Minutes of November 14-15,1994 Meeting Tuesday, November 14, 1994 Attending: Ruth Faden, Kenneth Feinberg, Eli Glatstein, Jay Katz, Pat King, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Philip Russell, Mary Ann Stevenson, Duncan Thomas, Reed Tuckson. Philip Caplan, special assistant to the President for Cabinet Affairs, opened the meeting at 9 a.m. in the Ballroom of the Renaissance Techworld Hotel, 999 Ninth Street NW, Washington, D.C. Dr. Faden briefed members on the objectives of the meeting and noted that the Public Comment Period would be held on Wednesday morning. Approval of Minutes The Committee approved the minutes of the October 11-13 meeting as drafted. Agency Updates Dr. Faden briefed members on the continuing dialogue with agency search teams. She reported that the staff plans to meet soon with the Central Intelligence Agency. Records reviews continue at the National Archives and at the Department of Energy complex at Oak Ridge. She reported that large and important collections remain to be reviewed from the Department of Defense, and that the Department of the Army has agreed to review Chemical Corps records. The inspector-general of the Department of Veterans Affairs has become involved in the search for records of the atomic medicine division in VA. The Department of Health and Human Services has engaged a contractor to search for additional data on lists of experiments sponsored by the radiation studies section before 1974. Records of intramural research at the National Institutes of Health Clinical Center should soon be available on an electronic database. Dr. Faden noted that all agencies have been cooperative in efforts to provide research proposals from the 1990s for Committee sampling of contemporary studies. Staff Report: Subject Interview Study. Jeremy Sugarman and Nancy Kass. Dr. Sugarman reported on the subject interview study, including criteria for selection of institutions. Dr. Sugarman will be identifying experts in each region who can participate in multicenter investigations. Each investigation will be submitted to a local IRB. A modified task order for contractors and a general budget has been presented to administrative officials of the Department of Energy. Dr. Kass said that focus groups have helped to develop instruments for the subject interviews. A draft instrument should be available by the March meeting of the Advisory Committee. The goal of the project is to conduct about 150 shorter interviews at each institution, leading to the selection of 10 to 15 subjects for in-depth questioning. Dr. Sugarman emphasized that the staff and Committee are working against a deadline and said that every effort will be made to expedite the budgetary and IRB processes. Staff Report: Introduction of New Staff. Jeffrey Kahn. Dr. Kahn introduced new staff and consultants to the Committee. These included Consultants Steve Goodman and John Till, Research Analyst Wilhelmine Miller, Research Associates Valerie Hurt and Pat Perentesis. Briefing: Historical Relativism and Retrospective Moral Judgment. Ruth Macklin. Dr. Macklin briefed members on standards of judgment of historical events, outlining a spectrum of possibilities ranging from the strict view that actions may be assessed in the context of what agents ought to have known, and a more lenient view that judgment may be based only on prevalent standards of the times. She outlined three examples of ways retrospective moral judgments may be framed between the two extremes: (1) judgments based on the articulated if not widely accepted views of the time, e.g. abolition in the 1850s; (2) judgments based on known principles or ideals accepted in other spheres but not necessarily in the field under scrutiny, e.g. a right to privacy recognized before its elaboration on sexual matters in the Griswold decision; (3) known principles or ideals to which lip service has been paid in a society which does not in fact follow the same standards in practice, e.g. the written consent standard of the Nuremberg Code. She said the Committee's task included not only deciding which criteria to use, but also decisions about to whom and where in an organization the criteria might apply. One important guide might be to search for analogies elsewhere in medicine than radiation research, e.g. the longstanding practice of infectious disease researchers involving themselves as subjects in studies. Committee members discussed at length the distinction between a judgment that wrong actions were taken and that agents of the action were in fact morally culpable. Other issues raised included the diffusion of ethical standards through societies and professions, and the varying levels of sophistication by which ethical issues are addressed; the importance of policy pronouncements like the Defense Department's adoption of the Nuremberg Code in 1953; accountability in government; and the importance of greater or lesser physical risk in research. Staff Report: Case Study of Radiation Research with Health Adults. Jon Harkness and Stephen Klaidman. Mr. Klaidman reported on the origins and development of testicular radiation experiments in Oregon and Washington state prisons. He said new documentation has been recently made available from state archives, including documents on why state prison officials ended access to prisoners for experimentation. The documents give insights into the quality of the ethical debate, especially 1969-70 concerns about quality of consent on the part of prison volunteers. Dr. Harkness said experimentation on prisoners was approved by the American Medical Association under a committee headed by Andrew Ivy in the wake of the Nuremberg trials. Many prisoners historically were eager to participate, and white prisoners were predominantly used because of racist tendencies to reserve such "privileges" for whites. He traced the development of national concern about prison experiments and the development of federal regulations for prison experimentation. Dr. Katz observed that consent is the prominent issue, as investigator Carl Heller conceded in a federal court deposition that he did not wish to frighten subjects with warnings about cancer risk. Dr. Macklin and Dr. Russell said the prison experiments require Committee scrutiny because of questions about consent. Dr. Oleinick said an interesting component of the prisoner story is the debate over standards for neutron experiments as against the standards for X-ray experiments. Dr. Royal said the imagery of irradiating testicles would make the experiments unlikely to be approved today, although the risk of harm would probably not be very different from permissible studies. Dr. Glatstein said the prison studies are practically all that is available today on the effects of radiation on testicular function and fertility, and that large-animal studies were unlikely to have yielded data useful for understanding human functions. Members discussed goals of discussion of case studies and the value of guidelines arising from past experience, and questioned Mr. Feinberg about the legal implications of the discussion. Subcommittee Report: Cincinnati Panel Meeting. Reed Tuckson. Dr. Tuckson said the Cincinnati meeting was an important contribution to the Committee's outreach efforts to institutions and advocacy organizations. Dr. Tuckson said a key concern was the lack of information about patient care reported by family members of subjects of the Cincinnati General Hospital experiments. Family members also questioned the validity of end-state prognoses cited by investigators who selected the subjects for the study. Assurances were received from the University of Cincinnati that all records would be made available to families or survivors. The panel, consisting of Dr. Tuckson, Dr. Stevenson and Mrs. Norris, also heard from veterans of atomic weapons tests, some of whom raised concerns about the interaction between the military and the Veterans Administration in determination of disability benefits. Some comments, about exposures in the atomic weapons industry, raised issues that may not be within the Committee's scope, but contribute to the overall story, Dr. Tuckson said. Tissue sampling programs were criticized by a labor union representative. Dr. Tuckson said the Outreach subcommittee strongly recommends that a similar meeting be held in Tennessee in the spring. Members expressed concern that the panel hearings not raise expectations of remedy in all subjects brought before them. Dr. Faden said an important element of advance work for the panel meetings is to make clear where the Committee is in its work and how its mandate is limited. The Committee continues to seek first-hand accounts from survivors and family members to contribute to its deliberations. Appropriate follow-up, such as helping subjects or family members to get medical records, is an important priority, Dr. Tuckson said. Members approved the suggestion of a panel meeting in Tennessee. Staff Report: Case Study of External Radiation Research with Patients. Gary Stern and Ron Neumann. Mr. Stern and Dr. Neumann reported on the approximately 20 pre-1974 total-body irradiation (TBI) studies , with nine involving treatment of radioresistant cancers, with eight of the nine funded at least in part by the government. Military and aerospace authorities sought TBI data because of concerns about exposure of service personnel or civilians to atomic warfare. TBI was also of importance in the debate over development of a nuclear engine for aircraft. Members discussed at length questions of consent, in particular whether Department of Defense policies should have applied to the Cincinnati research. Members also discussed the goals and objectives of the Cincinnati studies, as well as the written protocols, or lack thereof, for the work. Dr. Neumann and Mr. Stern outlined the evolution of consent forms in the Cincinnati studies. Update: Research Involving or Affecting Children. Sandra Thomas. Dr. Thomas briefed members on the existence of an estimated 100 radiation experiments involving pregnant women and healthy children. Most were identified through searches of public literature. Update: Ethics Criteria. Jeffrey Kahn. Dr. Kahn told members that a paper on retrospective ethical judgment will be distributed soon to members in preparation for the December meeting. Update: Institutional Case Studies. Dan Guttman. Mr. Guttman reported on progress of case studies in Northern California and Oak Ridge, and on other staff research at Los Alamos and elsewhere. Update: Biodistribution. Barbara Berney. Dr. Berney said identified experiments involving the transuranics and chelating agents are being thoroughly researched. Oral interviews with investigators at key institutions, and research into archives, are planned. November 15, 1994 Attending: Ruth Faden, Kenneth Feinberg, Eli Glatstein, Jay Katz, Patricia King, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Philip Russell, Mary Ann Stevenson, Duncan Thomas. Subcommittee Report: Remedies. Ken Feinberg. Mr. Feinberg briefed members on the subcommittee report. The subcommittee recommended that the goal of the Committee should be to draft remedies guidelines, for ultimate consideration by policymakers. Mr. Feinberg said a blueprint is the goal, to lay out a series of options for Congress or the Executive Branch to address areas of concern. The subcommittee recommended that any remedies recommendations should distinguish among the types of experiments, recognizing that experiments may have involved individuals or mass exposures, but he noted the prospect of divisiveness if recommendations make invidious distinctions among classes of victims. Mr. Feinberg noted that, in law, it is difficult to impose culpability for acts done in the past in conformity with existing standards. He said that a key question is whether or to what extent recommended remedies should embrace the kind of retrospective moral judgment discussed earlier in the meeting by Dr. Macklin. Mr. Feinberg said it is unlikely the Committee will be able to make judgments of medical causation of harms, given the passage of time and the limits of evidence and of Committee resources. Some presumptions about wrongs are likely to be necessary, but fashioning remedies for cases of violation of the personal integrity of patients, as in absence of consent, is likely to be very difficult. While retributive justice may be difficult to fashion in a remedies chapter, Mr. Feinberg said it is his personal view that the Committee should consider a prospective remedy, such as guidelines for future violations of ethical standards. Dr. Thomas, a member of the subcommittee, expressed the view that remedies may be different for different types of experiments or intentional releases, and that the Committee may wish to recommend revisions in legislation previously adopted by Congress. Members discussed issues arising from the report, including the applicability of remedies guidelines to other types or research; the utility of medical monitoring in dealing with mass exposures; the scope of recommendations and fears of raising high expectations for substantial monetary compensation; the need for work on the conceptual framework for remedies. Public Comment Period. Mrs. Marcia Haggard, Silver Spring, Maryland. Mrs. Haggard related her experience with medical problems arising some 50 years after radium treatment on a childhood hemangioma. She urged the Committee to recommend followup for radium treatment victims. Dr. Kathy Platoni, Beaver Creek, Ohio. Dr. Platoni reported on the death of her father, Eugene Platoni, and her own extensive medical problems arising from what he believed was exposure to radiation in Navy service. Her father told the family before his death that he had witnesses the atomic explosions at Hiroshima and Nagasaki. Dr. Dennis Nelson, Kensington, Maryland. A retired military scientist and downwinder, Dr. Nelson reported on the heavy fallout exposure in St. George, Utah, after the 1953 Shot Harry nuclear test. He criticized the Atomic Energy Commission and the government generally for failing to respond to medical problems suffered by downwinders. Dr. Nelson offered a statement from the Task Force on Radiation and Human Rights urging the Committee to make recommendations for remedies. Mayor George N. Ahmaogak and Mr. Rossman E. Peetok, of the North Slope Borough Assembly, Alaska.. Mr. Peetok testified, through an interpreter, of medical problems of Wainwright, Alaska, residents who participated in a U.S. Army Aeromedical Laboratory I-131 study. Mayor Ahmaogak said Alaskans involved in Operation Chariot were subjected to intentional releases at Cape Thompson as well as experimental ingestion of radionuclides. The studies were conducted without informed consent, which was compromised by language barriers between the Inuit and researchers. The mayor asked that the Committee look into the series of exposures and particularly inquire into the impact on a minority population. Members questioned the mayor about the communications or lack thereof that surrounded the tests, and the authority of village elders to provide informed consent. Briefing: Environmental Dosimetry. John Till. Dr. Till, head of the Hanford Dose Reconstruction Project, briefed members on the difficulties of reconstructing dose from environmental releases of radionuclides. He described the process of calculating dose from historical records, which are often in a chaotic condition. He said the project has found no dose estimates made at the Hanford site until the 1980s. Staff Report: Case Study, Intentional Releases (Green Run). Dan Guttman, Mark Goodman and Patrick Fitzgerald. Dr. Goodman briefed the Committee on the history of the Green Run and Professor Fitzgerald discussed the ethics analysis. Dr. Goodman discussed applicable environmental laws that might allow agencies to conduct a test similar to a Green Run today. The National Environmental Policy Act allows secret tests and the Clean Air Act allows the President to authorize exemptions to the act, without prior review, so long as Congress is notified annually. Professor Fitzgerald discussed ethical concerns raised by the Green Run. Under today's laws, national security considerations can override Clean Air or other environmental laws, and decisions can be made in secret. Questions raised by the analysis include whether public or Congressional review is ethically necessary in cases of intentional releases conducted for national security reasons. Dr. Royal recommended Justice Stephen Breyer's book on environmental regulation. Dr. Macklin said the traditional assessment of harms and benefits may not be a useful approach in intentional releases, but Professor Fitzgerald noted that the traditional method is what is pragmatically applied, below criticality thresholds, in today's exposure guidelines for the Department of Energy. Dr. Glatstein questioned why part of the Green Run documents remain classified, and Mr. Guttman noted that Senator Glenn of Ohio has written to the Department of Defense posing the same question. Members discussed dispatching cleared staff to review the classified portions of the documents. Members agreed that a member, other than Dr. Faden or Dr. Russell, should also review the material when appropriate clearances are obtained. Subcommittee Report: Research Proposal Review Project. Ruth Macklin, Sara Chandros and Gail Geller. Ms. Chandros and Ms. Geller briefed members on efforts to implement a quota sampling program for all categories of the proposal review. She said the staff is awaiting Department of Defense extramural proposals. Members discussed and suggested improvements to the review form. Dr. Macklin asked that the Committee authorize the subcommittee to work out details about the form, and members agreed. Committee Discussion: Strategy and Discussion. Ruth Faden. Dr. Faden proposed that the December meeting be given over, other than the public comment period, to discussion of large and complex questions: retrospective moral judgments; remedies; interpretation of pre-1974 policies; interpretation of pre-1974 practices; national security and secrecy. The goal is a tentative working framework linking ethics criteria and remedies. Dr. Faden said a super-subcommittee might be formed as a result of the combination of ethics criteria and remedies subcommittees, so that discussion papers for the December meeting can represent a crystallization of views in both areas. The super-subcommittee would also oversee the continuing research into pre-1974 ethics policies. Dr. Katz suggested that the staff prepare a report on what projects can be successfully completed to meet the Committee's charge. Members also agreed to combine for purposes of guiding staff work the subcommittees overseeing Oak Ridge and Northern California case studies, and the subcommittees overseeing biodistribution and biomedical experimentation. A single subcommittee would also deal with external radiation for healthy adults and ill patients. Consideration of national security and secrecy issues will be overseen by the intentional releases subcommittee. Members asked Dr. Faden to circulate a revised roster of subcommittees to members. Dr. Faden said that members will be polled to see if an additional half-day of deliberations can be added to the regular meeting schedule in 1995. Mr. Caplan closed the meeting at 5 p.m.