Minutes of December 15-16, 1994 Meeting December 15, 1994 Present: Ruth Faden, Kenneth Feinberg, Eli Glatstein, Jay Katz, Patricia King, Susan Lederer, 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, called to order the ninth meeting of the Advisory Committee on Human Radiation Experiments at 9 a.m. in the Empire Room of the Omni Shoreham Hotel, 2500 Calvert Street NW, Washington, D.C. Dr. Faden briefed members on the agenda, which she noted included extensive time for committee discussion on ethics criteria and remedies. She said the Advisory Committee and its staff continues to pursue relevant document collections and said the staff would report on those searches at the January meeting. Approval of Minutes The Committee amended page 3 of November meeting minutes to reflect Mary Ann Stevenson's attendance at the Cincinnati public meeting. The Committee approved the minutes as amended. Committee Discussion: Retrospective Moral Judgment. Allen Buchanan, Jonathan Moreno. Dr. Buchanan introduced the discussion of moral evaluation of historical events. The Committee discussed the ability to assign culpability to individuals either in terms of their roles as doctors or bureaucrats and whether it was possible to assign such blame based on the availability or lack of facts. Dr. Macklin noted the Committee s charter requires the determination of wrongs or harms done and remedies for those wronged or harmed. Dr. Faden noted some degree of consensus that it may be possible to make moral appraisals. Committee Discussion: Remedies. Kenneth Feinberg, Gary Stern. Mr. Feinberg briefed members on the remedies memorandum (Tab G). Committee members discussed the application of retrospective moral judgment to remedies, with particular attention to issues of informed consent. Questions about levels of evidence were also raised. Discussion focused on (1) a December 12 memorandum to the Committee from Dr. Faden attempting to link culpability and remedy issues and (2) a staff memo addressing the evidentiary basis for judgments about government culpability (Tab H). Members questioned staff about how scenarios in the staff memorandum applied to specific sets of experiments. Staff described documentary evidence related to the plutonium injections and consent standards understood in the 1940s. The 1953 Wilson memorandum and the debate over human subject experimentation for the nuclear-powered aircraft project were discussed. Staff members outlined the case for concluding that there were articulated standards for government-sponsored research within the Department of Defense (DoD), and (from the Committee on Medical Sciences) for the Manhattan Project period before establishment of the Atomic Energy Commission. The Committee discussed at length the application of military standards to civilian and academic investigators, and relationships between these arenas -- specifically the application of the Nuremberg Code standards described in the 1953 Wilson memorandum to Army contractors. Members questioned staff about the evidentiary basis for making decisions in a number of cases, such as experiments related to atomic weapons tests, AEC biodistribution studies and total-body irradiation experiments sponsored by the Department of Defense. Members decided that the evidence supports the following conclusions: (1) The Wilson memorandum applied to DoD research with atomic, biological, and chemical warfare, and that the Department could be culpable for research that failed to comply with these standards; (2) The Wilson memorandum applied to DoD contractors whose research was funded by DoD for atomic, biological, and chemical warfare purposes. Therefore, the Department could be held culpable for research that failed to comply with Nuremberg Code standards unless DoD had done everything that it reasonably could (like putting in place implementation guidelines) to assure compliance with the memo's standards; (3) The Wilson memo standards applied to sick as well as healthy subjects of DoD funded or conducted research when the purpose of the research was related to atomic, biological, or chemical warfare. The Committee noted ambiguity about whether the Wilson memorandum was intended to apply to sick persons. While the intention of the memorandum is not to apply the Nuremberg Code to clinical research or diagnostic techniques, the Committee agreed that the policy should apply to research on sick people when the purpose of the research was related to atomic, biological, and chemical warfare. Thus, the reach of the Wilson standards flows from the nature of the research, not the health of the volunteer; (4) For mixed purpose experiments funded by the DoD, the committee may need to look both at prevailing standards in science and medicine and the Wilson memorandum rules. The Committee requested that staff prepare information regarding the applicability of the Wilson memo in such cases. Committee members requested that the staff prepare the documentation showing the level of noncompliance with the Wilson memo. The Committee decided to review the 1975 Army Inspector General (IG) report on chemical warfare research, and asked that the staff supplement the IG report with reports about contractors who appear to have experimented in violation of the Wilson memo standards. Additional documents were also requested to flesh out compliance processes in the Department, e.g. Navy review processes for volunteers. Members also discussed evidence that the Wilson memorandum s reach was limited to research involving healthy volunteers. Dr. Moreno noted that the exclusion for therapeutic research was not explicitly stated until the 1962 publication of new regulations. Members discussed the shared responsibility of the government on the one hand and the medical and academic community on the other, and discussed how to assess community standards of informed consent. Members noted the differences in dissemination of and compliance with standards articulated by the American Medical Association or other voluntary groups and the AEC or DoD policies. Members asked the staff to integrate preliminary findings from oral histories with the documentation requested on compliance with policies and standards in government agencies. Dr. Royal also requested that the staff report on the remedial actions taken as a result of the 1975 Inspector General's report on chemical and biological research, changed policies and authority under the Surgeon General after the IG report, and efforts taken to respond to the subjects found to be wronged, but not harmed. Friday, December 16, 1994 Present: Ruth Faden, Kenneth Feinberg, Eli Glatstein, Jay Katz, Patricia King, Susan Lederer, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Philip Russell, Mary Ann Stevenson, Duncan Thomas. The Committee reconvened at 8 a.m. at the Omni Shoreham Hotel. Public Comment Doris Baker, Cincinnati, Ohio. Ms. Baker told members about the loss of her great-grandmother, Gertrude Newell, at Cincinnati General Hospital. Vina Colley, Pike County, Ohio. Ms. Colley, president of Portsmouth/Piketon Residents for Environmental Safety and Security (PRESS), told members of the deaths and hazards her group ascribes to the nuclear weapons facilities in Pike County. Members questioned Ms. Colley about the response of public health authorities to these concerns. Diana Salisbury, Portsmouth, Ohio. Ms. Salisbury appeared on behalf of environmental groups in the areas of the Pike County uranium enrichment facilities. She described concerns about secrecy and distortion of evidence about pollution and the harms caused to workers. Lenore Fenn, Boston Massachusetts. Ms. Fenn described her experience as a young worker at Massachusetts General Hospital in 1955, where she said she witnessed episodes in which a patient was subjected to experiments without consent by the patient or his family. Peter Lewis, Uniontown, Pennsylvania. Mr. Lewis said that he was the subject of experiments at Walter Reed Army Hospital, but that on advice of counsel he could not elaborate in public at this time. Robert Proctor, State College, Pa. Professor Proctor, of Pennsylvania State University, discussed the experience of uranium miners in Bohemia and the United States, outlining the process by which miners were denied appropriate medical care or knowledge of unsafe conditions in the American mines. William Jackling, Rochester, New York. Mr. Jackling of the Rochester Radiation Victims Survivors Association related the cases of patients injected with radioisotopes without consent. Fred Boyce, Boston, Massachusetts. Mr. Boyce, who attended the Fernald State School in Massachusetts, related his experience in the "Science Club" study. He offered to make available records of doctors purchased at estate sales by himself and others. Pat Broudy, Laguna Niguel, California. Ms. Broudy, of the National Association of Atomic Veterans, told members that exposure of servicemen falls within the scope of the Advisory Committee's charter. She made available to the Committee data from a NAAV study about early deaths among atomic veterans. Committee Discussion: Historical Ethics Policies. Jonathan Moreno, Denise Holmes. Dr. Moreno outlined the development of policies in the Atomic Energy Commission, concentrating on meetings and correspondence in the AEC's formative years. He noted a 1947 memorandum suggesting that the Commission expected that testing would continue only when there was an expected therapeutic effect. Members discussed whether documents show a "policy" per se, or a general practice, which raised questions about standards for consent. Dr. Faden said the Committee must grapple with questions about research standards relating to consent: Was a standard for consent established? To what kind of research did it apply? Ms. Holmes and Dr. Moreno summarized the status of the search for relevant records in the Department of Veterans Affairs (VA). Ms. Holmes reported that only limited information has come to light about what kind of standards regarding research on human subjects may have existed at VA institutions. She said that it is the opinion of Committee staff that the VA's 1958 General Counsel opinion responded to two specific projects, but that there was no agency-wide policy articulated therein; the earliest document found relating to standards of informed consent is a 1967 regulation which superseded a 1964 regulation. Ms. Holmes said that staff is attempting to understand how these standards were applied in the field. Members discussed the VA policies and whether it is appropriate to apply standards set by some agencies to the entire government community. Dr. Oleinick said that without documents on ethical standards for VA at an early date, the Committee may have to revert to the "one-government" approach. Dr. Macklin proposed that an agency's culpability may be even greater if all other agencies had some kind of standard and it did not, especially seeing as there was a great deal of interagency research. Ms. Holmes also pointed out that the Committee would have to take into account the limited documentary evidence found to date. Dr. Faden stated that the Committee would continue its discussion with respect to VA in January. Committee Discussion: Remedies (continued). Dr. Faden asked members to revisit the issue of culpability in light of the Remedies subcommittee memorandum. Dr. Thomas noted that the memorandum lacked a guideline on the degree of evidence needed with respect to whether an ethical policy was in place, and if so, if it was implemented. He expressed the concern that evidentiary questions were inextricably linked to the culpability issue and emphasized that they must be thought about carefully. Members discussed how guidelines might be drawn from specific cases. Professor King said that this would ultimately be a two-step process; step one would be to determine why, in general, remedies are justified, and step two would be to make the case with respect to individuals or groups. The second stage, Professor King said, is when standards of evidence come into play. Dr. Faden noted that the first stage had been generally addressed in the discussion at this meeting, but that consideration of specific cases would have to wait until the January meeting. Committee Discussion: Final Report. Ruth Faden, Dan Guttman. Committee members discussed Mr. Guttman's memorandum circulated at the Committee meeting proposing a general outline for the final report. Mr. Guttman said staff is organized into project teams that would feed into chapters of the final report. Dr. Faden and Mr. Guttman said the staff envisioned four companion volumes in which the detailed research and findings of the Committee would be reported. Dr. Katz suggested adding a section on the tradition of medical practice in terms of doctor/patient communication. Dr. Thomas suggested that two points were important in the discussion: (1) that the setting of research was one in which scientists were trying to accomplish several goals for the benefit of the whole society; (2) that people in leadership roles did not always act with dignity. Members discussed the themes to be addressed in the report and the diverse audiences -- officialdom, the press, the public, activists -- who would be reading the report. A general consensus emerged that the Committee's report is both to address the issues and questions brought up in the charter, and also to "tell the story" of this country's Cold War human radiation experiments. Dr. Katz suggested that the Committee ask for an extension of its work to provide adequate time for consideration of the final report. Professor King, however, suggested that it would be better to complete the work on time as a matter of urgency, and members agreed that work should continue to try to meet the April/May deadline for the report. Dr. Faden reported that the study of contemporary research activities was proceeding and that there would be fuller report on the contemporary research studies in January. Members asked that a portion of each meeting be set aside to review drafts of parts of the report as they were being written. The Committee asked Mr. Guttman to write a memo for the January meeting outlining where additional primary research is needed to fill in evidentiary gaps. Subcommittee Report: Intentional Releases. Duncan Thomas, Nancy Oleinick. Dr. Thomas and Dr. Oleinick reported on their review of classified Green Run material on December 14. They said that the Air Force has, at the Committee's request, declassified almost all of the 1950 Green Run report. The only deletions involve 20 words that were reviewed by Committee members and staff and found to be irrelevant to the needs of the Committee. Dr. Thomas said the Air Force told them that there were compelling reasons to keep those remaining words secret. Dr. Faden said the Committee would have a fuller report regarding intentional releases and experiments of opportunity at the January meeting. Committee Discussion: Committee Strategy and Discussion. Members discussed the conceptual overview of the report and continuing work of the staff. Dr. Stevenson noted that the report should reflect the fact that much about radiation health effects is not known today, and that researchers of 40 and 50 years ago were trying to set standards through the experiments that are today under scrutiny. She said it is important not to leave the impression that scientists were omniscient about the effects of radiation at the time of these experiments and that they were withholding this information for purposes of national security. Dr. Glatstein agreed and noted that many estimates derived from the Cold War-era experiments hold up today. Dr. Macklin asked, in preparation for the January meeting, that the Committee receive updates on staff projects, and Professor King added that it would be helpful to have the material from staff organized to fuel deliberations on key topics. Mr. Guttman, acting for Mr. Caplan, closed the meeting at 4:30 p.m. CERTIFICATION The above minutes represent a summary of the December meeting of the Advisory Committee on Human Radiation Experiments, as approved by the Committee. Ruth R. Faden, Chair