Advisory Committee on Human Radiation Experiments Minutes of Meeting of April 10-13, 1995 Monday, April 10, 1995 Attending: Ruth Faden, Kenneth Feinberg, Eli Glatstein, Jay Katz, Patricia King, Susan Lederer, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Mary Ann Stevenson, Duncan Thomas, Reed Tuckson. Mr. Philip Caplan, Special Assistant to the President for Cabinet Affairs, opened the meeting at the Madison Hotel, Fifteenth and M Streets, Washington, D.C. Dr. Faden briefed members on the agenda. Approval of Minutes Members approved without objection the minutes of the March meeting. Public Comment Gwendon Plair, Washington. Dr. Plair, chairman of Concerned Relatives of Cancer Study Patients, addressed members on the Cincinnati total-body irradiation experiments. He praised the Committee for its work and urged members to seek additional months to continue its studies. James Tidwell, Cincinnati, Ohio. Mr. Tidwell read a letter into the record from Clifford Tidwell, son of the late James Tidwell, a patient in the Cincinnati experiments. Clifford Tidwell reported that his father was healthy before being abused by researchers in the course of cancer treatments. He said doctors took advantage of Mr. Tidwell's lack of education and reliance on Cincinnati General Hospital for medical care. Members questioned James Tidwell about his grandfather's medical records. Dr. Tuckson said that the Committee might wish to consider as a recommendation making available to families a consultant to evaluate medical records. Barbara Tatterson, Cincinnati, Ohio. Ms. Tatterson testified on the case of her cousin, David Jungnickel, a Cincinnati subject who died at 19. She described his great pain and degrading conditions at a nursing home to which he was sent from Cincinnati General Hospital. Members questioned Mrs. Tatterson about Mr. Jungnickel's treatment and his medical records. Joseph Peterson, Carson City, Nevada. Mr. Peterson spoke about his late mother, who worked at Oak Ridge and Hanford nuclear reservations in World War II and died in 1964 of leukemia. Mr. Peterson said he and his sister have thyroid problems and believe them associated with Hanford exposures, and urged members to look closely at the threat of genetic damage to offspring of those exposed to ionizing radiation. Members asked Mr. Peterson about the anxieties induced by fears of genetic damage, and about the records of his parents' work at Oak Ridge and Hanford during World War II. Banny deBrum, acting Ambassador of the Embassy of the Republic of the Marshall Islands. Ambassador deBrum appeared with a panel of citizens and officials from the Republic of the Marshall Islands, site of U.S. nuclear weapons tests. He said a long-term mechanism for information access, without burdensome costs to the small island republic, would constitute one of the key recommendations of interest to the Marshalls. Members questioned the delegation about the return of Rongelap residents to the atoll in 1957 and whether islanders were informed by the U.S. Government of the dangers inherent in the resettlement. Drs. Tuckson and Thomas expressed concern that the Marshalls embassy was billed by the U.S. Government for copies of records that bear on the Marshallese exposures. Rebecca Harrod Stringer, St. Augustine, Florida. Mr. Klaidman read into the record a letter from Mrs. Stringer about the Navy service of her late father in Operation Dominic I, a nuclear weapons test in the Pacific. Staff Report: Research Proposal Review Project. Sara Chandros, Shobita Parthasarathy, Gail Geller. Ms. Chandros briefed members on preliminary results of the review project. She noted that most of the ethically troubling studies emerged in cases where risks are higher. Drs. Thomas and Oleinick suggested that staff should avoid statistical presentations in what is basically a qualitative study. Dr. Macklin suggested that the staff try to establish, where the language of the consent form is ambiguous, whether the doctor described in the form as providing more detailed information to the potential patient-subject is an investigator, the patient's referring physician, or both. Dr. Glatstein said consent forms represent documentation that an effort was made to explain procedures to a patient, but that many forms continue to include enough jargon to raise questions about whether patients can adequately understand the explanation. Dr. Oleinick said the report also should reflect whether any IRB-approved studies have been identified that should not have been done at all for scientific reasons. She said there may be none, and if so it should be noted in the final report. Dr. Katz said he disagrees with draft conclusions that most research protocols reviewed in the study are ethically acceptable. Dr. Katz added that IRBs are not sufficiently informed about risks and potential benefits -- particularly comparing standard treatments with investigational interventions, in which the former may provide a better quality of life for the patient. Members discussed how to conduct a second-order analysis of consent issues in the reviews that received middling overall ratings in Committee reviews. Staff Report: Subject Interview Study. Jeremy Sugarman, Nancy Kass, Steve Goodman. Dr. Sugarman briefed members on preliminary data from the Subject Interview Study. Two groups of respondents in the early returns from the subject interview study were of particular interest. One group consists of people who believe they are in studies, but for whom there is not evidence of actual participation. Some may have been in studies for which there are no records available to the Committee, Dr. Sugarman said. A second group is those who are or have been research subjects, according to reviews of relevant documents, but who said they are not aware of having been or being participants in research. Dr. Sugarman said much more extensive analysis is necessary to see if the very preliminary numbers hold up. Dr. Goodman briefed members on the statistical analysis and Dr. Kass on the in-depth interviews with persons who said they were involved in research. Dr. Kass said that the word "experiment" evokes images of riskier, more complex research than words like "study" or "clinical investigation." She said many respondents cited their trust in a doctor or institution, or of the medical world generally, as a reason to feel that research interventions would not be allowed to harm a subject. Dr. Macklin said integrating the findings of the protocol review and subject interviews would be an important task for the Committee in the coming weeks. Dr. Goodman noted that a very high percentage of respondents in the preliminary survey expressed satisfaction with the process by which consent was obtained from them. Committee Discussion: Strategy and Direction. Ruth Faden. Members discussed the proper presentation of several key issues in the report, including the benefits of radiation research to society and the assessment of national security concerns by officials. Drs. Thomas and Oleinick raised the issue of properly representing the benefits of radiation research. Drs. Oleinick and Stevenson said a separate chapter would be necessary to make those points. Dr. Thomas praised staff for bringing to the writing process the interchange of member and staff ideas, but noted that the Committee has only one more meeting scheduled for discussion of major chapters in the final report. Professor King suggested that after May's meeting, a final meeting be held in the summer, allowing some time for recrafting and filling any remaining gaps in the final report. Members discussed ways to schedule one or more additional meetings to consider the final report chapters. Several members suggested that members might write addenda or dissents as part of the process, requiring additional time for deliberation and revisions. Dr. Macklin noted the effect of dissents overshadowing conclusions, as happened in the faculty committee report on the plutonium injections at the University of California at San Francisco. Dr. Macklin suggested, and members agreed, that the Committee should identify issues upon which members disagree, and identify issues which the Committee has yet to discuss in depth, during the remainder of the April meeting. Members asked the staff to ensure that each member's comments on chapters be circulated to all on the Committee. Committee Discussion: Forward-looking Recommendations. Ruth Faden. Dr. Faden asked members' reaction to eight general areas of recommendations regarding the contemporary world. Members discussed how to establish or improve mechanisms for the continuing interpretation and application of ethics rules and principles in research. Members discussed what kind of bodies now oversee research and how these could be improved, or replaced with a body of a broader scope. Tuesday, April 11, 1995 Attending: Ruth Faden, Eli Glatstein, Jay Katz, Patricia King, Susan Lederer, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Mary Ann Stevenson, Duncan Thomas, Reed Tuckson. Committee Discussion: Intentional Releases. Mark Goodman. Members discussed decisionmaking by the Atomic Energy Commission regarding public information policies on intentional releases; the difficulty of communicating risk and the need to do so in light of the concern expressed by citizens who feel their health was harmed by exposure from releases; the difficulties of weighing risks against potential benefits to national security, or other non-health-related benefits. Dr. Royal suggested that the draft chapter overestimates the risks of the Hanford releases, but he said that issue is part of the larger problem of how to adequately communicate risk. He said risks may be more relevantly communicated in terms of risk of excess deaths from radioiodine releases from Hanford. Members agreed that risk should be presented in terms of excess cancer deaths compared to the general population. Dr. Thomas noted that what is easily quantifiable is the quantity of the release, but it does not easily translate into risk analysis without dose reconstructions, which are available for Hanford but rarely elsewhere. Dr. Royal said it is important that the Committee clearly communicate risks, especially in light of the moving testimony from many persons worried about risks to their health from intentional releases. Dr. Glatstein questioned whether a risk-benefit model is appropriate for intentional releases, in which officials decided to expose large numbers of people without their knowledge. Societal benefits from intentional releases are not the same as benefits that might accrue to an individual in a biomedical setting, he said, and risks were often calculated by officials unwilling to acknowledge their ignorance of the health effects of the exposures. Dr. Glatstein said it's hard to believe that the information gained was worth the risk of exposures to people. Members discussed the assessment of national security concerns in connection with intentional releases and bomb tests. Dr. Tuckson said it is important to include in the chapter a thorough explanation of concerns of citizens subjected to intentional releases. Committee Discussion: Experimentation in Connection With Atomic Weapons Tests. Patrick Fitzgerald. Members discussed the treatment in the draft chapter of flights through mushroom clouds, and the indoctrination of ground troops during weapons test maneuvers. Key questions, Mr. Guttman said, included how well existing compensations schemes work for veterans of the weapons testing, and how treatment of soldier-subjects would have changed if authorities had clearly defined some activities as "experiments," rather than "training" or "indoctrination." Dr. Faden said inquiries continue into the effectiveness of current protections of soldiers involved in experiments. Members discussed the scope of the Committee's charge relative to atomic weapons testing; the process by which Committee suggestions could be incorporated into the chapter; and the potential recommendations that could arise from the chapter's findings. Dr. Royal stated the importance of members feeling ownership of the report's findings and recommendations. Members generally expressed the view that the military should have kept better records of exposures and operations in connection with weapons tests. Dr. Faden noted that Congress has apologized on behalf of the nation for endangerment of troops during the weapons tests. Committee Discussion: Observational Studies. Barbara Berney. Members discussed the chapter on observational studies, with Dr. Thomas and Ms. Berney noting that the material on Operation Sunshine and other fallout studies was moved to the chapter on secrecy, where drafters felt it was more appropriately discussed. Members discussed several key issues involving uranium miners, whose radon exposures might have been limited by more prompt action by officials in the 1940s and 1950s. Issues included ethical implications of awaiting the results of long- term studies before attempting public-health measures to minimize exposures; the adequacy of information on the uranium mining hazards that was available to officials in the mid-1940s; an apparent lack of disclosure to miners of the risks involved in the exposures. Members discussed the Marshall Islands section of the chapter, focusing on the blurring of general medical care and research activities in the exposed population; the resettlement of islands later found to contaminated; and the disrespectful attitudes of researchers to native populations generally. Professor King noted that it is a commonplace in the Committee's work that Indians, Marshallese and poor people are populations for study, and in many cases it is later difficult to find evidence to evaluate the processes of subject selection. Dr. Faden asked that staff include information or quotes from documentaries that demonstrate disrespectful attitudes to the Marshallese on the part of U.S. medical authorities. Professor King suggested changes in the draft to make clear that medical care provisions should not be conditioned upon participation in research. Dr. Faden suggested that the Committee acknowledge the epidemiological issues raised by worker studies and atomic bomb survivor studies, but without treating those issues in great detail. Members agreed. Members agreed to treat Operation Sunshine and other fallout studies in the secrecy chapter. Dr. Thomas noted that the failure to warn populations exposed to fallout of the risks, as in Operation Buster-Jangle in 1953, raised serious ethical concerns. Committee Discussion: National Security. Dan Guttman. Mr. Guttman said the Committee's research shows how national security or other concerns such as fear of liability or bad publicity have been invoked in the context of research. Dr. Katz said national security remains an ill-defined concept, and Dr. Macklin noted that not everything that is in the national interest is a matter of national security. Dr. Glatstein said there needs to be more emphasis in draft chapters on the linkage between secrecy and distrust of the government, e.g. abuse of classification powers. Mr. Guttman said tensions about openness and secrecy exist in bureaucracies today. Dr. Macklin said the staff should find instances of national security being invoked as justification for official secrecy and present them for Committee discussion. Professor King said the staff should provide evidence to justify any claims that national security was not a sufficient rationale for actions criticized in the final report. Committee Discussion: Strategy and Direction. Ruth Faden. Dr. Faden asked that members revisit the process questions and the suggestion that another meeting be scheduled. She said plans to circulate important issues in drafts to all members, agreed to earlier Tuesday, would deal with some of the process concerns raised by members. Professor King said a longer time frame between May's meeting and a final meeting would vastly improve the prospect of a strong report. Members discussed how to structure staff and Committee time and resources if additional time is available to complete the final report and companion volumes during the summer months. Dr. Faden said the sense of the Committee, despite considerable scheduling difficulties, is that additional meetings were essential to completion of the final report. She said that she would speak to Administration officials about an extension. Committee Discussion: Professional Standards and Practices, 1946- 66. Jon Harkness. Dr. Macklin discussed the importance of American Medical Association statements about ethics to ordinary physicians; references in the draft chapter to Nazi practices; and references to "proxy consent." Dr. Katz said he felt problems with the chapter were remediable, and that these arose from the many burdens of interpretation borne by the Nuremberg Code -- by judges at the Nuremberg trials, by officials in the American government and by American doctors who felt it did not apply to their beneficent practices with patients. Distinctly different ethical implications arise from these "faces" of the Code, and each manifestation of the Code could be more sharply distinguished from the others in the draft chapter, Dr. Katz suggested. Dr. Faden remarked that the chapter represents both an insight into the nature of professional practices but also a distinct and important contribution to scholarship about the Nuremberg Code. Professor King said that the Committee and staff should take care to view the Code in context when it appears in other manifestations in different parts of the final report. Professor Harkness noted that the key Defense officials who saw the Code as a significant statement were generally not physicians. Committee Discussion: Findings. Dan Guttman. Members discussed a draft set of findings, that Mr. Guttman said would form the basis for an executive summary in the final report. Dr. Faden also noted that findings would be a set of guidelines to make sure that relevant evidence is fully explained in the text of the final report. Wednesday, April 12 1995 Attending: Ruth Faden, Eli Glatstein, Patricia King, Susan Lederer, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Mary Ann Stevenson, Duncan Thomas, Reed Tuckson. Committee Discussion: Remedies. Ruth Faden, Gary Stern. Dr. Faden briefed members on the drafts of the recommendations addressing past wrongs in experimentation. Members discussed the differences in proposed remedies for several situations. These included remedies for dignitary harms, or for situations in which persons suffer physical harms and are unable to seek redress because of government secrecy or obstruction of access to the record. Members discussed the definition of consent for purposes of the remedies findings, and also discussed the mechanisms for appropriate response on the part of the government. Members particularly focused on the burdens of proof for the government, institutions where biomedical experiments were performed, and individual subjects. Dr. Stevenson asked whether there are any cases before the Committee in which national security considerations justified secrecy. She said that members need to discuss whether national security grounds can ever justify using citizens as subjects without their consent. Dr. Faden said that discussion would be held in May. Drs. Tuckson and Glatstein raised the suggestion of some intermediate reaction between apology and compensation that would involve censure or sanction of culpable government agencies, while reflecting the fact that the responsible officials may have long since died or retired. Dr. Faden said staff and members would work on developing that concept for discussion at the May meeting. Members discussed the difficulties of crafting appropriate remedies in cases where there has been some therapeutic benefit to the subject, as well as some physical harm. Members also discussed how to compensate subjects properly for costs of medical care. Dr. Faden called members' attention to a staff memorandum on studies involving nasopharyngeal irradiation. She said discussion of the nasopharyngeal studies would be reserved for May's presentation on the chapter involving children and pregnant women, but that the issue might also arise in discussion of recommendations involving epidemiological studies. Members discussed the notification of subjects and questions arising from that charge in the Committee charter. Issues included whether the subject's right to know of his/her participation also includes an obligation on the part of institutions to inform the subject of participation. Dr. Macklin noted that the good-faith obligation for institutions should include making a records search when asked by subjects or their families. Dr. Faden said it is important to make information accessible to the public so that persons could learn locations and dates of studies, where available. Members added that the Committee should notify institutions that experiments conducted at those institutions are on the Committee's database, and thus may generate questions from citizens believing they were subjects of the studies. Dr. Thomas said that family members should inherit the right to know and members agreed in light of the need for families to access remedies. Dr. Royal said the question of whether to notify subjects should be assessed by a public health consultant to determine whether notification is a health benefit. Dr. Thomas asked that thought go into making provision for efforts to find the poor or otherwise disenfranchised. Members discussed the differing nature of remedies for biomedical experimentation and for intentional releases and other mass exposures. Dr. Macklin said individual cases vary, as some cases involve harms and definite coverups, e.g. uranium miners, and other members noted that Congress has provided compensation schemes in several of the cases before the Committee. Dr. Faden said that starting afresh on these questions is not practical, but the Committee can recommend changes in Congressionally mandated schemes. Members discussed difficulties in addressing citizens' concerns about the work of government agencies under existing compensation schemes, e.g. the lack of ombudsmen; long delays in processing veterans' claims; long delays in updating radioepidemiologic tables. Members agreed that for reasons of equity that Hanford downwinders should receive benefits equivalent to those provided to Nevada Test Site downwinders should the Hanford health projects now under way demonstrate similar health effects. Dr. Macklin said that the Committee should take care not to force analogies between biomedical cases and mass exposures. Committee Updates: Committee Strategy and Direction. Ruth Faden, Anna Mastroianni. Ms. Mastroianni asked that members check their calendars and report to staff if the May meeting could be rescheduled to give more time for consideration of chapter drafts. Dr. Faden emphasized to the public that draft chapters, recommendations and memoranda are only drafts, and do not represent conclusions or decisions by the Committee. As the designated federal official, Mr. Guttman closed the meeting.