National Academies Press: OpenBook

Society's Choices: Social and Ethical Decision Making in Biomedicine (1995)

Chapter: 4. The Spectrum of Societal Responses

« Previous: 3. Systematic Approaches to Bioethics
Suggested Citation:"4. The Spectrum of Societal Responses." 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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4
The Spectrum of Societal Responses

Public moral discourse on bioethics has been fostered in a variety of ways in the United States. Some of the mechanisms described in this chapter entail the formation of a group of persons, as in grassroots organizations, while others relate to the activities of long-established social institutions, such as the legal system. Each mechanism offers distinctive capacities and limitations, and together they shed light from many perspectives on the complicated process of public deliberation of ethical issues. This chapter summarizes salient features and activities of some of the more prominent of these institutions.

Past social responses to ethical quandaries in biomedicine have succeeded in a variety of ways. For example, many public commissions, at the minimum, have enlisted outstanding scholars to contribute their insights on the issue of concern. Many of the products of these commissions have been viewed as authoritative and have had a substantial impact on policy decisions, as for example occurred in the cases of defining brain death and establishing standards for human experimentation. These and other similar examples are described later in this chapter.

Commissions and other deliberative bodies operate in a world where deadlines, personalities, and special interests converge. The necessity for compromise is unavoidable. Many products of these commissions have stood the test of time and continue to have a prominent role in education for health professionals and ethicists. Hospital ethics committees, for example, are often able to soften advocacy of patient interest in order to gain the willing participation of health care providers (Hoffman, 1991). While

Suggested Citation:"4. The Spectrum of Societal Responses." 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 does not attempt in this report to perform a comprehensive assessment of the performance of every social mechanism for deliberation of ethical issues, one of the background papers in this volume by Gray does assess some of the accomplishments, determinants of success, and views of participants in the National Commission and President's Commission. The accomplishments of other deliberative bodies described in this chapter are outlined in greater detail in Appendix A.

The social and institutional context within which bioethics deliberation takes place was described in Chapter 2. In this chapter, we are concerned with the vast array of specific responses and mechanisms that facilitate the public deliberation of ethical issues in biomedicine. Whether, and to what extent, the activities of these various groups and institutions have been effective is a separate question that receives attention in Chapter 5, where criteria for evaluating the effectiveness of the work of these bodies are set forth.

For organizational purposes, this chapter categorizes ethics bodies according to their source of sponsorship or authority: political and legal (e.g., federal commissions), professional and institutional (e.g., institutional review boards), or grassroots (e.g., individual and community initiatives). It will become obvious, however, that there is significant overlap in the functions served by the different mechanisms, an overlap that defies neat categorization. In some cases, there are functional similarities between mechanisms that have significant structural differences and operate in separate societal spheres. The mechanisms have been created to fulfill numerous functions-some very general, some quite specific, many interrelated-including the following:

  • to bring to the larger public the opportunity and the responsibility (that previously belonged to elite groups) to define ethical issues;

  • to identify ethical issues at stake in areas of societal controversy;

  • to undertake a careful analysis of an issue;

  • to develop and/or document areas of consensus;

  • to expose and document areas of disagreement;

  • to unify the expertise of authorities from a wide variety of relevant fields;

  • to represent competing interests;

  • to generate public awareness and debate;

  • to be a lightning rod for public concern;

  • to educate;

  • to correct misunderstandings and errors in reasoning;

  • to develop factual bases for public policy;

  • to offer guidance for decision making;

  • to develop recommendations for action;

Suggested Citation:"4. The Spectrum of Societal Responses." 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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  • to recommend new legislation or changes or improvements in existing public policy;

  • to sanction delays or recommend unpopular policies;

  • to dignify and legitimize official action;

  • to overcome bureaucratic obstacles; and

  • to justify the expenditure of money.

The functions served by a particular mechanism or group may be dictated by a sponsor's mandate, or, as is frequently the case, be simply incidental. For example, a group convened to recommend legislation on a controversial issue may be unable to reach agreement on a plan of legislative action but, in the course of its work, may succeed at educating members of society and perhaps even at reducing controversy by clarifying various viewpoints. Finally, experience has shown that what is ultimately achieved through public deliberation often depends more on the particular issue and on societal circumstances than on the intended outcome of the deliberation.

POLITICAL AND LEGAL MECHANISMS

It is not surprising-at least in democratic societies-that governments should look for means to address the ethical and social consequences of biomedical research, since research is heavily supported and encouraged by government as a means of advancing human welfare. Yet during the 20 years following the Nuremburg tribunal, neither governments nor professional bodies paid more than glancing attention to the actual or potential problems inherent in the activities and discoveries of biomedical scientists. During this period, no framework existed for judging when, how, and for what reasons the government should get involved, nor was there a means for determining which developments in the life sciences might pose significant problems.

Beginning in the late 1960s, however, the first steps were taken toward sustained examination of the ethical and social effects of the processes and products of biomedical research. In 1966, for example, Surgeon General William H. Stewart promulgated rules for peer examination of the ethics of research protocols at Public Health Service grantee institutions (U.S. Public Health Service, 1966). In 1968, the Government Research Subcommittee of the Senate Committee on Government Operations held hearings on a joint resolution sponsored by Senator Walter Mondale to establish a National Advisory Commission on Health Science and Society (National Commission on Health Science and Society, 1968). After the Ad Hoc Task Force on Cardiac Replacement of the National Heart Institute acknowledged that this new technology had ethical and social implications that

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

should be explored (1969), Dr. Theodore Cooper, then Director of the National Heart Institute, appointed the Artificial Heart Assessment Panel, which issued the first major government report on the ethical implications of new technologies (1973).

Commissions Established by Congress

When Senator Mondale initially proposed a commission, the first human-to-human heart transplants had just been performed, and his intention was for the commission to address ethical issues in biomedical developments and human subjects research. Over the next several years, further developments in human reproduction (such as in vitro fertilization), neuroscience, behavioral medicine, and control of lethal diseases underscored the need for a commission. Yet it was scandal in the research process rather than the worrisome products of research that apparently convinced the U.S. Congress to establish the first national commission on bioethics. In the wake of the revelation in 1972 of the Tuskegee Syphilis Study, the Senate Committee on Labor and Public Welfare held further hearings into research abuses in state mental facilities and prisons (Senate Committee on Labor and Public Welfare, 1973). The hearings were chaired by Senator Edward Kennedy, whose family has long been interested in issues affecting retarded persons and whose family foundation had recently established one of the first ''bioethics" centers at Georgetown University.

National Commission

As a result of these hearings, provisions were included in the National Research Act of 1974 (P.L. 93-348) to create the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission), as well as to require that Public Health Service (PHS) grantee institutions establish institutional review boards (IRBs) to review the ethics of research projects carried out by their employees. Although Senator Mondale's proposed examination of the ethical and social implications of medical developments was incorporated as a special study for the National Commission, the body's primary mandate was to make recommendations for the ethical conduct of research, including research that involved various vulnerable populations.

The National Commission, which functioned from 1974 to 1978, was appointed by the Secretary of Health, Education, and Welfare and operated within that department (DHEW). It was made up of 11 members, all from outside the federal government: three physicians (one of whom was elected chair of the body), two psychologists, three lawyers, two professors of ethics, and one civic leader. Their work was aided by a professional and

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

support staff of 12 and further assisted by a number of consultants from medicine, philosophy, law, and the social and natural sciences. The public was allowed access to the commission's deliberations, as well as to draft papers; the commission also held several public hearings and made site visits. During its four years, the National Commission issued ten reports: five dealt with special groups of subjects (fetuses, prisoners, children, patients undergoing psychosurgery, and the institutionalized mentally infirm); two dealt with research review (reports on IRBs and on disclosure of information under the Freedom of Information Act); one provided ethical guidelines for delivery of health services by DHEW; and one reported the results of the "special study" (the implications of research advances, the topic inherited from the Mondale bill).

The best-known of the National Commission's reports was the Belmont Report (1978a), which abstracted the general principles for protection of research subjects that lay behind its other reports on particular aspects of biomedical and behavioral research. It set forth three comprehensive principles to "serve as a basic justification for the many practical ethical prescriptions and evaluation of human actions": (1) respect for persons, (2) beneficence, and (3) justice. Respect for persons requires that individuals be treated as autonomous agents, while persons with diminished autonomy are entitled to protection. Beneficence calls not only for protecting individuals from harm, but also for making efforts to secure their well-being.1 Justice relates to fairness in distribution of the benefits and burdens of research. The commission's provision of these explicit principles for the analysis of ethical issues in language that was clear and accessible to a lay audience enabled the general public to engage in informed and effective discussion of such issues, and opened up a whole new field for public discourse.

The recommendations in the commission's report on fetal research were made in May 1975 and were quickly translated into proposed federal regulations. In that instance, DHEW's need for regulations was at least as important in provoking a rapid response as was the commission's statutory "action-forcing power" (i.e., the secretary had to either accept the commission's recommendations or make public the reasons for rejection). Not all of the commission's recommendations were as influential, however, and while its core points provided the basis for what are now government-wide regulations on human subjects research, several of the reports had little influence. For example, DHEW did not respond to the commission's report on the institutionalized mentally infirm (1978c). But in light of the novel nature of this enterprise, the work of the commission was impressive:

1  

While the Belmont Report did not employ the term "non-maleficence" (to do no harm), the language it employed makes it clear that it encompasses this notion in the discussion of beneficence.

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

its products met high standards of intellectual rigor, and the papers it commissioned from major scholarly figures catalyzed the study of bioethics as noted scholars became actively involved in addressing these issues.

President's Commission

The statute establishing the National Commission suggested that, at the conclusion of its term, a standing National Council for the Protection of Human Subjects would be established to carry its work forward. Instead, in 1978 the Congress authorized the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission), thereby combining Senator Kennedy's interest in elevating the National Commission above the departmental level with the desire of Representative Paul Rogers and his colleagues on the House Health Subcommittee that the successor body take on topics beyond research with human subjects (P.L. 95-622). In addition to requiring biennial reports on the latter topic, Congress mandated that the President's Commission also report on the ethical and legal aspects of determining death, informed consent, confidentiality and privacy, genetic issues, and disparities in access to health care.

While the National Commission had been quickly appointed, the President's Commission was not sworn in for 14 months after the passage of its authorizing statute. Like the National Commission, membership in the President's Commission was divided into several categories: three from biomedical or behavioral research (initially a professor of human genetics, a professor of psychiatry, and a molecular biologist), three from the practice of medicine (a general internist, a cardiologist, and a pediatrician), and five from other fields (a medical economist, a medical sociologist, a professor of law, a professor of ethics, and a lawyer who was appointed by the president to chair the commission). Two commissioners (the professors of ethics and law) had served on the National Commission, although one had to resign almost immediately when she was appointed to a high position in the federal government. Two other commissioners resigned later, and seven others were replaced as their terms expired, so that 21 people in total served on the President's Commission. The staff usually numbered about 20 (including 6 in support positions), but several of the professional staff (a total of 23 individuals over the life of the commission) served for only a year while on leave from academic positions. Additionally, 16 students (primarily from medicine, law, and philosophy) served as Congressional Fellows and interns.

Part of the delay in appointing the original commissioners apparently resulted from political friction between the White House and Congress. The executive branch was slow to choose the commissioners, and even

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

after they had been named in the summer of 1979, the commission could not begin its work because no funds had been requested (or appropriated) for it in the FY 1980 budget. When pressed to "reprogram" monies from other activities, the leadership of DHEW eventually complied, but only after deciding that it would end operation of its Ethics Advisory Board (EAB) on the grounds that the President's Commission made the EAB redundant (see below) and then transferred the funds originally allocated for the EAB to the President's Commission (1983d).

The commission's statute included a "sunset" clause with a termination date of December 31, 1982. In 1982, Senator Kennedy proposed that the date be changed to 1984, but a provision of the December 1982 Continuing Resolution (P.L. 97-377) extended the commission only through March 31, 1983.

During its 39 months, the President's Commission issued 17 volumes, consisting of 10 reports (several with one or more appendix volumes), the proceedings of a workshop on policies and procedures for responding to reports of scientific misconduct ( Whistleblowing in Biomedical Research, 1981), and a loose-leaf book (The Official IRB Guidebook). Five of the reports dealt with health care issues; four of these responded to the commission's statutory mandate: Defining Death (1981), Making Health Care Decisions (1982a), Screening and Counseling for Genetic Conditions (1983b), and Securing Access to Health Care (1983c). The fifth, Deciding to Forego Life-Sustaining Treatment (1983a), grew out of the studies on determining death, informed consent, and access to care. Four reports dealt with biomedical and behavioral research, including the subject of human genetic engineering (at the request of the president's science advisor) and compensation for research injuries (at the request of the EAB, shortly before its demise). Finally, on March 31, 1983, as it closed its doors, the commission issued a last report, entitled Summing Up, that provided an overview of its work and that addressed the one topic (privacy and confidentiality) in its original statutory mandate that had not been the subject of a separate report (1983d).

Biomedical Ethics Board

The third major congressionally chartered bioethics effort was less fortunate than its predecessors. Following 1982 hearings on the President's Commission report, Splicing Life (1982b), then-Representative Albert Gore, Jr., proposed the establishment of a presidential commission on genetic engineering, a proposal that was later broadened to include other bioethical issues. Because of differences in viewpoint between Senate conservatives and House liberals over what would result if another presidential bioethics panel were authorized (Cook-Deegan, 1994), Congress in 1985 chose to locate the successor within the legislative branch. A Biomedical

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

Ethics Board (BEB) was authorized through September 30, 1988, to be composed of six Senators and six Representatives (equally divided between the two major parties) (P.L. 99-158). The BEB was responsible for appointing a 14-member Biomedical Ethics Advisory Committee (BEAC) made up of experts from law, medicine, research, and ethics, as well as members of the general public. The BEAC was instructed to begin its work by studying three topics: human genetic engineering, fetal research, and food and fluids for dying patients (see Appendix A for a further description of the BEAC).

From the outset, politics-especially the sharp division in Congress over the abortion issue-complicated the operation of the BEB and the BEAC. It took nearly a year to choose the 12-member BEB and another 30 months of internal wrangling before BEB members could agree on 14 people for the BEAC; one of the 14 died before the BEAC could even hold its first meeting. Congress passed a two-year extension and an appropriation for FY 1989, but withheld authority to meet or to expend funds until the BEB agreed upon a new chair (which with the start of the 101st Congress had shifted from the House back to the Senate) and named a replacement for the BEAC member who had died. The BEB was unable to do so, and the BEAC had no further sessions after its second meeting in February 1989. It issued no reports, its staff departed by the end of FY 1989, and its mandate expired on September 30, 1990.

Ethics Bodies in the Executive Branch
Ethics Advisory Board, DHEW

Among the recommendations of the National Commission was the establishment of a group within DHEW to provide ethical advice regarding proposals that involved particularly sensitive types of research. This recommendation became a part of the department's regulations (45 C.F.R. 46), and in September 1977 Secretary Joseph Califano appointed a 14-member Ethics Advisory Board to review problematic protocols that required special scrutiny under the human subjects regulations (e.g., problematic protocols having to do with more than minimal risk for nonconsenting subjects). The group had a distinguished interdisciplinary membership (see Appendix A for further description of the EAB).

Between 1978 and 1980, the EAB's principal work was to produce a major report on Research Involving Human In Vitro Fertilization and Embryo Transfer (May 4, 1979), which came in response to an approved application for NIH support of research that would have used in vitro fertilization (IVF) in basic research. The EAB also conducted two inquiries in response to requests from NIH and the Centers for Disease Control for legislative recommendations that would provide for limited exemptions from the

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

Freedom of Information Act. At the time it was disbanded in 1980, it had also embarked on a study of another policy topic-compensation for research injuries-that had previously been examined by a DHEW task force (U.S. Department of Health, Education, and Welfare, 1977).

The EAB did creditable work, but for several reasons it remains at best a footnote in the history of public bioethics. First, its report on IVF was delivered to Dr. Califano's successor, Patricia Harris, who had little interest in the field. Neither she nor any of her successors have officially accepted or rejected the EAB's recommendations. Second, although the department's regulations continue to provide for the existence of an EAB, Secretary Harris disbanded the existing body due to what was perceived as duplication with the President's Commission, even though the EAB focused on intra-agency issues and the commission on broad, national issues. Finally, the lack of an EAB allowed the Reagan and Bush administrations to avoid approving any research with human embryos or tissues between 1981 and 1992, during some of which time explicit moratoria on such research were written into various congressional bills.

Recombinant DNA Advisory Committee, NIH

In 1975, the Director of NIH established a Recombinant DNA Advisory Committee (RAC). This committee and its implementing regulations were a response to the conclusions reached at a meeting held at the Asilomar Conference Center in California under the sponsorship of the National Academy of Sciences. The meeting addressed the concerns that had led several leading molecular biologists to call for an international moratorium on certain classes of laboratory research using newly developed methods of cutting and splicing DNA. As a result of the meeting, the scientists in attendance voted to lift the moratorium and adopted certain procedures for their research, including developing means to carry it out more safely. Since some members of Congress seemed to believe that these methods of self-regulation by scientists might be too self-interested, NIH Director Donald Fredrickson broadened the membership of the RAC to include nonscientists.

The primary concern of the RAC in its first years was laboratory safety; thereafter, it began to confront issues involved with commercial development of recombinant techniques and release of altered organisms into the environment. While ethical issues were inherent in such deliberations, the major focus was on technical concerns about the relative riskiness of particular microorganisms, with or without genetic alteration. In response to the 1982 report of the President's Commission, Splicing Life, the RAC decided to address ethical issues more intensely by appointing a task force on human gene therapy, subsequently modified into a standing Subcommit-

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

tee on Human Gene Therapy. This body eventually established the benchmarks for review and approval of protocols to apply the techniques of gene transfer to human beings in a set of "Points to Consider," which was first issued in 1988 and subsequently modified on a number of occasions. For several years, protocols were reviewed first by the subcommittee and then by the RAC; by 1992, it was decided that, since the RAC was devoting most of its own time to human gene protocols, the subcommittee's work was redundant and all proposals would come directly to RAC. On all matters, the RAC is advisory to the Director of NIH, who publishes the committee's recommendations in the course of announcing which studies have been approved for NIH funding or sponsorship.

The RAC is a multidisciplinary committee, a majority of whose members are physicians and scientists who work in some aspect of molecular biology or genetics. The committee also includes lawyers, social scientists, ethicists, and members of the general public with an interest in genetic disease. Although traditionally chaired by one of its scientific members, the current chair is an ethicist with long involvement in genetic engineering issues. As a federal advisory committee, its meetings are announced in the Federal Register and are open to the public; when important new scientific projects are before the committee for review, media attention is often intense and the group's recommendations are given extensive coverage.

At the present time, the protocols that come before the RAC usually involve the transfer of genes to serve as markers on cells being administered in experimental therapies or to enhance the effectiveness of various immunological methods of fighting diseases like cancer and AIDS; in addition, some studies involving gene transfer to treat single-gene diseases have been approved. Beyond such somatic cell gene therapy, the "Points to Consider" state that the RAC will not now entertain proposals for gene transfers that would affect germ-line cells. In light of developments in molecular genetics, it may soon become necessary to consider when (if ever), under what conditions, and for what reasons it would be appropriate to broaden gene therapy to germ-line cells, or for purposes of genetic enhancement. No attention has been given to such issues because RAC meetings for several years have been absorbed with protocols under the existing guidelines. At its September 1993 meeting, however, the RAC placed these issues on its agenda for the coming year (see Appendix for further description of the RAC).

Ethical, Legal, and Social Implications (ELSI) Working Group, NCHGR and DOE

The Ethical, Legal, and Social Implications (ELSI) Working Group was founded in 1988 at the National Center for Human Genome Research

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

(NCHGR) of NIH. The U.S. Department of Energy (DOE) joined in support of the ELSI Working Group in 1989. Having recognized that the capabilities arising out of the Human Genome Initiative are likely to have a profound impact on individuals and society, NIH created the ELSI Working Group to explore such issues as fairness in the use of genetic information with respect to insurance, employment, and the criminal justice system; privacy of genetic information; and the influence of genetic information on reproductive decisions (see Appendix A and the background paper by Hanna in this volume for further descriptions of the ELSI Working Group).

Today, a sizable portion of the budgets for both NCHGR and DOE (from 3 to 5 percent) is formally designated to support studies on the identification and examination of these broader impacts of genetic science. This seems to be the first instance in which a portion of a science budget has been devoted specifically to the study of the ethical, legal, and social impacts of science. In all other instances, we have allowed the technology to develop and to be applied, and the resulting ethical, legal, and social dilemmas to arise, and then attempted to resolve them largely in retrospect.

The impact of the ELSI program is not yet clear. Arguments that it is overly academic and not adequately representative of society merit consideration (see Hanna, this volume). At the same time, however, many observers and even some critics seem to agree that the ELSI program is indeed stimulating effective ethical inquiries into genetic technologies and encouraging the molecular biology community to design their technological studies accordingly. Such an effect would be of great benefit to the genome project, and the success of this earmarked ELSI funding program could serve as a very useful model for other areas of science.

Human Fetal Tissue Transplantation Research Panel, DHHS

The NIH Human Fetal Tissue Transplantation Research Panel was convened in 1988 at the request of Assistant Secretary for Health Robert Windom. Following discussions with NIH Director James Wyngaarden about proposed research that involved the transplantation of human fetal neural tissue into patients with Parkinson's disease, Dr. Windom requested that a panel be formed to investigate the issue and formulated ten questions the panel was to address. Wyngaarden believed that the research was extremely important, but that it also had the potential to stir controversy and perhaps even to send a message to the public that NIH encouraged abortions (Childress, 1991). Windom responded to Wyngaarden's concerns by issuing a moratorium on the use of fetal tissue in federally funded transplantation research until NIH could convene a panel to deliberate the issue and offer recommendations.

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

In the summer of 1988, the 21-member Human Fetal Tissue Transplantation Research Panel was appointed. Nominations were submitted by members of Congress and the executive branch, and by other interested parties; categories for nominations included ethicists, lawyers, biomedical researchers, physicians, public policy experts, and clergy. The panel selection process was closely watched by outsiders on both sides of the abortion debate. Retired federal judge Arlin Adams, appointed as chairman of the panel by an internal NIH committee, was a Republican who was opposed to abortion.

When the panel met for the first time in September 1988, it was asked to respond to ten questions pertaining to the ethical implications of fetal tissue transplantation research. Concerns about the source of the tissue to be used in such research-elective abortions-figured heavily in these questions. For example:

  • Is it morally relevant whether the source of tissue is from an induced or spontaneous abortion?

  • Does the use of the fetal tissue in research encourage women to have an abortion that they might not otherwise undertake?

  • Should there be and could there be a prohibition on the donation of fetal tissue between family members, or friends and acquaintances? (NIH, 1988).

In the course of this three-day meeting it became apparent that a single meeting did not allow sufficient time to address such complex and controversial issues. The panel had also intended to meet in executive session, but amidst vigorous public outcry it was decided that panel deliberations would be open to the public. At the September meeting, the panel heard from more than 50 invited speakers, as well as from representatives of various interest groups. The panel held a second meeting in October and a third in December, at which it prepared its final report to the assistant secretary. Volume 1 contained responses to the ten questions, along with panel members' votes on each question; a summary of the current scientific literature relevant to human fetal tissues transplantation research; three concurring statements; two dissenting statements; and a final dissenting letter. Volume 2 of the report contained text of the testimony submitted to the panel.

The majority of panel members (17 out of 21) voted in favor of permitting fetal tissue transplantation research, provided that a woman's decision to abort be kept carefully separated from research. The panel's report was unanimously approved by the Advisory Committee to the NIH Director, which urged acceptance of its recommendations, including the lifting of the moratorium on federal funding of fetal tissue transplantation research utilizing tissue from induced abortions, and the development of additional

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

policy guidance by NIH as needed. The recommendations of the panel were not accepted, however, and the moratorium that had been declared prior to their meeting continued.

State Commissions
New York State Task Force on Life and the Law

Following a public outcry over apparent abuses of "do not resuscitate" orders in health care facilities, Governor Mario Cuomo of New York decided to appoint a multidisciplinary panel under the leadership of his Commissioner of Health, Dr. David Axelrod, to advise the executive and legislative branches on a range of bioethical topics. Because of the strongly held views of several religious communities in the state on some of these issues, the New York State Task Force on Life and the Law has had (in addition to the usual mixture of researchers, physicians, lawyers, and philosophers) a larger representation of religious leaders than the equivalent federal advisory commissions (see Appendix A and the background paper by Brody for further descriptions of the New York State Task Force).

In other ways, however, the New York group is quite similar to its federal counterparts. By 1993 it had issued eight reports on topics ranging from surrogate parenting to the determination of death, from health care proxies for incompetent patients to procuring and distributing organs for transplantation. Although the task force has attempted to develop a consensus position on the issues it addresses, its reports have sometimes contained dissenting positions. By holding its meetings in private, it does not use the meeting process itself to foster a consensus within the general community or to test its tentative conclusions by airing them before the community. Its reports are usually oriented toward practical recommendations for changes in state policy and hence are subject to public examination during the hearings held on any legislation proposed as a result. The task force operates with annual appropriations, and its small staff is supplemented by the volunteered services of consultants.

New Jersey Bioethics Commission

Beginning in 1983, an active grassroots group emerged in New Jersey to involve lay people and health care professionals alike in responding to the medical and legal developments reflected in such landmark cases as In re Quinlan. This group, the Citizens' Committee on Biomedical Ethics, encouraged the legislature to establish an official body in 1985 in the wake of the Conroy case regarding the withdrawal of artificial nutrition and hydration from an incompetent, dying patient. The State of New Jersey

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

Commission on Legal and Ethical Problems in the Delivery of Health Care—known informally as the New Jersey Bioethics Commission-was mandated to ''provide a comprehensive and scholarly examination of the impact of advancing technology on health care decisions" and specifically to recommend policies to the governor, the legislature, and the citizens of New Jersey (NJ. Public Law 1985, Ch. 363). The group was large (27 members) and included 4 legislators and 9 members designated from executive agencies and major statewide professional and health care organizations. Its membership, which included representatives from law, medicine, nursing, science, humanities, theology, health care administration, and the New Jersey Citizen's Committee, was appointed by the governor, the Senate president, and the speaker of the General Assembly (see Appendix A for further description of the Bioethics Commission).

Within its broad mandate, the commission chose to focus its half-dozen reports on three areas: surrogate motherhood (in light of the landmark Baby M case), decision making about medical treatment (especially the use of advance directives), and the determination of death. The commission also established ad hoc task forces on other topics (ethics, AIDS, protection of vulnerable subjects); these groups, which included noncommissioners, made recommendations to the parent body. Besides obtaining consultants' advice and supporting research (to supplement the work of its small staff of two to five professionals), the commission took testimony at public hearings. Its work resulted in considerable public and professional education on its topics in New Jersey and in the adoption of two statutes (on the determination of death and on advance directives for health care). However, conflicts within the commission and between the staff and commissioners (particularly the legislator members) brought its work to an end in 1991 after six years.

Analysis of Governmental Bodies

Experience with officially established and supported efforts to examine bioethical issues is too limited to justify definitive conclusions, but it is sufficient to support some general findings. Since the broadest and best documented experience involved the National Commission and the President's Commission, our analysis begins with them and then widens to encompass other federal and state panels.

Comparing the Commissions

The two national commissions had several features in common: both were made up of 11 people from a variety of fields (about half from medicine or research); they came from outside government; they met regularly

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

(on average, for two days nearly once a month) and in public; their work was carried out by a multidisciplinary staff; and they had "action-forcing power" (that is, although the commissions could not issue regulations, any federal agency to which they made recommendations was required to publish the recommendations and then respond within a specified time, either adopting the recommendations or explaining why they had been rejected).

There were also some marked differences between the two commissions: the mandate of the President's Commission was considerably broader, and it operated independently of any department or agency; no new members were added to the National Commission during its four-year life, whereas only three of the original members served throughout the life of the President's Commission; and the staff of the President's Commission-which began with much greater expertise in bioethics than the National Commission staff-was divided into working groups for the various reports, meaning that many worked only on specified topics with no involvement in other reports that concerned unrelated topics.

The President's Commission mandate was broader, more responsive to varied public concerns, and thus more publicly visible. Its first publication, Defining Death (1981), was eagerly awaited by various professional groups and legislators who had been involved in ongoing debate over policies that differed in only minor respects. The report presented a proposed resolution of the policy issues, and it also presented two very important consensus documents: (1) a new model statute that was endorsed by key professional groups (the American Bar Association, the American Medical Association, and the National Conference of Commissions on Uniform State Laws) and (2) a comprehensive statement of the criteria for the determination of death, which was endorsed by 56 coauthors, including virtually all of the physicians who had written about the subject in the United States. Thus, this publication eliminated the perception that the relevant professionals could not agree as to who should count as having died and what should count as a good statute, factors that had posed barriers to adoption of legislation in many states. The criteria for determination of death were also published shortly thereafter (AMA, 1981), which led to widespread awareness of the report itself.

Many of the later reports were awaited by engaged and eager audiences, although these concerned publics were smaller or less visible than the audience that welcomed Defining Death. In the last month of its term, the President's Commission published two reports that had broader appeal and receptive audiences: Deciding to Forego Life-Sustaining Treatment and Securing Access to Health Care. The former document had been circulated to hundreds of concerned citizens in draft and it included not only clear recommendations about practice but also extensive appendices outlining palliative care, statutes on advance directives, and policies on foregoing

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

treatments. The Deciding report specifically addressed a series of troubling dichotomies (e.g., withholding and withdrawing, killing and letting die) and a series of troubling clinical settings (e.g., seriously ill newborns, orders to withhold attempts at resuscitation, decisions for adults who do not have decision-making capacity, treatment for patients who have permanently lost consciousness). Also, its prose and presentation was specifically designed to be accessible to any health care professional. By chance, the report was released just as the "Baby Doe" case and the federal response to it was unfolding, and it took a much more temperate tone than the official federal response. For these reasons, Deciding was one of the "best sellers" printed by the Government Printing Office, which made it available at cost. It remains a classic reference used in court cases, professional literature, and education.

Securing also had an eager public, since allocation and equity were at least as central to public concern in 1983 as now. However, this report underwent many changes as the commission gained new members in its final months. The central ethical argument stayed largely intact, but many examples and much strong language were excised. The report thus ended up being an academic discourse on the role and function of commissions, rather than affecting the public issue of access to health care.

The National Commission spoke primarily to federal officials responsible for human subjects regulations and to the biomedical research community (including members of IRBs). The President's Commission, on the other hand, chose to address many constituencies (which varied depending upon the topic). As a result, its reports on some subjects were virtually unknown to readers who were concerned solely with other topics, although specialists in bioethics generally kept abreast of-and commented on-the commission's work across the board, just as they had the work of the National Commission. Both commissions considered some reports more important than others, and these same reports were usually regarded as more influential and important by outsiders as well (see background paper by Gray in this volume).

The central characteristics of both commissions were that they undertook to study complex and sometimes quite highly charged topics; they were able to do so in a thoughtful way because they operated outside the usual political channels; and they were influential both because they operated with an official mandate and because they produced reports that were accessible to the intelligent lay person as well as the scientific or ethical expert. The ideal of impartiality, one of the primary characteristics of ethical discourse, may not have been met completely, but the work of these commissions was a serious approximation. They both attempted to examine all sides of the issues and to move beyond the limits of self-interest and advocacy to find broad grounds of agreement on controversial positions.

Suggested Citation:"4. The Spectrum of Societal Responses." 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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Location and Autonomy

Two other influential characteristics of these commissions also stand out: (1) national scope and (2) independence from political or ideological control. Ethics committees appointed by professional organizations and study groups established by bioethics centers have much to contribute, but the public and its representatives do not place any particular weight on the recommendations of these groups, which are neither accountable to the public nor burdened with obligations toward the broad and unbiased inquiry that is incumbent upon public panels.

Further, while state and local ethics committees (both those appointed by governmental entities and those established by institutions and professional groups) can play important roles, many of the most troublesome issues do not stop at state borders, and some process for national deliberation and formulation is needed. Not all states or localities have the resources (or interest) to mount an effective effort, but they may still be able to benefit from the conclusions and recommendations of a national commission. Many of the issues being studied are of greatest concern to the federal government, such as the ethics of various types of research supported by federal agencies. And even when the issues involve matters of state law and policy (such as the regulation of health care professionals and institutions or the rules of family law), a national inquiry avoids duplication and may have the added advantage of leading to uniformity among the states on issues where differences in policy or regulation can produce undesirable results.

The greater the visibility of a panel, however, the greater the danger that its work will be encumbered by bureaucratic, ideological, or political interference. In this sense, the sort of independence that the National Commission and especially the President's Commission enjoyed was critical to the work of these groups. The movement from departmental to presidential status and the freedom from the polarizing issue of abortion made the latter more independent and gave it greater visibility, higher prestige, and better access to sources of information and advice, both inside and outside the government.

The close relationship between an ethics panel and its appointing officer can also have beneficial results in terms of having its recommendations implemented. But there are other means of ensuring that the panel will be listened to; in the end, it is more likely to be widely influential because of the thoroughness of its inquiries and the soundness of its recommendations than because of its political connections. Moreover, the danger of too much entanglement with the political process (particularly when appointments are made by the legislative branch or involve legislators) is clearly evident in the experience of the Biomedical Ethics Advisory Committee and the New Jersey Bioethics Commission.

Suggested Citation:"4. The Spectrum of Societal Responses." 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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Courts, Regulation, and Legislation

Society can also handle the ethical issues related to developments in biomedicine through legal mechanisms such as courts, regulation, and legislation. Ethics commissions and other consensual mechanisms can be useful, but since these issues reflect choices among competing values, as well as assessments of available data, even groups composed of highly expert and well-intentioned professionals can produce markedly different decisions about bioethical questions. (See background paper by Gostin for further description of the ways in which courts, regulation, and legislation can impact such decisions).

Courts as Ethical Decision Makers

In our litigious society, courts often are the forum where ethical quandaries related to biomedicine first make their appearance and demand resolution. Courts therefore are necessary participants in the bioethics debate, although their special institutional features both facilitate and detract from their effectiveness in making health policy.

On the positive side, common law courts have developed for centuries a tradition of ethically relevant decision making that places a high value on reasoned explanation of judicial holdings. The practice of justification by precedent obliges courts to draw on settled legal principles, thereby reducing the likelihood of ill-considered or arbitrary judgments. Courts determine ethical issues in the context of specific cases; this heightens the immediacy of the questions, but, especially in the case of lower court decisions, also usefully limits the negative impact of poorly reasoned opinions. A dramatic case, such as Quinlan or Cruzan, provides a gripping narrative through which abstract ethical concerns are made concrete for varied publics. At the same time, the tiered structure of the court system, the existence of multiple jurisdictions, and the practice of writing dissenting opinions all serve to open up judicial reasoning to public criticism and improvement.

On the negative side, courts employ an adversarial process that is not necessarily conducive to dispassionate analysis or fact finding. Unlike legislatures, courts are compelled to resolve the issues related to specific cases and individuals that come before them, even if the basis for a principled decision has not been fully laid. Yet courts are fundamentally reactive, in that they cannot make policy unless decisions are put to them. This lack of capacity may be especially evident when courts are confronted with conflicts arising out of developments in biomedical science and technology. Finally, the decentralized nature of the court system leads to contradictory and confusing ethical pronouncements that may take years to sort out through legislation or an authoritative higher court ruling.

Suggested Citation:"4. The Spectrum of Societal Responses." 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 institutional strengths and weaknesses of courts have been revealed in instances where new treatments raised ethical questions that were submitted to the courts. For example, judicial leadership on questions concerning the use of life-supporting technologies began with the New Jersey Supreme Court's decision about Karen Ann Quinlan's right to be disconnected from a life support system. Since then, a series of decisions by federal and state courts on refusing or withholding care have guided the nation's policy on these issues. Most significant was the Supreme Court's decision in Cruzan, which held that competent patients had a "liberty interest" in refusing treatment and provided an impetus for state legislation. Many state courts have extended this right of refusal to people who are incapable of making a decision by respecting the decisions of surrogates, particularly family members (see the background paper by Gostin in this volume).

In some cases, courts have turned to other bodies for guidance in defining the circumstances under which treatment can be terminated. The President's Commission report on foregoing treatment was instrumental in leading most courts to reject the distinction between withholding and withdrawing treatment, between ordinary and extraordinary treatments, and between terminal and nonterminal cases. In other cases, courts have acted independently to set out procedures and criteria for decision making, ranging from second opinions to the use of ethics committees or ombudsmen.

Many times state legislatures became involved in these issues; they acted only some time after court decisions and usually followed policies implicit in those decisions. The most recent national actions in this area came about when Congress passed the Patient Self-Determination Act, which was implemented on December 1, 1991. The law requires health care providers to inform their patients of the right to accept or refuse medical care, including the right to give advance directives on the use of medical means of sustaining life. Other times, state legislative action has preceded court decisions and set policy in this area, most notably in natural death acts, determination of death (which many states enacted before any court action as well), surrogacy, and, in recent times, reproductive decisions. An example is the California Natural Death Act of 1976, which preceded all court decisions, including Quinlan.

Courts have also been involved in a major way in the field of reproductive rights. Beginning with the landmark cases of Griswold v. Connecticut and Roe v. Wade, the courts for nearly two decades defined the reproductive rights of women. In the early cases, the Supreme Court found a constitutional right of "privacy" even though no mention of the concept appears in the Bill of Rights. In Griswold the Court used the newly identified right to privacy to prevent states from interfering with the sale and distribution of

Suggested Citation:"4. The Spectrum of Societal Responses." 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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contraceptives. The Court explained that contraception concerns "the most intimate of human activities and relationships."

In Roe the Supreme Court stated that the constitutional promise of privacy protects not only the right to use contraceptives but also the right to decide whether to carry a fetus to term and the privacy of a woman's relationship with her physician (see the background paper by Gostin in this volume). In recent years, there has been a significant erosion of privacy rights. The Court has upheld the authority of the state to restrict the use of public employees and facilities for the use of nontherapeutic abortions (see Gostin). The Court also upheld a regulation prohibiting federally funded family planning clinics from counseling or referring women to abortions (the so-called "gag rule") (see Gostin). In Planned Parenthood of Southeastern Pennsylvania v. Casey (see Gostin), the Court changed the legal standard by which to evaluate restrictions on abortion. This rule may allow states to place new restrictions on access, timing, and information provision in abortion decisions.

In spite of these retrenchments, it has been argued that the extension of the right to privacy since 1965 has had profound and positive effects on reproductive policy (see Gostin). Prior to the Supreme Court's entry into the area, neither the legislative nor executive branch produced policies that adequately recognized the need to balance the interests of pregnant women against those of the state or the fetus. Current efforts to protect reproductive privacy use the same "fundamental rights" analysis that the Supreme Court employed in Roe v. Wade. State legislatures are also emulating thoughtful court rulings on related reproductive issues such as surrogate motherhood and artificial reproduction.

Courts will continue to play an important role in the deliberation of emotionally charged issues in health care and biomedical innovation where no formal policy is in place and where there is a fundamental claim of human rights by individuals and groups. If, as has frequently occurred in certain states, legislators have not proactively addressed issues of this character that flow from biomedical advances, the courts have been and will be required to take the lead in resolving the legal and ethical issues that arise in particular cases. For, while legislatures may choose not to act, courts cannot avoid this burden once a case is before them. For example, courts have been involved in such issues as the right to die and the ownership of sperm in a sperm bank. If no statute provides a definite answer, courts must decide which precedents seem most helpful, whether the scientific aspects are supported by sound data, whether the common law provides guidance, and so on. Many court decisions in these areas read like laws-some even set up specific administrative procedures to handle future cases-and they provide a blueprint for subsequent legislation. Courts will also continue to play a significant secondary role through their power to review federal regulations.

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

Regulations can take several forms-instructions, findings, definitions of terms, and so on-but a prescribed set of actions, including solicitation of public comment, must take place before federal regulations become effective. It has become common for interested parties to pose legal challenges to regulations (in either their proposed or final form). These challenges may be made on several grounds-the law does not authorize them, they do not follow the law, the issuing process was faulty, and so on. Some of these issues also have strong ethical elements. For example, the Supreme Court has rejected challenges against several regulations issued by the Secretary of Health and Human Services that limited women's rights to abortion as established by Roe v. Wade.

Courts have to take the limited view imposed upon them by the case as presented and by precedent; legislatures are buffered by special interests and any legislation is inevitably marked by compromises. Public bioethical deliberation can provide the broader view that the courts, which are set up to focus on individual cases and circumstances, cannot easily provide and can attempt an impartiality that legislation cannot always achieve. The existence of bioethical opinion may inform the courts, as did the President's Commission opinion on foregoing life support in the Herbert case (California Court of Appeals, Barber v. Superior Court, 1983), and may influence the legislatures, as did the New York State Task Force on Life and Law.

International Perspectives 2

Bioethics is generally regarded as a subject first developed in the United States. Until recently, a clear majority of books and articles in the field was published here, and the number of academic departments, courses, and conferences was far greater in the United States than abroad. Similarly, the U.S. government took the lead in investigating bioethical issues and in issuing regulations when it established the National Commission and President's Commission in the 1970s. In the past few years, however, bioethics has rapidly internationalized. Hospitals the world over have sprouted ethics committees, new journals are appearing in foreign languages, and regional and international bioethics societies have been formed.

While the United States has been notable for launching new initiatives and sponsoring numerous activities on bioethics in the academic world, it has not been as active in the support of governmental bioethics activity. Since the demise of the President's Commission in 1983, the United States has had no national bioethics commission, despite the still-increasing public and academic fascination with bioethical issues. In Europe, govern-

2  

This section is based on research by committee member Daniel Wikler while he worked as a consultant to the Office of Technology Assessment.

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

ments have taken the initiative in this area; elsewhere, development of bioethics is often prodded by governmental organizations. Multinational organizations also have begun to deal with bioethical issues. As the U.S. government considers the possible reestablishment of a bioethics agency or commission, these foreign bioethics groups are available as positive and negative models. A brief examination of the structure and agendas of some of these bodies may provide valuable guidance for future government-sponsored efforts in our own country.

A number of international organizations have been active in the field of bioethics. The Council for International Organizations of Medical Science (CIOMS) was established in 1949 by two United Nations agencies: the World Health Organization and UNESCO. In 1985, it constituted a steering committee on bioethics representing a variety of professional backgrounds and geographical areas, which in turn organized "international dialogues" on ethical issues arising in such subjects as battered children, human genome research, and family planning.

Over the years, CIOMS groups have offered international ethical guidelines on a number of topics, ranging from protection of human subjects of medical experimentation (1982 and 1993) to ethical review of epidemiological studies (1991). In addition, the Office of Health Legislation of the World Health Organization keeps track of bioethics actions of governments and multinational bodies, some of which are reported in its quarterly International Digest of Health Legislation. In 1993, UNESCO formed an International Bioethics Committee with 46 members, chaired by Mme. Noelle Lenoir, an attorney and member of France's Conseil Constitutional. Thus far this committee has held one meeting; another is planned.

The Council of Europe (CE), an organization created by European governments in part for cooperation in cultural and scientific affairs, has also become active in bioethics. Following a resolution presented by the French Minister of Justice to the European Ministerial Conference on Human Rights in Vienna in 1985, the CE created an Ad Hoc Committee of Experts on Bioethics (CAHBI) to further the interests of member states in bioethical issues. CAHBI's aim is "to fill the political and legal gaps that may result from the rapid development of biomedical sciences," but it must achieve the voluntary consensus of member states. In 1992, the CE elevated the group to full legal status and gave it a new acronym: CDBI, for Comité Directeur de Bioethique Internationale.

CAHBI/CDBI was given a proposal in 1989 to create a European Bioethics Committee; in 1992, it judged such a step premature. However, the committee recently held a Framework Convention for Bioethics, designed to present norms on a variety of issues for consideration by the European members of CE. The convention, which was open to nonmember states,

Suggested Citation:"4. The Spectrum of Societal Responses." 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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considered general ethical principles related to organ transplantation, medical research on humans, including embryos, and the use of genetic information for nonmedical purposes.

Representatives of national bioethics committees, primarily but not exclusively European, have met three times under CAHBI/CDBI auspices. The council also empaneled a commission on ethical issues in reproductive technology, known as the Glover Commission after its chairman, Oxford philosopher and bioethicist Jonathan Glover.

The government of the European Community (EC), which is distinct both in members and in function from the CE, has not yet sought to establish a general European bioethics commission. In three instances, however, the EC has initiated working groups on specific topics: one on human embryos and research; a second on ethical, social, and legal aspects of human genome analysis; and a third on ethical issues in biotechnology. A fourth initiative involves the establishment of a research program in bioethics, offering grants to scholars on a competitive basis. This appears to be the world's sole general fund for investigator-initiated bioethics research. In addition, the European Parliament looks for technical advice to its Scientific and Technological Options Assessment (STOA) Programme, just as the U.S. Congress relies on its Office of Technology Assessment.

In the Americas, the Pan American Health Organization (PAHO, a regional office of the World Health Organization) has fostered the development of bioethics in Central and South America. PAHO's general counsel sits on the board of directors of the International Association of Bioethics, an international bioethics group founded in 1992. Planning is currently under way to establish a Pan American Institute of Bioethics, to be located at the University of Chile in Santiago. The institute, slated to begin its work in 1994, is charged to provide a "permanent place for . . . discussion of bioethical subjects." However, its chief mission will be support of research and training in bioethics for the region. Given the novelty of bioethics research and policy in Latin America, its prospectus does not suggest the kind of intergovernmental authority vested in the European organizations (PAHO, 1992).

Other international organizations dealing with bioethics include international medical specialty societies and international bioethics societies. The International Association of Bioethics (IAB) held its inaugural congress in 1992, hosted by the National Health Council of the Netherlands with the support of the EC. The IAB, headquartered in Australia, provides a forum for diverse views on bioethical issues but does not itself take positions on any of them. None of the other organizations has yet attempted to form an international bioethics commission.

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×
Models of National Deliberation on Bioethics

Bioethics commissions have been widely used in other English-speaking countries. A number of federal and state bioethics commissions have contributed to health policy development in Australia, including the Law Reform Commission on Human Tissue Transplant, the Medical Research Ethics Committee, and the new Australian Health Ethics Committee (AHEC), a committee of the National Health and Medical Research Council (approximately analogous to the U.S. National Institutes of Health). Bioethical issues have been discussed in regard to potential legislation by Law Reform Commissions of both the Canadian government and the various provinces. A Human Subjects Research Ethics Committee advises Canada's National Research Council on issues arising in experimentation on human subjects.

Canada's Royal Commission on New Reproductive Technologies is a notably well-funded initiative that has only partially escaped the kind of political heat generated by abortion politics that doomed the Biomedical Ethics Advisory Committee in our Congress. It is charged with performing a comprehensive and authoritative review of Canadian laws and practices on present and forthcoming reproductive technologies. The commission has a large professional staff, has sponsored considerable research, and held hearings and open meetings around the country. Its reports were recently published in 1993.

Latin American countries are just beginning to establish bioethics commissions. In Mexico, a Commission Nacionale de Bioetica, sponsored by the federal government and reporting to the Ministry of Health, was created in 1992. The commission's broad mandate includes oversight on environmental as well as medical issues. In December 1992, Argentina's National Ministry of Health and Social Welfare established a National Bioethics Commission for that country.

Despite the growing number of national bioethics commissions, few commissions make a visible and significant impact on national debate and policy. There is considerable diversity of approach among the well-established commissions, and the United States can learn from the experience of each of them. Three models of national deliberation on bioethics merit particular attention: the Danish commission, which stresses public education and participation; the French commission, distilling the considered judgment of an elite; and the current British approach, in which a private commission takes on a public function.

Denmark, A Populist Model. Denmark's national bioethics committee is notable for at least two reasons. First, the country has not one but two national bioethics commissions, with overlapping areas of interest. Second, one of these commissions has a uniquely active program of public education.

Suggested Citation:"4. The Spectrum of Societal Responses." 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 Central Scientific-Ethical Committee (CSEC) has been in operation since the late 1970s. It was created in the wake of the Helsinki II declaration on human experimentation and has been chaired by one of its drafters. CSEC originally played its role through a voluntary arrangement of professional groups, but in 1992 it was given statutory authority. CSEC is at the apex of a system of human subjects review boards that covers the whole of Denmark; it acts on disputed proposals and in cases in which a matter of principle must be decided.

In 1988, Parliament created a second council, the Danish Council of Ethics, with a mandate to consider a broader range of bioethical issues. The council's 17 members are predominantly laypersons. Though the reports are written by the members of the council, it has a slightly larger staff than is common in Europe: three professionals, including a physician, as well as administrative support; it also takes on academics for short periods of service.

The council's public education efforts go beyond anything attempted by U.S. bioethics commissions. In considering the definition of death, for example, the council held public hearings and financed local debates. It produced a film that was shown not only on national television but also in movie theaters. The council produced booklets and brochures explaining the basic facts about the definitions of death and distributed them at public libraries. The council reportedly gathered the editors of 20 newspapers and induced them to carry articles and exchanges on the subject; 1,000 articles and editorials were published over three years, drawing hundreds of letters to editors. A competition for young people invited art works on the concept of death; the winner of a poster contest won the privilege of display as the cover of the council's annual report.

For the report Protection of Human Gametes, Fertilized Ova, Embryos and Fetuses, the council focused on schools (1990). It gathered educational materials and prepared teaching material for education on these ethical issues in the context of 17 subjects, ranging from biology and philosophy to drama, music, and literature. These were sent to every high school in the country. The council held a short-story contest, in cooperation with a newspaper, which drew hundreds of entries. Its film ''Onskebarn" ("Wished-for Child") won a medal at the International Film and Television Festival in New York.

The Danish Council of Ethics appears to be closer to the grass roots than any other foreign commission, but it is not without its critics. Its findings on the definition of death rejected the current global consensus, which favors a brain death formulation, a step that drew criticism from members of the other Danish group, the CSEC. The two commissions also disagreed on the propriety of preserving brain tissue for research and teaching purposes. Moreover, the council's own surveys revealed wide-

Suggested Citation:"4. The Spectrum of Societal Responses." 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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spread misunderstanding about brain death, not only before but also after the massive public education campaigns.

France, An Elite Model A Comité Consultatif National d'Ethique Pour les Sciences de la Vie et de la Santé (National Consultative Ethics Committee on Life and Medical Sciences) (CCNE) was created by the President of the Republic in 1983. CCNE has over 40 members, drawn not only from scholarly specialties and professional groups but also representative of philosophical currents in France. The chair is appointed by the president, and half of the membership is renewed every two years. Members are not paid, and several have publicly complained about the lack of staff.

CCNE has issued over 30 reports thus far on topics ranging from the testing of drug addicts in employment to genetic fingerprints to reproductive technology. The committee also issues statements on topical questions, such as the introduction of RU-486 (the so-called abortion pill) and sex-determination procedures in the Olympics. The committee is housed at INSERM, which is analogous to NIH. Meetings are closed, and minutes, which are released to the public, do not reflect the identity of those making the remarks. However, a two-day public symposium is held each year (see the background paper by Charo for a further description of the CCNE).

Questions can be brought to the committee by members of the government, presidents of the two houses of parliament, or by public institutions involved in research. CCNE also takes up topics of its own choosing. The committee typically creates a subcommittee for each question or topic, which eventually reports to CCNE as a whole. The latter has occasionally rejected a subcommittee's report.

CCNE aims to play a central role in the country's deliberations over bioethical issues. Its unusually large size permits wider representation of views and interests. It attempts to enunciate general principles for the whole of French society (e.g., that body parts must not be traded in commerce). The committee not only carries out studies of the chief bioethical issues of the day, but also involves itself in day-to-day controversies arising in the hospitals and courts. High in visibility and prestige, its meetings have been addressed on several occasions by the President of the Republic. Its outgoing chairman has been venerated as a public sage, the more-or-less official national voice on bioethics. Its deliberations and findings are covered extensively by the press; the newspaper Le Monde covers the commission closely, providing reportage and commentary even on its philosophical deliberations. Thus, the French model, as opposed to the Danish one, might be characterized as prescriptive, elite, and centralized.

United Kingdom, A Private Model. Bioethics policy is developed in many ways and in many bodies in the United Kingdom. Its research councils, particularly the Medical Research Council, publish an ethics series that focuses

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

primarily on human subjects issues. The British Medical Association has a medical ethics committee, and the Royal Colleges (e.g., of Psychiatrists) have issued numerous guidelines and position papers. Most prominent among the bioethics councils was the recent Warnock Commission on embryos and reproductive technology. Closely studied by academics as well as patients and physicians, its recommendations were largely embodied in new legislation.

However, the government has rejected suggestions that it create a national bioethics commission with a broader mandate. Explanations for this reticence vary; one reason seems to be the past prime minister's wish to avoid placing undue restrictions on scientists. In this respect, as in others, the United Kingdom is out of step with its fellow European states; prominent bioethicists have complained that without a national commission they are not able to identify and pursue the "British position" on these issues in pan-European councils and conferences.

With an interest in a national commission rising in the face of governmental refusal to go along, a private solution has been attempted. The Nuffield Foundation, an educational and charitable trust, was asked to consider the organization of a private body that would function like the governmental bioethics bodies in other European states. The new Nuffield Council on Bioethics was founded after elaborate soundings of professional, scientific, legal, and consumer groups. Its 15 members do not represent constituencies but are chosen for diversity. The council aims to stimulate coordination between the diverse groups now contributing to bioethics policy; to anticipate new problems, and to increase the public's awareness of the issues and of their importance. Several working groups have already been set up. The staff consists of an executive director and two administrative assistants.

The Nuffield Council on Bioethics, as a private advisory body, will have no regulatory role. Nevertheless, the foundation's initiative was welcomed by the government, and one of its staff is government salaried. The council seems to be fixed in the minds of British bioethicists as the national body. Indeed, in its makeup and procedures, the council is conducting itself just as it would if it were a creation of the national government. Whether it will achieve the same influence and authority in national deliberations over bioethical issues as its governmental counterparts abroad remains uncertain.

Dimensions of Bioethics Commissions

This brief survey of bioethics commissions abroad permits no firm judgments on relative successes and failures. However, the differences between national approaches suggest a number of questions that might be

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

considered by the United States in designing its own mechanisms for deliberation on bioethics.

Scope. Until recently, most bioethics commissions abroad have been topical-i.e., devoted to one or a small number of issues-and temporary. Topics have been selected in advance by the sponsor. The French commission, however, is wide ranging and seemingly permanent, with the power to investigate topics of its own choosing. Other commissions established in Europe since the founding of the French commission, and perhaps in imitation of it, have also been general, self-generating, and open ended. Among the most influential commissions have been some single-topic efforts, such as the Warnock Commission in the United Kingdom.

Sponsorship. The independence of ethics commissions abroad has been regarded by most observers as essential to its moral authority. Whether based in the legislature or in the executive branch, all commissions but the U.K's are public. Most answer to, and are located within, the ministries of health. The U.S. President's Commission, which was administratively located outside the departmental structure of the executive branch, has not been seen as a precedent.

Public Access. Most of the commissions allow only limited public access. Meetings are generally closed. In some cases, members of the public may offer their views. Some commissions hold periodic public symposia. One reason offered for the lack of public access is that some commissions rule on particular cases and therefore require confidentiality.

Professional Dominance. All governments have striven to ensure lay membership on their commissions; in some cases, physicians and scientists are in a clear minority. No survey data exist regarding public perceptions of the commissions as independent or as "captured." Unsystematic opinion sampling suggests that, where separate boards or committees exist to oversee human subjects research, these tend to be perceived as protective of the interests of physicians and scientists, lay membership or majorities notwithstanding.

Evaluation and Soundness. Bioethics commissions may be evaluated in many dimensions such as productivity, influence, and soundness. Very little evaluation has been done in any country to date. In this sense, all countries are flying blind. Soundness is the most difficult of the criteria to assess, but it is among the most important. In responses to a survey conducted by OTA, the firmer the commentator's credentials in academic bioethics, the lower his or her opinion of the soundness of the bioethics commission reports. Complaints that commission's findings are poorly argued, or even not argued at all, are common. Only a few commissions have followed the

Suggested Citation:"4. The Spectrum of Societal Responses." 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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U.S. example of rotating professional staff recruited via paid leaves from academic departments.

A different perspective emerges in some of the solicited comments and in the literature: some believe that there is no such thing as expertise in ethics; the commissions' role is to act as forum, broker, and mediator for diverse points of view. Thus a finding that represents a compromise between conflicting commissioners representing diverse constituencies would be regarded as a successful one, even if none of the commissioners could (or would wish to) support the compromised conclusion with data or argument.

Role. National bioethics commissions differ in their basic purpose. In some instances, they are directly advisory to parliaments; their existence is justified by the need to develop legislation on complex technological and scientific issues that can go slower and deeper than the usual legislative process permits. In other cases, the commission exists to stimulate and educate the public. Still others take on the role of distilling and articulating the national sensibility on these matters.

Structure. All the commissions have a chair and numerous commissioners, though they vary in size by a factor of four. Large commissions can be more representative, but sacrifice working efficiency. More striking is the difference in the size of the staff. Most have hardly any, although in a few cases the staff is larger and well trained. Only Canada has provided to its bioethics commission a staff comparable to that of the National Commission or the President's Commission in the United States. As noted above, there is considerable complaining among commissioners over the lack of staff.

A National Voice? Particularly in international councils, the national bioethics committees are increasingly seen as defining their nation's position on bioethics issues. To this extent, they act as national spokesperson, even though few commissioners are elected to their posts. In the United States, commissions have not been regarded as bioethics policymakers except and until their recommendations have been adopted as law (e.g., the human subjects regulations of the National Commission, or the statutory definition of death of the President's Commission). As new entities multiply within and outside of government, the designation of a national voice will become more difficult, and the goal itself open to further question.

PROFESSIONAL AND INSTITUTIONAL MECHANISMS

When Americans are confronted with a change in the moral landscape arising from a change in our capacities to affect the world (e.g., a development in biomedicine), we often slip into an assumption that the relevant

Suggested Citation:"4. The Spectrum of Societal Responses." 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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moral discourse need only address two questions: What should I do? And what should our government do? For example, when we worry about environmental degradation, we think of what each individual should recycle and what action the federal government should take with regard to environmental pollutants. When we worry about mapping the humane genome, we focus on the opportunities and risks for individuals afflicted with undesirable genotypes, and on the government's role in regulating the use and abuse of this information.

Between the isolated individual and the impersonal actions of government, however, lie numerous social institutions composed of deeply ingrained, patterned sets of behaviors that shape our expectations and opportunities (Bellah et al., 1991). Social institutions include both large-scale entities, such as the economy, the polity, religion, and the educational system, and small-scale entities such as the family and professional and voluntary associations. Voluntary and professional associations in particular often play active roles in changing policies and practices. For example, local citizens' groups, homeowners' associations, architects' and urban planners' professional associations actively participate in environmental decision making. Similarly, groups interested in possible effects upon the family, insurance pools and disability insuring, and the uses and abuses of genetic testing become active in shaping the ethical discourse and formulating guidelines and policies pertinent to genetic mapping.

Professional Societies and Voluntary Organizations

Professional medical associations and specialty societies [e.g., American Medical Association (AMA)], research institutes (e.g., RAND, the Hastings Center), and even individual health maintenance organizations (HMOs) (e.g., Group Health of Puget Sound, Harvard Community Health Plan) have responded individually and cooperatively to the changes introduced into the medical, legal, and ethical communities by biomedical technology. Medical associations in particular have long been involved in the formulation of clinical practice guidelines and ethical policies in an attempt to assist clinicians in the rendering of proper and appropriate care to their patients.

An impetus to these guidance efforts has been the frequent abdication by the federal government of responsibility for providing ethical guidance to clinicians in many of the fastest-growing areas of biomedical technology. In some cases, the guidance provided by professional societies is the sole source of up-to-date scientific, legal, and practical information available to practitioners. For example, the federal refusal to fund research on in vitro fertilization left both researchers and clinicians with no organized forum to consider practical and ethical issues presented by this technique. In

Suggested Citation:"4. The Spectrum of Societal Responses." 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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response to this neglect, many medical associations have stepped up their efforts to provide ethical and practical guidelines to their members, and several associations have established subcommittees to explore the uncharted areas of biomedical technology and delineate practice options.

Medical associations have been in the forefront of the movement to guide physicians through the legal and ethical quagmire produced by the dual developments of greater technological advancement and government inaction. Four that have been influential, active, and prolific are the AMA, the American College of Obstetricians and Gynecologists (ACOG), the National Advisory Board on Ethics in Reproduction (NABER), and the American College of Physicians (ACP).

AMA

The American Medical Association has taken a lead in the attempt to guide its members through the ethical and legal dilemmas that surround medical treatment decisions and the use of new technologies. It has a long history of such guidance, beginning in 1847 with the establishment of a code of ethics. The nine-member Council on Ethical and Judicial Affairs addresses the moral and legal concerns that attend clinical practice, primarily through the issuance of regular reports containing opinions, guidelines, and relevant case law regarding a vast array of ethical and legal issues presented by the rapid advancement of biomedical technology. Periodic updates ensure that guidance provided to practitioners is based on the most current scientific and legal information.

Recent reports address a wide range of concerns and provide detailed advice to clinicians on topics such as:

  • confidential care for minors, particularly those minors who may seek contraceptive information and/or abortions without parental knowledge or consent;

  • the difficult issues to be resolved if a patient's AIDS status is to be kept confidential on autopsy reports; and

  • complexities of treatment decisions for seriously ill newborns (AMA, 1992b).

Two groups within the AMA issue recommendations for clinical practice on specific technologies: the Council on Scientific Affairs and the Diagnostic and Therapeutic Technology Assessment Program. The AMA also promulgates guidelines and recommendations through the widely read Journal of the American Medical Association.

In addition, the AMA has been instrumental in fostering cooperation among specialized medical societies in order to provide professional guidance and forums for discussion of biomedical technology and clinical prac-

Suggested Citation:"4. The Spectrum of Societal Responses." 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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tice issues. The Practice Parameters Forum (PPF) is composed of nearly 50 volunteer specialty and state medical societies that attempt to devise criteria for judging the soundness of processes for developing practice parameters, define minimum standards of care, and set priorities for insurance coverage.

ACOG

The American College of Obstetricians and Gynecologists exemplifies the critical role that a medical specialty society can play in providing guidance to physicians. ACOG produces detailed reports and guidelines for a number of procedures that pose highly sensitive ethical and practical dilemmas for practitioners. Recent publications cover a wide range of issues, including the following:

  • sterilization, and in particular the use of this procedure among the mentally retarded;

  • multifetal pregnancy reduction, selective fetal termination, and the distinction between these procedures and abortion;

  • surrogate motherhood;

  • withholding or withdrawing life-sustaining medical therapy, which carefully explored the tension between the obligation to alleviate pain and suffering and prolong life;

  • the potential for industry's financial and educational support of physicians to lead to conflict of interest and how best to avoid it; and

  • the conflicts that arise when providing expert testimony in a trial and the need to distinguish between maloccurrence and malpractice when evaluating another physician's actions (ACOG, 1992).

NABER

Fetal tissue research is governed by state law and federal regulation. Department of Health and Human Services (DHHS) regulations, for example, require that all funding of in vitro fertilization research involving humans be reviewed by an officially constituted board that-with the disbanding of the EAB in 1980-no longer exists. Since 1980, the country has been without an officially constituted group to provide analysis and advice on ethically and socially controversial biomedical research protocols, and clinicians and investigators have been without much-needed guidance. Created in 1991 through the joint efforts of the American Fertility Society (AFS) and ACOG, the National Advisory Board on Ethics and Reproduction deals exclusively with the rapid growth in reproductive technology. NABER has two stated purposes:

Suggested Citation:"4. The Spectrum of Societal Responses." 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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  1. To provide a public forum for informed and nonpartisan national debate over the ethical issues raised by modern reproductive sciences and technology.

  2. To offer to the public, professionals, and policymakers sound, well researched, and nonpartisan counsel on the ethics of research and clinical practice involving reproductive services and technology (NABER, 1991).

The 12 members of NABER represent a variety of disciplines, including theology, pediatrics, biomedical ethics, law, public policy, and obstetrics and gynecology. NABER offers itself as an independent body for review of research protocols that have raised ethical problems difficult for local IRBs to resolve. It also conducted the initial work on the implications of fetal cell sorting and oocyte donation.

ACP

The American College of Physicians publishes the American College of Physicians Ethics Manual, now in its third edition (1992), which provides guidance to physicians in clinical and research settings. The newly revised manual treats a wide range of issues, including:

  • end-of-life care;

  • physician-assisted suicide;

  • HIV and physician/patient susceptibility to infection;

  • sexual contact between physicians and patients; and

  • physician/pharmaceutical industry relations and potential conflict of interest.

The ACP also has an Ethics Committee that disseminates guidelines through the publication of background papers and policy statements in the Annals of Internal Medicine. ACP also has established a Clinical Efficacy Assessment Project that carefully evaluates the merits of medical interventions such as cardiac rehabilitation and certain diagnostic tests.

Other Medical Associations

A number of other medical societies has been actively engaged in providing ethical guidance to their members. The American Academy of Pediatrics (AAP) has developed influential guidelines for establishing hospital ethics committees and authored many papers on bioethical subjects such as informed consent, forced maternal treatment, research involving children, Baby Doe issues, religious exemption from child abuse laws, and organ procurement from anencephalic infants. The American Thoracic Society has developed guidelines on foregoing life-sustaining treatment (ATS, 1991) and on allocation within intensive care units.

Suggested Citation:"4. The Spectrum of Societal Responses." 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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A recently created organization called the American Association of Bioethics (AAB) aims to provide a forum for collaboration among varied professional societies in addressing ethical issues confronted in health science and health care. The AAB board is composed of representatives from the AMA, ACP, AHA, American Bar Association, and other professional organizations, as well as several bioethicists.

Health Maintenance Organizations

In addition to the efforts of medical associations, individual HMOs, motivated primarily by desires to reduce costs and simultaneously preserve a reasonable standard of care, have made several efforts to guide physicians and patients in their use of biomedical technology. Group Health of Puget Sound (GHPS) developed a preventive care manual for its primary care practitioners and has attempted to involve subscribers to the health plan in decisions about the allocation of resources. The manual includes, for example, risk-based guidelines for preventive services such as mammograms. Harvard Community Health Plan (HCHP) has also developed scientifically based clinical algorithms.

Challenges Presented by the Creation of Guidelines

All of these efforts to provide physicians with up-to-date information and guidance are welcome, particularly in light of limited governmental action in many areas. However, such efforts have not been without problems. Guidelines are devised by a variety of groups for a variety of purposes, and the resulting welter of guidelines can often be inconsistent and thus confusing. First, guidelines are sometimes not based on universally accepted scientific evidence. Second, they are sometimes haphazardly and inefficiently disseminated to their intended users. Third, they are sometimes offensive to physicians, who may not be receptive to guidelines that do not mesh well with their practice and experience. Fourth, the various guidelines may offer competing and contradictory advice, presenting practitioners with additional ethical problems (IOM, 1992). For example, AMA and ACOG offer conflicting guidance on the handling of surrogate motherhood: AMA disapproves of the practice and advises against involvement in it (AMA, 1992a), while ACOG regards it as a difficult but potentially acceptable pregnancy option (ACOG, 1990). Fifth, such guidelines often do not incorporate patient preferences. Finally, the professional self-interest of some groups may inadvertently inform and bias their specific recommendations.

IOM examined many of these issues in a 1992 report on the difficulties encountered by the Agency for Health Care Policy and Research (AHCPR)

Suggested Citation:"4. The Spectrum of Societal Responses." 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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in its attempt to comply with the congressional mandate to facilitate the creation of clinical practice guidelines. As the importance of such guidelines becomes more apparent, however, greater care and increased attention are being devoted to rectifying these problems. As a result of such attention, more systematic, consistent, and scientifically grounded guidelines may be formulated by individual societies as well. Two specific cases illustrate the ways in which professional associations have dealt effectively with the challenges presented by technological change.

Seriously Ill Newborns. Between the mid-1960s and the early 1980s, an array of devices and interventions greatly improved our ability to sustain the lives of very small or seriously ill newborns. Lives were saved by these new interventions, but often at the cost of severe physical and developmental disabilities. Also, many lives were prolonged only to be lost after great suffering. Thus, neonatal intensive care became a laboratory for the ethical questions: should life always be saved, and at what cost? (see Jonsen, 1974).

In 1982, for example, a child was born in Bloomington, Indiana with treatable physical defects that threatened its life and with an untreatable genetic defect that predicted limited mental development. The parents chose not to correct the physical defect. Reports of this event reached President Reagan, who ordered DHHS to establish regulations to prevent such events in the future. The department ordered neonatal intensive care units to post conspicuous signs warning that children might be neglected and giving a hotline number to report alleged neglect. This crude effort was successfully challenged in court. Further efforts were made to regulate clinical practice, finally resulting in legislation passed by Congress. However, in a most unusual move, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists were invited to participate in drafting the language of the statute, allowing them to bring up considerations that reflected the bioethical discussions on such cases. The subsequent ''Baby Doe Rules," issued in 1982, were far from perfect, but they were much improved by this contribution.

Artificial Nutrition and Hydration. Only a few decades ago, an elderly person with serious disabilities who lost the ability to eat would die. During the 1960s, advances in the use of feeding tubes allowed doctors to alter the timing and manner of death for these patients. Practitioners and scholars were among the first groups to question the advisability of such a procedure (Micetich et al., 1983; Lynn and Childress, 1983; Zerwekh, 1983). This new technology arrived without fanfare, without evaluation, and without significant direct cost (at least until the advent of total parental nutrition).

When the inevitable court cases arose, they were met with a surprising

Suggested Citation:"4. The Spectrum of Societal Responses." 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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array of amici from professional societies. Briefs filed on behalf of the American Geriatrics Society (Lynn, 1984) and the members of the President's Commission (which had disbanded) were referenced in the Conroy opinion (1985). Throughout the discourse, various multidisciplinary and specialty groups, including the Hastings Center, American Nurses Association, and American Dietetic Association, issued guidelines designed to shape practice and public opinion. In the Cruzan case, for example, 19 health care provider associations supported the removal of the feeding tube.

These examples demonstrate that professional and voluntary societies, including HMOs, insurers, and research institutes, as well as medical associations, can play an impressive and central role in the response to biomedical advances. Without the intervention of these groups, practitioners would have little guidance in the proper employment of many new technologies and the ethical problems that their usage prompts. It seems reasonable to conclude that these associations can also influence the future course of policy and practice in the realm of biomedical technology.

Institutional Review Boards and Institutional Guidelines

The National Research Act of 1974 (P.L. 93-348), which mandated the establishment of institutional review boards in all research organizations receiving federal funds to support research using human subjects, also directed the National Commission to identify ethical principles relevant to human subjects research, develop guidelines for the conduct of such research, and examine IRB mechanisms for review of applications for human subjects research, particularly in the case of research involving vulnerable subjects. The National Commission described the purpose of an IRB as the balancing of the interests of society in protecting the rights of individual subjects with the developing of knowledge that can benefit not only specific subjects but society as a whole (National Commission, 1978b).

The commission recommended that IRBs include persons who are independent from the research process, so that objectivity is enhanced. It also recommended that IRBs be situated at the local level, since local committees would be more familiar with the conditions surrounding human studies research at particular institutions. The IRB protects the rights and the welfare of individuals who participate in research protocols at the institution that establishes the board. In reviewing human subjects research protocols, the IRB can approve or disapprove the proposed activity, or it can require modifications that will make the proposed research acceptable. Each IRB must have a minimum of five members with varying expertise, attitudes, and backgrounds, including racial and cultural heritage. Areas of expertise would include professional competence as well as understandings of institutional commitments, regulations, and law. The IRB is

Suggested Citation:"4. The Spectrum of Societal Responses." 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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required to keep detailed records of its actions. Prior to conducting research on human beings, the institution must provide assurances to the funding agencies that it will comply with policy requirements. These requirements, the so-called Common Federal Policy, were adopted in 1991 by 16 federal agencies (not including the FDA, which has maintained its own regulations) that conduct, support, or regulate research utilizing human subjects.

Before endorsing a proposed protocol, the IRB reviews six basic areas of the protocol: the risks, informed consent procedures, equity, privacy, vulnerable subjects, and undesirable incentives.

  1. Risk. The risks (defined in terms of probabilities or magnitude of harm or discomfort) and benefits (either providing new knowledge or improving the health of the individual) to subjects. These risks can be classified as physical, psychological, social, and economic (Levine, 1986).

  2. Informed consent procedures. The human subject must clearly understand the proposed research, have the capacity to give consent, and voluntarily decide whether to participate. The kinds of information that must be presented include the nature, purpose, and length of the experiments; foreseeable risks and discomforts; potential benefits to the subject or to society; alternative procedures; the degree of confidentiality for the research records; whether compensation or medical treatments will be provided in the case of research-related injury; and a statement that the research is voluntary and refusal to participate will not result in any penalty.

  3. Equity. The IRB must also consider whether the selection of subjects will be equitable so that burdens and benefits are fairly distributed.

  4. Privacy. Will the proposed research assure that the subject cannot be identified in the research results and that the confidentiality of the information about the individual that is obtained will not be improperly divulged?

  5. Vulnerable subjects and undue influences. Subjects classified as vulnerable include children, pregnant women, mentally disabled persons, prisoners, and economically or educationally disadvantaged persons. Distinct limitations on the use of research on fetuses, research on human in vitro fertilization, children, and prisoners are provided in the 1981 DHHS Common Federal Policy (45 C.F.R. 46).

  6. Incentives. Finally the IRB considers whether the presence and kind of incentives provided to the patient present undue pressure limiting the voluntary nature of the participation decision. Payments can involve money, free health care, free contraception, or a variety of other benefits.

IRBs are an example of an innovative public mechanism for addressing social and ethical issues related to research involving human subjects. IRBs have been able to function with some efficiency because they have the

Suggested Citation:"4. The Spectrum of Societal Responses." 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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guidance of the federal regulations that resulted from the work of the National Commission, especially from the principles established in the Belmont Report. In addition, the constant stream of bioethical literature on the ethics of research can provide insights about special problems that arise.

Although the presence of IRB review has seemingly avoided any new sensational transgressions in human investigation, at least three major problems remain to be addressed: (1) there has been little systematic study of the adequacy of the decision-making process; (2) uncertainty exists about the adequacy of balancing risks and benefits as used in IRBs; and (3) claims have been made that the IRB protects the interests of institutions and investigators over those of subjects (Levine, 1986). Another criticism is that, although IRBs are effective at using rights-based criteria that protect certain values such as autonomy, privacy, and justice, they are unsuccessful at protecting the welfare of subjects as defined in the federal regulations that call for the balancing of the risks and benefits of research (Williams, 1984). The reasons for this problem relate to the bias for approval in the DHHS guidelines, the composition of the committee, and the operation of committees (e.g., unwillingness to truly evaluate an investigator's competence, the unappealing dilemma of either having to reject or redesign the research, and the collective decision making that leads to greater willingness to countenance risks (Veatch, 1987).

An additional problem with which IRBs must contend is that patients may not adequately understand the scientific methodology used in a randomized clinical trial (Appelbaum et al., 1987). In spite of acceptable informed consent procedures, patients often distort or misinterpret the research so that the research is seen to benefit the person directly. This has been labeled the "therapeutic misconception." These concerns were also raised in an article concerning the deaths of participants in the NIH drug trial of Fialuridine, which raised questions not only about whether the consent form gave the volunteers enough information, but whether desperately ill patients involved in a study can truly be informed (Altman, 1993).

Another problem is the time, space, and effort required to deal with the paperwork generated by IRB review and monitoring. In the case of large-scale, multicentered clinical trials, the logistics of separate review by IRBs at all involved institutions, and responding to the concerns raised by each, are also problematic. Lynn et al. (1994) describe the many differences that arose in the proposed informed consent procedures in 50 applications for a health services research project sponsored by the Robert Wood Johnson Foundation. A similar diversity of institutional approaches to consent requirements and risk determination was found by Kavanaugh et al. (1979) when surveying genetic counseling centers.

Suggested Citation:"4. The Spectrum of Societal Responses." 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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Because of problems with the IRB system of review, NIH awarded a contract in 1992 to assess the status of the IRB system, in order to ensure that the criteria for the protection of human subjects is still adequate in light of the many changes that have occurred in biomedical, behavioral, and social science research in recent years. This study is designed to examine the costs and burdens borne by IRBs, and to make recommendations to improve the review process.

Hospital Ethics Committees and Physicians
Historical Development of Hospital Ethics Committees

In the last two decades many hospitals have instituted ethics committees charged with providing the institution and its staff with ethical guidance in policy and practice. The development of the hospital ethics committee (HEC) parallels the history of medical ethics and, more particularly, its rise as a clinical discipline (see the background paper by Heitman in this volume). HECs evolved as physicians and other health care professionals, hospital administrators, legal authorities, clergy, and patients and their families struggled to make good decisions about applying resuscitative and life-sustaining technologies. Hospital ethics committees constitute an evolving mechanism for sharing power that traditionally has belonged to physicians. The existence of HECs confirms that others also have the standing to define, discuss, and intervene when significant ethical problems interrupt the continuum of patient care. While most of the work on and by HECs has reflected developments in academic medical ethics, the constraints and practical nature of clinical ethics and institutional policy have sometimes led to significant divergence from theoretical ideals.

In 1990, the Joint Commission on Accreditation of the Health Care Organizations (JCAHO, formerly JCAH) proposed new accreditation standards on patient rights that included a requirement for "mechanism (s) for the consideration of ethical issues in the care of patients and to provide education to caregivers and patients on ethical issues in health care" (JCAHO, 1992). These standards took effect on January 1, 1992, making the existence of an ethics committee (or a similar body or process) a requirement for accreditation and eligibility for Medicare payments for all hospitals in the United States.

The actual prevalence of HECs has been difficult to determine, although there has clearly been remarkable growth in the last decade. The President's Commission survey of 602 hospitals found that in 1982 only 3 percent had an HEC or similar structure, all of them in hospitals with over 200 beds (President's Commission, 1983a). In 1983, 26 percent of hospitals responding to a national survey conducted by AHA's National Society

Suggested Citation:"4. The Spectrum of Societal Responses." 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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for Patient Representatives reported having an HEC; in a repeat survey in 1985, that number had risen to 60 percent (Hospitals, 1985). Large teaching hospitals were much more likely than others to have an HEC, and the proportion of nonteaching hospitals with an ethics committee dropped almost 10 percent in the two years between the surveys.

Despite the fact that over three years have passed since JCAHO's patient rights standards were proposed, some hospitals-particularly small private hospitals and those in rural areas-still do not have formal mechanisms in place, and many are scrambling to determine what is required of them. Even in many hospitals that have established HECs, committee members remain uncertain about their roles, true purpose, and the adequacy of their knowledge in ethics, law, or medicine (Hoffman, 1991; Ross, 1991; and Cohen et al., 1992).

Roles of the HEC

As described in the extensive literature on clinical ethics, the HEC has three typical roles:

  1. the creation or recommendation of policy on ethical issues in patient care;

  2. the education of hospital staff, patients, family members, and the community on ethical issues and the institution's policies; an

  3. deliberation and consultation on specific questions in the treatment of identified patients.

Not all HECs engage in all three activities, and some have additional responsibilities. JCAHO standards call only for committees to provide education on ethical issues and to provide a forum for the discussion of those issues. However, these three aspects of clinical ethics are complementary and mutually sustaining.

The membership of the HECs ultimately reflects the question of who the committee is intended to serve: the hospital, the physician, the staff, the patient and family, or some other entity. Diversity of discipline and professional expertise expands the HEC's ability to recognize and understand the medical and medically related problems and options that particular issues and cases may entail; the need for such diversity is widely appreciated and addressed in practice. Less well addressed in practice is the need for diversity of age, race, gender, ethnicity, and socioeconomic status.

In the past five years, networks of HECs have appeared across the United States as individual committees consult with one another in an effort to improve themselves (Kushner, 1988). Typically, members of networks share institutional policies and general advice with newly developing committees, coordinate educational efforts, and review the handling of particu-

Suggested Citation:"4. The Spectrum of Societal Responses." 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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larly troublesome cases, real or fictional. Such administrative umbrellas may become increasingly important with the implementation of health care reform, both to facilitate the integration of allied HECs and to ensure that managed competition does not compromise the ethical quality of care.

As some HECs enter their second decade, many others are just getting started. A tremendous amount remains unknown about the future of ethics committees. A few issues on the horizon include the development of HECs in nursing homes and other long-term care facilities, the liability of HECs and their members for advisory opinions, the role of HECs in cost containment, and the need for careful evaluation of HECs in their many capacities.

In the more than 10 years that professional organizations and licensing and accrediting bodies have recommended or required the establishment of HECs, there have been many calls for substantive evaluation of their effects (Levine, 1977; President's Commission, 1983a; Rosner, 1985; Craig et al., 1986; Hosford, 1986; Ross et al., 1986; Lo, 1987; van Allen et al., 1989; McCloskey, 1991; West and Gibson, 1992). To date, assessment has been limited to a few academic articles (primarily on their effects on do-not resuscitate orders and limiting intervention), workshops at professional meetings, and the informal shoptalk of clinical ethicists.

IOM and OTA

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.

Institute of Medicine

IOM was chartered by NAS in 1970 to enlist distinguished members of the medical and other professions in the study of issues and problems that affect human health. IOM's principal resource for carrying out its mission is its elected membership of nearly 1,000 professionals from the fields of basic science, clinical science, behavioral and social science, and health care. As mandated, at least 20 percent of IOM members are drawn from fields outside of medicine, including law, economics, engineering, and the physical sciences, lending to the membership a diversity that ensures a

Suggested Citation:"4. The Spectrum of Societal Responses." 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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breadth of perspective and multidisciplinary approach to IOM activities. Other distinguished professionals who are not IOM members also contribute greatly to the work of IOM through service on committees and advisory boards and through scholarly review of IOM reports.

IOM addresses health issues through a variety of mechanisms, including workshops, roundtable sessions, forums, and symposia. Most frequently, however, IOM convenes committees of persons with relevant expertise to conduct comprehensive studies of specific issues. Conducted in response to requests from the federal government and other public and private agencies, these studies usually last between 6 and 24 months and result in independently reviewed, published reports with policy recommendations. A large majority of the studies are funded by governmental agencies; a smaller proportion are funded by foundations, voluntary organizations, and industry representatives. In some cases, ideas about issues that merit study are generated within IOM and funded either from outside sources or from IOM/NAS internal sources. Reports and other products of IOM are disseminated to sponsoring agencies, interested professionals, and the public.

IOM has a long-standing interest in bioethics, which was a new discipline when IOM was founded. It seems evident from the wording of the IOM charter and from some of its initial activities that its establishment was prompted by some of the same concerns that pushed bioethics into the limelight as a discipline in its own right in the late 1960s and early 1970s. At that time, medicine was struggling (as it continues to do today) with new dilemmas brought on in large part by the development of new and expensive medical technologies. How should health care resources be allocated? When is it appropriate or inappropriate to use medical technologies to delay the end of life? These were some of the first questions that IOM attempted to answer in a 1973 conference on Health Care and Changing Values. The report that resulted from this conference, Ethics of Health Care (1974), examined such issues as the preciousness of life, the consumer's perception of health as a value, ethical problems in treating the chronically ill and aged, and the origin of professional values.

Throughout the 1970s, "ethical and legal aspects of health care delivery" remained an IOM program priority. A Division of Legal, Ethical, and Educational Aspects of Health was established in 1977 and subsequently published several reports, including The Elderly and Functional Dependency (1977) and Beyond Malpractice: Compensation for Medical Injuries (1978a), as well as commissioned papers such as The Rights of Physicians: A Philosophical Essay (1978c) and Ethical Issues in Governmental Efforts to Promote Health (1978b). Only one year after its establishment, a funding crisis stemming from changes in federal policy regarding indirect costs challenged the division's core funding and it was eliminated. Although several ongoing

Suggested Citation:"4. The Spectrum of Societal Responses." 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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and newly initiated projects were shifted to other divisions and completed, the division itself-and IOM's only focused program on ethics-was not preserved.

IOM nevertheless continues to address social and ethical issues in the context of its reports. IOM has half a dozen of the leading bioethicists among its elected members. Other ethicists have been sought to serve as committee members and report reviewers, and social and ethical issues have been made the focus of report chapters in some cases, and integrated throughout reports in others (IOM, 1986, 1991a, 1991b, 1993). More recently, IOM's Division of Health Sciences Policy has taken on studies that explicitly address social and ethical issues. In 1989, the division published The Responsible Conduct of Research in the Health Sciences, a report that proposed ways to encourage high ethical standards in the conduct of research without harming the freedom and creativity that have traditionally characterized U.S. research institutions. In 1990, NIH's and Department of Energy's Ethical, Legal, and Social Implications Program commissioned an IOM study of the issues raised by new capacities in genetic testing. The report of this study committee, entitled, Assessing Genetic Risks, was recently published (IOM, 1994). In 1992, NIH also provided funding for an IOM committee to explore the legal and ethical issues relating to the inclusion of women in clinical studies. While both studies addressed some scientific issues, their primary focus was on ethical, legal, and social considerations.

How best to study ethical issues in medicine and health policy has been another recurrent concern. In June 1983, IOM convened a conference on strategies for deliberation of ethical issues at the national level. The President's Commission had expired at the end of March 1983, and the IOM conference was intended for discussion of the need for a new group to replace the President's Commission and of the role, if any, that IOM should play. Conference participants were unanimous in their belief that a new bioethics body was needed, but not in their opinions about whether IOM should have a role. In their debate about the role of IOM in national bioethics deliberation, they noted several advantages and disadvantages of IOM as a professional/institutional mechanism for deliberation of ethical issues.

Characteristics that enhance IOM's ability to address ethical issues carefully and credibly include the fact that IOM is a private organization and therefore less subject than a government agency or federal body to changing political winds. Its membership is large and diverse, and it frequently draws on the expertise of nonmember professionals when needed. Significant care is taken in the composition of IOM committees to ensure that diverse viewpoints on an issue are represented, that biases are disclosed, and that individuals with potential conflicts of interest do not participate in the development of recommendations in the area of conflict.

Other characteristics could be said to detract from IOM's ability to

Suggested Citation:"4. The Spectrum of Societal Responses." 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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address ethical issues credibly. IOM has little stable funding and therefore has limited ability to direct its attention to issues that it deems important but for which funding might not be available from government or private sources. In addition, administrative complications arising from multiple sources of funding can delay the initiation of projects considerably, limiting IOM's ability to take on ethical issues or dilemmas requiring a prompt response. Recently, administrative reforms have enhanced IOM's capacity to conduct rapid studies on focused issues, once funding is secured.

IOM's effectiveness could also be called into question because it conducts the majority of its work in private. IOM is not subject to the Federal Advisory Committee Act of 1972, which requires federal advisory bodies to permit public access to their deliberations. Particularly in the American cultural context, people may be reluctant to embrace conclusions on value-laden ethical issues when they are reached behind closed doors.

Office of Technology Assessment

OTA was established by Congress in 1972 to respond to requests by congressional committees for analyses of emerging and complex technical issues in a wide range of fields. Governed by a 12-member Technology Assessment Board composed of six Senators and six Representatives, OTA organizes briefings, provides testimony, and conducts extensive studies, some requiring more than two years to complete. Participants include OTA staff, professionals from the private sector and the academic community, representatives from public interest groups and state and local governments, and citizens at large. Through these activities, OTA assists Congress in clarifying uncertainties, resolving conflicting claims, and explicating options in the vast arena of science and technology policy. As its name implies, one of OTA's foremost responsibilities is to assess the impact of new developments on future federal policy. While OTA frequently identifies the pros and cons of proposed policies or actions, however, it does not make policy recommendations.

OTA began to address ethical issues explicitly in the early 1980s, beginning with a 1983 report on the role of genetic testing in the prevention of occupational disease (OTA, 1983). The following year, OTA published a report on human gene therapy that specifically addressed the ethical acceptability of different kinds of gene therapy and their implications for society (OTA, 1984a). A series of reports followed that included chapters on ethical considerations or extensive discussions of ethical issues (OTA, 1984b; 1985a; 1986; 1987c; 1988b,c). Bioethicists were increasingly sought to consult on OTA projects related to health policy and biomedical research. At one point, each OTA report generally contained an ethics chapter, and, at times, OTA employed a resident bioethicist.

Suggested Citation:"4. The Spectrum of Societal Responses." 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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In the late 1980s and early 1990s, several more reports that gave primary emphasis to ethical considerations were issued by OTA: Technology and Aging in America (1985b), Ownership of Human Tissues and Cells (1987b), Life-Sustaining Technologies and the Elderly (1987a), Infertility: Medical and Social Choices (1988a), Patenting Life (1989), Neural Grafting: Repairing the Brain and Spinal Cord (1990), and Summary: Evaluation of the Oregon Medicaid Proposal (1992b). OTA continues to be involved in ethics today, having recently conducted studies of cystic fibrosis and health insurers (1992a) and ethics in U.S. public policy (1993).

Thus, while OTA has never had an explicit mandate to address bioethical issues, its efforts to assess the impacts of emerging technologies on society have forced it to confront complex ethical dilemmas on several occasions. Like IOM, OTA has inherent strengths and weaknesses as a deliberator of ethical issues in medicine and health policy. One of OTA's strengths is its ability to enlist the expertise of a wide range of persons representing different social and ethical perspectives to participate in working groups or to provide testimony. In addition, OTA has an informal policy that all of its activities are accessible to the public, a policy that enhances its ability to gather information as well as its credibility. Another strength is stable funding: OTA need not raise funds from outside sources to conduct its activities; all funding is provided by congressional allocation. This allows OTA to activate studies quickly and deliver reports in a timely fashion.

One of OTA's weaknesses as a deliberator of value-laden ethical issues is that, by virtue of its attachment to Congress, it is perceived as a highly political entity. When the President's Commission expired in 1983, OTA (like IOM) was considered as a possible locus for a replacement ethics body. Claims that an OTA-based ethics body would be ''bureaucratized and inadequately buffered from the political process" and that "elected officials would retain direct control over OTA policy" in part kept this from coming to fruition (Abram and Wolf, 1984). Finally, while OTA is able to respond rapidly to direct congressional requests for studies, it is not well situated to respond quickly to needs that arise outside of Congress, whether in federal agencies or elsewhere. Federal agencies hoping to initiate an OTA study must work with Congress to have the study commissioned. In the case of ethical dilemmas requiring prompt resolution, delays in the commissioning of a study pose serious disadvantages.

Ethics Centers

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. Described

Suggested Citation:"4. The Spectrum of Societal Responses." 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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here are the Hastings Center and the Kennedy Institute of Ethics, two of the best-known ethics centers in this country. However, they are only two of a cadre of centers devoted to bioethics research and education that have experienced tremendous growth in the past two decades. Together, hundreds of bioethics organizations around the world comprise a remarkable new resource for policymaking, analysis, consultation, and education in medicine and the life sciences. Ethics centers such as Hastings and Kennedy influence policy development in the area of ethics through conferences, publications, and educational programs. In addition, staff 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.

Hastings Center

Founded in 1969, the Hastings Center is an independent, nonprofit, and nonpartisan research and educational institute for the examination of ethical and social issues in medicine, the life sciences, and the professions. The center is located in Briarcliff Manor, New York, and employs a professional staff of 13 persons with special interest and expertise in biomedical ethics. The center has three primary goals:

  1. to raise the level of competence and research in the examination of the ethical and social problems arising out of advances in the life, behavioral, and social sciences;

  2. to assist educational institutions in the development of programs designed to make a consideration of ethical problems an integral part of higher education; and

  3. to bring the importance of the ethical and social problems to the attention of professional and policymaking bodies and to assist them, when requested, by supplying technical advice and by making available results of analysis, study, and research (Nolen and Coutts, 1993).

The Hastings Center strives to achieve these goals through sponsorship of conferences on topics in biomedical ethics and support of educational opportunities such as student internships, a visiting scholars program, and international fellowships. The center publishes the Hastings Center Report, a bimonthly publication that features articles, commentary, literature reviews, and announcements of conferences and educational and employment opportunities throughout the country and abroad. The center also publishes

Suggested Citation:"4. The Spectrum of Societal Responses." 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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IRB: A Review of Human Subjects, a bimonthly journal featuring articles of relevance to the work of institutional review boards.

Kennedy Institute of Ethics

The Joseph and Rose Kennedy Institute of Ethics was established in 1971 at Georgetown University in Washington, D.C., as a research and teaching center to offer moral and ethical perspectives on public policy issues (Nolen and Coutts, 1993). With 12 senior research scholars, 2 international scholars, and 29 senior research fellows, the Kennedy Institute represents the largest university-based group of scholars in the world devoted to research and teaching in biomedical ethics and other fields of applied ethics. Faculty members bring expertise from such disciplines as philosophy, religion, medicine, social science, and law. Bioethical issues such as in vitro fertilization, abortion, health resource allocation, use of life-sustaining technologies, organ transplantation, euthanasia, and gene therapy have been the focus of research.

In addition to activities in this country, the Kennedy Institute conducts an "Asian Bioethics Program" that, together with the Waseda University's Center for Human Sciences in Tokyo, has been organizing a series of U.S.- Japan Bioethics Conferences since 1985. These conferences have focused on cross-cultural aspects of both biomedical ethics and business ethics. The institute's European Program in Bioethics was established with the aim of developing and enriching moral awareness in the fields of business, environment, regulation, engineering, and medicine. Courses and symposia for this program are initially developed in Germany and subsequently in other European countries.

The Kennedy Institute also houses the National Reference Center for Bioethics Literature, the world's largest collection of books and articles related to ethical issues in health care and biomedical research. The reference center has several special collections, including collections on Jewish ethics, Christian ethics, and federal bioethics commissions. It also maintains and administers an online database of bioethics literature that is part of the National Library of Medicine's database system, which is accessible worldwide.

The Kennedy Institute produces several publications, including the quarterly Kennedy Institute of Ethics Journal, which contains essays and reviews; the Bibliography of Bioethics, an annual collection of citations to books, journals, court decisions, government documents, and other materials related to bioethics; and the Encyclopedia of Bioethics, a basic reference work containing information about ethical issues in the life sciences. A new edition of the Encyclopedia of Bioethics, first published in 1976, is currently being prepared.

Suggested Citation:"4. The Spectrum of Societal Responses." 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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Religious Groups

The connection between religion and health is as old as human culture. While conflicts have appeared along the way (traditional versus scientific medical practice, and the refusal of some religious groups to accept certain medical procedures, etc.), religion and medicine have developed a productive partnership over the past 100 years in most parts of the world. That partnership has been greatly enriched in recent decades.

Religion has made noteworthy contributions to medicine, especially in the area of patient care and in helping patients to understand and deal with disease and catastrophes. At the same time, religious beliefs have proved to be a formidable stimulus to the evaluation of some developments in biomedicine-especially contraception, birth control, and other aspects of human sexuality, as well as end-of-life issues.

Roman Catholic theologians have examined certain central questions about the ethical aspects of medical care for several centuries. They have written treatises in which they applied their principal ethical theory, natural law, to subjects such as abortion, sterilization, and the obligation to accept lifesaving treatments. Similarly, Jewish law has for centuries attended to similar questions about life, death, health, and illness, and the acute analyses of the rabbinical scholars has become familiar to the orthodox. Thus, as the new issues of bioethics began to appear, two major religious traditions already had a stock of concepts and opinions on certain of these issues and scholars in those traditions began to apply them to the new questions.

In recent years, North American religious groups have produced some excellent, carefully researched reports for their national or regional bodies; the Presbyterian report on health care is a good example (Presbyterian Church, U.S.A., 1988). These documents have sometimes failed to gain full endorsement of the groups for which they were prepared, but as working documents available for study and reflection in the life of the religious communities, such documents have exercised great influence. And some of these documents produced by and for religious groups (churches, synagogues, religious societies) have become valued literature in the field.

As noted in Chapter 2, some twentieth century theologians and philosophers of religion were pioneers in reflecting on the import of religion for biomedical developments and in giving an entirely new character to the area in medicine called medical ethics. Theologians and clergy have continued to be important contributors to bioethics. The establishment of professorships at Georgetown University, the University of Notre Dame, and Vanderbilt University charged to deal directly with the relations of religion, law, and philosophy to medical sciences and practice has followed, giving further standing to the place of religion in biomedicine. Such work has

Suggested Citation:"4. The Spectrum of Societal Responses." 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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been greatly furthered by separate institutions dealing with medical ethics described above. Work of this sort has also taken place in Great Britain and Commonwealth countries and is gaining ground in European nations.

Interfaith and ecumenical bodies have also begun to study the import for religion of developments in biomedicine. The World Council of Churches and the National Council of Churches have worked to develop guidelines dealing with such issues as population control, access to medical treatment, and ways to face life's end. Studies of this sort are particularly timely and valuable in light of today's widespread religious pluralism. Consensus is difficult on many of the issues in medical ethics that religious groups discuss, but religious pluralism itself may require of the leaders of religious groups not only more civility in dealing with opponents of their views but also greater understanding of positions different from their own. Some rapprochement may have developed in the summer of 1993 as the World Parliament of Religions sought common understanding on moral questions at its Chicago gathering.

On June 20, 1980, the General Secretaries of the National Council of Churches, the Synagogue Council of America, and the United States Catholic Conference addressed a letter to President Carter expressing concern over the ethical implications of genetic engineering. Their letter stated, "We are rapidly moving into a new era of fundamental danger triggered by the rapid growth of genetic engineering, albeit there may be opportunity for doing good; the term suggests the danger" and called upon President Carter to remedy the lack of "adequate oversight or control . . . by providing a way for representatives of a broad spectrum of our society to consider these matters and advise the government of its necessary role" (President's Commission, 1982b). President Carter passed the letter to his science advisor, who requested the President's Commission to consider it. The commission decided to undertake a special study, not included in its congressional mandate, that explored the questions raised by the religious leaders. This study, entitled Splicing Life, reviewed the religious and moral questions in light of the scientific possibilities and attempted to delineate with care the precise areas of concern to which public attention should be directed. Many of these areas now fall within the mandate of the ELSI Program of the National Center for Human Genome Research.

Religious groups often find it difficult to affirm their own stance and values without ruling out alternative views and visions. Intolerance is not, of course, restricted to persons of religious faith. But the sheer number of individuals and groups working on these issues offers some encouragement that more useful modes of discourse will be developed, and that religious controversies in the field of biomedicine will become more productive. Such a development would be a boon to religion, to medical science and practice, and to the public good.

Suggested Citation:"4. The Spectrum of Societal Responses." 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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INDIVIDUAL AND COMMUNITY RESPONSES

The widespread American tendency to initiate and develop voluntary associations around a whole range of social, moral, and political purposes has a long history. In the early nineteenth century (1835), visiting French social theorist Alexis de Tocqueville commented on the tendency for self help groups to emerge in American communities. Indeed, Tocqueville appropriately characterized the proliferation of voluntary associations as a distinctly American phenomenon:

In no country in the world has the principle of association been more successfully used or applied to a greater multitude of objects than in America .... The citizen of the United States is taught from infancy to rely upon his own exertions in order to resist the evils and the difficulties of life....

While voluntary associations are hardly new to the American cultural scene, the self-conscious application of voluntarism and wider public participation in the medical sphere emerged most strongly out of the consumer and community organizing movements of the 1960s. For example, although self-care has always been an unacknowledged part of the informal health care system, the practice of self-care has increased dramatically in the past 20 years. Some have argued that the current embrace of self-help and health support groups, particularly by HMOs, reflects the transformation of a movement of consumers organized for themselves into an incorporated and co-opted component of the American medical establishment (DeFriese, 1989). Patient advocacy groups, family support groups, and disease-specific self-help groups, once considered radical for their aim of increasing individual control and responsibility over health, have become integral to the nation's dominant public health policy (Crawford, 1977; Stone, 1989; Taylor, 1986; Tesh, 1988). Such lifestyle changes and the public discussions they inspire touch the boundaries of important ethical issues concerning individual autonomy. Thus, activities that initially appear to be political and social in nature frequently have relevance to central ethical problems in biomedicine.

Grassroots Efforts

Individuals, groups, and communities are often spurred to action in the wake of changes wrought by developments in biomedicine. We have already seen the critical role that professional associations have played, primarily by providing ethical and practical guidance to physicians in the use of these technologies. Yet voluntary efforts are not confined to organizations with preexisting structures and stable numbers of professionally educated members. Some voluntary organizations are more loosely struc-

Suggested Citation:"4. The Spectrum of Societal Responses." 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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tured and come into being as a result of a perceived crisis, as did the National Abortion Rights League (NARAL) or in response to a particular condition or disease as did the AIDS Coalition to Unleash Power (ACTUP). They often inspire the loyal support of individuals who have little else in common than their interest in resolving the crisis or managing the treatment for the disease. Others, such as the broad-based citizen-sponsored forums on health care that took place in Vermont, Maine, California, and Oregon, have devoted long hours to the examination of a wide variety of challenging issues in health care, attempting to provide both policy and personal guidance to legislators and fellow citizens.

Increasingly, patients actively participate in the delivery of health services, disease prevention practices, and health education. Contemporary "self-care" movements include participation in a variety of self-help groups from postoperative recovery groups, cancer support groups, support groups for those with a family member who has a chronic disease, and the various permutations in twelve-step recovery programs (from alcohol or drug problems to obesity). Practitioners, scholars, and ethicists justify the shift of responsibility to individuals on the grounds that it increases both patient control and the efficiency of care. Others argue that incorporating self care improves health outcomes while increasing the experience of self control and enhancing quality of life.

Such efforts and groups are best characterized as "grassroots," and, depending on their structure and purpose, sometimes are also known as community-based organizations (CBOs) (National Research Council, 1993). There are so many grassroots efforts and CBOs that it would be impractical to discuss all of them here; hence, the groups described in this section merely illustrate the wide variety of groups that exist. Some of these groups have had a significant impact on the research into and use of biomedical technologies, as well as public discussion of these issues. The impact of grassroots organizations has been particularly notable in the field of AIDS research and treatment, as well as in the areas of contraceptive technology and fetal tissue transplantation research.

AIDS Grassroots Organizations

Grassroots organizations have proliferated in direct response to the AIDS epidemic. It is estimated that more than 600 such organizations formed in the last decade alone (National Research Council, 1993). Many of these organizations had their roots in the gay community, which had created a network of medical self-help groups years earlier in response to perceived discrimination by the medical establishment. Such groups were flexible and quick to adapt to the needs of AIDS sufferers and their families. Their initial aims were to provide appropriate medical care and social

Suggested Citation:"4. The Spectrum of Societal Responses." 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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support, but some extended their efforts into the political arena, challenging the way in which both the government and the medical community were responding to the AIDS crisis.

The AIDS Coalition to Unleash Power is one of the most visible and proactive of these groups, combining public protest, acts of civil disobedience, and media events with the more traditional political methods of lobbying and education to raise public awareness and change policies. ACT-UP is notable for its unprecedented success in changing federal drug development procedures to allow the early release of a promising new AIDS drug. Through careful organization, sustained contact with sympathetic elected representatives, and the acquisition of a well-deserved reputation for being knowledgeable and articulate on medical developments in AIDS, members of its Treatment and Data Committee gained standing to participate in pivotal discussions in NIH, FDA, and other forums. Their views influenced critical policy decisions concerning the research process for experimental drugs and set the stage for greater citizen involvement in the future in such decisions (Levi, 1991).

Abortion Grassroots Organizations

The National Abortion Rights Action League supports a woman's right to choose and has been vocal in its opposition to efforts to restrict that right. Although other women's organizations actively support the availability of abortion (e.g., National Organization of Women and the National Women's Health Network), no other has abortion as its raison d'être. NARAL publishes newsletters, rallies its supporters to public protests, lobbies representatives, and sponsors forums in which scientific, legal, and ethical scholars and legislators sympathetic to this cause present compelling arguments for policies that guarantee women's reproductive autonomy, including the continued availability of abortion and research into contraceptive technologies that make abortion less necessary. In 1991, NARAL sponsored a symposium on the federal ban on fetal tissue transplantation research at which participants decried both the policy itself and the tenuous linkage that DHHS had made between such research and a hypothetical increase in abortions (NARAL, 1991).

NARAL's antiabortion counterpart is found in the National Right to Life Committee (NRLC), a pro-life organization that opposes abortion, euthanasia, and infanticide. NRLC supports abortion alternative programs involving counseling and adoption, provides ongoing public education programs, lobbies before congressional committees, and conducts research. The NRLC was instrumental in preventing RU486, a highly effective abortifacient, from being introduced into this country. Pharmaceutical companies have been very reluctant to conduct research on contraception, not

Suggested Citation:"4. The Spectrum of Societal Responses." 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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only because of weak governmental support for such research but also because of the willingness of NRLC and other antiabortion groups to engage in public protests and threaten boycotts if they do proceed with such research. The history of the development and distribution of RU486 in France confirms that these fears of reprisal are well founded. Because many drug companies are unwilling to become the target of controversial protests, they will avoid areas of research that may provoke such action. In the case of RU-486, and in the development of contraceptive technology in general, the grassroots antiabortion movement thus far has been largely successful in its goal (Charo, 1991).

Community Prevention

Sometimes entire communities (whether geographic, ethnic, or cultural) respond to the changes brought about by technological advances. The response of communities has been variable: weaker for general health initiatives, but often stronger for specific initiatives such as screening for genetic disease. Success in the latter enterprise has also varied widely depending on the particular community and the strategies of the agencies that initiate and organize the screening. In general, however, large-scale community-based health education and intervention programs-in such areas as heart disease, nutrition, smoking, and drugs-have either not worked or worked only within certain limited class, educational, cultural, and racially or ethnically distinct community segments. Few have succeeded in effecting lasting changes in health behavior (Mechanic, 1990, 1992). Their failure is increasingly recognized as a function of treating health behavior as an individual rather than a social and cultural phenomenon (Mechanic, 1990; Syme and Alcalay, 1982). One notable exception is the recent series of efforts to curb smoking by stepping up public education and by banning smoking in public places; these initiatives seem to have reduced smoking behavior in many sectors of society. A growing body of research shows that cultural factors are critical to understanding and modifying health-related behavior, including preventive action (Cruickshank and Beevers, 1989; Graham, 1984; Mascie-Taylor, 1993; Strauss, 1991; Helman, 1990; Biersecker et al., 1987; Armstrong, 1989).

Assessing Genetic Risks

Cultural issues are particularly salient in understanding responses to new genetic knowledge and screening possibilities, in part because genetic disorders, to a greater extent than other health problems, coincide with "risk populations" that are ethnically and racially demarcated. Thus, each disorder may exist in a different cultural context: Americans of African

Suggested Citation:"4. The Spectrum of Societal Responses." 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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descent are at greater risk for sickle cell anemia; Americans of European descent are at greater risk for cystic fibrosis; Americans of Ashkenazi Jewish descent are at greater risk for Tay-Sachs disease; Americans of Southern Italian descent are at greater risk for beta-thalassemia (McKusick, 1988). Because genetic disorders are typically located in subsets of populations at greater risk due to ethnic and racial endogamy, because transmission is limited to offspring, and because there are no cures for any of these genetic disorders, the question of who screens whom and for what purpose is potentially charged and culturally loaded.

Genetic disorders are experienced not only by individuals and their families, but also simultaneously by risk populations that are culturally distinct, and these populations will have highly variable responses to "their disease." The variability will be linked to their social attributes, including the meaning of a genetic disorder in their respective cultural, racial, or ethnic groups. In the past, many community health interventions have not worked because they have not been articulated with the cultural meanings and constructions which are at the center of people's everyday life priorities (Syme and Alcalay, 1982). For example, important elements of genetic knowledge do penetrate into the popular culture, and people do use genetic explanations to account for maladies and odd traits in their families, but in most cases they do not use genetic information (through testing, screening, counseling) to guide their health-related behaviors. The exceptions to this pattern occur when the larger social context of a genetic disorder becomes either highly politicized, as with sickle cell anemia in the late 1960s, or when a community "takes over and possesses its own genetic disorder," as with Tay-Sachs disease during the early 1970s.

With respect to the latter, a community-based carrier screening program was initiated in the greater Baltimore/Washington area in the early 1970s. The program had the support of leading rabbis, and worked with a committee of committed lay people. Brochures from supportive physicians blanketed the Jewish community. Mass mailings and television and radio announcements were also used, all in support of a community-ratified voluntary screening program. Before the program, 98 percent of the Jews in the area that were surveyed had never heard of Tay-Sachs. Within a year, not only were 95 percent of those surveyed aware of the disorder, but thousands volunteered for screening (Stine, 1977). In the first year of the program, 7,000 adults, approximately 10 percent of the total eligible population, were screened (NAS, 1975). One of the key architects of this program, Michael Kaback, perhaps the world's leading specialist on the topic, had this to say about the issue of voluntary versus mandatory screening:

An alternative approach, mandatory (or legislated) screening, although easier to implement perhaps, was regarded as unwarranted, unnecessary and ethically unacceptable (Kaback et al., 1974).

Suggested Citation:"4. The Spectrum of Societal Responses." 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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The estimated cost of the program was $65,000 to provide equipment, supplies, and personnel. All those screened were asked to contribute $5, and most did so. At-risk couples received counseling, and reports indicate that it was direct, careful, and sensitive (Stine, 1977). The success of the initial Baltimore/Washington project was such that scores of Jewish communities around the United States followed suit and were later joined by Jewish communities in five other countries. By the early 1980s, over 310,000 Jews around the world had been screened voluntarily, leading to the identification of 268 couples in which both partners were carriers. In New York city, Hasidic Jews developed a program, the Chevra Dor Yeshorim program, to deter the marriage of partners who were both carriers of the Tay- Sachs gene (Merz, 1987).

The history of screening for sickle cell was very different. Perhaps most significantly, many of the screening programs were developed without adequate consultation and education of the affected communities (IOM, 1994). Little could be offered to high-risk couples once they were identified and safe prenatal diagnosis of sickle cell disease was not possible at the time (as it was for Tay-Sachs). The failure of the Black Panthers (who were among the first to start and favor sickle cell screening) as well as the politically motivated whites, to recognize the technological limitations made the experience of sickle cell screening a very negative one for the African American community. Some have also suggested that, while many of those who were managing or recruiting for these screening programs were doing so for health and medical reasons, a sizeable proportion came from community-based organizations that had a political agenda, including urban poverty programs and methadone clinics (Duster, 1990).

Rationalizing Health Care Priorities

One of the side effects of advances in biomedicine has been skyrocketing health care costs, particularly of the elderly, premature infants, and those with rare disorders. In contrast, preventive medicine has sometimes gotten short shrift, despite the demonstrable cost savings to society. This situation has led to several attempts around the nation to ''rationalize" the allocation of health care. The most famous case has been the work of the Oregon Health Services Commission, which expanded the notion of community responses to include well-organized, focused, volunteer-led group discussion of vital health care issues. The higher-level initiative brought together citizens from different geographical, socioeconomic, and cultural communities.

In the mid-1980s, Oregon was faced with a series of very difficult decisions about the provision of transplants for poor children. The cost for one liver transplant was so high that the same amount of money could

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

provide prenatal care for poor women in the state for almost a year. As a result, Oregon ended funding for soft-tissue transplants. The rationale was simple enough: that it would be more cost-effective to transfer a projected $1.1 million per year from the transplants to prenatal care (Daniels, 1991). This action initiated fierce debate, but the debate itself provided neither the criteria for ranking health care procedures nor the process that would establish such criteria. It was not clear whether such a project should be entrusted to a group of medical experts, elected officials, the general public, or some combination thereof.

The solution was a major, statewide grassroots effort. Oregon Health Decisions, a private, nonprofit community educational group, sponsored citizen meetings throughout the state, encouraging serious thought about the proper allocation of Medicaid dollars through carefully led group discussions centering on specific difficult medical cases (Crawshaw et al., 1985; Garland, 1992; OTA, 1992b). The values under girding a desirable health care system were enumerated by citizens, and included equity, quality of life, cost, functional independence, and community compassion (Garland and Hasnain, 1990). A summary document set forth these and other principles, one of which was that the poor should be guaranteed access to basic health care services, even if it meant that the range of services available to that same group had to be restricted. Thus, citizens favored the breadth of service provision (minimal services to many) over the depth of service provision (extensive services to a few). Because these fundamental principles were arrived at through an open and democratic process, they achieved a certain legitimacy that might not have been earned by alternative approaches (Welch and Dixon, 1991). The information provided by these discussions and the results of a parliamentary debate and vote taken by citizens chosen from these statewide discussion groups was part of the information used by the 11-member Oregon Health Services Commission to guide the ranking of health care services (Klevit et al., 1991).

In early May of 1990, the commission published a list of health care services, with each assigned a different level of priority; coverage would be restricted to those conditions assigned a high priority (Hadorn, 1991). The Oregon experience has generated considerable debate and controversy, in part because of particular rankings but primarily because it highlights the essential and enduring conflict between individual and collective interests. As health care is increasingly viewed as an issue in the public domain, this conflict-between expensive procedures to save the lives of a few and inexpensive preventive measures to save the lives (or improve the quality of life) of the many-will increase. Another set of issues raised by citizen-sponsored health forums in Oregon and other states and regions (e.g., California's Orange County, Hawaii, Maine, Washington, Idaho) is that of participatory democracy and its role in the allocation of scarce

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

health resources, including the use and/or restriction of biomedical technologies (Jennings, 1988).

While political scientists have long argued that apathy pervades the democratic political arena (at least in the United States), this indifference has not been evident in the citizen-sponsored health forums (Jennings, 1993). On the contrary, citizens have been energized and active in these efforts, with minimal outside encouragement and no apparent rewards for their involvement other than the intrinsic satisfaction of participation. There was much variation among the states in their approach to these forums, but their successes had several critical elements in common:

  • building a base of community support by utilizing existing community groups and recognized leaders;

  • holding forums carefully structured to allow open discussion of competing views;

  • relying on motivated, trained volunteers; and

  • channeling the enthusiasm surrounding the discussions into constructive action (Jennings, 1988).

The success of these efforts suggests that true participatory democracy may play a unique and vibrant role in health care reform and practice. Not only does the process itself provide satisfaction to participants, it also confers legitimacy upon the decisions reached. Moreover, because biomedical advances are an integral part of the discussions concerning the allocation of health care, these forums set the stage for greater citizen monitoring of and influence in the development and use of biomedical technologies.

It is critical to note that these citizen efforts, while fruitful, are not without their limitations. Those who participated in these community discussions were more likely to be white, affluent, and better-educated than most Oregon residents. In some instances more than 50 percent of participants were health professionals. Only 9.4 percent of participants were persons without insurance. Given that the uninsured constitute 16 percent of Oregon's population, it is clear that this group was underrepresented. Medicaid recipients, too, were seriously underrepresented (Daniels, 1991). Thus, those least likely to attend these meetings-the poor, underemployed, elderly, minorities, and Medicaid recipients-were those most likely to be seriously affected by any rationing plan developed as part of health care reform. Without the input of these groups, the ultimate validity of such citizen proposals is seriously undermined.

Nearly every public issue requires moral judgment in its resolution. For some issues, however, consideration of moral ideas such as dignity, freedom, rights, justice, respect, and equality are especially critical to resolution. Scientific and social changes stemming from developments in biomedicine have raised such issues. These changes have exerted particular

Suggested Citation:"4. The Spectrum of Societal Responses." Institute of Medicine. 1995. Society's Choices: Social and Ethical Decision Making in Biomedicine. Washington, DC: The National Academies Press. doi: 10.17226/4771.
×

pressure on deep-rooted moral ideas acquired through experiences with one's family, church, and country, and have thus presented society with complex social and ethical quandaries. As we have seen in this chapter, debate about these quandaries is occurring in many places and in many ways throughout our society. Some of the debate has been conducted in an undisciplined fashion, in which the interests of particular interests groups have dominated. More constructively, however, the debate has involved open, informed, and impartial discussion, mutual respect, and rational moral deliberation. Given the impending changes in health care and the promise of continued scientific development, it will be important to ensure that there are places where this sort of deliberation can continue to take place so that the storm of debate can be picked up, channeled, made comprehensible, and perhaps even brought to bear on long-term solutions like the restructuring of institutions and laws.

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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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