Educational Resources: Appendices

Appendix A6

Protocol for emergency referrals to a clinical ethics committee

Code of Conduct for the Leeds Teaching Hospitals Clinical Ethics Committee

Members of the Committee are expected to:

1. Respect patient confidentiality.

They are expected to act responsibly in handling oral or written communication about individual patients, and to take all reasonable precautions to protect patient confidentiality.

2. Respect the rights of patients to be involved in decisions about their care.

They should take account of the competence of patients to be involved in such decisions, and of the position of those close to the patient.

3. Be honest and act with integrity.

The best interests of individual patients should be their first concern, though they may also need to consider wider interests. If the individual responsibilities of committee members result in conflicts of interest, these should be acknowledged and taken into account in the work of the committee.

4. Respect the views of other committee members, and colleagues.

The committee will seek to achieve agreement, but differences of opinion should be acknowledged and recorded.

5. Refer matters beyond the scope of the committee to the appropriate body.

This may include medico-legal questions, and matters concerning the quality of clinical care, and appropriate advice should then be sought.

6. Maintain awareness and understanding of clinical ethical issues.

This should involve the pursuit of appropriate educational opportunities, with the encouragement and support of the Trust.

7. Promote the awareness of ethical issues involved in the work of the Trust.

This should include the sharing and mutual understanding of specific professional guidance on the ethical standards of clinical practice.

8. Promote the fair and equitable treatment of patients and their carers.

The committee should encourage the Trust and its staff to treat patients and their carers in a fair and equitable manner.

References:

1. Code of conduct for NHS Managers. Department of Health 2002.

2. Code of Professional Conduct. Nursing and Midwifery Council. 2002.

3. Good Medical Practice. General Medical Council. 2001.

Terms of Reference of Clinical Ethics Consultation Groups

1. Establishment of each group to be in response to a request for advice about an individual clinical case or cases within the Trust.

2. Requests for such advice to be made to the chair of the Committee, who will be responsible for co-coordinating the response.

3. If a full Committee meeting is imminent, then requests for advice may be presented to the full Committee, but more urgent requests may require a response before the next meeting.

4. The establishment of a Case Consultation Group will depend on the complexity of the presenting problem, the time required to establish the group and the agreement and participation of the referring clinician.

5. Requests for urgent clinical ethical advice may need to involve the early participation of individual members of the Committee, at the discretion of the chair of the Committee. Whenever a Clinical Ethics Case Consultation Group is established, the group should include the following participants, depending on the availability of Committee members:

  1. Chair, or member nominated to chair the group
  2. Clinician involved in Clinical Risk management
  3. Lay or Academic member of the Committee
  4. Where possible, CEC member from relevant medical specialty
  5. Where possible, CEC member from unrelated medical specialty

6. The work of each Case Consultation Group will be reported to the next meeting of the full Committee.

7. The Case Consultation Groups will be responsible directly to the Clinical Ethics Committee, and therefore to the Clinical Governance Action Group.

Clinical Ethics Case Consultations Algorithm

A clinician with an ethical dilemma will either present their problem to the CEC Chair or a CEC member, if a CEC member they would then discuss the matter with the CEC Chair. The CEC Chair would then:

  1. Establish a clinical ethics case consultation group
  2. Present tha case and associated clinical ethical issues
  3. Consider the case-spcific legal issues (e.g. PVS)
  4. Consider the relevant professional guidelines
  5. Consider the need for specialist advice (e.g. Psychiatry)
  6. Take advice from individual members of the case consultation group

The Chair would then:

  1. record the advice given
  2. report the case to the main CEC meeting
  3. hold follow up meetings as required

Copyright of Appendix A6 is held by Leeds Teaching Hospitals Clinical Ethics Committee

Jim Eccles
Leeds Teaching Hospitals Clinical Ethics Committee
Clinical Ethics Committee Case Consultations Algorithm

Appendix A10

An example of a workshop outline used by one NHS Trust

Clinical Ethics Support
A Consultation Workshop

Thursday 18 March 2004 Between 9.30 am– 2.30 pm
Room DG117, Littlemore Mental Health Centre

ALL STAFF WELCOME

Aim:

To outline an action plan to provide clinical ethics support for the Trust

Method:

Stage 1 – Discussion of two clinical cases which raise a range of eithical issues and promote discussion of these issues within specific contexts

Stage 2 – Clarification of a spectrum of kinds of situations and issues where ethics support could be helpful.

Stage 3 – Discussion of the ways in which ethics support could be provided, taking into account existing models of support in other Trusts.

Stage 4 – Develop the first steps of an action plan for the Trust.

Programme:

Please see below

Facilitators

Tony Hope, Professor of Medical Ethics, University of Oxford and Honorary Consultant Psychiatrist

Jacinta Tan, Welcome Trust Research Fellow in Ethics and Honorary Consultant Child and Adolescent Psychiatrist

Anne Stewart, Consultant Child and Adolescent Psychiatrist, Highfield Unit

To apply:

To apply please complete the slip on the invitation letter and return to the OHSS Training Team, Littlemore Mental Health Centre or by E mail to the OHSS Training Dept. mail box or by fax on 01865 (2)23349. Enquiries to the OHSS Training Team telephone 01865 (2)23354

Clinical Ethics Support
A Consultation Workshop

Thursday 18 March 2004 Between 9.30 am– 2.30 pm
Room DG117, Littlemore Mental Health Centre

ALL STAFF WELCOME

Programme

10.00 am Coffee

10.15 am Introduction to the workshop

10.20 am Ethical issues in practice – Presentation of 2 case vignettes

10.30 am Small Group Discussion – Ethical issues arising from one of the two cases.

10.50 am Plenary Discussion

11.20 am Small Group Discussion – Identification of ethical issues that arise in your area of work and what ethical support might be helpful.

11.45 am Plenary Discussion – General discussion of the range of issues and contexts across the Trust where support might be helpful.

12.30 pm Lunch

1.00 pm Models of Clinical Ethics Support – Presentation and discussion of different models for clinical ethics support.

1.30 pm Formulation of an action plan and way forward

2.30 pm Close

Copyright of Appendix A10 is held by The Ethox Centre

Appendix A11

Example terms of reference

A: Draft Terms of reference, membership and Modus Operandi for the Sheffield Teaching Hospitals NHS Trust, Clinical Ethics Group

Click here to download this section of Appendix A11 as a pdf document.

The meeting will be called the STH Clinical Ethics Group (CEG)

1) Purpose

The purpose of the CEG is to:

  • Provide a forum for discussion on clinical ethical issues within STH
  • Raise the general awareness of clinical ethical problems within STH
  • Provide advice and guidance to the STH Trust Board, CMB and Directorates on ethical issues to facilitate the development of standards and policies, and improve the quality of care.
  • Provide ‘real time support to individual clinicians / practitioners.
  • To assist the education of STHT staff (including Group members) in Ethical matters

The CEG will not:

  • Provide legal advice
  • Undertake risk management
  • Provide advice on research matters
  • Consider any issue not primarily of an ethical nature

The CEG will be advisory and not executive.

Collaboration with others in Sheffield (notably the Sheffield Children’s Hospital) is essential.

2) Membership principles

The Chair will be appointed by the Group and serve for a term of three years at the end of which the filling of the position will be reviewed. There will be a Vice Chair appointed by the group, who will serve as above.

Members will serve for a period of three years. which may be renewable. Places shall be made available to new members where members retire from the group. Where no new members are ready to join the group, periods of service may be renewed. NB: care will be taken to ensure that periods of service are staggered to avoid significant problems of retirement from the group.

The CEG will be quorate, when either the Chair or Vice Chair and 5 members are present

  • Membership of the CEG. Membership will be limited to 12 – 15 individuals. There is a requirement to cross-reference with the Patients Council. CEG membership should be broadly acceptable to clinicians/practitioners.
  • Members should be ‘recruited’ on the basis of reputation, performance, skill and knowledge.
  • Lay representation is necessary, but specific pressure group representation should be avoided.
  • Members should be clear that they are present for their personal attributes (see second bullet point above) and not as representatives of any given body, group, profession or organisation.
  • Co-option of members in addition to a core membership for specific issues will take place as required.
  • Members will be willing to participate in ethical educational activities, including links with other Ethics Groups and the UK Clinical Ethics Network

3) Place within the Trust infrastructure

CEG is a formally constituted group, ratified by the Clinical Management Board and Trust Board.

The CEG will prepare a summary report on the activities of the Group on an annual basis and will submit the report to the Clinical management Board.

4) Meetings

  • There will be a formal agenda, issued not later than seven working days before each meeting. Agenda items / papers to be submitted to the Chair net less than ten working days before each meeting. Items of urgent business arising after this time will be accommodated with the agreement of the meeting.
  • Notes of the meeting will be taken, recording key discussion points, actions agreed and any advice / guidance agreed by the group. Notes will be issued to members not later than 14 working days following meetings.
  • Meetings will take place initially at a frequency of every six weeks (to be reviewed in the light of experience).

These Terms of Reference to be reviewed at least every three years.

Copyright of this terms of reference is held by Sheffield Teaching Hospital NHS Trust

Paul Gerrish
Sheffield Teaching Hospitals NHS Trust, Clinical Ethics Group

B: Great Ormond Street Hospital for Children NHS Trust Clinical Ethics Committee (formerly Clinical Ethics Forum) Terms of Reference

Click here to download this section of Appendix A11 as a pdf document.

Authority

The Committee will operate under the authority of the Trust Board.

Membership

The membership of the Committee is multidisciplinary. Initially members will be invited or canvassed. The balance of membership will be reviewed by the Committee.

The Committee includes at least one representative from medical, surgical, academic, nursing, social work and other paramedical specialties. It also includes representatives from Chaplaincy and a general practitioner. Lay members have been recommended and elected by the Committee and include those with specific ethical expertise and a representative of the local health authority. Academic representation is provided by a representative of the Institute of Child Health. It is hoped that the Committee will include a lawyer, though the latter will not be acting in a professional capacity.

The Chair and Committee have powers to co-opt individuals with expertise necessary for the discussion of particular issues.

From the experience of other groups, it would seem that membership should be limited to approximately 20. A quorum would consist of at least one representative from each professional group. plus at least two lay members and Chair or Vice-chair. The membership should generally be for three years, reviewable after that time.

Chair

The Chair should serve for a period not less than three years. The post should be open to all health care professionals or lay representatives.

Vice-Chair

The Vice-Chair should serve for a period of not less than three years. The post should be open to all disciplines. Either the Chair or Vice-Chair should be a lay member. The Committee should be a sub-committee of the Trust Board.

Aims and Objectives

  • To provide a forum for the confidential, multidisciplinary discussion and analysis of matters of ethical concern arising from clinical practice at the GOS Trust and to provide, where appropriate, an informed, reasoned and justifiable opinion on such matters.
  • To contribute to the integrated development of standards, guidelines and policies directed at enhancing good ethical practice and improving, patient care.
  • To advise on and develop institutional ethics policies and to evaluate their outcome, and to contribute to other policies which have a significant ethical impact.
  • To educate health care professionals in all disciplines in the principles required for good ethical practice and develop methods for the evaluation of the process.
  • To initiate and support research, in collaboration with the Research Ethics Committee and Institute of Child Health, in the health care ethics field.
  • To contribute an informed, reasoned view on matters of ethical concern arising from paediatric practice to the wider national and international communities and to provide a paediatric perspective on ethical issues of national importance.
  • Although discussion on the ethical principles which individual cases might raise is important, it is not to be regarded as the key focus of the Committee.
  • The role of the Committee is advisory and educational, rather than prescriptive, and there would be no compulsion for individual cases to be discussed by it. However, the Committee would be responsive to the need to discuss particular issues as they arose.

Teaching and Training

To be effective, members of the Committee will need to develop ethical expertise in a comparable fashion to members of the Research Ethics Committee by:

  • Becoming more familiar with principles, concepts and theory.
  • Studying relevant cases, legislation and policies.
  • Having, input from invited individuals with appropriate expertise.
  • Attending conferences etc. on health care ethics.
  • Having access to and discussing relevant literature.

There is sufficient expertise within the currently proposed membership of the Committee to oversee this process.

The Committee would have an important wider role in teaching and training on ethical issues within the Hospital and the Institute. It is envisaged that close co-operation with the Research Ethics Committee, in the areas of teaching and training and research and development would take place. It would support and develop the long-term strategy of linking research ethics and clinical ethics by an integrated Department of Ethics.

Evaluation

The Committee will seek to audit its activities and develop a technique for assessment of its function. The Committee will submit an annual report to the Trust Board which will include aspects of audit and performance evaluation.

Frequency of Meetings

The Committee will meet monthly, or as required.

Administration

Administrative support for the Committee is provided by the Research & Development Office.

Copyright of this terms of reference is held by Great Ormond Street Hospital for Children NHS Trust

Dr Richard Trompeter
Great Ormond Street Hospital for Children NHS Trust CEC

C: Royal United Hospital NHS Trust, Bath Clinical Ethics Committee Terms of Reference

Click here to download this section of Appendix A11 as a pdf document.

This is an informal group committed to helping to advise on problems of an ethical nature arising in a hospital setting. The members include ethicists from an academic institution, clinicians (doctors and nurses), a psychologist, solicitor and a cleric. Membership will lapse if a member fails to attend three consecutive meetings of the Committee.

Members of the group, who will be known within the hospital, can be contacted at any time by staff who feel that the opinion of group members may help to resolve particular difficulties. We would hope to receive enquiries relating to clinical ethical problems rather than to clinical competence, professional discipline or resource allocation. Enquiries outside our remit will, with the enquirers permission, be referred to the relevant person or group.

Once a member is contacted and the nature of the problem established, further members will be contacted as thought necessary. Members’ views will be summarised by the Chair before issue.

The enquirer and patient involved will normally remain anonymous during discussions and when records are kept. It is accepted that this will not always be possible particularly if a meeting with the patient or relatives is thought to be of benefit. But no such meetings will take place without the explicit consent of the patient (or the relative if the patient is not competent). No identifying details will be kept in the records of the ethics committee. However, with the consent of those involved, a note about the consultation may be put in the patient’s hospital records.

Records of all discussions will be kept on a pro-forma.

A regular audit of our work will be produced.

The group will meet quarterly. Some of these meetings will be open to members of the hospital staff. The group will be chaired by one of its members elected by the group for two years in the first instance. No person will act as Chair for longer than four consecutive years.

The group will consider a wider educational role, and there may be occasions on which it feels that written guidelines should be produced.

Copyright of this terms of reference is held by Royal United Hospital NHS Trust Clinical Ethics Committee.

Peter Rudd
Royal United Hospital NHS Trust CEC

Appendix A4

The Newcastle Upon Tyne Hospitals NHS Trust Clinical Ethics Advisory Group (CEAG) living wills policy

Stephen Louw Newcastle Upon Tyne Hospitals NHS Trust Clinical Ethics Advisory Group

Introduction
The CEAG discussed ‘Living Wills’ over a series of 5 meetings and the key conclusions and recommendations are presented below.

Helpful input was received from the Chairs of Ethics Committees of other Trusts, namely Dr M K Benson – Oxford Radcliffe Hospitals NHS Trust, Dr A K Watson – Nottingham and Dr J Dawson – Wirrell Hospital.

The group was assisted by Dr Anna Bachelor (Head, ITU services, RVI and NGH).

Documents that were tabled included:

  • ‘Advance Medical Directive’, published by Staywell;
  • The Voluntary Euthanasia Society’s Living Will;
  • The BMA’s ‘Physician Assisted Suicide Debating Pack’, Section 8 dealing with ‘Advance Statements about Medical Treatment’.

Key issues and Recommendations

1. Name of the document
It was agreed that the document should be called a ‘Living Will’, on the grounds that this has greater currency for the public, adequately expresses the purpose of the document and does not raise the expectation (as does ‘Directive’) that any related future decision by a doctor could be directed. However, in order to indicate the proper legal standing of a ‘Living Will’, the full title of any Trust document should include the phrase:

‘Living Will (Advance Refusal of Treatment)’

2. Legal status

The legal standing of Living Wills derives from case law, such as Re T (1993), which allowed that advance refusals of treatment are legally binding if: (a) they are clearly established; (b) they are applicable to the current circumstances; and (c) they have been made without undue pressure.

3. Medical Ethics Principles

3.1

The key principle of medical ethics that supports the use of Living Wills is that of autonomy, implying self-rule. It should be recognised, however, that this principle, despite its standing in discussion in most Anglo-American literature, is not universally accepted as being predominant. We recognise that most people should not be thought of atomistically as disengaged from the social environments in which they are embedded. For patients this means that they are normally engaged in a context that might include family, friends, neighbours, non-professional and professional carers, along with their legal advisers, spiritual leaders and advocates.

Hence, in making judgements about Living Wills medical staff must endeavour to become acquainted with the broader context in which the document was conceived.

This thought reflects the statement in the Green Paper Who Decides? Making Decisions on Behalf of Mentally Incapacitated Adults (1997, London: HMSO), namely:

‘The advance statement is not … to be seen in isolation, but against a background of doctor/patient dialogue and the involvement of other carers who might be able to give an insight as to what the patient would want in the particular circumstances of the case.’

3.2

Involving relatives and carers and indeed the patient (in so far as their competency will allow) in interpreting a Living Will is in keeping with the common law principle that, in the case of an adult who lacks capacity, the doctor must act in the patient’s ‘best interests’. The same document suggests that in determining ‘best interests’, attention should be paid to:

  • The ascertainable past and present wishes of the person and factors they would have considered if they were able;
  • Encouraging the full participation of the person concerned as far as this is possible;
  • The views of all significant others, both family, friends and all those involved in the person’s care;
  • The need to make sure that the purpose of any treatment is achieved in the least restrictive manner possible.

These criteria have been taken up in the government’s subsequent White Paper Making Decisions.

3.3

With these considerations in place, any decisions about Trust policy with respect to Living Wills should bear in mind the following underlying ethical and philosophical principles:

  • Living Wills exist in order to foster the autonomous agency of individuals who cannot otherwise exercise capacity;
  • The individual person, however, is embedded in a broad social context and patients (in particular those who lack capacity to make decisions about their treatment) must often depend to some extent on those around, both professional and non-professional, in order to exercise their agency;
  • It follows that professionals must pay attention to the views of others involved in the care of their patients; but also professionals must not be prevented from encouraging the agency of patients under their care. Indeed, in seeking the holistic well-being of their patients, professionals should encourage them to take steps to enhance their autonomous agency; this is in keeping with the principle of beneficence;
  • Meanwhile, the Trust must ensure both that the interests of the patients under its care are not compromised (the principle of non-maleficence), and that its staff are not compromised: neither through lack of training, nor through lack of appropriate support.

4. Applying the directives in a Living Will in clinical practice

In determining the best interests of a patient, where the patient has a Living Will, it will be appropriate for clinicians to consider whether or not the legal criteria for a valid Living Will (see 2 above) have been satisfied. In particular, clinicians need to consider whether the condition(s) anticipated in the Living Will are actually those that obtain. Experience of a condition could lead to a change of view over time – this might call into question the validity of a Living Will. While it is recognised that people usually grow to accept disability and may therefore seek to revoke the terms of a prior Living Will this acceptance of disability may not always occur and the Living Will may thus remain valid.

5. Should the Living Will document be offered to patients in hospital or should it be provided only on request?

The consensus in CEAG was that patients should be made generally aware of Living Wills, but they should not be actively offered to all patients who have contact with the Trust. This recommendation is made on the grounds that patients might feel that undue pressure is being brought to bear on them if the Living Will is actively promoted, breaching the principle of non-maleficence and potentially undermining the patient’s trust in their health carers in hospital. Suitable and morally acceptable methods of raising awareness include the use of posters or pamphlets.

Ideally, Living Wills should be part of a patient’s whole management. While involvement of the GP would be ideal in helping patients to complete their Living Wills, the Trust should be able to provide Living Wills and advice relating thereto if requested. Leaflets should be made available describing the purpose and implications of a Living Will. In giving advice to patients, there should be a general discussion about the patient’s values and beliefs before particular and detailed decisions are made; it would appropriate for any such discussions to take place over several meetings and to involve other family members or carers at the patient’s request. Therefore, giving such advice is likely to be time-consuming and staff will require proper training if in fact the Trust undertakes to provide such advice and support. Nevertheless, any clinician must be prepared to offer advice within the bounds of their competence, or to refer to an appropriately informed colleague, if a patient seeks their help. By these means the patient’s autonomous decision-making, in relation to whether they wish to have a Living Will and to the nature of such a document, is enhanced. There is a need to provide information and choice. Appropriate and authentic choices are likely to be made in situations where there is not any immediate urgency. However, if the patient freely requests a Living Will in hospital, the request should be responded to.

6. Recording the existence of a Living Will and its distribution.

Provided that patients give their consent, the Trust has a duty to ensure that the existence and content of the Living Will is made known to key health personnel. Thus, a copy of the Living Will should be sent with the patient’s Discharge Letter to the patient’s GP. A copy of the Living Will should also be kept in the patient’s hospital notes, with a prominent sticker inside the cover indicating that the notes contain a Living Will.

7. Safeguards

7.1 Safeguarding the patient’s autonomy – should staff play an active advisory role?

Ideally independent advice should be available to patients in the Trust, but such advisors should be senior and suitably trained.

It was agreed that a comprehensive leaflet should be made available, along the lines of ‘Advance Medical Directive’ (published by Staywell), describing the nature, purpose and practicalities of a Living Will. The leaflet should include an exploration of values and beliefs to help the patient to make their decisions in the Living Will document.

Since patients are often fearful of hospitals and do not necessarily understand the limits of Do Not Resuscitate decisions, there should be a clear definition of terms in the leaflet and in the Living Will document. The leaflet should make it plain that the hospital staff would act in the best interests of the patient.

7.2 Safeguarding the patient’s autonomy - should family members or carers be involved in discussions relating to a Living Will?

Patients should be encouraged to discuss their Living Will with family members, to avoid future conflicts of opinion regarding the patient’s intentions. This is based on the principle that it is in the patient’s interests to ensure that their wishes would be respected in future.

Trust staff may be called upon to safeguard the patient’s autonomy if s/he wishes to complete the form without support from their family. The patient should be given time for reflection and the patient should be encouraged to involve family when the patient feels that the time is right. It is felt important neither to be proscriptive nor prescriptive.

In patients with mild dementia, the situation may be made more difficult if the family is not there to provide a context to the patient’s life-experience and preferences. Nonetheless, patients must be encouraged to decide for themselves who should be involved in drawing up their Living Wills.

7.3 Safeguarding the patient’s autonomy – the role of the Trust’s solicitor.

Owing to financial considerations, a conflict of interest might arise where the Trust Solicitor is called on to advise on the appropriateness of completing a Living Will. It was agreed that a patient could request a solicitor and should be assisted in so doing, but that the document should not refer to the “Trust” solicitor.

8. Would it be acceptable for a member of staff to witness the patient’s signature?

In order to minimise the risk of undue influence, staff that witness a signature should not be those with day-to-day responsibility, but staff from another area who are at a distance from the patient. Clinicians might attach greater weight to the validity of a Living Will if there is evidence that it has been carefully considered and knowledge of the identity of the witness to the signature might provide such reassurances.

CEAG was uncertain whether the witness of the signature was in fact only required to confirm the patient’s identity in signing or whether the witness was confirming the legitimacy of the process of drawing up the Living Will. This would raise the issue of the person’s capacity to sign the Living Will and staff need to be made aware that they should seek expert advice if they have any doubts about the patient’s capacity.

It seems that if a member of the hospital team were asked to witness a Living Will, there would be a stricter criterion as to what might be expected from the witness than if a lay person acted as a witness. Staff have a duty to ensure that the process is carried out in the proper and appropriate manner. A further consideration is the need to guard against litigation. The Trust should consider the question of the seniority of the member of staff witnessing the document, who will require appropriate skills in assessing capacity.

If the document were only offered on request there would be a lower likelihood of coercion by a person signing their names as witness, but it might be considered that under some circumstances a clinician might wish to initiate thoughts about a Living Will.

It should go without saying that all discussions about Living Wills should be clearly, contemporaneously and accurately recorded in the clinical notes.

9. The contents of the Living Will

9.1 The Preamble

It was agreed that the preamble should contain the following statements:

11.1.1 The Trust wishes to assure you and your carers that under all circumstances the health team will strive to provide what they consider to be the best treatment for you.

11.1.2 This document is to record aspects of treatment that you do not wish to have under specified circumstances.

9.2 A statement of beliefs

CEAG considered whether a statement of the patient’s beliefs should be included in the Living Will. It was felt that caution should be exercised, since the Living Will is a legal document and requires precision; however, space for a free text statement of beliefs and values seems appropriate in case the patient wishes to record such beliefs and values – this would be similar to a standard practise pertaining to Last Will documents. In instances where staff are asked for help a patient with their Living Will, they should be alert to the possibility that a ‘statement of beliefs’ may be in conflict with some components of the remainder of the document.

10. Should there be an option stating: ‘If there is a medically indicated treatment available, my preference would be not to refuse such treatment’.

CEAG members were divided in their views on this matter. It was recognised that an affirmative guidance such as this (as opposed to an advance refusal of treatment) may be more relevant in some clinical scenarios. On the other hand, it could raise unrealistic expectations that future treatments could be demanded, or, alternatively, could engender fear that clinicians might withhold appropriate treatment unless such demands are clearly stated.

11. The duration and validity of a Living Will.

CEAG came to the conclusion that there were no ethical grounds on which to recommend that a time limit should apply to a Living Will. It follows that a Living Will should remain valid until the patient wishes to change it. However, CEAG recommends that the Trust’s information brochure should advise patients who sign a Living Will to review it from time to time. Since ordinary Wills make provision for codicils, they may well be appropriate in a Living Will as well.

12. Should a Living Will be deemed invalid if the patient develops dementia?

CEAG considers that no ethical grounds exist to regard cognitive disturbance as necessarily invalidating a Living Will.

Copyright of Appendix A4 is held by Newcastle upon Tyne Hospitals NHS Trust Clinical Ethics Advisory Group.

Dr Stephen Louw
Consultant Physician and Chair of the Newcastle Upon Tyne Hospitals NHS Trust Clinical Ethics Advisory Group
General Internal Medicine
Level 6
Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN

Acknowledgements: Membership of CEAG at the time of the above discussions included: Sir Miles Irving, Dr Julian Hughes, Dr Tom Shakespeare, Dr Jill Lothian, Dr Kath Mannix, Miss Clare Abley, Dr Anna Batchelor, Dr Andrew Cant, Dr Nick Plant, Dr Patrick Kestevan, Mrs Mary Midgley, Mr H Thomas, Ms Gill Finlay, Mrs L Simpson, Mr Steve Kirkup provided secretarial support.

The following further information produced by CEAG is available from the Network web site http://www.ethics-network.org.uk/Committee/functions/functions.htm

  • Explanatory Notes for Patients
  • Sample Form

Appendix A8

Role of a clinical ethicist

It is not uncommon for clinical ethics committees to include amongst their membership an academic ethicist, or to have links with academics working on ethical issues and based in a local university department of philosophy, law, theology or medicine. In some settings, even where there is not in fact an ethics committee, academic ethicists have developed good relationships with clinicians and other health professionals and have been willing to provide input into the discussion of cases. Many of the leading academics involved in research and teaching in medical ethics have for many years been contacted by health professionals facing difficult ethical issues and have offered ad hoc support and advice about ways of thinking such ethical problems through.

In recent years, one or two academic ethicists have developed closer relationships with clinical practice and have begun to practice what might be called the role of a ‘clinical ethicist’. As it has with ethics committees, this work has taken the form of support and advice rather than decision-making. It is as yet relatively uncommon for this work to be funded through the trust itself but in one or two cases some such funding has been available. What might a clinical ethicist do? To a great extent this will depend upon the needs of the particular clinical setting and upon the skills and experience of the ethicist. At the Oxford Radcliffe Hospitals Trust (ORHT) clinical ethics support mirrors to some extent the roles taken on by clinical ethics committees. That is, as an ethicist I have some educational role, some input into cases and some input into the development of policy. My role as the ethicist at ORHT takes something like the following form:

1. Supporting the clinical ethics committee.

I am a member of the clinical ethics committee, providing ethics input and helping to set the agenda. My relatively close relationship with the clinical setting means that I am able to identify and act as a collecting point for ethical issues and cases that might be suitable for discussion at the ethics committee. The availability of an ethicist makes it possible for the clinical ethics committee to provide relatively timely and flexible responses to health professionals. The clinical work of the ethicist can also act as a useful indicator of areas of practice in which there might be the need for policy development or education.

2. Case consultation

I run a monthly one-hour discussion in the clinical genetics unit at which ethical issues and cases arising during the past month are discussed in a multidisciplinary group of doctors, counsellors and nurses. I also run a similar discussion group for the cardiology genetics team. In addition to these regular sessions, I provide ad hoc support in any clinical areas that wants it. In many cases the team simply wants someone who can facilitate a one-off discussion about a particularly problematic issue. In some cases this leads on (as in genetics) to a more long-term involvement. In addition to genetics and cardiology, I have provided ethics support in Intensive care, to the resuscitation team, prenatal testing, the Women’s Centre, Neuro ITU, the Retained Organs Group, Paediatrics, among others. In many cases the ethical issues can be resolved locally, in others I am able to act as a link person encouraging access to the clinical ethics committee.

3. Education

The long-term input of an ethicist into a clinical team, in addition to helping with particular cases, has an educational and development function, helping health professionals to develop the awareness and skills they need to identify and address ethical issues in their own right. In addition to this, I have encouraged and participated in the educational activities of the committee. For example, running one hour open training sessions on ethical issues for members of trust staff on issues such as consent, confidentiality and so on.

4. Policy and guidance

In many cases, difficult ethical issues arising in practice can lead a clinical team to consider developing a new policy. The ethicist can play a role in helping a team to think through the broader ethical issues presented by a case and to think through the ethical implications of new policy initiatives and changes in practice. Similarly, with policy and guidelines developed externally (whether nationally or at the level of the trust) the ethicist can help clinical teams to consider the ethical implications.

Copyright of Appendix A8 is held by The Ethox Centre.

Michael Parker
Professor of Bioethics, The Ethox Centre, University of Oxford

Appendix A9

Steps on the road to a new clinical ethics committee

Graham Behr and Jon Ruddock, Central and North West London Mental Health NHS Trust

1. A core group of three clinicians (two consultant psychiatrists and one senior nurse) drove the process (and each other) from the outset.

2. Experience of established CECs was obtained by joining a local Acute trust CEC and visiting other CECs.

3. Core group attended training events through ETHOX and Imperial College, London.

4. Liaison with other new CECs was established (via ETHOX) and details of their functioning obtained (for example their remit, composition, process of selection, administration, and issues of liability and accountability).

5. The core group decided on local priorities to shape the remit of our CEC.

6. Discussions were then opened with the Medical Director

7. This was followed by a presentation of the proposal to the Trust-wide consultant meeting to sound out the reception such a committee might have, elicit concerns and involve consultants from the outset to avoid their being alienated.

8. Further discussions took place with the Chief Executive preparing the way for a formal proposal to the Trust Board.

9. Then followed a formal proposal submitted to the Trust Board with opportunity for the Board to put questions directly to the core group.

10. Following Board approval further meeting were held with the Chief executive to discuss particularly the composition of the CEC and begin seeking an independent chair (whom the Chief Executive subsequently appointed in consultation with the core group).

11. The core group then selected both the special members (lay person, religious representative, philosopher, lawyer etc.) as well as clinicians from within the Trust.

12. The ‘special’ members were selected by informal process; whomever the core group felt would do the job best was approached. However, for reasons of equity, a more formal process was adopted for clinicians. Explicit criteria were developed to judge suitability (Document 1), a Trust-wide advert was sent out on e-mail (Document 2) and applicants were short listed and interviewed by telephone. This process resulted in 24 applications and 10 interviewees for the four clinician places on the committee.

13. The Trust Secretary prepared contracts assuring confidentiality and indemnity which were completed by members before clinical discussions were embarked upon.

14. The CEC then invited referrals via Trust wide e-mail (Document 3). A pilot site was given priority for fear the CEC would be unable to meet the demand from the whole Trust initially. However, this turned out to be unnecessary (referrals have come in at a steady rate of about 1/month.)

15. The core group continued to meet between the monthly CEC meetings. This was both to iron out administrative issues (see pitfalls) and to develop a way of synthesising the discussions from the meeting into a format that was concise and helpful for the referrer, as well as forming the basis for a potential educational database.

Pitfalls

1. Having both a budget and an identified person for administration is essential from the outset. Vast amounts of clinician time were spent on administrative tasks and having this agreed from the outset would have smoothed the development of a functioning committee greatly.

2. The process, from conception to fruition, took two years in this instance. Clearly it need not take that long but the sorely tested patience of the core group was repaid by having a CEC which was acceptable to all stakeholders and whose composition allowed it to function effectively.

Document 1: Criteria for Clinical Members of the CEC

Criteria to enable short listing and interviewing

  • Interest in the subject of medical ethics
  • An ability to work in a group
  • A commitment to the group

Other considerations

  • To broaden range of clinical background
  • To broaden geographical representation
  • Prioritise bringing special knowledge/ability/experience

Process

  • Circulate ‘Expression of interest’ (EOI) form with core group contact details
  • Consider possibility of being on co-optee list
  • ‘EOI’ form has core members details for queries

Shortlist on basis of EOI then interview

Interview questions

  • Blurb about high interest and basis on which we are choosing
  • Clarify whether applicant is close to clinical decision making?
  • Would you be able to commit to a monthly meeting (e.g. every first Wednesday of the month 5.00- 6.30pm)?
  • What roles might this committee fulfil?
  • What case that you have encountered might such a committee usefully deal with in your view?

Document 2: Advertisement for Applicants for Members of the Clinical Ethics Committee

  • Should I divulge those details to his family?
  • Did she really consent to treatment as an informal patient?
  • At what point is my patient’s suicidality his responsibility rather than mine?
  • Why should I treat this patient; she wants treatment but has been unable to make use of anything offered?
  • How much of a threat must this patient pose before I feel we should withdraw treatment?
  • She says she chooses to live in squalor but is that a real choice she’s made?

These are the kinds of questions clinicians face every day in mental health. We often make them by consensus or by invoking a ‘senior’ opinion. Increasingly, however, clinicians across all disciplines and specialities are making use of clinical ethics committees to assist with decision making in complex challenging cases. There are currently over fifty such committees in the UK. This month CNWL has become the first mental health trust to establish such a committee.

The committee will comprise a chair (external), lay person, service user, lawyer, ethicist, faith representative and a number of clinicians.

If you are a clinician and:

  • have an interest in ethics
  • have expertise in ethics or some related field that would enrich the discussions
  • are willing to commit to a monthly meeting from 5.00 until 6.30pm for at least one year

...Consider applying to be a member of this committee!

In addition to the above criteria we will endeavour to represent clinicians from different disciplines and geographical parts of the trust.

Please note that this offer applies equally to employees of local authorities who are working within CNWL Trust structures.

If you are interested please send the following details to Dr Graham Behr

  • Name
  • Job
  • Site
  • Description of knowledge, skills or interest which would enhance the work of the committee

If there are more applicants than places available (four places available), a transparent selection process will be undertaken using the above criteria.

CLOSING DATE FOR APPLICATIONS IS FRIDAY 5 SEPTEMBER 2003

Document 3: Advertisement of Clinical Ethics Committee

CNWL now has a Clinical Ethics Committee (CEC), the purpose of which is to assist clinicians in making vexing clinical ethical decisions by reviewing them from an ethical perspective. Some examples might be:

  • At what point is my patient’s suicidality his responsibility rather than mine?
  • How much of a threat must this patient pose before I feel we should withdraw treatment?
  • She says she chooses to live in squalor but is that a real choice she’s made?

These are the kinds of questions clinicians face every day in mental health. We often make them by consensus or by invoking a ‘senior’ opinion. Increasingly, however, clinicians across all disciplines and specialties are making use of clinical ethics committees to assist with decision-making in complex challenging cases. There are currently over fifty such committees in the UK. This month CNWL has become the first mental health trust to establish such a committee.

The committee comprises of a chair (external), layperson, service user, lawyer, ethicist, faith representative and a number of clinicians who represent different disciplines and geographical parts of the trust.

The committee has begun to take on both casework and policy-related work. In an attempt to broaden the base of referral sources and increase access to the CEC, we are formally inviting referrals from all clinical professionals. However, to help us gauge the prospective volume of referrals, for the first month referrals are to be invited from one directorate. We would strongly advise that the service user’s care team is informed that the case is being discussed by the CEC, and that their contributions are encouraged.

Copyright of Appendix A9 is held by Central and North West London Mental Health NHS Trust

Graham Behr and Jon Ruddock

Central and North West London Mental Health NHS Trust

Appendix A14

Pro forma referrals form

Royal United Hospital, Bath, Clinical Ethics Committee

Proforma for Clinical Ethics Committee Records
Note these records are being kept solely for the purpose of statistical recording and audit of the committee’s work


Reference:
Name of Committee Member
Date and time of contact(s):
Source of Enquiry: (e.g. doctor (grade), nurse (grade), other health professional (position, grade), patient, relative)
Relationship of enquirer to patient:
Nature of problem:

(Note enquirer may remain anonymous)


Names of other members of Committee contacted:
Referral:

If enquiry referred elsewhere (with permission of enquirer) state to whom, and fill in outcome (below), when known


Outcome(s) with date(s):
Was enquirer happy with outcome?:
Other comments:

Please make 2 copies of this form, one to be retained by you and one forwarded to Chair of the Committee

Copyright of Appendix A14 is held by Royal United Hospital Clinical Ethics Committee

Peter Rudd
Royal United Hospital NHS Trust CEC

Appendix A7

Report on findings from the UK Clinical Ethics Network Questionnaire, May 2003

Purpose of questionnaire and response rate

In January 2003 a seven page questionnaire was sent out to all Chairs of clinical ethics committees (CECs) / fora that were known to the Network (as a result of the work Anne Slowther carried out for the Nuffield Trust Report, December 2000 and through Ethox training programmes). The purpose of the questionnaire was to find out how CECs are operating - their structure and the range of work that is carried out by them. With this information the Network will be in a position to provide relevant support.

Fifty-three questionnaires were distributed. A letter of reminder was sent out mid March. Thirty-eight questionnaires were received back (a response rate of 72%). This is a pleasing response rate and provides the Network with a good base of information from a range of CECs.

Updating information about Committees

Of the thirty-eight CECs that responded to the questionnaire three informed the Network that the Committee was no longer active.

Therefore we know that 35 CECs are active and we have up to date details for our database and relevant information useful for the website. The information in this report therefore relates to the 35 active CECs who responded to the questionnaire.

However we know there are other active CECs although they have not responded to the questionnaire. We shall be contacting CECs from whom we did not receive a response in order to find out if they are still active and, if so, to update our information.

Occasionally Ethox becomes aware of new CECs (where contact is made to find out about training workshops) although the CEC has not heard of the Network. The profile of the Network should be enhanced so that CECs are aware of the Network and can benefit from it. We hope to achieve this with the introduction of the Network website.

Contacting CECs

Those who have responded to the questionnaire have provided the Network with the most appropriate contact point whose address and email will be put on the website to facilitate ease and speed of communication between Committees.

Composition of CECs and the support they provide
The largest CEC has 26 members, the smallest 6 members (although this CEC has only recently been formed). On average, the number of members of a CEC is 13.

The majority of CECs have legal, religious and lay representation:

  • 21 Committees have a legal member
  • 26 Committees have religious representation
  • 29 Committees have lay representation

Medical members of CECs outnumber nursing members by 2:1.

Meetings

Of the 35 CECs who responded, just under half have meetings every month, 7 have meetings quarterly and 5 meet bi-monthly. In most cases meetings are of between one and a half hours and two hours duration.

Interestingly, 24 of 35 CECs indicated that the majority of members attended the meetings. This is despite the fact that only a small minority of CECs pay for members’ expenses to attend meetings, or their time in attending. We can conclude from this that committee members feel that they are fulfilling a worthwhile function.

Functions of CECs

Twenty-three CECs replied that they frequently provide ethical support to individual clinicians. However formal ethics case consultation is unusual . This suggests that those responding to the questionnaire are indicating informal advice or retrospective review of cases. It would be useful to explore in more detail what is the range of ethical support.

Nineteen CECs state that they frequently contribute to Trust policies and guidelines. It would be useful if the expertise generated could be available for other committees and the website will indicate where CECs have contributed to particular policies / guidelines (www.ethics-network.org.uk/Committee/functions/functions.htm)

Only thirteen CECs stated that they frequently provide ethics education within the Trust.

Interpreting national guidelines is done infrequently by most CECs – only seven indicated that this is a function they performed frequently.

Risk management, eligibility of foreign nationals for NHS treatment and police access to patient records were indicated as other issues that CECs have become involved in. It is relevant to ask what is / should be the ambit of involvement in issues that are not exclusively clinical ethics. Should CECs become involved in ethical issues relating to management or ‘organisational ethics’?

Ethical issues that CECs are most frequently asked to advise on are withholding and withdrawing treatment, consent and DNR orders.

  • 17 CECs frequently deal with withholding and withdrawing treatment
  • 16 CECs frequently deal with issues of consent
  • 12 CECs frequently deal with DNR orders

Other areas that arise with reasonable frequency are advance directives, capacity and refusal of treatment.

However in response to the question – ‘which area of clinical practice do you find creates the greatest ethical difficulties for your Committee’, those areas identified tended to be those that are not dealt with frequently by Committees – genetic testing, assisted reproduction, accident and emergency, intensive care, and NHS targets.

A question for discussion is whether the Network should provide education and training in those areas that frequently arise before CECs, or should it concentrate on developing training for those issues that CECs indicate cause greatest ethical difficulty even though they may arise infrequently?

Financial and other support for CECs

Twenty-nine CECs indicated that they have administrative support – mostly minute taking, distribution of papers and arranging meetings (six do not receive administrative support).

Nineteen committees receive some financial help from the Trust (four receive funding from other sources e.g. profit from an annual ethics forum).

In only two Committees are members paid for their time, and in only eight are members’ expenses covered.

There were only 18 positive responses to the question ‘are non Trust members of your Committee indemnified?’. Nine said that they were not and eight did not respond to this question. This leaves lay members of Committees potentially liable and is an area of concern that the Network will be addressing.

Ethics training

Training of members of CECs has improved since the Nuffield Trust survey. Twenty-four CECs have at least one member with a qualification in ethics and twenty-six CECs indicated that one or more members have attended a non-Ethox training course. Just under half of positive responses stated that Committees receive expenses for training of their members – it would be useful to identify the form this training takes.

It is worth considering whether there should be a minimum standard of ethics training of an ethics committee as a whole and any minimum standards of training for individual members (as is the case with LRECs).

Communication between Committees

Twenty-two Committees replied that they have contacted / collaborated with other Committees and where they have done so collaboration is reasonably frequent – twelve stating that they have collaborated two or more times a year. The outcome has been positive – Chairs have reported a useful validation of advice.

Of those CECs that have not communicated with others six felt it was unnecessary and one was concerned with issues of confidentiality.

In order to encourage dialogue between CECs it should be clear who to contact and how to do so – the website will make this information readily available.

Points for further discussion

  • Should members of CECs receive expenses / payment?
  • Indemnity of non Trust members
  • Function of CECs – should they become involved with organisational ethics?
  • How much should CECs be involved in formal case consultation?
  • Training and education – should the network concentrate on those areas that frequently arise before CECs, or those issues that CECs indicate cause greatest ethical difficulty even though they may arise infrequently? Should there be specific training for case consultation?
  • Should there be a minimum standard of ethics training for an ethics committee as a whole and/or any minimum standards of training for individual members?

Copyright of Appendix A7 is held by The Ethox Centre

Appendix A12

Issues to consider when appointing lay members

Dr Paul Gerrish, Clinical Ethics Group, Sheffield Teaching Hospitals NHS Trust

Appointment of lay members to Clinical Ethics Group

Appointment of lay representatives is sometimes regarded as an important aspect of membership of a Clinical Ethics Group (CEG) and also in line with the current approach of the NHS for greater lay or patient involvement. Identifying and appointing lay appointments is not always easy and the following is aimed at giving some guidance to the process. There is no standard solution and each CEG will need to consider what is appropriate for the local situation; however it is important to identify a clear strategy at the outset.

Does the Trust already have a lay appointment process?

Most NHS Trusts now have started to have lay / patient involvement in the management structure e.g. of Directorates and there may well may a process that has been used locally before, although this may need to be significantly adapted as the needs of the CEG may vary from previous appointments.

What is meant by lay?

There should be clear agreement at the outset of what is meant by a lay member, what is his/her function and what he / she is expected to contribute. The expected contribution is certainly something prospective candidates will raise, as there will often be some concern as to what they can contribute. The definition of “lay” is not as simple as it may appear but needs early definition as this will need to be used in both job specification and short listing. One aspect that is easy to define is the person should not be an employee of the Trust but what about an ex-employee? Is a nurse who has not practiced for significant time “lay”? Is somebody who has been an LREC lay member for 10 years still a lay representative?

How many appointments?

In what may be considered a potentially intimidating environment there is much to be said for having at least two lay members to minimise any effects of isolation.

Routes for obtaining applicants?

The appropriate route for obtaining applicants will be very much dependant on what has been agreed as a “lay” representative. There may well be many people who already are involved within the local Trust in some format. The advantage of this route is that the members may well be a known quantity but the disadvantage is that they may already represent particular constituencies, it also may exclude excellent candidates to which ethics may be applicable but who are less interested in other aspects of voluntary involvement. In any approach adopted the Trust will need to be reassured it meets equal opportunity issues and formal advertisement and appointments in open competition for the posts has much to commend it. An advert in the public notice section of the appropriate local paper will often produce a number of good quality candidates, especially if this coincides with a small piece that papers are often happy to run about wider community involvement in difficult ethical decisions.

Advert example

As part of the Trust’s Patient and Public involvement strategy and action plan we are looking to appoint members of the public as lay representatives to the Clinical Ethics Group. This group is a recently formed group to advise ad support the Trust and it’s staff on ethical issues.

We are looking for somebody who has a broad interest in ethical issues and who will be able to provide a balanced view from a lay perspective. Clinical qualifications or experience re not required but good team working is important for this innovative and challenging appointment. Applicants would be required to attend monthly meetings, usually in the evenings. Training and support will be provided. Although the post is voluntary reasonable related travel expenses will be paid.

The advert should contain a clear contact point for interested individuals to make enquiries and the information pack sent to individuals should contain a detailed description of what the CEG is, who is on it and broadly what its functions are; this is best written by the CEG.

The practicalities of the applications

The appointment procedure should follow the standard approach for most NHS appointments; this will have the advantage of meeting equal opportunity requirements. A detailed job description along with a detailed personal specification will help ensure that short listed candidates are suitable; the personal specification can also form the basis for the assessment criteria at interview. Categories such as team working, communication, conceptual thought etc. may offer opportunities to explore the skills which a CEG may require.

The appointment process

It should be remembered through the whole process these are volunteers and everything should be done to make the process as stress free as possible.

Many Trusts will be happy for the CEG to handle the process, often with a personnel representative present to ensure that procedures are followed. Following short listing, which should involve as many of the CEG as possible it is useful to invite the short listed candidates to an informal meeting with perhaps two members of the CEG to find out more detail about what Clinical Ethics is and how this works. Most will not know how or what a CEG is. A short presentation of what a CEG is, how they are developing, who the members are, how it functions, the national picture etc. if useful, as this will provide a framework for questions and discussion. It is important to state any downside to the CEG at this time e.g. work may be spasmodic, it may be embryonic etc. and what it is not e.g. research ethics.
The interview process needs some thought and planning, a traditional interview panel is probably not appropriate as this may seem intimidating and may not offer an opportunity to easily explore important areas. An alternative model is of three “mini” interviews each perhaps of 20 minutes, with perhaps 2 CEG members for each interview and the candidates rotating around with relevant gaps. One interview may cover traditional areas such as experience, CV etc. and the other two each deal with an ethical discussion, the scenarios being given to the candidates on arrival.

Example Scenarios

1. Mr Z made a written advanced directive 5 years ago. He suffers from a chronic chest disease and the advanced statement provides that if he is admitted in respiratory failure he must not be ventilated. The advanced directive is placed in his notes.

Mr Z is brought into A&E in respiratory failure and is intermittently confused due to low oxygen levels in his blood. He says that he wants “everything done” in order to save him. The doctor in charge of his care decides to ventilate him.

Q1. What are the relevant ethical issues to consider?

Q2. Can the doctor justify treating the patient?

2. Mr J is a 55 year old man with advanced lung cancer. He has had chemotherapy to which he initially responded, but has relapsed. In discussions with his consultant Mr J expresses a belief that he may respond to further treatment. The consensus amongst the medical team is that Mr J has only a few weeks left to live and that should he suffer a cardiac arrest whilst on the ward any attempts to resuscitate him would be futile. Mr J says he wants everything done to him including resuscitation.

Q1. Should Mr J be resuscitated in the event of a cardiac arrest?

Q2. What are the ethical issues and what other things could the medical team do to help this patient?

After the decision is made it is important to feedback to unsuccessful candidates, again remembering these are volunteers.

Post appointment practicalities

References will need to be taken up and candidates will also need to be warned that many Trusts will require clearance by Criminal Records Bureau. The candidates will need to be offered some form of contract which should include an agreement in relation to confidentiality and this will also mean that they will usually have appropriate indemnity for Trust employees (even of a voluntary nature). Initially a contract of a year may be useful as this allows both sides to avoid long term unsuitable appointments. They may also need Occupational Health clearance and should be provided with the standard ID and access to library resources etc. It may be helpful to explain that the pace of NHS personnel departments in processing these practicalities may not be what is experienced in the private sector. It is important to make lay members feel part of the Trust, especially as many existing CEG members may well be senior experienced members of the organisation.

Travel and support expense should be offered and it is important to consider a budget to offer some training e.g. the Ethox workshop.

Involvement in meetings

A mentor for lay members may be useful initially to ensure that they settle in and the chair of the meeting has a responsibility to ensure that any technical medical terms are tactfully explained to ensure that the lay members have adequate factual knowledge to contribute to the discussion. During the first year it is useful to have some of review to assess how the appointments are progressing.

Lay appointments by open application may seem daunting but there are also significant rewards providing the process is handled carefully. There are many lay members who can make an important contribution, often offering a well thought challenging viewpoint on difficult subjects.

Copyright of Appendix A12 is held by Clinical Ethics Group Sheffield Teaching Hospitals

Dr Paul Gerrish
Chairman, Clinical Ethics Group Sheffield Teaching Hospitals

Appendix A5

Issues to consider when setting up a case consultation service

Many clinical ethics committees (CEC) / groups provide ethics case consultation for clinicians within the trust. Case consultation may be undertaken by the whole committee, by a small consultation group, or by referral to an individual member of the committee who then consults with other members as appropriate.

Below we identify some issues that a CEC may wish to consider in providing a case consultation facility.

  • Who can refer cases to the CEC?
  • Process of referral
  • Pro forma referral forms
  • Ethical framework and critical reasoning
  • Who attends the consultation?
  • Writing up the case consultation
  • Disseminating information

Who can refer cases to the CEC?

Generally the Terms of Reference of a CEC / group are not prescriptive about who can refer cases. Some clinicians may be reluctant to refer cases in the belief that the view expressed by the CEC may limit his / her clinical autonomy. It should be made clear that the CEC provides an opportunity for difficult ethical issues to be considered but the view of the committee does not bind the clinician to a particular course of action.

In general fewer nurses and allied healthcare professionals refer cases to a CEC. This may be because any matter for consultation is channelled through the lead clinician. But what if the nursing team are faced with an ethical dilemma that the consultant does not feel merits referral to the CEC? How will the CEC / consultation group deal with referrals when there is conflict in the health care team over the need to make a referral?

Will patients or their families be able to refer cases to the CEC, and will they be involved in the case discussion when referral is by a clinician?

Process of referral

The committee will need a clear process for considering an initial referral, deciding whether it is appropriate for the committee / consultation group to consider the case, gathering of relevant information, convening a consultation meeting, and documenting the discussion.

Pro forma referral forms

It is very useful for a committee to produce a standard form for all case referrals made to it. This should state the name of the referring healthcare professional and clinical details (but excluding identifying information such as name and hospital number).

An example of a pro-forma for case consultation referral is shown in Appendix A14

Ethical framework and critical reasoning

In case consultation the ethics committee / group is being asked to consider the ethical issues arising in a particular case. It should therefore follow some process to ensure that the ethical issues are addressed and the Chair should ensure that all members have an opportunity to contribute to the discussion.

See Section C for ethical frameworks and critical reasoning.

Who attends the meeting?

The committee will need to consider who should be involved in the case consultation. This will include members of the CEC / consultation group, members of the clinical team, patients and their family or informal carers. How extensive should this group be. There needs to be a balance between the need to involve those people who are directly affected by the discussion, and to avoid an unwieldy meeting or delay in providing support. This may differ depending on the urgency and nature of the case.

Writing up the case consultation

There should be documentation of the case discussion for the CEC, including clear reference to the ethical reasoning leading to the conclusion. This will ensure transparency of process and contribute to consistency of decision-making by comparison of case discussions as part of the review process of the CEC. It will also be valuable in terms of auditing the work of the CEC. It may be useful if a form is created for this purpose.

If the case has been considered by a rapid response team and there has not been a full meeting of the CEC then there will be no formal CEC minutes. When the full Committee next meets the case should be presented for discussion so that all members can learn from the experience and give their views.

The patient’s notes should record the referral and the outline ethical advice given.

Disseminating information

The clinician / healthcare professional that referred the case to the committee should be provided with a write up of the case and the outline discussion (ideally in a standard format). This can be used by the health care team for ongoing education. The process of case consultation should include a review of the outcome of the case to both inform future case consultation and for evaluation of the service.

Copyright of Appendix A5 is held by The Ethox Centre.

Appendix A3

Issues for a CEC to consider in developing policies and guidelines

Does the CEC wish to have a role in developing policy and guidelines?

This is usually given as one of the core functions of a CEC and can be a way for the committee to influence practice on a trust wide level. However it can be very laborious and time consuming if a committee meets infrequently, and may leave little time for other functions that the committee members may see as more important. If policy and guideline development are to be part of the CEC’s role then the committee needs to clarify how it will carry out this role.

Options:

  1. The committee develops, or plays a significant role in developing, specific policies or guidelines which are accepted and ratified by the Trust Board, e.g. DNAR guidelines, consent policy.
  2. The committee reviews existing hospital policies and comments on the ethical considerations of these policies.
  3. The committee has input into the development of policies and guidelines drafted by other committees, e.g. resuscitation committee.
  4. The committee identifies areas where there is a need for a policy or guideline and either develops this or instigates development by another more appropriate committee.

Each option has advantages and disadvantages and the exact role of the committee will depend on where it fits within the structure of the Trust.

General considerations

There are some general considerations which will be applicable to whatever role the committee takes in guideline and policy development.

  1. Is the policy / guideline developed / considered by the whole committee or will sub-committees be used?
  2. If the policy / guideline is primarily developed by another committee, what feedback will the CEC have on its input, and on the subsequent dissemination and evaluation of the policy / guideline?
  3. If the policy / guideline is developed primarily by the CEC, how much consultation will there be with clinicians and other members of staff affected by the policy, what authority will the policy have and how will implementation and evaluation be achieved?

The process of policy/guideline development

  1. Identify the objectives of the policy / guidelines and summarise these
  2. Identify the underlying ethical principles that inform the policy / guideline
  3. Consider the application of the principles in relevant specific cases in order to formulate recommended procedures that will form the core of the policy / guideline.
  4. Consider any legal frameworks in which the policy / guideline must sit.
  5. Consider similar guidelines drafted by other institutions such as professional bodies and other CECs in order to refine or enhance the policy / guideline.
  6. Consult outside the committee.
  7. Aim for clarity in the final document; clarity in the definition of terms, clarity in describing the underlying ethical principles and clarity in setting out procedural steps.

Useful sources of existing guidelines

BMA guidelines www.bma.org.uk/ap.nsf/Content/Hubethics

GMC guidelines www.gmc-uk.org

Examples of CECs that have developed guidelines on the following issues:

Guidelines CEC names
  Wirral Hospitals NHS Trust
  Nottingham City Hospital NHS Trust
CPR/DNR guidelines Oxford Radcliffe Hospital NHS Trust
  Royal United Hospitals Bath NHS Trust
  St Mary’s NHS Trust
  St Mary’s NHS Trust
Withdrawal and withholding of life sustaining treatment The Royal Hospitals NHS Trust, London
  Wirral Hospitals NHS Trust
  Oxford Radcliffe Hospital NHS Trust
Advance directives Nottingham City Hospital NHS Trust
  Wirral Hospitals NHS Trust
Consent to treatment Nottingham City Hospital NHS Trust
  Royal Hospitals NHS Trust, London
Presence of relatives at CPR attempts Royal Hospitals NHS Trust, London
Retention of tissues and organs post mortem Royal United Hospitals Bath NHS Trust
Blood transfusion in Jehovah’s witnesses Royal United Hospitals Bath NHS Trust
Clinical alert policy (for investigations on infectious patients) Wirral Hospitals NHS Trust
Clinical confidentiality and the media Royal Hospitals NHS Trust, London

Copyright of Appendix A3 is held by The Ethox Centre

Appendix A2

Clinical ethics committees in German Hospitals

Dr Thela Wernstedt, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany

Clinical Ethics Committees (CECs) are new institutions of implementing clinical ethics in German hospitals and nursing homes. Most of the CECs are in hospitals that are members of the Protestant or Catholic Hospital Association, which recommended in 1997 the founding of CECs. There are CECs at only three University Hospitals: Hanover (2000), Erlangen (2002) and Mannheim (2004). Another three have ethics consultation without a CEC: Marburg, Ulm, Freiburg. There are some communal and confessional hospitals wich have active CEC or ethics consultation or other forms of ethical support (Hamburg, Hanover, Göttingen, Frankfurt and Nuremberg). Altogether there were 77 CECs in German hospitals in 2003.

In 2002 we posted a questionnaire with 13 items to medical directors and directors of nursing of all 36 German University Hospitals to find out why so few University hospitals have CECs.

We found, that the most relevant ethical issues in everyday clinical practice were limitation of treatment, informed consent and the conflict between beneficence and autonomy. Improvement of interdisciplinary teamwork, further education in ethics and improvement of guidelines have been identified in order to improve ethical professional performance. Additional support of their staff in ethical issues was mentioned by more directors of nursing than medical directors and also the regret about the low priority that ethical issues have in everyday patient care.

Five German University Hospitals are planning to establish a CEC, another two want to employ a clinical ethicist. There is high need for information about CECs in German university hospitals. Tasks, working methods and chances for further development of CECs are neither known nor used by the majority of German University Hospitals.

Literature

 

  1. Deutscher Evangelischer Krankenhausverband, Katholischer Krankenhausverband Deutschlands. Ethik-Komitee im Krankenhaus. 1. Auflage (Hrsg.). Stuttgart Freiburg: Selbstverlag 1997.
  2. Deutscher Evangelischer Krankenhausverband, Katholischer Krankenhausverband Deutschlands. Ethik-Komitee im Krankenhaus. Erfahrungsberichte zur Einrichtung von Klinischen Ethikkomitees. 1. Auflage (Hrsg.). Stuttgart Freiburg: Selbstverlag 1999.
  3. Gerdes B, Richter G. Ethik-Konsultationsdienst nach dem Konzept von J.C. Fletcher an der University of Virginia. Charlottsville, USA. Ethik Med 1999; 11: 249-261.
  4. Kettner M, May A. Landkarte Klinische Ethikkomitees in Deutschland. Unveröffentlichtes Manuskript, 2003.
  5. Neitzge G. Ethik im Krankenhaus: Funktion und Aufgaben eines Klinischen Ethikkomitees. Ärzteblatt Baden-Württemberg 2003; 4: 175-178.
  6. Reiter-Theil S. Ethik in der Klinik- Theorie und Praxis: Ziele, Aufgaben und Möglichkeiten des Ethik-Konsils. Ethik Med 1999; 11: 222-232.
  7. Simon A. A Report from a Catholic hospital- Neu Maria-Hilf, Göttingen. HEC Forum 2001; 13: 232-241.
  8. Simon A. Ethics Committees in Germany: An empirical survey of Christian Hospitals. HEC Forum 2001; 13: 225-231.
  9. Wernstedt T. Strukturen der Medizinethik in Deutschland, Teil 1 und 2 in Bayr. Ärzteblatt 1/2004: 69 und 5/2005:313.
  10. Vollmann J, Weidtmann A. Das Klinische Ethikkomitee des Erlanger Universitätsklinikums. Institutionalisierung – Arbeitsweise – Perspektiven. Ethik Med 2003; 15:229-238.
  11. Vollmann J, Burchardi N, Weidtmann A. Klinische Ethikkomitees an deutschen Universitätskliniken. Eine Befragung aller Ärztlichen Direktoren und Pflegedirektoren. Dtsch Med Wochenschr 2004; 129:1237-1242.

Copyright of Appendix A2 is held by Dr Wernstedt.

Dr Thela Wernstedt
Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany
Medical Doctor
Magistra Atrium for Philosophy
Anesthesiologist
Chair, Clinical Ethics Committee
Ethics Consultant

 

Appendix A1

A first hand account of the experience of ethics support in the United States.

Dr Ainsley Newson, Imperial College, London
In May 2004, I undertook a one-month placement with a Department of Clinical Bioethics in a large not-for-profit hospital in the United States. Here, I had the opportunity to observe ethics consultations and to discuss the various approaches to providing clinical ethics support with a variety of professionals in this field.

The Department in which I worked has been established for over twenty years and was one of the first such units in the US. Three clinical ethicists are employed in the department full-time, with ancillary research and support staff. On average, the Department handles around five ethics consultations a week, in addition to ongoing work in policy, education and academic research. Ethics consultants rotate on service approximately every three weeks.

The consultants make decisions about a similar range of issues as do clinical ethics committees in the UK: DNR orders, medical futility, withdrawal of treatment, decision-making capacity, treatment refusals, compliance concerns and disagreements between patients/families and health professionals. Cases also arose, however, to illustrate the broad range of theoretical and practical skills required to undertake successful ethics consultation. For example:

  • Should an ethics consultant become involved when a dying child’s family wants to undertake a loud and involved religious service at the bedside?
  • What, on a practical level, should an ethics consultant do when a potentially manageable genetic condition is identified in a donor organ?
  • How much knowledge of surgery and its attendant risks is required in order to ensure a patient is providing fully informed consent rather than mere acquiescence?
  • Should patients with impaired mental capacity who have limited family support be denied access to risky surgery?
  • Should parents who ‘want everything’ for their terminally ill newborn have access to a full range of treatments even if these are futile?
  • How should the demands of agitated families be managed?

The largely theoretical nature of the discussion and debate on these topics in the literature and the lack of consensus on many ethical issues in health care are brought into stark reality when a decision has to be made.

The level of consultation the Department provides varies with the kind of issue at hand. Ethics consultants regularly provide advice to the health care team, facilitate at patient/family meetings, provide education or refer on to another service (such as the institutional ethics committee). In contrast to the majority of UK clinical ethics committees, Department members undertake a significant proportion of their consults directly with patients. Often, ethics consultants take on a role beyond that typically construed as ‘clinical ethics’; Bioethics is often paged by health care team when, for instance, the hospital ombudsman or the social work team are unavailable. Staff also perform research ethics consults: assisting with the creation of consent forms or deliberating on the sensitive ethical issues in a proposed trial.

The approach to ethics consultation is largely individual, although unusually complex or difficult problems are discussed amongst the team. Cases are reviewed at a fortnightly meeting, in collaboration with other clinical staff interested in bioethics and academic medical ethicists from nearby universities.

The Department is also supported by an institutional ethics committee. This committee, like the majority of those in the UK, tended to work at arm’s length; generating and responding to hospital policy and considering more difficult cases, such as maternal-foetal relations.

The Department also provides regular ethics liaison services throughout the hospital, including twice-weekly rounds in Intensive Treatment Units. Bioethics staff also provide regular support to a number of clinical programs, notably those committees assessing candidates for organ transplantation, living donor transplants and pre-surgical consults for procedures such as deep brain stimulation for Parkinson’s disease, or epilepsy surgery. This more ‘proactive’ or preventive approach to ethics consultation has three main aims:

  1. 1. To address specific ethical questions raised by patients, families, or the health care team;
  2. 2. To determine whether there are any ethical contra-indications;
  3. 3. To ensure the patient has the ability to judge the risks and benefits of the intervention and that the patient’s values match with the desire for the intervention.

All ethics consultations (whether simple or complex) are logged using a written summary report. This contains all relevant patient information, the requestor’s details, a description of the problem and a report of the processes used in resolving it. In many cases, the clinical ethicist will make a note in the patient’s chart or electronic patient record reporting his / her view as to the most appropriate course of action.

During my visit, I was struck by the significant integration of Bioethics into the provision of standard clinical care. Clinical staff were very aware of the bioethics service, and demonstrated no hesitation in asking for advice. The Department’s details were highly visible on all hospital paperwork and the availability of bioethics was well-publicised to patients. After-hours access to consultation was also possible.

My observations also indicated that the success or failure of an ethics consultation is easily determined by the approach taken. Ethics consultation will only rarely involve one particular issue. If a consultant immediately jumps to classifying a problem, then it is likely that the consultation will fail as this will limit the range of thinking that will be undertaken. Rather, it is important to think widely and creatively about any given scenario: approaching problems in clinical ethics is a very creative process. Further, the qualities of a good ethics consultant range far beyond mere theoretical knowledge. Consultants need to be able to engage with a wide variety of people, listen, facilitate and show empathy.

The minutiae of details discussed in a consultation can also be vital: one patient being assessed for epilepsy surgery told the consultant that she knew the risk of her surgery being successful was 60%. Yet, when asked how many people from a room of 100 would represent this percentage, she could not answer. What does this indicate about her understanding of the surgery? What impact might this have on her ability to provide informed consent, and what are the ethical implications?

US clinical ethics consultation is by no means a static discipline and several methodological issues are currently being debated. For example, there is increasing concern about the ‘professionalisation’ of ethics consultation and the kind of qualifications and training that should be required. Additionally, anonymous consultations sometimes occur, particularly where there is a disagreement within the clinical team.

Further Reading

Aulisio MP, Arnold RM, Younger SJ (eds) Ethics consultation: From theory to practice. Baltimore: Johns Hopkins University Press (2003).

Dr Newson’s visit to the United States was supported by a Small Research Grant from the British Academy.

Copyright of Appendix A1 is held by Dr Newson.

Dr Ainsley Newson
Medical Ethics Unit, Imperial College London
London IDEAS Genetics Knowledge Park

Appendix A13

An example of a proposal to a trust board for the setting up of a clinical ethics committee

Graham Behr, Jo Emmanuel and Jon Ruddock, Central and North West London Mental Health NHS Trust

Introduction

Public expectations of health care, and public criticism of health care professionals has increased over the past few years. The demand for greater public accountability in health care decision making means that health care professionals will need to justify both the clinical and ethical reasons for their decisions both to their patients and to society. Judicial involvement in medical decision making has also increased, often in cases where competing moral values need to be weighed against each other.

Much of the debate about how best to help mentally ill clients centres on the degree to which clinicians should intervene paternalistically (i.e. make choices on people’s behalf) to safeguard the best interests of those clients who may have a reduced ability to make treatment decisions. The Mental Health Act 1983, associated commentaries and Code of Practice provide a framework to help clinicians faced with these decisions. However there are many facets of the care of people with mental illness that are not covered by the above mentioned guides, which present ethical dilemmas.

Furthermore some of the most difficult treatment decisions involve withholding or withdrawing treatment from people who want treatment but for whom clinicians feel treatment is conferring no good or may even have unwanted or unhelpful effects. In some cases clients and clinicians can agree together that ‘not treating’ is the best option. However, in a substantial number where agreement cannot be reached there is a risk of suicidal or violent behaviour. Clinicians, and also their managers, are anxious in the current political climate to minimise the likelihood of a resulting ‘serious untoward incident’ occurring.

Professionals also face decisions about withdrawing treatment when the patient is so threatening or violent that the treatment required can not be given without compromising the safety of the clinicians or other service users. This creates difficult management decisions within the Trust, and has led to differences of opinion between clinicians and managers.

These are the kinds of examples in every day mental health practice which require principles to guide us rather than purely senior opinion or group consensus.

The transition from a model of ethical paternalism to one of respect for autonomy and clinician/client partnership means that clinicians have to reassess the value systems used in their clinical decision making. Policies which guide the actions of clinicians must similarly be based on sound ethical principles.

In addition, the introduction of medical ethics into the undergraduate curriculum for medical students means that clinical teachers need to have an understanding of medical ethics, as applied to psychiatric practice.

Within this framework of raised ethical awareness and demand for public accountability, how can individual health professionals and Trusts ensure high ethical standards in all aspects of patient care? Some guidance already exists at a national level through DoH and GMC, but local resources need to be developed to provide support that is both responsive and relevant to local circumstances.

The way in which many Trusts deal with this challenge is by invoking the assistance of a Clinical Ethics Committee (CEC). The proposal for the development of a CEC in CNWL, recently highlighted in the NHS Clinical Governance Support Team Accelerated Service Improvement Program Evaluation Report (2002), arose from work undertaken following the Protected Time Initiative, held in North Westminster in 2001.

The national governing body of clinical ethics committees, ETHOX is not aware of any Mental Health Trust which has yet developed a dedicated CEC. It is our view that in a Trust the size of CNWL, the volume and complexity of clinical issues merits this.

Remit of a CEC

The CNWL CEC will have as its primary remit, the support of decision making by clinicians within an ethical framework. It may also extend its role to providing support for Trust policy development and education for Trust employees

1. Clinical management
CECs do not have the same executive decision making powers as Research Ethics Committees. Rather their function is to enable the professionals involved in any given decision to look at the situation from many viewpoints, and as such make better informed and considered decisions about their own cases. The responsibility for the decision remains with the clinicians bringing the case for consideration. There is no onus on a clinician to discuss cases in the CEC; it is available as a facility to be used at clinicians’ discretion. It is recommended that a decision to bring a case be agreed by the relevant team though any member of the team may initiate this.

2. Input into policy development
Some examples of this (which might be pertinent to a Mental Health Trust) are: Advance directives, rights and duties of relatives, confidentiality, consent to participate in undergraduate education, withholding and withdrawing of treatment, use of restraining techniques, possession of illicit drugs, the abuse of the service by members of the public.

3. Education
We would wish to assist in the education of clinicians and students. Initially this may take place by the involvement of clinicians who sit on the committee and those who bring cases as well as by dissemination of the summarised debates of the committee.

Structure

Membership of Clinical Ethics Committee

Members should have:

  • Interest in the subject of medical ethics
  • An ability to work in a group
  • A commitment to the group
  • Some personal experience which would be useful to the group (clinical / service user / lawyer etc)

The committee will comprise:

  • Professional ethicist
  • Legal professional
  • Clergyman
  • Service user
  • Non-executive member of the Trust Board
  • Administrator
  • Four other Trust clinicians
  • Chair
  • Core group (three Trust employees) to initiate and drive the process

The non-executive member of the Trust Board will be appointed by the Board.

The chair and the core group will be responsible for recruiting the other members of the committee and reviewing that membership on an annual basis.

All members of the CEC will be legally indemnified from prosecution by the Trust.

The role and responsibility of the chair

The chair will be recruited and appointed by the Chief Executive and will not be a Trust employee or member of the Board. This will reduce the likelihood of conflict of interest arising.

The chair is likely to become the ‘public face’ of the committee and, as such it is crucial that they have broad acceptability to clinicians bringing cases.

The role of the chair would have particular requirements:

  • To summarise ethical debate
  • To clarify strands of argument
  • To separate administration/managerial discussion from clinical discussion
  • To ensure the discussion’s primary focus is on ethical considerations
  • To frame conclusions in a way which is helpful to clinicians

The chair has the right to co-opt additional members to provide specialist expertise.

Accountability and reporting of proceedings

  • The CEC will be constituted as a subcommittee of the CNWL Clinical Governance committee.
  • The discussions of each meeting will be summarised and anonymised so that :
    • They may be tabled at meetings of the clinical governance committee
    • They may be accessed by clinicians as an educational tool
  • The detail of the discussion will remain privy to the participants. The committee would divulge information to management only when there was a clear breach of the law
  • An audit tool is currently being designed to determine the usefulness to clinicians of the committee.
  • The CEC will continue to link with ETHOX, other CECs and other relevant organizations. In this way, the committee will continue to learn about ways of working which best support clinical decision-making.

Resource Implications

There are four areas with resource requirements:

1. Administration
Administration is required for: accurate minute-taking, telephone and email liaison with group members, clinicians and outside organizations, maintenance of a database, arranging training and education, carrying out audit, dissemination of information Trust-wide, input into Intranet etc.. It is expected that 4 sessions per week are required.

2. Education and Training
Although some members will have training in medical ethics, a basic level of knowledge for all members will assist the effectiveness of the CEC. This might best take the form of an annual training day, with initial training upon the commencement of the committee. Costs would involve the trainer/facilitator of such days. Access to key literature may also involve a small cost.

3. Honorarium payment to members
The chair will receive an honorary payment.

Trust employees would be expected to participate in this committee voluntarily. However, whilst our sense is that we are unlikely to have to pay for the services of other participants at this time, such payment may be required in the future.

4. Sundries
To include coffee facilities, possible remuneration of transport costs for any unemployed members, and other minor expenses as they arise.

Copyright of Appendix A13 is held by Central and North West London Mental Health NHS Trust

Graham Behr, Jo Emmanuel, Jon Ruddock
Central and North West London Mental Health NHS Trust

Ethical considerations underpinning the Act

pdf version

This is one of a series of resource materials for clinical ethics committees providing explanation and discussion of the sections of the Mental Capacity Act which arte particularly relevant to their work.

Key ethical principles informing the Act

  • Respect for valid choice
  • Best interests principle
  • Liberty of movement
  • Avoidance of harm
  • Doctrine of necessity

1. Priority given to valid patient choice

1.1: What is valid choice?

It has long been a principle of English law that an adult with capacity has the right to refuse any treatment, even life-saving treatment. This principle is endorsed and extended by the MCA.

Valid patient choice, either to refuse a treatment on offer, or to choose between treatments on offer, trumps all other considerations. A valid choice is one made by a patient with capacity who is properly informed and who chooses voluntarily (without coercion).

1.2: Respecting valid choice is not the same as acting in a patient’s best interests

The concept of best interests, both as explained within the MCA and in most philosophical accounts, is logically distinct from valid choice.

On most analyses of best interests (see section 2 below), including that in the MCA, it is (logically) possible for a person to make a valid decision that is against his best interests. A person can be mistaken, for example, about what is best for him; or can make a valid decision knowing that it is unlikely to be in his best interests. ‘When the Gods want to punish us they answer our prayers’ (Oscar Wilde, An Ideal Husband, Act 2). A person might for example validly choose to take risks, or to pursue a life of gambling, even though, on any account, this is not in the person’s best interests. Thus, the assessment of the validity of a choice does not depend on whether the choice itself is in the person’s best interests.

Under the MCA valid patient choice is given priority over other considerations, including what is in a patient’s best interests.

1.3: Respecting valid choice is not the same as respecting patient autonomy

It might reasonably be thought that the MCA’s position on respecting valid choice can itself be seen as identical with respecting patient autonomy. The concept of autonomy however is not straightforward, and respecting what a patient says (e.g. her refusal of treatment) and respecting her autonomy may, on occasions, be different.

One key issue in the analysis of autonomy is what conditions need to be met for a person’s decisions and actions to be autonomous, i.e. truly her own. Three aspects have been the focus of recent analysis.

a) To be autonomous one must make evaluations. The ideal of the autonomous person is the person who forms desires for how her life is to go (life plans) and can act on those desires. In order to create such a life plan for ourselves we need to make evaluations, in particular about what kind of life we think we should live, or that we think might be best for us.

b) Evaluations should be rational. In the ideal of autonomy day-to-day decisions should be rational, i.e. consistent with the person’s life plans. If a desire, or choice, is not based on a rational evaluation then it is not autonomous. This is one reason why respecting a person’s autonomy is not always the same as respecting her choice.

c) Desires higher in the hierarchy should be respected. A person may have a simultaneous conflict in desires. For example, a person addicted to alcohol may simultaneously desire alcohol and desire not to have the desire for alcohol. The desire for alcohol is a ‘first-order’ desire and the desire not to desire alcohol is a ‘second-order’ desire. Some have argued that respecting autonomy implies respecting the higher (second-order) desire on the grounds that it is the one that is part of the life plan.

English common law has developed the idea that patients can refuse treatment for reasons which are rational or irrational or for no reason, as long as they have capacity. Irrational decisions, or decisions made for no reasons at all, might therefore be valid decisions but would not necessarily be autonomous decisions (according to most accounts of autonomy).

1.4: The assumptions underlying the assessment of capacity (MCA section 1(3)

The MCA gives a particular account of what it is to have, or to lack, capacity – an account that has been developed in common law jurisdictions (such as English and US law). This notion of capacity is not value free. It plays a crucial ethical role in that it determines when a person’s refusal of medical treatment should be respected and when it may be overridden in the patient’s best interests. The notion of capacity in the MCA has the following three features:

a) The assessment of capacity is specific to the specific decision, so that a person may have the capacity to make one decision (e.g. to live in her own home) but lack capacity to make another decision (e.g. to have an operation for bowel cancer).

b) With regard to a specific decision a person either has capacity or lacks capacity: there are no degrees of capacity.

c) The account of capacity is almost exclusively intellectual. A person has capacity if he: understands the key information, retains it, can use or weigh the information as part of the process of making the decision, and communicate the decision.

The first feature – a) above – is widely accepted.

What about the second feature? Imagine a person whose intellectual abilities are gradually deteriorating due to Alzheimer’s disease. Is it plausible that there is a moment when that person’s capacity with regard to a particular decision flips from full capacity to no capacity? Some argue that it is not plausible and that capacity must have degrees from full capacity, through partial capacity to no capacity. Even if the underlying concept is a graded one, however, it might be that in practice it is best for the law to take an all-or-none approach. For example, suppose a patient who was refusing beneficial treatment was assessed as having partial capacity. Should we then give partial weight to her refusal? In theory this might make sense: it might mean that the refusal would be balanced against the likely harm of not giving the treatment, and a decision made. In practice this may be too complex and the binary approach to capacity may be more workable and effective.

The third feature – the almost exclusive focus on intellectual abilities – has received the most criticism. There are situations, particularly in the context of mental disorder, where a patient may refuse beneficial treatment not because he fails to understand, retain and use the information but because the way in which he uses the information is affected by the mental illness. A depressed person, for example, may give little weight to the risk of death in not receiving treatment for a physical illness because he does not put much value on carrying on living. A patient with anorexia may refuse treatment not because she fails to understand the risk of death, nor because she wants to die, but because she values remaining thin to such an extent that she would prefer to risk death than put on weight. A drug addict might refuse treatment because the addiction means that he cannot choose to avoid the substance to which he is addicted. Thus mental illness may affect both values and agency and thus the decision, without interfering substantially with intellectual abilities. It is not clear how to interpret the criterion: ‘to use and weigh that information as part of the process of making the decision’ in these types of case. The Code of Practice (4.2.2) briefly discusses anorexia and suggests that a person may have a ‘compulsion to eat’ that is too strong to ignore and (by implication) that she therefore lacks the ability to weigh up the information and lack capacity. This suggests that lack of agency might be a reason for lack of capacity under the MCA. Whatever the interpretation of the law, and this may need to wait for court decisions, there remains an important and difficult issue as to what is ethically right in these situations. When is capacity compromised and when is it right to override treatment refusal?

1.5: A duty to take active steps to promote valid patient choice

The emphasis given to valid patient choice, in the MCA, is greater than was clear in prior common law in that health professionals have a duty to try and ensure, if at all possible, that the patient can make valid choices. If a patient lacks capacity then health professionals must not treat in best interests until they have done whatever can be done to enable the patient to have capacity. Respecting valid patient choice is therefore not simply a passive duty (that if the patient is able currently to make a valid choice that must be respected) but it is an active duty (that a patient currently unable to make a valid choice must be helped to do so if at all possible).

1.6: Advance decisions

The principle that an adult with capacity has the right to refuse any treatment (see above, section 1.1) relates to contemporaneous decisions. The MCA extends this principle to cover decisions made now about situations in the future (when the patient lacks capacity). It does this by giving the same weight to an advance decision as it does to a contemporaneous decision (e.g. to refuse treatment) as long as that advance decision is ‘valid and applicable’. The position taken by the MCA is that a valid and applicable advance decision, just like a contemporaneous capacitous decision, may or may not be in the patient’s best interests but it should be respected in any case as part of respecting patient choice.

There has been much ethical debate concerning advance decisions. There are reasons for considering the extension from contemporaneous to future decisions problematic although these are not discussed in the MCA, nor in the Code of Practice.

There are two reasons against giving as much weight to an advance decision as to a contemporaneous decision. First, in the case of contemporaneous decisions, if a person is making what seems to others a foolish decision, health professionals can go to considerable lengths to ensure that the decision really is what the person wants. Second, the experience of illness can change people’s values in ways important to the decision. For example, anecdotal evidence suggests that a person following a stroke may have different views about life-extending treatment than she had when healthy and imagining a future scenario in which she suffers a stroke.

Health professionals may doubt the ‘validity and applicability’ of an advance decision refusing a treatment that they believe is strongly in the patient’s best interests. For an advance decision to be valid it would have to have been completed by the relevant person at a time when he had capacity and was informed of the relevant information. For the decision to be applicable the circumstances and treatment that actually arise would need to have been specified. It will often be the case that there will be some uncertainty over at least one of these elements. For an example of a problematic case see section 2.5 below.

2. If no valid choice then primacy given to best interests

2.1 The principle of best interests MCA section 1(4)

The MCA gives a particular account of best interests. It does not, however, define best interests, nor does it provide a criterion for judging best interests. Instead it gives a checklist of issues that should be considered (or at least ascertained) in making the judgment about best interests. The Code of Practice states that this checklist is not complete and that the agent may need to take further unspecified issues into account.

2.2 Three different accounts of best interests (well being) in the philosophical literature

The philosophical concept most closely allied to best interests is well-being. A person’s best interests are served by maximising his well-being. There are several different accounts of well-being in the philosophical literature. The MCA does not address these nor state which of these accounts underlie the legal concept of best interests. The judgment of best interests based on the checklist items may differ depending on which accounts of well being are adopted or given most prominence.

Three accounts of well-being are as follows.

a) Mental state theories

According to mental state theories, well-being is defined in terms of mental states. At its simplest (hedonism) it is the view that happiness or pleasure is the only positive mental state, and unhappiness or pain the only negative one. The theory can be enriched (and complicated) by allowing a greater plurality of states of mind as contributing to well-being, although this raises the problem of which mental states these should be.

The idea is that at any one time it is meaningful to say that a person is experiencing a certain level of ‘happiness’ (or whatever mental state is relevant) and that this might change over time. At the moment, for example, I might rate this ‘moment happiness’ at say level 4 on a scale where 0 is neither happy nor sad, negative values are more sad than happy, and 10 is the happiest that I can be. Perhaps this evening over supper my rating will rise to 6; and tomorrow as I face the beginning of another day at work my rating will be -2. My overall ‘happiness’ over a year would then be the integral of my level as it changes over time. Suppose we were to ask whether it is in my best interests to go for job A or job B. The answer would be determined by working out the integral of my states of happiness over the rest of my life were I to choose job A, or job B. My best interests would be served by choosing that job that gave the higher figure to these integrals of moment happiness. Of course these figures are difficult to work out and judgments and guesses have to be made. But the point is that what is at the root of the question of best interests is choosing that path that, all things considered, is likely to lead to the highest overall rating for these moment to moment levels of happiness (or whatever states of mind are considered relevant to judgments of well-being).

b) Desire fulfilment theories

According to desire fulfillment theories, well-being consists in having one’s desires fulfilled. It is plausible that to maximize a person’s well-being we ought to give the person what they want. If desire fulfilment theories are to provide a plausible account of well-being, it is necessary to restrict the relevant set of desires. On one view only those desires pertaining to life as a whole count as relevant in the analysis of well-being. These are desires that relate to a person’s life plan.

I might have a strong desire to achieve a certain outcome in my life. I might for example want to write a book on the Mental Capacity Act. Fulfilling this ambition may be important to me. On this view it might be strongly in my best interests that I do this. But it does not follow from this that writing this book will maximise my ‘hedonic’ pleasure. It may be that taking more holidays instead of writing the book would increase the overall integral of my moment happinesses. So the desire-fulfillment theory and the mental state theory are not the same. They are alternative conceptions of the basis for best interests.

c) Objective list theories

According to objective list theories best interests are multidimensional and, more importantly, the dimensions are determined not by each individual but are seen as intrinsic to the concept. On this view certain things contribute to a person’s best interests whether or not they are desired, or lead to pleasurable mental states, for example engaging in deep personal relationships, rational activity and the development of one’s abilities. Things that might, on this view, act against best interests include being betrayed, deceived, or gaining pleasure from cruelty.

Suppose, for example that we are judging the best interests for a particular person of two different ways of living. The first is that the person lives a life with no deep personal relationships. His work is mundane and he has no significant hobbies. But he is reasonably content. The second life is one in which the person lives a life of deep personal relationships and has a complex and worthwhile job. But the second life also has greater variation in hedonic pleasure and more ups and downs. Overall let us suppose the second life gives less hedonic pleasure. On the objective list theory of well being it might be argued that living the second life is in the person’s best interests – even though the overall integral of happiness is less - because it is a richer life.

Box 1: Case example: Mrs K

Mrs K has moderately severe Alzheimer’s disease, as had her mother. She cannot recognise her close relatives. She is generally cheerful and appears to enjoy watching TV ‘soaps’ although it is unlikely that she can follow the plots. She enjoys wandering around the nursing home garden smelling the flowers. She enjoys cups of tea and mealtimes.

Mrs K has contracted a severe chest infection. Without treatment she is expected to die. With IV antibiotics she will almost certainly be cured of the chest infection.

Mrs K had been a university lecturer and had always valued intellectual pursuits. She had said to her daughter that she would rather die than be like her mother.

2.3 Applying the three theories of well-being to the case example

Is it in Mrs K’s best interests to give the IV antibiotics or not? On a mental state theory of best interests (well being) the issue is about her moment to moment experience. It appears that currently her moment to moment happiness is positive: that overall the sum (integral) of her pleasure is positive. It is not easy to judge this over the whole time between now and when she dies but there seems no overriding reason to believe that the overall sum will be negative, if she is treated with antibiotics.  Given the clear pleasures that she seems to currently enjoy it seems likely that saving her life now will lead to more overall pleasure than if her life now ended. On the mental state view her prior values, disvaluing the state of dementia are not relevant.

On the desire fulfilment theory we presumably need to take into account her former desires before dementia. So if we withhold antibiotics we are contributing to her well being since we are fulfilling her earlier desires. There is then a question of whether she has any current desires that are relevant to the judgment of best interests. She appears to enjoy watching TV and walking round the garden, but does she have a desire to do these things? The answer depends on how we count desires and to what extent desires, in the sense in which they contribute to well being, are conscious and intellectually assessed desires or simply what drives behaviour towards a particular action. If the desires that are most important are the intellectually held desires that relate to life plans then the former pre-dementia desires would seem the most significant. On this view it is probably in the person’s best interests to withhold IV antibiotics allowing the person to die because this maximises the fulfilment of those desires.

On an objective list theory it may be the case that a life without dementia is objectively rated as giving much greater well being than a life with dementia. This is not on the grounds that the integral of moment happiness is greater but that living without dementia contributes more to a person’s objective well-being than living with dementia. Living without dementia, however, is no longer a possibility for that person. The rest of the person’s life will be in a state of dementia so the question is whether living with dementia is overall worse than no life at all. The answer will depend crucially on what aspects of life are included on the ‘objective list’ of the elements of best interests.

2.4 Applying the MCA checklist to the case of Mrs K

The MCA identifies seven considerations in its checklist of best interests (see box 1)

Box 2: MCA considerations for assessing best interests

1. The person’s past wishes.

2. The person’s past feelings.

3. The person’s present wishes.

4. The person’s present feelings.

5. The beliefs that would be likely to influence his decision if he had capacity

6. The values that would be likely to influence his decision if he had capacity

7. Other factors that he would be likely to consider if he were able to do so.

How are the MCA criteria for best interests to be applied to a particular case such as that of Mrs K? There is, it would seem, considerable room for health professionals or members of clinical ethics committees to use their own conception of best interests based on ethical considerations. This is for three reasons: the MCA gives no general account of best interests; the checklist covers a wide range of issues so that the decision made may vary depending on what weight is given to each consideration; and the Code of Practice states that further (unspecified) considerations can be taken into account. It is important to remeber however that the considerations to be taken into account are relevant only if they help in the assessment of a patient’s present beat interests and do not carry weight independantly of this.

Factors 1 and 2 (past wishes and feelings) require health professionals to take the prior views of Mrs K into account. Factor 4 (present feelings) could be used to justify giving weight to the (presumed) fact that Mrs K is generally enjoying life, that is to adopt aspects of the mental state theory of well-being. Indeed the Code of Practice (5.40) says that ‘Expressions of pleasure or distress and emotional responses will also be relevant in working out what is in their best interests’. In addition one might argue that Mrs K’s present wishes include the wish to watch TV, and to walk round the garden. Although Mrs K lacks capacity to decide about IV treatment she nevertheless has such wishes and these provide grounds for saying that her best interests involve her continuing to live.

Factors 5, 6, and 7 raise the thorny issue of what is sometimes called ‘substituted judgment’: the judgment about which beliefs and values Mrs K would take into account ‘if she (magically) regained capacity’ but otherwise remained in her current state . The answer, however, depends crucially on the assumptions made in this magical state. Would Mrs K, in this magical state, have the intellectual ability to understand and weigh up the issues about antibiotic treatment but lack her previously held values concerning the importance of intellectual pursuits, or would she also regain her old values and despise the watching of TV soaps? Would she judge the pleasure of walking round the garden in the light of her old values, or through the lens of her current more restricted intellectual abilities? It would seem that we must first decide our position on balancing her old values against her current experience, and then interpret the application of factors 5, 6, and 7 from the MCA checklist accordingly.

In short the decision about best interests must be made by professionals, proxy decision-makers and clinical ethics committees on the basis of ethical considerations: the MCA requires only that the items on the checklist are taken into account.

2.5 The case of Mrs K and advance decisions

Suppose Mrs K (see box 1 section 2.3) has written an advance decision, at the time when she had capacity, to the effect that if she, at any time in the future had Alzheimer’s disease and lived in a nursing home, then she refuses treatment for any chest infection including antibiotic treatment. Suppose she had explained, in her written advance decision, that she would prefer to die than to live with Alzheimer’s disease and that this is because of the great value that she puts on intellectual pursuits. Suppose further that she realises that a person with Alzheimer’s might enjoy her life, indeed she believes that this was the case with her mother. She stated in her advance decision that even if she appeared to enjoy herself she refuses life-extending treatments.

In this imagined case it would seem difficult to argue that the advance decision was not ‘valid and applicable’. If that is the case then it would seem that under the MCA, life-saving antibiotics should not be given: Mrs K would have to be made comfortable and allowed to die. Opinions differ over whether this is ethically right. This is an example of where the MCA appears to take a specific position that is, ethically, contentious.

3: Exceptions to giving best interests full weight

As we have seen, if the person can validly make the decision himself (either because he has capacity or because of a valid and applicable advance decision) then best interests are irrelevant. But there are also several circumstances, according to the MCA, in which factors in addition to best interests need to be taken into account by carers and professionals even when the person lacks capacity and there is no valid and applicable advance decision.

3.1 Restraint and restriction of liberty

Box 3: Some examples of restraint in health care

  • Holding a patient’s arm against her will to take a blood sample
  • The use of mittens or bandaging to prevent patients pulling out nasogastric or endotracheal tubes.
  • The use of bed rails to prevent patients falling out of bed
  • Preventing patients leaving a hospital or nursing home
  • Electronic tagging of patients
  • Physical restraint of a violent patient
  • Chemical sedation in cases of extreme agitation (e.g. post operatively)
  • Rapid tranquilisation in acutely disturbed patients to reduce the risk of violence or injury

The sixth principle set out in section 1 of the MCA states that:

‘Before the act is done or the decision made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action (MCA section 1)

In section 1(6) the MCA sets out two further conditions that must be satisfied (over and above the conditions of lack of capacity and best interests) before a person can be restrained.  These are

  • That the restraint is necessary in order to prevent harm to the person.
  • That the restraint is proportionate to:-

a) the likelihood of the person suffering harm if not restrained, and

b) the seriousness of that harm

This introduces two further ethical principles into the Act, that of liberty (as expressed by freedom of movement) and avoidance of harm or non maleficence.  The MCA places a special emphasis on the importance of liberty over and above the weight it would be given in an assessment of the person’s best interests.  At first sight this emphasis on minimising restraint and avoiding harm might be seen as simply ensuring that health professionals and others give due regard to these factors in assessing best interests. A proper assessment, however, of best interests, including consultation with family and other carers, should take the harm of restraints into account.  The MCA appears to go further than this by specifically linking restraint to the prevention of harm rather than to the promotion of best interests.  Thus the MCA appears to forbid restraint if such restraint is not necessary to prevent harm even if, overall, it is in the person’s best interests. The case example in box 4 describes a situation when restraint may be in the person’s best interests but is not needed to prevent harm. Whether, in passing the MCA, Parliament intended that carers should not use some restraint in order to promote patient’s best interests (even though it is not necessary to prevent harm) is unclear.

Box 4: Case example: Emma Jones


Emma Jones is 25 and has severe learning disabilities as well as congenital heart disease.  She lives with her parents and every two months spends one week in a young adult hospice. When at the hospice Emma enjoys herself greatly and interacts well with staff and other residents.  Her mood and general well being improve and this improvement lasts for at least a week after she returns home.  However Emma finds it distressing and becomes agitated when she is required to get into a car to travel to and from the hospice.  She struggles and tries to get back into the house or hospice.  In order to get her into the car it is necessary to use some restraint and pressure.  Her parents and hospice staff wonder whether this restraint is justified under the MCA.

Emma does not have capacity to make a decision about whether she should go to the hospice. An assessment of her best interests cannot take into account her previously held wishes on this subject as she has never had capacity to make such a decision.  Overall the hospice staff and her parents agree that the benefit she gains from her time at the hospice outweighs the distress she suffers in getting there.  However when considering the conditions of section 6 of the MCA, and the emphasis on protection from harm, it is not so clear that restraint is legally justified.  In order to legally justify the restraint it would have to be argued that Emma was harmed by not going to the hospice and this seems to be a different, and a more stringent, test than whether she benefits from her visits there.  The concept of harm is not normally interpreted simply as lack of benefit, and by using the term harm and not simply best interests in the context of restraint, it would seem that under the Act restraint to enable her to benefit from the hospice care would not be legally justified.  Even if (contrary to the position for which we have argued) it is considered that Emma is harmed by not going to the hospice, that harm is unlikely to be considered a serious harm and the level of restraint would have to be minimal to be justified as proportionate.  Thus the question of whether restraint is justified under the MCA in this case rests both on an assessment of Emma’s best interests and also on an interpretation of harm and degree of restraint.

Deprivation of liberty

The MCA excludes from the definition of restraint a deprivation of liberty as defined in article 5 of the European Convention on Human Rights Convention. Deprivation of liberty is seen as such a significant harm that separate amendments to the MCA have been made through the Mental Health Act 2007 (www.opsi.gov.uk) to restrict deprivation of liberty to cases where there has been approval by a court or under the specific regulation of a new Schedule (Schedule A1. hospital and care home residents: deprivation of liberty www.opsi.gov.uk). The requirements of this schedule (as with the requirement for restraint) specify that deprivation of liberty must be to prevent harm separately from the general consideration of best interests (see code of practice addendum section 3.45).  A further requirement of this Schedule is that the person is suffering from a mental disorder within the meaning of the Mental Health Act (see section on MCA and MHA).

The definition of deprivation of liberty is not clear cut and is addressed in the Code of Practice Addendum Deprivation of Liberty Safeguards section 2.8 states:

Based on existing case law, the following factors may be considered by the courts to be relevant when considering whether or not deprivation of liberty is occurring:

  • The person is not allowed to leave the facility.
  • The person has no, or very limited, choice about their life within the care home or hospital.
  • The person is prevented from maintaining contact with the world outside the care home or hospital.

It is possible to deprive a person who lacks capacity of their liberty in an emergency situation to give life sustaining treatment or to prevent a serious deterioration in the person’s condition. Thus the doctrine of necessity still holds for treating someone in an emergency situation (see ethical issues pages on consent

3.2: Research (MCA section 1(30)

Much medical research is non-therapeutic. That is, the participants (patients) are not being given treatment as part of the research. An example of non-therapeutic research is taking a blood sample to measure a chemical in order to see whether the level of the chemical provides as useful diagnostic test. Such research might help patients in the future but would not help the patients who took part in the research. Such participants might face some discomfort and some risks of harm as a result of taking part in the research. International guidelines limit the harm as a result of taking part in medical research even for participants who have the capacity to consent to take part, and who have been fully informed of the risks. But guidelines do allow fully informed participants with capacity to be placed at some discomfort and some risk of harm (often termed ‘minimal harm’).

One major issue arises with regard to non-therapeutic research with patients who lack capacity. Such research may be valuable for people in the future. If the research places the participant at any discomfort or risk of harm then it can be argued that, since the research has no benefit for the participant (because it is non-therapeutic) it will always be in the person’s best interests not to be a participant. In common law and prior to the MCA, since no one can give consent on behalf of an adult without capacity and since it is arguable that from a legal point of view any researcher must act in the patient’s best interests, the question arises as to whether non-therapeutic research (even involving only the slightest risks or discomfort) with adults who lack capacity can be lawful.

The MCA has clarified this issue. According to the MCA (non-therapeutic) research can be carried out on people who lack capacity to consent to research under certain restricted circumstances. These circumstances include the provision that: ‘the risk to P from taking part in the project is “likely to be negligible”. It is noteworthy that although the risk must be likely to be negligible, the risk is not zero. It would seem here that the MCA does allow research to be carried out on people who lack capacity that is not in the best interests of the person (since there is some, albeit negligible risk). There is good ethical justification for this position in terms of the benefit to people in the future as a result of the research but it does seem to be an exception to the best interests principle. Against this, the MCA also requires researchers to consult carers and to ask carers what in their opinion ‘P’s wishes and feelings about taking part in the project would be likely to be if P had capacity in relation to the matter’. It could be argued that the overall judgment is still whether taking part in the research is in the person’s best interests if in assessing best interests one is weighing up both the risks of harm and the person’s likely (or prior) views. As we have seen, consideration of the person’s prior (capacitous) views are part of the best interests assessment. Some risk of harm may be seen as in the person’s best interests if that person would in all likelihood (given her prior views) have given consent to the research had she had capacity. But if that were the justification then it is not clear that the restriction on risk (as likely to be negligible) is appropriate since some people might have given consent to taking part even if the risk were greater than ‘negligible’.

The most straightforward reading of the ethical position taken by the MCA is that the benefit that research may bring to people in the future provides grounds for acting against a person’s best interests – although only when the risks of harm are ‘negligible’.

4: Interests of others and conflicts of interests

We have seen that the position that the MCA takes with regard to research gives weight to the interests of those who might benefit in the future from the research. In this section we will examine to what extent the MCA gives weight to the interests of specific people in addition to the person who lacks capacity.

4.1 Carers’ interests have no independent weight

In deciding the care and medical treatment of a person who lacks capacity the position in common law prior to the MCA was that the person should be treated in his or her best interests and that no independent weight should be given to the interests of any carers including family carers. Thus, for example, suppose that the wife of a person with dementia is willing to carry on caring for her husband at home but that this is very wearing for her. Suppose further that there is a good care home available but overall the husband would get better care from his wife in his own home. It might be the case that it is best for the husband that he remains in his own home but best for his wife that he go to a care home. Of course it may be that in the long run it is better for the husband that he goes into a care home now because if he stays in his own home his wife may become so exhausted that she can no longer properly care for him. But suppose that this is not the case. The doctor, who wants to do what is overall best, might believe that although it is in the husband’s best interests to remain in his own home overall it is better for him to go to the care home: his care would be only a little less good but his wife’s quality of life would be a great deal better.

The MCA does not change the position in common law. The doctor, or other carer, must act in the patient’s best interests and should not weigh these against the interests of others, not even of family carers. From an ethical point of view this position can be criticised since according to many ethical positions the interests of others, in addition to the patient, have moral weight.

There is a possible exception under the MCA to the view that the wife’s interests (in the example given above) should not be taken into account. That exception is if the husband, when he had the capacity to consider the matter, would have wanted his wife’s interests to be taken into account and would have wanted to go into the care home. Under those circumstances it might be argued that it is in the husband’s overall best interests to go into the care home (see best interests checklist, box 1 section 2.4). Even if this is persuasive it remains the case that if the husband is not likely to have taken his wife’s interests into account, then health professionals cannot do so either.

4.2 Lasting power of attorney (potential conflicts of interest)

A person with capacity who is over the age of 18 can appoint one or more people as attorneys to make decisions on their behalf should they lack capacity in the future. Attorneys will usually, we imagine, be members of the person’s family or close friends, particularly if they are being given power to make welfare decisions, including giving or refusing consent for heath care decisions on behalf of the person who lacks capacity.  There is a potential for conflicts of interest to arise for the attorney. Imagine, for example, a daughter who has lasting power of attorney to make welfare decisions for her mother and is also the sole beneficiary of her mother’s will. A decision to provide home nursing care privately might be in her mother’s best interests and affordable but would reduce the financial capital that will be left to the daughter when her mother dies. The MCA and the Code of Practice (sections 7.54 and 7.6) make it clear that an attorney must act in accordance with the statutory principles and in the best interests of the person who lacks capacity. The Code of Practice also states that the attorney has a fiduciary duty such that they should not take advantage of their position ‘(n)or should they put themselves in a position where their personal interests conflict with their duties’ (7.6). A person who confers a lasting power of attorney must be able to trust the attorney to act solely in their interests when making decisions on their behalf. Ethical principles of beneficence, protection of the vulnerable and trustworthiness are reinforced by a legal duty of care enshrined in the MCA. Concerns that an attorney is not acting in a person’s best interests can be referred to the Court of Protection.

It is not clear what the legal position is in the following situation. Suppose that a person validly appoints his daughter as Lasting Power of Attorney (LPA). Suppose further that the person makes it clear (perhaps in writing) that he does not want his savings spent on paying for him to live in a private care home, if at all possible: he wants to maximise the value of what he can pass on to his daughter after his death. He is willing for his future (incapacitous) self to live less comfortably or safely in his own home rather than to live more comfortably, and more expensively, in a care home.

What, in these circumstances, is in his best interests, according the MCA? The answer depends on how much weight one gives, in assessing best interests, to his previous values and wishes and how much one gives to his current experiences. It would seem consistent with the general position of the MCA for the LPA (e.g. the daughter) to give some weight to his wishes that his daughter’s inheritance be maximised.

4.3 Conscientious objection

People may make advance refusals of life sustaining treatment or may appoint attorneys to make decisions to refuse life sustaining treatment on their behalf.  Some clinicians might feel that their own deeply held beliefs or values require them to treat patients who lack capacity in order to prevent death.  For such clinicians, or indeed other carers, the sanctity of life principle might outweigh other ethical principles.  The MCA is clear that respect for valid choice means that a valid and applicable advance refusal of life sustaining treatment must be followed. The Code of Practice, however, allows for conscientious objection to advance refusals of treatment.  Clinicians cannot be required to act against their own beliefs but they are required to make arrangements for their patients’ care to be transferred to other clinicians willing to comply with patients’ wishes.  A clinician’s beliefs or moral values cannot override a patient’s valid choice.

5. Exceptions to respecting valid choice and right to liberty

5.1 Advance refusal of treatment for mental illness.

Respect for valid choice is not absolute under the MCA.  An advance refusal of treatment (and an attorney’s refusal of treatment) for a mental disorder can be overruled if the person is at the time that the treatment is required admitted under an appropriate section of the Mental Health Act (MHA) (see resource materials on the relationship between the MCA and MHA).  The provisions under the MHA for compulsory detention and treatment of people with mental disorder trump the MCA even when the detention or treatment is solely for the health or safety of the patient. The principle of protecting from harm outweighs the principle of respect for valid choice in the setting of mental disorder.

5.2 Refusal of basic care.

Under Section 9.28 of the code of practice a person cannot make an advance refusal of basic care (i.e. provision of warmth, shelter and food by mouth).  In this instance the principle of best interests overrides the principle of respect for valid choice.  From an ethical perspective this is an interesting exception.  It suggests that the provision of basic care has more ethical weight than treatment, including provision of artificial hydration and nutrition.  The Act appears to view the provision of warmth, shelter and food, as values over and above their contribution to the interests or wishes of the person.

Further reading/notes/references

The case of Mrs K is based on that of Margo [Firlik A. Margo’s Logo. JAMA. 1991: 265: 201]

Dworkin [Dworkin R. Life’s Dominion: an argument about abortion and euthanasia. London: HarperCollins. 1993.] argues that in cases like Mrs K her prior values (what he calls ‘critical interests’) should take precedence over her current best interests (what he calls ‘experiential interests’). Dresser argues that Dworkin is wrong in this [Dresser R. Dworkin on dementia: elegant theory, questionable policy. Hastings Center Report. 1995; 25: 32-38.].

Advance directives have been criticised by many authors [see for example Fagerlin A, Schnieder C. Enough: the failure of the living will. Hastings Center Report. 2004; 34: 30-42.]. Other authors sees them as potentially valuable but not determinative [for example: Widdershoven G, Berghmans R. Advance directives in dementia care: from instructions to instruments. Patient education and counselling. 2001; 44: 179-186.]

A classic general account of decision making for people who lack capacity is given in: Buchanan A, Brock D. Deciding for others: the ethics of surrogate decision making. Cambridge University Press: Cambridge. 1989.

Some relationships between the philosophical accounts of values and well being on the one hand and the concept of best interests on the other hand are discussed in: Degrazia D 1995 Value theory and the best interests standard. Bioethics 9 50-61. Various accounts of best interests are articulated in McCubbin M, Weisstub D 1998 Toward a Pure Best Interests Model of Proxy Decision Making for Incompetent Psychiatric Patients.  International Journal of Law and Psychiatry. 21 1-30.

 

Research involving persons who lack capacity

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The provisions governing research aim to strike a balance between protecting and respecting the interests, wishes and feelings of those (aged 16 and over) who lack capacity, with the need for appropriate research. Such research is considered essential if knowledge of what causes a person to lack or lose capacity, and the treatment,  of people who lack capacity is to be improved. The Act includes a range of safeguards, in particular the fundamental principle that the person’s interests must be assumed to outweigh those of science and society.

Change: Prior to the Act any intervention without the consent of an adult was lawful only if it was in the person’s best interests. This principle persists but now has statutory status. The legality of non-therapeutic research involving adults – although widely supported in national and international ethical guidelines – was uncertain. The Act codifies, clarifies and supplements the common law in relation to research involving those over 16 who lack capacity. In so doing it distinguishes between therapeutic and non-therapeutic research (by introducing more stringent requirements for the latter) and imposes new legal responsibilities on researchers (e.g. to consult carers).

The Act is limited in its scope –it does not apply to the testing of new drugs. However, the combined effect of the Act, the Human Tissue Act 2004 and The Medicines for Human Use (Clinical Trials) Regulations 2004 is that there is now a comprehensive legislative framework regulating research involving those who lack capacity.

What research does the Act cover?


The Act applies to research that is ‘intrusive’ ( Box 1), i.e. research normally requiring consent. The Act does not apply to research involving the testing of new drugs.  Although no specific definition of research is given in the Act, the Code of Practice provides guidance on the general meaning of the term.

NB 1. Clinical Trials involving medicines are regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004.

2. Under the Human Tissue Act 2004 (which defines adults as 18 or over) research that only deals with human tissue that has been anonymised does not require consent. This applies to tissue both from adults who have capacity and those who do not. But the research must have ethical approval, and the tissue must come from a living person.

What legal duties do researchers have?


Section 30 lays down several conditions that must be complied with if research involves adults (i.e. those of 16 and over) who lack capacity. Failure to comply with them means that the research is unlawful. For clarity these will be divided into three sections, i.e. a) those that researchers must comply with before the research is started, b) those apply before any decision is taken to involve a particular person in approved research and c) those that apply once the research has begun.

1. Conditions to be complied with before the research is started

Obtain approval from the ‘appropriate body (s.30)

The appropriate body will normally be a research ethics committee. For such approval to be granted all the following further 4 requirements must be met. These requirements (in s. 31) are that;

1) the research must:

  • be linked to an impairing condition (Box 2) affecting the person who lacks capacity, or
  • treatment,

2) there must be reasonable grounds for believing that the research would be less effective if only people with capacity were involved (s.31(4)), and       

3) there must be reasonable arrangements to consult carers and to follow

the Act’s other requirements, and

the research must either:

  • have the potential to produce a benefit to the person that outweighs any risk or burden or
  • be intended to be provide knowledge about the cause of, or treatment or care of people with, the same impairing condition- or a similiar condition (note this does not cover research that is not related to a condition from which the person who lacks capacity suffers), and there must be reasonable grounds for believing that:
  •  

1) the risk to the person will be negligible, and

2) there must be no significant interference with the freedom of action or privacy of the person who lacks capacity, and

3) nothing must be done to or in relation to the person who lacks capacity which unduly invasive or restrictive, s.31(6)(a) & (b) 

Conditions to be complied before any decision is taken to involve a particular person who lacks capacity in research (s.32).

Researchers must:

Decide who should be consulted (Box 1). 

Box 1: Consultation

 

Who should be consulted?

S. 32 states that before a person who lacks capacity can be included in research the researcher must take reasonable steps to identify someone whom they can consult.

This person (the consultee) must be:

  • engaged in caring for the person, or
  • interested in his welfare, and
  • willing to help

The consultee can be:

  • an attorney appointed under a registered Lasting Power of Attorney, or
  • a deputy appointed by the Court of Protection

The consultee cannot be:

  • a person working in a professional capacity, or
  • paid care worker


NB. If there is no-one who can fulfil the role of consultee the researcher must nominate a person (who must not have any connection with the research project).

After identifying a consultee the researcher must:

a) Provide information to the consultee about the research project (s.32(4))

Neither the Act nor the Code of Practice provide any further detail of what this information must consist of. The assumption must be, therefore, that researchers are expected to provide all the information they would normally disclose to a person with capacity in order to obtain their consent to participate in the research project.   

b) Obtain advice from the consultee

The purpose of the consultation process is to make sure that the person lacking capacity would want to join the research project. Note that those who are consulted do not have the right to consent to the research on the person’s behalf. Rather the Act gives them the legal right to be consulted.

The legal duty of consultation (in s.34(4)) means that researchers must ask the consultee:

1) whether the person should take part in the project, and

2) what they think the person’s wishes and feelings would be, if he had capacity to decide whether to take part.

Note that this right of consultation is not absolute, i.e. it does not apply in urgent situations (Box 2)

Box 2 ‘Urgent’ situations

 

S.32 (8)&(9) sets out limited circumstances when the advice from a consultee need not be sought.

These circumstances apply where;

  • treatment is being (or is about to be) to be provided for the person who lacks capacity as a matter of urgency, and
  • having regard to the nature of the research, the researcher thinks it is also necessary to take urgent action for the purposes of the research, but
  • it is not reasonably practical to consult anyone

To avoid consulting anyone, however, one of two further conditions must be satisfied. These are that the researcher must :

1. get the agreement of a doctor who is not connected to the project, or

2. follow a procedure agreed by the appropriate body (e.g. REC) at the time of approval.   

Examples of urgent circumstances are typically those when it is not possible to separate the research from the urgent treatment e.g. taking samples or measurements in the few minutes following a serious head injury or stroke, and then taking further samples after some type of treatment to compare with the first set.

NB. This exception to the duty of consultation only applies: 

a) for as long as the person needs urgent treatment, and

b)  when the researcher needs to take action urgently for the research to be valid.

The research proposal must give enough information about what ill be done if a person lacking capacity needs urgent treatment during research and it is not possible to speak to the person’s carer or someone else.

c) Ensure consultee’s advice is taken into account

Sometimes the consultee will say that in his opinion the person lacking capacity would probably not take part in the project or that they would ask to be withdrawn. In this situation, the researcher must not include the person in the project, or should withdraw him from it if the research is already under way (s.32(5).

3. Conditions to be complied with after the research has started

Most of the conditions that must be complied once the research has begun are designed to provide additional safeguards, in particular to ensure that incapacitated persons are only involved in research to which they assent (or clearly acquiesce in). A fundamental principle underpinning the section is that the interests of the person lacking capacity must always be assumed to outweigh those of science and society (s.33 (3)).

The specific responsibilities imposed on researchers are:

a) To respect the person’s objections   

Section 33(2) makes it clear that nothing can be done to the person in the course of the research (or in relation to him) to which he appears to object. Researchers are expected to be sensitive to the various ways in which a person may express his objections. Thus although the section refers specifically to a person ‘showing signs of resistance, it also notes that any other indication of resistance should be respected, e.g if the patient becomes upset or distressed.

Note however, that despite the person’s objections anything can be done which is intended to ‘protect him from harm or to reduce pain or discomfort .

b) To take into account any advance decision or other statement         

This related safeguard prohibits anything being done to the person (or in relation to him) in the course of research which is contrary to either to an advance decision or to any other form of statement which the person lacking capacity d previously made in which they had expressed their preferences about their care or treatment.

c) To withdraw the person from the research without delay 

There are three types of situations which must result in the person being withdrawn from the project. These are:

1) if the person indicates (in any way) that he wishes to be withdrawn, or

2) if a consultee (under s.32(5)) whose advice has been sought (about the person’s wishes and feelings and whether he should take part in the research) advises the researcher that the person would want to be withdrawn from the research, or

3) if the researcher has ‘reasonable grounds’ for believing that any of the Act’s requirements for approval (set out in s.31 (2) – (7)) are no longer met..

NB. In all of the above 3 situations the person can still receive any treatment he was receiving as part of the research project if withdrawing him from it would cause a significant risk to his health.

4. Conditions that must be followed if research started before the Act came into force

2 types of situations are covered here:

Type 1: The person has capacity when the research starts but loses capacity

In this type of situation the person will have been able to give consent to participate in the research but subsequently loses the capacity to consent (i.e before the research project ends). Regulations covering this type of situation apply but only if the research involves tissue and data collected in certain circumstances (Box 3).

Box 3 Research involving those who lose capacity (before the end of the project).

The regulations apply to research (starting before 1.10.07) on tissue and data from a person who gave consent (before 31.03.08)

Research can only continue (on the tissue and date) if:

  • the project already had procedures to deal with people who lose capacity
  • An appropriate body must have approved the procedures (which the researcher must follow)
  • the appropriate body is satisfied that the research project has reasonable arrangements to meet the following requirements imposed on researchers


Researchers must also:

  • seek out the views of someone involved in the person’s care or interested in their welfare (If a carer cannot be found they must nominate someone (see Box 1)
  • respect advance decisions and expressed preferences, wishes or objections that the person has made in the past
  • treat the person’s interests as more important than those of science and society


Researchers must withdraw the person from research if:

  • the person indicates that he wishes the research in relation to him to be discontinued
  • procedures are no longer in place or the appropriate body no longer approves the research


NB 1. These regulations do not cover research involving direct intervention (e.g. taking of   further blood pressure readings or the taking of further tissue after loss of capacity).

2. Such research must comply fully with sections 30-33.


Type 2. The person participating in research never had the capacity to agree to it.

There are no regulations governing research projects that started before the Act came into force, and which involve a person who never had capacity.

The Code (11.7) advises that

a) projects that already have ethical approval will need to obtain approval from an appropriate body (under sections 30 &31) and comply with sections 32 and 33 by 1 October 2008.

b) research that does not have ethical approval must get approval from an appropriate body by 1 October 2007 to continue lawfully.

Implications for health professionals


Health professionals caring for and treating adults who are involved in research might need to check the following

1. Is there evidence of research approval?

Guidance issued by the Department of Health (Core Training Set, 2007) suggests that it is good practice for healthcare staff to ask to see evidence that the research has received approval (i.e. from a REC).

2. Is the situation Urgent?

One of the most important provisions (the duty of consultation) designed to safeguard the interests of participants who lack capacity and ensure that their wishes and feelings are respected, does not apply in ‘urgent’ situations. These are likely to be limited to research into procedures or treatments used in emergencies (i.e. not to those where the researcher simply wants to act quickly) when it is not possible to separate the research from the urgent treatment.

In this type of situation the legal duty to consult a person who is caring for the person or interested in their welfare is relaxed. This means that such a person need not be consulted before the action is taken. It is important to remember, however, that the urgent action cannot be taken unless either a doctor’s agreement has been obtained or a procedure (agreed at the approval stage) is followed.

3. Are the person’s objections or advance wishes being taken into account?

The Act makes it clear that nothing can be done to a person in the course of research (or in relation to him) to which he objects. Healthcare staff must therefore be alert to signs of ‘unhappiness’ or resistance which they should immediately report to the appropriate person.

It must be remembered though that despite a person’s objections actions can still be taken to ‘protect the person from harm or reduce or prevent pain or discomfort’.

Similarly healthcare staff may become aware that something is being done to a person which is contrary to an advance decision or another form of statement. In such cases the action should be stopped.

4. Should the person be withdrawn from the research (without delay)?

The Act states that the person must be withdrawn from the research in 3 situations, namely:

1) if he indicates (in any way) that he wishes to be withdrawn, or

2) the consultee’s advice is that the person would ask to be withdrawn, or

3) the researcher has reasonable grounds for believing that any of the Act’s requirements (in s.31) are no longer met (i.e. that the research must relate to an impairing condition, have potential to benefit the person lacking cpacity or be intended to provide knowledge about the same or a similar condition).

NB. In all the above 3 situations the person can still receive any treatment he was receiving as part of the research project if withdrawing him from it would cause a significant risk to his health.

 

MCA and the Mental Health Act

pdf version

Introduction

Mental disorder may sometimes be associated with impaired decision making capacity. This incapacity may be temporary during acute periods of illness or more sustained in those with severe and enduring mental health problems. In such circumstances treatment will proceed using the provisions contained in the MCA.

On occasions a person may be so unwell that they may also fulfill the criteria for detention in hospital under the Mental Health Act (MHA) for assessment and treatment of their mental disorder. When this occurs it may be unclear as to the most appropriate legislative route to take (see link for a summary of the MHA
www.dh.gov.uk/

Case example

Mrs A is severely depressed and extremely withdrawn. She passively goes along with her husband who brings her to the ward for admission. She makes no attempt to go when her husband leaves but later sits staring at the door asking to go home. She cannot engage in any discussion about the treatment plan. The team thinks she lacks decision making capacity. The team then discusses whether she should be treated under the MCA (as she lacks capacity) or, given that she has not consented to the admission and looks as if she wants to leave, whether the MHA would be more appropriate.

The differences between the 2 Acts and pointers to the most appropriate course of action will be considered under the following headings.

1. Purpose and scope

2. Principles and policy concerns

3. The role of capacity

4. Role of 3rd parties in decision making

5. Planning ahead for future incapacity

6. Relationship between the 2 Acts

7. Deprivation of liberty

8. Pointers to the use of the MHA rather than MCA

9. Potential areas of conflict between the 2 Acts.

10. Ethical Implications of preferring one legislative route over the other

1. Purpose and scope of the MCA and the MHA

Mental Capacity Act

  • The MCA provides a framework for decision making on behalf of people who lack capacity to decide for themselves. This Act only applies to those over 16.
  • Decisions can be wide-ranging, simple or complex and include decisions regarding medical treatment for both physical and mental disorder.

Mental Health Act

  • The MHA provides a framework for treating mental disorder in the absence of consent, whether due to lack of capacity or valid refusal of treatment, if the criteria for detention are fulfilled.

2. The two Acts are guided by different principles and policy concerns

Mental Capacity Act

The MCA is underpinned by explicit principles which seek to promote autonomy, offer the least restrictive interventions and avoid discrimination (section one) www.opsi.gov.uk/

The MCA contains mechanisms for planning in advance for periods of incapacity (if a person is aged 18 or over) by way of advance decisions, and for the appointment of an attorney to make decisions on behalf of the person when they become incapacitated.

Mental Health Act

Unlike the MCA this Act does not outline the specific principles which underpin its operation although Section 1.1 of the Code of Practice outlines some broad principles which also include promoting autonomy, non discrimination and using the least restrictive interventions compatible with ensuring the safety of the patient and others.

www.dh.gov.uk

Over the last decade, following some high profile incidents involving mentally disordered individuals, public protection from those suffering from mental disorder has increasingly become a major policy concern.

3. The presence or absence of capacity carries different weight

Mental Capacity Act

The issue of capacity (or more accurately lack of capacity) is central to the operation of this Act. Statutory provisions only come into play if a person lacks capacity for the specific decision in question. If capacity is retained then the common law and professional guidance relating to consent applies. (see section on assessing capacity)

The test of capacity is clearly defined and if a person has capacity for the decision in question then, that decision, however unwise, must be respected.
www.opsi.gov.uk

Mental Health Act

Unlike the MCA capacity is not central to the operation of the Mental Health Act. The issue of capacity only arises in three circumstances under the MHA

  • Consent to treatment with Electroconvulsive Therapy (ECT) at any time during a period of detention (s58 MHA, regulation 16 Mental Health ( Hospital, Guardianship and Consent to Treatment) Regulations 1983.
  • Consent to the continuation of medication after 3 months from the onset of detention (s58 MHA)
  • Consent for Psychosurgery or the implantation of hormones (s57)

The test of capacity is not defined within the MHA other than requiring that the person is “capable of understanding” the proposed treatment.

LJ Hale in R (Wilkinson) v Broadmoor Special Hospital Authority and others [1] commented obiter dictum that the test contained in s 58 of the MHA is the same as the common law test of capacity as outlined in Re C/ MB. [2] With the introduction of the MCA the test for capacity would now be that outlined in the MCA.

Despite detention under the MHA, a person may still retain capacity to give or refuse consent to treatment. The Code of Practice relating to the Act acknowledges this when it states:

“A detained patient is not necessarily incapable of giving consent. The patient’s consent should be sought for all proposed treatments which may be lawfully given under the Act.” [3]

Refusal of treatment for a physical disorder by a patient with capacity who is detained under the MHA must be respected. However, the refusal of treatment for the mental disorder for which the patient is detained by a patient who has capacity can be overridden and the patient treated at the discretion of the responsible medical officer (RMO). [4]

4. Role of third parties in decision making

Mental Capacity Act

Lasting Power of Attorney (LPA)

The MCA provides for the appointment of an attorney who may be authorised to make healthcare decisions. For the first time in English law, if the statutory provisions are complied with, a third party will be able to consent / refuse medical treatment on behalf of another adult. (see section on decision-making of attorneys and deputies)

Independent Mental Capacity Advocate (IMCA)

The MCA contains requires the appointment of an Independent Mental Capacity Advocate (IMCA) where a person who has no one else (other than a paid carer) to help and support them and decisions are being made about serious medical treatment [5] or place of residence.

The IMCA is not a decision maker on behalf of the incapacitated person but will contribute to the best interests discussion. In order to do this effectively the IMCA may have access to the records pertinent to the decision in question. (see section on the role of the MCA)

Mental Health Act

The primary decision maker under the MHA is the Responsible Medical Officer (RMO) although certain decisions, under certain circumstances will be subject to external review by the second opinion appointed doctor or by a Mental Health Review Tribunal.

5. Planning ahead for future incapacity

The MCA provides two mechanisms for advance planning;

1. advance decisions to refuse treatment and (see section on advance decision-making)

2. granting a Lasting Power of Attorney (see section on the role of attorneys).

The new MHA 2007 (which amends the 1983 MHA) states that a valid and applicable advance decision to refuse electroconvulsive therapy (ECT), even if detained under the MHA, will be binding except in an emergency. (S27(5)
www.opsi.gov.uk/

6. Relationship between the two Acts

Section 28 of the MCA states:

(1) Nothing in this Act authorises anyone-

(a) to give a patient medical treatment for mental disorder, or

(b) to consent to a patient’s being given medical treatment for mental disorder, if, at the time when it is proposed to treat the patient, his treatment is regulated by Part IV of the Mental Health Act.

(2) “Medical treatment”, “mental disorder” and “patient” have the same meaning as in that Act (Mental Health Act).

The MHA will therefore trump the MCA in the treatment of mental disorder.

Part IV of the MHA authorises treatment for mental disorder for those detained under the relevant sections of the Act.

Those on short term sections which are for emergency detention of patients until full assessment can be carried out such as s4 or s5(2) or s5(4) are not included in part IV. If, in such a situation, the person lacks decision making capacity regarding the proposed treatment then this can, if in their best interests, be given under the MCA.

Case example

Mrs B is admitted informally having made a serious attempt on her life. She becomes distressed and agitated and insists on leaving hospital stating that it is her intention to “do it properly.” The duty doctor is called, believes she is at substantial risk of self harm if she were to leave hospital and therefore detains her on s 5(2) MHA. Whilst waiting for the further assessment to consider detention under s2 or 3 Mrs B starts banging her head against the wall causing a large abrasion to her forehead. Despite restraint by the nursing team she remains agitated, continues to try and harm herself and is unable to engage in discussion about treatment options. The doctor decides that an IM injection of lorazepam needs to be administered. Her distress makes it impossible to discuss this and the team agree that her decision making capacity is currently impaired. It is in her best interests to prevent further harm and, as nursing intervention does not appear to be sufficient, treatment with lorazepam is in her best interests. The injection is therefore given under the MCA.

7. Deprivation of liberty under the two Acts

The MCA allows restriction of liberty / restraint as long as certain conditions are fulfilled (S 6) www.opsi.gov.uk The Act distinguishes between restriction of liberty or restraint and deprivation of liberty. The Mental Health Act 2007 amends the MCA to include a section on deprivation of liberty. Except in emergency situations a person should not be deprived of their liberty without the authority of the court.

Where the line between restriction and deprivation of liberty should be drawn can be difficult to determine and will depend on the facts of the particular case. The European Court of Human Rights has held that the difference was “one of degree or intensity, not one of nature or substance.” [6] The MCA code of practice considers this question and advises that the decision will depend on specific factors in an individual case including:

  • the type of care being provided
  • how long the situation lasts
  • its effects, or
  • the way in a particular situation came about.

Where there is deprivation of liberty and the person also fulfils criteria for detention under the MHA then use of the MHA should be considered if there is no less restrictive way that the care and treatment for the mental disorder can be given. Unlike the MCA the MHA contains procedures to ensure compliance with rights under Article 5 of the Human Rights Act 1998 (Right to Liberty and Security).

There will, however, be a small group of incapacitated individuals who will need to be deprived of their liberty in their best interests but who do not necessarily meet criteria for detention under the MHA. These may include those with head injury, learning disability or dementia. Provisions for such individuals are now covered by amendment to the MCA in the .Mental Health Act 2007.

9. Pointers to the use of the MHA rather than MCA

  • If there is deprivation of liberty and the criteria for detention under the MHA are present.
  • To over-ride an Advance Decision to refuse treatment for mental disorder (with the exception of ECT when the new MHA 2007 comes into operation)
  • to over-ride an attorney who is refusing consent to treatment for mental disorder
  • If the person is resisting treatment for mental disorder and restraint is required regularly or for a prolonged period of time

10. Potential areas of conflict between the 2 Acts

Case example: Advance decisions

Mr B suffers schizophrenia and has previously been admitted to hospital and treated successfully with a antipsychotic drugs. Between episodes he makes a good recovery and decides to make an advance refusal of treatment with all antipsychotics as he considers the side effects of this type of treatment unacceptable. Mr B becomes unwell again and passively co-operates with admission to hospital. He is extremely frightened by auditory hallucinations stating that he is going to executed. He refuses oral antipsychotics believing these drugs will kill him. It is the view of the psychiatric team that Mr B lacks capacity to decide about treatment. The consultant thinks treatment should be given by injection. The team is aware that Mr B has made an advance decision to refuse treatment with all antipsychotic drugs.

If, in the above case, the person was dealt with under the MCA the advance refusal of antipsychotic drugs, if valid and applicable would be binding.

This advance decision could, however, be circumvented by detaining the person under the MHA. Using the provisions contained in Part IV (s 63 MHA 1983) depot antipsychotic medication could be given despite the advance decision to refuse this form of treatment.

Lasting Power of Attorney (LPA)

As outlined above, it is now possible for a third party to make treatment decisions on behalf of an incapacitated adult but the MHA can trump this with regard to treatment for mental but not physical disorder.

Mr B, instead of making an advance decision has appointed his son as his attorney and has authorised him to make all decisions regarding treatment for his mental disorder if he lacks capacity to decide for himself. His wife does not wish to be burdened by this responsibility. His son is aware of his views regarding antipsychotics and gives his wishes considerable weight when deciding what will be in his best interests. He agrees that he requires treatment and is happy for him to receive night sedation believing that if his father can sleep then his mental state will improve. Despite lengthy discussion with the team he does not alter his position. The consultant thinks that Mr B requires antipsychotic treatment and therefore detains Mr B under the MHA having fully explained his reasons to Mrs B and her son.

Mr B. then develops abdominal pain which is thought to be due to intestinal obstruction. He refuses the proposed investigations. The psychiatrist, applying the statutory criteria in the MCA, considers he lacks capacity to consent to the proposed investigations. The junior doctor suggests that the investigations can be done as he is detained under the MHA but the consultant points out that the MHA only authorises treatment for mental disorder. As Mr B’s son has been appointed to make welfare decisions on behalf of his father the tests are discussed with him and he consents to the investigations proceeding.

11. Ethical Implications of preferring one legislative route over the other

The above examples illustrate the tension between the two Acts. In some instances there will be a clear legal route that should be chosen, for example, when a severely mentally disordered person is being deprived of their liberty. In other situations the most appropriate route may be less clear cut and it is important to recognise that there may be different consequences of choosing one legislative route over the other.

Respect for autonomy

  • the statutory route that is chosen will determine whether or not autonomy must be respected (despite the current incapacity) via the mechanisms of a valid and applicable advance decision
  • Under the MCA, third parties such as an attorney acting under a Lasting Power of Attorney (LPA) or a court appointed deputy may, if certain conditions are met, give or refuse consent to the proposed treatment on behalf of the incapacitated person and such decisions will be binding on the healthcare professional. This mechanism is less directly autonomy promoting than advance decisions as the attorney is required to act in the persons best interests, not as a substitute decision maker.

Issues of distributive justice

  • Section 117 MHA imposes a duty to provide after-care following a period of detention under certain sections of the MHA. The court has held that such services be provided free of charge. (R v Manchester City Council Ex p. Stenett [2002] UKHL 34.) This includes payment for residential accommodation. This may lead to the situation whereby patients with essentially the same needs will be treated differently depending on which legislative route is used. In the above judgement their Lordships considered the issue of a person with severe dementia requiring residential accommodation and the different financial implications of being admitted to hospital under the MHA or not.

Protection of rights and freedoms

  • Safeguards available to patients vary between the two statutes. In particular s58 MHA requires that, in the absence of capacity, treatment decisions are reviewed by Second Opinion Appointed Doctor.
  • In the MCA there is no in-built review of treatment decisions (and therefore protection from arbitrary decision making) although the Court of Protection may be called upon to decide if there is major disagreement amongst those considering the best course of action.
  • Article 5 rights are protected under the MHA as there are mechanisms to review detention although in many instances referral for review of detention is not automatic and must be requested by the detained individual

[1] R (Wilkinson) v Broadmoor Special Hospital Authority and others [2001] EWCA 1545.

[2] Re MB (An adult: Medical treatment) [1997] 2 FCR 541 Re C (adult: refusal of medical treatment) [1994] 1 All ER 819

[3] Mental Health Act 1983 Code of Practice, Department of Health and Welsh Office.1999, London, Stationary Office para 16.3.

[4] Mental Health Act 1983 Code of Practice, Department of Health and Welsh Office.1999, London, Stationary Office para 16.21.

[5] See Code of Practice (MCA) 10.42 – 10.50

[6] HL v UK (Application no. 45508/99 5th October 2004 para 89

 

Resolving disagreements and disputes

pdf version

As the Code makes clear it is in everybody’s interests to settle disagreements and quickly and effectively. Various options are available: which one will be most appropriate will depend on the type of disagreement or dispute and the context in which it has arisen.

In general disputes and disagreements involving health professionals can be resolved by either formal or informal procedures.

Informal procedures

The various informal procedures outlined below are identified in the Code (15.3) as the best initial approach when health professionals are in disagreement with a person’s family. Thus the Code suggests that it is good idea to start by:

  • setting out the different options in a way that is easy to understand
  • inviting a colleague to talk to the family and offer a second opinion
  • offering to get independent expert advice
  • using an advocate to support and represent the person who lacks capacity
  • arranging a case conference or meeting to discuss matters in detail
  • listening to, acknowledging and addressing worries, and
  • where the situation is not urgent, allowing the family time to think it over


Other informal procedures include:

  • mediation: A mediator helps people to come to an agreement that is acceptable to all parties
  • Patient Advice and Liaison Service (PALS):

PALS provides an informal way of dealing with problems before they reach the complaints stage. PALS provide advice and information to patients (or their relatives or carers).

Formal procedures

The range of formal procedures for resolving disputes about issues covered in the Act is more limited and basically consists of two options. These are:

  • NHS complaints procedure
  •  

This procedure deals with complaints about NHS services provided by NHS organisations (or primary care practitioners).

  • Court of Protection

The court deals with all areas of decision-making for adults who lack capacity.   

NB. The Court has emergency procedures which operate 24 hours a day to deal with urgent cases quickly

In the next section the options available for resolving specific disputes will be outlined.

Disputes about capacity

Disputes about capacity can arise if:

  1. a person wants to challenge a decision that they lack capacity
  2. professionals disagree about a person’s capacity to make a specific (usually serious)decision there is a dispute over whether the person has capacity

If an assessment about capacity has been challenged (e.g. by a patient’s family) the Code (4.63) suggests the following series of steps should be taken:

The person who made the assessment should:

  • give reasons why they believe the person lacks capacity to make the decision, and
  • provide objective evidence to support that belief
  • show he has applied the principles of the Act
  • show he has followed the guidance in the Code
  • obtain a second opinion (from an independent professional or another expert in assessing capacity)


If the disagreement remains unresolved the following options should be considered:

  1. an informal method (outlined above)
  2. an application to the Court of Protection –the court can, for example, make a declaration (i.e. ruling) on whether a person has capacity to make a particular decision or give consent for a particular action.

Disputes about best interests

A patient’s family, carers or heath professionals may not always agree about whether proposed treatment is in his best interests. A family member (a member of the healthcare treating the patient) may believe, for example, that the treatment;

a. does not take into account the person’s wishes or feelings, or

b. that a carer or other person interested in his welfare has not been consulted, or

c. another element in the best interests check-list (in s.4) was ignored, or

d. one (or more) of the 5 statutory principles was not followed.


According to the Code (5.68) the following options should be considered to resolve ‘best interest’ disputes:

1. Involve an advocate

An advocate acts on behalf of the person who lacks capacity to make the decision. This option is particularly useful if family members disagree, there is conflict between those who have been consulted, the proposed course of action may lead to the use of restraint, or the person who lacks capacity has no family or friends to take n interest in their welfare but they do not qualify for an IMCA.

2. Get a second opinion

3. Hold a ‘best interests’ case conference

4. Attempt mediation

5. Pursue a complaint through the NHS formal complaints procedure

6. Apply to the Court of Protection

The Court has the power, for example, to make a declaration as to the lawfulness or otherwise of any specific act relating to a patient’s care or treatment (either where somebody has carried out the action or is proposing to) This action can include an omission or failure to provide care or treatment that the person needs.

Note that the Court’s powers (to make declarations, decisions, or order on health related (and other matters) are subject to the provisions of the Act, i.e. it too must follow best interests checklist and apply the statutoryprinciples.

Disputes about advance decisions to refuse treatment (life-sustaining or otherwise)

The Code makes it clear that it is ultimately the responsibility of the healthcare professional who is in charge of the person’s care when the treatment is required to decide about the whether there is an advance decision covering the situation (Code 9.64). Disagreements can nevertheless arise (either between health professionals, or between health professionals and family members or others close to the person, are likely to be about whether an advance decision:

  • exists, and/or
  • is valid and/or
  • is applicable

Whatever the reason for the dispute or disagreement the Code recommends that the senior clinician must:

1. Consider all the available evidence

2. Consult with appropriate people: this includes relevant colleagues and others who are close to or familiar with the patient. All staff involved in the patient’s care should be given the opportunity to express their views (including the patient’s GP).

3. Record the discussion in the patient’s healthcare notes

4. Apply to the Court of Protection: the court can decide that the advance decision to refuse treatment does (or does not)  exist, is (or is not) valid or is (or is not) applicable to the proposed treatment in the current circumstances. 

Disputes involving attorneys

Disputes involving personal welfare attorneys appointed under a Lasting Power of Attorney (LPA) are most likely to arise when health professionals have concerns about the attorney’s:

  • assessment of the patient’s capacity
  • decision as to what is in the person’s best interests
  • belief that life- sustaining treatment should be refused
  • role e,g, that it has been overridden by a subsequent valid and applicable advance decision
  • failure to comply with conditions in an LPA
  • have doubts about the validity of an LPA


According to the Code (7.29) when health professionals have concerns about an attorney’s assessment of best interests they should:

1) discuss the case with other medical experts, and/or

2) get a formal second opinion

3) discuss the matter further with the attorney

4) apply to the Court of Protection: if the dispute cannot be resolved in any other way.


In disputes about the validity of an LPA the Court of Protection it has a wide range of powers. It can decide whether the LPA is valid or invalid – because it, for example fails to meet the Act’s requirements or was made under undue pressure. Alternatively the Court can stop someone registering an LPA. The Court can also clarify the meaning of an LPA. 

Disputes with IMCAs

The IMCA’s role is to support and represent their client by- asking questions, raising issues, offering information and writing a report. They will also often be involved in meeting different healthcare staff to work out what is in a patient’s best interests. Sometimes an IMCA may want to challenge a decision-maker believing that he has:

  • not paid enough attention to their report (and/or other relevant information patient, or
  • made a decision that is not in the patient’s best interests, or
  • assessed a patient (wrongly) as lacking capacity.


According to the Code (10.34) various options are available should an IMCA - who has the same right to challenge a decision as any other person caring for the person or interested in his welfare – have a disagreement about health care or treatment. These options are:-

Informal procedures:


1. Discuss areas of disagreement with the decision-maker

2. Involve an steering group from the IMCA service and any appropriate representatives from local NHS organisations:  these negotiators can sometimes negotiate between different views.

3. Follow any relevant procedures recommended by IMCA service provider.

Formal procedures:

  • Consult the Patient Advice and Liaison Service (England)
  • Consult the Community Health Council (Wales)
  • Use the NHS Complaints Procedure
  • Use the services of the Independent Complaints Advocacy Service (in England) or another advocate.
  • Refer the case to the Court of Protection
  • Apply to the High Court (for judicial review).

The role of the Mental Capacity Advocate

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An independent mental capacity advocate (IMCA) is a specific type of advocate whose role is to provide representation and support for particularly vulnerable people (aged 16 or over)who lack capacity and who are facing important decisions about certain serious life-changing events without a supportive network of family or friends. An IMCA is not the decision-maker (although decision-makers have a duty to take into account information they provide).

The main general benefits of the independent mental capacity service are:

  1. having an independent person to review significant decisions being made
  2. having an advocate who is articulate and knowledgeable not just about the Act but also a person’s rights, health and social care systems and community care law
  3. receiving support from a person who is skilled at helping people who have difficulties with communication to make their views known.

Change: the IMCA service is a new statutory service. It does not replace other existing forms of independent advocacy, but its role differs from these in a number of ways, e.g.

  1. The IMCA is decision - specific: it concerns decisions around serious medical treatment and changes of accommodation as well as discretionary adult protection cases and care reviews
  2. The IMCA role has time constraints: IMCAs need to complete their work and submit their reports within the time available to make decisions
  3. NHS bodies have a legal duty to instruct and consult IMCAs

When must an IMCA be appointed?

An IMCA must be appointed when:

1) the person (aged over 16) lacks capacity, and

2) there is no-one (other than a person providing treatment in a professional capacity or for remuneration) who can be consulted about their best interests, and

3) the decision being made is about either one of the 3 sets of circumstances noted below, i.e.

1) Serious medical treatment (s.37) being proposed by an NHS body (or by another organisation on behalf of the NHS, see Box 1), or

Box 1 ‘Serious medical treatment’

Defined in s.37 as

  • giving new treatment
  • stopping treatment that has already started
  • withholding treatment that could be offered

And where there is either:

  • a fine balance between benefits and the burdens and risks of a single treatment
  • a choice of treatments that are finely balanced
  • what is involved is likely to involve serious consequences

‘Serious consequences’

Defined as those which could have a serious impact on the patient either from the effect of the treatment itself or its wider implications.

Examples include treatment which:

1) causes serious and prolonged pain distress or side effects

2) has potentially major consequences for the patient (e.g. stopping life-sustaining treatment or having major surgery such as heart surgery

3) has a serious impact on the patient’s future life choices (e.g. interventions for ovarian cancer

The Code (10.45) provides a list of the following non-exhaustive list of treatments (for both mental and physical conditions) that would be considered ‘serious’

  • chemotherapy
  • major surgery (e.g. open-heart or brain/neuro surgery)
  • therapeutic sterilisation
  • electro-convulsive therapy
  • major amputations ( e.g. loss of arm/leg)
  • treatment which result in permanent loss of hearing or sight)
  • withholding or stopping artificial nutrition/hydration
  • termination of pregnancy
    • NB 1. In an emergency when urgent treatment (e.g. to save a person’s life) is needed there is no legal obligation to instruct an IMCA 2. An IMCA cannot be involved if the proposed treatment (despite being ‘serious’ )is authorised under the Mental Health Act 1983
2) Long -term NHS accommodation (s.38) An IMCA is required when a NHS body proposes to: a) place a person who lacks capacity in a hospital – or move them to another hospital or –for a stay likely to last longer than 28 days, or b) place them in a care home – or move them to another care home for a stay likely to last longer than 8 weeks. 3) Long-term local authority accommodation (s.39) An IMCA is required when a local authority proposes in relation to a person who lacks capacity to: a) provide residential accommodation in a care home (or its equivalent) for a period which is likely to be longer than 8 weeks, or b) move the person to another care home (or its equivalent) for a period which is likely to be longer than 8 weeks

When may an IMCA be appointed?

An IMCA can also be appointed (but there is no legal duty to do so) in 3 further situations. These are:

1) Adult protection cases: this applies to those who lacks capacity and, a) have been or are alleged to be a victim of abuse or neglect, or b) have been alleged or proven to be an abuser.

NB. An IMCA may be appointed in adult protection cases regardless of family involvement. In other words even if the person has friends of family who are involved/ interested in their care and welfare.

2) Care reviews: this applies to those who have been placed in accommodation by the NHS or local authority (for 12 weeks or longer), and whose accommodations arrangement are being reviewed.

3) Where a person has no family or friends to represent them, but does have an attorney or deputy who has been appointed solely to deal with their property and affairs the Code (10.71) states that they should not be denied access to an IMCA (if they lack the capacity to make decisions relating to e.g. serious medical treatment).

When does an IMCA not have a role?

The Act states that an IMCA (s.40) that an IMCA cannot be involved if:

  1. the person lacking capacity has appointed in advance (in whatever manner) someone who is to be consulted about his care and treatment
  2. has appointed an LPA
  3. the court has appointed a deputy to deal with the act in question.

Who has a duty to instruct an IMCA?

For serious medical treatment, NHS staff, e.g. doctors or other healthcare professional who is proposing to take an action in relation to the care or treatment of an adult who lacks capacity (or who is contemplating making a decision on behalf of that person) will usually be the person responsible for instructing an IMCA.

What is the role and functions of an IMCA?

The role and functions of an IMCA are defined in the Act, regulations and the Code of Practice. To facilitate understanding the approach taken here will be to identify (in Box2) what the Act says about the IMCA’s role and (in Box 3) how that role should/can be carried out. Box 4 provides a summary of the IMCA’s work.

Box 2 Duties of IMCA

s.36 (2) imposes the following duties:

a) providing support to the person who lacks capacity so that he can participate as fully as possible in the decision

b) obtain and evaluate relevant information

c) ascertain the person’s wishes and feelings, beliefs and values

d) ascertain alternative courses of action

d) obtain further medical opinion where necessary

In addition the IMCA must

e) prepare a written report of his findings for the NHS body.

f) follow the principles in the Act (i.e. the 5 statutory principles in s.1)

g) take account of relevant guidance in the Code.

Box 3 How IMCAs should carry out their duties

According to Regulations and the Code of Practice (chapter 10) an IMCA

a) must confirm that the person instructing them has the authority to do so

b) must find out what support the person has had to enable him make the decision

c) must try to find what the person’s wishes, feelings, beliefs and values would be likely to influence him if he had capacity

d) should consider the person’s religion and any cultural factors

e) should interview or meet in private the person who lacks capacity

f) should get the views of professionals and paid workers providing care and treatment

g) should get the views of anybody else who can give information about the person’s wishes, feelings beliefs or values

In addition an IMCA may

h) examine any relevant records (e.g. health records).

i) challenge the decision- maker (e.g. about their assessment of capacity or whether the decision is in the person’s best interests).

Box 4 Summary of IMCA work

The 4 elements of IMCA work can be broadly summarised as:

1. Ascertaining the person’s wishes, feelings, beliefs and values: using whichever communication method is preferred by the client and ensuring that those views are communicated to, and considered by, the decision-maker.

2. Non-instructed advocacy: asking questions on behalf of the person and representing them. Making sure that the the person’s rights are upheld and that they are kept involved and at the centre of the decision-making process.

3. Investigating the circumstances: gathering and evaluating information from relevant professionals and people who know the person well; carrying out any necessary research relevant to the decision.

4. Auditing the decision-making process: checking that the decision -maker is complying with the Act; the decision is in the person’s best interests; challenging the decision if necessary.

When does the IMCA’s work end?

The IMCA will stop being involved in a case once the decision has been finalised and they are aware that the proposed treatment has been carried out. The IMCA cannot provide on-going advocacy support to the patient. If it is felt that a patient needs advocacy support after the IMCA has withdrawn, it may be necessary to make a referral to a local advocacy organisation.

Implications for health professionals

Although an IMCA does not make the decision about what is in the best interests of a patient their involvement nevertheless has important implications for health professionals. These are divided into section A and B (note that both sections are subject to any local processes or procedures that state otherwise)

Section A

The following checks should be made before providing treatment:

1. Should an IMCA be appointed?

An IMCA must be appointed if:

1) the decision involves ‘serious medical treatment ‘ (as defined in Box 1)

2) the patient lacks capacity to make that particular decision

3) the patient is over 16 years old

4) there is nobody (other than paid staff providing care or professionals) who is willing and able to be consulted about the decision. This may arise because:

  • the family member or friend is not willing to be consulted
  • the family member or friend is too ill or frail
  • there are reasons which make it inappropriate or impracticable to consult with the family member or friend, for example, they live too far away
  • a family member or friend may refuse to be consulted
  • there is abuse by the family member or friend.

2. Whether an LPA or deputy has been appointed?

If serious medical treatment is proposed for a patient (who lacks capacity and who has no friends or family to represent them), but who does have an attorney or deputy appointed solely to deal with their property and affairs, then the Code of Practice (10.70) recommends that an IMCA should be appointed.

3. Is the ‘serious medical treatment’ urgent?

The only situation in which the duty to instruct an IMCA need not be followed is in if an urgent decision is needed, for example, to save a person’s life. However, if further serious treatment follows an emergency situation, an IMCA must be instructed.

NB. If treatment is ‘urgent’ the decision must be recorded together with the reason for the non-referral to an IMCA.

Section B

To ensure effective collaboration between an IMCA and health professionals the following actions may need to be taken:

4. Provide access to patient’s records

An IMCA has the right (under s.35(6)), at all reasonable times (when practicable and appropriate) , to examine and take copies of any health records that the IMCA thinks are relevant to their investigation, for example, clinical records, care plans and social care assessments.

5. Facilitate the IMCA’s interview with the patient

An IMCA has the right to have an interview the patient in private (when it is practicable and appropriate). Given the range of legal duties imposed on IMCAs by the Act (s.36(2)), in particular, to provide support to the patient and ascertain what their wishes and feelings would be likely to be, and the values and beliefs that would be likely to influence them, health professionals are likely to be asked to help facilitate an interview (or more than one, if necessary).

6. Take into account information provided by IMCA

The Act (s.37 (5) imposes a legal duty on the decision-makers to take into account any information given, or submissions made, by the IMCA. All health professionals involved in the person’s treatment will therefore need to be aware of this duty (if they have, for example, been given information by the IMCA relevant to the decision in question).

Information from the IMCA may be given verbally or in a written report (which the IMCA has a legal duty to submit). Either way the intention is to make sure that decisions are based on a full understanding of the patient’s past and present wishes (Code. 10.21).

7. Record the role of the IMCA in the case

The IMCA’s role should be recorded (Code 10.14). This record should include:

  1. the extent of the IMCA’s involvement
  2. any information provided by the IMCA to help decision-making
  3. how the decision-maker has taken into account the IMCA’s written report
  4. any reasons for disagreeing with the IMCA’s advice.

8. Inform the IMCA of the final decision

Although it is unlikely that at this stage the IMCA is unaware of the decision that has been made, the Code (10.14) nevertheless recommends that she or he be informed by the decision-maker(s) of any decision and the reason for it.

Decision-making by attorneys and deputies

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The Act introduces several mechanisms to allow people to prepare for a time in the future when they no longer have capacity. One of these mechanisms is the advance decision. Another is to appoint an attorney who has the authority to make certain decisions on their behalf. Under common law it was not possible to appoint another person to make healthcare decisions. By enabling people to appoint attorneys to make healthcare decisions the Act therefore fills in a significant gap in the law. This file focuses mainly on attorneys but it also outlines the role of Deputies (appointed by the Court of Protection).

Attorneys

A. Personal welfare attorney 

Personal welfare attorneys appointed under the Act – by a legal document called a lasting power of attorney (LPA) – are given legal authority to make decisions on behalf of another.

Two types of LPA’s can be created under the Act. One deals with ‘property and affairs’, including financial matters (no further information will be provided here on this type of LPA)). The other type of LPA is called a personal welfare LPA. The personal welfare LPA authorises the attorney to make decisions about various aspects of a person’s personal life when he no longer has the capacity to make the particular decision in question (see Box 1). Most importantly, this type of LPA can authorise the attorney (called the donee) to make healthcare and medical treatment decisions on behalf of the person who appointed them (called the donor in the act but hereafter referred to as the patient).

Change: The personal welfare lasting power of attorney is a new form of power of

Box 1: Personal welfare LPAs

     

A general personal welfare LPA might include decisions about:                                 

  • where the patient should live and with whom
  •                    
  • day-to-day care
  •                                      
  • who the patient can have contact with
  •                            
  • assessments for community care services
  •                      
  • involvement in social/leisure activities, education or training
  • personal correspondence and papers

NB. The standard form general personal LPA allows attorneys to make decisions about anything that relates to the patient’ s personal welfare. But patients can add restrictions or conditions.                             

A personal welfare LPA covering healthcare might include decisions about:

a)  consenting to or refusing medical examination / treatment/assessments on the patient’s behalf

b) arrangements needed for the patient to be given medical, dental, or optical treatment

c) nursing care

d)  complaints about the patient’ s care or treatment

NB. An attorney can only consent to or refuse life- sustaining treatment on behalf of the patient if the LPA states that the attorney is to have this authority.

B. Creating a valid LPA

There are a number of stringent formalities (see e.g. s.9 and 10) governing the creation of a valid LPA. They stipulate that both the person appointing the proxy (called the donor) and the donee (the attorney decision-maker) must be aged 18 or over. In summary the following conditions must be complied with if the LPA is to be legally valid:

  • the patient must have capacity when s/he makes the LPA
  • the document must include prescribed information about the nature and effect of the LPA
  • the patient must sign a statement saying that they have read the prescribed information (or somebody has read it to them) and that they want the LPA to apply when they no longer have capacity
  • the document must name people (not any of the attorneys) who should be told about an application to register the LPA, or it should say that there is no-one they wish to be told
  • the attorneys must sign a statement saying that they have read the prescribed information and that they understand their duties –in particular the duty to act in the donor’s best interests
  • the LPA must be registered with the Office of the Public Guardian
  • the document must include a certificate completed by an independent third party confirming that:

a) in their opinion, the patient understands the LPA’s purpose

b) nobody used fraud or undue pressure to trick or force the patient into making the LPA and

c) there is nothing to stop the LPA being created.

C. Who can be an attorney?

An attorney is likely to be a friend, relative or a professional (who must be clearly named). The Code advises that a paid care worker (such as a care home manager) should not agree to act as an attorney unless there are special circumstances (such as they are the only close relative of the patient). Otherwise it recommends appointing someone who is trustworthy, competent and reliable with the skills necessary to carry out the necessary tasks (Code 7.8).

It is possible to appoint more than one attorney at a time and to specify whether they should act jointly, jointly and severally or jointly in respect of some matters and jointly and severally in respect of others (see Box 2).

Box 2: Attorneys

Joint attorneys:                                         

1) Must always act together

2) Must all agree and sign any relevant documents              

Joint and several attorneys:

1) Can act together

2) Can act independently if they wish

3) Any action taken by any attorney alone is as valid as if they were the only attorney.   

NB.

1. The patient may appoint personal welfare attorneys to act jointly and severally but specify that they must , e.g. act jointly in relation to giving consent to surgery.

2. If a patient has appointed two or more attorneys does not specify how they should act, they must always act jointly (s.10(5))

3. A patient may chose to name replacement attorneys to take over duties in certain circumstances.

D) Duties of attorneys making healthcare decisions

According to s. 9(4) and the Code (7.19) they must meet the requirements of the Act. Most importantly they must:


1) follow the 5 statutory principles 

2) consider whether the patient has capacity to make the decision for themselves. If not, consider whether the patient is likely to regain capacity to make the decision in the future. If so, consider delaying the decision until the patient can make it.

3) make sure that they have a ‘reasonable belief’ that the donor lacks capacity.

4) make decision in the patient’s best interests (i.e. follow s.4 checklist

5) respect any conditions or restrictions that the LPA document contains

6) have regard to the guidance in the Code of Practice

7) only use restraint if: a) the patient lacks capacity (or the attorney reasonably believes he lacks capacity), b) it is necessary to do the act in order to prevent harm to the patient, and c) the restraint is a proportionate response to the likelihood of the patient suffering harm,  and the seriousness of that harm. 

NB. For details of an attorney’s other duties see Box 3.

Box 3: Attorney’s duties

Code 7.58-66 species that attorneys take on a role which carries a great deal of power. They are expected to use this carefully and responsibly. In particular they have a duty to:

  • the patient’s instructions
  • not take advantage of their position
  • not delegate decisions, unless authorised to do so
  • act in good faith
  • respect confidentiality
  • not give up the role without telling the patient and the court of protection
  • apply certain standards of care and skill (duty of care) when making decisions


A valid personal welfare lasting power of attorney exists gives an attorney the legal right to make healthcare and treatment decisions. Nevertheless health professionals should ask the following questions:

1.  Is the person (patient) 18 or over?

Only adults aged 18 or over can make an LPA (and they can only make one if they have capacity to do so)

2. Is the attorney 18 or over?

Only adults aged 18 or over can be attorneys under an LPA

3. Does the patient have capacity?

If the person has capacity to make the decision in question then the person must be given all the support necessary to make that decision. In other words if health professionals consider that the person has the capacity to make his own treatment decisions, the attorney has no legal right to make the decision on his behalf.

4. Is the patient detained under the Mental Health Act 1983?

An attorney cannot consent or refuse treatment for a mental disorder for a patient detained under the Mental Health Act 1983.

5. Is there an advance decision?

An attorney cannot consent to treatment if the patient has made (after the LPA was signed) a valid and applicable advance decision covering the treatment in question.  However, if the advance decision was made before the LPA giving the attorney the right to consent or refuse treatment, the attorney can choose not to follow the advance decision. In other words the advance decision is overtaken by the LPA.

6. Is treatment in question life-sustaining?

An attorney has no power to consent to or refuse life-sustaining treatment (described in the LPA as treatment needed to keep a person alive) unless the LPA document expressly authorises this. 

7. Is the attorney refusing life-sustaining treatment?

An attorney given legal authority to consent to or refuse life-sustaining treatment under the terms of the LPA has the legal authority to refuse such treatment (the decision must, of course, be in the best interests of the person).

In addition s.4(5) applies, i.e. in making any decision about whether life-sustaining treatment is (or is not) in the person’s best interests the attorney must not be motivated by a desire to bring about the patient’s death for whatever reason, even if this from a sense of compassion (Code 5.31).

8. Is there concern that the attorney is failing to act in the patient’s best interests?

Attorneys must always follow the Act’s principles and make decisions in the patient’s best interests. Healthcare staff may, however, disagree with how an attorney is applying the Act.

NB While concerns or disputes are being resolved about the actions of an attorney healthcare staff can give life- sustaining treatment to prolong the patient’s life or stop their condition from getting worse. 

Deputies


A) Appointment of deputies

Deputies are appointed by the Court of Protection to make personal welfare decisions on behalf of a person who lacks capacity. The Act makes it clear that where possible the court should make the decisions itself rather than appoint a deputy, but that if one needs to be appointed, their appointment should be as limited in scope and for as short a time as possible(s.16(4)(a)).

Deputies for personal welfare decisions are likely to be required only in the most difficult cases, Box 4)

Box 4: Deputies

Code 8.38 : examples of when a deputy might be appropriate to make personal welfare (including healthcare decisions):

  • someone needs to make series of linked welfare decisions over time – e.g.a family carer close to a person with profound and multiple learning disabilities might apply to be appointed as a deputy
  • the most appropriate way to act in the person’s best interests is to have a deputy, who will consult relevant people but have the final authority to make decisions
  • there is a history of serious family disputes that could have a detrimental effect on the person’s future care unless a deputy is appointed to make necessary decisions
  • the person who lacks capacity is felt to be at risk of serious harm if left in the care of family members.

NB: A deputy might also be appointed by the court to replace an personal welfare LPA (if the attorney is, e.g., not acting in patient’s best interests).

Deputies must be at least 18 years old. They can be family members or any other person (but not paid care workers unless there are exceptional circumstances (e.g. if the care worker is the only close relative of the person who lacks capacity)). Deputies can be appointed to act jointly or jointly and severally.

B) Duties of deputies making healthcare decisions 

Although deputies may be given the legal authority to make healthcare decisions the Act imposes several restrictions on their powers. They have no authority to make decisions or take action in the following situations:

  • Capacity: If the deputy knows or has reasonable grounds for believing that the person has capacity to make the particular decision for themselves.
  • LPA: If their decision goes against a decision made by an attorney acting under a personal welfare lasting power of attorney granted by the patient before they lost capacity.
  • Refusing life-sustaining treatment: The Act prohibits deputies from refusing consent to the carrying or continuation of life-sustaining treatment in relation to the patient.

In all other situations when deputies are making healthcare decisions they must:


1) follow the Act’s 5 statutory principles

2) consider whether the patient has capacity or is likely to regain capacity to make the decision in the future. If so, it may be possible to delay the decision until the person can make it

3) make decisions in the patient’s best interests (i.e. follow s.4 checklist)

4) have regard to guidance in the Code of Practice

5) only make decisions the court has given them the authority to make

6) only use restraint if: a) he is acting within the scope of an authority expressly conferred on him, b)the patient lacks capacity (or the deputy reasonably believes that he lacks capacity) in relation to the matter in question, c) restraint is necessary to prevent harm, and, d) the restraint is proportionate.

Box 5: Deputy’s duties

 

Code 8.55-67 states that deputies must carry out their duties carefully and responsibly. In particular they have a duty to:

  • act with due care and skill
  • not take advantage of their situation
  • not delegate duties
  • act in good faith
  • respect confidentiality
  • comply with directions from the Court of Protection

                       

Implications for healthcare professionals


In the unlikely event that a deputy is empowered by the Court of Protection to make healthcare decisions on behalf of a person who lacks capacity, health professionals should nevertheless address the following questions:

1. Does the patient have capacity?

If the patient has capacity to make the decision in question (or the deputy has reasonable grounds for believing that the patient has capacity) then the deputy has no power to make the decision on the patient’s behalf.

2. Is there concern that the deputy is not acting in the patient’s best interests?

Deputies must always follow the Act’s principles and act in accordance with the Court of Protection’s authority. If healthcare staff disagree with how a deputy is applying the Act or is not acting in the patient’s best interests they should raise their concerns with an appropriate person.

3. How should concerns be dealt with?

As the Code makes clear, the Office of the Public Guardian is responsible for supervising deputies. Anyone suspecting that a deputy is abusing their position should contact the OPG immediately.

Determining best interests

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The best interests principle set out in section 1(5) states:

An act done, or decision made, under this Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests

The concept of best interests was well established in the common law. Except in two situations (see step 1 below) the principle must guide all actions taken or decisions made under the Act (whether by individuals or the courts).

Essentially the best interests approach asks whether any proposed course of action is the best one for the patient all things considered. The term is not defined in the Act - a universally applicable explanation was considered inappropriate given the wide range of people likely to making decisions covered by the Act and the variety of decisions that would need to be made. However in section 4 a statutory ‘list’ of   common factors is set out that must always be considered (as a minimum) by anyone who makes a decisions for someone who lacks capacity. Note that none of the factors in the list carries more weight or priority than another (rather they must be balanced).

Decisions can relate to a person’s financial affairs, personal welfare or health care. Some decisions will be routine, minor one whereas others could have serious consequences – such as major surgery. 

Change: Although the best interests approach was a common law principle the statutory version is both more extensive and coherent, essentially codifying the common law. It provides a systematic set of procedures and criteria that are designed to ensure that the proposed action is ‘ best’ for the person while also paying due respect to their autonomy. 

Step 1: Establish whether the best interests principle applies

There are two circumstances when the best interests principle does not apply (because there are other safeguardsthat are presumed to be effective). These are:

1) Advance decisions – if the person lacking capacity has previously

made a valid and applicable advance decision to refuse medical treatment (while they had capacity to do so) their advance decision must be respected.

2) Research – in certain circumstances a person lacking capacity can be involved in research. If so, the criteria that must be followed replace the best interest test.

In all other cases in which decisions are made under the Act the best interests principle must be applied. 

Step 2: Identify the decision-maker

The person who makes a decision or acts on behalf of someone who lacks capacity is referred to as ‘D’ in the Act and the ‘decision-maker’ in the Code. Decision-makers can include the following range of people:

  • day-to day actions / decisions - family carers, other carers and care workers
  • health care contexts – doctors or other member of healthcare staff responsible for carrying out the particular treatment/procedure. Treatment includes investigations such as X-rays, as well as procedures like operations and injections
  • nursing or paid care – the relevant nurse or paid carer will be the decision-maker
  • Lasting Power of Attorney (LPA) – once registered with the Office of Public Guardian attorneys have legal authority according to the terms of their appointment. There are two types of LPAs under the Act, a personal welfare LPA which can include healthcare and medical treatment decisions and a property and affairs LPA which can include financial matters.
  • deputies – appointed by the court and typically a family member or person who knows the person well. A deputy can make decisions about a person’s welfare (including healthcare). 

The decision made by any of the above can either be a sole decision –made by one person or a joint decision. The latter may be appropriate when several different people, e.g. healthcare and social care staff are involved in a person’s care. It is laways good practice to consult widely amongst people who have an interest in, or knowledge of, the patient (see step 7 below).

Step 3: Apply the principle of equal consideration

The principle of equal consideration (s.4(1)) is identical to the one which must be applied when assessing capacity. It is repeated in section 4 to remind decision-makers that they must not make unjustified assumptions about what a person’s best interests might be simply on the basis of their age, appearance, condition or behaviour. Its repetition is designed to ensure that in the early stages of making a decision about someone else’s life – when preconceptions may be particularly influential in shaping how a person is treated -every effort is made not to act in a discriminatory way.

Change: The principle of equal consideration is new. Its prominence in s 4, despite not being one of the five statutory principles underpinning the whole Act, draws attention to the requirement that people who lack capacity must not be prejudged or discriminated against.

Step 4: Involve the person in decision-making

The process of making a decision on behalf of a person who lacks capacity is designed to ensure that all reasonable efforts are made to involve them as much as possible in working out their own best interests. This requirement is bolstered by two very specific sub sections:

1) s.4(3) imposes a duty on decision-makers to consider the chances of the person regaining capacity and, if so, to defer the decision until then, and  

2) s.4(4): whenever reasonably practicable the decision-maker must permit and encourage the person to improve his ability to participate.

Essentially these two subsections bolster the duty to do everything possible to help and support the person make their own decision. The Code (see Box 1) provides guidance on how the person lacking capacity can be involved in working out their own best interests.

Box 1: Regaining capacity / participation

                               

Code 5.28 Factors to be considered include:           

1) treating the cause of incapacity (by e.g. medication)

2) in cases of fluctuating capacity arrange for the decision to be made at a lucid time                                              

3) whether new skills could be learnt or easier forms of communication developed

Permitting and encouraging                                         

Code 5.2 Practicable steps include:

1) using simple language

2) putting the person at ease by choosing most appropriate time/location. 

3) breaking information down to easy to understand sections

4) using specialist interpreters or signers

Step 5: Consider all the relevant circumstances

This step basically involves identifying all the things that a person who lacks capacity would normally take into account if they were making their own decision or acting for themselves. Section s 4(2) states that:

the decision-maker must consider all relevant circumstances when making a decision, i.e. specifically those -

a) of which the decision -maker is aware, and

b) which it would be reasonable to regard as relevant

The Code provides some guidance on the meaning of relevant circumstances (see Box 2)

Box 2: ‘all relevant circumstances’

Code 5.19 For major medical treatment a doctor should consider:

  • clinical needs of patient
  • potential benefits and burdens of treatment on person’s health and life expectancy
  • other factors relevant to making a professional judgement.

Step 6: Find out the person’s wishes/feelings/beliefs/values

S. 4(6) makes it clear that the person who lacks capacity must be put at the centre of any decision made under the Act. Thus the decision-maker:

‘must consider, so far as is reasonably ascertainable -

a) the person’s past and present wishes and feelings (and in particular,  any relevant written statement made by him when he had capacity),

b) the beliefs and values that would be likely to influence his decision if he had capacity, and

c) the other factors that he would be likely to consider if he were able to do so

To achieve the aims in section S. 4(6) two different approaches are possible, either:

1) to make the person’s wishes determinative. Such an approach would require decision-makers to guess what the person would have decided if he had been competent. As an approach it can only really work properly where the person has been competent in the past;

or

2) decide that the person’s wishes etc will not necessarily be the decisive factor -although they should be a very important consideration, i.e. they must be given a great deal of weight. Under this approach an objective element may well be introduced when working out best interests.

The Act adopts this second approach (see Box 3).

Box 3: General guidance on best interests

Code 5.38 explains the intention behind s.4(6) as:

‘...[their]  wishes and feelings, beliefs and values will not necessarily be the deciding factor in working out their best interests. Any such assessment must consider past and current wishes and feelings, beliefs and values alongside all other factors, but the final decision must be based entirely on what is in the person’s best interests

Explaining other terms used in s4(6), the Code states:

‘reasonably ascertainable’ means:  considering all information at the time available. Accordingly what is available in an emergency will differ from what is available when there is no urgency. Even so attempts should still be made to facilitate communication (Code 5.39).

‘past and present wishes and feelings’: These can be expressed through behaviour , expressions of pleasure/distress,  and emotional responses. All reasonable efforts must be made to establish past wishes in so far as they may influence the decision that needs to be made.

Written statements (made when the person had capacity ) are particularly important evidence of what a person may now wish, especially if they refer to preferred medical treatment (Code 5.42). 

NB. A written statement does not have the legal force as a valid and applicable advance decision. It may be very persuasive, however, even if not determinative.                                

‘beliefs and values’: 

Evidence of a person’s beliefs etc can be found in things like their e.g.cultural background, religious and political convictions and past behaviour and habits (Code 5.46).

  • ‘other factors’:
  • These could include e.g. the effect of the decision on other people, obligations to dependants or the duties of a responsible citizen (Code 5.47).

Change: Prior to the Act both common law and guidance from the Department of Health had interpreted the term ‘best interests’ to extend beyond just medical interests. As such factors such as a patient’s wishes and beliefs when competent as well as their current wishes etc would normally be taken into account. The statutory version explicitly now incorporates such a requirement. There is now no doubt that they form an integral part of working out a person’s best interests (and so incorporate a significant subjective element). 

Step 7:  Consult significant people,

S.4(7) imposes a qualified duty ( the duty only arises when it is ‘practicable and appropriate’)  on decision-makers to consult a wide range of people ( Box 4) close to the person lacking capacity. The views ascertained must be taken into account. 


1) what would be in the person’s best interests, and

2) what information can they provide on the person’s wishes and feelings etc

Box 4: Who must be consulted

S.4(7) imposes a duty to consult the following people:

a) anyone previously mentioned by the person lacking capacity as someone they want to be consulted

b) anyone involved in caring for that person

c) anyone interested in their welfare

d) an attorney appointed under a Lasting Power of Attorney

e) a deputy appointed by the Court of Protection

NB. 1) The duty of consultation is qualified, i.e. it applies only if ‘practicable and appropriate’.

2) If there is no-one in the above category an Independent Mental Capacity Advocate may have to be consulted (see step 8).

3) If a LPA has been made and registered the attorney will be the decision-maker (rather than just having a right to be consulted ) for decisions within the scope of their authority (see Code 5.8 ).

Change: s.4 (7) incorporates what was long (but mistakenly) previously believed to be a legal duty rather than simply good practice. Now there is no doubt that various people, who may shed some light on a person’s best interests, should be consulted. Their views are not, however, determinative.

Step 8: Categorise the level of treatment

For convenience health care and treatment decisions will be divided into three categories, reflecting their different levels of ‘seriousness’.

a) Level 1: Minor treatment

This category includes routine minor healthcare care and treatment options such as nursing care, giving medication, taking blood and urine samples,  physiotherapy, chiropody and carrying out diagnostic examinations and tests (to identify an illness, condition or other problem).

b) Level 2: Serious treatment

This category includes major healthcare and treatment decisions which have significant consequences for the person concerned. Thus it will include major surgery or a decision not to attempt to resuscitate a patient (DNAR order) as well as emergency treatment such as CPR.

It also includes what the act refers to as ‘serious ‘medical treatment (being proposed by an NHS body (or one that an NHS body is proposing that another organisation such as private hospital carry out) that would trigger the appointment of an Independent Mental Capacity Advocate (because there is no appropriate person to consult under step 7 above other than paid care staff:see resource materials on Independant Mental Capacity Advocates).

The concept of ‘serious medical treatment’ is defined in Regulations (2006 No.1832) as treatment which involves:

‘providing, withdrawing or withholding treatment in circumstances where-

a) a single treatment is being proposed, there is a fine balance between its benefits to the patient and the burdens and risks,

b) there is a choice of treatments, the decision as to which one to use is finely balanced, or

c) what is proposed would be likely to involve serious consequences for the patient.

The Code (10.43) provides examples of what the terms ‘serious medical treatment’  and ‘serious consequences’ mean in this context (see Box 5).

Box 5: ‘Serious medical treatment’

                           

Code 10.45 identifies the following non-exhaustive list :                     

1) chemopherapy and surgery for cancer                                    

2) electro-convulsive therapy  

3) therapeutic sterilisation                                          

4) major surgery (e.g. open-surgery)                           

5) treatments involving permanent loss of hearing or sight

6) major amputations (e.g. loss of arm/leg)             

7) withholding or stopping artificial nutrition or hydration

8) termination of pregnancy

‘Serious consequences’‘Serious consequences’ 

Code 10.44 identifies treatments with serious consequences as those which could have a serious impact on the patient either from the treatment itself or its wider implications e.g. they: 

1) cause serious and prolonged pain or side- effects, 

2) have potentially major consequences for the patient,  e.g. stopping life-sustaining treatment, or having major surgery such as heart surgery

3) have a serious impact on the patient’s future life choices (e.g. interventions for ovarian cancer)

NB. A special factor applies to decisions life- sustaining treatment (s.4(5)), i.e.  the fundamental rule that anyone deciding whether or not life-sustaining treatment is in the best interests of a patient must not be motivated by a desire to bring about that person’s death.
         
c) Level 3: Court sanctioned treatment

Some treatment decisions are so serious that only a court has the power to make them- unless the person lacking capacity has:

a) made a Lasting Power of Attorney authorising an attorney to make the healthcare decision in question , or

b) has a valid and applicable advance decision to refuse the proposed treatment.

According to the Code(6.18) Court of Protection approval must be obtained for the following cases:

  1. withholding/ withdrawal of artificial nutrition and hydration (ANH) from a patient in PVS
  2. where it is proposed that a person who lacks capacity to consent should donate an organ or bone marrow to another person
  3. non-therapeutic sterilisation of a person who lacks capacity to consent (e.g. for contraceptive purposes)
  4. where there is doubt about whether a particular treatment is in a person’s best interests
  5. involving ethical dilemmas in untested areas, such as innovative treatment for variant CJD
  6. where there are irresolvable conflicts between healthcare staff, or between staff and family.

Step 9:  Choose the least restrictive option

The last of the five statutory principles comes into play at this stage:

s.1(6) Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action.

This fundamental principle obliges decision-makers to question if they can choose a different less invasive course of action. The effect of this principle is to introduce a presumption in favour of the least intrusive action. Referred to in the Code as finding the ‘less restrictive alternative’, it includes deciding whether there is a need to act or make a decision at all. It also includes exploring ways that would allow the greatest freedom for a person who lacks capacity to make the decision in question. 

Change: This statutory principle had previously been recognised by common law, most notably in relation to sterilisation cases. Its incorporation in s.1 makes it clear that it must govern all actions and decisions taken under the Act.

Step 10: Demonstrate ‘reasonable belief’ that treatment is in a person’s best interests (to gain legal Protection)

   
As was noted in relation to assessing capacity, s.5 operates to protect those caring and treating people without consent – providing they have a ‘reasonable belief ‘that the person did in fact lack the capacity to give permission for the action. But to gain s.5 protection – i.e. to treat person without their consent without fear of legal action- it is also necessary to have a reasonable belief the care and treatment is in the person’s best interests (s.5(1)(b)(ii)). 

According to s.4(9) if someone acts or makes a decision in the ‘reasonable belief’ that what they are doing is in the person’s best interests then –provided they have followed the checklist in s.4- they will have complied with the best interests principle set out in the Act.

Further guidance on ‘reasonable belief’ about best interests is contained in the Code (Box 6).

Box 6: ‘Reasonable belief in relation to ‘best interests’

Code 6.28 - 34 states that to demonstrate ‘reasonable belief’ in relation to best interests decision -makers should:

  • apply all elements of the best interests test (in s.4)
  • consider all relevant circumstances
  • consider whether the person is likely to regain capacity to make the decision in the future
  • consider whether a less restrictive option is available
  • have objective reasons for thinking an action is in the best interests of the person who lacks capacity
  • be aware that the skills and knowledge of healthcare staff will affect what is classed as ‘reasonable’, i.e. they should apply normal clinical and professional standards when deciding what treatments to offer.

     

NB.

1. S.5 does not provide a defence in cases of negligence ( because a belief negligently held is by definition not reasonable)       

2. Valid decisions by attorneys or deputies take priority over any action which might be taken under S.5 (although action can be taken to sustain life while any dispute is being resolved). 

3. In cases where emergency treatment is necessary to save a person’s life (or prevent them form serious harm) what steps are ‘reasonable’ will differ to those in an emergency. Furthermore in emergencies, it will almost always be in a person’s best interests to give urgent treatment without delay (Code 6.35)

Step 11: Keep a record


The final responsibility for deciding what is in a person’s best interests lies with the health professional proposing to carry out treatment. To make sure the clearest evidence exists of the decision-making process – should any doubt subsequently arise- the Code recommends that the following should be recorded (and should remain on the person’s file):

  1. the decision itself
  2. how the decision was reached
  3. why a written statement (e.g. expressing preferences about medical treatment) was not followed
  4. what the objective reasons for reaching the decision were
  5. who was consulted to help work out best interests
  6. why was a particular person or persons not consulted (who should have been consulted according to s.4(7)
  7. what particular factors were taken into account

Step 12: Final checks


As precautionary measure the following checks should be made to make sure that the decision-maker (e.g. doctor) has legal authority to treat the person without capacity. 

1) whether an attorney has been appointed (under an LPA) to make the decision in question

2) whether a deputy (appointed by the court)  has been given the authority to make the decision

3) that no valid and applicable advance decision exists covering the situation.

4) that the treatment does not need require the court’s permission before it can be carried out.

Step 13:  Carry out the treatment (or do not treat)


If the previous 12 steps have been followed care and treatment can now be provided (or it can be withdrawn or withheld). If treatment is provided but cannot be provided one further condition must be met (Box 7).

Basically a person uses restraint if they:

a) use, or threaten to use force, to make someone do something they are resisting, or

b) restrict a person’s freedom of movement, whether they are resisting or not (s 6(4))

To be lawful (and thus come within the protection of s.5 (see step 10) two conditions must be met. These are set out in s.6(2) & (3) and require the person using the restraint to

1) believe reasonably that the restraint is necessary to prevent harm to the person who lacks capacity, and

2) that the restraint must be a proportionate response to the likelihood and seriousness of the harm

Box 7: Use of Restaint

Restraint can consist of verbal threats or physical actions (such as using cot sides, administering sedatives in order to undertake treatment or when a person’s movements are confined)

Code 6.44 Restraint is necessary:

  • if the person using the restraint has objective reasons to justify that the restraint is necessary
  • if it is not appropriate to get an advocate to work with the person to see if restraint can be avoided all together. An example of necessary restraint would be what is appropriate to enable e.g. a blood test to be taken

Code 6.45 Harm

The definition of harm very much depends on the context but it could include e.g.

  • behaving in a dangerously provocative way
  • encouraging others to assault or exploit them
  •                  


Code 6.47 Proportionate response means   

a) using the least intrusive type and the minimum amount of restraint
b) using restraint for the shortest possible time

NB
1. Although s.5 permits the use of restraint there is no protection under the Act for actions that result in someone being deprived of their liberty (unless formal authorisation from the court has been obtained.

   
2. Restraint can also be used at common law where there is a risk that the person lacking capacity may harm someone else.                                                                               


Advance decisions regarding treatment

pdf version

An advance decision enables a person to refuse particular types of treatment they would not want to have at a time in the future (when they no longer have capacity). Advance refusals ( referred to previously in common law as ‘living wills’ or ‘advance directives’ ) have been recognised by the courts as being in some circumstances as effective as a contemporaneous refusal , i.e they are legally binding. In building upon the common law the Act codifies and clarifies existing common law rules. It also introduces new conditions and safeguards.

The Act distinguishes between advance refusals to refuse life-sustaining treatment and other types of advance refusals (referred in this document as type 1 and 2 refusals respectively). In some cases too an attorney may have been given the authority to refuse treatment on the patient’s behalf.

NB. An advance decision to refuse treatment (if made in accordance with the Act) is not the same as an advance written statement setting out the person’s wishes and feelings which may be taken in to account in assessing their best interests.

Step 1: Preliminary questions

In cases where an advance decision may be relevant, following questions should first be asked:

a) How old is the patient?

The Act’s provisions about advance refusals only apply to someone aged 18 and over. Advance refusals by young people under 18 are governed by the common law and statute law (e.g. Children Act 1989).

b) Did the person have capacity when they made their advance decision?

An advance decision refusing treatment can only be legally binding if the person had capacity when they made it.

c) Is the advance decision attempting to demand specific treatment (rather than refuse it)?

Only advance decisions to refuse treatment can be made. Nobody has the legal right to demand specific treatment (either at the time or in advance) that health professionals consider clinically unnecessary, futile or inappropriate. Any preferences or requests that are expressed, however, should be considered when deciding what is in a patient’s best interests unless they relate to procedures that are against the law.

d) Does the advance decision cover basic care?

An advance decision cannot refuse actions that are needed to keep a person comfortable (sometimes called basic or essential care). Examples of basic care include warmth, shelter, actions to keep a person clean and the offer of food and water by mouth (Code.9.28). Section 5 of the Act allows healthcare professionals to carry out these actions (without consent) in the best interests of the patient without incurring legal liability.

e) Does the Mental Health Act 1983 apply?

Where people are detained under the Mental Health Act 1983 (and can therefore be treated for their disorder without their consent under Part 4), they can be treated even though they have made an advance decision refusing the treatment in question (see resource materials on the relationship between the MCA and MHA).

f) Is the person asking for their life to be ended?

Nobody can receive procedures that are against the law (for example, help with committing suicide). The Act does not change any of the laws relating to murder, manslaughter or helping someone to commit suicide.

Once it has been established that the patient was 18 or over when the advance decision was made, had capacity to make it when it was made and that the advance decision does not relate to basic care, the following steps should be followed:

Step 1: Establish what type advance decision exists

There are two types of advance decisions refusing treatment. Type 1 covers advance decisions refusing all treatment and care (other than life-sustaining treatment). Type 2 covers life-sustaining treatment.

Type 1: Advance decisions refusing treatment (not life-sustaining)

Type 1 advance decisions cover the refusal of a wide range of treatment options, i.e. not just minor one such as routine interventions, but also major surgery, the refusal of which may have serious consequences. The definition of treatment includes treatment and the continuation of treatment. Thus an advance decision could state that the person wants treatment but only for a certain amount of time.

The Act does not impose any particular formalities about the format of this type of advance decision. This means that they can be made either verbally or in writing. But whatever format is adopted the responsibility for drawing attention to the existence of the advance refusal lies with the person making it.

The Code identifies various ways in which people making advance decisions can be sure their advance decision is drawn to the attention of health professionals (and others). In order to establish whether an advance decision exists (see Box 1& 2).

Box 1: Establishing the existence of an advance decision

Verbal decisions (Type 1)

The person who made the advance decision could have alerted relatives/friends/healthcare professionals to its existence. Alternatively such people may simply be aware that one exists.

The Code (9.23) recommends that health professionals record (where possible) a verbal advance decision and that the record should include:

  • a note that the decision should apply if the person lacks capacity to make treatment decisions in the future
  • a clear note of the decision, the treatment to be refused and the circumstances in which the decision will apply
  • details of someone who was present when the oral advance decision was recorded and the role in which they were present (e.g. healthcare professional or family member), and
  • whether they heard the decision, took part in it or are just aware that it exists

Box 2: Establishing the existence of an advance decision

Written decisions (Type 1)

The Code (9.18-20) recommends that even though there is no set format for written advance decisions that do not refuse life-sustaining treatment they should nevertheless ideally include:

  • full details of the person making it, including their date of birth, home address and any distinguishing features
  • the name and address of the person’s GP and whether they have a copy of the document
  • a statement that the document should be used if the person ever lacks capacity to make treatment decisions
  • a clear statement of the decision, the treatment to be refused and the circumstances in which the decision will applyv
  • the person’s signature (or the signature of someone the person has asked to sign on their behalf)
  • the date the document was written or reviewed
  • the signature of the person witnessing the signature, if there is one

Although witnessing the signature is not essential if the witness is a healthcare professional they may also be the person assessing capacity. If so a record of the assessment of incapacity should be made).

NB. 1. A written document is very strong evidence of an advance decision.

2. The person who makes the advance decision has the responsibility to tell others it exists and where it is

3. In addition they may want to carry it with them or carry a card, bracelet or other indication.

Type 2: Advance decisions refusing life-sustaining treatment

Type 2 advance decisions cover life-sustaining treatment. Life-sustaining treatment is defined as treatment which ‘a health care professional who is providing care for the patient regards as necessary to sustain life’ (s.4(10)).As the Code explains, whether a particular treatment will, or will not, be life-sustaining depends on the circumstances of each particular case. Thus, for example, whereas a refusal of artificial nutrition and hydration (ANH) is likely to result in a person’s death, antibiotics may (or may not) be life-sustaining (Code.9.25).

It is in relation to type 2 advance decisions that the Act makes the most significant changes to the common law - by imposing specific formalities and safeguards(see Box 3).

Box 3 Advance decisions refusing life-sustaining treatment (Type 2)

s.(26) (5)&(6) Code 9.24-28

To have legal effect the following criteria must be met:

a) the advance decision:

  • must be in writing ( a record in medical notes is considered to be in writing). If the person is unable to write, someone else should write it down for them
  • must include a clear, specific written statement from the person making the advance decision that the decision is to apply to the specific treatment even if life is at risk (‘life’ includes the life of an unborn child).
  • must be witnessed

NB. The ‘written statement’ can be made at a different time or in a separate document to the advance decision. If so, it too must be signed and witnessed

b) the person making the advance decision must:

  • sign the advance decision. If the person is unable to sign it, they can direct someone else to sign it for them in their presence

c) the witness must:

  • sign the advance decision (and the ‘written statement’ if it is in a separate document) in the presence of the person making it, or
  • if the person making the advance decision (and any separate ‘written statement’) is unable to sign the witness can witness them directing someone else to sign it on their behalf, and if so, then
  • sign to indicate that they have witnessed the nominated person signing the document in front of the person making the advance decision.

NB. The Code states that it is very important to discuss advance decisions to refuse life-sustaining treatment with a healthcare professional. But it is not compulsory (9.27)

Change: Under the common law there were no special legal formalities governing the format of an advance decision refusing life-sustaining treatment. The Act now requires these to be in writing, signed, witnessed and to include a specific statement that the advance decision is to apply even if life is at risk.

Step 2: Check whether the advance decision has been withdrawn or altered

Once it has been established that an advance decision exists it is necessary to check that it has not been altered or cancelled (in whole or part). The advance decision may have been made many years previously. Since then views and circumstances may have changed or new treatments may be available. A change in personal circumstances may also mean that an advance decision may not present a person’s previous views. As the Code advises anyone who has made an advance decision should regularly review and update it, as necessary (9.29),

Section 24(3) allows people to withdraw or alter their advance decision at any time – provided, of course, they have capacity to do so. Both a withdrawal (which can be partial) and any alteration, can be verbal or in writing. The one exception is any change that includes a refusal of life-sustaining treatment (which must comply with the formalities outlined in Box 3.

The implications of these sections for the two types of advance decisions are outlined in Box 4

Box 4 Withdrawing/ altering advance decisions

Type 1: advance decisions (not life-sustaining)

  • can be cancelled or altered verbally or in writing (irrespective of the format of the original advance decision)
  • whatever the format adopted, responsibility for bringing the change to the attention of health professionals lies with the person amking the advance decision
  • health professionals should record any changes of decision in the person’s healthcare notes.

NB. If the alteration includes a refusal of life-sustaining treatment the formalities in Box 3 must be followed

Type 2: advance decisions refusing life-sustaining treatment

  • can be cancelled or altered either verbally or in writing
  • responsibility for alerting health professionals to the change lies with the person making it
  • health professionals should record any changes of decision in the person’s healthcare notes.

Step 3: Decide whether the advance decision is ‘valid’

This step is the first of two important safeguards introduced to ensure that the person who made the advance decision (either type 1 or 2) still intends to be bound it when they no longer have capacity. Questioning the validity of an advance decision is basically a way of establishing a) whether one still exists and/or b) whether it has been cancelled by the person’s subsequent actions or behaviour.

Determining the validity of an advance decision basically involves three crucial questions (set out in s.25(2)):


1) has the person withdrawn their advance decision when they had capacity to do so?

2) has the advance decision been overridden by a Lasting Power of Attorney (LPA) appointed after the advance decision was originally made ( giving the attorney authority to make the treatment decision in question? (see Box 5)

Box 5 Decisions by LPAs (appointed after the advance decision was made)

1. An attorney has no power to refuse life-sustaining treatment unless the LPA document expressly authorises such a refusal.

2. In reaching any decision about refusing life-saving treatment the attorney must not be motivated in any way by the desire to bring about the person’s death (s.4(5)).

3. If reaching any decision, i.e. whether to consent to or refuse treatment(life-having or otherwise), the attorney must act in the best interests of the person (see Code 7.29).

Change: The Act has created a new statutory power to appoint an attorney to make end of life decisions. This proxy can refuse life-sustaining treatment if: a) the ‘personal welfare’ Lasting Power of Attorney gives the attorney to make such a s decision and b) if the decision is in the person’s best interests..

3) has the person done anything clearly inconsistent with the advance decision suggesting they have changed their mind? (Box 6)

Box 6: ‘Clearly inconsistent’

With no guidance in the Act as to what amounts to ‘inconsistent’ actions or behaviour it seems that:

  • a person could invalidate their advance decision indirectly by subsequent actions/behaviour
  • explicit actions, such as renouncing the religious beliefs on which their advance decision was based, constitute stronger evidence of inconsistent behaviour
  • the person’s ‘inconsistent’ behaviour could have occurred when they no longer had capacity.

If the answer to any of the above three questions is: Yes, the advance decision is not valid. This means health professionals are not legally obliged to follow it. Nevertheless it would need to be seriously considered as part of the process of determining the person’s best interests- assuming, of course, that it is a true expression of the person’s wishes. Once a decision has been made that the advance decision is not valid then health professionals must act according to the person’s best interests.

If there is any doubt about the validity of an advance decision step 5 should be followed next.

If the answer to all of the above 3 questions is: No, then step 4 must be followed.

Step 4: Decide whether the advance decision is ‘applicable’

The second safeguard governing advance decisions to refuse treatment requires health professionals to decide whether the advance decision is applicable to the treatment in question. This safeguard is necessay even though an advance decision does exist and is valid, it may not actually apply to the current circumstances.

S.25 (3) - (6) deals with applicability, and again basically requires health professionals to ask a series of questions:

1) does the person have the capacity to accept or refuse treatment at the relevant time?

NB. If the person now has capacity they can refuse treatment there and then, i.e. any advance decision lapses if the person regains capacity, to come into effect again if capacity is again lost

2) is the proposed treatment different from the treatment specified in the advance decision?

NB. A decision may be regarded as specifying a treatment or circumstances even though it is expressed in everyday language rather than medical terminology

3) are the circumstances in which the person finds himself different from those set out in the advance decision?

4) are there reasonable grounds for believing that that there has been an unanticipated change of circumstance which casts doubt on whether the advance decision now truly reflects the person’s wishes?

5) if the advance decision applies to life-sustaining treatment, does it fail to comply with the requirements set out in Box 3?

Because the answers to these 5 questions may be difficult the Code provides guidance on the factors healthcare professionals should consider, Box 7)

Box 7 Is the advance decision applicable?

Code of practice section 9.43 states that in deciding whether an advance decision is applicable to the proposed treatment, healthcare professionals must consider:

  • how long ago the advance decision was made
  • whether there have been changes in the patient’s personal life (e.g. the person is pregnant, and this was not anticipated when they made the advance decision)
  • whether there have been developments in medical treatment that the person did not foresee such as new medications, treatment or therapies.

Code 9.51 advises that healthcare professionals must take special care if:

  • the advance decision seems not to have been reviewed or updated for some time
  • if the person’s current circumstances are significantly different from those when the decision was made

If the answers to any of the above 5 questions is: Yes, the advance decision is not applicable. This means that health professionals are not legally obliged to follow it. It would, however, need to be seriously considered as part of the process of determining the person’s best interests. Once a decision has been made that the advance decision is not applicable health professionals must make a decision based on the person best interests.

If there is any doubt about the applicability of the advance decision, step 5 should be taken.

If the answer to all of the above questions is: No, the advance decision is applicable. Go to step 6.

Step 5: Postpone making a decision

Because it may sometimes be very difficult to determine whether or not an advance decision refusing treatment exists, that the person had capacity when they made it and it is both valid and applicable, it may be wise to postpone making a decision until any uncertainties are resolved or a declaration from the court is obtained . According to the Code (9.60) the following situations might be enough in themselves to raise concerns:

NB. The Act makes it clear that if there is doubt or dispute about whether a particular refusal exists, is valid or applicable, treatment that is necessary -to prevent the death of the person concerned, or a serious deterioration in their condition – can be provided until the matter is resolved.

Step 6: Ensure that legal protection is available

Valid and applicable advance decisions to refuse treatment have the same legal status as decisions made by people with capacity at the time of treatment. This means that if healthcare professionals are satisfied that an advance decision to refuse treatment exists, is valid and applicable, they must follow it (i.e. not provide the treatment refused in the advance decision). Failure to do so could result in legal action – a civil claim for damages or a criminal charge of assault.

Alternatively legal action could follow if health professionals do not provide treatment believing (wrongly) that an advance decision refusing the treatment exists.

So health professionals may either:

1) give treatment that has been refused in an advance decision

Section 26(2) makes it clear that a treatment-provider can safely treat (i.e. without fear of liability) if he is not satisfied that a valid and applicable advance decision exists,

or

2) withdraw or withhold treatment thinking (wrongly) that there is an advance decision?

Section 26(3) makes it clear that a treatment-provider may safely withdraw or withhold treatment as long as he reasonably believes that an advance decision exists which is valid and applicable (Box 8)

Box 8: Reasonable belief

The Code of practice section 9.59 states that health care professionals must be able:to demonstrate that their belief was reasonable point to reasonable grounds showing why they believe this

Section 9.49 states that if someone alerts a healthcare professional to the possibility that an advance decision exists reasonable efforts might include discussions with relatives of the patient, looking in the patient’s clinical notes and contacting the patient’s GP

Change: Sections 26 (2) and (3) clarify the rules about legal liability. Previously it was assumed that under common law a defence of ‘reasonable mistake’ would have protected healthcare professionals from liability.

Step 7: Make a final decisions

At this final stage there are two options: either to:

a) Follow the advance decision- by withdrawing/ withholding treatment specified, or

b) Reject the advance decision and provide treatment (that must be in the person’s best interests).

Assessing Capacity

pdf version

Step 1:Establish person’s age

Most of the Act applies to adults of 16 years and above who lack capacity. However, because the Act does not repeal the existing law of consent in relation to children and young people, there is an overlap between the common law, the Children Act 1989 and the Act in relation to young people aged 16 and 17. If health professionals provide care and treatment under the Act to a 16 or 17 year old they will not incur legal liability providing the young person lacks capacity to consent under the Act, the actions are in the young person’s best interests and all the Act’s principles are followed.

Step 2: Assume person has capacity

Section 1(2) states: A person must be assumed to have capacity unless it is established that he lacks capacity.

This is the first principle (of 5 statutory principles) set out in section 1 of the Act. These five principles reflect the fundamental values that underpin the Act’s legal requirements, namely to protect people who lack capacity and help them to take part, as much as possible, in decisions that affect them. To remove any doubt that this is the case the Code (2.2) makes it clear that all the five principles apply to every act done or decision made under the Act. 

The presumption of capacity is a well established common law principle. Its prominence in the section 1 list of five is a strong reminder that the starting point for all decision-making under the Act must be the assumption that people have the right and the ability to make their own decisions. It also acts as a reminder that just because someone has lacked capacity to make a previous decision that does not necessarily mean that they cannot make the decision in question.

The Act bolsters the presumption of capacity by adding two related principles. These are:

Step 3: Do everything possible to support the person make their own decision

Section 1(3) states:

A person is not to be treated as unable to make a decision unless all practicable steps to help him to do so have been taken without success.

The Act does not define the words ‘practicable steps’. As this is a new principle, i.e. not one which was established by the courts prior to the Act, the Code gives very detailed guidance on the various ways patients can be helped to make their own decisions (Box 1).

Box 1: ‘Practicable steps’

Code chap 3.1- 16

Examples of how people can be helped to make their own decisions include:

provide relevant information, e.g. explain purpose and effect of treatment, describe risks and benefits, explain effects of decision and possible choices

communicate in an appropriate way, adopt the easiest form of communication such as simple language or use pictures or objects,  speak at the right volume and speed, break down difficult information, be aware of cultural, ethnic or religious factors, use professional language interpreter or an advocate.

make the person feel at ease, get the location and the timing right, e.g. quiet, private room when the person is at their most alert.

support the person, consider whether someone such a person the patient trusts can give support.

treat a medical condition which may affect the patient’s capacity

involve family/friends if they can provide practicable help (as well as an IMCA (if appropriate))

NB In emergency medical situations it may not be practicable to take any of the above steps although healthcare staff should still try to communicate with the patient and keep them informed.

Change: Statutory principle 2 is new (i.e. it had not been established by the courts in common law before the Act).

 

Step 4: Be aware that a person has the right to make an ‘unwise’ decision

Section 1(4) states: A person is not to be treated as unable to make a decision merely he makes an unwise decision 

The third fundamental statutory principle bolstering the presumption of capacity is another well-established common law principle. It is included to remind those assessing capacity that even though a person’s decision may seem unreasonable, irrational, unusual or eccentric, it may nevertheless make sense in the context of the person’s religious and personal beliefs and values. Accordingly the person should not necessarily be assumed to be incompetent.

But an ‘unwise’ decision may be evidence of incompetence –it may, for example, reveal that a patient is incapable of understanding the consequences of their decision. This is explained in the Code, Box 2.

Box 2: Unwise’ decisions

Code 2.1   

Explains ‘unwise’ decisions:

Whilst everybody has their own values, beliefs, preferences and attitudes there may be cause for concern if somebody:

  • repeatedly makes unwise decisions that put them at significant risk or harm or exploitation or
  • makes a particular unwise decision that is obviously irrational or out of character.

NB These things do not necessarily mean that someone lacks capacity but they may prompt a need for further investigation, taking into account previous decisions and choices.

Step 5: Apply the principle of equal consideration

Section. 2(3) states: ‘a lack of capacity cannot be established merely be reference to:


a) a persons’ age or appearance, or
b) a condition of his, or an aspect of his behaviour, which might lead others to make unjustified assumptions about his capacity

This new principle is not one of the 5 ‘statutory principles underpinning the whole Act). However it bolsters them by ensuring that people are not treated less favourably than anyone else because of the preconceptions and prejudicial judgments that may be made about their abilities. The device used by the Act to avoid such discrimination is to expressly prohibit unjustified assumptions being made about a patient’s abilities based either of their age, appearance or condition, behaviour , Box 3. 

Box 3: Appearance, condition and behaviour

  • ‘appearance’ means all aspects of the way people look,
  • i.e. physical characteristics as well as skin colour etc.
  •  
  • condition’ is similarly wide ranging, i.e. it includes physical disabilities, learning disabilities, illness related to age and temporary conditions such as drunkenness.
  • ‘behaviour’ may include extrovert or withdrawn behaviour.


Change: The principle of equal consideration is new. Although not one of the five statutory principles underpinning the whole Act,  it is nevertheless very significant in furthering the Act’s purpose, namely to ensure that those with capacity problems are given as much support as possible to help them make their own decisions.

Step 6: Assess capacity

This step in the assessment process will be reached if the person’s ability to make the decision seems questionable. Assessing capacity at this point involves applying the two stage test (see below). This means deciding whether a patient has the ability to make a specific decision at the time it needs to be made, i.e. about surgery - rather than whether they have the capacity to make decisions in general. The legal test for capacity is therefore functional and decision-specific. This means that no-one can be labelled incapable just because they have a certain medical condition or diagnosis.


The Act adopts a two-stage legal test of capacity which essentially involves asked two questions, namely:

1. Does the person have an impairment of, or disturbance of the mind or brain and, if so,

2. Does the impairment or disturbance mean they are unable to make a particular decision?

Stage 1: The impairment/disturbance

The impairment/disturbance can be partial, temporary or change over time but it must exist- if it does not then the person will not lack capacity under the Act. Examples of conditions that may affect a person’s ability to make decisions are given in the Code. They include conditions associated with mental illness, dementia, long-term effects of brain damage and so on. 


Stage 2: The inability to make a particular decision

Stage 2 involves establishing whether the person is unable to make a decision for himself. The Act briefly sets out a definition of when a person is deemed unable to make a decision (but is supplemented by the Code (see Box 4)).

According to section s.3: a person is unable to make a decision if he is unable

a) to understand the information relevant to the decision

Box 4: ‘Relevant information’

‘Relevant information’ is defined in s 3(4) as information about the reasonably foreseeable consequences of a) deciding one way or another, or b) failing to make the decision.

The Code (4.16) adds that relevant information also includes:

  • the nature of the decision
  • the reason why the decision is needed

NB. Remember

  • to provide information in an appropriate way (using simple language, visual aids etc ( s 3(2))
  • to consider whether a broad explanation is sufficient or because of the nature of the decision more detailed information should be given
  • that if the decision has serious consequences it is even more important that the person understands the information


b) to retain that information

A person retains information if he holds it in his mind long enough to use it to make an effective decision. Note that the Act states just because a person can only retain information for short period this alone should not prevent him from being regarded as able to make the decision (s 3(3)). The Code (4.20) also stresses how aids to retention should be used, such as notebooks, videos and voice recorders.

c) to use or weigh up that information as part of the process of making the decision

As the Code (4.21) explains, sometimes people can understand information but the impairment or disturbance stops them using it. In other cases, although a person may make a specific decision, the impairment or disturbance means they have made it without understanding or using the information they have been given.

d) to communicate his decision (whether by talking, using sign language or any other means).

The Code suggests that few people will be in this position. Nevertheless even in such cases, those assessing capacity must comply with statutory principle 2 and ensure that all practicable and appropriate efforts must be made to help them communicate ( Box 1 above).

NB. To ‘pass’ the capacity test all for elements (i.e. a) – d) need to be satisfied. 

Factors that may need to be considered in applying the 2 stage test are:

  • general intellectual ability
  • memory
  • attention and concentration
  • reasoning
  • information processing – how a person interprets what they are told
  • verbal comprehension and all forms of communication
  • cultural influences
  • social context
  • ability to communicate

Nobody can be forced to undergo an assessment of capacity. Threats or attempts to force the person to agree to an assessment are not acceptable (Code 4.57).   

Change: The Act broadly adopts the common law test for capacity established in Re C [1994]. Although it makes no specific reference to the need for the person to believe the information it can be assumed that belief is now to be viewed as part of understanding. The statutory version of Re C also differs from the common law test as it adds a requirement that information relevant to the decision be given in a way that is relevant to the person’s circumstances (using simple language, visual aids or any other means, s.3(4). 

Step 7: Prove lack of capacity

The burden of proving a person lacks capacity is on the person making the claim. In healthcare contexts this will usually be the health professional (e.g. doctor or nurse) who is proposing to provide the care or treatment. The legal test of proof in this context is the balance of probabilities, i.e. being able to show that it is more likely than not that a patient lacks capacity to make the decision in question.

Step 8: Demonstrate ‘reasonable belief’ of lack of capacity (to gain legal protection)

Section 5 legitimates acts in connection with care and treatment that would otherwise constitute battery or assault. Section 5 essentially confers legal authority on anyone caring or treating a patient without their consent. This means there is no need to obtain any formal legal powers or authority to act. But to gain protection from liability ‘reasonable steps’ must be taken to establish whether the person lacks capacity. In addition when doing the act the person carrying it out (e.g. doctor) must ‘reasonably believe’ that the person lacks capacity (s. 5(1)(a)and (b)).

The Act gives no guidance on what constitutes ‘reasonable’ in this context but it is supplemented by the Code ( see Box 6).

Box 6: ‘Reasonable belief and reasonable steps’

Code 2.44- 54

To have ‘reasonable belief’ carers must have taken ‘reasonable steps’ to establish that the person lacks capacity. What these reasonable steps are will depend on individual circumstances and the urgency of the decision

Formal processes do not necessarily need to be taken but if an assessment of capacity is challenged

a) steps taken is the assessment process must be described and

b) objective reasons for believing the person lacks capacity must be given.

Professionals, who are qualified in their particular field are normally expected to undertake a fuller assessment of capacity, reflecting their higher degree of knowledge and experience than family members or other carers who have no qualifications

Other practical steps include:

making sure the person understands the nature and effect of the specific decision to be made

applying all the statutory principles

ensuring that all relevant documents and background information has been accessed

ensuring that the two stage test has been applied

ensuring consultation with family members and close friends to provide background information

explaining again to the person all the relevant information

checking the person’s understanding after a few minutes

avoiding questions that need only a ‘yes’ or ‘no’ answer

repeating any steps that can help confirm assessment or a review of it.

Code 4.45 sets out other steps that may be helpful in confirming reasonable belief of incapacity (much of which repeats steps that need to be taken to establish incapacity in the first place).


Change: Section 5 provides unambiguous statutory protection to those caring for and treating patients who lack capacity under the Act (providing the reasonable steps criteria are followed). In so doing there is now no doubt that they are in the same legal position as carers and health professionals treating patients from whom valid consent has been obtained. Furthermore s.5 resolves any doubt (in the absence of clear common law authority covering the situation) that health professionals treating a patient without consent -  in the mistaken belief that they lack capacity- will not be liable ( assuming, of course, that the mistaken belief is ‘reasonable’).

Step 9: Record the assessment process

The following should be recorded by health professionals in the person’s case notes or file:

  • the steps taken is assessing capacity
  • the assessment of incapacity
  • objective reasons to explain why there is a ‘reasonable belief –that a person lacks capacity

NB: The record should be reviewed regularly.

 

Overview of the Act

pdf version

This is one of a series of resource materials for clinical ethics committees providing explanation and discussion of the sections of the Mental Capacity Act which are particularly relevant to their work. This overview highlights the areas of the Act relevant to clinical ethics committees. Each area is covered in more depth in a separate web page or pdf document.

Introduction

The Mental Capacity Act 2005, which came fully into force in October 2007, provides the legal framework for acting and making decisions on behalf of individuals who lack the capacity to make specific decisions for themselves in relation to personal welfare, healthcare and financial matters.  It applies to persons age 16 and over.  The Act draws on common law principles that have been established through judicial decisions in individual legal cases and clarifies and develops these principles in addition to introducing several new roles, bodies and powers to support the Act’s provisions (see chapter one of the code of practice for further explanation of the Act).

The Mental Capacity Act (MCA) applies to England and Wales. The relevant legislation in Scotland dealing with making decisions for people who lack capacity is the Adults with Incapacity (Scotland) Act 2000

Principles of the Act

The Act sets out five principles which guide the legislation. These are:


‘A person must be assumed to have capacity unless it is established that he lacks capacity.

(3) A person is not to be treated as unable to make a decision unless all practicable steps to help him to do so have been taken without success.

(4) A person is not to be treated as unable to make a decision merely because he makes an unwise decision.

(5) An act done, or decision made, under this Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests.

(6) Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action.’

The main regulatory framework is set out in Part 1 of the Act. Part 2 deals with the establishment of a new court to deal with matters arising from the Act (the Court of Protection), and a new office of the Public Guardian.  Part 3 deals with a range of miscellaneous issues relating to the Act.

Key sections of the Act

Determining capacity

Sections 2 and 3 of the Act set out the legal requirement for assessing capacity.  This builds on the common law test for capacity as set out in Re C (1990).

The best interests principle

Section 4 sets expands on the principle that any act or decision on behalf of a person who lacks capacity should be made in that person’s best interests.  This again follows common law principles but the Act is much more specific about the process that must be followed to determine what is in the person’s best interests (the best interests checklist).

Restraining a person who lacks capacity

Section 5 sets out the additional conditions that must be fulfilled if a person who lacks capacity is to be restrained.  These relate to the degree of harm that is likely to be suffered by the person if he is not restrained.

Lasting powers of attorney

Section 9 creates a new power, Lasting Power of Attorney, by which a person who has capacity can confer authority on another person (the donee) to make decisions about her personal welfare, property or affairs at a future date when she no longer has capacity to make decisions for herself.  This is a new power in England and Wales and was not legally possible under common law.

Advance decisions to refuse treatment

Sections 24-26 set out the legal framework within which a person with capacity can make an advance decision to refuse treatment (including life sustaining treatment) that is applicable when that person no longer has capacity to make such a decision for himself.  This clarifies and sets in statute the legal position on advance refusals of treatment.

Research

Sections 30 to 34 of the Act set out the legal framework within which researchers must act if they are conducting research that involves persons who lack capacity to consent to the research being conducted. 

Independent Mental Capacity Advocates

Sections 35 to 41 of the Act introduce and set out the role of Independent Mental Capacity Advocate (IMCA). This is a new service created under the Act and is explained in more detail in section 10 of the Code of Practice to the Act.  Its aim is to provide independent safeguards for people who lack capacity when important decisions need to be made and there is no-one other than paid carers to represent the person who lacks capacity or to be consulted on their behalf.

Court of Protection

Part 2 of the Act creates a new superior court of record to be known as the Court of Protection. This court has the same powers, rights, privileges and authority as the High Court. The powers of the court are set out in Part 1 sections 15-21 of the Act.

In summary the Court has the powers to:

‘decide whether a person has capacity to make a particular decision for themselves

make declarations, decisions or orders on financial or welfare matters affecting people who lack capacity to make such decisions

appoint deputies to make decisions for people lacking capacity to make those decisions

decide whether an LPA or EPA is valid, and

remove deputies or attorneys who fail to carry out their duties.’

Code of Practice section 8

Protection for people providing care or treatment

Section 5 of the Act sets out the conditions under which a person caring for someone who lacks capacity will not incur liability for their actions in caring for that person.  Section 6 sets out further conditions if the person who lacks capacity is to be restrained.  Section 26(2) and (3) specifies when a doctor is protected from liability in the context of advance refusals of treatment.  See the Code of Practice section 6 for further guidance.

The offence of ill treatment or neglect

Section 44 of the Act creates an offence of ill treatment or neglect. If a carer or donee of a lasting power of attorney is found guilty, he or she is liable to imprisonment of up to five years or a fine (or both).

The Code of Practice

The Code of Practice provides explanatory notes on the Act and examples of how the Act will work in practice.  There are no specific sanctions if someone does not comply with the Code, but failure to comply can be used as evidence before a court in civil or criminal proceedings. Therefore everyone caring for a person who lacks capacity is required to be familiar with the Code.

Introduction to the resource

A brief introduction and explanation of how to use this resource

This resource has been developed as part of a project aimed at raising awareness of the Mental Capacity Act 2005.  It provides a range of materials, many of which can be downloaded in pdf format and used by clinical ethics committees as part of their continuing educational programme.  The materials are divided broadly into five sections;

  • An analysis of ethical principles underlying the Act,
  • a step wise guide to assessment of capacity and determination of best interests under the Act,
  • summaries of key areas of the Act and their relevance to health care,
  • an analysis of the relationship between the MCA and the Mental Health Act,

Where appropriate a comparison between the legal requirements under the Act and the previous provisions in Common Law governing decisions for persons who lack capacity to decide for themselves.

Section A: Appendices

Appendix A1 A first hand account of the expreience of ethics support in the United States.

Appendix A2 Clinical ethics committees and ethics consultation in German hospitals

Appendix A3 Issues for a CEC to consider when developing guidelines.

Appendix A4 The Newcastle upon Tyne Hospitals NHS Trust Clinical Ethics Advisory Group (CEAG) living wills.

Appendix A5 List of issues to consider when setting up a case consultation service.

Appendix A6 Protocol for emergency referrals to a clinical ethics committee.

Appendix A7 Report on the findings from the UK Clinical Ethics Network questionnaire, May 2003.

Appendix A8 Role of a clinical ethicist.

Appendix A9 Setting up a mental health trust clinical ethics committee.

Appendix A10 An example of a workshop outline used by one NHS Trust.

Appendix A11 Example terms of reference.

Appendix A12 Issues to consider when appointing lay members.

Appendix A13 An example of a proposal to a trust board for the setting up of a CEC.

Appendix A14 Pro forma referrals form.

Section I: Some useful websites

UK Clinical Ethics Network

www.ukcen.net
This site offers additional information to the manual. The site contains the contact details of clinical ethics committees throughout the UK, categorised into the CECs geographical area and the issues the CEC commonly discuss. There is also information on Committee Functions, with examples of policies that have been formed by CECs and methods of case consultation.

The site also contains information on the most common issues faced by CECs, such as consent and confidentiality, with explanations of the legal position, professional guidelines, hypothetical case studies and suggested reading.

BioethicsWeb

www.bioethicsweb.ac.uk
A searchable catalogue of internet sites covering all areas of biomedical ethics. The recommended sites have been reviewed to ensure their suitability for this useful resource.

British Medical Association

www.bma.org.uk
As well as useful information about the many roles of the BMA, this site has extensive details of the activities of the BMA Ethics Committee, with the full documents of many of the ethical guidelines produced by the Committee.

Bulletin of Medical Ethics

http://www.portlandpress.com/pcs/journals/journal.cfm?product=BME
An independent publication offering views on healthcare ethics issues in the news, both in the UK and abroad.

Cardiff Centre for Ethics, Law and Society

www.ccels.cardiff.ac.uk
This site is based at the Cardiff Law School and is a very useful resource for policy makers, and researchers with educational information, a comprehensive database of international useful links and articles.

Department of Health

www.dh.gov.uk
This section of the website contains the publications by the Department of Health; nearly all the publications are available electronically and are categorised alphabetically into the subject area.

General Medical Council

www.gmc-uk.org
This site contains more general information about the GMC, but it also has a good section on ethical guidance. The full documents of the Guidance on Good Practice are available.

Human Fertilisation and Embryology Authority

www.hfea.gov.uk
The HFEA is the UK statutory body that regulates, licences and collects data on fertility treatment, IVF, donor insemination and human embryo research. The web site contains useful information about the Authority, patient information leaflets, code of practice and details of the HFEA publications.

The Internet Encyclopedia of Philosophy

www.iep.utm.edu
A searchable encyclopedia of philosophical theories and thinkers with a good section on ethical theory. The site covers approaches to ethical thinking including virtue theory, dentology, consequentialism and utilitarianism.

Journal of Medical Ethics

http://jme.bmjjournals.com
The official journal of the Institute of Medical Ethics. The web site contains a lot of useful resources, as well as original articles and case conferences the site also contains a supplement produced in 2001 dedicated to clinical ethics committees at jme.bmjjournals.com. There is also an archive of articles categorised by the main topic at jme.bmjjournals.com making searching for specific subject areas simpler.

Provincial Health Ethics Network

www.phen.ab.ca
The website of the Provincial Health Ethics Network (PHEN) for Alberta, Canada provides education and resources for developing and existing ethics support.

Copyright of Section I is held by The Ethox Centre.

Section H: Reading list

Aulisio MP, Arnold RM, Younger SJ (eds) Ethics consultation: From theory to practice. Baltimore: Johns Hopkins University Press (2003).

Beauchamp T, Childress J. 2001. Principles of Biomedical Ethics. 5th edition Oxford University Press

Blackburn, S. 2001. Ethics: a very short introduction. Oxford University Press

BMA . 2004. Medical Ethics Today. London, BMA Books

Boyd, K.M., Higgs, R., Pinching, A.J., (1997) The New Dictionary of Medical Ethics BMJ Publishing Group, London

Campell A, Gillett G, Jones G. 2001. Medical Ethics. 3rd edition. Oxford University Press

Ehleben C M, Childs B H, Saltzman S L. What is it exactly that you do? A “snapshot” of an ethicist at work. HEC Forum. 1998;10(1):71-4.

Gillon, R., (1986) Philosophical Medical Ethics Chichester, Wiley

Glover, J., (1997) Causing Death and Saving Lives Harmondsworth, Penguin

Hope T (2004) Medical Ethics A Very Short Introduction Oxford University Press

Hope T, Savulescu J, Hendrick J 2003 Medical ethics and the law, the core curriculum.
Churchill Livingston. Chapter 1

Jiwani B. An introduction to health ethics committees. Provisional Health Ethics Network (2001).

Journal of Medical Ethics – Clinical Ethics Committees Supplement 2001, April, Vol 27, Supplement 1.

Komatsu G I, Goodman-Crews P, Cohn F, Young E W. Effect of ethics consultations on non beneficial life-sustaining treatments in the intensive care setting: a randomised controlled trial. Journal of the American Medical Association. 2003;290(9):1166-72.

Larcher V, Lask B, McCarthy J. Paediatrics at the cutting edge: do we need clinical ethics committees? JME1997;23:245 - 249.

Mautner, T., ed. (1997) Penguin Dictionary of Philosophy Penguin Books

McCall Smith A, Tonks A, Smith R. An ethics committee for the BMJ. BMJ 2000; 321: 720

Meslin E, Rayner C, Larcher V, Hope T, Savulescu J. Hospital Ethics Committees in the United Kingdom. HEC Forum 1996; 8(5):301-315

Parker M, Dickenson D. 2001. The Cambridge medical ethics workbook: case studies, commentaries and activities. Cambridge University Press.

Parker M, Hope T. Ways of Thinking About Ethics. Medicine 2000;28:10:2-5

Rachels J. 1995. The elements of moral philosophy. 2nd edition Mc Graw Hill

Singer, P., ed. (1986) Applied Ethics (e.g. vi, J. Harris, The Survival Lottery) Oxford University Press

Singer, P., ed. (1991) A Companion to Ethics (e.g. Essays 10, 14, 20, 21 and 22) Oxford, Blackwell

Slowther A, Bunch C, Woolnough B, Hope T. Clinical Ethics Support in the UK: A review of the current position and likely development. 2001; London; The Nuffield Trust

Slowther A, Hope T. Clinical ethics committees: They can change clinical practice but need evaluation. BMJ 2000;321:649-650

Slowther A, Johnston C, Goodall J and Hope T. Development of clinical ethics committees. BMJ 2004;328:950 - 952

Slowther A, Underwood M. Is there a need for a clinical ethics support service in the UK? JME1998;24:207.

Spicker S (ed) The Healthcare Ethics Committee Experience. Krieger Publishing Company. 1998

The Report of the American Society for Bioethics and Humanities, Core Competencies for Health Care Ethics Consultation, 1998

Thomson A. Critical Reasoning in Ethics: a practical introduction. Routledge. 1999.

Tonks A, McCall Smith A, Smith R. The BMJ’s ethics committee is open for business. BMJ 2001;322:1263 –1264

UK Clinical Ethics Network, Report on the Network Questionnaire, 2003

Warburton, N., (1999) Philosophy, the Basics Routedge. 3rd Edition. Introduction and Chapter 2.

Warburton, N., (1998) Philosophy, the Classics Routledge. Chapters 1, 2, 11, and 14.

Watson AR. An ethics if clinical practice committee: should every hospital have one? Proc Roy Coll Phys Edin 1999;29:335-337

Wilson Ross J, Glaser JW, Rasinski-Gregory JD, McIver Gibson J, Bayley C. Health Care Ethics Committees: the next generation. American Hospital Publishing, Inc. 1993.

Section G: Patient organisations

Alcohol Concern
Waterbridge House
32-36 Loman Street
London
SE1 0EE
Web site: www.alcoholconcern.org.uk

Alcohol Concern is the national agency on alcohol misuse.

Alzheimer’s Society
Gordon House
10 Greencoat Place
London
SW1P 1PH
Tel: 020 7306 0606
Fax: 020 7306 0808
Web site: www.alzheimers.org.uk/index.htm

The Alzheimer’s Society aims to maintain, promote and improve knowledge and understanding of dementia. They provide information and advice to carers and professionals about all forms of dementia, caring, legal and financial issues, social and health services and benefits.

British Heart Foundation
14 Fitzhardinge Street
London
W1H 6DH
Tel: 020 7935 0185
Web site: www.bhf.org.uk/index.asp

The British Heart Foundation provides support and information for people with heart disease, their families and carers. They also promote training and education into heart disease, and fund research into causes, prevention and treatment of heart disease.

British Lung Foundation
73-75 Goswell Road
London
EC1V 7ER
Tel: 020 7688 5555
Fax: 020 7688 5556
Web site: http://www.blf.org.uk/Home

The British Lung Foundation provides support and advice for people with lung disease and their carers.

Carers UK
20-25 Glasshouse Yard
London
EC1A 4JT
Tel: 020 7490 8818
Fax: 020 7490 8824
Web site: www.carersuk.org/

Children’s Heart Foundation
Tel: 020 7820 8517
Fax: 020 7735 8718
Web Site: www.childrensheartfoundation.org/

Free phone Helpline: 0808 808 5000 (9.30 am – 9.30 pm Monday to Friday)

A federation of local and national support groups for families of children with heart disorders in the UK and Ireland.

Depression Alliance
35 Westminster Bridge Road
London
SE1 7JB
Tel: 020 7633 0557
Web site: www.depressionalliance.org

DIPEx
41 Cornmarket Street
Oxford
OX1 3HA
Web site: www.dipex.org

DIPEx is an online database of patient experiences of health and illness, provides reliable information on treatment choices and information on where to find support.

Eating Disorders Association
103 Prince of Wales Road
Norwich
NR1 1DW
Tel: 0845 634 1414
Open 8.30am to 8.30pm Monday to Friday and 1.00pm to 4.30pm Saturdays

The Eating Disorders Association provides information, help and support in the UK on all aspects of eating disorders.

Epilepsy Action
New Anstey House
Gate Way Drive
Yeadon
Leeds
LS19 7XY
Tel: 0113 210 880
Fax: 0113 391 0300
Web site: www.epilepsy.org.uk

Epilepsy Action is a working name of the British Epilepsy Association. They provide comprehensive information on epilepsy and how to control it for people with epilepsy, their friends, family and carers. They also have a Helpline for anyone with queries about epilepsy or the group.

Hospital Information Service for Jehovah’s Witnesses
IBSA House
The Ridgeway
London
NW7 1RN
Tel: 020 8906 2211
E-mail: his@wtbts.org.uk

Jehovah’s Witnesses have developed a Hospital Liaison Committee Network to assist healthcare professionals in the treatment of Jehovah’s Witnesses. They have a 24 hour contact number to provide advice and explain the Jehovah’s Witness stance on certain forms of medical treatments.

Long-Term Medical Conditions Alliance (LMCA)
Unit 212
16 Baldwins Gardens
London
EC1N 7RJ
Tel: 020 7813 3637
Fax: 020 7813 3640
Website: www.erpho.org.uk

LMCA is the umbrella body for national voluntary organisations working to meet the needs of people with long-term health conditions.

The Mental Health Foundation
Foundation for People with Learning Disabilities
UK Office
7th Floor, 83 Victoria Street
London
SW1H 0HW.
Tel: 020 7802 0300
Web Site: http://www.mentalhealth.org.uk/

The Migraine Trust
2nd Floor
55056 Russell Square
London
WC1B 4HP
Tel: 020 7436 1336
Fax: 020 7436 2880
Web site: www.migrainetrust.org

The Migraine Trust is the UK’s leading medical research and patient support charity for the condition. The Trust is committed to supporting sufferers and their families by funding and promoting research, improving diagnosis and treatment, providing information and advice, and raising awareness of migraine as a significant public health problem.

Multiple Sclerosis Resource Centre
7 Peartree Business Centre
Peartree Road
Stanway
Colchester
CO3 5JN
National Helpline: 0800 783 0518 (8.30am – 5.30pm Mondays to Fridays)
Website: http://www.ms-uk.org/

Patients Association
PO Box 935
Harrow
Middlesex
HA1 3YJ
Help Line: 0845 4239111
Tel: 020 8423 9111
Fax: 020 8423 9119
Web site: www.patients-association.com/

The Patients Association offer useful information on healthcare in the UK, offering help and support for patients. The web site contains comments on healthcare issues and items in the news, as well as a Guide to Living Wills, how to access your own medical records and other useful advice.

Patient UK
Web Site: www.patient.co.uk

Patient UK provides free information for patients on health and disease, GP leaflets and a directory of patient support groups.

Voluntary Euthanasia Society
13 Prince of Wales Terrace
London
W8 5PG
Tel: 020 7937 7770
Fax: 020 7376 2648
Web site: www.dignityindying.org.uk

The Voluntary Euthanasia Society, VES, actively campaigns to change the law regarding euthanasia. They are the leading UK supplier of Living Wills and provide comprehensive information about the current law and the legal status of living wills.

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.

Section E: Examples of professional guidelines

British Medical Association (BMA)

The following guidelines have been published by the British Medical Association. All the guidelines are available on their web site, http://www.bma.org.uk free of charge.

The Law and Ethics of Abortion, BMA Views

www.bma.org.uk

March 1997

Revised December 1999

  • Legal considerations
  • Conscientious objections clause
  • Ethical considerations
  • Consent
  • Confidentiality

Access to Health Records by Patients

www.bma.org.uk

Revised December 2002

  • Legal rights of access to health records and information
  • Rights under the Data Protection Act 1998
  • Applications for access
  • Information which cannot be disclosed
  • Access to records of deceased patients
  • BMA advice on record keeping

Access to Medical Report Act (1988)

www.bma.org.uk

December 1988

Revised September 1995

  • Consent
  • Individual’s rights
  • Seeing the report
  • Amendments
  • Delayed access
  • Withholding of information

Medical treatment for adults with Incapacity – guidance on ethical and medico-legal issues in Scotland

www.bma.org.uk

2nd Edition October 2002

  • Adults with Incapacity (Scotland) Act
  • Assessment of capacity
  • Adults with capacity
  • Certificate of incapacity
  • Proxy decision making
  • General authority to treat
  • Mental Health (Scotland) Act
  • Special safeguards

Advance Statements – BMA Views

www.bma.org.uk

November 1992
Revised May 1995

  • What is an advance statement?
  • Legal scope of an advance statement
  • Assistance with drafting
  • Healthcare advocates and proxy decision makers
  • Doctors’ responsibilities

Advance Statements about Medical Treatment – Code of Practice

www.bma.org.uk/ap.nsf/Content/codeofpractice

April 1995

  • Making treatment choices
  • Drafting
  • Implementation

Decisions Relating to Cardiopulmonary Resuscitation

http://www.bma.org.uk="">October 1999

  • http://www.bma.org.uk="">Disclosure without consent in the subject’s vital interests
  • http://www.bma.org.uk="">Other disclosures and their safeguards
  • http://www.bma.org.uk="">Examples of disclosure in the public interest
  • http://www.bma.org.uk="">Confidentiality and People Under 16

    www.bma.org.uk

    January 1994

    • Teenage sexual activity
    • Reasons for concern
    • The legal position
    • Consulting another doctor
    • Confidentiality
    • Immature patients
    • Exceptional circumstances
    • Breach of confidentiality

    End of Life Decisions – Views of the BMA

    www.bma.org.uk

    June 2000

    • Refusal of treatment
    • Euthanasia
    • Physician-assisted suicide
    • Withholding and withdrawing life prolonging medical treatment
    • Advance statements

    Parental Responsibility – Guidance from the Ethics Department

    www.bma.org.uk/ap.nsf/Content/Parental
    February 2004

    • What is parental responsibility?
    • Who possesses parental responsibility?
    • Consent from people with parental responsibility
    • What are the limits to parental responsibility?
    • What happens when people with parental responsibility disagree?
    • Some common questions relating to parental responsibility
    • Parental responsibility and Human Rights
    • Competent children and the limits to parental responsibility

    Treatment Decisions for People in Persistent Vegetative State

    www.bma.org.uk/

    Revised June 1996

    • Defining PVS
    • Misdiagnosis
    • Initial assessment and treatment
    • Diagnosis
    • Review of treatment options
    • Views of the patient
    • Views of people close to the patient
    • Views of healthcare professionals
    • Conscientious objection
    • The legal position
    • Use of tissue
    • Research on PVS
    • Pregnant PVS patients

    General Medical Council (GMC)

    The following guidelines have been published by the General Medical Council. All the guidelines are available on their web site, http://www.gmc-uk.org, free of charge.

    Seeking Patients’ Consent: the Ethical Considerations

    www.gmc-uk.org/standards/consent.htm

    November 1998

    • Consent to investigation and treatment
    • Providing sufficient information
    • Presenting information to patients
    • Ensuring voluntary decision making
    • Establishing capacity to make consent
    • ‘Best Interests’ principle
    • Applying to the court
    • Forms of consent

    Confidentiality: Protecting and Providing Information

    www.gmc-uk.org/standards/confidentiality.htm

    April 2004

    • Patients’ right to confidentiality
    • Sharing information with patients
    • Disclosure of information
    • Frequently asked questions

    Withholding and Withdrawing Life Pro-longing Treatments: Good Practice in Decision-making

    www.gmc-uk.org/standards/whwd.htm
    August 2002

    • Guiding principles
    • Good practice framework
    • Areas for special consideration

    Antenatal Testing for HIV

    www.gmc-uk.org
    November 2002

    Priorities and Choices

    www.gmc-uk.org
    July 2000

    • The duties of care
    • The provision of services
    • The role and responsibility of doctors
    • Quantity or Quality?

    Management in Healthcare – the Role of Doctors

    www.gmc-uk.org
    May 1999

    • Managers’ responsibilities - what takes priority when they conflict?
    • When are doctors held accountable for management decisions
    • Protecting patients from serious harm
    • Dealing with colleagues - the role of managers
    • Public health
    • Occupational health
    • Standards of practice
    • Management practice
    • Honesty in financial matters
    • A short selection of publications for doctors in management

    Department of Health (DH)

    The following guidelines have been published by the Department of Health. All the guidelines are available as pdf documents on their web site, http://www.dh.gov.uk, free of charge.

    Seeking Consent Working with Children

    www.dh.gov.uk
    November 2001

    • Who can give consent?
    • Seeking consent
    • Consent to treatment for mental disorder

    Seeking Consent Working with Older People

    www.dh.gov.uk
    November 2001

    • Seeking consent: people with capacity
    • When adults lack capacity
    • Withdrawing and withholding life-prolonging treatment

    Seeking Consent Working with People with Learning Disabilities

    www.dh.gov.uk
    November 2001

    • Seeking consent: people with capacity
    • When adults lack capacity
    • Withdrawing and withholding life-prolonging treatment

    The Use of Human Organs and Tissue. An Interim Statement.

    www.dh.gov.uk
    April 2003

    • Organs and tissues taken in the future
    • Existing stored organs and tissues
    • Genetics research
    • Disposal of tissue

    The Import and Export of Human Body Parts and Tissue for Non-therapeutic Uses. A Code of Practice.

    www.dh.gov.uk

    Royal Colleges and Societies

    The following guidelines are available on the Royal Colleges and Societies web sites free of charge.

    Royal College of General Practitioners

    Confidentiality – Examining the principle of medical confidentiality

    www.rcgp.org.uk
    November 2000

    • Confidentiality
    • Implied consent
    • Explicit consent

    Royal College of Midwives

    Maternal choice and caesarean section

    www.rcm.org.uk

    Umbilical cord blood collection

    www.rcm.org.uk

    Enforced caesarean sections and consent to treatment

    www.rcm.org.uk

    Royal College of Nurses

    Confidentiality – RCN guidance for occupational health nurses

    www.rcn.org.uk

    Royal College of Obstetrics and Gynaecology

    A consideration of the law and ethics in relation to court-authorised obstetric intervention

    www.rcog.org.uk

    April 1994

    • Good practice
    • United Kingdom law
    • Consent
    • Refusal of consent
    • Possible exception to right to refuse consent
    • Court-authorised caesarean section – United Kingdom
    • The Infant Life Preservation Act (1929)
    • Professional ethics

    Confidentiality and disclosure of health information: RCOG Ethics Committee comments on a BMA document

    www.rcog.org.uk

    October 2000

    Royal College of Ophthalmologists

    Guidance on the retrieval of human eyes used in transplantation and research

    www.rcophth.ac.uk

    1998

    • Consent
    • Donor medical assessment
    • Acknowledgement of eye donation

    Royal College of Paediatrics and Child Health

    The British Paediatric Surveillance Unit (BPSU) and patient confidentiality

    www.rcpch.ac.uk

    2001

    • The BPSU mechanism
    • Maintaining confidentiality in BPSU investigations
    • Ethical consent for BPSU studies

    Responsibilities of doctors in child protection cases with regard to confidentiality

    www.rcpch.ac.uk

    Royal College of Physicians

    Guidelines on the practice of ethics committees in medical research involving human subjects

    www.rcplondon.ac.uk
    Third Edition 1996

    Royal College of Psychiatrists

    Good psychiatric practice

    www.rcpsych.ac.uk
    2002

    • The trusting relationship
    • Consent to treatment
    • Confidentiality

    Good practice guide on confidentiality

    www.rcpsych.ac.uk/
    2001

    • Keeping patients informed
    • Consultant responsibility with respect to other professionals in multi-disciplinary teams
    • Disclosure
    • Situations with dual obligations
    • Provision of reports
    • Requests for case notes
    • Child and adolescent issues
    • Issues arising in relation to people with learning disabilities and people with dementia
    • Security and secondary use of patient information

    Royal College of Surgeons of England

    Code of practice for the surgical management of Jehovah’s Witnesses

    www.rcseng.ac.uk
    2002

    • Ethical considerations
    • Legal and consent issues
    • Preoperative considerations
    • Surgical techniques

    Good surgical practice

    www.rcseng.ac.uk
    2002

    • Good clinical care
    • Maintaining good surgical practice
    • Teaching, training and supervising
    • Relationship with patients

    Nursing and Midwifery Council

    Code of professional conduct

    www.nmc-uk.org

    Guidelines for mental health and learning disabilities nursing

    www.nmc-uk.org

    UKCC position statement on the covert administration of medicines

    http://www.nmc-uk.org

    Copyright for Section E is held by The Ethox Centre.

Section D: Professional guidelines, Law and Ethics

Introduction

The role of an ethics committee or group is to provide support and advice on the ethical issues involved in clinical practice, at the level of both individual cases and organisational policy. Thus the focus of a committee’s discussion must be on the ethical considerations raised rather than on, for example, risk management issues. However, ethics committees, like clinicians and the institutions in which they work, must be aware of the legal and professional frameworks that govern health care practice, and their advice should be situated in the context of legal and professional guidance. In section C we have discussed briefly some moral theories and ethical frameworks that will inform a discussion of ethical issues presenting to an ethics committee. In this section we give a brief description of the legal framework in the UK, with particular reference to health care law, and an introduction to sources of professional guidance relevant to health care. We illustrate how an ethics committee may use ethics, law and professional guidance to inform a discussion by using an example case study that might be brought to an ethics committee.

Relationship between Law and Ethics

“It would not be correct to say that every moral obligation involves a legal duty; but every legal duty is founded on a moral obligation.” 1

For example, the law on informed consent gives effect to ethical principle of respect for autonomy, and the current development of a Mental Capacity Bill in the UK highlights the need to enable patients to make treatment decisions for themselves.

Law and ethics are both normative, that is they are concerned with a minimum standard of behaviour that may be considered acceptable or unacceptable by the relevant society.

Nevertheless there are clear differences. Compliance with legal rules is mandatory and a failure to comply may result in penalties. By comparison ethics could be seen as aspirational – it attempts to articulate a framework for reflection. Whilst this may affect the way that a person acts as a result of such reflection it is by no means necessary that it would or even that it should produce the same action by all people in specific cases.

Law is more specific in its terminology and application. Legislation, i.e., an Act of Parliament, and case law will state what should happen if a certain set of circumstances are fulfilled. Although law does not always offer clear answers there is a set framework for discussion.

For example the legal framework for human reproductive technology is set out in the Human Fertilisation and Embryology Act 1990 and the nuances of its application have been considered by the courts. Court cases have shown how the law is to be applied, although there have been many difficult areas of interpretation, e.g. the meaning of ‘embryo’ etc.

The moral and ethical considerations are much more difficult to pin down. Not only do individuals possess different moral perspectives, but also ethical considerations may conflict. In the debate over ‘saviour siblings’, for example, the issues of parental choice and autonomy may conflict with the benefits to society overall; acting beneficently towards the future children created and issues of justice.

Ethics committees are not a substitute for consideration of legal issues. If there is concern about the legal position in a clinical case, or if there is serious conflict between clinicians and patients or their relatives, a legal opinion should be sought and, if appropriate, a referral made to court. The court may take into account the view of a clinical ethics committee (CEC), but it is not constrained by it. Nevertheless an ethical dimension is increasingly assuming greater prominence in the deliberations of the court. In the Nationwide Organ Group Litigation 2 case the court was supplied with a consideration of the ethical issues arising from the retention of organs from dead children without the parents’ consent.

The Legal Framework in the UK

There are two strands to UK law, statute and case law, both of which have a bearing on health care. Within the UK, Scotland and Northern Ireland have their own legal system so it is important to be clear about which law applies in particular circumstances. While there are often similarities between the different jurisdictions, there may also be significant differences. For example, in Scotland it is possible for a person to appoint a welfare attorney to make decisions about medical treatment for that person in the event that he / she becomes incompetent (Adults with Incapacity (Scotland) Act 2000) but this, as yet, is not possible in England.

Statute

Statutes or Acts of Parliament can only be overturned by a further Act of Parliament. The Courts may interpret statute in particular cases, but they cannot overrule it. Major Parliamentary legislation usually follows widespread consultation and includes several stages, culminating in a Bill that is put before Parliament. There are several statutes that have relevance for health care and we list a range in Appendix D1. The Human Rights Act 1998 is likely to have an increasing impact on health care in the UK.

Case law (common law)

Case law is a body of law built up by judicial consideration of cases over many years. It is also known as common law. A court must follow any previous ruling of the court on the same matter – this is known as the doctrine of precedent. However, a court hearing a matter may consider that the issues are sufficiently different from a previously decided case not to bind it and in that respect it can make ’new’ law. Higher courts are not bound by decisions of lower courts, so for example the House of Lords, the highest national court, is not bound by decisions of the Court of Appeal.

A number of high profile medical cases have been heard in recent years, for example, assisting suicide 3 , refusal of medical treatment by a competent patient 4 , use of frozen embryos created by IVF 5.

Many of the medical cases that come before a Court involve treatment of a patient who lacks capacity to make a decision regarding his / her own treatment. In England currently no one (including the Court) can consent to treatment on behalf of an incompetent adult. Thus, when there is disagreement over treatment of an incompetent adult the Court is asked to make a declaration that the proposed treatment, or treatment withdrawal, is in the patient’s best interests. In the case of children the Court may, in some circumstances, give, or withhold, consent to treatment for a child.

A declaration of the Court must be sought about the best interests of the patient in some areas of medical practice e.g. removal of artificial nutrition / hydration from patients in permanent vegetative state, non therapeutic sterilisation of mentally handicapped adult patients, neonatal circumcision for religious reasons where parents disagree.

A list of some of the key cases in English law relevant to health care can be found in Appendix D2

Guidance for Health Professionals in the UK

A range of organisations, including professional organisations, regulatory bodies and government departments, provide guidance for health professionals on ethical issues relating to clinical practice. Below we describe the type of guidance provided by some of these organisations. A detailed list of guidance can be found in Section E.

General Medical Council (GMC)

The General Medical Council is a statutory body. Its purpose is to protect the public by maintaining a register of doctors who are competent and fit to practise medicine. There are about 200,000 doctors on the medical register. The GMC handles complaints about doctors’ performance.

The general responsibilities and ethical standards of a doctor are summarised in 14 key principles, called the duties of a doctor.

The General Medical Council has built upon these principles by issuing guidance on the general aspects of good medical practice and specific areas, including guidance on confidentiality, consent and withholding and withdrawing life-prolonging treatment 6.

“This guidance describes the principles of good medical practice and standards of competence, care and conduct expected of doctors in all aspects of their professional work. Serious or persistent failures to meet these standards may put a doctor’s registration at risk” 7.

Although guidance produced by the GMC creates no statutory legal obligation, it does carry weight in law and the Courts have recognised the importance of such guidance. In the case of W v Egdell 8 the Court of Appeal referred to and applied the (then) current GMC guidelines on confidentiality. However, the Courts may also question GMC guidance.

British Medical Association (BMA)

The British Medical Association is a professional association of doctors, representing their interests and providing services for its 128,000 members. Almost 80% of UK practising doctors are members.

The BMA has a medical ethics department that answers individual ethical enquiries from doctors, and produces guidelines and books on ethical issues. It also provides the secretariat to the Medical Ethics Committee (MEC) of the BMA. The MEC comprises 18 members, including doctors, philosophers, lawyers, theologians and lay people, thus providing expertise from diverse fields. The MEC debates ‘issues of principle in medical ethics, medical law, and ethical matters concerning the relationship between the medical profession, the public and the state’ 9.

The BMA produces a number of publications on a wide variety of topics, such as consent and refusal of treatment and patient access to health records. These publications highlight the ethical issues but do not have force of law but, as with GMC guidance, may be taken into account by the Court in specific cases.

Nursing and Midwifery Council

‘The Nursing and Midwifery Council is an organisation set up by Parliament to protect the public by ensuring that nurses and midwives provide high standards of care to their patients and clients.’
www.nmc-uk.org/

It sets standards for education and practice, provides advice for nurses and midwives and considers allegations of misconduct. It has published a range of documents on standards and guidance for nurses on issues including a Code of Professional Conduct: Standards for conduct, performance and ethics.

Royal Colleges

Many of the Royal Colleges and Healthcare Professional Organisations provide guidance to their members on ethical issue relating to practice. Some Royal Colleges have an ethics committee that considers ethical policy and guidelines on specific issues. In general, these organisations do not provide advice on individual cases.

Department of Health (DH)

www.dh.gov.uk/

The Department of Health is responsible for setting health and social care policy, and providing guidance on healthcare issues in England.

Relevant documents can be accessed from the Department web site.

Links to DH guidance on specific issues such as consent can be found on the Network website http://www.ukcen.net/

Appendix D3 provides information about the National Institute of Clinical Excellence

Ethics, law, and professional guidance in case consultation

Below we use a case scenario to illustrate how a CEC will use ethical principles, professional guidance, and knowledge of relevant law in providing support and advice to health professionals.

Consent to Medical Treatment, Confidentiality and Teenage Patients

Dr Jennings, a consultant gynaecologist at an NHS trust, approaches the chair of the trust’s clinical ethics committee requesting the advice of the ethics committee on the following case. She has just seen a 15 year old girl (pseudonym Mary) in her gynaecology out patient clinic who has been referred by her GP for termination of pregnancy. Mary is 9 weeks pregnant. She has had the same boyfriend for the past 12 months and he is believed to be the father of the baby. Mary was extremely upset when seen in clinic. She had been using the oral contraceptive pill on a regular basis and was shocked that she had become pregnant. She said that she did not really agree with abortion but that after talking it through with her boyfriend she had decided that she would not be able to go through with the pregnancy and bring up a baby. A factor in her decision was the likely reaction of her mother to the news that she was pregnant, and she stated clearly that she did not want her mother to know anything about the pregnancy or the abortion. Mary’s father had left home when Mary was two and she had no contact with him. She had no brothers or sisters, and no other close relatives. Dr Jennings is unhappy about performing a termination without informing Mary’s mother. She thinks it is important for Mary’s mother to know in case there are problems after Mary is discharged, and she is concerned that Mary will have no emotional support in her distressed state. She has contacted Mary’s GP who said that he would not be prepared to breach Mary’s confidentiality by telling her mother.

Ethical Issues

Respecting autonomy

A key principle of medical ethics is that of respecting a person’s decisions about his/ her own health care. A person who understands all the relevant information about his/her medical problem, possible treatments and consequences of not having treatment, should be able to make a decision about what treatment to have, if any. This principle would also confer a duty on a doctor to respect a patient’s confidentiality and not divulge information about her to another person without her consent. The important consideration here is whether a patient is competent to make a decision about the particular treatment or particular breach of confidence. Thus, if Mary understands the nature of the treatment required, and the potential consequences of not telling her mother, and is clear that she does not want her mother to be told, the principle of respect for autonomy dictates that her confidentiality must be respected.

Consequences of the decision

While the principle of respect for autonomy is crucially important, there may be other ethical considerations that argue against respecting an individual’s autonomous decision in a particular case. It is possible that complying with a patient’s request for confidentiality might have harmful consequences for the patient him/her self (best interests and non maleficence conflicting with respect for autonomy), or for others. A careful assessment of the likely consequences of breaching Mary’s confidentiality, and the consequences of not breaching it, will need to be made but the risk of harm as a result of not breaching her confidentiality would need to be significant to justify overriding her autonomy by telling her mother.

Beneficence

Consideration of beneficence, or acting in Mary’s best interests, has a wider implication than simply assessing consequences of different courses of action. If Mary’s autonomous request for confidentiality is respected, the principle of beneficence would still require that the health professionals involved in her care did all that they could to ensure a good outcome to the process for Mary. For example, they could try and identify someone in whom Mary would confide and who could offer support to her, if not a relative or friend then professional support such as a youth worker.

Legal Issues

In English law a patient is a minor until 18 years of age. In Scotland the age limit is 16.

The Family Law Reform Act 1969 in England and Wales provides a person who is 16 or 17 years old with a statutory right to consent to medical treatment. Section 8, provides that:

Consent of a minor who is 16 years and over to any surgical medical or dental treatment is as effective as if an adult.

If a minor aged 16 or 17 has given effective consent then there is no necessity to obtain consent from a parent. (Consent to certain procedures, such as organ donation and non- therapeutic research, is not covered by this provision).

A person who is below 16 years old may consent to medical treatment provided that they have ‘sufficient intelligence and understanding to appreciate the information and advice about treatment and what it involves’. This is a statement of common (case) law. The issue was considered in detail by the case of Gillick v West Norfolk and Wisbech AHA 10. This case dealt with the issue of a teenage girl consenting to receive contraceptive advice independently of the consent and knowledge of her parents.

While the issue in Gillick judgement was whether a child under the age of 16 years could consent to treatment, the case also raises the question; in what circumstances may the duty of confidentiality owed to a teenage patient be breached? As the law recognises a duty of confidentiality to adults by health care professionals 11, it seems to follow that this duty would also apply to children who were competent to consent to treatment without requiring parental consent.

This issue has recently been considered by the Department of Health in the context of teenage girls seeking termination of pregnancy without parental knowledge 12.

Professional Guidelines

GMC

Confidentiality: Protecting and providing information

April 2004
www.gmc-uk.org/
The GMC has issued extensive guidelines on confidentiality, laying out the general principle that confidentiality should only be breached if there is a risk of serious harm as a consequence of maintaining confidentiality.

Disclosures to protect the patient or others

Paragraph 27
“Disclosure of personal information without consent may be justified in the public interest where failure to do so may expose the patient or others to risk of death or serious harm”.

This principle holds true whether the patient is an adult or a competent minor, as set out in the joint guidance on confidentiality and people under 18 published in 1994.

Guidance issued jointly by the BMA, GMSC, HEA, Brook Advisory Centres, FPA and RCGP January 1994

www.bma.org.uk

Confidentiality & people under 16

Exceptional Circumstances

“Although respect for confidentiality is an essential element of doctor-patient relationships, no patient, adult or minor, has an absolute right to complete confidentiality in all circumstances. Confidentiality must be balanced against society’s interests in protecting vulnerable people from serious harm. Thus, in rare cases for example, a breach of confidentiality may be justified if the patient’s silence puts others at risk and the doctor cannot persuade the patient to make a voluntary disclosure.”

Department of Health guidance

www.dh.gov.uk

In 2004, the Department of Health published revised guidance for health professionals on the provision of contraceptive services for under 16s entitled Publication of revised guidance for health professionals on the provision of contraceptive services for under 16s.

“The new guidance highlights for the first time that where a request for contraception is made by a person under the age of 16, doctors and other health professionals should establish a rapport with the young person and give the young person the time and support to make an informed choice.

They should do this by discussing:

  • The emotional and physical implications of sexual activity, including the risks of pregnancy and sexually transmitted infections;
  • Whether the relationship is mutually agreed or whether there may be coercion or abuse;
  • The benefits of informing their GP and encouraging discussion with a parent of carer. Any refusal should be respected. In the case of abortion, where the young woman is competent to consent but cannot be persuaded to involve a parent, every effort should be made to help them find another adult to provide support, for example another family member or specialist youth worker.
  • Any additional counselling or support needs.

The Ethics Case Consultation Process

When a clinical ethics committee considers a case referral such as that brought by Dr Jennings in the case described on page D6, its discussion will be informed by consideration of the ethical principles involved in the case, the legal framework and professional guidance on the issue. Working within the structure of general legal and professional guidance, the ethical issues in this particular case will need to be considered carefully before appropriate advice and support can be offered to Dr Jennings. As we have illustrated, it is important for a clinical ethics committee to have knowledge of the relevant law and professional guidance, if it exists, when considering an issue, to guide the ethical discussion but not to pre-empt it.

Reading

Tonks A, McCall Smith A, Smith R. The BMJ’s ethics committee is open for business. BMJ 2001;322:1263 –1264

Mc Call Smith A, Tonks A, Smith R. An ethics committee for the BMJ. BMJ 2000; 321: 720

Hope, T, Savulescu J, Hendrick J. 2003 Medical ethics and law, the core curriculum. Chapter 4 – An introduction to law. Churchill Livingstone

Copyright of Section D is held by The Ethox Centre

Return to top

References

1. Lord Chief Justice Coleridge R v Instan [1893] 1 QB at 4532. A B and Others v Leeds Teaching Hospital NHS Trust, Cardiff and Vale NHS Trust [2004] EWHC 644, (2004) 77 B.M.L.R. 145

2. A B and Others v Leeds Teaching Hospital NHS Trust, Cardiff and Vale NHS Trust [2004] EWHC 644, (2004) 77 B.M.L.R. 145

3. R (on the application of Pretty) v DPP, [2001] UKHL 61, [2002] 1 A.C. 800

4. Re B (Consent to Treatment: Capacity), [2002] EWHC 429, [2002] 2 All E.R. 449

5. Evans v Amicus Healthcare Ltd & Ors [2004] EWCA (Civ) 727

6. The lawfulness of this Guidance has been considered by the court in R (on the application of Burke) v GMC [2004] EWHC 1879 (Admin). In October 2004 the GMC stated it would appeal this decision.

7. GMC, Ethical Guidance http://www.gmc-uk.org/standards/default.htm

8. W v Edgell [1990] Ch. 359, [1990] 2 W.L.R. 471

9. http://www.bma.org.uk/ap.nsf/content/hubmedicalethicscommittee

10. Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402 (HL).

11. W v Edgell [1990] Ch.359, [1990] 2 W.L.R. 471

12. Publication of revised guidance for health professionals on the provision of contraceptive services for under 16s.
http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4086804&chk=gId6AB

 

Section C: Ethical frameworks

Introduction

If a clinical ethics committee (CEC) is to provide support on ethical issues relating to clinical practice, and to facilitate discussion of the ethical dimension of clinical problems, members of a CEC will require an understanding of the moral theories and ethical frameworks that have informed the development of medical ethics. Although not all CEC members are expected to be experts in ethics (indeed one advantage of an ethics committee is that its members bring a variety of different expertise and experience to bear on a particular issue), they will need to justify their claim to be providing ethics support and advice over and above that which could be obtained from any other committee or informal group. In this section we provide a brief introduction to some of the key moral theories and ethical frameworks that have had an important influence on health care practice, particularly in Western medicine. The section concludes with one example of a practical framework for approaching an ethical dilemma.

Definitions

Moral philosophy

‘Moral philosophy is the attempt to achieve a systematic understanding of the nature of morality and what it requires of us - in Socrates’ words, of “how we ought to live,” and why’.

Morality

Morality is usually construed as meaning what is right and wrong.

‘The term morality refers to social conventions about right and wrong human conduct that are so widely shared that they form a stable (although usually incomplete) communal consensus, whereas ethics is a general term referring to both morality and ethical theory’

Nevertheless, the words ‘ethics’ and ‘morality’ are often used interchangeably.

Ethics

‘Ethics is a generic term for various ways of understanding and examining the moral life’

‘Ethics requires us to go beyond ‘I’ and ‘you’ to the universal law, the universalisable judgment, the standpoint of the impartial spectator or ideal observer, or whatever we choose to call it’

Normative and Descriptive Ethics

Normative ethics is a systematic theory that tells us how one ought to live. An approach to ethics that is normative is one that presents standards of right or good action. An example would be deontological theory - ‘do not kill, ‘do not lie’.

Descriptive ethics reports on how people act, or what they believe, and is not committed to any particular normative ethical system.

Medical ethics / Healthcare ethics

These terms could simply be used to refer to ethical thinking in the healthcare setting.

Codes of Professional Ethics

Formal codes of medical, nursing and research ethics have been created, reflecting the application of ethical thinking to the issues arising in the relevant healthcare environment. Examples include the GMC ‘Withholding and withdrawing medical treatment’. Ethical behaviour in this context may be understood as behaviour conforming to the relevant professional code of ethics.

Ethical Theory

We may feel instinctively that a certain conclusion to a problem is ‘fair’ or ‘unfair’, but what criteria do we use to make such judgments? There are different ethical theories that can be applied to a problem to elucidate our thinking, but even so the results may not fit with our moral intuition.

There are several types of normative ethical theory including consequentialism, deontology - such as Kantianism - and virtue ethics. They can be applied in several procedures of ethical analysis, such as in analysis of cases (casuistry) and in different settings such as in a range of ‘communitarian ethics’: for example, a feminist approach or a social class based approach.

Moral or ethical theory may consider the application of rules or the consequences of actions.

Deontological theory - what one MUST do, based on duties and obligations

Teleological theory - the purpose or consequences of the moral acts

Consequentialist Theory

This is one sub class of teleological moral theory. According to consequentialist accounts of morality the moral value of an act, rule or policy is to be found in its consequences, not in intentions or motives. Utilitarianism is the most influential consequentialist theory. Jeremy Bentham in the late 18th century and John Stuart Mill in the 19th century formulated this way of thinking. Such ‘hedonistic’ utilitarians argue that the principle to judge our moral thinking is utility, that is, the maximisation of happiness, in the sense of pleasure and the minimisation of suffering, in the sense of pain. In any situation the morally right thing to do is the action that promotes the greatest happiness for the greatest number of people.

However pain and pleasure are not the only criteria that later utilitarians have used to evaluate the consequences of actions, rules or policies. Welfare-utilitarians consider the contribution to, or lessening of, human welfare. Preference-utilitarians seek to establish and satisfy human preferences.

Some key issues:

Calculate net benefit

The net benefit or dis-benefit is found by balancing the happiness and unhappiness resulting from an act or policy. If one then seeks the greatest happiness of the greatest number that may be taken to justify overriding individual unhappiness in the interests of the happiness of the greatest number

Difficulty in calculating consequences

This theory requires that the consequences of acts or policies must be calculated. However in many situations one cannot predict consequences with any certainty and therefore consequentialism is probabilistic, one forecasts the consequences to the best of one’s ability. Ethics committees using consequentialist criteria necessarily operate in an area of uncertainty.

Act and rule utilitarianism

Bentham tended to deal with the consequences of acts. However, ‘rule utilitariansim’ justifies certain rules on utilitarian grounds. For example, one might justify the general rule ‘do not lie’ on the utilitarian ground that lying produces more bad consequences than good consequences overall.

Deontological Theory

A criticism of consequentialist theory is that it is so concerned with ends that it may overlook the moral importance of means - the ways in which the ends or goals are achieved.

Deontological theory uses rules rather than consequences to justify an action or policy.

The best-known deontological theory is that of Immanuel Kant in the 18th century. ‘Kantianism’ is a modern term, referring to a Kant-like emphasis on duties and rules. Kant defended rules such as ‘do not lie’, ‘keep promises’, ‘do not kill’ on what he claimed were rational grounds. Rules should comply with the categorical imperative. The categorical imperative holds that:

  • Moral rules should be universalisable i.e. applied to all rational, moral members of the community rather than to just some
  • All persons should be treated never simply as means but also always as ends in themselves
  • Members of the moral community should take a hand in making the laws as well as living by them

Many modern Kantians, as opposed to Kant himself, are not absolutist in their application of moral rules or laws, whilst nevertheless stressing the importance of generally living by moral rules or laws.

Virtue ethics

Virtue ethics is the name given to a modern revival and revision of Aristotle’s ethical thinking. Aristotle’s ethics, while not generally thought of as consequentialist, is certainly teleological. For him, the telos, or purpose, of a human life is to live according to reason. This leads to ‘happiness’ in the sense of human flourishing. This flourishing is achieved by the habitual practice of moral and intellectual excellences, or ‘virtues’.

For Aristotle, the excellences are of two types. A moral virtue is an excellence of character, a ‘mean’ between two vices. One of Aristotle’s virtues is courage, a mean between recklessness and cowardice, which are vices. Modern virtue ethics sets itself the task of discerning the virtues for our time. In a healthcare setting what virtues would we like doctors, nurses, etc. to possess - self-control, truthfulness, generosity, compassion, discernment, integrity?

Aristotle also identified a second type of excellences, intellectual virtues, which constitute a preference for truth over falsehood and for clarity over muddle, both in pure reason and in practical affairs. Both the moral and intellectual virtues are, for Aristotle, the expression of reason.

Casuistry

Casuistry, or case based reasoning, does not focus on rules and theories but rather on practical decision-making in particular cases based on precedent. So first the particular features of a case would be identified, and then a comparison would be made with other similar cases and prior experiences, attempting to determine not only the similarities but also the differences.

So if a clinical ethics committee were asked to consider whether it was ethical for a clinician to breach his / her duty of confidence, the committee would identify key factors, like the health risks to others if information was not disclosed. It would then make a comparison with other similar cases, identifying the relative risks of non-disclosure.

Casuistry should not be divorced from consequentialism, deontology, or virtue ethics but complement them.

The Four Principles

Beauchamp and Childress’ Four Principles approach is one of the most widely used frameworks and offers a broad consideration of medical ethics issues generally, not just for use in a clinical setting.

The Four Principles provide a general guide and leave considerable room for judgement in specific cases.

Respect for autonomy:

respecting the decision-making capacities of autonomous persons; enabling individuals to make reasoned informed choices.

Beneficence:

balancing benefits of treatment against the risks and costs; the healthcare professional should act in a way that benefits the patient.

Non maleficence:

avoiding causing harm; the healthcare professional should not harm the patient. Most treatment involves some harm, even if minimal, but the harm should not be disproportionate to the benefits of the treatment.

Justice:

respect for justice takes several forms:

  • Distribution of a fair share of benefits
  • Legal justice - doing what the law says
  • Rights based justice, which deals in the language, and perhaps the rhetoric, of claimed human rights, and hence goes beyond, though it includes, legal rights.

These principles are prima facie – that is, each to be followed unless it conflicts with one or more of the others - and non-hierarchical i.e. one is not ranked higher than another. In recent years however, respect for patient autonomy has assumed great significance in the context of patient choice, underpinned by the requirement to provide the patient with sufficient information to put him / her in a position to choose.

The ‘Four Principles’ are intended as an aid to balance judgement, not a substitute for it.

We would like to thank Don Hill, Co-ordinator of Postgraduate Education, The Ethox Centre, University of Oxford for his assistance in producing this section.

The following is a practical clinical ethics framework that may be useful for a clinical ethics committee to work through in discussion of a case

1. What are the relevant clinical and other facts (e.g. family dynamics, GP support availability)?

2. What would constitute an appropriate decision-making process?

  • Who is to be held responsible?
  • When does the decision have to be made?
  • Who should be involved?
  • What are the procedural rules e.g. confidentiality?

3. List the available options

4. What are the morally significant features of each option e.g.

  • What does the patient want to happen?
  • Is the patient competent?
  • If the patient is not competent, what is in his or her ‘best interests’?
  • What are the foreseeable consequences of each option?

5. What does the law / guidance say about each of these options?

6. For each realistic option, identify the moral arguments in favour and against.

7. Choose an option based on your judgment of the relative merits of these arguments using the following tools.

  • Are there any key terms the meaning of which needs to be agreed e.g. ‘best interest’, ‘person’?
  • Are the arguments valid?
  • Consider the foreseeable consequences (local and more broad)
  • Do the options ‘respect persons’?
  • What would be the implications of this decision applied as a general rule?
  • How does this case compare with other cases?

8. Identify the strongest counter-argument to the option you have chosen.

9. Can you rebut this argument? What are your reasons?

10. Make a decision

11. Review this decision in the light of what actually happens, and learn from it.

Further discussion of approaches to ethical decision-making can be found in Appendix C1

Reading

2 and 3. Beauchamp T, Childress J. 2001. Principles of Biomedical Ethics. 5th edition Oxford University Press ISBN 0-19-514332-9

BMA . 2004. Medical Ethics Today. London, BMA Books

Boyd, K.M., Higgs, R., Pinching, A.J., (1997) The New Dictionary of Medical Ethics BMJ Publishing Group, London

Campell A, Gillett G, Jones G. 2001. Medical Ethics. 3rd edition Oxford University Press

Gillon, R., (1986) Philosophical Medical Ethics Chichester, Wiley

Glover, J., (1997) Causing Death and Saving Lives Harmondsworth, Penguin

Hope T (2004) Medical Ethics A Very Short Introduction Oxford University Press

Hope T, Savulescu J, Hendrick J 2003 Medical ethics and the law, the core curriculum. Churchill Livingston Chapters 1-3

Mautner, T., ed. (1997) Penguin Dictionary of Philosophy Penguin Books

Parker M, Dickenson D. 2001. The Cambridge medical ethics workbook: case studies, commentaries and activities. Cambridge University Press.

Parker M, Hope T. Ways of Thinking About Ethics. Medicine 2000;28:10:2-5

1. Rachels J. 1995. The elements of moral philosophy. 2nd edition Mc Graw Hill

Singer, P., ed. (1986) Applied Ethics (e.g. vi, J. Harris, The Survival Lottery) Oxford University Press

Singer, P., ed. (1991) A Companion to Ethics (e.g. Essays 10, 14, 20, 21 and 22) Oxford, Blackwell

4. Singer, P. (1993) Practical Ethics, 2nd Edition, Cambridge University Press. Page 12.

Warburton, N., (1999) Philosophy, the Basics Routedge. 3rd Edition. Introduction and Chapter 2.

Warburton, N., (1998) Philosophy, the Classics Routledge. Chapters 1, 2, 11, and 14.

Copyright of Section is held by The Ethox Centre.

Section B: UK clinical ethics Network

Introduction

In January 2001, 20 representatives of clinical ethics committees in NHS trusts met to discuss the future development of clinical ethics committees (CECs), and other forms of clinical ethics support, in the UK. This meeting prompted the development of the UK Clinical Ethics Network. The Network provides information and support for those involved in setting up CECs and for established CECs.

UK Clinical Ethics Network – who’s who:

The Network Committee

Chair - Dr Alan Watson, Director of the Children and Young People’s Kidney Unit at Nottingham City Hospital.

Vice Chair - Dr Stephen Louw, Clinical Director for General Medicine and Care of the Elderly Services at the Freeman Hospital in Newcastle upon Tyne.

The 11 other Network Committee members are chairs and representatives of CECs from across the UK covering a wide range of clinical specialities.

The remit of the Network Committee is to consider the aims, objectives and future development of the Network. It holds an annual general meeting for all members of the Network.

Network Support Project: Run by the Ethox Centre, University of Oxford

Dr Anne Slowther is supervising the development of the Network Support Project. Anne is also a GP and a Senior Lecturer in Clinical Ethics at Warwick Medical School.

Andy Cooper is the Clinical Ethics Support Project administrator.

The objectives of the UK Clinical Ethics Network are to:

  • Offer support and advice to developing and established clinical ethics groups
  • Provide networking facilities including a newsletter, electronic mailing and network website
  • Facilitate training for members of clinical ethics groups
  • Support regional initiatives
  • Organise an annual conference
  • Produce a database of useful and relevant information for clinical ethics groups
  • Establish links with clinical ethics groups internationally

Support the Network can offer:

Newsletter

The Network newsletter is distributed three times a year to Chairs of CECs known to the Network and to individual members (where details have been supplied). Topical issues are dealt with on an occasional basis and have included Assisted Conception (Spring 2003), processes adopted by CECs and the Data Protection Act 1998 (Autumn 2003) and the Human Tissue Bill / Organ donation (Summer 2004). Click here to view the latest newsletter.

Network facilitation

The Network facilitates the sharing of information between clinical ethics committees through the electronic database of members. This often takes the form of an enquiry for information from a clinical ethics committee. The Network circulates this request to all members of the Network by email. Replies are collated and, together with additional information on the subject identified and summarised by the support team, form a brief discussion document that is sent to the requesting CEC and all CECs who responded to the request. Some of these summaries are published in the Network Newsletter.

Topics that have arisen for discussion / clarification include;

  • Rationing of services due to lack of staff
  • Ethical scrutiny of management decisions
  • Developing a framework for ethical discussions
  • Patients access to minutes of CEC meetings
  • Medical student interaction with patients
  • Committee membership and terms of office
  • Service users sitting on mental health CECs
  • Use of drugs of porcine origin
  • Neonatal circumcision for religious reasons
  • Developing a Do Not Attempt Resuscitation policy
  • Case Consultation and Access to Minutes
  • Electronic Tagging of Vulnerable Patients

Annual conference

Since 2001 the Network has organised a conference on clinical ethics in conjunction with an individual host CEC. The aim of the conference is to stimulate interest and discussion in clinical ethics and focuses on examples of the work of clinical ethics committees in the UK. Practical consideration of case studies has been a major part of the conference. The fourth annual conference, held in London in May 2004, focussed on end of life issues and included a European perspective with presentations from Germany and the Netherlands. The 2005 conference, to be held in Newcastle, will look at the issues of resource allocation.

Website

The Network website was launched in September 2003. The aim of the website is to provide relevant information that is easily accessible for CEC members, clinicians and patients.

It provides:

  • Contact details for all CECs known to the Network and, where relevant, topics that the CEC has frequently considered and whether it has drafted / provided input into trust policy or guidelines
  • Worked through hypothetical case studies
  • Ethical and legal discussion of topical issues including Consent and Refusal of Treatment, Patient Confidentiality, End of Life issues and Resource Allocation
  • Examples of frameworks for ethical discussion
  • Links to national guidelines and a glossary of terms
  • Commentaries and perspectives on ethical issues
  • An ‘International Page’ that provides information about CECs abroad, international perspectives on clinical ethics, and details of courses and conferences held outside the UK.
  • Details of courses and conferences in the UK
  • Suggested reading to enable further research

Enquiries for further information about the Network have come from Norway, the Netherlands, Germany and North America. Several UK enquiries have been made requiring information and advice on setting up a clinical ethics committee.

Training for CECs

The Network Support Project provides support and information for those involved in establishing CECs. This includes presentations to trusts thinking of setting up a committee, or to a recently established committee. The Network website advertises courses that provide training relevant for CEC members. The Ethox team runs workshops that can be tailored to the requirements of an individual CEC.

Projects that involve the Network

Two projects concerned with Clinical Ethics Committees have been funded by a grant from the Department of Health to the Ethox Foundation. These projects are run in close collaboration with the UK Clinical Ethics Network.

1. Network Support Project

This project is to facilitate the development of a national network for clinical ethics committees in the UK. The project is funded from December 2002 for two years. It has spearheaded the ongoing development of the Network and has enabled the website and production of this Guide.

2. Education and Training Project

This project is to explore the education and training needs of members of clinical ethics committees (CECs) and to develop a range of teaching materials for them. The project runs from April 2003 to March 2005. As part of this project, pilot workshops were held on the following topics in 2004

  • Ethics and genetics
  • Ethics and the vulnerable patient
  • Ethics and resource allocation

Teaching materials will be prepared for members of CECs to pursue independently.

Contacting the Network

The Network can be contacted at:

Ethox Centre
Gibson Building
Block 21, Radcliffe Infirmary
Woodstock Road
Oxford OX2 6HA
Telephone: +44 (0) 1865 228793

Fax: +44 (0) 1865 2287884

Email: info@ukcen.net

Web site: www.ukcen.net

Reading

Slowther A, Johnston C, Goodall J and Hope T. Development of clinical ethics committees. BMJ 2004;328:950 - 952

Slowther A, Bunch C, Woolnough B, Hope T. Clinical Ethics Support in the UK: A review of the current position and likely development. 2001; The Nuffield Trust, London.

Blackburn, S. 2001. Ethics: a very short introduction. Oxford University Press

Copyright of Section B is held by The Ethox Centre.

Section A: clinical ethics support

Introduction

What is clinical ethics support?

Clinical ethics support describes the provision of advice and support on ethical issues arising from clinical practice and patient care within a health care organisation. Initially models of clinical ethics support focused on provision of advice to health professionals working in hospitals, usually through a hospital ethics committee or an individual ethicist. More recently models of clinical ethics support have developed to include support for other groups within the organisation, specifically patients and managers, and to provide support across institutions, for example, area-wide ethics committees supporting primary and secondary care trusts. The most common model of clinical ethics support in the UK is an ethics committee or group. These committees are distinct from research ethics committees (see page A4). As of September 2004, 68 clinical ethics committees (CECs) had registered with the UK Clinical Ethics Network.

55 CECs in Acute and Community Trusts (out of 161 Trusts)
2 CECs in Primary Care Trusts (out of 303 Primary Care Trusts)
6 CECs in Mental Health Trusts (out of 83 Mental Health Trusts)
1 CEC in a Scottish Health Board (out of 3 Scottish Health Boards)
1 CEC in Northern Ireland (out of 39 Hospitals)
2 CECs in Private Hospitals
1 area wide CEC in England

Why do we need clinical ethics support?

There is an increasing awareness among health professionals and the wider public of the importance of ethical issues in health care. In 2001 a study of the provision of clinical ethics support in the UK 1 found that there was a perceived need for advice on ethical issues among senior health professionals and health service managers. An increasing number of legal cases, and two public enquiries (into the conduct of heart surgeons in Bristol and into the retention of organs during post mortem examinations in Alder Hey) have highlighted the importance of ethical considerations in clinical practice, and there is now an expectation that health professionals are openly accountable for their decisions, including the ethical aspects of those decisions.

This section of the Manual covers the following areas:

  • Development of clinical ethics support internationally.
  • Development of clinical ethics support In the UK.
  • The difference between clinical ethics committees and research ethics committees.
  • Functions and scope of clinical ethics committees.
  • Different models of clinical ethics support, their strengths and weaknesses.
  • A step-by-step guide to setting up a clinical ethics committee.

International development of clinical ethics support

The North American experience

  • Clinical Ethics Committees and Hospital Ethics committees have been in existence in hospitals in North America since the 1970s.
  • There are a variety of models of clinical ethics support.
  • Ethics support may be required by regulation or legislation.

Clinical Ethics Committees (CECs) are also known as hospital or health care ethics committees (HECs) in North America. They have been in existence since the early 1970s, much earlier than the European equivalent.

In addition to an ethics committee, many North American hospitals also have formally trained ethicists. Ethics support may be provided by the ethicist, by an ethics team or by the full committee.

In North America it is a requirement for hospital accreditation that the institution has a mechanism for addressing ethical issues arising from patient care. Both the Joint Commission on Accreditation of Health Care in the US, and the Canadian Council on Hospital Accreditation suggest the establishment of a multi-disciplinary ethics committee to meet this requirement. 2, 3 In some US states, for example Maryland, hospitals are required by law to have an ethics committee.

A first hand account of the experience of ethics support in the United States is provided in Appendix A1.

The European experience

  • CECs have been in existence since the 1980s in the Netherlands.
  • Many countries have committees combining research and clinical ethics.
  • Regulation requiring clinical ethics support varies from country to country.

Clinical ethics support has developed more slowly in Europe in comparison with North America. Clinical ethics committees have been in existence since the 1980s in the Netherlands, including ethics committees in nursing homes, but there are still many European countries with no formally recognised ethics support. Some countries have legislation regarding ethics support, for example in Belgium it is a legal requirement that every hospital should have an ethics committee that addresses research and clinical issues. 4 The Norwegian parliament has recommended that all hospitals have a clinical ethics committee and it has funded a national centre to co-ordinate their development. 5

In several European countries ethics committees consider both research and clinical ethics. However, the experience of this system in the Netherlands was that research issues dominated the agenda, and there has been a move to separate research ethics committees and clinical ethics committees.

A report on the position of clinical ethics committees and ethics consultation in German Hospitals appears in Appendix A2.

The UK experience

  • CECs were first described in the mid 1990s.
  • There has been a rapid increase in the number of CECs since 2001.
  • The main model of ethics support is an ethics committee or group.
  • There is a national network of clinical ethics committees – the UK Clinical Ethics Network.
  • CECs in the UK are quite different from RECs

Before 2000 there was very little information available about clinical ethics support in the UK. In 1996 Meslin and colleagues 6 described the work of 3 Hospital Ethics Committees and in 1999 Watson 7 described the work undertaken by the Ethics of Clinical Practice Committee in Nottingham. A review of clinical ethics support in 2001 8 found that twenty NHS trusts (4%) had a CEC, and a further twenty were thinking about establishing one. Since 2001 there has been a rapid increase in the number of NHS trusts that have established a CEC. Currently 61 acute and community trusts have a CEC, and in the past 12 months two primary care trusts (PCTs) have registered a committee with the UK Clinical Ethics Network. Unlike North America, and some European countries, it is rare for individual ethicists to work in UK NHS trusts. The most common model of ethics support is a committee / group.

The following shows the range of trusts that have a CEC as a percentage of the total number of CECs in the country (based on 2004 data).

  • Acute Adult 69%
  • Children 6%
  • Mental Health 5%
  • Area Wide 3%
  • Private 3%
  • Hospice 2%
  • Primary Care Trust (PCT) 2%

There is a wide geographical distribution of CECs throughout the UK .

Development of the UK Clinical Ethics Network

In January 2001 representatives of a small group of clinical ethics committees (CECs) met to discuss the future development of clinical ethics support in the UK. This led to the establishment of the UK Clinical Ethics Network, which provides support to CECs in the UK.

See Section B for more detailed information about the Network.

The distinction between Clinical Ethics Committees and Research Ethics Committees

Research Ethics Committees (RECs) were set up to review the ethical issues arising from research within the NHS. It is a requirement under the governance arrangements for NHS research ethics committees (GafREC) issued by the Department of Health 9 that research involving NHS patients or NHS resources receives approval from a REC prior to commencement of the research. The role and conduct of RECs is closely regulated, and is the responsibility of the relevant Strategic Health Authority. There is a central co-ordinating office for RECs that issues guidance and facilitates provision of training of REC members.

In contrast to RECs, clinical ethics committees are advisory and are not governed by government regulation. They sit within individual trusts and often develop as a result of clinician concern rather than managerial directive. There is no requirement for training of members of CECs.

Comparison of clinical and research ethics committees
Advisory Decision-making
Ethics of clinical care Ethics of medical research involving human participants
Not regulated Regulated
Training not compulsory Compulsory training for members
Situated within the Trust / healthcare institution Required to be outside the Trust
No central funding Funding for training of members and administrative support
www.ukcen.net www.corec.org.uk
Clinical Ethics Committees Research Ethics Committees

Functions of Clinical Ethics Committees

The work of clinical ethics committees falls into three broad areas. Some CECs carry out work in all three areas, others focus on just one or two of these areas.

  1. Providing ethics input into trust policy and guidelines around patient care.
  2. Facilitating ethics education for health professionals within the trust.
  3. Providing ethics advice to clinicians on individual cases.

1. Providing ethics input into trust policy and guidelines around patient care

This may take the following form:

  • Developing local guidelines for use within the trust, drawing on national guidance or professional guidance where available
  • Providing ethics input on guidelines produced by other committees or clinical groups within the trust
  • Commenting on and clarifying existing national policies and guidelines

Appendix A3 sets out a list of points for a committee to consider when having input into guidelines.

Appendix A4 describes one ethics committee’s experience of developing a policy on advance directives.

2. Facilitating ethics education for health professionals within the trust

In order to raise awareness of ethical issues arising in clinical practice, and to support decision-making in difficult areas, a CEC may provide or facilitate ethics education and training for healthcare professionals.

This could be achieved in a variety of ways including:

An outline of ethical considerations / frameworks to be included in an induction booklet for new members of staff.
Examples of ethical issues arising in clinical cases discussed in a grand round, facilitated by a member of the CEC.
The CEC hosting an ‘open day’ or session advertising its work and highlighting common ethical issues and ways of addressing them.
Producing an ethics booklet for the trust.
Workshops for groups of healthcare professionals to talk through issues of concern arising for them. For example midwives may have concerns about the ethics of informed consent and antenatal screening.
Seminars / lectures for healthcare professionals covering specific issues, e.g. consent, consent and vulnerable patients; consent and children; confidentiality.

3. Providing ethical advice to clinicians on clinical cases

Many CECs provide support to clinicians by way of identification and discussion of ethical issues arising in particular cases. Such ‘case consultation’ arises from individual clinicians approaching the committee, or often in the first instance the committee chair, for advice about a case that is causing them concern. These cases may be retrospective, where the situation has now been resolved but the clinician is not sure that the decisions made were the right ones; or current, where the decisions are still to be made. Committees that deal with current cases will need to develop a mechanism for responding quickly to requests for advice, including requests that occur out of hours. Discussion of the case will include identification of the ethical issues, consideration of current professional guidance and legal requirements, formulating a view on the most appropriate course to follow, and justification of that view. A key consideration in developing a protocol for dealing with case referrals is the involvement of members of the health care team, patients and / or family members in the discussion.

Where cases frequently arise on the same topic the CEC may identify a need for general guidance on this issue by the trust, and can then provide ethics input into the development of such guidance.

Frameworks for thinking about ethical issues are discussed in section C

Appendix A5 provides a list of issues to consider in setting up a case consultation service

Appendix A6 gives an example of one CEC’s protocol for emergency referral of cases to the committee.

Example of the range of cases presenting to one CEC

  • Autonomy of a patient lacking capacity
  • Treating disruptive patients
  • Breaching confidentiality
  • Rights of a foetus
  • Conflict within team on best treatment for patient
  • Refusal to perform treatment requested by patient
  • DNR Orders
  • Treating violent patients
  • Duty of care
  • Treating prisoners
  • Experimental treatment with an unlicensed drug
  • Treating a patient without his / her consent
  • Health tourism
  • Treatment of Jehovah’s Witnessv
  • Patient decision to refuse treatment
  • Withdrawing treatment
  • Need for consent to treatment
  • Withholding treatment
  • Informing patient of status when test done in error
  • Withholding information from relatives

Example of the range of referring specialities presenting to one CEC

  • Care of the Elderly
  • Intensive Care
  • Chaplaincy
  • Paediatrics
  • Fertility Clinic
  • Psychiatry
  • General Medicine
  • Urology
  • Haematology

Scope of work undertaken by Clinical Ethics Committees

The scope of work undertaken by CECs is extensive and could include:

  • Clinical care.
  • Management issues, for example treatment of staff.
  • Resource allocation at both individual patient and population level.
  • Innovative treatments and the boundary with clinical research.

Some committees will focus on a particular area and not all committees undertake involvement in all areas. The scope of work that a committee is prepared to deal with will probably depend on the perceived need within the trust, but may also depend on the expertise of the members of the CEC. The scope of work that a CEC will undertake should be delineated in its Terms of Reference.

A recent survey of Clinical Ethics Committees identified the range of work undertaken by them, although not all CECs consider the whole range.

The questionnaire findings are summarised in Appendix A7

Range of support provided by CECs (shown as a percentage of CECs surveyed)

  • Advice to clinicians by way of case discussion 82%
  • Contribution to trust policies and guidelines 84%
  • Provision of ethics education within the trust 76%
  • Interpretation of national guidelines 66%

Range of issues on which CECs provide ethical advice (shown as a percentage of those surveyed)

  • Withholding/withdrawing treatment 87%
  • Issues of consent to treatment 82%
  • DNAR orders 79%
  • Advance directives 79%
  • Issues of capacity 79%
  • Refusal of treatment 82%

Different models of clinical ethics support

While a clinical ethics committee or group is the most common model of ethics support in the UK, it will not necessarily be the most appropriate model for some settings or some functions. Other models of ethics support may have advantages in some areas. Below we consider a range of models of ethics support, their strengths and limitations, beginning with the committee model.

  • Clinical Ethics Committee / Group / Forum
  • Sub Committees
  • Case consultation groups
  • Hub and spoke model
  • Ethicist

Clinical Ethics Committee / Group / Forum

A clinical ethics committee (CEC) is multi-disciplinary, usually with lay membership i.e. non-clinical members who are not employed by the trust.

The number of members of CECs in the UK varies from 6 to 26. Medical members tend to outweigh nursing members by two to one. 10 The majority of CECs have a clinician as chair, which has a possible advantage of facilitating access by clinicians to the committee. Committees meet on average once a month for between one and two hours.

The range of membership within one UK CEC
Medical Director Family Liaison Nurse, Paediatrics Anaesthetist Senior Occupational Therapist Lecturer in Medical Law SpR, GUM/HIV Chaplain
Chief Executive Staff Nurse, PICU Gynaecology   Bioethicist HO, Paediatrics Lay Member
Ward Manager Clinical Support Nurse, Surgery Physician   Postdoctoral Research Fellow SHO, Care of the Elderly Secretary to the Committee
Unit Manager for Day Surgery Mental Health Nurse Paediatrician in Intensive Care   Professor of Medical Ethics SHO, Ophthalmology Senior Occupational Therapist
  Palliative Care Team Leader Transplant Surgeon     SpR, Department of Medicine for the Elderly  
    Physician, Care of the elderly        
    Psychiatrist        
Management Nurses Consultants Professions Allied to Medicine Academics Junior Doctors Other

Referrals to CECs are mostly commonly made by clinicians but other healthcare professionals, managers, and increasingly GPs, will bring issues for consideration. Current practice of most UK CECs does not usually involve patients or their families and carers in the committee’s discussion but some committees have considered cases at the request of a patient’s family or carer.

Strengths of the committee model

  • A formal Committee is easily recognised as part of the institutional structure and therefore may have more influence with both clinicians and managers.
  • Multi-disciplinary membership provides different perspectives.
  • Group thinking promotes wide discussion.
  • Relatively easy to set up.

Limitations of the committee model

  • A Committee may be seen to be part of the management structure and disciplinary procedures within the trust and not as a source of support to clinicians.
  • It may not be able to respond rapidly to a request for ethical advice.
  • Case discussion by committee may be intimidating for a clinician (and even more so for the parent or partner of a patient) who has asked for advice and support.
  • Discussing and drafting policies and guidelines in a large group may be unwieldy.

In order to address the limitations of the single committee other models of support may be developed in addition to, or in place of a committee.

Sub committees

A sub-committee may be constituted to consider a particular issue, for example to discuss implementation of a hospital policy or to consider and draft policy or guidelines.

Strengths of the sub committee model

  • Flexible.
  • Small groups of individuals may quickly build up areas of expertise.
  • An efficient way to develop policy and guidelines.
  • Can engage in consultation with specialist groups as necessary.

Limitations of the sub-committee model

  • More limited range of representation / views.

Case consultation groups

This model has been developed to provide a quick response to urgent ethical issues arising within a trust where it would be difficult to constitute a full meeting of the CEC. Those comprising the ‘rapid response’ group typically include clinical and non-clinical members of the CEC. It is necessary to consider how many people will constitute the case consultation group, which members of the committee would be willing to be contacted in an emergency and whether there is sufficiently wide representation from this pool. Cases considered in this way would then be discussed by, or their outcome reported to, the whole committee at a regular CEC meeting. This model is useful where ethics support is frequently provided for case consultations.

Strengths of the case consultation group

  • Responsive to individual cases.
  • Answers immediate needs for ethics support.
  • Less intimidating than a full committee in stressful situations.
  • Group members will develop experience and expertise in case consultation because of increased opportunity to consider cases.

Limitations of rapid response model

  • Requires members of CECs to be available for consultation outside normal meeting times.
  • Constitution of the group may be limited, resulting in a narrow range of views
  • Potential for insufficient review by the committee of individual case consultations. This limitation can be overcome by ensuring a robust process for adequate review of decisions by the full CEC.

Hub and spoke model

In this model the ‘spokes’ are individuals taking the ethics lead within their clinical areas and acting as the first point of contact and ethics resource. If an ethical issue arises within that clinical area the individual lead within that area will facilitate discussion of the issue, and if necessary refer on to the CEC or identify an educational need that requires further attention. Ideally the individual lead will have some ethics education or training. Indeed such training of both ‘spokes’ and members of CECs should perhaps become mandatory. In order to ensure sufficient review, the ‘spoke’ should provide a summary of each case consultation to the next full meeting of the clinical ethics committee (the hub). There should also be a reference back to the hub where the individual lead considers the matter is beyond his / her scope of experience or expertise, or if he / she thinks the discussion would benefit from the wider range of views available in the committee.

Strengths of the hub and spoke model

  • Flexible.
  • Able to respond quickly and informally.
  • Similar cases arising frequently enable a body of experience to build up.
  • The individual lead in each clinical area can be identified and contacted easily.
  • ‘Ear to the ground’ – able to identify ethical issues in clinical areas that might otherwise be missed.

Limitations of the hub and spoke model

  • Potential for insufficient review of spoke deliberations.
  • Difficulty of ensuring sufficient level of ethics expertise in all clinical areas.
  • Individual leads may provide a limited view of the issues.

Appendix A6 show in more detail how a rapid response model may work in practice and the processes to consider in setting up such a model

Ethicist

It is more common in North America than in the UK / Europe for individual ethicists to provide support to health professionals, patients and carers within a health care institution, although some NHS trusts have benefited from the work of an ethicist, for example the Oxford Radcliffe Hospitals NHS Trust.
A brief description of the work of an ethicist is described in Appendix A8.

A guide to setting up clinical ethics support in your trust

In the next section we set out the various stages involved in setting up clinical ethics support in a health care organisation, suggesting things to consider and possible options for an individual or group working their way through the process. It should not be seen as a didactic protocol, rather as a prompt, or aide memoire. Some clinical ethics groups have begun as an informal discussion forum and the following guide may seem too formal an approach for them. However informal forums often evolve into a more formal model and some of the issues discussed will be relevant to all models of ethics support. The related appendices provide examples of the experience of ethics committees as they have worked through various aspects of this process. These are an invaluable resource and we would recommend that you refer to them as you read through this guide.

A detailed account of one group’s experience of setting up a Mental Health Trust CEC is shown at Appendix A9.

Stage 1: Identifying the need and securing an ‘expression of interest’

The perceived need for some form of clinical ethics support in a health care organisation can arise from a range of sources and in different ways. These include:

  • Individual clinicians struggling with ethical issues in their daily practice.
  • Clinicians or managers with an interest in ethics, or with some knowledge of the development of ethics support elsewhere.
  • Managers who wish to incorporate ethics support into the governance structure of the organisation.

Once a perceived need has been identified it will be necessary to gain some expression of interest in the concept from senior managers and clinicians. At this stage this may be no more than support for exploring the issue further within the wider organisation. It could take the form of an approach by clinicians to the chief executive or an approach by a senior manager to clinical directors. One possibility is a brief presentation to a key committee such as the clinical governance committee.

Stage 2: Assessing the level of support / raising interest within the organisation

While it is important to have some champions for the concept of ethics support who will lead its development, it is unlikely to be successful without the interest of a significant number of health professionals working in the trust. A key barrier to the effectiveness of ethics support noted by many CECs is the lack of awareness of the CEC’s existence by many people working in the trust. In the early stages of developing ethics support you need to discover what models of support are likely to be useful and relevant to clinicians, patients and managers. This is often done by informal enquiries among colleagues but a more effective method, albeit one that requires some resources, is to hold a meeting within the organisation to provide information about clinical ethics support and gain the views of as wide a range of people as possible on models of support and type of issue requiring support.

Areas to discuss in the meeting could include:

  • Key ethical issues identified by health professionals within the trust.
  • Description of clinical ethics support, experience from other trusts.
  • Different models of ethics support and preferred model for this trust.
  • Possible functions and scope of ethics support in this trust.
  • Suggestions for membership.
  • Agreement of a core group to draft a proposal to the trust Board.

An example of a workshop outline used by one NHS trust can be found in Appendix A10.

Stage 3: Developing an outline proposal for the trust Board

Information gained from the meeting / workshop in stage 2 can be used in the drafting of an outline proposal to the trust board/executive. Thus if a particular model of ethics support was favoured in the meeting, the drafting group would need to give this model serious consideration as the recommended model in the proposal. It is possible that the preferred model would not be practically achievable, at least in the short term (for example it may be impossible to appoint a clinical ethicist or to recruit and support enough personnel for a hub and spoke model). Specific issues to cover in the outline proposal include:

Reasons for establishing clinical ethics support

Identify why you, or any of your colleagues, see value in setting up a CEC, or other model of ethics support. What led to your interest in this? What were the specific problems that led you to identify a need for ethics support? More generally, what issues might an ethics support service address? You may wish to point out that CECs / ethics support are developing in many trusts across the NHS and that ethics is increasingly recognised as integral to good governance, both at the clinical and managerial level.

Preferred model of support

It is worth pointing out at this stage that the development of ethics support will be an evolving process, so the initial model may be modified in the light of experience, for example the initial model is often a committee but this may evolve to include a rapid response group or a hub and spoke model.

Aims of the CEC / ethics support

Identify the aims of the CEC / support, what does it want to achieve and what does it want to produce by way of recognisable outcomes?

Mode of Action

Will the CEC / support be proactive in the sense of promoting ethics education within the trust and providing input into hospital policy and creating guidelines, or is it more likely to respond to requests from clinicians regarding case consultation?

Role of the CEC

What range of work is it likely to undertake, for example will it principally provide support for clinicians, will it address managerial and resource allocation issues, will it respond to requests from patients and relatives?

Status within the trust

Where will the CEC fit within the trust structure, for example, will it come under the auspices of clinical governance? A successful committee requires institutional support so it is important to think about how the trust perceives the CEC.

Consider:

  • Will the work of the CEC feed into the management structure?
  • Where will the minutes of meetings be sent?
  • To whom is the CEC responsible?

Once approval in principle has been obtained for the outline proposal, a more detailed document can be developed that will form the basis of formal establishment of clinical ethics support in the organisation.

Stage 4 Detailed formal proposal

At this stage you will need to consider some specific issues in detail, including drafting terms of reference for a CEC / support service and CEC membership requirements.

Terms of reference

These should outline:

  • The aims of ethics support.
  • The model of support.
  • The objectives of the CEC / support.
  • The functions and scope of the support.
  • Selection of CEC / case consultation group members, and terms of membership.
  • Referral process for cases and other issues.

Appendix A11 includes examples of Terms of Reference for UK CECs

Membership of the CEC

Chair:

The role of chair is crucial to the effective functioning of a CEC (or of a case consultation group). There are different approaches to selection of a CEC chair, and different approaches may be appropriate for different organizations. These approaches include:

  • The trust / organisation executive can appoint a senior clinician or manager to chair the committee and to take responsibility for setting up the committee and any other support processes.
  • The trust / organisation can appoint an external chair who takes over the chairmanship when the committee is ready to begin work.
  • The committee can elect a chair, once it is established.

These three approaches to selection of a chair have advantages and disadvantages. An external chair provides reassurance that the committee is not an internal clique and emphasises the importance of the patient / public perspective. A senior clinician as chair provides reassurance to clinicians that this is not a quasi-disciplinary process and is more likely to encourage referrals from clinicians. An elected chair reflects a more democratic process, which may be a more appropriate image for an ethics committee to have.

Vice chair

The choice of vice chair can be significant and it is worth considering what the role of the vice chair will be.

  • Carrying out the duties of the chair in his / her absence.
  • Providing a different perspective from that of the chair, for example specifying that either the chair or vice chair is a lay member and the other is a clinician.

In addition you may wish to consider allocating specific roles to members of the committee, for example raising the profile of the committee, convening case consultation groups, developing an educational programme for the committee.

Other members

As CECs are multi-disciplinary it will be worth considering the range of disciplines and backgrounds you would like to include to ensure that the committee provides a broad range of perspectives. Also consider the ideal size for the committee. Too large a group may result in lack of cohesion between members and the way they work together. But disadvantages of a small committee include a lack of diversity of views and the potential that insufficient members may attend on any one occasion therefore meetings may not be quorate. Some CECs have a small core group and co-opt members with particular expertise relevant to the issue or case to be discussed (core plus option).

Membership of CECs in UK NHS trusts usually includes:

  • Doctors
  • Nurses
  • Other healthcare professionals e.g. dieticians, speech therapists
  • Lay members
  • A lawyer
  • A chaplain or other religious leader
  • A patient/user of the service
  • An ethicist or philosopher
  • See above for an example of the membership of one UK CEC.

A ‘lay’ member can be described as a person with no clinical experience or other expertise that the committee is seeking (e.g. legal expertise), and who is not employed by the trust. Think carefully whether you wish to have a patient or service user perspective or a more general lay perspective, or both. For a patient or service user perspective, the lay members should be patients or former patients, or a member of a patient organisation. A more general lay perspective could be provided by non executive members of the trust, or by people from the local community who fulfil the above definition of lay member.

A discussion of issues to consider in appointing lay members is provided in Appendix A12.

If there is to be a legal member of the committee then consider whether this will be the trust legal advisor. If the trust legal advisor is a member of the committee then his / her role needs to be clarified. He / she will be able to advise the committee on what is legally permissible, but may also channel the discussion along a line that is dictated by legal risk management rather than ethical considerations. It is important that he / she distinguishes his / her role as a committee member from his / her role as legal advisor to the trust. Several CECs in the UK have successfully included the trust legal advisor as a member of the committee. If a non-trust lawyer is a member of the committee, his / her particular area of expertise may have a bearing on his / her contribution. A lawyer who specialises in medical law will be able to comment more authoritatively on legal aspects of the issues brought to the committee than say a lawyer whose expertise is commercial law.

Other issues for membership

  • How will you ensure appropriate ethics expertise or experience across the membership of the committee?
  • Is there an expectation of a minimum yearly attendance, and if so would non- attendance require resignation?
  • What is the length of term of office of a) members, b) chair and vice chair?

Secretarial / Administrative support

Administrative support is important to the smooth functioning of the committee and involves a number of functions:

  • Sending out notices of meetings.
  • Circulating in advance cases and documents to be discussed at meetings.
  • Writing up and circulating minutes and cases discussed.
  • Identifying relevant training for members.
  • Creating a library of ethics resources.

Financial support

Consider whether the administrator will be paid or have set aside protected time for duties associated with the work of the CEC. Will there be funding available for education and training of members of the committee? A business plan should be drafted with realistic costings for various options depending on the level of CEC activity envisaged.

A formal proposal is then presented to the board/executive

Appendix A13 is an example of a proposal document for the trust.

Stage 5: Getting started

When formal approval is obtained the following practical considerations may be addressed:

Recruiting members

There is a need to consider how members will be recruited. To ensure a diversity of expertise and moral perspectives, it would be most appropriate to advertise for members rather than relying on ‘word of mouth’ recommendations or simply using the core group that developed the initial proposal. Advertising can be done through the trust intranet or newsletter, or perhaps by direct approaches to heads of clinical units to disseminate information about the CEC and invitations for applications. A personal approach to people who attended the initial meeting, if one was held, may target those with an interest in joining the committee. For potential members from outside the trust you may wish to consider advertising through the local PCT (GPs and other primary care professionals), and relevant departments in the local University (ethics / philosophy / law). Some committees have found that recruiting lay members is a difficult process.

A discussion of issues to consider in appointing lay members is provided in Appendix A12.

Few CECs in the UK have interviewed for committee members but this may become more common as CECs become an accepted part of NHS organisations. CECs already established may wish to consider interviewing potential new members as current members reach the end of their tenure. Conducting interviews for CEC members requires some thought. Key considerations are:

  • Who will conduct the interviews?
  • What criteria are used to guide the interview process?
  • Will the same procedure be used for initial membership of the committee and subsequent replacement when an individual member leaves the committee?

Criteria used by one committee in interviewing potential committee members is given in Appendix A9.

Promotion / advertising of CEC

In order to generate sufficient referrals to the CEC it must have a recognised profile within the trust. Consider advertising the work of the CEC:

  • In the handbook for new staff
  • In the trust newsletter
  • On the intranet
  • With the Patient Advisory and Liaison Service
  • In leaflets placed around the hospital
  • Local GP surgeries

Meetings

Frequency of meetings

Most CECs meet once a month or once every two months but some meet only where a case has been brought for discussion or there is ongoing work such as drafting of guidelines or consideration of a policy.

When and Where

If members are attending in their own time then it will be necessary to choose a time when most can attend on a regular basis. If it will prove difficult to choose a generally convenient time and place for meetings of the committee, then the hub and spoke model described above may provide the necessary flexibility.

Training and education

In order for the CEC to be seen to have authority, for its views to stand scrutiny and to merit referrals by members of staff, there should be sufficient ethics experience and knowledge within the committee. It is usually the case that one or two members will have some formal ethics education but to ask them to provide training for the other members of the committee could be seen as unduly onerous.

  • Will members themselves be responsible for their ethics education?
  • Will they receive financial support to attend workshops, buy books and if so what is the limit per member?
  • Consider ethics training sessions perhaps with an invited speaker / facilitator.

Committee process – considerations about how the CEC functions

Process of ethical discussion

It is necessary for the CEC to be able to demonstrate to the trust that its decision-making process and the advice it gives can be justified. Therefore the CEC needs to have an explicit process for ethical discussion. This will ensure accountability and consistency of its decisions.

The following points are important in considering the process for ethical discussion:

  • Declaration of personal interests and views, such as membership of relevant interests groups e.g. Voluntary Euthanasia Society.
  • An explicit framework for the process of considering a case. An example of such a framework is set out in Section C.
  • A mechanism for ensuring that the relevant facts of the case are ascertained, including the views of all those who will be affected by the outcome.
  • The views of all members of the committee / group should be heard.
  • Members should be prepared to justify their views in the light of counter arguments.
  • Formally test the consensus view of the committee with counter-arguments in order to justify the final conclusion.
  • Clearly state the ethical reasoning behind individual and consensus views.
  • Identify the relevant legal and professional frameworks (See Section D).
  • If legal terms such as ‘battery’ are used in the deliberations of the committee legal advice may need to be sought to ensure correct usage of the terms when recorded in the minutes.
  • Minutes of meetings of the CEC may in some instances be disclosed to those outside the trust (see Section F). Discussion of an ongoing case forms part of the medical record of the patient. Therefore it is extremely important that the committee adopts measures to ensure that its deliberations and decisions are transparent, factually and legally accurate and can withstand scrutiny.

Referrals and documentation

  • Consider a pro forma for case referrals that sets out details of the person referring the case, the outline issues of the case and the advice sought.
  • Who will be able to refer cases to the CEC?
  • Is there a procedure to be followed if a member of the CEC is approached for informal ethics advice because of their position on the CEC?
  • Consider whether a rapid response service will be provided and if so the process to implement it.
  • What administrative systems are in place - drafting of minutes, filing records and disseminating information to members and those in the trust?

An example of a pro forma referral form is shown in Appendix A14.

Confidentiality of committee

Consider the process to be put in place to ensure all members, and those attending meetings to present cases, are aware that they are under a duty of confidence. Members of the CEC who are healthcare professionals will have a professional, ethical and legal duty to maintain confidences of patients of the trust. Lay (non trust) members should be made aware that they too have a duty of confidence, and this may best be achieved by asking that they sign a confidentiality agreement on joining the CEC.

Confidentiality issues also arise in respect of drafting cases for discussion at CEC meetings and writing up of minutes of the meeting.

Cases for discussion

There should be sufficient anonymisation of those cases brought to the CEC for discussion. Care should be taken to ensure that no factors identifying a patient are included in the write up of the case to be circulated to members for discussion. If certain factors are relevant for the discussion then perhaps the Chair could be ‘key-holder’ of the information, to exercise his / her discretion to reveal it to the meeting if he / she considers that necessary.

Minutes of meetings

Where individual cases have been discussed, the minutes of the meeting should not contain information identifying the patient. Nor should they identify a member of the CEC who has expressed an opinion. You may wish to consider having a general summary of the meeting that can be distributed fairly widely and a confidential section of the minutes, which is only available to committee members. Remember that sections of the minutes relevant to a particular case will form part of that patient’s record if the patient is identifiable or if the case discussion had an impact on the patient’s management.

Indemnity

In theory it may be possible for a member of a committee who is not a trust employee to be individually liable to legal action. Many trusts provide indemnity for non-employee members of the CEC. The contact details of CECs where this is the case can be obtained from the Network (admin@ethics-network.org.uk)

See Section F for more information about confidentiality and the legal liability of members.

Reading

Aulisio MP, Arnold RM, Younger SJ (eds) Ethics consultation: From theory to practice. Baltimore: Johns Hopkins University Press (2003).

Ehleben C M, Childs B H, Saltzman S L. What is it exactly that you do? A “snapshot” of an ethicist at work. HEC Forum. 1998;10(1):71-4.

Jiwani B. An introduction to health ethics committees. Provisional Health Ethics Network (2001).

Journal of Medical Ethics – Clinical Ethics Committees Supplement 2001, April, Vol 27, Supplement 1.

Komatsu G I, Goodman-Crews P, Cohn F, Young E W. Effect of ethics consultations on non beneficial life-sustaining treatments in the intensive care setting: a randomised controlled trial. Journal of the American Medical Association. 2003;290(9):1166-72.

Larcher V, Lask B. McCarthy J. M. Paediatrics at the cutting edge: Do we need ethics committees? JME1997;23:245-9.

Slowther A, Bunch C, Woolnough B, Hope T. Clinical Ethics Support in the UK: A review of the current position and likely development. 2001; London; The Nuffield Trust

Slowther A, Hope T. Clinical ethics committees: They can change clinical practice but need evaluation. BMJ 2000;321:649-650

Spicker S (ed) The Healthcare Ethics Committee Experience. Krieger Publishing Company. 1998

The report of the American Society for Bioethics and Humanities, Core Competencies for Health Care Ethics Consultation, 1998

Thomson A. Critical Reasoning in Ethics: a practical introduction. Routledge. 1999.

Watson AR. An ethics if clinical practice committee: should every hospital have one? Proc Roy Coll Phys Edin 1999;29:335-337

Wilson Ross J, Glaser JW, Rasinski-Gregory JD, McIver Gibson J, Bayley C. Health Care Ethics Committees: the next generation. American Hospital Publishing, Inc. 1993.

Copyright for Section A is held by The Ethox Centre.

References

1. Slowther A, Bunch C, Woolnough B, Hope T. Clinical Ethics Support in the UK: A review of the current position and likely development. 2001; London; The Nuffield Trust paragraph 3.1.

2. Joint Commission for Accreditation of Healthcare Organisations. 1996 Comprehensive Manual for Hospitals. Chicago: JCAHO, 1996: 95 – 97.

3.Meslin E, Rayner C, Larcher V, Hope T, Savulescu J. Hospital Ethics Committees in the United Kingdom. HEC Forum 1996; 8(5):301-315 page 301

4. Slowther A, Bunch C, Woolnough B, Hope T. Clinical Ethics Support in the UK: A review of the current position and likely development. 2001; London; The Nuffield Trust paragraph 9.4.1

5. Holm S, Clinical Ethics Committee in Norway - Highly Recommended by the Norwegian Parliament http://www.ethics-network.org.uk/international/intlspec/norway.htm

6. Meslin E, Rayner C, Larcher V, Hope T, Savulescu J. Hospital Ethics Committees in the United Kingdom. HEC Forum 1996; 8(5):301-315

7. Watson AR. An ethics of clinical practice committee: should every hospital have one? Proc Roy Coll Phys Edin 1999;29:335-337

8. Slowther A, Bunch C, Woolnough B, Hope T. Clinical Ethics Support in the UK: A review of the current position and likely development. 2001; London; The Nuffield Trust

9. Governance arrangements for NHS research ethics committees. Department of Health. 2001. Available online

10. UK Clinical Ethics Network, Report on the Network Questionnaire, 2003, see Appendix A7