ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS Minutes: Meeting of June 13-14. Monday, June 13 Attending: Ruth Faden, Susan Lederer, Jay Katz, Philip Russell, Lois Norris, Kenneth Feinberg, Henry Royal, Duncan Thomas, Nancy Oleinick. Dr. Faden, chair. Philip Caplan, Special Assistant to the President for Cabinet Affairs, opened the meeting of the Advisory Committee on Human Radiation Experiments at 9:30 a.m. at the Ramada Plaza Hotel, 10 Thomas Circle, Washington, D.C. Patricia King and Eli Glatstein were unable to attend the meeting and Reed Tuckson and Mary Ann Stevenson joined the Committee on the following day. Dr. Faden outlined the objectives of the meeting: continuing the series of presentations by Committee members about their specialties relevant to the Committee's work; updates from staff of document searches; public comment on issues before the Committee; and hearing reports from subcommittees appointed at the May meeting. Staff Director Jeffrey Kahn introduced new staff members: Sara Chandros, Gwen Davis, Patrick Fitzgerald, Mark Goodman, Gary Stern, and Kathy Taylor. Dr. Kahn also introduced Ted Webster of Harvard University, who will be a consultant to the Committee on radiation dosimetry. Draft minutes of the May 18-19 meeting were distributed, and the Committee authorized Dr. Faden to approve the minutes after review of Committee comments. Briefing: Introduction to Remedies. Mr. Feinberg. Mr. Feinberg discussed how harms alleged from mass exposures to potentially harmful substances, including pesticides, breast implants or defective medical devices, as well as ionizing radiation, pose challenges to traditional notions of tort remedies in the judicial system. He noted the difficulty in devising methods of compensating groups exposed to hazardous substances, and the heavy burdens of proof for plaintiffs alleging government wrongdoing. Mr. Feinberg referred members to the report of the Presidential Commission on Catastrophic Nuclear Accidents as a potential aid to the work of the Committee. Committee members questioned Mr. Feinberg about compensation for increased risk of illness or injury; the mitigating effect of benefits from drugs or pesticides, and the aggravating effect of fears of potential harm; payments to estates of survivors; whether statutes of limitations apply to latent diseases; and the influence of epidemiological evidence. Briefing: Risk Communication. Stephen Klaidman. Mr. Klaidman briefed the members on the problems of risk communication. He discussed conservative biases of federal risk assessment methods and policies and how the public as well as experts evaluate risk information, including the public's difficulty in evaluating risk assessments because of its resistance to uncertainty and probabilistic thinking, and other cognitive and emotional challenges. Staff Report: Overview of Staff Work. Daniel Guttman. Mr. Guttman briefed the Committee on the records search being conducted by Federal agencies that might have sponsored or conducted radiation experiments on human subjects. He reported that the focus on policymaking organizations that authorized and directed experiments, a priority in the Committee's May instructions to staff, is producing a more targeted agenda for staff follow-ups with agencies. Federal agencies, having completed or nearing completion of their initial searches, are seeking direction from the Committee about how to proceed. Mr. Guttman discussed the operating logic of the Committee staff in mapping the experiments currently known, identifying additional experiments, and categorizing experiments by the goals of sponsoring agencies or of researchers. Three major lines of work are indicated: Institutions. Work with agencies to identify the funding and management authorities overseeing human experimentation. This process allows the staff to fill gaps in knowledge about where and by whom experiments were conducted, and takes advantage of new document searches to lead to further experiments. Accomplishments have included the recent declassification of minutes of meetings of the Medical Advisory Committee to the Secretary of Defense. Significant challenges to a comprehensive understanding of the experiments include tracking the complex series of changes in the management of the government's radiation research program, including changes in agencies, and the complex nature of government collaboration with private institutions. Ethics. Develop a timeline of ethical policies and procedures. Mr. Guttman noted that informed consent policies were discussed in the armed services as early as 1932, according to recent research by the Navy. Experiments. Group experiments by the nature of the study (e.g., whole body irradiation) and the purpose of the experiments. In some cases, Mr. Guttman said, it is unclear whether the most important impetus for experimentation was government purposes such as protecting arms workers, or biomedical research that was funded by the government. Potential categories to group experiments include scientific objective, intentional releases apparently designed to satisfy the need for knowledge about exposure to radiation, and radiation warfare studies. Mr. Guttman said staff work to date suggests several new lines of inquiry, including indications that whole-body irradiation and excretion studies were more widespread than previously known. The last category, radiological warfare, involves substantial amounts of classified material, Mr. Guttman said, but he reported that the Committee had received assurances that biomedical research files would be speedily declassified if they were not already in the public domain. Difficult issues for the staff are likely to include grouping of experiments in meaningful fashion; keeping documents flowing from the variety of Federal agencies; dealing with the large volume of tracer isotope studies; and working with agencies on classification issues. Mr. Guttman said the staff particularly seeks guidance from the Committee about the appropriate grouping of experiments by scientific purpose. Members of the Committee questioned Mr. Guttman about different ways to map information about ethics policies and exposure standards, and about allocation of staff time to Cold War experiments in the early phases of the inquiry. Staff Report: Update on Ethics Data Collection. Jonathan Moreno. Dr. Moreno briefed the Committee on the ethics search, particularly noting the prevalence of formal ethics policies earlier than previously known and reporting on efforts to develop more information about the 1953 promulgation of the Nuremberg Code by the Department of Defense. Dr. Russell noted that ethics researchers may find that eminent nongovernmental institutions were assumed to have adequate policies for protection of volunteers, and that in particular the armed services may have not had the knowledgeable staff to look into those issues. Dr. Gordon Soper, Deputy Assistant Secretary of Defense, told the Committee that the Department will be aided in its efforts if the Committee staff provides the earliest possible guidance on the time frame in which to search for documents. Dr. Moreno and members of the Committee noted that Federal agencies have a substantial task but that there are major finds in the 1930s and 1940s because of internal debates about ethical standards in experiments involving nonradioactive substances. Dr. Royal said that the Committee staff's work should be tightly focused because of the large task. Dr. Faden noted that there are few histories or summaries that would help to focus the inquiry, requiring the initial document searches sought by the Committee. Staff Report: Methodological Review of Agency Data Collection Efforts, Department of Defense. Mr. Guttman reported on the document searches by Department of Defense agencies, including the armed services and the Defense Nuclear Agency. He said much work remains to be done to identify headquarters policy records and to gain access to some records dispersed through organizational changes in the 1950s and 1960s. Members discussed the targeting of research on funding sources in DOD and other Federal agencies, and suggested that the Committee and staff better define their goals through a discussion of alternative objectives in the current meeting. The Committee agreed to begin initial discussions in Tuesday's meeting of a vision statement that could be agreed upon by the July meetings of the Committee, in order to help focus work through the summer. The staff was instructed to prepare reports that would give members a better understanding of priorities in the period before the September meeting. In the interim, staff members were given approval to use their judgment in directing the DOD searches in preparation for the July meetings. Staff Report: Review of Progress of Agency Data Collection. Don Weightman. Mr. Weightman briefed the Committee on the difficulties of collecting and assessing data from different agencies, which even within departments do not lend themselves to "one-stop shopping.'' He stressed that staff members are keenly aware of the amount of archival material that must be accessed as efficiently as possible, and noted steps taken to pinpoint searches in relevant batches of materials. Mr. Weightman noted that policy documents provide a context and background that may aid in the targeting process, but that secrecy classifications may be a barrier to efficiency, as researchers may not know what questions to ask of agencies. Computerization of the document classification system will make the work of the Committee staff much easier, he said. Coordination of the work of staff groups and identification of long-range milestones in their work are top priorities. Staff Report: Methodological Review of Agency Data Collection Efforts. Department of Veterans Affairs. Denise Holmes. Ms. Holmes briefed the Committee on the data collection in Veterans Affairs, particularly about the previously secret Atomic Medicine Division. The division was apparently created in response to concern about service-related disability claims. She traced VA participation in use of isotopes for research and therapeutic purposes. The Committee endorsed staff-proposed options for further research within the context of the strategic plan to be defined at the July meeting. Staff Report: Update on Review of Agency Data Collection Efforts, Department of Energy. Jim David and Dan Guttman. Mr. Guttman said the staff is following up on data collection based on the staff options approved in May. The staff sought Committee direction on a second phase of research, and reported on the assessment of the large volume of materials received from DOE. The Committee approved the staff plan to follow up on document searches with the Department. Staff Report: Update on Agency Data Collections, Health and Human Services. Faith Bulger. Ms. Bulger reported on the follow-up to research in HHS, particularly efforts to identify potentially relevant experiments and compile lists of documents. She discussed the significant links among the Public Health Service, the Atomic Energy Commission and the Department of Defense on radiation research work. The Committee endorsed options for follow-up within the context of general targeting priorities to be discussed later. Dr. Katz added that staff should be mindful of experience from the Tuskegee studies that showed that the Surgeon-General knew relatively little first-hand about those experiments. The staff's work should assess whether there was active participation in management of experiments by high-level officials. Staff Report: Declassification. Dan Guttman. Dr. Faden wrote on behalf of the Committee urging agencies to quickly declassify documents sought by the Committee. The Committee discussed responses received from three of the six agencies, DOE, CIA and NASA, and asked Dr. Faden to write again to the CIA as the CIA's letter did not speak specifically to a three-week time limit for declassification suggested by Dr. Faden. Public Comment Period Mr. Klaidman read into the record two letters from the National Association of Radiation Survivors. Dr. John J. McCarthy of Sacramento Radiation Survivors Group urged the Committee to examine nasal radiation treatments. Ms. Cherie Anderson of the group wrote that such treatments, while widespread in the 1950s, are more accurately characterized as experiments. Dr. Faden requested that the Scope Subcommittee look into the issue, and that Committee staff prepare a summary of those groups known to the Committee that have an interest in specific types of experimentation. Members emphasized that they wished to ensure continuing contact with survivors groups. Thomas Smith, regional vice president, National Association of Radiation Survivors, addressed the Committee as a veteran of witnessing atomic blasts at Eniwetok atoll. He said a complete report of the Committee should cover a wide range of radiation illnesses suffered by veterans, and urged the appointment of a victim representative to the Committee. Mrs. Pat Broudy, national legislative director, National Association of Atomic Veterans, seconded Mr. Smith's statement and said that the government has not dealt fairly with the atomic veterans. Dr. Faden directed that staff work with Mrs. Broudy to make the Atomic Veterans group's records available to the Committee. Mr. Tod Ensign, director, Citizen Soldier, New York, addressed the Committee to urge a broad report covering cases where soldiers were exposed to radiation, noting that veterans do not feel that there were significant differences between clinical settings and repeated exposures at weapons test sites. Mr. Ensign also urged compensation for victims as well as medical treatment. Tuesday, June 14. Drs. Stevenson and Tuckson joined the Committee. Dr. Faden called the meeting to order at the Washington Vista Hotel ballroom at 10 a.m. Dr. Faden reported that the meeting had to be moved because of air-conditioning failure at the original meeting place, and that the new location of the meeting had been posted. Staff Report: Organization. Jeffrey Kahn. Dr. Kahn briefed the Committee on staff organization, including time lines and current staff assignments for existing projects. Dr. Kahn noted that members are welcome to visit the M Street office and participate in staff meetings. Subcommittee Report: Ethics Data Collection. Dr. Faden. Reporting for Dr. Macklin, Dr. Faden stated that the subcommittee has outlined an extensive program of work in the ethics area. The Ethics Subcommittee report outlined a program of surveying selected institutions to determine the conduct of clinical science to the present day, and to discuss how research in radiation studies has differed from other research. Members discussed the report and raised issues of its scope and mission, including whether to survey pharmaceutical companies' clinical trials, which institutions will participate in the study, and the value of the study. The Committee agreed to seek the counsel of the White House as to whether institutions with which Committee members are affiliated can participate in the study. Dr. Faden suggested that it may be advisable to seek the counsel of university presidents in designing the study. Dr. Moreno told the Committee that the ethics working group expects to gather a panel of experts to develop the plan in June and submit it to the Committee in July meetings. The prospective timetable is to identify local research groups by late August and hear their reports by late January, with the presentation of the results by the February meeting of the Committee. Dr. Faden said the work must be parallel with the Committee's other work in order to have findings available in time for consideration of the final report. The Committee accepted the Ethics Subcommittee report and asked that the subcommittee report at the next meeting on the feasibility of the proposal. The subcommittee will also consider whether there are in other fields, such as DNA research, useful parallels to study implementation of ethical standards in human subject research. Subcommittee Report: Scope and Priorities. Dr. Thomas. Dr. Thomas reported that there was within the Scope Subcommittee an emerging consensus that intentional exposures must appear in the Committee's report, as part of the overall Cold War radiation story. Where earlier studies have detailed the history of intentional releases the Committee has considerable discretion in how much time to devote to specific experiments, and may decide to focus on particular aspects of the experiments that have received inadequate attention in the past. Members discussed the classification and organization of medical experiments that should be the focus of Committee work, including whether to exclude from the Committee's scope studies in which imaging techniques were used but the effects of radiation exposure were not themselves under study. Issues discussed included the need to identify and report on hitherto secret experiments and studies in the public domain which have prompted much public concern. Subcommittee Report: Cold War Data Collection. Dr. Stevenson. The subcommittee concluded that a meaningful screening and categorizing of experiments from existing summary indexes or other lists is not possible, underscoring the need for continuing to research policy documents to determine where to target searches for primary information on human experimentation. Members discussed the rationales for grouping experiments in various ways, as general as notoriety or as specific as defense- related purpose. Dr. Faden said the Cold War Subcommittee and the Ethics Subcommittee approaches mesh in the discovery process, as the policy history guides both discovery of new experiments and the discovery of ethical standards and rules. The staff was directed to pursue the Cold War story through research into policy documents, and pursue other leads into areas like secret research, radiological warfare and intentional releases. The staff was directed to pursue leads within reasonable bounds of time, with an eye toward classifying experiments within the categories suggested in the Cold War Subcommittee report. Dr. Faden said the Scope Subcommittee will look at the controversial cases and recommend which ones must be addressed in the Committee report, and suggest a list of those to the Committee and suggest how far the Committee wishes to go in investigating particular cases. The Committee and staff will also develop a method to sample efficiently the huge number of cases indexed in summary lists provided by the Federal agencies. Subcommittee Report: Outreach. Dr. Tuckson. Dr. Tuckson reported that the subcommittee will prepare letters to reach out to stakeholders and the expert communities interested in the Committee's work. Staff has already pursued substantial contacts with stakeholder groups, although these lists may change as decisions about the scope of the Committee's study are made. The subcommittee will seek the widest review possible of the views of professional organizations, researchers and others in the expert communities. These include institutional review boards, historians, the medical societies and others. The subcommittee recommended that the Committee hold at least two of its full meetings in cities around the country, with San Francisco being suggested for the West Coast, and Chicago, Atlanta or another Southern/Midwestern venue for another meeting. Smaller groups of Committee members might take testimony in other cities around the country. Issues include ease of access for the public, although members expressed caution about venues that might be dominated by discussion of particular cases. At each off-site meeting, members may also gain the opportunity to view uses of nuclear medicine procedures in today's research institutions or hospitals. Committee Discussion The Committee asked Dr. Faden and Mr. Guttman to draft a memorandum as a basis for a discussion of the vision of the Committee's work and report. Members were asked to submit draft goals, report agendas or mission statements to work with in the draft statement. Dr. Faden said that members should indicate if they wished the vision statement suggestions to be circulated to all the Advisory Committee members. The statement will be discussed in the first or second meeting in July. Dr. Faden announced that the subcommittees would meet briefly at the close of the meeting. She said the meeting of July 5-6 will be held at 11 a.m. at the Vista Hotel. Mr. Caplan of the White House closed the meeting at 3:10 p.m. APPENDIX A The following persons signed in to attend all or part of the Committee's meeting: Troy Jenkins, Potomac TV; John Kruger, Group for Public Integrity; Tod Ensign, Citizen Soldier; Dan Brown, U.S. Air Force; Stacey Cunningham, APA; Hal Halpern, Elly Mewmen, Ellyn Weiss, G. Yount, V. Johnson, DOE; Neil Otchin, VA; Amy Hall, NIH; Karen MacPherson, Scripps Howard; Jonathan Weisgall, Bikini Atoll; Janis Stoklosa, John Howell, John Lyver, NASA; Paul Barton, Gannett News Service; Michael S. Yesley, Los Alamos; Craig Cobdell, DOE; Stephanie Niemier, NIH; Darren R. Fisher, Battelle; Arthur Simon; Robert Allen Jr., GAO; Les Blumenthal, McClatchy Newspapers; Pat Broudy, NAAV; Oscar Rosen, NAAV; Tom Smith, NARS; Kitty Tucker, Health and Energy Institute; Gwendon Plair, Ohio CROSP. CERTIFICATION The above minutes represent an accurate summary of the June meeting of the Advisory Committee on Human Radiation Experiments, held in Washington, D.C., June 13-14, 1994. RUTH R. FADEN, Ph.D., M.P.H.