program, such participation shall be subject to the following conditions:

a. The voluntary consent of the human subject is absolutely essential.

(1) 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, over-reaching, or other ulterior form of constraint or coercion; and 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. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and 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.

(2) The concept [sic] of the human subject shall be in writing; his signature shall be affixed to a written instrument setting forth substantially the aforementioned requirements and shall be signed in the presence of at least one witness who shall attest to such signature in writing.

(a) In experiments where personnel from more than one Service are involved the Secretary of the Service which is exercising primary responsibility for conducting the experiment is designated to prepare such an instrument and coordinate it for use by all the Services having human volunteers involved in the experiment.

(3) The duty and responsibility for ascertaining the quality of the consent rests upon 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.

b. 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.

c. The number of volunteers used shall be kept at a minimum consistent with item b., above.

d. 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 problem under study that the anticipated results will justify the performance of the experiment.

e. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

f. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur.

g. 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.

h. Proper preparation should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

i. 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.

j. 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.

k. 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 experimental subject.

l. The established policy, which prohibits the use of prisoners of war in human experimentation, is continued and they will not be used under any circumstances.

3. The Secretaries of the Army, Navy and Air Force are authorized to conduct experiments in connection with the development of defenses of all types against atomic, biological and/or chemical warfare agents involving the use of human subjects within the limits prescribed above.

4. In each instance in which an experiment is proposed pursuant to this memorandum, the nature and purpose of the proposed experiment and the name of the person who will be in charge of such experiment shall be submitted for approval to the Secretary of the military department in which the proposed experiment is to be conducted. No such experiment shall be undertaken until such Secretary has approved in writing the experiment proposed, the person who will be in charge of conducting it, as well as informing the Secretary of Defense.

5. The addresses will be responsible for insuring compliance with the provisions of this memorandum within their respective Services.

/signed/

C. E. Wilson

copies furnished:

Joint Chiefs of Staff

Research and Development Board

TOP SECRET

Downgraded to UNCLASSIFIED

22 Aug 75

On February 26, 1953, Secretary of Defense Wilson signed off on the AFMPC policy. It was issued in a Top Secret memorandum to the secretaries of the Army, Navy, and Air Force. The Wilson memorandum reiterates the principles of the Nuremberg Code, requires written and witnessed informed consent of research subjects, and prohibits the use of prisoners of war. The policy was to "govern the use of human volunteers by the Department of Defense in experimental research in the fields of atomic, biological, and/or chemical warfare for defensive purposes."[83]

The basis for the classification of the 1953 memorandum is not clear. Since the memorandum dealt with atomic and other unconventional forms of warfare, its classification may have been routine. There is evidence that the DOD had a general desire to keep hidden from public view any indication that it was involved in biological and chemical warfare-related research; the Wilson memorandum, of course, was just such an indication. In September 1952, the Joint Chiefs of Staff advised the services to "[e]nsure, insofar as practicable, that all published articles stemming from BW [biological warfare] and CW [chemical warfare] research and development programs are disassociated from anything which might connect them with U.S. military endeavor."[84]

In one sense the memorandum is a landmark in its official recognition of the Nuremberg Code, but in another sense it also generates important questions. Having determined to recognize international principles of human rights, why, or how, could the secretary have limited their application to some, but not all, human experiments? Why was the policy directed exclusively to experiments related to "atomic, biological, and chemical warfare"? Moreover, was the policy intended to govern such research wherever it was conducted; for example, when it was performed by private contractors, as well as by intramural researchers? How was a directive issued in secret implemented?

Communicating the 1953 Wilson Memorandum

On further inquiry, the AFSWP reviewer found that a policy already existed, but had not been disseminated to investigators. A follow-up memorandum, evidently written in early 1954, records:

In November 53 it was learned that there existed a T/S [Top Secret] document signed by the Secretary of Defense which listed various requirements and criteria which had to be met by individuals contemplating the use of human volunteers in Bio-medical or other types of experimentation. . . . It was learned that although this document details very definite and specific steps which must be taken before volunteers may be used in experimentation, no serious attempt has been made to disseminate the information to those experimenters who have a definite need-to-know.[86]

"The lowest level at which it had been circulated," the AFSWP reviewer learned, "was that of the three Secretaries of the Services." Efforts by an assistant secretary to "downgrade" the document had "not been able to obtain concurrence." The reviewer hoped that "this letter shall point up the need for some relaxation of the grip in which this document is now held, at least on a definite need-to-know basis."[87] (The application of the Wilson memorandum to further experiments conducted at atomic bomb tests is discussed in chapter 10.)

Implementation in the Army

Interestingly, choice of subjects was to be governed by the Army's ability to ensure compensation in the case of death or disability.[90] This could be provided, the lawyers declared, only upon express congressional action. In the case of military personnel and contractor employees there was such provision. But there was no such authority in the case of private citizens who offered their services. The Army lawyers recommended, and the CS:385 policy provided, that private citizens not employed by Army contractors could not serve as research subjects.[91]

On March 12, 1954, the Army Office of the Surgeon General (OSG) issued an unclassified statement entitled "Use of Human Volunteers in Medical Research: Principles, Policies, and Rules."[92] This document too restated the Nuremberg principles. In contrast with the Wilson and Oakes memorandums, it was not restricted to research related to atomic, biological, or chemical warfare. Instead, the OSG statement was directed to "medical research" with human volunteers generally.[93]

Moreover, while CS:385 did not state directly whether it applied to contract researchers, the 1954 OSG statement was transmitted to at least some university researchers with the prefatory note, "To be used as far as applicable as a non-mandatory guide for planning and conducting contract research."[94] There is evidence that the OSG's requirements were sometimes more than "non-mandatory guides." For example, in a June 27, 1956, letter to the the Armed Forces Epidemiological Board, a Tulane University public health researcher agreed that his vaccine experiments with prisoner subjects would be conducted only after written consent was obtained from the subjects.[95] The Tulane researcher indicated that, with respect to his application for funding, "I have held it up since Dr. Dingle indicated I be familiar with the statement of the Office of the Surgeon General re the use of human volunteers. . . . I have read it and believe that our past and future work have [sic] and will comply with the rules stipulated."[96] Moreover, this researcher provided a written statement to supplement his original proposal that explained how the OSG requirements would be met. In another case, a proposal involving measles and normal children, an AFEB official advised the researcher to "take [the OSG policy] into consideration in writing the proposal."[97]

As discussed earlier, in 1952 the Army obtained congressional authority to indemnify contract researchers in the event that an experiment caused injury or death. There is evidence that the Army sought to link the grant of an indemnification clause (ASPR 7.203.22, "Insurance--Liability to Third Persons") to contractor acceptance of the principles stated by the Army surgeon general. In a March 1957 letter to the University of Pittsburgh, which was proposing to use medical student-volunteers in a (nonradiation) experiment, the Army told Pittsburgh that the provision of the clause was "contingent upon your adhering to the following [March 1954 Office of the Surgeon General] principles, policies, and rules for the use of human volunteers in performing subject medical research contracts."[98]

While the evidence clearly shows that Army officials sought to apply the Nuremberg Code policy to contractors, it did not meet with complete success, and the full extent of its efforts remains unclear. As we see in chapter 2, in the early 1960s Harvard successfully resisted the inclusion of the Nuremberg Code language in its medical research contracts with the Army. As we see in chapter 8, which discusses DOD funding of research on the effects of total-body irradiation, the indemnification language was included in at least some contracts in which the surgeon general's policy was not mentioned. By 1969, however, the policy may have become standard in Army contracts under the authority of the Medical Research and Development Command.[99]

There are several possible explanations for the seeming absence of widespread inclusion of the surgeon general's memo as a contractual requirement, at least where indemnification was provided for. First, as discussed below, it is possible that the 1954 policy was meant to apply to research with healthy subjects, and not sick patients. (However, even if that were generally the case, the provision of indemnification might be expected to have triggered reflection on this limitation.) Second, as a related matter, the evidence we are reviewing shows a tension between the government's declaration of a principle and its readiness to actively insist that the principle be honored within the privacy of the doctor-patient relationship.

Finally, Army imposition of the surgeon general's principles may also have depended on the nature of its interest in the research being done. An April 3, 1957, memo distinguished cases where the institution "because of its primary interest, would conduct the research even without support of the OSG," from cases where "the study is conducted at the insistence of OSG." In the former case the strategy would be to seek cost-sharing contracts, in which the institution would "assume all responsibility for any possible effects resulting from the experimentation." In the latter case, the indemnification clause would be provided, but the March 1954 policy would also be required and included in the contract directly or by reference.[100]

It is not clear that the 1954 OSG policy on human volunteers was intended to apply to research with patients. The term volunteer is ambiguous but at the time was commonly used to refer to healthy subjects. Nonetheless, a 1962 Army memorandum that declared that since World War II "by and large research has been conducted in strict accordance with the Nuremberg Code" mentions patients.[101] The memo reported that a recent survey of contract research found that the volunteers treated in accord with the Nuremberg Code included "3,000 students, 250 patients, and 300 prisoners." It is not known what kind of research these 250 patients were involved in, nor is it known what proportion of the patients who had been subjects of research supported or conducted by the Army since World War II were represented by these 250.

Unfortunately, the 1962 review's confident declaration that Army research complied with the Nuremberg Code was too sanguine. In 1975, following public revelations that the Army and the CIA had conducted LSD experiments on unwitting subjects, the Army inspector general reviewed the application of the June 1953 policy to drug testing. The inspector general's review led to the declassification of the 1953 Wilson memorandum. The inspector general found that the Army had, with one or two exceptions, used only "volunteers" for its drug-testing program. However, the "volunteers were not fully informed, as required, prior to their participation, and the methods of procuring their services in many cases appeared not to have been in accord with the intent of Department of the Army policies governing use of volunteers in research."[102]

Additional DOD Research Requirements

At least for research with radioisotopes, the requirement for voluntary participation may have applied to patient-subjects as well as healthy subjects. In 1951 the Navy debated adoption of a permission form for the use of radioisotopes for patients at naval hospitals.[106] This form, to be signed by either the patient or the responsible next of kin, authorized the use of "tracer-therapeutic" doses "obtained from the Atomic Energy Commission for research purposes."[107]

Although it is not clear that the Army rules implementing the 1953 Wilson memorandum applied to patient-subjects, there is some evidence that consent forms that were usually used for surgical procedures were used in patient-related experimental settings involving radioisotopes. In 1955 an official from the Letterman Army Hospital in San Francisco asked the Walter Reed Hospital about the need for written "permission" forms for "test doses" of radioisotopes.[108] In response, the Army indicated that a standard form used for operations and anesthesia should also be employed, at the physician's discretion, when "authorization for administration of radioisotope therapy is desired."[109]

In the Air Force, a 1952 regulation on clinical research mandated safety and administrative procedures for the use of humans in experiments at Air Force medical facilities.[110] This regulation required prior group review but did not mention consent provisions or refer to the subjects as volunteers. In 1958 a letter from the Air Force's Air Research and Development Command describes the policy for the use of humans in "hazardous research and development tests." This policy reiterated the requirement for prior review discussed in the 1952 regulation. In this context, however, subjects were to be "volunteer[s]" who "underst[ood] the degree of risk involved in the experiment."[111]

What, then, were the operative rules in the Department of Defense for research involving human subjects in the 1940s and 1950s? By the mid-1950s, for the entire DOD for research related to atomic, biological, and chemical warfare, and for all research involving "human volunteers" in the Army, the formal rules were the ten principles of the Nuremberg Code and the additions included in the secretary of defense's 1953 policy. According to the 1975 testimony of the surgeon general of the Army before the U.S. Senate and the internal review conducted by the Army inspector general, these principles were Army "policy."[112] See also, U.S. Army Inspector General, Use of Volunteers in Chemical Agent Research (Washington D.C.: GPO, 1975), 77. At the same time, as the inspector general reported in 1975 and as we discuss further in chapter 10, these requirements were not always known or followed. While there were attempts to implement the Army surgeon general's 1954 policy, it is not known how the policy's provisions, including the requirement to obtain voluntary consent, were interpreted. The Navy's 1951 requirements for prior review and voluntariness applied to all research involving Navy personnel.

The extent to which research rules applied to patient-subjects in the clinical setting is less clear. There is some indication that in some cases standard consent forms, akin to the surgical permits in use at the time, were employed with patients at military hospitals who were administered "test doses" of radioisotopes.