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Society's Choices: Social and Ethical Decision Making in Biomedicine 6 Conclusions and Recommendations INTERPRETING THE COMMITTEE'S CHARGE One motivating factor behind this report was the fact that little public bioethics activity took place in the 1980s when the country was sharply divided on several ethical issues. After the closing of the President's Commission, no mechanisms for public discussion and consensus building have been employed effectively. Ethical issues that have been left unresolved include: the nation's public health response to AIDS, research on fetuses and embryos, research involving RU-486, research on the sexual practices of teenagers and adults and their link to sexually transmitted diseases, and the wide range of implications by findings by the Human Genome Project. The committee's initial charge was to analyze the nation's current capacity to anticipate, recognize, and respond to social and ethical issues arising from advances in biomedical science and technology. Part of this analysis was a survey and evaluation of the mechanisms that have been used in the past-at national, state, and local levels-to resolve such issues. Where such mechanisms are needed but no historical models exist, it was the committee's task to make recommendations regarding processes and structures by which the functions of anticipation, recognition, and response could be established. During its discussions, however, the committee decided that "anticipating" social, legal, and ethical problems associated with as yet unknown discoveries was not practical, given the difficulty of accurately foreseeing the future. In retrospect, most of the ethical dilemmas generated by innovative technologies in the past would have been impossible to predict.
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Society's Choices: Social and Ethical Decision Making in Biomedicine Furthermore, it seems impractical to spend time and energy imagining potential dilemmas when we are already faced with so many. Hence, the concepts of "anticipation" and "recognition" were merged into "early recognition" for the purpose of the committee's deliberations. Next, the committee was asked to propose processes and/or structures by which early recognition and response could be accomplished on an ongoing basis; the committee was not asked to resolve any particular issue or set of issues. This portion of the committee's charge reflects the idea that the need to anticipate new issues becomes less pressing if established processes exist to address issues promptly as they arise. The committee was apprehensive about the wording of its charge, noting that not all scientific and technological "advances" are, in fact, advances. The word "advances" implies positive impact, which is not always the case for new technologies. With this in mind, the committee agreed that it was actually addressing "developments" in biomedical science and technology. Spheres of Concern Finally, the committee recognized that not all ethical quandaries that have confronted society in the context of biomedicine have resulted from a single radical change or the introduction of a unique new technology. Limiting discussion to single radical changes or unique technologies did not produce a useful boundary for the committee's mandate. Rather, it pointed to a need to define more carefully the variety of circumstances under which troubling social and ethical issues can arise. The committee identified four illustrative scenarios, which follow. Novel Developments Novel developments may raise unique ethical concerns that did not exist prior to their introduction. The controversy provoked by the recently reported cloning of human embryos is illustrative (Kolata, 1993). So too are developments in genetics, which raise new questions about the interplay of free will and genetic determinism in generating behavior and about the value of information about future health status. Innovations Already Integrated into Practice Innovations may diffuse into medical practice more rapidly than related ethical issues can be resolved. Last year's innovations sometimes become this year's practices, with application far outpacing our capacity as a society to cope with the ethical dimensions raised by these new practices.
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Society's Choices: Social and Ethical Decision Making in Biomedicine When doctors routinely employ a procedure, and when insurance companies reimburse for that procedure, we tend to think that ethical quandaries raised by that procedure have been resolved. This is not always the case. For example, in vitro fertilization is no longer regarded as new in many quarters, yet the ethical dilemmas it raises have never been satisfactorily addressed in the United States. Along with other new reproductive methods (such as surrogate motherhood), in vitro fertilization continues to challenge widely accepted understandings of parenthood and the legal status of the embryo/fetus. Aggregate Effect Some technical changes or developments, considered individually, may not raise substantial ethical issues. Yet an accumulation of such developments can present a novel circumstance that alters existing practices and beliefs, triggering a sense that the developments as a whole require deeper examination because they raise unexamined ethical questions. For example, the accumulation of developments in health care, such as immunizations and antibiotics that prevent or cure infectious disease and arterial bypasses that avert death from heart disease, have made it possible for people to live longer than ever before. Longer life spans, however, have increased the incidence of chronic disease, which in turn has provoked reflection on social and ethical issues related to death and dying, the rationing of medical care, and the ends of medicine. Organizational Innovation Organizational changes can also raise new ethical concerns. Our society is about to undergo significant change in the delivery of health care services, including both established and new technologies. This raises new ethical quandaries related to equity. It is likely that health care reform will necessitate explicit ordering of priorities regarding health resources as well as new judgments about rationing of expensive medical technologies. The empowerment of distinct social groups, discussed in Chapter 2, is also illustrative of an organizational change that can engender new social and ethical quandaries. For example, the success of women's health advocates has compelled NIH, the scientific community, and others to address questions of justice and self-determination in health care and health care research. Limitations in Scope As illustrated in Chapter 4, the committee recognized that efforts to address the sorts of social and ethical quandaries described above can take
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Society's Choices: Social and Ethical Decision Making in Biomedicine a variety of shapes, from community groups to hospital ethics committees to state and national ethics commissions. The committee also recognized that the way in which our society responds to such quandaries is influenced significantly by actions that take place in the context of the legal system, sometimes through individual landmark cases such as Roe v. Wade or In re Quinlan, and sometimes through more subtle accumulations of legal decisions. The role of the legal system in influencing the atmosphere for social and ethical quandaries in biomedicine is fascinating and complex. Given resource and time limitations, however, the committee chose not to address the legal system in a comprehensive fashion. In order to introduce readers to the role played by courts, legislatures, and other lawmaking bodies in bioethics deliberation and policymaking, a background paper by Lawrence Gostin is included in this volume. CRITERIA FOR EVALUATION Potential Yardsticks The committee worked to develop a series of criteria by which past efforts-public ethics bodies and the products of these bodies alike-could be evaluated. These criteria were described in Chapter 5. Other criteria can and frequently have been used. In his background paper for this report, for example, Bradford Gray evaluated the President's Commission and the National Commission by examining the frequency with which the work of these bodies has been cited in court cases, the Federal Register, medical journals, and law reviews. He also solicited the opinions of former commissioners and staff of the two groups. In a recent publication entitled Biomedical Ethics in U.S. Public Policy (1993), the Office of Technology Assessment (OTA) judged public ethics bodies and their products as successful on the basis of prevailing sentiment among OTA study participants and advisors, as well as on the basis of whether or not the recommendations of a particular body stimulated legislation. Several problems arose in attempting to apply the criteria identified by the committee in a uniform, checklist fashion. First, although one can list what might be valued about a public ethics body or its products, the committee recognized that such bodies operate in complex situations in which some of these values necessarily come into conflict, or at least tension, with other values. For example, the committee believes that the practice of holding open meetings enhances the effectiveness of ethics bodies because openness is consistent with the democratic orientation of our country. Yet in some situations, as with the New York State Task Force on Life and Law, closed meetings may enhance internal collegiality, efficiency, and consensus building-also important considerations.
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Society's Choices: Social and Ethical Decision Making in Biomedicine Another complexity arises from the fact that public ethics bodies operate in a pluralistic society where citizens' values vary greatly. For example, agreement on issues that involve abortion is extremely difficult, if not impossible, due to the deep divisions in our society on this subject. In fact, partisan adherence to strongly held opinions on abortion played a major role in the failure of the Biomedical Ethics Board (BEB) and the Human Fetal Tissue Transplantation Research Panel (HFTTRP), as well as the failure of efforts to reestablish the Ethics Advisory Board (EAB). The mandate given to a public ethics body will also affect the way in which the success of that body or its products are judged. One reason that the National Commission has been judged a success by many observers is that it led to revised regulations for human subjects research (OTA, 1993). However, that success might have been impossible without the action-forcing clause in the original law, which forced the Department of Health, Education, and Welfare either to accept the commission's recommendations or publicly state its reasons for not accepting them. Conversely, the HFTTRP was charged to respond to ten specific questions-a charge that stimulated the majority of panel members to develop responses to the individual questions rather than to provide comprehensive and consistent justifications for all of its conclusions (King, 1991.) Some observers believe that the report of this panel would have been more persuasive had it developed an analytical framework for considering the issue that took account of existing norms, methodologies, and cultural perspectives (King, 1991). Baruch Brody in his background paper in this volume maintains that both context and mandate were important factors in the effectiveness of the three New York State Task Force reports, Do Not Resuscitate Orders, Life- Sustaining Treatment: Making Decisions and Appointing a Health Care Agent, and When Others Must Choose, as well as that of the President's Commission report, Deciding to Forego Life-Sustaining Treatment. The three reports of the New York State Task Force on the topic of life-sustaining treatment occasioned more controversy because they were focused on the development of proposed legislation-an activity that is frequently accompanied by conflict. Finally, some public ethics bodies serve functions that they were not specifically mandated to serve. For example, a body convened to draft legislation may be unsuccessful in that regard but may increase public awareness of an issue through its deliberations. Consequently, the evaluation of the success of a particular public ethics body may be more meaningful if it also takes into account achievements that are incidental to or unrelated to a group's mandated function. It is also necessary to ask whether public ethics bodies are to be judged on the basis of overall effect or on the basis of their particular products. When evaluating the overall
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Society's Choices: Social and Ethical Decision Making in Biomedicine effect of an ethics body, factors such as the authority of the appointing body, the esteem in which its members are held by society, the adequacy of the staff and resources available, and the impact of previous products issued by the group, in addition to the criteria outlined in Chapter 5, may be influential. Applying the Yardstick Although the criteria for success cannot be reduced to a checklist, the committee members believe that-with the appropriate scholarly analysis-general agreement on the success of public ethics bodies often can be obtained. As noted in Chapter 4, the Ethics Advisory Board, established in 1978 by the Secretary of DHEW as a permanent advisory body, met frequently for two years and produced four documents, marking a degree of success. However, the EAB was disbanded in 1980 and the recommendations of its principal report were never acted upon by DHHS. Moreover, since DHHS regulations require that all research involving human in vitro fertilization or embryo transfer be reviewed by such a board, work in this area has virtually ceased. Disbanding the EAB might be considered a success by individuals who wish to block controversial research. The committee disagrees and considers the demise of the EAB to have left unmet a critical need for bioethical deliberation and decision making. Without the EAB, the country has had no officially constituted group of national scope to provide analysis and advice on ethically and socially controversial biomedical research protocols or guidance to the research community. Human in vitro fertilization has nevertheless become a standard accepted form of medical practice, but without what many would consider sufficient scientific, social, and ethical underpinnings to optimize clinical practice (IOM, 1989; OTA, 1988). The HFTTRP, also described in Chapter 4, was convened in 1988 by the NIH and concluded that the use of human fetal tissue in transplantation research was acceptable public policy if certain guidelines were in place (Childress, 1991). Although the panel's report lies within the range of an international consensus (Walters, 1988), the Reagan and Bush administrations did not accept the panel's recommendations and the moratorium on the funding of research using fetal tissue from induced abortions remained in effect until rescinded by the Clinton administration in 1993. Some analysts believe that the continuation of the moratorium stemmed from the report's failure to make clear how persons holding radically different views about abortion could nonetheless agree that use of fetal tissue from induced abortion could be acceptable public policy under specific conditions (King, 1991).
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Society's Choices: Social and Ethical Decision Making in Biomedicine The National Commission is an example of an advisory body that was housed within the agency it advised and had an action-forcing mandate. The commission published several effective reports on specific topics and summarized its thinking in The Belmont Report (1978), which clearly enunciated the underlying ethical principles that should guide research involving human subjects. Whether or not due to National Commission reports, the incidence of gross abuse of research subjects appears to have diminished subsequent to their publication. The requirements that the commission's recommendations be published in the Federal Register and that DHEW respond in writing within 180 days proved useful in the implementation of the recommendations. The President's Commission, on the other hand, is an example of a commission convened to examine issues that spanned the concerns of several agencies-not only human subjects research, but also aspects of medical practice. With a prodigious output of reports, many of which have influenced thought in ethics, law, and subsequent legislation, the President's Commission can be considered overall to have been an effective societal mechanism for deliberation about social and ethical issues in biomedicine. A MULTILEVEL APPROACH TO BIOETHICS DELIBERATION After considering all of these factors, the committee concluded that the most effective method for dealing with complex ethical and social quandaries would be a capacity for response at multiple levels of society. The committee therefore proposes strengthening the multitiered system of public deliberation at local, institutional, professional, community, state, and national levels, and particularly recommends filling a key gap through reestablishing a supra-agency ethics commission at the national level. The recommendation for a multitiered system rests on the conviction that capacities for public ethical deliberation (through academic experts, health professionals, religious communities, secular agencies, and an increasingly informed and interested public) have blossomed in all regions of the country. At the same time, certain contemporary ethical quandaries, including many ramifications of molecular genetic research, can best be considered for the nation as a whole through a supra-agency national commission. Two supra-agency models presented by the committee are a single national commission with a broad mandate and a set of national commissions, each with a more focused charge. The recommendations elaborate on the elements proposed for the multitiered system and the features the committee deems desirable for any new national commission. In general, the committee believes that decisions about public policy should occur as closely as
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Society's Choices: Social and Ethical Decision Making in Biomedicine possible to the levels at which relevant actions are taken, and must involve those likely to be affected by the policy. The committee is not proposing a new policymaking authority, but a system, separate from existing political structures, for reflecting on and informing public policy decisions at all levels. In considering issues related to genetic technology, for example, some questions will require resolution on the level of the individual, the family, health care workers (such as physicians and counselors), and other trusted advisors such as ministers. Many of these scientific, social, and ethical issues will also require examination during the training of the professionals who aid in the decision-making process. Professional societies will need to provide their members with guidelines and educational materials to ensure that patients receive accurate medical advice as well as appropriate and empathetic treatment and guidance. As the process of genetic screening moves out of the research laboratory and into the primary care arena, a consensus must be developed on the kinds of information needed by physicians and patients (IOM, 1994). At the level of the institution, hospital ethics committees will confront issues relating to provider-patient interactions in the case of patients with genetic conditions. Within institutions that conduct research on humans, institutional review boards will have to determine the appropriate risks and benefits for research subjects as genetic testing and screening move into wider use. Should research subjects involved in the development of genetic tests be provided with preliminary diagnostic information, and if so, when? When should such testing or screening procedures become part of medical practice? Social and ethical issues related to genetics must also be addressed at the state level. States, which regulate many aspects of medical practice, form the locus for legal decisions concerning not only what genetic screening should be done at various stages of life, but what information, counseling, and quality assessment will accompany each step of the processes. Several federal agencies are also involved with research and practice relating to human genetic disease. One example is the Health Care Financing Agency, which is responsible for laboratory quality assurance in genetic testing; it must assure that the information given to the individual is accurate, since crucial decisions are often made on the basis of this information. The NIH Recombinant DNA Advisory Committee assures that present and future gene therapy research involving human subjects is undertaken appropriately. The Ethical, Legal, and Social Implications Working Group provides a funding mechanism for ethicists, social scientists, lawyers, and health care professionals to describe, analyze, and educate professionals and the public concerning the many issues this new technology raises (see the background paper by Hanna in this volume).
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Society's Choices: Social and Ethical Decision Making in Biomedicine To date, however, the ELSI Working Group has not developed an effective mechanism for translating the work being done in various professional communities into public policy. Governmental agencies have also solicited advice from groups such as OTA (OTA, 1993) and IOM (IOM, 1994) on issues related to research in human genetics. The issues raised by what has been called the ''genetic revolution" are so ubiquitous that it may be appropriate to appoint a commission charged with oversight of issues related to human genetics and situated so as to span the various agency concerns. Issues of individual privacy and confidentiality of medical information, employment and insurance discrimination, and various eugenic implications are national in scope. The recommendations made by the committee are divided into nongovernmental, state, and national levels for ease of description. The committee recognizes and applauds the growth that has occurred over the past several decades in our nation's capacity to deliberate social and ethical issues. The committee envisions a strengthening of this capacity to fulfill the broad array of functions (understanding, education, analysis, and debate) necessary to facilitate the development of consensus in our pluralistic society. In facing contemporary social and ethical quandaries stemming from developments in biotechnology, society now has a richer capacity for deliberation and a deeper pool of expertise than was available as few as 10 to 20 years ago. The modern bioethics movement is now in its fourth decade. Since its origins in the 1960s, it has grown and matured in several ways. Paralleling the growth in bioethics, there has been a growing body of literature in the social science arena. Academic experts, members of the public, government officials, and health care professionals with basic knowledge and genuine interest in bioethics and social concerns can be found in every region of the country. RECOMMENDATIONS Since much of the structure for dealing with the impacts of biomedical developments is already in place at the local level (e.g., IRBs, HECs, and professional organizations) many desirable actions might be taken at this level. The committee addresses these recommendations to consumers of biotechnology and biomedical research, as well as professional organizations at all levels, recognizing that their members and staffs have unique capabilities for dealing with some of these impacts. In addition, hospitals and IRBs have particular opportunities and responsibilities to confront issues and problems presented by biomedical developments. Many of the social and ethical impacts of developments in biomedicine are better addressed at the state or national level, for reasons indicated below. The committee presents its recommendations for state or national response,
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Society's Choices: Social and Ethical Decision Making in Biomedicine noting the advantages that state-level action can have. Finally, the committee describes the value that national advisory bodies would have and recommends establishing a national bioethics commission at the supra-agency level. A Multitiered Response The committee envisions multitiered response to social and ethical issues arising from developments in biomedicine, with deliberations and decisions occurring as close as possible to the level at which relevant actions should be taken. These efforts should be democratic in nature, with a capacity to combine individual and community preferences and values, practical experience in biomedicine, the academic knowledge of bioethicists, as well as the expertise of other disciplines in which ethical discourse is prominent (e.g., law, philosophy, and religion), into its operational procedures. The committee envisions these efforts taking place at locations at which social and ethical policy decisions related to health science and health care are being made. The matching of deliberation to the level at which the decisions are made could be achieved through the creation of deliberative capacity * at levels within the health care system where decisions are jointly made among consumers, providers, payers, and policymakers. The committee is not proposing a new focus of policy-making authority, but a deliberative capacity, separate from political structures, for reflecting on and informing public policy decisions at all levels. Given the growth in the discipline of bioethics over the past 20 years, and the growth in public interest in social and ethical issues in health and health care, the "infrastructure" for such a diffuse capacity seems to be already largely in place. This capacity can be further strengthened to provide for greater consideration of the social and ethical issues that almost invariably accompany technologies and organizational developments in biomedicine. The committee believes that many ethical decisions are best made by the affected individuals and families, with the help of advisors such as health care professionals and ministers. However, some issues will require communal levels of decision making about quandaries that may affect every citizen of the community. Ongoing changes in the structure of the health care system, in combination with focused national efforts at health care reform, are creating new * By "deliberative capacity" the committee means some formal assignment of persons and resources that can make possible the gathering of persons to deliberate in an impartial and informed way on specific ethical issues. This can be inside or outside of an agency, it can be public or private, it can be an office or committee.
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Society's Choices: Social and Ethical Decision Making in Biomedicine opportunities to address social and ethical issues in public policy decision making. The mechanisms for addressing these issues should be consistent with the structure of health care in each state, and if health care reform brings central authorities, they too should be supplemented by an ethics deliberative capacity. If health alliances are established, an ethics capacity should be built into the alliances at those points where major allocation decisions are made. Some states might prefer a freestanding ethics commission to advise on a broad range of bioethical issues. State committees, in turn, could communicate with a national bioethics committee, one of whose functions would be to help coordinate the activities of state committees and bring together individuals to deal with national issues that require special attention. Ethical deliberations will be particularly important in the case of decisions about allocation of health care resources so that health care plans, at whatever level, balance ethical and social considerations with considerations of cost. Health care reform is entering unknown and uncharted territory characterized by an explicit focus on health care costs and financing. The system is presently in flux and the future will bring major changes in the way health care services are delivered. Traditional ways of making decisions will also change. It seems likely that a local ethical deliberative body can best balance the competing interests of individual needs and desires for intervention and the economic burdens borne by the institution or community. However, deliberations at the local level should not replace consideration of related issues at higher levels. The committee notes that there are large disparities among the citizens of this country with respect to income, wealth, and power. Concerns about social justice, which drive some of the present efforts to explore the social and ethical impacts of developments in biomedicine, point to a need for national deliberations. One advantage of a national deliberative capacity is the authority and credibility with which it is imbued, and which make it better able to reflect on and account for the interests of the disadvantaged in these deliberative efforts. Nongovernmental Organizations and Individuals The committee considered the current and potential roles of individuals and nongovernmental organizations-grassroots efforts, hospitals, institutional review boards, professional societies, and health professional educational institutions-in responding to social and ethical issues raised by biomedical developments. The committee believes that those people who play major roles in the generation and proliferation of new biomedical capabilities bear an ongoing obligation to consider the potential impacts
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Society's Choices: Social and Ethical Decision Making in Biomedicine In a democratic society such as ours, mechanisms should be in place for participation of the public in decision making about public policy. Such efforts may be designated as "public" either by virtue of their funding or governmental sponsorship (e.g., state-sponsored commissions or publicly supported "town meetings"), or merely by virtue of the fact that deliberations take place in open meetings. States should assume a special responsibility to establish or participate in such a process for several reasons, one being that states are responsible for administering programs that inevitably raise ethical issues (e.g., Medicaid, maternal and child health programs) and for developing health care regulations. For example, in response to the Patient Self-Determination Act, a number of states did solicit input from a wide variety of individuals and groups regarding how the Act should be implemented (Teno et al., 1993). Because states are also the primary locus for family law, public health law, malpractice provisions, and criminal law, states should play an important role in stimulating public discussion and resolution of such issues as the use of reproductive technologies; laws and regulations concerning the "definition" of death and foregoing life-sustaining treatments; the practice of assisted suicide and active euthanasia; public health measures involving screening, contact tracing, and quarantining for infectious diseases; screening programs to detect either the presence of genetic disease or susceptibility to diseases such as cancer or heart disease; the procurement and allocation of organs for transplantation; and so on. State mechanisms can also channel consensus into the particular legislative form that is appropriate for and acceptable to citizens of a particular state. The committee does not recommend a single specific mechanism for public deliberation of ethical issues at the state level, nor does it recommend a formal institutionalized response in each of the 50 states. Some states may want to establish their own ethics commissions, such as that in New York. Other states lacking the resources or breadth of representation for such undertakings may wish to cooperate with neighboring states to form regional ethics commissions and information exchange programs. There are several advantages of having a commission operating at the state or regional level. State-level commissions, by virtue of their more restricted geographic domain (compared to national-level commissions) may be better able to target their deliberations to reflect local conditions, constituencies, historical traditions, and legal requirements. Second, with respect to some controversial issues regulated at the state level, a state-level commission may be successful at achieving consensus. In some instances, reports based on national-level deliberations may fail to appear to a locally focused citizenry as being pertinent to meeting their needs. For issues on which nationwide consensus is unlikely at present
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Society's Choices: Social and Ethical Decision Making in Biomedicine (e.g., rationing health care), some states have managed to confront the issue in a more direct way. Oregon showed a willingness to deal with the complexities of prioritizing health care services; the state was also able to develop a public process that included grassroots input unlikely to be replicated at this time at a national level. Third, no matter how well a national commission might frame its policy recommendations, these will in any case have to be implemented at the state level. A state-level commission can serve as a helpful mediator between a nationally articulated consensus and the particular demographic and legislative constraints of a given state or region. Particular religious constituencies or interest groups may exercise little influence at the national level but play pivotal roles at the local or state level. By working closely over time with a state legislature or by inviting the representatives of particular groups to participate in its deliberations, a state- or regional-level commission may find it easier to implement a policy consensus that has been forged at the national level. Grassroots efforts may also be effective, as illustrated by efforts in Oregon, Vermont, and Colorado (Jennings, 1988). Assuming that some form of health reform is enacted, states may also wish to recommend or perhaps even require that each regional or corporate health alliance set up an ethics committee charged with forging policy on access questions. Still other states may wish to sponsor or encourage a wide variety of educational efforts in schools, museums, and other forums and via print and electronic media. The committee acknowledges the possible objections to these recommendations. For example, all this activity on the state level could be construed as duplicative and different states could take different positions on controversial issues, as they once did regarding the definition of death. In addition, states may not choose to commit adequate funds for the kind of staffing and process that the committee recommends elsewhere in this report. It should be noted, however, that states have the right and responsibility to make these decisions. The fact that they will disagree, especially on highly contested policy questions, can and should be regarded as an advantage. The states provide a much-needed laboratory for social policy experimentation. The New Jersey Bioethics Commission, for example, acknowledged the essentially philosophical and religious nature of the debate over brain death; it then took the bold step of allowing members of certain religious groups to define death for themselves, in accordance with their religious beliefs. New Jersey's experience with this legislation may provide the rest of the nation with an interesting counterpoint to the proposition, endorsed by the President's Commission and the New York State Task Force, that strict uniformity is a prerequisite of good public policy in this area.
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Society's Choices: Social and Ethical Decision Making in Biomedicine The National Level Agency-level Advisory Bodies The committee recommends the establishment of a deliberative capacity within relevant government agencies and departments to provide advice on issues relating to biomedical research and applications of biomedical technology. The committee strongly recommends that as a first step, the Ethics Advisory Board or a similar body within the Department of Health and Human Services be reestablished. The committee perceives a need for a permanent ethics staff within governmental agencies. Ethics panels located within, and related to, specific agencies have provided valuable advice to these agencies in the past. Specific examples of advisory bodies located within agencies have been the National Commission, the NIH Recombinant DNA Advisory Committee with its Subcommittee on Human Gene Therapy, and the Ethics Advisory Board. All three of these bodies provided advice to their sponsoring agencies regarding research ethics. The committee strongly supports the reestablishment of an EAB-like body, because the tasks assigned to it in its originating regulation are not being accomplished at present and constitute a national need and a missed opportunity for leadership in this area. Comparable bodies, often located in ministries of health, have been established in many countries in the past 10 years. A Supra-agency Commission For certain issues of broad national interest, the committee believes that it would be highly desirable to have a national-level commission address these issues as they concern multiple governmental agencies. Some complex issues are better examined and analyzed in a disciplined fashion at a national level, because they affect people throughout the country. In addition, some issues may be ripe for a broad social consensus. The committee believes that at the present time there are several such issues that might be incorporated into the mandates of one or more national commissions: issues related to scientific advances in genetics, including new possibilities for shaping future generations in unusual and unexpected ways, and the impact of genetic knowledge on peoples' insurability and employability; issues related to confidentiality and privacy of medical information, especially in light of health care reform; the interplay of serious disability and life-sustaining treatment, as well as discrimination on the basis of disability;
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Society's Choices: Social and Ethical Decision Making in Biomedicine the principles to be used for allocation of medical services and integration of costs with social and ethical considerations into clinical and allocation policy decisions; and issues related to reproduction and research and medical treatment of embryos and fetuses. A high-level commission has several institutional advantages over efforts at a lower level, including greater visibility, higher prestige, greater capacity to address a broad mandate, and more independence. A centrally situated body would be readily available to work on complex issues and give coherent responses. A national body can more readily call upon the national and international expertise that is required for complicated and difficult issues; experts can function as commissioners, staff, witnesses, and/or authors of background papers. A national body is also in a better position to formulate and represent distinctively American views on bioethics, at a time when issues relating to biomedical research and applications are becoming increasingly internationalized. National professional bodies may have the expertise to deal with social and ethical issues, but may lack the authority and legitimacy that comes from being authorized and appointed by the federal government. The National Commission and President's Commission demonstrated the effectiveness of federally appointed bodies in dealing with ethical issues. The committee recommends that the federal government establish a public deliberative body (or bodies, depending on the breadth of the mandate to be addressed) for a limited term at the supra-agency level to consider social and ethical issues stemming from technological and organizational developments in biomedicine that are of concern simultaneously to several governmental agencies or are nationwide in scope. The experience of BEAC should not be forgotten, however, in any vision of a national-level commission and the sorts of issues it might address. BEAC has been described as having "crashed on the shoals of abortion politics," an idea that raises the question of how another national-level commission might navigate through some of the issues that BEAC was convened to address. As Hanna and colleagues describe (1994), issues in which abortion is a factor may be issues of which public bioethics deliberation must simply steer clear. They suggest that abortion and issues involving abortion are issues that simply cannot be productively engaged at the present time because they elicit "strongly held incompatible views that rational people reach from different moral premises." Even if competing biases were equally balanced on a commission, opinions about abortion are usually so strongly held that it is unlikely that significant movement toward a middle ground could occur. At some time in the future, bioethi-
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Society's Choices: Social and Ethical Decision Making in Biomedicine cal issues that touch on such divisive issues as abortion may be ripe for some form of useful explication or consensus, but they are decidedly unripe now. In the event that one or more national ethics commissions are established, the committee recommends that each have the following attributes: Mandate. The body must have a broad yet clearly defined and coherent mandate, as well as the ability to add additional related topics as they become salient. The committee was unable to reach consensus regarding the appropriate breadth of a national commission's mandate. The majority of committee members believe that it is not feasible for a single national commission to address all social and ethical issues in biomedicine, since the expertise and experience required by such a broad mandate could not be encompassed in a membership of reasonable size. These committee members propose that a national commission's mandate include a set of related social and ethical issues. This proposal reflects a perception that some of the topics in the mandate of the National Commission were quite removed from the central issues of that body and hence were less well handled by the group. Examples of such topics include the study on Psychosurgery and the Ethical Guidelines for Delivery of Health Services by DHEW. Commissions with a mandate to address interrelated issues will ordinarily have an easier time studying and resolving subsequent issues after they have reached conclusions in one area. A second group of committee members believed that a national commission with a broad mandate was preferable, so long as it had sufficient time and funding to hire staff and commission background papers to encompass all of the appropriate expertise needed. In this case, commission members-who could be generalists-would evaluate background papers and staff research in order to reach conclusions. One advantage of a commission with a broad and general mandate is that knowledge gained by commissioners and staff in one area may be applied to the subsequent study of other areas. Furthermore, if the group is effective in resolving issues, the credibility of its conclusions on subsequent topics will-and should-be enhanced. When Congress or the president identifies issues in special need of attention, they could ask for a national commission's advice on these topics. Yet it is also desirable to permit the commission to add extra topics to its mandate, as its time and resources allow and as dictated by the urgency and importance of such additional topics. This prerogative was usefully exercised by the President's Commission in its reports on Deciding to Forego Life-Sustaining Treatment and Splicing Life.
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Society's Choices: Social and Ethical Decision Making in Biomedicine Sponsorship. National commissions could be appointed by the president or Congress. Wherever located, each national commission should operate autonomously. Appointment by the president enhances a commission's prestige and may also increase its access to government and other information. In addition, if the appointing power is vested in the president, it can be made subject to certain categorical requirements that would ensure that members reflect the range of views relevant to the topics under study. Congressional power over appropriations may encourage responsiveness to statutory expectations. Both the perception and reality of independence are important to the credibility of a commission's recommendations. In spite of appointment by the president or Congress, a national commission needs insulation from self-serving, narrow political interests at the same time as it needs strong ties to affected or vulnerable groups. Membership. Each national commission should have a diverse membership in order to represent the points of view of all those concerned with or affected by the social and ethical issues to be considered. The composition of the body should enhance the qualities of impartiality. All of the national-level public ethics bodies convened in the past have been composed of experts in a range of relevant disciplines, including academic bioethics, the health professions, biomedical science, social and behavioral sciences, law, philosophy, and religion. Some have also included members representing the general public. Given the logistical desirability of limiting the group to a relatively small size (11 to 20 members), care must be taken to ensure that the group reflect not only disciplinary expertise but also the diversity of views and personal characteristics relevant to the topics under study. Members should be able to rise above their representation of groups or constituencies. The appointment procedure needs to strive for a delicate balance among the needs of such a body. While the committee recommends that the membership represent a diversity of interests, members should be chosen in order that they may be free to consider issues independently, to deliberate, argue, and reach conclusions based on the information presented, without fear of being removed from or disappointing any particular constituency. Efforts need to be made to include people with formal or informal training in bioethics or who are willing to read and discuss the literature of bioethics seriously. Membership on federal ethics bodies has traditionally been restricted to persons not employed by the federal government-a restriction that has helped to ensure independence from political influences. There may be reasons in some instances to deviate from this pattern through the appoint-
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Society's Choices: Social and Ethical Decision Making in Biomedicine ment of executive or legislative branch personnel. Given the volatility of some issues in bioethics, however, any arrangement that ties the appointment process directly to the president or Congress, or to a governor or legislature, can engender a struggle over ideological ''balance." This can result in a group that is potentially polarized, with at least some members who regard themselves (and are regarded by others) as "representatives" of the groups or organizations that lobbied for their appointment. Such a group does not serve one of the most useful functions of a commission, which is to remove sensitive topics from the political arena and consider them in a more neutral atmosphere, allowing individuals who come with differing views to discover common ground, as issues are fleshed out and relevant data are collected. Ideological polarization was responsible for the failure of BEAC. Public Access. To the extent possible, a national commission should deliberate in public. If such public deliberation is not possible, means need to be found to gain input from all persons and groups with interests in the deliberations. A national commission must reach out to segments of the population whose voices are less regularly heard. Public media coverage can help to educate the public about the deliberations of a national commission. Public meetings can also facilitate broad public involvement. The National Commission and President's Commission did not find that public meetings interfered with full and frank exchange of views. Advisory Role. A national commission should provide advice not only to its authorizing body but to all concerned parties, including the biomedical community; federal, state, and local governmental bodies; and the public. The commission could be required to report to the president, to Congress, and to any departments or agencies affected by its recommendations, but commission reports should also be disseminated to all interested parties outside of the government. Some findings and recommendations of a national commission may lead to federal legislation or regulation; others may be of primary importance to individuals, as patients or professionals, or to state legislators, judges, and officers of health care institutions. A national commission might well address topics of interest to all these groups. Local bodies (e.g., HECs and IRBs) can also benefit from national advice. The experience of the President's Commission demonstrates that conceiving of a commission's audience broadly encourages better communication and wider dissemination of findings. Commissions at all levels should therefore take specific steps to assure that the results of their deliberations are made accessible to the public. In addition to the
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Society's Choices: Social and Ethical Decision Making in Biomedicine use of newspaper and radio, thought needs to be given to how newer methods of information transmission (e.g., electronic means such as computer bulletin boards) might be utilized to communicate commission conclusions. Action-forcing Powers. Although a national commission should be advisory, its recommendations should be published, and relevant federal agencies should be required to respond to those recommendations within a defined "comment period" (e.g., 180 days), either by adopting the recommendations or by explaining why they are not being adopted. For recommendations that are addressed to federal departments and agencies, action-forcing authority is highly desirable, as the positive experiences of both the National Commission and President's Commission and the negative experiences of the HFTTRP demonstrate. However, such authority is not self-executing, and agency officials who want neither to act nor to explain their inaction may sometimes disregard the statutory requirements. This is especially easy for them to do once the commission goes out of existence. Having action-forcing powers means that deliberations will be approached more thoughtfully by all, including members of the commission itself. National commissions of the past have worked more effectively in reaching their recommendations when they knew that the recommendations would be responded to by others and would potentially have a direct regulatory impact. Funding and Staff. A national commission should be given adequate resources and staff to accomplish its task. It should be funded by direct appropriation to ensure its independence. It should have authority over its own budget and the hiring and firing of its staff. The cost of running a national commission depends on the breadth of the group's mandate, the estimated number of commissioners and staff needed, the number and location of the anticipated meetings, and the cost of printing and disseminating the reports that will be produced. The President's Commission was authorized for $5 million per year for four years; in operation, it expended under $5 million over its entire lifetime (39 months), meeting 28 times (generally for 2 days) and publishing a total of 17 volumes. The ability to bring highly qualified experts to the staff for one- and two-year terms of service has several beneficial results: it accelerates a commission's work, because of the experts' knowledge of their fields; it enhances the quality of the work, because such staff members want to produce work they can be proud of when they return to their home institutions; and it helps to avoid bureaucratization of the commission.
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Society's Choices: Social and Ethical Decision Making in Biomedicine Duration. The commission should have a defined term that is adequate to allow for achievement of assigned tasks. There are important reasons to limit a national commission's term, one of which is that limited terms enhance members' ability to maintain energy, focus, and timeliness. The committee considered two possibilities: (1) the term of the commission could be approximately 3 years, with commissioners serving for the entire term, or (2) the commission could have a longer term, with rotating appointments so that one-third of the membership would be replaced every 2 years. As the experience of both the National and President's Commissions indicates, the existence of a date by which work must be completed can result in a high level of productivity. Furthermore, time-limited commissions are less likely than standing commissions to become overly bureaucratic in their approaches. Arguments for longer terms (up to 6 years, with staggered terms for members) include considerations of consistency, credibility, and efficiency of group interaction. The majority of the committee favored a commission with a defined lifetime as well as a mechanism for initiation of new commissions to consider future issues as they arise (see next recommendation). Some committee members favored the idea of a fixed-term national commission with a "sunset clause," which sets an initial date for termination while still making it easy to extend the commission's term if the issues it is addressing merit further attention and if the quality of its work justifies, in the eyes of the Congress and the president, the commission's continuation. If a national commission has a limited term, then the value of continuity and the "learning curve" favor a fixed membership. If the group is constituted as a longer-term body (subject to periodic review and renewal), then a rotating membership with staggered terms seems advisable, both to ensure diversity of views and to avoid bureaucratic narrowing of the group's collective vision. If a term-limited national commission is appointed, the committee recommends that responsibility be located within some existing government locus for ongoing monitoring/reporting on social and ethical issues in biomedicine and for recommending the appointment of new commissions as serious issues of national scope emerge. This responsibility could be located in the Office of Science and Technology Policy, the Office of the Secretary of Health and Human Services, or at some other location chosen by the president or Congress. The committee believes that, during times when no national commission is functioning or when issues arise at an agency level but remain unaddressed, there should be a continuing surveillance mechanism to iden-
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Society's Choices: Social and Ethical Decision Making in Biomedicine tify developing unsolved problems that require more focused attention. A governmental locus for such monitoring could provide several specific functions: it could initiate/prepare a biennial report to be published in the Federal Register on social and ethical issues emerging from biomedical technology; it could serve as a receptor for the input of local communities, individuals, institutions, and states that identify issues that need to be addressed in a broad fashion; it could facilitate networking among the various groups addressing social and ethical issues; and it could advise the executive branch about special social and ethical issues that need immediate attention. At the same time, by virtue of its location, it would allow the solution to be part of the political process. Most of the committee members felt that this function could be accomplished in an existing governmental office, without increasing the bureaucracy by creating a new office. A few of the committee members favored having an external advisory committee, related to the governmental locus, that is charged with identifying issues to be dealt with at a departmental or interdepartmental level, developing mandates, and nominating commissioners. REFERENCES Childress, J.A. 1991. Deliberations of the Human Fetal Tissue Transplantation Research Panel. In: Biomedical Politics, Institute of Medicine. Washington, D.C.: National Academy Press. Hanna, K.E., Cook-Deegan, R.M., and Nishimi, R. 1994. Finding a forum for bioethics in public policy. Politics and the Life Sciences 12:205-219. Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, D.C.: National Academy Press. Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, D.C.: National Academy Press. Jennings, B. 1988. A grassroots movement in bioethics. Hastings Center Report 18 (June/ July):Supplement S.1-S.16. King, P. 1991. Commentary (on Human Fetal Tissue Transplantation Research Panel article by J.A. Childress) In: Biomedical Politics, Institute of Medicine. Washington, D.C.: National Academy Press. Kolata, G. 1993. Cloning human embryos: Debate erupts over ethics; some see nightmare, but others hope to begin. New York Times (October 26):A1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1978. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects in Research. Washington, D.C.: U.S. Government Printing Office. Office of Technology Assessment (OTA). 1988. Infertility: Medical and Social Choices. Washington, D.C.: U.S. Government Printing Office. OTA. 1993. Biomedical Ethics in U.S. Public Policy. Washington, D.C.: U.S. Government Printing Office. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 1983. Deciding to Forego Life-Sustaining Treatment. Washington, D.C: U.S. Government Printing Office.
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Society's Choices: Social and Ethical Decision Making in Biomedicine Teno, J.M., Sabatino, C., Pariser, L., Rouse, F., and J. Lynn. 1993. The impact of the Patient Self-Determination Act's requirement that states describe law concerning patients' rights. Journal of Law, Medicine, and Ethics 21 (1):102-108. Walters, L. 1988. Statement. In: Human Fetal Tissue Transplantation Research Advisory Committee to the Director. Bethesda, Maryland. Wolf, S.M. 1991. Ethics committees and due process. Maryland Law Review 50(3):798-858. Wolf, S.M. 1992. Toward a theory of process. Law, Medicine, and Health Care 20:278-290.
Representative terms from entire chapter: