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Practical Guide to Clinical Ethics Support

Section F: Legal issues and clinical ethics

A clinical ethics committee (CEC) sits within the framework of the institution (NHS trust or private hospital) and carries out its functions with the approval, and within the control, of the trust. Many CECs report directly to the trust Board while others report to one of the other committees within the trust management structure, for example the clinical governance committee. In any event, the trust will be responsible for the conduct of the CEC to external scrutiny. The trust will be concerned therefore to ensure that the CEC has adequate processes in place to address issues such as confidentiality (of individual patient information and information relating to the trust), and to ensure that the advice and support provided by the CEC is consistent and ethically informed. In this section we consider some areas where the law may have an impact on the work carried out by a CEC, including:

  • Legal liability of a CEC and of individual members of a CEC
  • Patients’ notes and referrals to a CECs
  • Action taken by the healthcare professional following a case referral to a CEC

Legal liability of the members of a CEC

Relevant issues for consideration include:

  • The extent to which individual members as opposed to the CEC itself, can be legally liable - for what and to whom?
  • The extent to which a member of a CEC represents the view of the trust, and/or its own views and/or the individual views of its members.

As Judith Hendrick commented in 2001,

“...the vulnerability of committee members to legal action is difficult to assess with certainty.” 1

In the United States, where CECs have been a feature of hospitals for the past 30 years, there have been no occasions to our knowledge when an ethics committee, or an individual ethicist, has been held legally liable for the advice that they have given. However, there is increasing concern that this will not continue to be the case, and concerns about legal liability have in part driven the debate about developing standards for ethics consultation. The potential for legal action is most likely to arise where a CEC has been asked for prospective advice concerning the care of a patient, for example whether it is ethical to withhold treatment from a patient. The patient, or his / her relatives, may argue that the view of the CEC was inappropriately persuasive, coercive and/or negligent. If perceived to be exercising its functions as part of the NHS, which is a public body, then a CEC could find its decisions and processes open to judicial review. However, the most likely action taken against a CEC would be a negligence claim.

Negligence of the CEC

In order for an action in negligence to succeed, three conditions must be met.

The claimant must establish that he/she was owed a duty of care

Certainly the doctor with clinical care of the patient who refers the case for consideration to the CEC owes a duty of care to the patient. The hospital or trust also owes a duty of care to all patients for whom it is providing health care, including the establishment of systems necessary for the safe operation of the trust. A clinical ethics committee too may be considered to owe a duty to the patient, and the patient’s relatives if acting as part of the health care team.

There must be a breach of the established duty

In establishing a breach of duty it is necessary to demonstrate that the required standard of care has not been met. Unlike research ethics committees, CECs are presently unregulated so it may be difficult to determine the standard by which a CEC should be judged. Essentially there would be a breach of the duty if the CEC fell below a standard required by the common law, established with reference to current case law precedents.

There must be a causal link between the duty of care and some legally recognised form of harm

For a claimant to succeed it must have been foreseeable that the breach of duty suffered would cause, and has caused, some legally recognised form of harm. Forseeability is judged upon whether the type of harm suffered could reasonably have been predicted. In this context a claimant may argue that the clinician would have acted differently without the advice of the CEC and accordingly that the involvement of the CEC has led to foreseeable but avoidable harm.

There are some difficulties in applying the conditions of a negligence action to the work of CECs as they currently stand in the UK. Firstly, there is no requirement to refer a case or an issue to a CEC (in contrast to the position in some States in North America). Secondly, even if there is a referral, the role of a CEC is seen as advisory and supportive rather than decisive. Only in situations where a health professional was required to follow the advice of a CEC could it be clearly demonstrated that a breach of duty on the part of the CEC had directly led to the ensuing harm. The legal position would be much less clear when, as is the case in the UK, a health professional is held responsible for the standard of their own actions and decisions, and can ignore the advice of a CEC.

Negligence of the trust

Whilst a trust need not have a CEC to demonstrate that it has systems and processes of a reasonable standard, appropriately organised CEC’s may facilitate clinical management and play an active part in clinical training supportive of best practice in relation to patient care. However, if the clinical ethics support provided by the CEC fell far short of what could reasonably be expected i.e. no-one on the committee had any ethics training, then the trust could be said to have breached its direct duty and be liable in negligence.

Unreasonableness of CEC view

The role of a CEC in advising trusts on policy and guidelines, or in providing advice on individual cases, may be scrutinised by a judicial review of trust policy or treatment decisions. The advice of a CEC could be challenged on the grounds that it acted unreasonably or took into account irrelevant considerations. The Human Rights Act 1998 and case law developments related to treatment decisions suggests that health organisations will increasingly face challenges about the fairness of decisions which may be perceived as adversely affecting the rights of individual patients or patients’ relatives.

Points for a CEC to consider

  • In order for a CEC to show that it is acting reasonably it is essential that the processes by which it operates are open and transparent. It should also be able to demonstrate that the manner in which it comes to a decision is informed and consistent i.e. like cases are considered in like fashion and any deviation can be explained on relevant grounds.
  • A CEC will need to demonstrate that its members have sufficient knowledge of ethics to enable ethical issues to be identified and informed ethical debate to take place. Different levels of knowledge and skills may be required for different committee functions, for example case consultation may require specific skills that are less important in advising on policy and guidelines. This raises the question of appropriate training for CEC members.
  • It is important that CECs have clear terms of reference about the extent to which individuals represent, and may act independently, of the committee. For example what happens if a member is approached by a clinician for advice on an urgent ethical dilemma? When is advice informal and when is it seen as having the authority of the committee?
  • CEC’s should be aware of, and be able to access, relevant national guidelines, for example GMC guidance on confidentiality. They will also need to be aware of, and have access to information about, relevant law. While they should not be seen as providers of legal advice, they should know when legal advice is likely to be required in specific cases.
  • It is important for the committee to establish proper criteria for membership. There should be a transparent process by which members are selected, and continue to be part of the committee. Members who are not employed by the trust will need to undergo an appropriate checking procedure before appointment akin to that applied in relation to the selection and appointment of Non-Executive Directors.

Legal indemnity

There is a statutory exemption that covers liability for negligence for trust employees, for acts and omissions carried out in the course of their employment. Thus, in the event of a CEC being sued for negligence, trust employees would have indemnity from personal liability. This would not apply to those members of a CEC not employed by the trust. Thus we would recommend that a trust makes arrangements to provide indemnity for CEC members who are not employed by the trust for their work as members of the CEC.

The obvious point to emphasise in respect of any indemnity afforded by the trust is that it will only extend to acts and omissions arising in the course of the committee members normal duties (as members of the CEC). Hence the importance of setting out the boundaries of the role of committee members, for instance in providing ‘informal’ ethics advice outside the committee.

Several CECs have Trust indemnity for lay members of the committee. Contact details of these CECs can be obtained from the Network administrator.

Confidentiality and exceptions to duty of confidence

Members of a CEC will owe an ethical, professional and legal duty of confidentiality to patients and other third party non-healthcare professionals named within a patient’s medical records except in limited circumstances where there is a duty to disclose these records, for example, in situations where the is a risk of a serious crime. Lay members are also under a legal duty of confidentiality in respect of their discussions of cases in CEC meetings. Lay members should be made aware of this obligation upon joining the committee and an undertaking of confidentiality should be signed.

Patients’ notes and referrals to CECs

CEC documents i.e. minutes, case write ups, agendas etc. are not public documents as such but) they may be disclosable as part of a court action if considered relevant to issues arising in the legal case.

If sufficient information is available for the patient to be identified then the case write up, or minutes of the meeting appertaining to that case, could be deemed part of the patient record. Accordingly, as far as possible facts identifying the patient – name and hospital number should not be used in the discussions of the CEC nor in writing up minutes of meetings. However, it may be impossible to anonymise a case sufficiently because of the unique nature of individual cases, and the likelihood that a case difficult enough to be brought to a CEC will be recognisable, even if it is anonymised. It is probably best to assume that discussions of active cases (rather than retrospective case discussion) are part of the patient’s record.

The provisions of the Data Protection Act 1998 (as amended by the Freedom of Information Act 2000) will come into play where a patient can be identified. CEC’s should therefore be aware of the patient’s rights to access records of the CEC meeting at which his/her case was discussed. 2 A helpful summary of frequently asked questions about accessing health records is available on the Department of Health website.

Action taken by the healthcare professional following a referral to CEC

It is important to note that presently there is no requirement for a clinician to refer a case to a CEC. The existence of a CEC within a trust does not impose an obligation to use it. Accordingly, the role of the CEC is consultative and not prescriptive. The CEC will consider the ethical issues that a particular case raises but will not tell the clinician what to do. Responsibility for the decision lies with the clinician who may use the ethical discussion, and comments of the committee, to inform or guide that decision. However, if the responsibility for the clinical decision is to lie with the referring clinician the committee has a duty to make this clear in its terms of reference. This is particularly important when the referring health professional is a junior member of trust staff.

In the event of a negligence claim being brought against a clinician when a CEC had been consulted, the court would need to establish if there had been a breach of a duty of care on the part of the clinician (see above re conditions for proving negligence). Failure to consult a CEC, or making a decision contrary to the advice of a CEC would not of itself be seen as falling below a minimum accepted standard of clinical practice. Nor would following the advice of a CEC be a defence against a negligence claim. However, if a CEC had been consulted about the case, the court may consider the process of consultation and the nature of the committee’s advice or input, when considering whether the clinician had acted reasonably and whether the trust had appropriate systems in place to support provision of patient care. Thus a CEC’s deliberations could come under scrutiny in a negligence claim against an individual clinician.

If a clinician, having consulted a CEC, decides to go against the advice of the CEC, they will need to document their reasons for their decision clearly in the patient’s notes, as they would with any other clinical decision.

References

1. Hendrick J. Legal aspects of clinical ethics committees. Journal of Medical Ethics. 2001;27 supp 1:i50-53.

2. See Appendix F1 for relevant issues of the Data Protection Act 1998

Copyright for Section F is held by The Ethox Centre.