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While the energy and knowledge of advocacy groups can be an important asset to bodies engaged in bioethical deliberation, the possibility for capture, diversion, and conflict of interest in bioethical deliberation must be carefully monitored. This caution may be particularly important in deliberations regarding health care reform, where ethical and financial considerations are inextricably linked. Another possible risk associated with public bioethical deliberation is that some might expect bioethics to deliver something-answers, certainty, or the morally correct view-that it is not equipped to produce.

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It must be clear that "ethical analysis" is not a single, straightforward method, like algebra or geometry. Different ethicists favor different approaches and methodologies and claim different philosophical antecedents. Moreover, even if there existed a single logical formula for ethical argument, such a formula could not account for the substantive elements of ethical argument that arise from individuals' deeply held values and norms, which are colored by culture, religion, heritage, personal history, preferences, and tastes.

Ethicists can often do little more than ask for clarification about the meaning of these values and norms in the minds of those who hold them, attempt to discover when the values and norms arise from misunderstanding, and invite those who hold them to find practical ways of living together. The best conclusion of an ethical analysis may be the description of alternative views. Thus, while this committee believes that more good than bad can come from public moral discourse, it also recommends prudent caution whenever an ethical analysis of a major problem is proposed.

Broad representation of distinct opinions is probably the best antidote. In formulating its conclusions and recommendations, the committee recognized that not all social and 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.

While this is certainly the case in some instances-as in the recently reported cloning of. In vitro fertilization IVF is an example; many physicians employ the technology, which is no longer regarded as new, despite the fact that IVF continues to challenge widely accepted understandings of parenthood and the legal status of the embryo and fetus.

The commercialization of university-based research: Balancing risks and benefits

Social and ethical quandaries may also arise when technological changes or developments that do not by themselves raise ethical questions accumulate to present a novel circumstance that alters existing practices and beliefs. For example, the accumulation of several 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.

Significant organizational changes-like the impending health care reform can also raise new ethical concerns. For example, 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. Ethical quandaries arise in the context of everyday interactions with medicine as well as from vanguard research laboratories, and effective mechanisms can be valuable at many levels to recognize and resolve social and ethical quandaries in biomedicine.

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, may best be considered for the nation as a whole through a supra-agency national commission.

The committee presents two supra-agency models: 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. In general, the committee believes that decisions about public policy should occur as closely as possible to the levels at which relevant actions are taken, and should involve those likely to be affected by the policy. The committee is not proposing a new focus of policy-making authority, but a system, separate from existing political structures, for reflecting on and informing public policy decisions at all levels.

Based on letters solicited by the committee from scientists and practitioners in a variety of medical areas, the committee noted that those who discover, develop, or apply new technologies in biomedicine are often well positioned to recognize the potential for adverse social and ethical consequences of these technologies. One of the most efficient ways to initiate deliberation of and responses to such consequences may therefore be to call upon researchers, developers of technologies, and medical providers who use new technologies to share their special knowledge of these technologies in ways that could facilitate awareness.

Such avenues might include publications and professional presentations; perhaps inquiry about such consequences could even be made part of grant applications. The more that it becomes the norm for consideration of these issues to be part of scientific investigation, the greater would be our society's capacity to catch problems in their early stages and address them more effectively.

The committee recommends that the people or organizations that conduct, fund, and commercialize research, as well as those medical providers who apply new technologies, establish a formal capacity whereby they can participate in public moral discourse about the ethical implications of developments in their field. They should attempt to anticipate how these developments may affect society for better or worse and to prepare ways in which adverse effects on social values can be prevented.

The committee recommends that the National Institutes of Health provide funding mechanisms to support 1 the exploration by individual investigators of social and ethical aspects of biomedical technologies as they are developed and 2 the creation of a social and ethical knowledge base for all of biomedical science e. Professions exist as part of a societal contract that grants learned experts a certain latitude of discretion and self-control in return for the expectation of service to the public.

Designer Babies: The Science and Ethics of Genetic Engineering

In addition, the resources used to support biomedical innovation and development are generated by the com-. These economic considerations support a role for professional organizations in bioethics deliberations. The committee recommends that organizations of biomedical professionals establish ethics committees that can be easily mobilized to respond to social and ethical issues as they are identified. Collaboration among professional associations dealing with related issues is to be encouraged. The committee recommends that professional associations, including those for health care providers and biomedical scientists, recognize their special obligation to investigate the ethical implications of biomedical developments and advocate for the interests of the public and of patients, especially when those adversely affected by change are unable to advocate for themselves.

The committee believes that hospital ethics committees or similar committees operating across health plans could help patients and health care professionals deal with social and ethical quandaries arising from developments in biomedicine. However, little is known about the range and characteristics of effectiveness of HECs. This knowledge needs to be expanded so that it can be applied in the design and evaluation of similar ethics committees that may accompany health care reform. Preliminary evidence indicates that hospital ethics committees provide many useful support functions for staff, patients, and their families relating to the handling of social and ethical issues that arise from developments in biomedicine.

The committee nevertheless recommends that formal studies of the optimum roles, use, and outcomes of HECs be undertaken by such groups as the Office of Technology Assessment, Institute of Medicine, and foundations interested in health care issues. Like HECs, institutional review boards have played a significant role in the democratization of social and ethical decision making in biomedicine. Given the continuing importance of IRBs, the committee believes that the present structure and role of these bodies should be evaluated and, if necessary, modified.

The committee believes that the NIH, in conjunction with other federal agencies such as the Food and Drug Administration to which IRBs relate, need to carefully examine the IRB system and assess whether it is functioning well. Some questions that could be assessed include:. Are IRBs successfully representing the interests of human subjects in research and not merely those of their sponsoring institution?

What lessons can be learned about effective IRB function from the wide variation in actual IRB practices, and should greater uniformity be encouraged? Would communication among different IRBs facilitate effective functioning? Are there adequate forums for the appeal of institutional rulings or for resolution of issues that an individual IRB cannot easily address? How do freestanding IRBs operate, especially with respect to conflict-of-interest considerations?

The committee believes that improved integration of social and ethical concepts into health professional education is needed, particularly in the training of students in basic and clinical research. The committee believes that it is important for health care providers and research scientists to be part of the process of examining the social and ethical dimensions of science and technology because: 1 the tradition of openness and internal criticism found in science could fruitfully be extended to the deliberation of ethical issues; 2 biomedical scientists and medical practitioners, due to their understanding of the use of technology as part of the practice of medicine, might have special insight into related ethical issues; and 3 scientists may facilitate the discrimination between factual and value-laden components of scientific belief.

The committee recommends that an evaluation be undertaken of the process of education for graduate students in the health sciences on the social and ethical implications of technology as part of the current educational efforts on scientific responsibility. The committee also urges increased efforts to integrate social and ethical issues in biomedicine into the curriculum of undergraduate and graduate health professional programs. The committee believes that states must play an active role in defining a capacity for ethical deliberation, particularly in a reformed health care system.

State governments might facilitate public ethical deliberation through their oversight of professional certification, medical practice, health care financing, and legal liability. Examples of issues that might be addressed at the state level include the use of reproductive technologies; laws and regulations concerning the "definition" of death and forgoing life-sustaining treatments; the practice of assisted suicide and active eutha-.

State mechanisms may be effective at shaping a consensus into the particular legislative form that is appropriate for and acceptable to citizens of a particular state i. 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, as has 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 or information exchange programs.

The committee recommends that states foster or participate in a public deliberative process for responding to social and ethical quandaries stemming from technological and organizational developments in biomedicine and health care. 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.

The committee strongly supports the reestablishment of a body similar to the Ethics Advisory Board 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. 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. For certain issues of broad national interest the committee finds it highly desirable to have a supra-agency national commission to address these issues as they concern the broad public interest and span multiple governmental agencies. At the present time there are several issues that. A high-level commission has several institutional advantages over lower level bodies, including greater visibility, prestige, and independence, as well as greater capacity to address a broad mandate.

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. 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.

In the event that one or more national ethics commissions are established, the committee recommends that each have the following attributes:. 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 no longer feasible for any single national commission to address all aspects of social and ethical issues in biomedicine, since the expertise and experience that such a broad mandate would require 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. 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.

If a national commission were to have a mandate limited to a defined set of related issues, it is possible that more than one national commission would be necessary at any one time. A second group of committee members believed that a single national commission with a broad mandate was preferable if sufficient time and funding were available to hire staff and commission background papers to encompass all of the appropriate expertise needed. In this case, commission members could be generalists, and background papers and staff research would play a far more critical role than in a commission with a thematic mandate.

National commissions could be appointed by the president or Congress. Wherever located, each national commission should operate autonomously. 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 short-term political interests at the same time as it needs strong ties to affected or vulnerable groups, consumers, and public interest groups.

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. Public media coverage can help to educate the public about the deliberations of a national commission. Public meetings can also facilitate broad public involvement.

Public Access. To the extent possible, a national commission should deliberate in public. The committee recognizes that 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. Commissions at all levels should take specific steps to assure that the results of their deliberations are made accessible to the public.

In addition to the use of newspaper and radio, thought needs to be given to how newer methods of information transmission e. 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. 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 the recommendations within. 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.

Integrating Genomics into Public Health Policy and Practice | Books | CDC

The commission should have a defined term that is adequate to allow for achievement of assigned tasks. In determining the duration of a national commission's term, considerations of timeliness, as well as commission members' abilities to maintain energy and concentration of focus come into play. Committee members favored two different possibilities: 1 the term of the commission could be approximately three years, with commissioners serving for the entire term, or 2 the commission could have a longer term, with rotating appointments that replace one-third of the membership every two years.

Proponents of shorter-term commissions noted that the existence of a date by which work must be completed can result in a high level of productivity and that shorter-term commissions are less likely to become overly bureaucratic in their work approaches. Those who argued for longer-term commissions pointed to considerations of efficiency of group interaction, consistency, and credibility.

The majority of committee members favored commissions with fixed lifetimes.

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The majority also believed that a mechanism should be created for initiation of new commissions to consider future issues as they arise. Some committee members favored the idea of a fixed-term national commission with a "sunset clause," which sets an initial date for termination but permits extensions of the commission's term if the issues it is addressing merit further attention.

If a national commission has a fixed term, then the value of continuity and the "learning curve" favor a fixed membership. If a national commission has a sunset clause, then a rotating membership with staggered terms seems advisable, in part as a means to ensure diversity of views and avoid bureaucratic narrowing of the group's collective vision. 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, a continuing surveillance mechanism should be in place to identify developing unsolved problems that require more focused attention. A governmental locus for such monitoring could provide several specific functions: it could commission or 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 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.

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 across-departmental level, developing mandates, and nominating commissioners.

Breakthroughs in biomedicine often lead to new life-giving treatments but may also raise troubling, even life-and-death, quandaries. Society's Choices discusses ways for people to handle today's bioethics issues in the context of America's unique history and culture--and from the perspectives of various interest groups.

The book explores how Americans have grappled with specific aspects of bioethics through commission deliberations, programs by organizations, and other mechanisms and identifies criteria for evaluating the outcomes of these efforts. The committee offers recommendations on the role of government and professional societies, the function of commissions and institutional review boards, and bioethics in health professional education and research.

The volume includes a series of 12 superb background papers on public moral discourse, mechanisms for handling social and ethical dilemmas, and other specific areas of controversy by well-known experts Ronald Bayer, Martin Benjamin, Dan W. Brock, Baruch A. Brody, H. Gray, Kathi E. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

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  • Do you enjoy reading reports from the Academies online for free? Sign up for email notifications and we'll let you know about new publications in your areas of interest when they're released. Get This Book. Visit NAP. Looking for other ways to read this? No thanks. Suggested Citation: "Executive Summary. Executive Summary. Page 2 Share Cite. Page 3 Share Cite. Page 4 Share Cite. Page 5 Share Cite. Political and Legal Mechanisms.

    Page 6 Share Cite. Page 7 Share Cite. Professional and Institutional Mechanisms. Page 8 Share Cite. Individual and Community Responses. Page 9 Share Cite. Page 10 Share Cite. Page 11 Share Cite. Page 12 Share Cite. Effectiveness: Communication, Authority. Page 13 Share Cite.

    Page 14 Share Cite. Can Bioethics Be Disadvantageous? Page 15 Share Cite. A Multilevel Approach to Bioethics Deliberation. Page 16 Share Cite. Nongovernmental Organizations and Individuals. Page 17 Share Cite. Page 18 Share Cite. Do IRBs generally fulfill their goals? Page 19 Share Cite. Advisory Bodies in Federal Agencies. Page 20 Share Cite. In the event that one or more national ethics commissions are established, the committee recommends that each have the following attributes: Mandate.

    Page 21 Share Cite. Page 22 Share Cite. Page 23 Share Cite. Page 24 Share Cite. This page in the original is blank. Page 1 Share Cite. Login or Register to save! Introduction 27—42 2. Systematic Approaches to Bioethics 67—86 4. The Spectrum of Societal Responses 87— 5. User Account Log in Register Help. Search Close Advanced Search Help.

    Genomics, Ethics, and Intellectual Property

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