Clinical Ethics Committees: a due process wasteland?

At present in the UK, ethics support services, including Clinical Ethics Committees (CECs), ¹ are essentially informal in nature. ² They may also take different forms, and, according to Slowther et al., ³ the model of clinical ethics deliberation has changed over the years. Initially, they report, clinical ethics support ‘focused on the provision of advice to health professionals working in hospitals, usually through a hospital ethical committee or an individual ethicist’. However, this, they say, has changed, with services now including ‘support for other groups within the organization, specifically patients and managers’, as well as the provision of ‘support across institutions…’. ⁴ Moreover, many groups or committees have responded to the often urgent nature of ethical dilemmas by establishing subgroups or designated individuals who are capable of responding quickly to an issue as it arises.

The development of clinical ethics support and the interest in the issue demonstrate the extent to which the practice of modern medicine has become increasingly complex and sensitive. Clinical ethics support services have often been generated by clinicians themselves. ⁵

Where CECs (however designated) exist within hospitals (as opposed to within institutions, such as the Royal College of Nursing) it is, however, not mandatory to seek their opinion, and where an opinion/recommendation is forthcoming, it is not necessary to adhere to it. However limited their current authority, it is clear that some (if not all) clinicians welcome the support that ethics support services can offer, given the enhanced awareness of patients' rights in the medical interaction and the very nature of modern health-care delivery itself. Slowther et al., ⁶ for example, in a survey of clinical ethics support in the UK noted that ‘…many senior clinicians, as well as trust and health authority chief executives, believe that some form of ethics support service is desirable’. Moreover, they suggest that ‘…local support services may be needed to provide support that is responsive and relevant to local circumstances’. ⁷ The Royal College of Physicians agrees, saying that ‘[e]thics support is needed everywhere healthcare is provided…’, ⁸ also citing the ‘increasing awareness among health professionals of the need for appropriate local forms of advice…’. ⁹

However, despite this support, CEC provision in the UK remains patchy, with – for example – only one established CEC in Scotland (Grampian), and one pilot committee (Highland) which was established by the author and her co-researchers as part of a project funded by the Wellcome Trust's Biomedical Ethics Panel. ¹⁰ There is still time, therefore, to consider what functions are being, or should be, performed by such committees, as well as to evaluate any problems which might arise from their nature and structure.

In this discussion, I will pay particular attention to the issue of process in the provision of clinical ethics advice, since the quality of any advice offered is, I argue, intimately linked to the quality of the procedures and processes by which it is reached. Initially, the US experience will be used as a template both to identify the benefits and disbenefits of such committees and as an early indicator of how they may – accidentally or deliberately – come to have an expanded influence in the UK.

At present, UK CECs have no mandatory formal requirements as to membership and often no formal standing within health-care institutions, although the Royal College of Physicians ¹¹ and the experts at Ethox ¹² have produced documents which offer a ‘best practice’ template for CECs. Doyal argues that ‘their presence is necessary for any coherent approach to the formulation and implementation of good ethicolegal policy in a modern hospital setting’. ¹³ This, of course, presumes that the main, if not the only, function of CECs is the formulation of policy, whereas a number of other possible functions have been noted; for example, education, raising awareness of ethical issues and consultation on actual cases. ¹⁴ Campbell believes that CECs ‘can indirectly improve the quality of care by providing support to clinicians and managers as they face difficult clinical decisions; and they could help to create the kind of reflective and self critical culture within the NHS which will be essential for clinical governance to be a genuine, rather than a cosmetic, change’. ¹⁵

Nobody could sensibly deny that reflection on ethical issues is important in modern health care. The question remains, however, whether or not this is best achieved by the kind of support offered at present in the UK (and elsewhere). For the purposes of this discussion this is not the central question, although it has received some academic attention. Sokol, for example, has suggested that, while CECs can ‘provide a valuable service in drafting hospital policies and helping doctors resolve ethical dilemmas…’, they ‘are ill suited to respond to the immediate problems that doctors encounter in their daily work’. ¹⁶

Rather, the aim here is to explore what the future might hold for clinical ethics services in the UK, based on experiences elsewhere – most particularly in the USA – and given the current ‘state of the art’ in the UK. Specifically, I am concerned with the potential of CECs to evaluate real cases as opposed to developing policy or dealing with hypothetical cases, and the extent to which – if at all – they are alert to the requirements of procedural regularity. Some CECs (or subgroups) are already dealing with ‘live’ cases, involving real people. Making inquiry into how they do this is, therefore, of considerable importance, particularly since the range of issues raised with CECs covers an extremely wide and important set of matters of direct importance to patients and their families as well as to health-care providers. ¹⁷

Clinical ethics provision in the USA

Although it would be unwise to assume that what happens in the USA will inevitably happen in the UK, we have often seen trends migrate between jurisdictions. Indeed, it could be argued that the US experience was one impetus for the development of CECs in the UK. Clinicians on both sides of the Atlantic seem to have identified (albeit rather later in the UK) the need for some form of support when confronting ethical dilemmas in health-care delivery. While not every clinician will use the available services, research suggests that they will be utilized when certain incentives are present. In one study, these were reported to be as follows:

The most common factors that triggered physicians' requests for ethics consultation were: (1) wanting help resolving a conflict; (2) wanting assistance interacting with a difficult family, patient or surrogate; (3) wanting help making a decision or planning care; and (4) emotional triggers. ¹⁸

In a study conducted in the USA, while noting that ‘most ethically difficult situations are not referred to [ethics committees]’, Hurst et al. identified what drove the respondents in their survey to seek assistance. The main reasons articulated were as follows:

A need to obtain help in deciding what to do;

To identify a practical way of doing what had already been decided should be done;

To implement a practical solution;

To obtain reassurance that the correct decision was being made;

Better to face people who might otherwise think that the decision was inappropriate;

To seek consensus. ¹⁹

Despite the fact that the USA (and the UK) experience suggests that ethics services are not always used when ethical dilemmas arise, there is strong support for them in some quarters in the UK, ²⁰ and a survey in Quebec also showed considerable enthusiasm. Racine and Hayes, for example, report that in Canada:

Respondents overwhelmingly felt that the creation of an ethics service answered a need and would be very important. Many qualitative comments in the surveys welcomed enthusiastically the clinical ethics service project. Survey responses supported the idea of a broadly construed ethics service that includes case consultation and also ethics training, sensitization and information services. ²¹

Slowther et al. further explain the possible value of ethics committees as follows:

A model of ethics support that facilitates and informs a shared understanding of difficult ethical issues can support and reassure both clinicians and patients, without presupposing that there is an ethically correct outcome. Thus, a principal value of ethics support may lie in its contribution to the process of ethical decision making. ²²

In some countries, ethics committees are either effectively (some US States) or actually (Belgium) mandated by law. ²³ In Belgium, the function of the committees is legally defined as ‘a guiding and consultative task with regard to the ethical aspects of hospital care and a review task with regard to all protocols concerning human experimentation and reproductive human material. By law, the existing ethics committees also acquired the task to perform ethics consultations…’ ²⁴ Thus, there is a developing pattern in which ethics committees – both here and overseas – move beyond a merely policy-shaping role towards one which deals with actual cases. In fact, in the USA, the position has now been reached where ‘[e]thics committees and consultants are frequently called upon to help when disputes arise between physicians and patients, physicians and families, or physicians and nurses’. ²⁵

In the USA, some jurisdictions have taken this even further, proposing that ethics committees should perform a quasi-judicial role. For example, the case that probably was responsible for bringing ethics committees to wider attention was that of In The Matter of Quinlan. ²⁶ In this case, which involved the possible removal of life-sustaining treatment from a young woman in PVS, the Court was impressed by the earlier proposal from a Dr Karen Teel, ²⁷ that ethics committees could usefully review major ethical dilemmas in health care, and argued that ‘[t]he most appealing factor in the technique suggested by Dr Teel seems to us to be the diffusion of professional responsibility for decision, comparable in a way to the value of multi-court judges…’ ²⁸ While this may be unobjectionable, the Quinlan court without explanation, beyond it being ‘impossibly cumbersome’, also declared that decisions of ethics committees should effectively be final, and did not generally favour ‘a practice of applying to a court to confirm such decisions…’ ²⁹

Subsequently, in the case of In Re Conservatorship of Torres, ³⁰ which involved the decision whether or not to remove the ventilator from a 57-year-old comatose man, the court record showed that three ethics committee reports agreed with the decision to stop treatment. The Court said ‘…these committees are uniquely suited to provide guidance to physicians, families and guardians when ethical dilemmas arise’. ³¹ Finally, in the case of Re AC, ³² which concerned the performance of an enforced Caesarean section on a terminally ill woman, Terry J said:

We observe… that it would be far better if judges were not called to patients' bedsides and required to make quick decisions on issues of life and death. Because judgment in such a case involves complex medical and ethical issues as well as the application of legal principles, we would urge the establishment – through legislation or otherwise – of another tribunal to make these decisions, with limited opportunity for judicial review. ³³

Each of these cases, apparently without real scrutiny of, or concern about, the actual abilities or procedures of ethics committees, seemed content to cede considerable authority to their advice or recommendations, even to the extent of effectively barring the law from reviewing them. In what, to this author at least, is a more realistic counter-argument, the court in the case of Superintendent of Belchertown State Hospital v Saikewicz ³⁴ was considerably more cautious, saying:

Questions of life and death seem to us to require the process of detached but passionate investigation and decision that forms the ideal on which the judicial branch of government was created. Achieving this idea is our responsibility… and not to be entrusted to any other group purporting to represent the ‘morality and conscience of our society’, no matter how highly motivated or impressively constituted. ³⁵

Despite the reasons to be concerned about non-legal bodies being permitted to substitute their judgement for that of a court – especially in life and death matters – even in the legal community in the USA, reportedly, ‘[t]here have….been some murmurings…. that the role and authority of ethics committees be expanded to allow them to substitute for judicial decision-making in certain cases’. ³⁶ The US experience suggests an all-too-easy move from advice to authority and from commentary to decision-making. This has occurred irrespective of the declared aspirations of committees and their members alike. In fact, as Ritchie points out, in the USA, ‘[t]he institutional force of some recommendations is so strong that they are, in effect, mandatory… Initially, ethics committees tended to be informal groups… Today's ethics committees are more likely to have official status… and their recommendations may be seen as more binding.’ ³⁷ Wolf further notes that ‘… committees, even when they protest that they are merely advisory, can actually wield significant power’. ³⁸ A similar possibility was noted by the (UK) Royal College of Physicians in its 2005 Report. The College said that ‘… even where the CEC makes it clear that it is not a decision-making or regulatory body, there is a potential for its advice to be seen as binding…’ ³⁹

Although CECs in the UK do not apparently aspire to an equivalent role to their US counterparts, at least one leading commentator on ethics services in health care has proposed that they might play a similar role. Slowther ⁴⁰ has suggested that, in the case of Ms B (a woman who wished to have ventilation discontinued) ‘[h]ad the NHS trust caring for Ms B had a Clinical Ethics Committee, it could have provided a neutral forum for clarification and discussion of the issues which may have led to a resolution without the need to apply to the High Court for a decision’ ⁴¹ (emphasis added). While not directly proposing that ethics committees should supplant courts, this suggestion bears some similarities to the path trodden in the USA from advice to decision-making without the need to refer to courts. However, even if there has been no direct call in the UK to turn ethics support services into more than the advisory bodies they currently are, there are legal questions that require attention. Not only have court judgements been instrumental in generating awareness of the dilemmas of modern medicine, but the Royal College of Physicians believes that ‘[t]he boundary between medical ethics and the law is becoming more complex. Matters formerly regarded as “purely ethical” are now subject to common law and shaped by decisions in specific cases…’ ⁴² Thus, for advice to be appropriate, it is also the case that attention to legal rules is mandatory in many, if not all, cases.

Arguably, this will have an impact on the nature of ethics support services, requiring them not just to ‘do ethics’, but also to have some expertise in, and awareness of, legal matters. This pattern has already been acknowledged in the USA. Scheirton and Kissell, for example, note the ‘increasing influence [of the law] on bioethical decision-making and on Health-care Ethics Committees (HECs) in general’. ⁴³ As De Ville and Hassler have said:

While it is true that what is ethical may differ from what is legal (or from the option that poses the fewest legal risks), this is not always the case. Law, after all, is not devoid of moral content and is relevant at least as a guide or articulation of the minimally accepted bounds of behaviour. ⁴⁴

Not only has the difference between law and bioethics narrowed but attention to law and legal norms requires that some kind of formal justice is achieved even by purely advisory bodies. Indeed, the Royal College of Physicians recommended that the decisions of ethics support services should be audited for consistency – one of the most important constituents of formal justice. ⁴⁵

Irrespective of the formal legal position of ethics committees, two trends emerge from the USA experience. First, that ethics committees may incrementally gain in authority; second, that judicial recognition of their existence and role can lead to an enhanced status and authority without a thorough (or in some cases any) investigation of their abilities, expertise, processes and procedures.

As Wolf says, ‘…ethics committees now wield sufficient influence over the fate of real patients that they must do so responsibly, accountably, and with some guiding rules…’ ⁴⁶

Clinical Ethics Committees, formal justice and due process

While some efforts have been made in the UK to encourage and foster accountability and transparency in ethics support services – and this is endorsed both by the Royal College of Physicians ⁴⁷ and Ethox ⁴⁸ – the extent to which the need for formal justice is recognized and brought to bear on practice is less than clear. In the questionnaire sent to all CEC Chairs in the UK, we asked a question designed to elucidate the extent to which CECs were alert to the need for serious attention to process by instituting operational policies. Although only eight (24%) of the 33 CEC chairs who completed our questionnaire stated that their CEC did not have a written operational policy, with one chair stating that their written policy was currently in draft form, the extent to which these operational policies would satisfy the perceived need for accountability and transparency in CEC decision-making is not clear. While this may be less than urgent for the moment, the increased activity in ethics consultations arguably makes it a matter of importance for early consideration. Even if CECs in the UK do not seek or achieve the more powerful position occupied by some of their US counterparts, this does not mean that attention to process is irrelevant, either for the committees themselves or for those they serve.

Slowther et al. ⁴⁹ agree with this proposition, saying that, especially during the development of CECs, it is ‘important that any services have clearly stated objectives, and that there is a rigorous evaluation of both process and outcome during their development’. Effectively, this is a plea for attention to what in law would be called due process. Moreover, it is in line with the requirements of Article 6 of the European Convention on Human Rights (incorporated into UK law by the Human Rights Act 1998) as to the right to a fair hearing. This Article, among other things, states that ‘[i]n the determination of his civil rights and obligations… everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial tribunal established by law’. If, as has been suggested, the deliberations and advice of clinical ethics support services can and do have a direct impact on patients, then it would seem desirable that any relevant committee should be able to demonstrate its independence and impartiality as well as its fairness. Exemptions to the need for a public hearing are contained in the Article, and need not concern us here.

Admittedly, whether or not CECs are subject to the strict terms of the Convention will depend on whether or not they are deemed to be ‘public bodies’, but it is surely incontrovertible that ‘best practice’ would mandate adopting the spirit of the Convention. Thus, both formal justice and due process are concepts which need to be borne in mind when constituting and operating clinical ethics support services. This may seem obvious, but it is not yet clear to what extent existing services actually pay close attention to these concepts.

Even if the provision of ethics support in the UK remains advisory only – and experience elsewhere suggests that this may be merely a transient phase in their development – there are important legal as well as ethical considerations that require attention. Doyal suggests that CECs can make a ‘positive contribution to improving clinical practice and the general quality of healthcare’ if ‘the creation and effective use of substantive moral and legal principles… [are] grounded in collective discussion… [which] should conform to procedural principles that ensure the participation of those with relevant expertise and effective, fair debate between them’. ⁵⁰

The rules of formal justice and due process (or even non-legal equivalents) are taken seriously in the Royal College of Physicians' Report already referred to, and doubtless committees and other services will take this seriously. Indeed, Wolf has claimed that ‘[e]ven when the law would not strictly impose these process obligations, committees have an ethical obligation to accord due process because of the power they may exercise over the resolution of treatment disputes’. ⁵¹ While this comment relates to committees in the USA, it plausibly applies also in the UK even if the authority of clinical ethics services is less pervasive than it is in the USA.

However, perhaps inevitably, it is not yet clear whether every UK committee actually abides by these concepts in terms of their procedures and processes. That being so, there must at present be reason to consider whether the (relatively) ad hoc nature of these committees or services is in need of review. While, as has been noted, no serious suggestion has been made that ethics support services in the UK should take on the role adopted by some of their US counterparts, their perceived success may yet lead to a re-consideration of their role. Equally, it has been suggested that while ‘no [UK] court has yet considered an ethics committee's recommendation…’, nonetheless ‘in view of the UK courts’ traditional deference to the medical profession, it is unlikely that they would seriously challenge a CEC's decision – unless of course, it failed to comply with a responsible body of medical opinion'. ⁵² In addition, the Royal College of Physicians notes that CEC advice may carry additional legal consequences. For example, its Report says that any perception that the committee's advice is mandatory may ‘produce difficulties if a clinician were to override the CEC or to even fail to consult it at all and subsequently be sued for negligence. Another, opposite, problem might arise if the CEC's advice were to be followed by a clinician who is then the subject of a legal action. In a situation such as this, the committee might be concerned about its legal liability.’ ⁵³ Thus, while formally, the advice given by ethics support services such as CECs may be purely advisory (and intended as such) in practice there may be legal consequences which merit serious consideration.

Most committees in the UK (as in the USA) developed by initiatives from the coalface. Doctors and other health-care professionals recognized the need for a reflective approach to the dilemmas they increasingly faced, yet – if these committees develop in an ad hoc manner without careful regard to procedural (and other) requirements – they may struggle to provide the service being sought.

It might, of course, reasonably be objected that requiring CECs to conform to legal and procedural rules would so significantly change their nature that they would cease to be ‘ethics’ committees and would become ‘legal’ committees. This is, in fact, at the crux of the question. If it is important – as is argued here – that attention is paid to procedural requirements, such as the right to a fair hearing and due process, CECs might become different entities. Arguably, they might need mandated rather than advisory policies on recruitment, membership, procedures and so on. As Annas argues:

If they are to provide a forum for dispute resolution, ethics committees must follow some basic due process guidelines. Once these are provided, however, the committee becomes a mini court… and both its procedures and the substantive rules it applies are likely (and appropriately) to be much more legal in nature than ethical. ⁵⁴

In the final analysis, this is the major challenge for CECs. If they want to ‘do ethics’, they need to be equipped with ethical expertise. But even if this remains their only aspiration, the more they attend to the procedural rules which their very existence arguably demands, the more they may become legalized and less like ‘ethics’ committees. If ethics support services are to play (or continue to play) an important role in modern health-care delivery, this is an enigma that needs to be solved.

Conclusion

The remaining question, then, is – what should be the future of clinical ethics support services, and most particularly of CECs? Our research showed little appetite among those CEC chairs who responded to us (admittedly less than 50% of those invited to participate) for regulation by law, but 85% of respondents believed that guidelines were required, believing that national guidelines would achieve a number of things. They could assist in directing CEC agendas, enhance practice and ensure a degree of consistency between committees with regard to standards, CEC membership and training of members. While the need for national guidelines was emphasized, the need for such guidelines to be flexible to take into account the individual needs, aims and objectives of CECs was also stressed.

Doyal believes, however, that more is needed in the way of regulation, arguing:

There is no reason any longer to tolerate a double standard where rigorous regulation of clinical activity is confined only to research. A high standard of clinical care is essential, whatever the context of its delivery. Properly organized and functioning CECs can help to ensure such a standard through the active involvement of clinicians themselves. ⁵⁵

Without going so far as this, Campbell suggests that it is imperative that CECs should be subject to review by the demands of clinical governance. He says:

…ethics committees themselves should not be exempt from the sustained and planned scrutiny of clinical governance. Do they provide a service that meets national standards of professional ethical consultancy? How do they audit their own performance? And what measures are they taking to remedy deficiencies in their own procedures? If – to return one last time to the maritime image of governance – they see themselves as part of the good ship NHS as it tries to chart its somewhat perilous voyage, we need to know that they are professional and trustworthy members of the crew. ⁵⁶

Whether legislation or internal review is the way forward remains moot. While Hoffman believes that (in the US) legislation is needed to ‘provide “quality control” for such committees and to protect patients from them…’, ⁵⁷ clinical ethics support services in the UK arguably have less authority. This may suggest that there is less need to consider providing for them in law. However, if concerns about the need for formal justice and due process are taken seriously, it may well be that a legal structure, such as that introduced recently for Research Ethics Committees (RECs), is one obvious way of achieving these goals. After all, the criticisms that may be levelled at CECs are not dissimilar to those that were previously made in respect of RECs. Consideration of the impact of legislation on RECs may point the way for CECs in the future. While their tasks are different, each committee has an ethical remit and a need to ensure fairness in operation. This is not to argue that the legislative model need be the same in each case, but rather to reinforce the argument here that even doing ‘good’ ethics is not a sufficient safeguard. Procedural regularity is also important, even if occasionally under-rated.