Advisory Committee on Human Radiation Experiments Minutes of meeting of June 21-23, 1995 Wednesday, June 21, 1995 Attending: 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. Philip Caplan, Special Assistant to the President for Cabinet Affairs, opened the meeting at 9 a.m. in the Executive Chambers, Madison Hotel, 15th and M Streets, Washington, D.C. Dr. Faden briefed members on the agenda. Public Comment Period Martin Freeman, Rochester, New York. Mr. Freeman, an attorney for families of subjects in the Rochester uranium injection experiments, said the Advisory Committee's recommendations should not preclude litigation by subjects or their survivors. Anthony Roisman, Washington, D.C. Mr. Roisman, an attorney representing the National Committee of Radiation Victims, praised the efforts of the Committee and the government in opening the record of radiation experiments. He criticized draft recommendations as failing to adequately deal with what he called civil rights violations in human experimentation. Geoffrey Sea, Oakland, California. Mr. Sea represented the Task Force on Radiation and Human Rights, and International Radiation Injury Survivors. He briefed members on relevant international treaties or covenants to which the United States is a signatory. As a representative of attorneys litigating in Nashville and Cincinnati, Mr. Sea commented on treatment of both cases in draft chapters of the Committee's report. Philip Harrison, Shiprock, New Mexico. Mr. Harrison spoke on behalf of the Uranium Radiation Victims Committee. He urged the Advisory Committee to recommend major changes in the 1990 law compensating uranium miners in the American West. Rachel Greene, Hyattsville, Maryland, and Zina Greene, Washington, D.C. Rachel Greene described her radiation treatment as a child in 1964 in California and what she called misdiagnosis of her subsequent medical problems because of limited followup of her radiation treatment. Zina Greene reported on the consent process and the lack of followup on Rachel Greene, her daughter. Members questioned the Greenes about the consent process and about followup of childhood cancer cases. Julie Boddy, Takoma Park, Maryland. Ms. Boddy reported on her radiation treatment for burns as a child, and the difficulties of getting information about her treatment after the fact. Committee Discussion: Findings (1944-74). Dr. Faden polled members on whether they had significant objections to draft findings. Members were asked to send editorial changes directly to the staff. Members agreed to group findings differently, organizing them by themes -- descriptions of the experimental universe, intentional releases and ethical policies. Members discussed the draft findings and suggested changes. Issues included the difficulty of making retrospective moral judgments; the difficulty of defining the boundaries between therapeutic and nontherapeutic research; accurately describing risks, benefits and ethical issues in various experiments; expressing as findings the Committee's views on secrecy, disclosure and preservation of government records. Members reviewed revised language on ethical findings relating to past experiments (Draft Finding 9) and approved revised language expressing a scale of circumstances that might militate against judgments of blameworthiness. Committee Discussion: Recommendations for Remedies for Former Subjects. Members discussed the draft recommendations and suggested numerous changes. Professor King suggested generally that the report should direct recommendations to specific agencies or officials, e.g. the President, and should be careful in phrasing recommendations to avoid seeming to overstep the prerogatives of agencies or the Congress. Members discussed the implications of secrecy for establishing grounds for compensation, the means by which subjects would gain an apology from the government, and the methods by which compensation could be granted to former subjects or surviving immediate family members. Members discussed the implications of the revised Finding 9 language for recommendations involving compensation for subjects of therapeutic research. Members agreed to a recommendation for compensation in cases of nontherapeutic research in which subjects were injured; members agreed not to address in the recommendations research that offered a plausible prospect of medical benefit, because the Committee had not focused on this type of research in its inquiry. Dr. Katz suggested that the recommendations chapter might begin with mass exposures because more people are involved. Members discussed recommendations involving persons exposed at atomic weapons tests, and agreed to recommend an updating of radioepidemiologic tables. Members suggested redrafting recommendations on compensation schemes and further studies of veterans exposed at weapons tests. Professor King said it was important to bring the Committee's findings to the attention of the executive branch, but that the Committee as a whole was not in a position to evaluate and to recommend all the potential responses to the problems discussed in the draft recommendation. Members discussed the draft recommendation on compensation to uranium miners. Dr. Thomas outlined potential ways to liberalize the existing compensation law and Drs. Royal, Macklin and Katz urged that the Committee endorse presumptive compensation for all uranium miners who contract lung cancer. Professor King and Mr. Feinberg suggested that the language of the recommendation that the law be amended be modified more as a suggestion to Congress. Dr. Thomas said a more forceful recommendation is necessary to outline the direction said language would be drafted to reflect several options, and the Committee would revisit the issue. Members discussed the Marshallese and downwinder recommendations, and Dr. Faden noted that both are directed to another body, e.g. Congress, urging another look at the issues in light of the evidence presented by the Advisory Committee. Professor King said the report should note the similarities in the set of recommendations that address population exposures that have led to earlier Congressional action. The report might be a useful binding-together of related issues, she said. Dr. Katz said it is important that the report not lose its moral overtone in the course of directing detailed recommendations to in the bureaucracy. Thursday, June 22, 1995 Attending: 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. Committee Discussion: Subject Interview Study. Jeremy Sugarman, Steve Goodman, Nancy Kass, Patt Perentesis. Drs. Sugarman and Goodman briefed members on the results of the subject interview study (SIS), with a particular emphasis on the discordance between those subjects identified as participants in research who reported in the survey that they were not research subjects. The discussion focused on those involved in research of more than minimal risk. Dr. Sugarman noted that an overwhelming majority of those interviewed favored research, but observed that persons may often be confused about what constitutes research. Dr. Kass briefed members on in-depth interviews with persons who believed they were in research. Members discussed the discordances in the studies and questioned Dr. Kass about respondents' attitudes toward research, and its association in respondents' minds with high-quality treatment. Professor King asked that the SIS chapter include a discussion of how patients' confusion about what constitutes research integrates in daily practice with existing research regulations and the obligations they imposed on researchers and institutions. Committee Discussion: Research Proposal Review Project. Sara Chandros, Gail Geller, Shobita Parthasarathy. Members discussed the draft research proposal review (RPR) chapter and Dr. Katz's memorandum on his review of proposals. Members discussed the qualitative nature of the RPR chapter, and its integration with Dr. Katz's independent review. Dr. Glatstein said the problems were concentrated in Phase One toxicity studies, in which an overemphasis on enrolling subjects causes problems in the consent process. Members reviewed the draft language of the chapter and suggested editorial changes. Drs. Stevenson and Katz said the chapter summary was vague. Members urged changes to descriptions of the nature of voluntariness in the protocols, and discussed the quality of conclusions drawn from dealing with documentary evidence. Dr. Glatstein suggested highlighting Dr. Katz's observation that there were some excellent consent forms among the protocols. Committee Discussion: Contemporary Projects Ethical Analysis. Members discussed the draft chapter and generally suggested that the draft chapter should synthesize issues arising from the contemporary projects. Professor King suggested it be redrafted to focus on today's human subject protections and why the protections are not working as they should. Members discussed the effectiveness of today's system of locally autonomous institutional review boards and the treatment of ethical concerns by IRBs. Committee Discussion: Findings. Members discussed the draft findings for the contemporary world, with a particular focus on draft Finding 17, regarding human-subject protections. Members agreed that the findings would be redrafted to indicate where serious deficiencies in consent procedures were found by the research proposal review and reasons for concern about the quality of information available to subjects (e.g., misunderstandings about research and treatment) were found by the subject interview project. Members discussed whether to cite in the finding evidence of positive outcomes that can arise from today's process, e.g. high- quality consent forms and a capacity for subjects to refuse to participate in research. Dr. Faden said redrafted language would be circulated to the Committee. Committee Discussion: Contemporary Recommendations. Members discussed draft recommendations responding to the findings from the RPRP and SIS. Members noted wide variations in the effectiveness and quality of IRBs that review research proposals. Members discussed to whom to direct recommendations about improvements of the IRB process. Members disagreed about the need for a new agency to oversee ethical practices in human subject research. Dr. Katz argued that critical national issues must be assessed and reforms carried through in a national forum. Dr. Russell questioned the usefulness of an office or body in the national bureaucracy that will attempt to deal with operational issues of the decentralized IRB system. Professor King suggested that a permanent national body would not find favor with policy makers. She suggested casting the recommendation in terms of characteristics needed for the mechanism, such as a temporary advisory committee to deal with ethical issues and to advise the agencies covered by the Common Rule. Mr. Feinberg suggested a recommendation that the government ensure greater attention to ethical issues, and then lay out possible options to get the job done. Dr. Glatstein and Ms. Norris said it was critical to provide a mechanism that would be a sounding board for IRBs, which Dr. Glatstein said operate in a local vacuum. Committee Discussion: Strategy and Direction. Ruth Faden. Dr. Faden briefed members on the Committee's publications that require sign-off from members: the final report, an executive summary and supplementary volumes. Ms. Mastroianni briefed members on dates and mechanisms for distribution of, and comment on, preliminary and final drafts for the final report. Members discussed possible mechanisms for adding to the report personal statements by members. Friday, June 23, 1995 Attending: Ruth Faden, 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. Committee Discussion: Contemporary Recommendations. The Committee discussed Recommendation 12 for the contemporary world and suggested changes regarding recruitment of subjects for research conducted by the military. Members noted the difficulties of obtaining curriculum space for training on human subjects protections in both military and civilian worlds. Members discussed today's regulations on recruitment of subjects in light of Committee research about studies conducted in connection with training maneuvers during Cold War tests of atomic devices. Members discussed the economic risks of research, including unclarities concerning the role of third-party payers. Members rejected a draft recommendation for compensation for dignitary harms in the future, even in absence of injury. Dr. Macklin suggested that sanctions against researchers or institutions would be a more meaningful incentive to ensure compliance. Dr. Faden said staff would research the issue of sanctions and return with a recommendation to the Committee at its July meeting. Members agreed to include in the text of the recommendation chapter a suggestion that compensation for dignitary harms be considered by the appropriate agency of the federal government. Members discussed mechanisms to improve education about ethical issues and providing federal incentives for improvements in the ethical preparation of the research community. Committee Discussion: Recommendations National Security, Human Research and (Intentional Releases). Members suggested changes in draft recommendations on future classified research and intentional releases. Members sought to ensure review of whether experiments or releases are justified and to ensure consent in classified research. Members discussed the draft recommendations and how they might be implemented in connection with existing environmental protection laws. Members agreed to delete a draft recommendation regarding standards for a population-based estimate of the risks of intentional releases, but noted that relevant information on the health effects of intentional releases is included in the draft chapter on intentional releases. Committee Discussion: Recommendations for Remedies for Former Subjects. Members discussed a redrafted recommendation dealing with the compensation of uranium miners and millers. Members agreed to criteria by which specific groups of subjects would be considered for notification of the possible need for medical followup. Dr. Faden said the specific numbers would be developed by a working group of consultants and included in the draft recommendation to be circulated to members. Dr. Royal asked that a conference call be arranged within a week. Committee Discussion: Contemporary Recommendations. Members discussed recommendations with respect to openness in government, and generally agreed to changes in the draft language that lay out options for policymakers to deal with the serious problems of secrecy and lack of citizen access to information about research. Members suggested changes in the detailed list of openness recommendations to track more closely the findings. Members asked for staff to review and resubmit in July language regarding Central Intelligence Agency documentation, and language regarding maintenance of a registry of human subjects research. Approval of Minutes Members approved without amendment the minutes of the May 1995 meeting of the Committee. Mr. Guttman, acting as the designated federal official, closed the meeting.