Ethics Committees: Time to Experiment with Standards

Ethics committees for patient care issues have become a fixture in hospitals in the United States. A 1992 survey (Phillips DF. Personal communication) by the American Hospital Association found that of 5916 respondent hospitals, 3015 (51%) had such a committee. These committees had their beginnings in the area of research [1]. As early as 1966, the Public Health Service required [2] that projects submitted to the National Institutes of Health involving research with humans receive previous local group review. In 1974, federal law [3] mandated institutional review boards for institutions or other entities applying for a grant or contract to conduct research involving human subjects.

In the area of patient care, ethics committees were established in some institutions in the 1970s in response to recommendations by the New Jersey Supreme Court in the Quinlan case [4], and later, in response to recommendations of a President's Commission [5] and the “Baby Doe” guidelines [6]. A few states have passed legislative mandates. In Maryland [7], for example, all licensed hospitals and nursing homes must have a “patient care advisory committee”. In New Jersey [8], hospital-licensing standards include a provision that a hospital have either an ethics committee or a prognosis committee. New York State has legislation [9] pending that would mandate the establishment of committees. Recent legislation has even stipulated that certain types of cases or disputes be taken to these committees. For example, the recently enacted Maryland Health Care Decisions Act [10] requires that if a disagreement exists among family members of the same class (for example, the patient's children) about termination of life support, the dispute must be referred to the institution's ethics committee; the health care provider may follow the recommendation of the committee without fear of liability for failure to obtain the appropriate consent. The Arizona Living Wills and Health Care Directives Act [11] permits that if a listed surrogate cannot be located, the patient's attending physician may make health care treatment decisions for the patient after consulting with and obtaining the recommendations of an institutional ethics committee. The proposed New York State legislation, similarly, would allow a physician to rely on the advice of an ethics committee for a patient who has no agent or close family members, thus avoiding guardianship proceedings.

As ethics committees have evolved, the scope of their legitimate authority and their legal status have often been debated. In this issue of Annals, Fleetwood and Unger [12] argue against proposals to give legal immunity to those who implement recommendations of an ethics committee, as a Hawaii statute does [13]. We agree with their conclusion primarily because of the variability in what committees do and the absence of any standards by which to evaluate their performance. Thus, it is premature to grant such immunity or to otherwise elevate the status of these committees without better “quality control” of their operation [14]. At this stage of their evolution, what is needed are evaluative studies on their operations and effectiveness as well as experimentation with “quality” standards.

In 1991, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) mandated [15] the establishment of a “mechanism” to consider ethical issues in patient care and to educate health care professionals and patients in these issues. However, it has not issued guidelines for what satisfies this bare rule. This “notably vague” [16] requirement allows for vast diversity among institutions to address ethical issues in patient care. This diversity is evident in the many names used for these “committees” (for example, “hospital ethics,” “bioethics,” “institutional ethics,” “patient care advisory,” “human rights”). Some institutions rely on individual consultants for services and may not have a committee. The similarities and important differences between committee and consultant models in the provision of bioethics services have been documented elsewhere [17]. Although our comments will focus on ethics committees, our suggestions with experimental standards may also be applicable to ethics consultants.

A recent survey of committees [18] showed that their three most common tasks were educating clinical staff and patients about ethical issues in patient care, developing institutional policies, and providing consultative services on request. Despite this general agreement on tasks, little consensus exists about standards for education and skills necessary for membership on a committee, or for the internal operations of committees, for providing consultation as a committee member, or for procedural guidelines for the conduct of consultations.

We have given a major part of our careers to work with ethics committees in the Mid-Atlantic states. With some important exceptions, most members of ethics committees engage in little or no serious study of clinical ethics or related topics. In practice, each member tends to maintain his or her own personal concept of ethics, which is rarely examined in serious debate. In many places, committee members begin to serve without even a modest orientation to the committee's tasks. Moreover, we have seen committees, which are confused about their advisory role, make decisions “behind closed doors” [19] at the request of clinicians who approach the committee without notifying the patient or surrogate decision makers. Standards of due process are not followed and may even be unknown to the committee. Inattention to procedural due process raises concerns that the rights of caregivers, patients, and patients' families are possibly being compromised or violated [16, 20]. The degree of respect for confidentiality is difficult to judge, but patient's charts are easily obtained by consultants whose participation in care is unknown to the patient. Some committees also call on the services or advice of external consultants who have no locus of accountability in the institution. In short, we worry that an “ethics disaster” is waiting to happen.

Even at their best, ethics committees are not well used by clinicians or patients and surrogates. Major causes include lack of knowledge about the committee's services, poor institutional support, and a lack of confidence due to the absence of research on the outcomes of consultations [21, 22]. The literature on ethics consultation consists of collections of case reports [23, 24] and evaluations focused on physicians [25-27] who requested consultation. To our knowledge, no epidemiologic research exists on the efficacy of ethics consultations for specific decisions made in patient care. The absence of such studies has lowered expectations of committees and has increased physicians' skepticism about contacting them in ethically troubling cases [28].

Another source of confusion stems from role conflicts among the ethics committee, legal officers, and risk managers. When committee members are unsure of their mission and administrators are overly concerned about protecting the institution, legal and risk management concerns can easily displace the committee's authentic role. Macklin [29] describes a classic situation in which excessive legalistic concerns undermined an ethics committee's efforts to shape a hospital policy for pregnant women who refused blood transfusions because they were Jehovah's Witnesses. An ethics committee that becomes a forum for risk management has abdicated its mission [30].

Dependence by a committee on a single ethics consultant risks unchecked ethical bias and the exclusion of other important participants in what should be a multidisciplinary process. Scofield [31] has warned about the professionalization of ethicists and has expressed his skepticism about their expertise, adding to concerns about the qualifications of a single consultant providing bioethics services in patient care, even as part of a committee.

Hospitals that invest in the education of resource persons for committees can point to some progress in remedying these major problems [32]. Good multi-institutional epidemiologic studies of the process and outcomes of ethics consultations depend on agreeing on the goals of consultation [33], on strengthening an educational and training infrastructure for ethics consultation, and on experimenting with standards. Wide diversity in consultation practices now presents major obstacles to such studies. For example, crucial data are missing because some committees or consultants do not enter chart notes or submit reports of their work to review committees.

Diversity also exists on the most important issue of consultation, that is, whether a committee should make a single recommendation for the resolution of the ethical problem or should merely frame the ethically acceptable options and only assist key decision makers with moral and legal standing to choose a course of action, including choices with which committee members might disagree. Although many committees recommend a preferred course of action, such an approach may infringe on the moral autonomy of those persons they are supposed to serve. Of interest in this regard is a recent survey [34] to assess consensus among 154 ethics consultants, 81% of whom are ethics committee members, about eight variations on a hypothetical case of a patient in a persistent vegetative state. The study found wide variation in the specific recommendations from the respondents for seven of eight scenarios. We are concerned that although the authors discussed the importance of diverse approaches in assisting participants during an ethics consultation, the unintended message may be that ethics committees should always make a single consensus recommendation to resolve an ethical problem.

Where do we go from here? The time for a laissez faire approach to ethics committees is long past. Some form of regulatory oversight is to be expected because the activities of ethics committees bear directly on patients' rights and enable life-and-death decision making. Committees are also aiding institutions in the dialogue about medical futility and rationing of efficacious treatments in the face of economic scarcity [35]. Although self-regulation is preferable, if it fails, committees potentially face regulation by the JCAHO [36], state or federal agencies, or court-imposed practices.

In response, we strongly recommend a period of experimentation with standards aimed at raising the level of accountability in practices of committees. Such standards should address: 1) access to the committee and its services; 2) education and training of committee members; 3) case consultation procedures; 4) documentation of consults; and 5) review of committee processes and recommendations [16]. Review ought to include a means for parties to consultations to lodge timely complaints and appeals, especially in cases in which undue control or influence may have been exercised by a committee or its consultants.

As to standards for appropriate education and training, more consensus is needed on what new and continuing members should learn about ethical concepts and approaches to ethical problems in patient care. We recommend that standards be structured in two tiers, one minimal and one exemplary, and that the locus of judgment about satisfaction of educational standards remain in each institution as it presently does for other hospital committees. At a minimum, new ethics committee members ought to receive a thorough orientation to the history and literature of ethics committees and to the specific mission and duties of their own committee. New members should also engage in a course of study of ethical concepts, types of ethical problems most frequently faced by clinicians and patients, and methods of ethical decision making. Relevant health law and differences between legal and ethical considerations need to be stressed. This minimal standard should be satisfied before new members are given full committee assignments.

The exemplary standard would be applied to members who plan to participate in clinical ethics consultations or for members responsible for training others in case consultation procedures. A 1988 conference sponsored by the Society for Bioethics Consultation [37] concluded that education and training of bioethics consultants required in-depth work in biomedical ethics, health care law and public policy, clinical medicine and decision making, cultural and religious traditions and their effects on health care decisions, and psychological and interpersonal knowledge and skills. These areas also appear appropriate for ethics committee members engaged in case consultation.

Several local or regional networks of ethics committees or “bioethics networks” have evolved [38-40]. A network usually begins as an alliance among clinicians and citizens who want ethics committees to succeed, committee members in need of support, and educators in bioethics and health care law familiar with the needs of committees and the local communities. We believe that such networks are good settings in which to debate, plan, and implement a trial period for standards because of the prevailing diversity of committees.

Institutions must make choices about how they shall proceed. La Puma and Priest [41] described an institutional model requiring medical staff privileges for ethics consultants designed to “protect patients” from those who lack expertise in clinical ethics. A broader option [42], as regional and local networks gain credibility and strength, would be for them to support orientation and education (initial and continuing) for committee members as well as provide technical assistance with and offer a training process for those conducting ethics consultation. Institutions and ethics networks desiring to improve quality in bioethics services and in the education of ethics committee members [43] can forge cooperative educational and training relationships. A newly formed, statewide network in Virginia has recently embarked on the task of defining how education and training will be organized and delivered.

Ethics committees are no longer in their infancy [20]—they are aiding decision makers to make important life-and-death choices. We agree that a great need exists for epidemiologic studies and evaluative research on ethics committees; this must continue to take place. But we cannot wait for the definitive study to begin to experiment with minimal standards for these committees.

• Copyright ©2004 by the American College of Physicians