THE HISTORICAL DEVELOPMENT OF INSTITUTIONAL ETHICS COMMITTEES

Institutional ethics committees (IECs) have evolved over the past two decades in the United States and Canada as health care professionals, hospital administrators, regulatory agencies and legal authorities, and patients and their families have struggled to make good decisions about applying resuscitative and life-sustaining technologies. Much of the history of the IEC parallels the development of medical ethics as an academic and, more particularly, clinical discipline. However, the practical nature of clinical ethics and constraints of law and institutional policy have also led IECs to a theory and practice distinct from academic ethics.

The first public call¹ for an advisory body on clinical ethics² came in 1971 from the Catholic Hospital Association of Canada (CHAC) and the Canadian Catholic bishops.³ Their Medico-Moral Guide (1), a handbook on the application of the Roman Catholic teachings known as the Ethical and Religious Directives for Catholic Hospitals, recommended that Catholic institutions establish special committees to: (a) educate the hospital community on the moral dimensions of life-sustaining technologies; (b) provide a forum for interdisciplinary dialogue on their appropriate use; (c) make institutional policy on the application of the CHAC's guidelines in treatment; and (d) serve as a legislative watchdog for Catholic interests.

The first mention of such committees in the United States appeared in a 1975 article on the highly publicized nontreatment of a newborn with Down's Syndrome at Johns Hopkins Hospital (2). Physician Karen Teel observed that doctors often hesitated to make difficult medical decisions because of the perceived threat of legal action against them. She suggested that an institutional sharing of responsibility for morally charged treatment decisions might make it easier for physicians to take appropriate action. Teel recommended that multidisciplinary committees analyze treatment options for deformed infants in light of their legal, ethical, and social aspects, and support physicians in their implementation.

In 1976 the NewJersey Supreme Court cited Teel's work in its ruling In re Quinlan (3). Although the Court assumed jurisdiction over the issue of surrogate decision making and awarded Karen Ann Quinlan's father guardianship for the express purpose of consenting to the withdrawal of her ventilator, it contended that the court was not the proper site for such decisions. Instead, it declared that the authority of an incompetent patient's guardian included decisions to limit or refuse life support, and that such decisions should be made in consultation with an "ethics committee," as described by Teel, or a "reasonable counterpart." The Court understood the committee's role more in terms of assessing the patient's prognosis than resolving the ethical dilemmas of treatment, and mistakenly assumed from Teel's comments that hospitals commonly had such committees. The state then issued guidelines for such prognostic bodies, consisting of physicians from varied specialties, and for their role in decisions to withdraw life support (4). In 1977, the Hastings Center held a conference on the actual and potential roles and responsibilities of IECs. Participants' experience of the roles and constitution of such bodies differed, but they generally agreed that multidisciplinary committees, well versed in the ethical issues of medicine, could serve in a valuable advisory capacity to physicians and families confronted with difficult treatment decisions (5).

In 1983, the President's Commission for the Study of Ethical Issues in Medicine and Biomedical and Behavioral Research issued its report on the ethical, medical, and legal issues in decisions to forego life-sustaining treatment (6). The report focused on the creation of procedures for such decisions, and examined the role of public and private organizations in establishing and governing the process. The Commission recommended that hospitals formulate specific policies on withholding and withdrawing life support for competent and incompetent adults, and children and infants. In evaluating procedures for surrogate decision making, they rejected the practice of seeking formal judicial review as too cumbersome, too adversarial, too expensive, too public, and too harmful to the process of patient care (6, 159). They concluded that institutions should establish institutional procedures to "promote effective decision making for incapacitated individuals" (6, 160), including neonates (6, 227); one such procedure was review by a hospital ethics committee (6, 439-442).

As envisioned in a model bill included in the report (6, 439-442), institutional ethics committees could serve to: (a) confirm the patient's diagnosis and prognosis; (b) provide a forum for discussing the social and ethical issues that a particular case might raise; (c) educate staff on the identification and resolution of ethical problems; (d) formulate institutional policy and procedural guidelines on decision making; (e) review treatment decisions made for specific patients by doctors and surrogates; and (f) mediate conflict over patient care between health care professionals, patients, family members, and the institution. They recommended a multidisciplinary committee that would be available to staff and patients and their families, and that would operate formally, keeping minutes and placing consultation records in patients' charts.

The Commission's survey of hospitals found that few had established formal institutional structures, and those that had reported them to have widely divergent functions and composition (6, 443-457). While the Commission concluded that IECs offered an appropriately sensitive, rapid, and private approach to safeguarding the interests of incompetent patients, it cautioned that there needed to be more study of their use and outcomes before their adoption could be recommended, much less required. It further suggested that both the American Hospital Association (AHA) and the Joint Commission on the Accreditation of Hospitals (JCAH) examine the formation and varied functions of IECs.

In 1983, when the federal government established guidelines equating nontreatment of severely impaired newborns with discrimination against the handicapped, known as the Baby Doe rules (7), both the AHA and the American Academy of Pediatrics (AAP) challenged the regulations on the grounds that local ethics review would be more valuable than federal oversight. The AHA, AAP, and American Medical Association (AMA) filed suit to have the rules invalidated, and later that year, the AAP issued guidelines for the establishment of multidisciplinary "infant bioethics committees" to review the proposed nontreatment of severely impaired infants using a best-interests standard that recognized the limits of technological intervention (8).

When the regulations were overturned in early 1984, a judgment subsequently affirmed by the U.S. Supreme Court (9), Congress attempted "compromise legislation" that made the withholding of "medically indicated" treatment a form of child abuse or neglect (10). An essential part of this legislation was the requirement that hospitals with neonatal intensive care units (NICUs) have a multidisciplinary Infant Care Review Committee (ICRC) to assist in the determination of appropriate intervention for affected infants, in keeping with the AAP guidelines. Also in 1984, the AMA (11) and AHA (12) each called for the formation of voluntary ethics committees in hospitals and other inpatient institutions to "consider and assist in resolving unusual, complicated ethical problems" in such areas as quality of life, terminal illness, and the use of limited resources (11). The AHA suggested that the IEC could serve to establish policies on withdrawing and withholding treatment at the end of life; to educate staff, patients, and the public on the medico-moral aspects of caring for terminally ill and/or severely deformed infants; and to provide consultation to doctors, other health professionals, patients, and families in situations where the use of medical technology created ethical conflict (12).

In 1987, the state of Maryland enacted legislation requiring hospitals to establish IECs to advise caregivers, patients, and family members on ethical aspects of the treatment of terminal illness (13). The law also suggested that committees review and formulate institutional policy on the use of life support as well as conduct educational programs for hospital staff and patients and their families on ethical issues in medical decision making. The Act specified standards for the IEC's composition, as well as a variety of procedural aspects, including that it: (a) notify all patients of its existence and their right to seek an advisory opinion; (b) consult all caregivers, the patient, and the patient's family in its deliberations; (c) and keep written, but confidential, records and place its formal recommendation in the patient's chart. The Act also freed the IEC from legal liability for recommendations given in good faith.

In 1990, the U.S. Supreme Court affirmed Missouri's right to impose a strict standard of evidence of patients' wishes regarding withholding and withdrawing treatment (14), ruling in the case of Nancy Cruzan, a permanently unconscious woman whose family sought to discontinue her tubal feeding. As Cruzan was unfolding, Missouri Senator John Danforth, intent on preventing the need for court intervention in treatment decisions, proposed legislation to require hospitals and other inpatient institutions to inform patients about their state's law on the use of life-sustaining treatment, and to ask patients upon admission whether they had an advance directive. The initial version of the federal Patient Self-Determination Act (PSDA) called for the creation of IECs to educate caregivers, patients, and the public about advance directives, and to consult on difficult treatment decisions. This provision was dropped in the final version of the bill (15), however, because of widespread concern that IECs were relatively new and their effectiveness unknown (16).

While the federal government ultimately did not mandate the creation of ethics committees, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO, formerly JCAH) did so in late 1990 in its 1992 Accreditation Manual for Hospitals (AMH) (17). JCAHO's new accreditation standards on patient rights included a requirement for a "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" (17, 156). As of January 1, 1992, these standards require U.S. hospitals to have an IEC or a similar body or process as a condition for accreditation and eligibility for Medicare payments.

There has been tremendous growth in the numbers of IECs in the last decade, although their actual prevalence has been difficult to assess. In 1982, the President's Commission survey of 602 hospitals found that only 3% had an IEC or other organizational body that might be involved in medical decision making; all were in hospitals with over 200 beds (6, 439-457). A 1983 national survey by the AHA's National Society for Patient Representatives found that 26% of hospitals responding had an IEC; by 1985 that number had grown to 60% (18). The most likely hospitals in the survey to have an IEC were large, teaching hospitals; surprisingly, the number of nonteaching hospitals with an IEC dropped almost 10% in the two years between the surveys. In a study of the effects of Maryland's 1987 law requiring IECs two years after the Act's passage, 55 of the 63 hospitals surveyed responded that they had an IEC, compared with 14 of 18 in the District of Columbia and 29 of 114 in Virginia (19). Hospitals with fewer than 250 beds were not likely to have an IEC, and many of the administrators of hospitals in the District of Columbia and Virginia commented that they did not perceive a need for such a committee.

Although considerable time has passed since JCAHO's patient rights standards were proposed, there are still hospitals with no formal mechanism in place, particularly small private hospitals and those in rural areas. Despite an extensive literature in clinical and hospital ethics and the availability of several handbooks on IECs (20-25), many hospital administrators are unsure of what is required of them or where to turn for information. Even in hospitals with established IECs, committee members may be uncertain about the committee's purpose, as well as their own roles and the adequacy of their knowledge in ethics, law, or medicine (19; 26; 27). This uncertainty, coupled with the fact that JCAHO instituted the requirement for IECs at the same time as a host of other changes, suggests that hospitals that create IECs primarily to conform to the AMH's standards are unlikely to have active committees for some time to come (19).

ROLES OF THE IEC

As described above, the IEC has three typical roles, which are complementary and mutually sustaining: (a) the recommendation or creation of policy on ethical issues in patient care; (b) the education of hospital staff, patients, family members, and the community on ethical issues and the philosophy and policies of the institution; and (c) the consideration of and consultation on ethical issues in patient care generally and questions about the treatment of specific patients. Not every IEC is involved in all of these activities, and some have additional responsibilities. JCAHO standards require only that committees provide education on ethical issues and a forum for their discussion (17).

ADMINISTRATIVE ASPECTS

Despite its broad mandate, the IEC is a hospital committee with the same administrative considerations as other committees, many of which are shaped more by the general practices and culture of the institution than by the IEC's formal charge. Several of the proposed guidelines for IECs attempt to define administrative structures and processes (11; 20-25). JCAHO's standards are exceptionally open, in keeping with its Principles of Quality Improvement, which are intended to support institutions' efforts to tailor guidelines to their own needs (17). Some basic administrative questions to be resolved at the institutional level include:

Should the IEC be under the jurisdiction of the medical staff, administration, or governing board? A number of aspects of the committee's structure and function may be influenced by its place in the hospital's administrative structure. The IEC's authority, accountability, leadership, membership, and length of terms may all be defined by its location in the institutional hierarchy. The AMA recommends that the IEC work under the Medical Executive Committee, primarily to ensure that physicians have a prominent voice in policy (11), but some would argue that such IECs might not have the independence necessary to question physicians' practice (29). Others place the committee under the administration, as administrators are typically responsible for what may be perceived as the risk-management and policy aspects of the committee's work. However, such placement may marginalize the committee in clinical practice if physicians do not have a sense of ownership (29). Placement under the governing board can give the IEC the authority and political freedom to work effectively throughout the institution, but requires strong committee leadership, and a self-critical sense of purpose among the members. The IEC's budget and the availability of support staff, meeting rooms, and other essentials may also be defined by its relationship to particular offices. These considerations are especially important in smaller hospitals, and where staff and facilities are overburdened owing to financial constraints.

The maintenance, availability, and discoverability of the IEC's records may also be affected by its placement in the hospital's administrative structure (22; 23; 27; 29; 45). The IEC's minutes and case reports might be safeguarded like quality assurance materials if the IEC is an administrative committee; records might come under peer review protection if the IEC is a medical staff committee. However, neither of these assumptions has been tested, and there is no consensus of legal opinion about the protection of IEC documents or the potential testimony of IEC members in litigation. Moreover, preoccupation with secrecy is not consistent with the publicly projected image of the IEC as a means of ensuring the accountability of health care professionals and institutions in decision making.

Who should chair the IEC? Leadership is crucial to the proper functioning of any group, especially one that has a potentially controversial role. The head of the IEC must have the respect of the hospital community for the committee to be effective (22; 23; 29). Some guidelines suggest that the chair have a highly visible position of authority within the hospital; elsewhere, experience suggests that a chair's high profile may limit the IEC's effectiveness (53). Practically, the chair should be someone to whom people already turn for advice. In the beginning, he or she must be able to recruit others to participate, create enthusiasm and a sense of accomplishment among the members, and establish the IEC's place and value in the institution. The chair needs to know enough about clinical ethics and institutional processes to guide the committee's self-education and the creation of policy, as well as to determine what problems will be appropriate "cases" for the IEC to address. Later, he or she must be able to facilitate discussion of emotionally charged issues in a way that mitigates power struggles and leads to specific resolution. Because very few individuals have the time or talent to do all these things in addition to their primary professional work, IECs may have co-chairs or a chair and an administrative or consultation coordinator. The rotation of leadership varies greatly among institutions, again dependent on structural and personal variables as much as administrative order.

Who should be members? Members need to be respected members of the hospital community, who can both represent their colleagues to the IEC and represent the IEC to their colleagues (23; 29). Official guidelines and handbooks on IECs unanimously stress the importance of a multidisciplinary membership, able to address the varied issues that policymaking and consultation may raise. Members also need good skills in reflective analysis and communication, compassion and emotional stability, open-mindedness and humility, integrity and courage of their convictions, and the willingness to spend time reading and thinking about topics outside their own areas of expertise.

Ultimately, the committee's membership reflects the question of who the IEC is intended to serve: the hospital's administration or corporate interests, physicians, nurses, patients and their families, or some other entity. The need for a diverse professional membership is widely acknowledged, as the IEC's ability to recognize and address the problems and options that particular situations may entail is enhanced by its members' broadly based professional expertise. The need for diversity of age, gender, ethnicity, and socioeconomic status, characteristics that shape members' values and perspectives on the meaning of specific practices, has been less well addressed in theory or practice.

Typically, IEC membership may include:

Physicians of various specialties, particularly critical care for expertise in life support and resuscitation; neurology for expertise in states of consciousness; psychiatry for expertise in decision-making capacity, competence, and the mental consequences of physical illness and its treatment; gerontology, to provide a comprehensive view of elderly patients; and other specialties that may be important in the individual institution.

From the beginning, physicians have been skeptical about the value of an IEC, and have been worried that the committee would be looking constantly over doctors' shoulders, telling them how to practice medicine (22; 29). While some of this initial hesitance has abated, especially among younger doctors, some physicians are unwilling to serve on what they perceive will be a meddlesome committee, or are fearful of the political consequences of appearing to sit in judgment of their peers (29). Others do not want to participate in a multidisciplinary IEC because they are unaccustomed to working with nonphysicians, or they may object to the implication that others can adequately assess the ethical dilemmas that doctors face. However, some IECs have found that critics of the committee can become its champions if they are invited to share their opinions as members.

Nurses of various specialties, including floor nursing, critical care, and administration. Nurses are especially important because of their experience in carrying out treatment orders in controversial situations and their appreciation of the more personal responses of patients and families to serious illness. Moreover, they often recognize the political issues at stake in both policy and practice, and know how to negotiate them. In most institutions, nurses are eager to take part in the IEC, and it may be difficult to determine who among a number of qualified candidates should serve. Some nurses hope that the IEC will provide an opportunity to redress injustices that nurses have suffered in the past; but just as physicians must work with others, nurses must be willing to work with doctors.

Social workers, patient representatives, and discharge planners, valuable because they are often called upon to handle the problems of "difficult" patients, whose "trouble making" may be the result of conflicting ethical or sociocultural values. They typically know both how to recognize the sources of conflict among caregivers, patients, and family members and often how to present options to resolve the conflict. Social workers and discharge planners can be central to the strategic aspects of an IEC's consultation, as they know what options are possible and how to use community resources to support patients' and families wishes for care that cannot be provided in the hospital.

Physical and respiratory therapists, seldom included in lists of prospective members, but whose familiarity with the care of the chronically ill and comatose, as well as knowledge of the stresses and rewards of rehabilitation, make them invaluable to some committees. They, like nurses, typically implement treatment orders for patients likely to fall under IEC policies, and they see the long-term consequences of critical care. They can be helpful in case consultation because they often give social and emotional support to patients and families, and their teaching skills often enable them to communicate complex medical concepts to lay people.

Clergy, whether hospital chaplains or clergy from the community, who can assist the IEC in appreciating the religious meaning that both health professionals and lay people may find in illness and medical care, and in identifying symbolic issues that can complicate decision making. Clergy can offer reassurance and reinterpretation of religious teachings to patients, family members, and staff who mistakenly fear that their intended actions are prohibited within certain religious traditions. Many clergy are trained in moral analysis, and although the perspective of their particular denomination may not be immediately applicable, their ability to identify central ethical themes and questions can be quite useful to the consultative process. Community-based clergy can be particularly helpful when they are familiar with the values, experiences, and daily life of the hospital's patient population.

Hospital administrators, who are often responsible for drafting and implementing hospital policy that may affect the IEC. As committee members they may both facilitate the IEC's work in policy and learn lessons from the IEC's experience that will make hospital policy more appropriate to clinical needs. The presence of the hospital's CEO or other upper management on the IEC can also lend authority to its work. Administrators, like physicians, however, must appreciate the necessary collegial nature of the IEC and its deliberation, and refrain from imposing top-down decisions based on business criteria.

Community representatives, including former patients or their family members who can provide important insight into the lay person's perspective on medical issues, and represent the committee and the hospital outside the institution. In case consultation they may be able to translate the language of health professionals into words and ideas more familiar to patients, and offer reassurance that the conflict over care is not a medical conspiracy. Community representatives are typically the most difficult for IECs to recruit and retain, often not because community members are unwilling to serve, but because the professional staff does not know whom to recruit. To identify potential community members, the IEC must know its patient population and what characteristics might be representative. Where community members are not effective representatives of the hospital's patient population, patients and their families may perceive the IEC to be simply another way in which the hospital protects its self-interest (29; 33).

Attorneys and ethicists, who may be found on the IECs of larger, urban hospitals, especially university-affiliated institutions with a program in medical ethics or medical humanities. Many of the country's first IECs were started in collaboration with faculty from such programs. Some university affiliated hospitals now have clinical ethics programs that offer ethics consultation services, as part of or independent of the IEC. Attorneys and ethicists have analytic skills and knowledge of tradition and contemporary standards that can strengthen the IEC's confidence and effectiveness. The place of lawyers and ethicists on the IEC has been debated, however, and many hospitals have no opportunity to include experienced professionals in health law or clinical ethics in their committees.

Lawyers and theoretical ethicists, with no clinical experience may misunderstand the issues and mislead the IEC with information and perspectives that, while technically correct, are inappropriately applied (22; 27; 54). Hospitals with an attorney on retainer are often hesitant to pay to have legal counsel attend committee meetings, and few nonuniversity hospitals contract for an ethicist's ongoing professional services. Small hospitals in large for-profit chains may work primarily with lawyers at a corporate headquarters who know little about the specific institution. Attorneys who see their single role as protecting the hospital from liability may encourage the IEC to become a risk-management committee; ethicists who see themselves as the patient's only advocate may put off the very caregivers who most need consultation; both may hamper the effectiveness of the IEC in consultation and the creation of policy.

Some handbooks written by clinical ethicists concede that there is no need for a staff ethicist on many IECs, but note that committees should attempt to include professional ethicists among their educational speakers (22; 23). However, the continued growth of this discipline and the educational opportunities in clinical ethics will almost certainly increase the prominence of clinical ethicists in the hospital setting.

Since the publication of its patient rights standards, JCAHO has taken interest in the makeup of IECs, and has begun to consider standards for IEC membership and ethics consultation (55). JCAHO's interest comes at a time when there is already a spirited discussion among clinical ethicists about the value of professional certification (56). Ethicists themselves are far from agreed on whether clinical ethics consultation is a profession, and if so what level of education, training, and expertise should be expected of its members. JCAHO is interested in the practice and credentials of clinical ethicists, but is particularly concerned about the quality of IECs in small and rural hospitals where ethicists are virtually nonexistent and few caregivers are likely to be proficient in clinical ethics. JCAHO is currently observing the creation of ethics committee networks in Virginia, with the hope that similar affiliations elsewhere could serve as cooperative regional ethics committees for institutions unable to create IECs individually (E.M. Spencer, personal communication).

Over the past several years, a number of local and statewide IEC networks have evolved across the country (57). Typically networks develop as members of newly formed IECs seek advice from other institutions, particularly in the areas of policy and consultation. Some networks have worked on standardized forms for DNR and supportive care orders, and others have defined community standards for withdrawing treatment; even informally, networks provide a means of establishing community standards for IECs by informing members about the operations and activities of other committees against which they may measure their own work. Some networks coordinate public educational efforts; others provide committee education or review difficult cases. With the implementation of health reform, such administrative umbrellas are likely to be increasingly important in facilitating the integration of IECs within health alliances, and safeguarding the ethical quality of care from the potential negative consequences of managed competition.

ISSUES ON THE HORIZON

As many new IECs become established, others are entering their second decade. The future of ethics committees will be difficult to predict, as much remains unknown about them currently. Some issues on the horizon include the development of IECs in long-term care facilities; the liability of IECs and their members for their consultation; the role of IECs in cost containment; and the need for formal evaluation of IECs and their varied roles.

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Footnotes

1. Some discussions of the development of IECs find important parallels to institutional review boards (IRBs) governing biomedical research with human subjects and/or Seattle's dialysis allocation committee of the 1960s. Like the IRB, hospital ethics committees are intended to safeguard patients' interests and right to informed consent; like Seattle's ''God Committee," IECs may deliberate on the appropriate use of advanced life-sustaining treatment. However, neither of these bodies is truly similar to the IEC. Its mandate has been much broader than that of the other structures, and was derived primarily from the need to define whether and how to end treatment that physicians might construe as being in the patient's interests.

2. For simplicity, all such institutional structures and processes will be referred to here as IECs.

3. Clinical ethics has developed as a field in Canada in parallel with the United States; although under somewhat different guidelines, IECs serve much the same purposes there as here.

4. In a some instances, however, patients and families will not seek transfer and doctors do not seek to remove themselves from the patient's case. Although this phenomenon has not been explored, it appears to be more common in community hospitals and where the physician and patient have had a long-term relationship. For patients, families, and doctors faced with a life-threatening situation, conflict in a familiar relationship may be preferable to the anxiety and unknown outcome of change.