DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. TAB I MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: September 1, 1994 RE: Ethics Data Collection Update The ethics data collection process now reaches into many specific subjects, the most salient of which are presented below under three headings: I. Development of Ethics Standards II. Proposal Review and Approval Process III. Experiments or Occupational Exposure Combined with Risk Measurement? I. Development of Ethics Standards A. Department of Defense -- Early 1950's (See organizational chart Attachment 1) Recently unclassified meeting transcripts of two Department of Defense committees shed further light on the discussions within the Pentagon preceding and leading up to the 1953 Wilson Memo. As previously reported, the Wilson Memo established the Nuremberg Code as the ethical standard for human experimentation in the DOD, related to atomic, biologic and chemical warfare for defensive purposes. Among the meeting minutes now in the possession of the Advisory Committee are several from the Committee on Medical Sciences and one from the Committee on Chemical Warfare for the period from early 1950 through late 1952. Within the Committee on Medical Sciences there was vigorous and even impassioned debate about the Joint Panel on Medical Aspects of Atomic Warfare proposal to conduct human experiments. The Committee had at first endorsed the Joint Panel's proposal without much debate, but later decided to refer the question back to the Panel for further consideration. While most members appeared to support the view that there was a need for human experiments (under conditions they understood as safe and 1 sensitive to the imperatives of using volunteers only), one or two members persistently disagreed. Reference was made to Shields Warren and his position that such experiments were not needed. There were also discussions about confidence levels concerning amounts of exposure known to be harmful, the traditions of use of volunteers in the military and in medical research, and various other issues. (See Attachment 2) The Committee on Chemical Warfare, in its November 10, 1952 meeting, was read a draft of the Armed Forces Medical Policy Council proposal, which would later become the substance of the Wilson Memo. After the reading, one member remarked "If they can get any volunteers after that I'm all in favor of it." (See Attachment 3, P. 125) B. Department of Defense -- Early 1960's On March 26, 1962 the Army published AR (Army Regulation) 70-25, which updated and supplemented the 1953 Wilson Memo. Note that whereas the Wilson Memo appeared to apply only to atomic, biological, and chemical warfare experiments for defensive purposes, 70-25 appears to apply to all human experiments. However, note further the three exemptions: 3.a. exempts research that involves "inherent occupational hazards to health or exposure of personnel to potentially hazardous situations encountered as part of training or other normal duties"; 3.b. exempts disclosures to participants that would invalidate experiments having to do with human factors; 3.c. exempts therapeutic research. This regulation raises a number of interesting questions about the evolution of Army policy which the staff is continuing to analyze. (See Attachment 4) C. Atomic Energy Commission In an earlier Briefing Book (No. 4) we reported that a 1951 letter from Shields Warren cited a 1947 letter from AEC General Manager Wilson, in which Wilson stated that the Advisory Committee on Biology and Medicine of the AEC had established a written informed consent standard from both the patient and his or her next of kin. It is not clear to what extent the rules stated in these letters were implemented. In 1956 the Health Division Leader at the Los Alamos National Laboratory (LANL) forwarded an inquiry to the AEC on "the experimental use of human volunteer subjects." In response, the Director of the Division of Biology and Medicine stated that tracer doses may be administered under four conditions, including that subjects be fully informed. Seven years later, in 1963, the Health Division Leader at LANL restated these rules. (See Attachment 5) It is not yet clear from the documents available to the Advisory Committee either how these rules were applied or the extent to which they applied to those who were not LANL employees, such as patients at area hospitals. 2 D. National Institutes of Health -- Early 1950's On December 5, 1952 an NIH attorney put into writing his recommendation that a written consent statement be obtained from all patients admitted to the NIH Clinical Center. Most members of the medical board rejected this proposal when it was presented, according to this memo, and preferred oral statements. However, the NIH legal counsel here expressed sharp exception to such a procedure. He argued that formal consent processes should apply with even greater force to clinical investigations than to standard surgical procedures. (See Attachment 6) II. Proposal Review and Approval Process A. Department of Defense 1953 Cold Study, Department of the Army -- A September 9, 1953 memorandum describes proposal to test soldiers' performance in cold environments and the effect of vitamin supplements. The memo states that consent was solicited from the 128 personnel, but it is not clear what they were told; no written consent form seems to have been used. (The participants are called "selected volunteers" on page two of the memo.) A specific unit was recommended for the test, but Puerto Rican and "Negro" personnel were excluded; no rationale was given. Various Army officials signed off on the proposal. (See Attachment 7) (It might be noted that the 1975 Army Inspector General Report on chemical warfare experiments states that interpretations of the 1953 Wilson Memo on the use of human volunteers were "flexible.") In addition, the Army has sent the Advisory Committee 15 experiment proposals that, were sent for approval to the Secretary of the Army. The earliest proposal is dated 19 April 1963. Each proposal cites Army regulation 70-25. (See above discussion of "Department of Defense -- Early 1960's," and Attachment 4) III. Experiments or Occupational Exposure Combined with Risk Measurement (Department of Defense)? A. Manned Sampling of Atomic Clouds An official Air Force history describes the manned atomic cloud sampling program, conducted from 1951 to 1961. Manned sampling became the method of choice for assessing nuclear weapons efficiency due to technical limitations of drone aircraft and following an accidental "fly-through" in 1947, whereupon it was concluded by operations officials that such activities could be conducted within an acceptable margin of safety. Manned samplers were also considered less expensive than drones. Although Air Force officials and program personnel believed that these flights could be done safely, the irradiation of personnel and aircraft was a matter of constant study, as were techniques for prevention or minimization of exposure and decontamination. Further, there was conflict between Los Alamos nuclear scientists and operational leaders concerning acceptable exposures. (See Attachment 8) These aviators were volunteers, but there was no written consent. 3 The manned sampling program is one of those that raises interesting questions about the differences between experiments on the one hand and occupational exposures combined with risk measurement on the other. Other cases that raise such questions follow. B. Beta Hazard Experiment A 1963 proposal entitled "Beta Hazard Experiment Using Volunteer Military Personnel" states that the experiment's purpose was "to determine the military significance of the beta radiation hazard under field clothing contaminated with radioactivity." Despite theoretical studies on the subject and the large amount of data collected from nuclear testing the proposal states that the opinions on the hazard varied significantly. (It appears from the documentation that the study was conducted, though we are not in possession of any follow-up reports.) The proposal also notes that "Army Regulations 70-25 require the consent of the Secretary of the Army for research wherein volunteer subjects will be deliberately exposed to nuclear radiation." However, there is no evidence in the documents in the possession of the Advisory Committee that the participants gave written consent. (See "Department of Defense -- Early 1960's," and Attachment 4) The researchers hypothesized that the soldiers who crawled through a fallout field may develop "severe beta burns on clothed skin," and that expedient field decontamination methods "will not significantly reduce the hazard of beta burns under clothing." The soldiers in this test were to be limited to 3 rem over the period of five days, similar to the 3.9 roentgen limit placed on troops involved in atomic tests. (See Attachment 9) C. Fallout Studies The declassified study "Recovery of Radioactive Iodine and Strontium from Human Urine--Operation Teapot," provides further confirmation of biomedical experimentation in connection with atomic tests. Operation Teapot was conducted in 1955, and was one of the series of nuclear weapons tests conducted in the Nevada Desert. The study tested 2,137 human urine specimens from a number of United States and foreign military stations and examined a collection of human thyroid glands procured from the Armed Forces Institute of Pathology. The study was designed to determine the biological hazard of the fallout from atomic tests. 4 Because the weapons tested during the Teapot series were small yields "limited positive data were expected." The study was primarily designed to provide a baseline for Operation Redwing (1956) which would test weapons of considerably greater yields. Despite these expectations "A number of samples were found to contain radioactive iodine and strontium." The study's findings shed light on the manner in which humans are exposed to the hazard of fallout. In a sample from a subject stationed at Camp Mercury iodine-133 was present as well as iodine-131. Because iodine-133 has a very short half-life (23 hours) its presence "strongly implicates inhalation as an important route of entry for man." As mentioned the study was initially classified and it is not clear how, or if, this information was passed on to the general public or the troops who participated in subsequent atomic tests. In addition to conclusions about how humans are exposed to radiation hazard the study raised questions about the accuracy of physical measurements of radiation hazard. According to the authors, the data indicates, "There is an apparent lack of correlation between urinary iodine and physical fallout measurements. This implies that the physical measurements, as currently determined, do not reflect the total biological hazard." The study does not appear to be isolated. The authors cite four previous studies on the subject although the previous studies examine distinct hypotheses such as the hazard posed by ingesting plants and animals exposed to fallout. In addition, a similar study was designed and conducted for Operation Redwing. The study's conclusion called for "further verification and delineation at future nuclear tests." D. Flashblindness Studies Recently declassified DOD documents have revealed a more detailed picture of flashblindness experiments conducted during nuclear tests. Project 4.5 during Operation Snapper (1952) was designed to determine whether military personnel could carry out assigned tasks which required vision if they were exposed to the flash of an atomic detonation at night. This project continued the earlier Buster Project 4.3 (1951) which tested the effect of flashblindness on daylight-adapted eyes. The subjects viewed the flash from 10 miles away some with red filter protection and some with no protection. The project cites the use of "human volunteers" and "was terminated after Shot 4 in order to evaluate the significance of lesions of the retina which were produced in two of the subjects. Subsequent examinations indicated complete healing with no subjective or objective findings remaining." There is no information as yet available concerning recruitment of volunteers or whether they signed consent forms. The studies continued during Operation Upshot-Knothole (1953). Twelve human volunteers (again, with no further information on recruitment or consent forms), and 700 rabbits were subjected to the "light flash from six atomic detonations to investigate its effect on the visual function of human eyes and to determine the burn injury processes in the dark adapted rabbit eye." 5 After these tests the research continued in the laboratory and at Operation Hardtack (1958). For example, a "Study of Flashblindness and Chorioretinal Burns in Personnel Using Optical Instruments" was listed in the Transfer of Funds for FY 63 to the Nuclear Weapons Effects Research (NWER) Programs (a budget request to Congress from the Defense Atomic Support Agency). A continuation was also proposed for FY 64 to continue until FY 67 under the study "Oculo-Visual Damage from Thermal Radiation." Interestingly, this proposal also cites the need to study the effects of ionizing radiation on vision. "Because of anatomical characteristics of the eye, it is vulnerable to the devastating effects of thermal and thermonuclear radiations. Therefore, research must be accomplished to obtain threshold data for ocular tissue damage for the entire spectrum of thermal and ionizing radiations." 6