Advisory Committee on Human Radiation Experiments Executive Summary Meeting, June 13-14, 1994

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MEETING, ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS, The Advisory Committee on Human Radiation Experiments conducted its third meeting on 13 and 14 June 1994. The 13 June session was held at the Ramada Plaza Hotel, 10 Thomas Circle, Washington, DC. Due to central air conditioning difficulties at the Ramada Plaza Hotel, the 14 June session was held at the Vista Hotel, 1400 M Street, N.W., 2.0 SUMMARY OF MEETING, 13 JUNE 1994 The 13 June session was called to order by Mr. Philip Caplan, Special Assistant to the President for Cabinet Affairs. The key agenda items accomplished were a briefing on remedies, conducted by Committee member Mr. Ken Feinberg; a briefing on risk communication, conducted by staff member Mr. Steve Klaidman; a series of staff reports on the status of the agency data collection efforts and a report on declassification efforts. 3.0 COMMITTEE MEMBER BRIEFING: REMEDIES Committee member Mr. Feinberg conducted a half-hour briefing on the background information for the Committee that would help in any discussion on compensation. 3.0.1 Mr. Feinberg identified two classes of remedies that the committee would have to deal with: Particularized Remedy and Mass Exposure Remedy. Particularized Remedy is characterized by an action-consequence chain of events and is usually linked to an individual or small group. For example, an individual is hit by a car, and as a consequence that individual's leg is broken. There is a direct cause and effect fiom which to base a remedy. 3.0.2 Mass Exposure Remedy is characterized by an inability to demonstrate particularized injury. Examples would include the Nevada "Down-Winders", the Marshall Islanders, and the people living in proximity to the Hanford Nuclear Reservation. The positive causal link between exposure to radiation and subsequent development of cancer is not proven simply by proximity. Many times epidemiological studies are the only "proof" available in these cases. 3.0.3 The Committee would need to develop creative solutions to the Mass Exposure Remedy question. In the case of particularized injury, clear tort-based precedents are available. The Committee would simply have to collect the pertinent facts, establish a criteria to evaluate

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- injury, and develop a remedy. In the Mass Exposure cases, developing remedies would be 3.0.4 One potential model Mr. Feinberg identified was the Disability/Workers Compensation Model. If individuals can satisfl the presumption of exposure, then they will not need to 4.0 STAFF BRIEFING: RISK COMMUNICATION Mr. Steve Klaidman, the staff Director of Communication, presented a briefing on risk communication to the Committee. experiment. Risk communication is intimately tied to informed consent because only after receiving a realistic portrayal of the possible risks can a subject give truly informed consent to participate in an experiment. He defined risk as the probability of any nontrivial negative outcome as a result of an 4.0.2 Risk communication has several major subcomponents, including risk perception and risk comparison. The investigator must convey to the subject the degree of risk to the individual. To accomplish this it is important to identify the target audience (based on a host of personal and cultural factors) and tailor the message appropriately. It is also important to frame the issue in such a way as to prevent any bias. Risk comparison is a valuable tool to communicate risk to a subject. It is often easier to assess the seriousness of an unfamiliar risk (ionizing radiation) if compared to a familiar risk. 5.0 REVIEW OF PROGRESS OF AGENCY DATA COLLECTION Committee staffer Mr. Don Weightman briefed the Committee on the progress of data collection activities by the agencies. documentation and breaking the records down into useful categories. He is responsible for managing the flow of 5.0.1 Mr. Weightman stated that the Committee had received an enormous quantity of records including approximately 11,000 pages (The quantity was described variously as pages or records, pages seems the more likely correct description.) of DOE material, and several boxes of DoD records. 5.0.2 He indicated that the Committee staff had conducted meaningful discussions with five of the six agencies (The recalcitrant agency was not identified, but the CIA was alluded to.). It was indicated that the DOE was the farthest along and was seriously committed to providing the Committee with all necessary information. The DoD had problems because of the large numbers of players on the field ("no one-stop shopping"). The Department of Health and Human Services (DHHS) was also experiencing the same types of problems as the DoD,b

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because it was also a decentralized agency. 5.0.3 He characterized the overall Staff/Committee/Agency interaction as an efficient working relationship. There were several qualifications including the debate on who was going to perform archival record research and when this was going to occur. 5.0.4 Mr. Weightman identified three types of information that the staff was looking for: Line ItemsBudget information, Program Areas, and Procurement Files. He did not define what these three types were. 5.0.5 Regarding the issue of classification, he indicated that the majority of the biomedical data was now or would soon be declassified. The classification of radiological warfare (RW) information was more problematic. Data on intentional releases was also problematic because (as indicated earlier) some DoD components had not looked for information on environmental 5.0.6 Mr. Weightman indicated that a Committee outreach program was currently in progress to contact relevant groups with document collections that might be of interest to the - 6.0 STAFF REPORTS ON STATUS OF AGENCY DATA COLLECTION: AN Mr. Dan Guttman, the Executive Staff Director, presented an overview of the status of the agency data collection efforts. 6.0.1 He reported that almost all agencies had completed Phase I research concerned with identifying participating organizations and developing basic information on experiments. 6.0.2 The Committee staff was involved in a series of exercises to map the information that had been forwarded to them into a usable format. This mapping is presently broken into three areas: Institutional (what agencies are connected by common research), Agency-Private Sector (what contractors worked for whom), and Ethics (the development of standardized ethical principles). The goal is to develop a comprehensive and usable scheme for evaluating the information that is forwarded to the Committee. 6.0.3 The staff had several high priority tasks, including identifying Governmental policy on human radiation experimentation for the purposes of revealing the intention of these experiments, the development of meaningful scientific categories for the experiments identified by the agencies, and developing more information on intentional environmental releases of radiation. - 6.0.4 The Committee agreed that the staff should continue to pursue these lines of research.

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6.1 UPDATE ON ETHICS DATA COLLECTION Staffer Jonathan Moreno presented a brief update on the status of the ethics data 6.1.1 He indicated that a steady stream of information from the agencies had been received. An effort was now being made to find data prior to the 1953 Wilson Memorandum with an emphasis on gathering information on the Armed Forces Medical Policy Council. 6.1.2 Dr. Gordon Soper, Principle Deputy to the Assistant Secretary of Defense (Atomic Energy) queried the-Committee on what the time parameters for the record search were going to be. He noted that the Committee was now discussing researching policy development in the 1920’s and 1930’s’ well prior to the 1944 start date identified by the Interagency Working Group and the White House. 6.1.3 Dr. Soper also asked the Committee to provide the agencies with advance warning if the timeframe the Committee decided to cover was expanded. This would help the agencies allocate their resources and obviate the need to retrace research the agencies thought was L 6.2 REVIEW OF DEPARTMENT OF DEFENSE DATA COLLECTION EFFORT Mr. Guttman presented a review of the Department of Defense data collection effort. 6.2.1 He noted that the Committee staff had met with the DoD officials on 20 May and that the DoD had completed Phase I and was looking for guidance from the Committee on how to focus Phase I1 research. 6.2.2 Mr. Guttman stated that the DoD had not done Headquarters or OSD searches and these needed to be done. 6.2.3 He also stated that no archive research had been done. It was unclear if this comment was directed specifically at the OSD search or, erroneously, at the DoD effort in its entirety. 6.2.4 Mr. Guttman also indicated that the Defense Nuclear Agency (DNA) and the Department of the Army (DA) had not searched for information on intentional environmental releases of radiation and would need to do so. 6.2.5 Mr. Guttman stated that a lot of staff effort was allocated to looking into the evolution of Governmental policy on human use in experiments. This was being done because it is necessary to develop definable and workable categories for the large quantity of data that is being forwarded to the Committee from the agencies. Looking at the policy structure would enable the staff to begin to categorize the data into logical groups.

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6.2.6 A tangential discussion on allocation of staff resources continued until the lunch break. Committee member Dr. Henry Royal stated that in order to properly prioritize staff work, it was necessary to look at what the Committee was striving to produce. In essence, this asked the question of what was the Committee's vision or mission. It was decided that discussion of the Committee's "vision" be put off until later. REVIEW OF DEPARTMENT OF VETERANS AFFAIRS DATA Staffer Ms. Denise Holmes briefed the Committee on the status of the data collection effort at the Department of Veterans Affairs (DVA). 6.3.1 She indicated that the effort was primarily a field exercise at the 172 Veterans Administration (VA) hospitals. The Secretary of Veterans Affairs was committed to an open and thorough record search process to disclose as much information as possible regarding the Atomic Medicine Committee. 6.3.2 Several key staff observations were that the DVA had not identified any further historical documents related to the Atomic Medicine Committee. The DVA had not searched in depth for historic policy records nor begun to coordinate with other agencies regarding 6.3.3 The staff presented eight recommendations for approval of the Committee. DVA should continue to trace the history of the Atomic Medicine Committee. DVA should expand the scope of its search to focus on documents at a higher (i.e., national policy) level. DVA should begin to trace the history of its coordination of research with other Committee staff should interview key DVA personnel. DVA should trace the history of the VNOmaha and other nuclear reactors. Committee staff should continue to interact with DVA personnel. Use the Committee staff to facilitate the transfer of information between the DVA and other agencies.

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0 Data collection should focus on : -Tracing DVA links with research schools -Tracing DVA links with individual researchers at research schools. 6.4 UPDATE ON DEPARTMENT OF ENERGY DATA COLLECTION EFFORT Mr. Guttman presented a brief update of DOE efforts to collect data. 6.4.1 He stated that the DOE was completed with Phase I sweep of its field offices. 6.4.2 The DOE is currently compiling an assessment of the quantity of records it holds related to human radiation experiments. 6.5 UPDATE ON DEPARTMENT OF HEALTH AND HUMAN SERVICES DATA Committee staffer Ms. Faith Bulger updated the Committee on the status of DHHS’s data collection effort. 6.5.1 She stated the Committee staff had developed a close working relationship with DHHS personnel and that DHHS had been responsive to the staff‘s requests for information. 6.5.2 One key area to focus on was the interrelationship of the Public Health Service (PHS) and other agencies, notably the DoD and the Atomic Energy Commission (AEC). A subsidiary data source was the Committee on Medical Research (No agency identification was given, but this Committee was probably part of DHHS’s predecessor.) which was closed in 1945 and had forty-five wartime programs transferred to the PHS. 7.0 REPORT ON DECLASSIFICATION Mr. Guttman briefed the Committee on the status of agency declassification efforts. 7.1.1 Mr. Guttman introduced a letter sent to the agencies requesting that the agencies agree to review for declassification within three weeks of a request any documents requested by the 7.1.2 Four agencies were identified as having responded: the Central Intelligence Agency (CIA), the DOE, the DoD, and the National Aeronautic and Space Administration (NASA). 7.1.3 The CIA responded that it would work with the Committee on this issue.\c-

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7.1.4 The DOE indicated that it could declassify 3 linear feet per week of material and that at present it had identified 10 linear feet of classified material related to human radiation 7.1.5 The DoD responded that all reasonable requests could be done in the required timeframe, but that many documents were classified by more than one agency. 7.1.6 Mr. Guttman noted that it would be important to have all agencies working in parallel to declassify records that have multiple agency classification’s. 7.1.7 The NASA response was vague, but affirmative. 8.0 PUBLIC COMMENTS SESSION 8.0.1 Representatives from three groups spoke to the Committee for five minutes each. The groups were the National Association of Radiation Survivors, the Survivors of Medical Radiation Experiments, and the Association of the Citizen-Soldier. 8.0.2 Their comments reflected the cynicism that veterans associated with atomic testing or related issues hold toward the Government. They encouraged the Committee to expand their brief to include a11 facets of American nuclear testing. 8.0.3 They also encouraged the Committee to be very inclusive when discussing what diseases to compensate as a result of radiation exposure. 8.0.4 The representatives indicated that veterans did not see the difference between participants in nuclear testing and participants in human radiation experiments. 9.0 SUMMARY OF MEETING, 14 JUNE 1994 The 14 June meeting had several key agenda points: a staff organization overview, and reports from the four subcommittees. The Advisory Committee staff is headed by a management team made up of five individuals, including the Committee Chair. A coordinating group comprised of the project leaders is responsible for project management. The project groups are structured along the lines of the Committee’s Subcommittees (Ethics Data Collection, Scope and Priorities, Cold War Data Collection, and Public Outreach). Individual staffers are also tasked to focus on

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Each of the four Subcommittees presented a briefing on their progress. 11.1 ETHICS DATA COLLECTION SUBCOMMITTEE Committee Chair, Dr. Faden, presented the Ethics Data Collection Subcommittee report on behalf of the Subcommittee chair Dr. Ruth Maklin. 11.1.1 She stated that the Subcommittee was tasked to identify the evolution of ethical standards related to medical research from 1944 to the present. 11.1.2 Data collection was divided into three parts. Part I data collection was on-going. Current activity was focused on finding policies, rules, guidelines, and procedures the agencies developed in relation to human radiation experimentation. Part I1 data collection focuses on understanding the roles, policies, guidelines, and procedures of universities and research organizations, including review boards and oversight groups, as it relates to human radiation experimentation. Part I11 data collection concerns the implementation and behavior of researchers in relation to those procedures laid out in Part 11. 11.1.3 The Subcommittee wants to conduct interviews with researchers and experiment subjects to gather complete data on ethical standards …