Introduction

Clinical ethics committees (CECs) are now well established in many countries (Fox et al. 2007; Dörries and Hespe-Jungesblut 2007). There are several reasons for this phenomenon including an increasing pluralism concerning attitudes towards health care decision-making, emergent medico-technical innovations and global financial constraints affecting all health care systems. These developments have increased the complexity of many health care decisions, requiring consideration of a range of often conflicting values to be considered. The perceived lack of a common good, on the one hand, and the increasing demands for hospitals to both improve their patients’ welfare and respect their patients’ choices has resulted in an expressed need for some form of support in making these complex decisions. The introduction of CECs is one model proposed for supporting health care professionals in resolving values conflicts and improving respect for values such as autonomy and equity in practice. The commonly described functions of a CEC are clinical case consultation, education of health professionals, and policy/guideline development. Increasingly, however, CECs are also asked to help with resource allocation or management decisions within hospitals (Hurst et al. 2008).

Because of the diverse roles a CEC can have in one institution there has been ongoing debate about the position of a CEC within the health care organization in which it sits: Should CECs be independent bodies, with a rather systematic critical role towards institutional management, or should they be part of the hospital organization, participating actively in management processes? How is a CEC perceived within the institution? Some commentators have suggested they are seen by clinicians and managers alike as serving management and political goals (Foerde et al. 2008; Beyleveld et al. 2002). CECs have tended to decry this description of their role and defend their independence as supporters of the individuals at the coal face of clinical practice; patients, families and clinicians. However, CECs have always had to work within an institutional framework and with the increasing focus on their potential role in organizational ethics (MacRae et al. 2008; Opel et al. 2009). There is a need to consider the challenges they face in balancing their multiple duties.

In Europe the development of CECs has in general been bottom-up with few countries citing them as a regulatory requirement for hospitals (Steinkamp et al. 2007). This circumstance is in contrast to North America where accreditation bodies have been more directive regarding the need explicitly to address ethical issues in clinical care. Within Europe there is also the experience of transitional countries rapidly moving to a more westernized system of health care but with strong influences from previous, more authoritarian, approaches. European CECs, therefore, may face particular challenges in integrating ethics into their institutions. In this paper, we will discuss the organizational context in which CECs functions drawing on our experience with CECs in our own countries. We will focus on five key areas: the position of a CEC within the organization, the risk of a CEC being seen as providing “alibi ethics”, the process of CECs’ work (proactive or reactive), the relationship between CECs and quality management, and the impact of a systemic approach.

The Position of CECs Within the Organizational Structure

One of the challenges that CECs share, despite their diversity of goals and functions, is clarifying and establishing their position within the institution in which they operate. Given the range of models of CECs both nationally and internationally there cannot be one preferred option for a committee’s institutional position. Thus, in countries where hospitals are required by government to have a CEC, or where the presence of a committee is part of the accreditation requirements for hospitals it may be likely that the committee is part of the management structure of the hospital, whereas in countries with no regulatory requirement for CECs committees may be more peripheral to the institutional management (Steinkamp et al. 2007).

CECs have different histories; those developed in a bottom-up manner may find more immediate acceptance among clinical staff, whereas others that originate from administrative directives (top down approach) may be met by more mixed feelings. In the UK most CECs initially developed as informal advisory groups for clinicians and many have preferred to keep the name ‘advisory group’ or ‘forum’ rather than the more formal title ‘committee’ to emphasize their independent and advisory nature in contrast to other regulatory committees such as clinical governance or risk management (Slowther et al. 2001). However, even informal advisory groups must work within the institution’s management framework, if their work is expected to have an impact on patient care, so true independence from management is illusory. The degree of independence or integration may vary in different contexts, but the tensions between them provide challenges for all CECs.

One perceived advantage of independence or at least of being fairly peripheral to the management structure, for a CEC is that clinicians and other health professionals working in the institution are more likely to seek the CEC’s advice when they have ethical difficulties. This is particularly true for the service of clinical ethics consultation sometimes, but not always, offered by CECs. Cases referred to a CEC often involve conflict between health care professionals and patients or their families, or conflict within the health care team. Clinicians may think that in a particular case the right thing to do goes against institutional policy or increases institutional risk. They may feel that bringing these dilemmas to the CEC lays them open to criticism or investigation by senior management. Reassurance that this is not the case may sound more convincing if the CEC is not, for example, a sub-committee of clinical governance. Low referral rates to committees are common (Hurst et al. 2005; Slowther et al. 2001; Fox et al. 2007) and sometimes concerns about committee independence may be related to this (Foerde et al. 2008).

However, a committee that is not clearly part of the organizational structure of the hospital in which it sits risks being ignored. An alternative explanation for low referral rates to committees is that clinicians see no point in seeking advice from a group which has no recognized authority within the institution. An independent committee is also more at risk of being out of touch with the individuals and groups it professes to serve. A study of different perceptions of ethical challenges in health care institutions found that CECs were not identifying or addressing the range of ethical challenges facing clinicians, managers and patients within their institution (Foglia et al. 2009).

Many CECs do not limit their role to case consultation but also provide ethics input into institutional policy formation. A number of challenges facing CECs in contributing to institutional policy have been identified, including lack of committee awareness of the organizational process of policy review, lack of time on the part of committee members, and lack of knowledge and skills in the relevant policy areas (Ells 2006). Two key challenges which are directly related to a committee’s position and recognition within the institution are lack of a formal process for including ethics review in policy formation and failure of policy makers and management to incorporate the ethical advice or recommendations into the relevant policy. Of course being positioned within the formal organizational structure does not itself guarantee that a CEC will effectively influence institutional policy. Of more importance is recognition and respect for the committee by senior management evidenced by its use of the committee on policy issues and the inclusion of committee recommendations in policy implementation. This recognition is more likely to be embedded in the organizational hierarchy if the committee has a formal role within the organizational structure rather than an informal group that is more dependent on the goodwill or personal interest of an individual senior manager who champions their cause.

Another way in which the CEC can improve recognition within the management structure of the organization is to have institutional managers as members of the committee, in the same way that having senior clinicians as members improves the acceptance and use of the committee by clinicians. A CEC member who also sits on the Board or Executive of the organization will be able to monitor the use of the committee by policy makers and argue for the importance of the committee at a senior management level. However, there will be potential conflicts of interest for manager members of a HEC which is reviewing institutional policy or advising clinicians in situations where there is conflict with institutional policy. Manager members will need to clarify their dual roles and be explicit about conflicts of interest in these situations. The need to separate the role of CEC member from other roles within the institution is of course not limited to managers.

There are clearly benefits for a committee in being part of the formal organizational structure of the institution, including increased impact on policy, greater recognition among staff, and more practical benefits such as provision of administrative support and funding. However, the more firmly the CEC is embedded in the organizational structure the more difficult it may be for it to maintain its ethical independence. Concern about conflict of interests for clinical ethicists who are paid by the institution within which they provide ethics advice has been discussed in the literature. How easy is it to ask ethical questions about institutional policy or practice in this situation? While CEC members are not usually paid, many members are employees of the institution and may feel reluctant to be too critical of management or colleagues. If the committee sits within the organizational structure of the institution there may be expectations about how it should behave in relation to complying with institutional policy. If a committee is to perform its role of advising on ethical practice within the institution it will be important for it to withstand any actual or perceived pressure to modify its advice from senior management.

CECs as “Alibi Ethics”

When research ethics committees were installed in the second half of the last century the phrase “alibi ethics” was coined indicating some doubts about whether these structures would contribute to a more ethical practice in medical research. A similar response was triggered during the more recent move to institutionalize medical ethics in the form of CECs. What does it mean when terms such as “alibi ethics” or related metaphors appear in the context of CECs?

The most familiar meaning of “alibi” for most of us concerns the (criminologically relevant) statement that somebody has not been in a certain place, but in another, at a certain time, that the alibi provides proof that the person could not have done the unlawful act he or she is accused of. But what does “alibi ethics” mean? Presumably the claim would be that the institution cannot have behaved unethically because it has an ethics committee (or, in the case of an individual health care professional or researcher, that he or she has sought the advice of an ethics committee). The claim seems to be that a CEC or ethics consultation service is a “mere ritual” or just pretends more ethicality in a situation than is actually practiced. There is another metaphor for well-meant, but dysfunctional activities: the “fig leaf” is famous for hiding something embarrassing—more or less effectively. Activities or structures can under the label of “ethics” serve to hide the fact that an institution has a problem with its moral credibility.

A good example of well-meant, but dysfunctional activities in the realm of medical ethics can be found in the work of CECs in transitional East European countries. In the transitional societies in Europe some authors are reporting a “failure to thrive” syndrome, in CECs (Gefenas 2001). Countries in transition in central, eastern, and south Eastern Europe share a similar path of development and historical background. In the health care institutions in those countries prior to transition little if any attention was paid to the age, personal characteristics, religious beliefs, and gender differences of patients or to ethical problems that arose in the process of providing health care. Unfortunately, the legacy of this approach can still be seen in the current health care structures in these countries. Therefore, a legalistic approach to the formation of CECs has developed which transforms CECs into bureaucratic bodies, the CECs existing only to fulfill the requirement of various laws and bylaws that deal with ethical issues in health care settings. Their institutionalization is through a top down approach which is not uncommon in countries in transition, where the development of a civil society has been constrained by a former totalitarian government. These societies feel more at ease when the regulatory frameworks in all areas as well as in health care are implemented by the state. This approach is expected in health care systems which have previously been monitored and regulated by the government in a highly bureaucratic manner with no sensitivity to practical issues and the needs of the healthcare professionals (Borovecki et al. 2005).

Laws and bylaws that deal with ethical issues in health care settings in transition countries are taken lightly and their breach is not uncommon (Borovecki et al. 2005). Thus, it is not surprising that the work of CECs in hospitals is not well understood or respected. The situation is exacerbated by loss of trust in medicine by patients, low educational level of patients, and misunderstandings and manipulations of patient rights by the health professionals (Borovecki et al. 2006). If patients do not trust health professionals why should they trust ethics committees that are part of the health care system? Some authors go further and point out that CECs can also provide a context in which decisions potentially damaging for patients’ welfare can be made, and for which no one takes ultimate responsibility. This is most likely to be the case in settings where most members of the committee have insufficient education in the field of biomedical ethics, where conflict of interest with the administrative perspective exists and where the group dynamic is legalistic (Kuczewski 1999; Siegler 1986); transitional countries often fulfill all of these criteria.

In this climate the idea that CECs are unnecessary, that ethics is discussed in hospitals anyway, and that it has always been present in everyday practice, that the majority of ethics issues can be solved or prevented by present legal standards or their improvement and that physicians and hospital staff do not have time for participation in yet another committee are stressed (Dörries 2003).

So how can CECs overcome their label of an “ethical fig leaf” or providers of “alibi ethics”? The rethinking of the role of CECs in a transitional health care system, especially through their educational function, may be a possible remedy. By engaging with hospital organizational practice and educating clinicians in the ethical dimension of their work, CECs can help to create an ethical climate in a hospital and persuade clinicians and patients alike that the CEC is an active participant in improving patient care and not an alibi for institutionalized bad practice.

Should CECs be Proactive or Reactive?

Most of CECs’ work is in response to a request for advice on a case or an institutional policy that raises ethical issues, which means that CECs usually work reactively. Clinical ethics consultation, to mention just one task of a CEC, is a service usually working “on demand” (Reiter-Theil 2000), responding to the needs and wishes of health professionals (Aleksandrova 2008; Beck et al. 2008; Hurst et al. 2007), not forgetting the needs of patients and their relatives (Newson et al. 2009; Reiter-Theil 2009). The advantage of this process is that the facilitation or advice is wanted and thus accepted by the health professionals or managers concerned. One disadvantage can be that especially when clinical ethics consultations have been introduced into a hospital recently, only very few consultations take place as the staffs are not familiar with the process, or indeed the concept of an ethics consultation. Another problem with a purely reactive approach is that CECs only respond to requests from those persons who recognize that there are ethical issues or conflicts and who appreciate advice on dealing with it. Thus, CECs become engaged with those hospital departments or wards that want help most, but not with those who may have ethical conflicts without realizing them or who want to solve them, for reasons unknown, without external support.

The educational role of a CEC is of course proactive. CECs plan and perform various types of further education and training ranging from high-level conferences (“annual ethics day”) to rather informal quarterly staff meetings (“ethics forum”, “ethics café”), to specific in-house training sessions with external experts (e.g., facilitation of ethics case discussions). Furthermore, sometimes hospital guidelines are written on the initiative of the CEC itself. CECs’ contribution to hospital guidelines and policy formation can thus be proactive, with CECs identifying topics for policy development often emerging from a series of case consultation requests on the same issue, e.g., tube feeding or DNR orders.

Some CECs take steps to increase their proactivity to encourage more referrals for case consultation, e.g., by regular reminders about the purpose of ethics consultations and information about successful outcomes by using selected anonymised consultation examples on the hospital intranet, or by other educational activities. For the implementation of a written guideline into the daily practice of a hospital, CECs use established institutional procedures and values, as well as key personnel likely to be affected by the guideline or crucial to its acceptance on the ward. Thus, a CEC needs to educate itself about the institution, its values, structures and processes, to make an impact through policy development. The danger for a CEC of being seen as proactive is that clinicians and managers will regard the CEC as having a regulatory function (“the ethics police”) rather than a facilitative one. This in turn may lead to a resistance towards the involvement of a CEC in areas of moral conflict. If there is resistance on the wards against an ethics consultation, these conflicts cannot be solved by enforcement. CECs work most successfully motivating staff rather than by enforcing rules of conduct.

On the other hand, if a CEC has a policy of reactivity only, it may also fail. Dealing with ethical conflicts explicitly in discussion is a rather recent and unfamiliar way of communicating in hospitals. CECs, therefore, have to be aware that introducing a new culture to hospitals will take some years and continuous efforts, thus avoiding frustration when too few ethics consultations take place in the first years.

In practice, reactivity and proactivity intermingle. Each CEC must negotiate its own balance in order to act effectively within the specific organizational and social context of its host institution.

CECs and Quality Management

In 2001 Singer et al. listed five challenges for clinical ethics in the next decade, the first of which was integrating CECs into the quality improvement culture of health care institutions. There are two key questions that CECs must answer in relation to quality management: first, how does the CEC contribute to quality management within the institution in which it works and, second, how does the CEC as an institutional committee demonstrate quality in its service within the metrics of institutional quality management. Providing robust answers to these questions is a key to the acceptance and sustainability of CECs within a health care system. If CECs cannot demonstrate that they can contribute to improvement in quality of patient care then it is legitimate to ask why have CECs at all, and if an individual CEC cannot demonstrate a recognized standard of quality in its work then it will be held accountable in the same way as other services within the organization.

Since the early 1990s there has been an increasing focus on achieving and maintaining quality within the European health care system with the development of various quality standards, monitoring agencies and local clinical governance frameworks. Often these developments have occurred with achievement of quality standards being linked to certification of hospitals, as in Germany (Kooperation für Transparenz und Qualität im Gesundheitswesen 2010) or, as in the UK public health care system, to the self governance status of the hospital (2009). The quality standards used share many common features across international boundaries and include underlying principles of patient safety, patient centered care, equitable distribution of resources, efficiency and value for money, and effective, evidence based care. A recent consultation launched by the UK Care Quality Commission on its strategy for 2010–2015 contains the following statement: “Our work to achieve improvement in these priority areas will always be underpinned by the principles of equalities and human rights. This will include a strong focus on the differences in access to services, the safety and effectiveness of care and peoples’ right to be treated with dignity and respect” (Care Quality Commission 2009).

The principles articulated in this statement are fundamentally value laden and, therefore, putting them into practice will require significant ethical reflection. CECs can contribute to the development of quality management by the facilitation of considered reflection on the values underpinning quality improvement within the institution and how those values are interpreted by managers and clinicians in the provision of patient care. Nelson et al. have described the collaboration of an institutional ethics service and patient safety programme to develop a proactive approach to preventing ethical conflict (Nelson et al. 2008).

The combination of quantitative quality management analysis and qualitative ethical analysis can itself cause tension in the institutional endeavor to improve quality of care; for example, the ethically most appropriate management of a situation might not be the most risk averse (Fox and Tulsky 1996). There is also a danger that managers will see CECs as instruments to set and impose ethical standards rather than to facilitate and reflect on ethical practice. However, in working with quality management programs at all levels CECs can contribute to quality improvement across the organization.

If CECs are to play an important role in the development and management of high quality patient care they too must work to certain quality standards (Vorstand der AEM 2010). To claim an influential role in this endeavor requires acceptance of responsibility for decisions made and work done, and openness to external scrutiny of that work. There has been much debate with the clinical ethics community about what standards should be set for clinical ethics services, including CECs, and how the service can be evaluated against the standards once agreed. Difficulties highlighted have included lack of consensus over the goals of CECs, the competencies needed to achieve those goals, and appropriate outcome measures to assess whether they are being achieved (Fox and Tulsky 1996). Some steps have been taken along the quality road with several national organizations developing core competency statements (Vorstand der AEM 2010), but there is still very little evidence of robust evaluation of the kind one might expect from evaluation of a clinical service within the quality management framework. It may not be possible to measure CEC performance in a standard quality management framework. Quality management tends to focus on quantitative measures and standards. Ethical deliberation is qualitative in nature and its effect more subtle and diffuse than that achieved by other measures such as improved operating procedures or waiting times. Special evaluation measures might be required (Molewijk et al. 2008).

The task of defining and evaluating the quality of CEC’s work may be difficult, but is not impossible and to some extent the burden is on CECs to develop appropriate evaluative measures. Nilson and Fins (Nilson and Fins 2006) have argued that ethics consultation (as one of the roles of a CEC) can fit broadly within the rubric of clinical quality standards of safe, efficient, equitable and patient centered care, but that research is needed to establish what the elements of a successful (or high quality) ethics consultation might be. If CECs are able to contribute to ethical reflection on the quality management programmes in other areas of patient care within the institution it would seem appropriate that they also use their skills to reflect on the quality of their own work.

CECs and Beyond

Many years have passed since CECs and ethics programs first emerged in hospitals and other health care institutions. Such initiatives arose from the questioning of health care professionals and from the conflicts of values raised by the use of innovations in health care. Within this reference frame, the essential aims of these initiatives were to contribute more effectively to the quality of healthcare and, more specifically, to increase opportunities for hospital practice to reach its objectives of patient welfare, of respect for patients and promotion of their autonomy, and for equity in provision of patient care (Singer et al. 2001).

The role, effectiveness and the impact of such initiatives have been the subject of ongoing debate (Pearson et al. 2003) but the development of CECs has shown that attention paid to conflicts of values can be something other than an academic activity; that it is both possible and useful to extend the discussion of such questions to health professionals other than doctors and that moral deliberation has a place in the hospital alongside scientific debate (Boitte 2005).

The question that is raised today is whether these ethical activities that have developed inside health care institutions have a genuine impact on practice and make a difference with respect to the care of patients. Aside from “alibi ethics” committees exclusively organized to respond formally to legal obligations and consequently functioning in a purely bureaucratic manner (Borovecki et al. 2005), it appears that there are two models: either initiatives taken by field actors as discussion or consulting groups, or more formal committees, required by public authorities or accreditation rules which are then part of the hospital’s management structure (Slowther et al. 2001). The first ones are close to the field but risk being ignored or not taken seriously for lack of institutional recognition, while the second have institutional power but are distrusted by field actors and disconnected from daily practice. Does one have to make a choice between these two models or is there another way of conceptualizing clinical ethics services?

If the aim is that CECs have a greater impact on practice, we need to integrate the clinical ethics work into the organizational culture and to consider it in what has been called by MacRae and others a systemic perspective, taking into account the relations, structures and processes that control behaviors. This approach emphasizes the plurality of actors interacting in health care and the collaborative nature of this practice as a fundamental string for health care quality (MacRae et al. 2008). It seems necessary to conceive of the ethical approach as a learning process in solving the problems stemming from the diversity of the normative expectations of the actors involved in hospital practice: patients, professionals, managers (Cobbaut 2009).

This learning process requires both an anchoring in practice and a reflexive approach involving the various groups of actors in order to properly identify and analyze the ethical issues raised. In this perspective, the various approaches to clinical ethics (Steinkamp and Gordijn 2003), be they conceived as processes either of “case consultation” or “moral deliberation”, contribute to the development of an ethical reflexivity by the actors. Nevertheless, in order to have an effective and durable impact on health care practice these approaches must make it possible to question the collective frameworks of action that govern healthcare practice. This in turn implies that these approaches be integrated into institutional ethical programs that not only support and organize these practices but also may emerge in connection with them an organizational learning (Argyris and Schön 1996) and higher reflexivity of institutional frames. What is concerned here is not making a choice between the two types of devices, but installing a reflexive governance of the ethical approach inside health care institutions allowing both to articulate devices and to make the institution more responsive to stakes emerging from the clinical ethics development.

Conclusion

European clinical ethics committees, whether imposed as a quasi legal mechanism in a bureaucratic health care system or initiated by enthusiastic health professionals “on the ground” share the common challenge of integrating ethics into their organization often against substantial resistance at various levels. The challenge has many facets. It includes the need to maintain a critical independence while generating acceptance of the CEC and its potential benefit to both individuals and the organization, and in some countries (or perhaps all to some extent) CECs must counter the charge of “alibi ethics”. The challenge also includes balancing a proactive and reactive approach to ethical issues, practicing preventive ethics but not being seen as the ethics police. CECs must define their contribution to in-house quality management in their respective health care organization, clarifying how ethical reflection on various levels serves the hospital and patient care in general. This last challenge is made more difficult by lack of consensus about appropriate quality outcomes for CECs internationally. These are daunting challenges but the fact that CECs continue to develop, and in some instances to thrive, suggests that we should make the effort to overcome them. We believe there is a need for further research that specifically addresses some of the institutional challenges facing CECs (and other forms of clinical ethics services). We hope that this paper stimulates further debate in this area.