Clinical Ethics: I. Development, Role, and Methodologies

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Formal efforts to address clinical ethics first developed in the United States and Canada, though similar efforts are clearly underway in western and central Europe and Japan. Indeed, interest in clinical ethics has spread to many areas of the world, including parts of Central and South America, eastern Europe, and parts of Africa. Though variously defined, clinical ethics involves the identification, analysis, and resolution of value conflicts or uncertainties that arise in the provision of healthcare in clinical settings (Fletcher and Boyle; Jonsen, Siegler, and Winslade). Clinical ethics activities include examination or formulation of relevant policies, ethics education, and ethics consultation to healthcare professionals, patients, families, surrogates, or organizations. Unlike some solely academic domains of the broader field of bioethics, clinical ethics must take into account the actual context in which clinical ethical issues arise because it aims to make contributions to clinical practice and to policy governing clinical practice. This context includes complex psychosocial, medical, legal, cultural, and political dimensions that have implications both for the types of ethical issues that arise and how those issues may be resolved (Aulisio, Arnold, and Youngner, 2000, 2003; May).

Traditionally, clinical ethics discussions tended to focus on issues related to informed consent, confidentiality and privacy, decision capacity or competence, decision making involving minors, resource allocation, and end-of-life care. Though these issues remain central to clinical ethics, the mid-1990s through early 2000s saw a growing recognition of the important relationship between clinical, organizational, and business ethics (Schyve et al.), along with the development of a number of new areas of concern, including physician-assisted suicide (Battin, Rhodes, and Silvers), palliative care (Barnard et al.), medical mistakes (Rubin and Zoloth; Institute of Medicine), ethics and genetics (Juengst), and even bioterrorism (Gostin).

The typical mechanism for addressing issues in clinical ethics in most healthcare institutions is an ethics committee. Ethics committees are present in most hospital settings in the United States and Canada, and increasingly in other settings, such as long-term care, as well. In some clinical settings, most often academic medical centers, ethics committees are part of a much larger clinical ethics program. Such programs are commonly staffed by full-time ethicists who are responsible for ethics education, service, and research.


Renée C. Fox and David J. Rothman both argued that bioethics began in the 1960s as a social and intellectual movement. The earliest concerns of bioethics were focused on acute ethical problems in research settings. Influenced by the U.S. civil rights movement, bioethical inquiry also exposed weaknesses in institutional arrangements that no longer adequately protected research subjects or patients (Fletcher). From its origins to the present, the bioethics movement has had two arms: (1) an interdisciplinary dialogue, known as bioethics, that became a new academic subdiscipline in the larger field of ethics; and (2) an agenda for institutional and social change to prevent abuses and enhance the values that guide decision making concerning research subjects and patients. Social changes in research settings to protect human subjects preceded such changes in patient-care settings by almost a decade.

The 1960s saw a number of widely publicized and much debated cases that brought to the fore the value-laden nature of clinical practice and the difficult choices posed, in part, by rapid advances in medical technology (Jonsen, 2000). The invention of a plastic arteriovenous shunt by an American physician, Belding H. Scribner, in 1960 made possible chronic hemodialysis and, simultaneously, created a profound ethical dilemma because there were far more patients in need of chronic hemodialysis than the Seattle Artificial Kidney Center could accommodate. This dilemma led to the establishment of the Admissions and Policy Committee, later infamously referred to as the "Seattle God Committee, " which employed "social worth criteria" to select candidates for dialysis. Throughout the decade, successes in organ transplantation created similar ethical dilemmas related to resource allocation. In 1967 South African surgeon Christiaan Barnard's successful transplantation of a beating heart from a patient with "irreversibly fatal brain damage" raised serious ethical questions about the definition of death. In response, a committee at Harvard Medical School, the following year, formulated a statement that defined "brain death" (Jonsen, 2000).

If the ethical dilemmas raised by chronic hemodialysis and organ transplantation remained a bit removed from the lives of ordinary people, the 1970s were dominated by cases that clearly resonated with the general populace. In the racially charged climate of the early 1970s, the New York Times ' 1972 expose of the U.S. Public Health Service's forty-year Tuskegee Syphilis Study of the progression of untreated syphilis in African-American men powerfully demonstrated how social values, even disvalues such as racism, can dramatically affect "scientific" practice in clinical settings. The study, which ran from 1932 to 1972, enrolled 600 African-American men from Tuskegee, Alabama. All participants were told that they had "bad blood" and were in need of regular medical exams, including spinal taps. In exchange for these exams, participants were given transportation to and from the hospital, hot lunches, medical care, and free burial (upon the completion of an autopsy). Of the study participants, 200 did not have syphilis, while the other 400 were diagnosed with syphilis but were never told their diagnosis or treated for their disease (even after effective treatment became available) (Jonsen, 2000; Pence). In January 1973, less than a year after the Tuskegee expose, the value-laden nature of clinical practice was again thrust into the public eye when the U.S. Supreme Court handed down its landmark decision in Roe v. Wade. In setting off a decades-long struggle over the morality and legality of abortion, the case also introduced extramedical notions such as "personhood, " "viability, " and "privacy" into the public debate.

Despite the significance of Tuskegee and Roe, no single case captured the public imagination or shaped the development of clinical ethics more than the tragedy of Karen Ann Quinlan did (Pence). Quinlan was a twenty-one-year-old patient at St. Clare's Hospital in Denville, New Jersey. Having lapsed into a coma in April 1975 as a result of the combined effects of alcohol, Valium, and, possibly, Librium, she was dependent on a respirator (ventilator) and was eventually deemed to be in a persistent vegetative state (sometimes referred to as being permanently unconscious ). In addition to the respirator, Quinlan was dependent on the technological administration of nutrition and hydration through the use of a nasogastric (NG) tube (one that delivers food and water to the stomach through the nose). After months of anguished deliberation, Quinlan's parents, Julia and Joseph Quinlan, in consultation with their parish priest, decided to remove her from the respirator and let her die. The Quinlan's decision, however, was opposed by hospital officials on the grounds that to remove the patient's respirator support in order to let her die was euthanasia—the moral and legal equivalent of murder (Pence).

Though New Jersey Supreme Court, in a 1976 ruling, ultimately supported the rights of the Quinlans to remove their daughter from the respirator, the tragedy of Karen Ann Quinlan had a dramatic impact on society and, in particular, on the rise of clinical ethics. Quinlan's dependence on a respirator and feeding tube came to symbolize, for many, "an oppressive medical technology, unnaturally prolonging dying" (Pence, p. 31). Once again, technological developments in medical science, this time the respirator and NG tube, had created new and difficult ethical dilemmas. Before the advent of respirators and feeding tubes, patients in Quinlan's situation simply died. There were no questions about "withholding" or "withdrawing" treatment, "active" or "passive" euthanasia, "ordinary" or "extraordinary" means, or who should be allowed to make life-and-death decisions and under what circumstances. If some people could not identify with chronic hemodialysis, organ transplantation, and the like, everyone could identify with the plight of Quinlan. Indeed, the New Jersey Supreme Court seemed to recognize this when it suggested that ethics committees be developed in hospitals so that future cases might be addressed before reaching the courts (In re Quinlan, 1976).

Not surprisingly, then, the 1970s saw the first clear growth of formal efforts in clinical ethics. Ethics committees began to be established in major hospitals. Scholars in bioethics increasingly taught new courses as faculty members of medical, nursing, and other professional schools. Bioethics scholars also served developing programs in the "medical humanities." In addition, some academic medical centers began to use bioethics and medical humanities scholars to offer ethics education and even ethics consultation in cases involving patients (Jonsen, 1980).

Throughout the 1980s difficult cases continued to spur the development of clinical ethics. In part because of the Quinlan case and a national debate on end-of-life decisions, 1980 saw the establishment of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which in 1983 issued its groundbreaking report, Deciding to Forego Life-Sustaining Treatment. The 1980s also saw the debate about withholding/withdrawing life-sustaining treatment extend to neonatal intensive care medicine with a series of hotly debated "Baby Doe" cases involving impaired newborns. The cases of Nancy Cruzan (Cruzan v. Director, 1990) and Elizabeth Bouvia (Bouvia v. Superior Court, 1986) raised additional ethical issues concerning end-of-life decisions and adults: Is artificially administered nutrition and hydration medical treatment? What evidentiary standard should be satisfied in making end-of-life decisions for formerly competent, but now incompetent, adults? Who is authorized to set such a standard? Does a competent adult have a right to refuse nutrition and hydration? Finally, the emergence of the HIV/AIDS epidemic raised a host of ethical issues that surfaced throughout the 1980s, including, but not limited to, concerns about: confidentiality and privacy; health professionals' duties to treat HIV-infected patients and duties to disclose their own HIV/AIDS status; duties to warn at-risk third parties; patient duties to disclose HIV/AIDS status to health providers; and mandatory testing for health professionals and others.

During the 1980s, several postgraduate training programs, some textbooks, and one journal declared that they addressed clinical ethics, a term that had not been used in the earlier bioethics movement. The practice of ethics consultation began to be defined in the early to mid-1980s (Fletcher, Quist, and Jonsen), and ethics committees multiplied in clinical settings to protect shared decision making with patients and family members.

With the Patient Self-Determination Act of 1991 and the stipulation of the Joint Commission on Accreditation of Healthcare Organizations (1993) that member institutions must have a "mechanism" for "the consideration of ethical issues arising in the care of patients and to provide education to caregivers and patients on ethical issues in health care"(R., p. 9), the importance of formal efforts in clinical ethics was given expression through regulatory requirements in the United States. These rules intensified the need for competence and leadership in clinical ethics. Partly in response to this, the 1990s saw efforts by groups in Canada and the United States to address standards for ethics consultants and consultation. From the mid-to late 1990s physician-assisted suicide and palliative care captured much of the clinical ethics debate, and the rise of managed care pushed organizational ethical issues into the clinical domain.

There can be little doubt that clinical ethics is becoming an established subdiscipline of the broader field of bioethics. Highly multidisciplinary, clinical ethics is pursued by clinicians—physicians, nurses, social workers, and other health professionals—as well as by those with backgrounds in the humanities (including philosophy, theology, history, and literature), social sciences (including sociology, anthropology, and public health), and law. By 2001 there were at least forty-seven academic institutions offering graduate training programs (including certificate and fellowship programs) in bioethics or medical humanities; a number had clinical ethics components; and several were specifically devoted to clinical ethics (Aulisio and Rothenberg). Despite the rapid increase in graduate training programs in bioethics and medical humanities, the vast majority of the people offering clinical ethics services at healthcare institutions have little or no formal education and training in clinical ethics (Aulisio, Arnold, and Youngner, 2003). This suggests a continued need for educational and training programs tailored specifically to this group.

Role and Methodologies

Education and service (e.g., consultation and policy formation) are the foci of clinical ethics efforts in most healthcare institutions. Typically, a clinical ethics program in a healthcare institution, such as a large hospital, will provide staff and community education, policy critique and formulation, retrospective and prospective case review, and case consultation. The most active clinical ethics programs tend to be at academic medical centers that employ clinical ethicists. In the academic medical setting, clinical ethicists may be involved in teaching at all levels of health-professional education (preclinical, clinical, graduate, postgraduate, and continuing education). Some institutions with programs in clinical ethics offer advanced education and training through fellowship or degree programs. They may also have outreach efforts to assist in the formation of clinical ethics programs and the training of leaders for these programs.

Although education and service are central to any clinical ethics program, research can be an important component as well, particularly in an academic setting. Such research may include the type of conceptual and analytic work characteristic of humanities research (e.g., case analysis, conceptual clarification, normative assessment of particular clinical ethics issues) or the type of empirical research more characteristic of the social sciences (e.g., frequency occurrence of various ethical problems; the practical impact of various policies or practices; attitudes and beliefs of specific populations toward particular ethical issues; effectiveness of certain interventions designed to promote informed consent, protect privacy, and so forth) (Singer, Siegler, and Pellegrino). The increasingly vast clinical ethics literature is indicative of the dramatic growth in clinical ethics research since the 1980s.

Like clinical ethics itself, discussions of methodological issues in clinical ethics have evolved and developed over the years. As clinical ethics emerged, the prevailing approach to bioethical inquiry (Beauchamp and Childress) used systematic reflection on moral principles and their relevance for resolving ethical problems in biomedicine by weighing and balancing the claims of competing principles (an approach known as principlism ). Although this mainstream approach achieved valuable work, criticisms pointed to three ways in which the approach needed to be strengthened: (1) more attention needed to be given to the nature of diseases and the clinical contexts in which clinicians and patients face ethical problems (Sider and Clements); (2) the criticism that principlism appeared to promote a hierarchical form of reasoning that deduced ethical resolutions for complex clinical problems from fixed moral principles and rules needed to be addressed (Jonsen and Toulmin); and (3) in addition to moral principles, more conceptual and methodological resources for ethical inquiry needed to be developed, because principlism appeared too vague and flexible to yield well-reasoned conclusions (Clouser and Gert).

In response to these perceived inadequacies in the forms of ethical inquiry, Glenn C. Graber and David C. Thomasma attempted to recast the theory and practice of medical ethics in terms of a "unitary ethical theory" founded in clinical medicine itself (Ackerman et al.). Their contribution, with strengths and weaknesses, was expertly reviewed in 1990 by Richard M. Zaner, a philosopher with significant clinical experience, who enriched the literature with narratives of illness and of the ethical conflicts over uses of high technology that are frequent in tertiary-care centers. Other contributors to the clinical ethics literature responded by drawing on the works of feminist (Gilligan; Noddings; Wolf; Tong) and theological (Hauerwas) writers who criticized bioethics for neglecting the ethical significance of specific clinical virtues, such as caring for persons in concrete human relationships.

Additional methodological resources for ethical inquiry appeared in the renewal of interest in casuistry, the art of ethical analysis that compares and contrasts relevantly similar cases (Jonsen and Toulmin; Brody, 1988; Arras). Clinical decision making is case-specific: It is directed at the care of a particular patient faced with a particular illness or injury. Each case has a history: what preceded the problems that needed medical attention, what needed to be done, and what was done to address the problems presented by the patient. Because it focuses on the ethics of clinical practice, clinical ethics strives for the richest possible descriptions of cases and their interpersonal dynamics and power differentials. In this vein, several anthologies of cases have appeared with well-informed clinical discussions (Pence; Crigger), including casebooks with cases drawn from ethics consultations (Kuczewski and Pinkus; Culver). Like the practice of clinical medicine, casuistry builds on the accumulated experience, both of the individual and of the professions, in dealing with a variety of cases. Comparing and contrasting related cases can reveal important ethical considerations that may not be apparent in isolated focus on a particular case.

Yet another response to critiques of earlier bioethics was to deepen and enrich the study of larger issues and themes in clinical practice, both by using cases and by drawing on knowledge available only through the intimacies of the clinician–patient encounter. Authors of such studies tend to be clinician-ethicists or ethicists who have adapted to the clinical setting sufficiently to share in such intimacies. Four examples among many are discussions of informed consent (Katz), life-and-death decision making (Brody, 1988), pain and suffering (Cassell), and the uses of power by clinicians (Brody, 1992). These studies draw on a variety of disciplines and experiential data obtained in clinical settings. As such, they encourage ethical scrutiny and reform of understandings and practices in the clinical encounters between patients and clinicians (Zaner). In this way, clinical ethics strengthens the conceptual underpinnings of bioethics with experiential data and helps motivate clinicians to reform their practices.

The continuing multidisciplinary growth in clinical ethics has, not surprisingly, created a great deal of methodological diversity in approaching clinical ethics issues. Methodological approaches characteristic of various health professions, the humanities, and the social sciences can be found in the literature (McGee; Charon and Montello; Kuczewski; Nelson; Bosk; Moreno). In practice, the approaches of different persons involved in clinical ethics efforts will, naturally, reflect, at least in part, their professional or disciplinary perspective. This is part of the great richness of clinical ethics.

In the face of this rich methodological diversity, clinical ethics, far from being fragmented, is held together by a profoundly practical aim: to make contributions to clinical practice and to policy governing clinical practice. To the extent that it is able to achieve this, clinical ethics must pay careful attention to and take into account certain features of the clinical context. As mentioned at the outset, these features include complex psychosocial, medical, legal, cultural, and political dimensions that have implications both for the types of ethical issues that arise and how these issues may be resolved (Society for Health and Human Values). For example, in the United States, the pluralistic societal context, the rights of individuals to live according to their values, and the value-laden nature of clinical practice make ethical conflict or uncertainty an inevitable feature of the clinical setting. Indeed, these features, in conjunction with advances in medical technology, arguably have created the need for formal efforts in clinical ethics. In the U.S. societal context, therefore, irrespective of the methodological approach employed by any particular person in working to address a given clinical ethics issue, the political rights of individuals must be taken into account if the approach is to make a contribution to actual clinical practice. Thus, in a very real sense, methodological approaches in clinical ethics and the theoretical commitments behind them are subordinated to the practical aim of this discipline.

john c. fletcher

howard brody (1995)

revised by mark p. aulisio

SEE ALSO: Autonomy; Beneficence; Bioethics; Casuistry; Ethics: Normative Ethical Theories; Feminism; Informed Consent; Justice; Narrative; Nursing Ethics; Principlism; Virtue and Character; and other Clinical Ethics subentries


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Clinical Ethics: I. Development, Role, and Methodologies

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