Executive Summary: Advisory Committee on Human Radiation Experiments, Meeting of 5-6 July 1994

Page 1

ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS MEETING OF 5-6 JULY 1994 The Advisory Committee on Human Radiation Experiments conducted its fourth meeting on 5 and 6 July 1994, at the Vista Hotel, 1400 M Street, N.W., Washington, DC. The meeting’s agenda is at Tab A. 2.0 SUMMARY OF MEETING, 5 JULY 1994 The Advisory Committee was called to order by Mr. Philip Caplan, Special Assistant to the President for Cabinet Affairs. The Committee chair, Dr. Ruth Faden, stated that the Committee had four main objectives for the next two days: Reviewing staff efforts to date and providing guidance on how best to allocate staff effort in the future; briefing staff and committee members on areas of importance; listening to public comment during the public comments period; and moving the work of the Committee forward. 3.0 STAFF BRIEFING: UPDATE ON ETHICS DATA COLLECTION EFFORTS Committee staff member Jonathan Moreno provided an update on the status of the Mr. Moreno concentrated on the Department of Defense (DoD) and the Department of Memorandum and seemed to indicate that prior to 1953 there was a regulatory vacuum regarding use of humans in radiation experimentation. The focus of the DoD search revolved around the 1953 Secretary of Defense Wilson 3.1.2 There also were indications that the tenets set down in the 1953 Wilson Memorandum were not excepted by all DoD components and that there was a great degree of concern about Soviet progress in the areas of radiological warfare (RW), biological warfare (BW) and level of and necessity for fully informed consent on the part of human experiment subjects. One area of DOE research centered on the debate and disagreement concerning the early 1950’s that the Commission was not participating in human use experimentation, when in fact this was not true. Another area of DOE research centered on statements made by AEC officials in the

Page 2

4.0 SUBCOMMITTEE REPORT: ETHICS DATA COLLECTION The Committee chair, Dr. Faden, provided a briefing on the progress of the Ethics Data Collection Subcommittee on behalf of that Subcommittee’s chair, Dr. Ruth Macklin, who was not present at this series of meetings. Dr. Faden stated that the Subcommittee has focused on continuing the ethics data of using humans in biomedical and ionizing radiation research. Dr. Faden indicated that there was an immediate need for information on the practice policy for conducting research was also needed. Information on the historical practice of research and its relationship to historical 4.1.3 The Subcommittee proposed conducting an oral history project with the intent of elucidating actual practices (as compared to the policy guidelines) of investigators. The project would entail identifying 15 to 20 investigators, approximately 10 in the field of ionizing radiation and 10 from another field, focusing on practices in the 1940’s and 1950’s. The project would be conducted by experienced oral historians and guided by an expert panel consisting of oral historians, biomedical ethicists, and other experts from pertinent fields. 4.1.4 The Subcommittee was also concerned with the portion of the Advisory Committee’s mandate that called for an evaluation of the current state of ethical policies and practices related to human experimentation. practices, a second project be initiated to review a sample of protocols currently being implemented that involved ionizing radiation and another nonradiation related field. Funding agencies would be asked to provide lists of grant proposals to the Committee for review by Committee members and staff. The purpose of the project was to answer questions such as The Subcommittee proposed that, in light of the absence of information on current 0 To what extent are humans exposed to more than minimal risk during research? 0 Is there an offsetting benefit for the subject to compensate for the risks 0 Is there any evidence that current informed consent procedures are adequate? 0 Are ‘vulnerable’ groups being especially singled out for use in Dr. Faden proposed this Project be led by Dr. Katz. may be involved in experiments. The plan is to identify 10 institutions (five academic The Subcommittee proposed a third project that would entail interviewing patients thatL

Page 3

institutions and five Government agencies) that received the highest volume of Federal funds for research involving humans and inviting these institutions to participate in this project. The focus of the project .would be on medical/radiological oncology and would involve interviewing patients in waiting rooms that may or may not currently be subjects in research projects. The project would involve getting permission to review patienvsubject medical files and verifying any information collected during the interview with the patienvsubject primary care giver (at that institution). 4.1.7 The Subcommittee called for these proposals to be approved. The oral history project was approved if a panel of experts believed it could be validly conducted. The proposal to review a sampling of current protocols was also approved. The majority of the Committee discussion period focused on the feasibility and practicability of the third proposal - to interview possible patients that may be involved in research. The discussion focused on problems of patient confidentiality, the degree of likelihood that an adequate sample of subjects could be found by interviewing patients in waiting rooms; and whether or not this proposal could be later seen as violating the standards of ethics that the Committee was created to review. 4.1.8 The Committee decided to send this proposal back to Subcommittee for more 5.0 SUBCOMMITTEE REPORT: SCOPE AND PRIORITIES SUBCOMMITTEE Committee member Dr. Duncan Thomas briefed the Committee on the status of the Scope and Priorities Subcommittee. draw the limits of what was in the scope of the Committee and what was not. The Subcommittee focused on the issue of intentional releases, especially attempting to established the Committee. These were definitely within the scope of the Committee. The first priority was the intentional releases identified in the Executive Order that within the scope of the Committee. There were, however, a large number of ‘borderline’ incidences that were not clearly The main issue the Subcommittee focused on when evaluating these ‘borderline’ 0 Whether harm was done 0 Whether there were secret aspects to any of these incidents 0 What type of information was provided to the subjects 0 To what extent the experiment was conducted for the purpose of researching human health effects of radiation.

Page 4

5.1.4 The first group examined was Marshall Islanders. The question to be answered by the Committee was whether testing done there constituted a human radiation experiment. sub-categories. First, those involved in clean up activities (Le., ship and aircraft decontamination). It was thought by the Subcommittee that this category fell under occupational exposure, not under the scope of the Committee’s mandate. Second, any experimentation involving human performance measurements after exposure to radiation. The feeling of the Subcommittee was that some of these exposures were very experimental in nature and may well fall under the scope of the Committee. The second group examined was atomic veterans. This group was divided into two was difficult to see any experimental aspects related to this group, although deep ethical questions are raised in this area. The third group examined was Uranium miners. The Subcommittee believed that it 5.1.7 The fourth group examined was the ‘Down-Winders’. The feeling of the Subcommittee was that this group was not an experimental category, but questions were raised about the quality of information provided to the public and the possible misrepresentation of workers. The feeling of the Subcommittee was that this group was clearly occupational, and not within the Committee’s scope. 5.1.9 The ensuing discussion focused on the desire of Committee members to fully review all available information before eliminating groups, the need to determine what other information and other groups were still “undiscovered” and the need for the Subcommittee to begin to focus on the area of Committee priorities. The last group examined was the Department of Energy (DOE) nuclear facility 6.0 SUBCOMMITTEE REPORT: COLD WAR SUBCOMMITTEE Committee member Dr. Maryanne Stevenson briefed the Committee on the progress of the Cold War Subcommittee. large quantity of information the Committee was receiving could be examined. The Subcommittee had focused on developing methodological aids through which the was to sharpen and define the criteria that are of interest in respect to each experiment. The first methodological aid was the development of a form. The purpose of the form briefing on the Pilot Project which used the form as a tool for digesting information. Dr. Faden stated that the Committee was free to critique the form after the next days The idea was to develop groups of experiments that could be examined together because they shared common features. These groupings were, effectively, a working classification scheme. The second methodological aid was the development of ‘groupings’ of experiments.

Page 5

7.0 SUBCOMMITTEE REPORT: OUTREACH SUBCOMMITTEE The chair of the Outreach Subcommittee, Dr. Reed Tuckson, was unable to make the Committee meetings because of overseas travel complications. Committee staff member Mr. Steve Klaidman briefed the Committee on Dr. Tuckson’s behalf. Mr. Klaidman stated that the issues before the Outreach Subcommittee were of a very and where these meetings were to take place. The major issue before the Subcommittee was how many field meetings were needed 7.1.2 The Subcommittee evaluated this issue with three criteria in mind 0 Making the Committee available to a concerned public 0 Making information and perspectives of interested groups available to the 0 Help to publicize the Committee’s work. be held, plus four field meetings with panels of approximately three Committee members The Subcommittee proposed that three full-scale Advisory Committee field meetings 7.1.4 The cities proposed for the hll-scale meetings were San Francisco, Atlanta, and Chicago. These cities were chosen because of geographic spread and because no large-scale human radiation experimentation took place in close proximity to these locations. 7.1.5 During the following Committee discussion period a counterproposal was offered calling for having only panel field meetings, possibly linked into a full-scale Committee 7.1.6 The issue was returned to the Subcommittee for review with direction to at least reduce the number of proposed full-scale field hearings and an examination of the idea of only field panel meetings, augmented by video-conferencing. 8.0 NEW STAFF INTRODUCTIONS, STAFF STRUCTURE AND CURRENT Committee staff member Mr. Jeffrey Kahn introduced three new staff additions to the Because of time constraints, staff structure and current project assignments were only

Page 6

9.0 COMMITTEE DISCUSSION OF GOALS AND OBJECTIVES OF THE Committee chair Dr. Faden and Executive Staff Director Mr. Dan Guttman briefed the Committee on the development of a draft document examining the goals and objectives of 9.1 This document was an outgrowth of the assignment to Dr. Faden and Mr. Guttman to produce a vision document that could be used to solidify the Committee’s sense of what they so that an in-depth discussion could take place on Wednesday. In effect, this document would be the working outline for the Committee’s interim and final reports. The goal of Tuesday’s briefing was to present an outline, for the Committee’s benefit, 9.1.2 The document was arranged in three sections: Foundation, Focal Point, Experiments and Intentional Releases, and Looking to the Future. to Human Use in Experimentation was envisioned. This section would focus on what the policies related to ethical procedures were, as well as what the actual practices were. In the Foundations section, a subsection titled Ethical Principles and Practices Related groupings and themes. The groupings were scheduled to be discussed on Wednesday so they were not examined, however, three basic themes were identified: In the Focal Point section, the intent was to put various pieces together using 0 Exploitation and power differential - basically the use or misuse of vulnerable 0 The idea of openness and full disclosure - this theme is intended to convey to the public the idea that this issue was exhaustively examined 0 The level of risk that subjects involved in these experiments were exposed to. as the aspect of the changing needs of national security. In the Looking to the Future section, the issue of remedy was to be examined, as well (or near final) version of this document, because it would embody all of the issues the Committee wanted examined. It was also made clear that this document would not be finalized for quite some time, and she envisioned a lot of restructuring along the way. Dr. Faden stated that the desire was to shape staff structure along the lines of the final 10.0 PUBLIC COMMENT PERIOD Three groups participated in the public comment period, a representative of the Government of the Marshall Islands, a representative of the people of Bikini, and a representative of the National Committee for Radiation Victims.

Page 7

11.0 SUMMARY OF MEETING, 6 JULY 1994 The 6 July 1994 meeting had several key agenda points: a briefing by a Committee member, two reports on agency data collection efforts, a discussion of the possible experiment groupings, and a discussion of the draft document on goals and objectives. 12.0 COMMITTEE MEMBER BRIEFING: HISTORY OF HUMAN Committee member Dr. Jay Katz conducted a one hour briefing on the history of human experimentation, as part of the Committee’s continuing effort to cross-educate each since the beginning of the nineteenth century. The general trend was toward increased need for informed consent from the subject of experiments, as well as increased responsibility for researchers to insure that adequate steps have been taken to obtain truly informed consent. Several key steps in this process have been: the 1900 Prussian Ministry of Medical Affairs directive on human experiments, which demanded unequivocal consent of the subject; the 1947 Nurenberg Code which calls for the consent of the experiment subject; and the 1969 World Medical Association’s Declaration of Helsinki, which contained less strident informed consent language than that embodied in the Nurenberg Code. Dr. Katz provided the Committee with a series of steps that medical ethics have taken 13.0 STAFF REPORT: METHODOLOGICAL REVIEW OF AGENCY DATA COLLECTION EFFORTS -- CENTRAL INTELLIGENCE AGENCY (CIA) Committee staff member Mr. Gary Stern briefed the Committee on the progress of the radiation experimentation, even in conjunction with the MKULTRA project that focused on manipulation of people by chemical and other means. Mr. Stern stated that the CIA had uncovered no records of any involvement in human 13.1.1 Several documents led the staff to believe that there was at least a possibility that the CIA was involved in human radiation experimentation. A 1963 CIA Inspector General report referred to radiological materials (along with a number of other substances) as a possible material to be used in MKULTRA. Additionally, in a 1977 report it was apparent that all possible materials, with the exception of radiological material, had been covered. 13.1.2 To date, the CIA had conducted a computer search of over 34 million records, had hand searched 480,000 records, and had conducted 50 interviews with personnel associated with the MKULTRA program, and it found no indication that the CIA had participated in any human radiation experiments. 13.1.3 The Committee staff met with CIA officials on 16 June 1994.

Page 8

13.1.4 The CIA has not focused on some issues of concern …