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Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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Executive Summary

During the past 30 years, social and ethical issues in biomedicine have vaulted to prominence, prompting public debate and deep reflection by governmental commissions, professional societies, and community organizations. The issues have at times demanded immediate public attention, as in the case of abuse of human research subjects, and, at other times, more gradually raised public concern, as have the possibilities provided by advances in genetic technology. More and more, the ethical implications of such issues as health care delivery and commercialization of biotechnology are being examined in a public fashion. Despite the increasing activity in this area, however, there has been little systematic study of the various social processes through which we subject the ethical and social issues in medicine and biotechnology to debate and analysis.

In an attempt to delineate these processes as they are manifested in this country, the committee considered those characteristics that make an issue an ethical issue and the circumstances under which it is determined that an ethical issue should be publicly deliberated. The word "ethical" typically connotes human values and ethical judgments-that is,judgments grounded in values. These issues arise during the deliberation and resolution of nearly every public issue. Some public issues especially prompt reference to the kinds of ethical ideas-dignity, freedom, rights, fairness, respect, equality, solidarity, and integrity-that are evoked in efforts to distinguish right from wrong. These are the sorts of issues that come within the purview of public ethics bodies, including congressionally or presidentially appointed bodies, community-centered bodies, institutional

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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bodies, and the like. This report explores how these bodies approach the task of deliberating ethical issues, and how their approaches reflect the character of our society.

SOURCES OF ETHICAL ISSUES IN BIOMEDICINE

The tasks of ethics bodies convened to address issues in biomedicine have originated from clashes of values, norms, principles, and practices that have occurred in a number of arenas, especially: biomedical research involving human subjects; health care decision making, delivery, and financing; advances in medical diagnostics and therapeutics; and academic industry relationships in biotechnology. From these arenas have come new technologies, the proper use of which is controversial; crises in resource allocation and perplexing questions of distributive justice; changes in the organization and delivery of health care and related concerns about the appropriate role of physicians; and financing challenges that have spawned new relationships of questionable appropriateness between researchers and their sponsors. It was in the arena of human studies research that the ethical dimensions of biomedicine and the need for public involvement in such ethical matters were first recognized.

Abuses of human research subjects by the Nazis during World War II outraged the public and stimulated formal inquiry into the inherent conflict in biomedical investigation between benefit to the subject and benefit to science and society. The Nuremberg Code of 1948, designed to be used as a standard by which to judge the actions of Nazi scientists, was the first formal enunciation of ethical standards that proscribed scientific zealotry and disregard for human consent and dignity. In the 1960s and 1970s, following revelations in the United States of such incidents as the Tuskegee syphilis study, federal regulations were issued to protect human research subjects. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission), which operated between 1974 and 1978 and became one of the most well-known public ethics bodies, was influential in developing these regulations and in stimulating the design of localized bodies, known as institutional review boards (IRBs), for the protection of human research subjects.

Changes in health care delivery and financing have also raised ethical concerns that have been subject to public deliberation. Informed consent, the linchpin of regulations for research on human subjects, was at the heart of a movement during the 1960s and 1970s toward greater patient autonomy. At issue were questions of information disclosure, decisional authority, and patient self-determination. At the same time, specialized medical technology began to flourish, health insurance companies grew and began to exert influence on health care decisions, and health care

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

began its transformation into the business-like enterprise it is today. Ethical aspects of the resulting specialization, fragmentation, depersonalization, and variable accessibility of health care became the topics put before such public ethics bodies as the President's Commission for the Study of Ethical Issues in Medicine and Biomedical and Behavioral Research (President's Commission), which operated between 1980 and 1983; institutional ethics bodies known as hospital ethics committees; and community-based groups of health care consumers.

Developments in the area of biotechnology have also raised publicly debated ethical quandaries. Some of these quandaries have reflected genuine societal uncertainty about the use of novel technologies; others have related to the propriety of financial relationships between scientists and biotechnology companies. Developments in genetic research illustrate the promise and hazard of scientific discoveries-at the same time that they offer the potential of an end to suffering from gene-linked disease, they also threaten our identity as humans. One product of this apprehension has been the creation of the Ethical, Legal, and Social Implications (ELSI) Program at the National Center for Human Genome Research. Illustrative of the ethical issues raised by the commercialization of scientific discoveries are the pricing and distribution of products developed with public funds and the degree to which they serve the public interest. Also of concern are the ethical issues raised by the increasing tendency of universities and government laboratories to establish closer ties with industry.

Our society's capacity for dealing humanely and wisely with the impact of technological and scientific innovation, in each of the above areas and in others, is enhanced by the creation of forums in which ethical deliberation can be carried out. The deliberation may draw on many resources: experience in the use of these technologies and in the practice of medicine; the personal values and life experiences of participants; bodies of thought, such as economics and the law, which reflect and systematize value-laden judgments; and the intellectual and scholarly resources of the field of ethics. Its character and form are inevitably influenced by the distinctive history and culture of our society.

THE SOCIETAL CONTEXT OF BIOETHICAL PROBLEM SOLVING

American history is replete with examples of stirring ethical debates that have mobilized huge numbers of citizens. Debates about child labor laws, women's suffrage, prohibition, and the abolition of slavery are illustrative. What stimulated these public deliberations in large part was what characterized this country at its founding: a strong will to reject tyranny, to self-govern, and to preserve individual liberty. The American penchant for celebrating the individual and the private fostered the growth and diversity

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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that has characterized this country. At the same time, these values exist in tension with concerns about responsibility for the community and public well-being. Such tension becomes particularly visible when an ethical issue is at stake.

Our society's capacity for deliberation about social and ethical issues in biomedicine has expanded and matured significantly within the past few decades. In the mid-1960s, ambivalence about authority and tension between public and private life combined to produce a wave of social movements in civil rights, feminism, and consumer activism. In biomedicine as in the whole of society, new voices began to gather volume, particularly those of patients and their families demanding to have a say in medical decision making. As medical technology flourished and new treatment options (e.g., life support) challenged long-held ideas about life and death, religious representatives began to voice their opinions. And as health care costs skyrocketed, additional factions-insurers, employers, and hospitals organized to represent their interests.

SYSTEMATIC APPROACHES TO BIOETHICS

The events of the 1960s lent impetus to a growing interest in systematic thinking about social and ethical issues in biomedicine. In the 1970s, scholars from several disciplines, principally moral philosophy, theological ethics, medicine, and law, began to study and write about the social and ethical issues of modern medical science and health care. A discipline called bioethics began to emerge, with specialized faculty (usually located in schools of medicine), courses, conferences, and journals. Today, academic bioethics has moved far beyond its beginnings. A number of academic programs prepare students for the field, teaching the foundation of ethical reasoning and a variety of analytic methods. In addition, ethics programs in health professional schools prepare care providers to apply these methods in the practice setting.

Systematic thinking about social and ethical issues in biomedicine also takes place in numerous religious communities. Clergy come into frequent contact with the wrenching moral dilemmas of life and death, and many clergy today have spent time in formal training programs in hospital pastoral counseling. Theological seminaries offer courses on bioethics and their faculty often contribute to the denominational literature on its topics. In addition, several centers of theological and religious reflection on bioethics exist with sponsorship from religious communities. Areas of tension remain with respect to religious participation in bioethical decision making for the entire community. Religious views, precisely because they are religious, are likely to be held with great confidence and tenacity, and inconsistent views may be espoused by leaders of different religious com-

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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munities. Many thoughtful religious specialists and leaders are willing to participate in public ethics deliberation, and many of them are qualified by temperament, knowledge, and experience to be valuable contributors.

Scientists and other technical experts also make unique contributions to deliberation about the social and ethical impacts of developments in biomedicine. Three arguments have been advanced to justify the importance of their participation in this deliberation. First, science, because of its openness and critical tradition, can be thought to provide a useful way of approaching ethical deliberation in a pluralist society. Second, scientists and physicians, because of their closeness to the practice of medicine and the use of technology, may have special insights into ethical issues arising from their practice that would not as easily be apparent to other users or consumers of technology. Third, science can be counted on to remove certain issues from ethical debate because they are "facts" and hence are no longer open to social negotiation. While there are limitations to each of these arguments, they point to the value of scientific and technical input in decisions made at the frontiers of medicine.

THE SPECTRUM OF SOCIETAL RESPONSES

With the growth in society's interest in and understanding of social and ethical issues in biomedicine has come the creation of a number of mechanisms for deliberation and decision making in this area. Some of these mechanisms entail the formation of a group of persons at a local level, as in grassroots organizations, hospital ethics committees (HECs), and institutional review boards (IRBs), while others relate to the activities of long-established social institutions, such as the legal system. Still others involve federally or state-sponsored groups convened to advise on public policy regarding biomedical developments. Despite their variation in location, sponsorship, and other characteristics, these mechanisms for public deliberation of social and ethical issues can share a variety of functions. Such functions include identification of ethical issues at stake in areas of societal controversy, analysis of an issue, development or documentation of areas of consensus, exposure and documentation of areas of disagreement, generation of public awareness and debate, development of factual bases for public policy, and recommendation of new legislation or improvements in existing public policy.

Political and Legal Mechanisms

Government responsibility to consider the ethical and social consequences of biomedical research arises from its support and encouragement of research as a means of advancing human welfare. Although the

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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timeliness of its initiatives in this area has been criticized, the Congress of the United States has in the past two decades established the National Commission, the President's Commission, and the Biomedical Ethics Advisory Committee (BEAC) to advise public policy on and illuminate issues raised by biomedical research. None of these bodies is currently active, and Congress is presently considering the creation of a new national ethics body that might echo the success of the National and President's Commissions.

Federally sponsored ethics bodies have also been situated within federal agencies that conduct biomedical research. Past examples include the Ethics Advisory Board in the Department of Health, Education, and Welfare, and the Human Fetal Tissue Transplantation Research Panel of the National Institutes of Health (NIH). Current examples include the NIH Recombinant DNA Advisory Committee and the Ethical, Legal, and Social Implications (ELSI) Program of the Human Genome Project, both of which are housed within the NIH. Ethics bodies housed within federal agencies generally consider issues that are specific to the work of their sponsoring agency; they may also review protocols for proposed research to be conducted or funded by that agency.

The governments of two states, New York and New Jersey, have established ethics commissions to advise the states' executive and legislative branches on a range of bioethical topics, including surrogate parenting, determination of death, the use of advance directives in medical care, and distribution of organs for transplantation. Both the New Jersey Bioethics Commission (closed in 1991) and the New York State Task Force on Life and Law issue(d) recommendations for changes in state policy related to these areas of medicine.

Courts, regulation, and legislation are mechanisms used by governments and others to contend with social and ethical issues related to developments in biomedicine. In our litigious society, in fact, courts often are the arena where ethical quandaries related to biomedicine first make their appearance and demand resolution. Dramatic cases like Quinlan or Cruzan illustrate how courts provide a forum in which abstract ethical concerns are made concrete.

While government-sponsored activity in bioethics has languished somewhat in this country since the closing of the President's Commission in 1983, several European countries-notably Denmark, France, and the United Kingdom-have recently taken the initiative. Multinational organizations also have begun to deal with bioethical issues. As the U.S. government considers the possible reestablishment of a national bioethics commission, the experiences of these foreign bioethics groups may hold useful lessons.

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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Professional and Institutional Mechanisms

Professional medical associations and specialty societies have responded individually and cooperatively to social and ethical questions raised by developments in medical technology and medical care. Several of these groups have formed ethics subcommittees or task forces to deal specifically with these questions and, in several cases, to formulate practice guidelines to assist health care providers in rendering appropriate care to their patients. The guidance provided by professional societies is often the best source of up-to-date scientific, legal, and practical information available to practitioners. Organizations like the American Medical Association, American Academy of Pediatrics, American College of Obstetricians and Gynecologists, American College of Physicians, American Thoracic Society, and National Advisory Board on Ethics in Reproduction, along with others, have taken the initiative to understand and advise on the complex issues that confront practitioners every day.

Institutional review boards and hospital ethics committees are institution-based mechanisms for deliberation on ethical issues in biomedical research and health care. IRBs review protocols for research involving human subjects to ensure that the research does not violate ethical standards. HECs exist to ensure that difficult ethical decisions about medical treatment are made in a careful and impartial fashion. By federal law, IRBs must exist in any institution that conducts or funds human subjects research using federal funds; hospital accreditation standards specify that accredited hospitals must have either a formal HEC or some other mechanism for the consideration of ethical issues in the care of patients. As mechanisms for ethical deliberation and decision making at a local level, IRBs and HECs are uniquely positioned to make decisions that are sensitive to local norms and values and to the particular circumstances of individual patients or research subjects.

The Institute of Medicine (IOM) and the Office of Technology Assessment (OTA) have also from time to time engaged in bioethics deliberation. An arm of the National Academy of Sciences (NAS), IOM is a private, nonprofit organization, associated with the government by virtue of the 1863 NAS congressional charter to advise the federal government on matters pertaining to science. OTA is a branch of the U.S. Congress, established to advise congressional committees on technical issues in all areas of science and technology. Both IOM and OTA have issued reports on a variety of ethical issues over the past 20 years, including health care resource allocation, genetic research, life-sustaining technology, and the responsible conduct of research. Both organizations have been sought to advise on complex ethical issues because of their ability to convene well informed and impartial study committees.

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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Deliberation about ethical issues arising from developments in biomedicine also takes place at several research and educational centers throughout the world devoted specifically to the study of ethics. Ethics centers such as the Hastings Center and the Kennedy Institute of Ethics influence policy development in the area of ethics through conferences, publications, and educational programs. In addition, experts in ethics from these centers are frequently called upon to serve on the boards of academic institutions, research centers, professional societies, and nonprofit organizations, as well as journal editorial boards. The Clinton administration's task force on health care reform provides a recent example of a public policy activity in which experts in ethics were called upon to participate in national bioethics deliberation. Together, hundreds of bioethics organizations around the world comprise a remarkable resource for policy-making, analysis, consultation, and education in medicine and the life sciences.

Religious bodies, including interfaith and ecumenical bodies, have also examined the import for religion of developments in biomedicine. In recent years, North American religious groups have produced some carefully researched reports on ethical issues in biomedicine; the Presbyterian Church's report on values and choices in health care is one example. Professorships in religious ethics have been established at several universities and a number of centers have been created for the study of religious ethics. The sheer number of individuals and groups now working on these issues offers some encouragement that useful modes of discourse may be developed, and that a variety of religious perspectives will be a constructive part of public deliberation on the ethical consequences of advances in biomedicine.

Individual and Community Responses

Individuals, groups, and communities are often spurred to action in the wake of changes brought about by developments in biomedicine. Their efforts often begin as loosely structured, grassroots organizations. These organizations frequently come into being as a result of a perceived crisis over abortion, over concerns about justice in clinical trials-as did the National Abortion Rights Action League, the National Right to Life Committee, and the AIDS Coalition to Unleash Power (ACT-UP). Grassroots organizations often inspire the loyal support of individuals who have little else in common other than their interest in resolving the crisis. The broad based citizen-sponsored forums on health care that have taken place in recent years in Vermont, Maine, California, and Oregon provide additional examples of community-based bioethics deliberation. The work of grassroots bioethics organizations has had a particularly significant impact

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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on public awareness of social and ethical issues raised by biomedical developments, as well as on public policy.

CRITERIA FOR SUCCESS

The committee developed an approach to evaluating the outcomes of public ethics bodies.1 These criteria apply particularly to those deliberations that lead to issuance of a document or report. While certain general criteria can be articulated, their importance for evaluating a particular public ethics body is crucially dependent upon context, including the nature of the controversy, the specific tasks of the body, the social setting, the legal environment, and the like. Notwithstanding this caveat, it is still possible to develop a number of important criteria that could be used in establishing, participating in, or judging the overall performance of public ethics bodies. The following discussion divides these criteria into three categories: intellectual integrity, sensitivity to democratic values, and effectiveness. As we shall see, however, there is a considerable amount of overlap and interplay among these categories.

In offering a list and discussion of criteria for judging the success of public ethics bodies, the committee does not mean to suggest that the business of evaluating the performance of these bodies might be reducible to some sort of perfunctory checklist. Often, public ethics bodies must grapple with extremely controversial and contested issues that involve our most fundamental individual and social values. The judgments that people bring to bear on the work of these bodies will naturally reflect their differing views on these fundamental controversies concerning life, death, and justice.

Intellectual Integrity: Logic, Scholarship, and Sound Judgment
Logic

Logic is the first prerequisite of a successful product from a public ethics body. At issue here are the soundness of the reasoning and the overall coherence of the document. Does it describe the topics and issues clearly? Do the conclusions, including the policy recommendations, follow

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The term "public ethics body" is used in the report to denote a group convened to deliberate about social and ethical issues stemming from developments in biomedicine. Such groups may exist at the level of the institution, professional society, community, state, federal agency, or federal government. Generally, these groups address public policy issues that involve moral ideas such as dignity, freedom, rights, fairness, respect, equality, solidarity, responsibility, justice, and integrity.

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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logically from clearly stated premises, or are they simply announced on the presumption that the authority or prestige of the body will carry over to its conclusions? Does the document present coherent arguments and recommendations, or is there unresolved contradiction between various parts of the report?

A related function of public ethics bodies is to help clarify, through logical analysis, the terms and nature of the debates covered in their reports. These bodies can often help to fully distinguish the various disciplinary perspectives on an issue, e.g., theological, ethical, economic, political, legal, medical, biological, and epidemiological.

Scholarship

Scholarship is another important dimension of intellectual integrity. The work of public ethics bodies must not only be coherent, it must also be competent-that is, based upon the soundest available scholarship. This means, first, that the body's ''findings" must be grounded upon solid, empirical, state-of-the-art information about the relevant area of technological innovation. Although it is reasonable to seek a broad range of cultural, professional, ethnic, and ideological diversity for membership, it is vital that the staff and members of these bodies possess the required expertise in ethics, law, medicine, biology, or related fields. If the membership or staff lacks this technical knowledge, it must consult with appropriate experts and seek out empirical studies bearing on the topic at hand.

Secondly, reports of public ethics bodies should reflect a thorough knowledge of the interdisciplinary field of bioethics. In addition to being factually accurate and well reasoned, such reports should be based upon an equally state-of-the-art understanding of the public and professional "conversation" surrounding a particular issue. The reasoning and conclusions of the report should reflect an awareness of "the best that has been thought" in the bioethical literature, journals of opinion, newspapers, and the like.

Sound Judgment

Sound judgment is also an important element-albeit less tangible and more controversial than logic and scholarship-of the intellectual integrity of public ethics bodies. Because ethical consideration is often complicated by uncertainty, lack of information, and conflicting values and principles, sound judgment in this area resides not so much in being able to apply a single ethical theory or principle to a set of facts, as in the ability to discern the unique particularities of the problem in its social setting, to creatively reframe a question, to reason by analogy, to perceive and acknowledge the interests of affected parties, and to judiciously weigh and balance compet-

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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ing principles and considerations. We call "judicious" those reports that strike an appropriate and fruitful balance between the relevant rights and interests, disciplinary perspectives, and cultural traditions of a given society.

Sensitivity to Democratic Values: Respect, Representation, and Openness
Respect for Affected Parties

Public ethics bodies should be attentive to all the significant contributors to the public conversation about an issue. Rather than focusing on and advancing their own preferred approach to a problem, members and staff should make an honest attempt to hear all plausible, responsible views. Public ethics bodies should be particularly attentive to minority or disenfranchised voices, not only because these voices can enrich public discourse, but also because they may speak to concerns about religion, culture, and individual rights that ought to be respected, so far as possible, by public policy.

Representation of Diverse Views

Public ethics bodies' consideration of the interests of affected parties should manifest itself not only in the solicitation of input from these parties, but also in the presence of representatives of (or advocates for) these parties in the bodies' membership. Representatives should be willing to deliberate in an open-minded fashion and not merely to champion their group's initial position.

Open versus Closed Meetings

The holding of open meetings by public ethics bodies is intuitively more consonant with democratic values than is the holding of private, closed meetings. Open meetings do not allow for the crafting of secret deals. Rather, they generally foster the effectiveness of public ethics bodies by providing an open forum for exchange of ideas and information among interested parties, all of whom are accountable for their positions.

On the other hand, those who argue that public ethics bodies should operate in private, at least occasionally, note that confidentiality fosters mutual trust and candor among members and staff. When people come together to discuss complex issues, they often require a good deal of intellectual elbow room in which to change their minds once confronted with compelling counter arguments. Proponents of closed meetings argue that it is easier to modify one's position in private than in public, where flexibil-

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

ity and openness to new evidence might be wrongly interpreted as fecklessness and inconsistency. Many of the issues addressed by public ethics bodies represent problems that have been generated in part by the presence of strongly held, conflicting views within society. If complete consensus is not possible on an issue, resolution may require compromise, a process that some believe can be more successful when undertaken in the absence of publicity. If a public ethics body holds closed meetings, it should make every effort to solicit the views of interested parties during the process of data gathering.

Effectiveness: Communication, Authority

Judgments about the effectiveness of a public ethics body must be based upon a clear understanding of the group's purpose, the public need to which it responds, and the social context in which it deliberates. Notwithstanding the importance of purpose and context, the committee notes two preconditions of effectiveness for any group regardless of its specific charge: communication and authority.

Communication

The reports of public ethics bodies must be clearly written, trenchantly argued, and comprehensible to as wide an audience as possible. Reports should also reflect a clear understanding of the makeup of their audiences; reports that respect the sensibilities of their readers will be more persuasive, and hence more effective, than those that do not. Even the most clearly written and persuasive reports can fail to be effective, however, if they are not disseminated to as broad an audience as possible. Adequate numbers of reports should be printed and made available at reasonable prices to consumers, professional groups, and public libraries; newer methods of dissemination, such as computer networks and CD ROMs, should also be explored. Members and staff should consider discussing findings and recommendations through a wide variety of media, including newspapers, editorial columns, book reviews, radio interviews, professional journals, and public and professional forums. If a public ethics body proposes new legislation, its staff and members should attempt to educate members of the legislature about the issues and about the body's views.

Authority

The effectiveness of a public ethics body is enhanced when it is viewed as an authoritative body-one whose recommendations carry weight with policymakers, professionals, and the general public. Authority can be bestowed through sponsorship by an authoritative figure like the president.

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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It can also be earned through, for example, the individual reputations of members and staff or a successful history of accomplishment. Authority can also be a function of democratic representation; the recommendations of a public ethics body may be perceived as authoritative if it is clear that all viewpoints have been heard.

Different Goals, Different Yardsticks of Success: Achieving Consensus, Achieving Results

The primary function of many public ethics bodies is to achieve consensus on issues that require some sort of public response. Thus, whatever may be the specific goals of a particular body, achieving consensus will usually be an explicit policy objective. Consensus can be instrumental in obtaining external acceptance and implementation of a body's recommendations, especially (and, some may argue, only) when members of a public ethics body bring to the deliberations an array of different viewpoints on an issue. On the other hand, consensus can be used to obscure deep philosophical issues. Excessive pressure to reach agreement may lead to underestimation of risks and objections, ignoring of unpopular viewpoints, or failure to consider alternatives or additional information.

Social and political circumstances play a significant role in determining not only the value of consensus, but also the possibility of achieving consensus in any form. A particularly salient factor in public ethics deliberation is the "ripeness" of the issue in question for public resolution. In some cases, a body might merely have to place its imprimatur on a consensus that has been gradually building and is now more or less in place. More frequently, however, public ethics bodies are faced with the harder task of forging a consensus that does not yet exist.

Apart from the objective of forging consensus, public ethics bodies may also seek to achieve more specific goals such as education, influencing of public debate, and stimulation of various government actions, including legislation. Public ethics bodies should successfully discharge the specific mandates that they are given. If a body fails to do what is asked of it, it cannot be judged a success. Depending on the circumstances, some specific objectives may be more difficult to achieve than others. Articulating the contours of an emergent consensus for educational purposes, while a demanding and important task, is not nearly as difficult as drafting legislation on controversial topics for a population divided by ideological and religious differences. Assessments of a body's accomplishments should consider the difficulty as well as the nature of the project assigned to it. Educational projects should be judged in part according to pedagogic standards, while judgment of legislative efforts should reflect the quality of the legal craft presented.

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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Can Bioethics Be Disadvantageous?

Although there has been no systematic research on the downside of public bioethics deliberation, the committee found it useful to identify two potential risks of public bioethical deliberation, if only as a suggestion for future research, evaluation, and monitoring. One such risk is diversion and capture by advocacy or sectarian groups, or by financially self-interested parties. To the extent that such factions could influence or capture a body charged with the task of bioethical deliberation-a task that aims at impartiality-they could undermine the public interest. 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. 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.

CONCLUSIONS AND RECOMMENDATIONS

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

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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human embryos-social and ethical quandaries may also stem from developments that are rapidly integrated into medical practice before related ethical issues can be resolved. 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.

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.

A Multilevel Approach to Bioethics Deliberation

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

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

for any new national commission. 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.

Nongovernmental Organizations and Individuals

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.g., extend the ELSI program to other institutes and other programs within the NIH).

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. In addition, the resources used to support biomedical innovation and development are generated by the com-

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

munity, largely through governmental support of research. 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:

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×
  1. Are IRBs successfully representing the interests of human subjects in research and not merely those of their sponsoring institution?

  2. Do IRBs generally fulfill their goals?

  3. What lessons can be learned about effective IRB function from the wide variation in actual IRB practices, and should greater uniformity be encouraged?

  4. Would communication among different IRBs facilitate effective functioning?

  5. Are there adequate forums for the appeal of institutional rulings or for resolution of issues that an individual IRB cannot easily address?

  6. 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.

States

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-

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

nasia; 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; and the procurement and allocation of organs for transplantation. 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.e., one that reflects local conditions, constituencies, historical traditions, and legal requirements).

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.

Advisory Bodies in Federal Agencies

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.

A Supra-agency Commission

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

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

might be incorporated into the mandates of one or more national commissions, including: (1) issues related to scientific advances in genetics, including new possibilities for shaping future generations and the impact of genetic knowledge on peoples' insurability and employability; (2) issues related to confidentiality and privacy of medical information, especially in light of health care reform; (3) the interplay of serious disability and life sustaining treatment, as well as discrimination on the basis of disability; (4) the integration of cost and social and ethical considerations into clinical and allocation policy decisions; and (5) issues related to reproductive technology and research and medical treatment of embryos and fetuses.

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:

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 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.

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

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.

Sponsorship. 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.

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.

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.g., electronic means) might be utilized to communicate commission conclusions.

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

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

a defined ''comment period" (e.g., 180 days), either by adopting the recommendations or by explaining why they are not being adopted.

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.

Duration. 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. 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.

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.

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

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.

Suggested Citation:"Executive Summary." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
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Society's Choices: Social and Ethical Decision Making in Biomedicine Get This Book
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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. Alta Charo, Lawrence Gostin, Bradford H. Gray, Kathi E. Hanna, Elizabeth Heitman, Thomas Nagel, Steven Shapin, and Charles M. Swezey.

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