The principle of autonomy would have the greatest bearing on what clinical situation

Q: Which definition best describes moral distress in the nursing environment?

According to Andrew Jametons influential definition, first published in 1984, moral distress occurs when a nurse knows the right thing to do, but institutional constraints make it nearly impossible to pursue the right course of action” [1].

Ethical Frameworks

Issues that might present to a CEC

Do not attempt resuscitation(DNAR) orders
Advance Directives
Decisions to withhold or withdraw treatment

These issues are discussed below using a short hypothetical case to illustrate some of the points to be considered.

DNAR Orders

A “do not attempt resuscitation”, or “DNAR” order is an advance decision that Cardiopulmonary resuscitation (CPR) will not be attempted. The guidelines issued by the BMA RCN and UK Resuscitation Council sets out a framework for developing a policy for DNAR orders. It is important to consider not only whether CPR will provide a benefit to the patient, but also the potential harm that may be caused by CPR. It would not be in the patient’s best interests to prolong treatment where it is futile to do so. The importance of discussing the decision with the patient and/or their relatives is highlighted in the professional guidance.

Case study:

John is a 55 year old man with lung cancer which initially responded to chemotherapy but has now relapsed. He is now nearing the end of a trial of a new chemotherapy regime with no sign of remission of his cancer. In discussion with the medical team John expresses a belief that he may respond to treatment although his consultant has told him that no further chemotherapy is possible and that he has only a few weeks left to live. As a result of his advanced disease, it is likely that vital organs such as his kidneys and heart will fail. The consensus of opinion from the medical team is that, if John has a cardiac arrest while on the ward, attempts at resuscitation would not be appropriate. This is because it is highly unlikely to be successful and it would inflict damage because of John’s fragile ribs (he has secondary deposits of cancer in his ribs) and because he will die very shortly from his cancer. After discussion with his consultant John says he wants everything done for him, including CPR.

Should John be given CPR in the event that he suffers a cardiac arrest?

At first glance this case seems to be a conflict between John’s autonomous choice and the objective view of the clinicians regarding his best interests. However further exploration of the clinicians’ reasons for not wishing to attempt CPR and John’s reasons for his choice is required.

If the clinicians think that CPR would be futile this raises questions about what is meant by futile treatment and how different people would regard the predicted level of success or failure in this case. For John, even a small chance of success may be seen as far from futile if he has the chance of another week of life.

In considering John’s autonomy it is necessary to know if he has understood what CPR entails and the likelihood of success or failure. Is he making an informed choice?

In considering his best interests, have the clinical team taken into account his personal perspective? Perhaps his daughter is getting married next week and he wants any chance, however small, to be able to see her married.

Should the possible effects on medical and nursing staff of attempting CPR on a patient with virtually no chance of success be considered? It maybe that with fuller discussion between John and his clinicians a consensus view will be achieved. If this is not possible, the joint BMA, RCN, and UKRC guidance advises that the patient’s wishes should be respected but that, in the event of a cardiac arrest occurring, the decision about precise measures to be taken should be made by the clinician.

Doctors cannot be required to give treatment contrary to their clinical judgement, but should be willing to consider and discuss patients ’wishes to receive treatment, even if it offers only a very small chance of success or benefit. Where attempted CPR has a reasonable chance of successfully re-starting the heart and breathing for a sustained period, and patients have decided that the quality of life that can reasonably be expected is acceptable to them, their wish for CPR should be respected. (section 7.2)

Advance Directives

Mental Capacity Act 2005 sections 24-26
GMC Treatment and care towards the end of life 2010 paragraphs 63-74
End of life decisions: views of the BMA 2009
The Patients Association. Living wills. How to make sure your wishes are known when you can no longer make yourself understood.

An advance directive, (also known as a ‘living will’) is a statement made by a competent adult about the way he/she wishes to be treated if, in the future, he/she becomes incompetent and therefore unable to make a valid choice as to treatment. As competent adult patients have a right to refuse medical treatment an advance directive is a way of prolonging autonomy. An advance directive cannot request treatment that is not in the best interests of the patient. The Mental Capacity Act recognises advance statements as legally binding if valid and applicable. However the Act specifies advance refusals of treatment.

Conditions for a valid advance refusal of treatment:

The advance refusal is made by a competent adult (18 and over).
It is entered into voluntarily - the individual was not coerced into making the statement.
The individual is sufficiently informed about the medical prognosis if the advance refusal is respected.
It is applicable to the circumstances that arise.

In general an advance refusal of treatment does not have to be written in order to be valid. However refusals of life sustaining treatment have to be written, signed and witnessed and specify that the treatment to be refused is life sustaining. Questions that a clinician or clinical ethics committee may need to consider:

Does a patient have a valid advance directive?
Is the advance directive applicable to the circumstances of the case?
Is there any evidence that the patient has revoked the advance directive or changed their mind?

Case Study

Mr Z made a written advance directive 5 years ago. Mr Z suffers from chronic obstructive pulmonary disease and the advance statement provides that if he is admitted in respiratory failure he will not be ventilated. The advance directive is placed in his notes. Mr Z is brought into A&E in respiratory failure and is acutely confused because of 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.

What issues should an ethics committee consider in reviewing such a case?

The advance directive was an exercise of Mr Z’s autonomy and an expression of how he wanted his future to be shaped in circumstances where his autonomy would be restricted by ill health. The principle of respect for autonomy requires that the advance directive be respected, if it was written as an autonomous act (if he was competent, free from coercion and had enough information to make the decision) and if it is still an expression of his true wishes.

Mr Z appears to contradict his advance directive when admitted to hospital semi conscious. The question is whether his current wishes should override his previously made advance directive. If he was fully conscious this would clearly be the case. A competent patient can change his/her mind about treatment at any time. If Mr Z is semi-conscious he may not be considered competent to make decisions about treatment, precisely the circumstances that the directive was meant to cover. However, assessment of competence in these circumstances is difficult and ignoring his currently stated wishes will have serious and possibly fatal consequences.

This is a difficult conundrum and perhaps the best solution where there is a real issue about the validity of a revocation of an advance statement is to take the course that preserves future choice for the patient. If Mr Z’s life could be saved by accepting his most recent statement of wishes then this preserves a future choice. This approach is reflected in professional guidance.

GMC Treatment and care towards the end of life 2010
Para 73 If there is doubt or disagreement about the validity or applicability of an advance refusal of treatment, you should make further enquiries (if time permits) and seek a ruling from the court if necessary. In an emergency, if there is no time to investigate further, the presumption should be in favour of providing treatment, if it has a realistic chance of prolonging life, improving the patient’s condition, or managing their symptoms.

Some clinical ethics committees have been involved in developing policies on advance directives. An example of such an exercise and the ensuing policy is described by Stephen Louw, Chair of Freeman Hospital Clinical Ethics Advisory Group in the section on Committee Functions.

Decisions to Withhold and Withdraw Life-Prolonging Treatment

Difficulties may arise for clinicians treating patients at the end of their lives, whether children or seriously ill adults, who are unable to make decisions about continuation of treatment – is it in the patient’s best interests?

The Mental Capacity Act 2005 has a ‘best interests checklist’ to guide clinicians and others making decisions for a person who lacks capacity. They should make reasonable attempts to seek the views of family and other carers of the person who may be able to provide information about the patient’s previous wishes, views and values. Unless someone has a Lasting Power of Attorney to make decisions for the patient then these discussions are for information sharing and not for the family to make a decision on behalf of the patient (see section on the Mental Capacity Act).

Where the patient is a baby or young child then the parents make decisions about treatment in the best interests of the child. If there is a difference of opinion between the parents and clinicians about what is in the child’s best interests then it may be necessary to ask the court for guidance The key factor in considering whether treatment should be provided or withdrawn is an assessment of the benefits and burdens of treatment. Criteria for deciding best interests are the same as for adults and include the ability to interact and the capacity for self-directed action and whether there will be suffering of severe unavoidable pain and distress (Section 14 BMA Guidance for decision making, Withholding and Withdrawing Life-prolonging Medical Treatment).

In the case of Re J (1990) the court considered whether, if treatment were provided, the patient’s life would be “so afflicted as to be intolerable”. If so, then it would not be in the patient’s best interests to provide treatment.

The GMC guidance Treatment and care towards the end of life 2010 sets out a decision making model for end of life care when a patient lacks capacity (paragraphs 15 and 16)

Case Study

Baby C born 8 weeks prematurely and contracted meningitis soon after birth. As a result she suffered severe brain damage and an inability to respond to stimuli. She was receiving artificial ventilation. The treating team thought that it was not in the baby’s best interests to continue with artificial ventilation, without which she would die within an hour. With continuance of such treatment she would live for at most one year, probably experiencing pain and distress. For religious reasons her parents could not agree to withdrawal of treatment.

What issues should an ethics committee consider in reviewing such a case?

Withdrawal of treatment will result in the death of baby C. On the other hand continuance of artificial ventilation would mean the continuance of suffering. Although the principle of sanctity of life is a fundamental consideration it is not an absolute principle and the duty of beneficence, doing the best for the patient, may lead to the conclusion that continued treatment is not in the best interests of baby C. Legal cases have indicated that it would not be in the best interests of the baby to continue treatment in order to prolong a life where suffering is intolerable (for the baby). (See above, Re J 1990).

The parents should decide on the course of treatment that is in the best interests of their child. However, they cannot, for religious reasons, consent to withdrawal of treatment. If clinical opinion concludes that the suffering baby C would endure with treatment would be intolerable, then there is a potential for conflict with the parents.

‘Best interests’ is not purely an assessment of medical interests and although consideration of the parents views of the interests of the child is an important part of the assessment these views cannot determine the course of treatment to be followed. GMC guidance addresses this difficulty of conflicting views of best interests in the case of children.

GMC End of life care
108 If disagreements arise about what course of action would be in a child or young person’s best interests, it is usually possible to resolve them by, for example, involving an independent advocate; seeking advice from a more experienced colleague; obtaining a second opinion; by holding a case conference or ethics consultation; or by using local mediation services. If, after taking such steps, significant disagreement remains, you should seek legal advice on applying to the appropriate court for an independent ruling. Approaching the court should be seen as a constructive way of thoroughly exploring the issues and providing reassurance for the child and parents that the child’s interests have been properly considered in the decision.

Another consideration in a case like this is the use of limited health care resources. If this baby continues to be ventilated with no chance of recovery, then an intensive care bed will be required. The demand on intensive care beds is great and this may mean that another child requiring a bed will need to be moved to a different unit, possibly reducing their chances of survival. How can a just use of resources be included in the assessment of what would be the right thing to do in this case? The GMC offers some guidance

GMC End of life care

37 Decisions about what treatment options can be offered may be complicated by resource constraints - such as funding restrictions on certain treatments in the NHS, or lack of availability of intensive care beds. In such circumstances, you must provide as good a standard of care as you can for the patient, while balancing sometimes competing duties towards the wider population, funding bodies and employers There will often be no simple solution. Ideally, decisions about access to treatments should be made on the basis of an agreed local or national policy that takes account of the human rights implications. Decisions made on a case by-case basis, without reference to agreed policy, risk introducing elements of unfair discrimination or failure to consider properly the patient’s legal rights

For an interesting discussion of the issues arising when a patient in intensive care is declared brain stem dead but according to the family’s religious beliefs is still alive and should continue to receive treatment: see
Brain stem death: managing care when accepted medical guidelines and religious beliefs are in conflict Inwald, Jakobovits, Petros, Fisher,and Raper, BMJ, May 2000; 320: 1266 - 1268.

Professional guidance

Various professional bodies, including the BMA and GMC, have issued guidance on end of life issues.

General Medical Council
The GMC published new guidance Treatment and care towards the end of life in 2010.
The publication followed extensive public consultation and provides advice on a range of issues relating to end of life care including frameworks for decision making for people who have capacity and those who do not, the role of families, working in teams, dealing with uncertainty, emotional issues and resource constraints. The principles underpinning the guidance are set out in paragraphs 7-13.

British Medical Association
The BMA has a range of publications on issues related to end of life decision making which can be found on the ethics page of its website. A Parliamentary brief from the BMA summarising their views on end of life decisions. The guidance covers three main areas:

contemporaneous and advance refusal of treatment
withholding and withdrawing life-prolonging medical treatment
assisted dying - euthanasia and assisted suicide.

The guidance summarises some of the BMA’s other guidance in this area.

The BMA has also published guidance on cardiopulmonary resuscitation in collaboration with the UK Resuscitation Council and the Royal College of Nursing.
Decisions relating to cardiopulmonary resuscitation (2007)

Royal College of Paediatrics and Child Health
The RCPCH sets out a framework for decision making and identifies ethical issues arising in decisions to withhold or withdraw treatment from children.
Good Medical Practice in Paediatrics and Child Health, Royal College of Paediatrics and Child Health (2002)

Legal Considerations

The legal position on end of life issues is clear but the application of the legal principles to actual cases can cause difficulty. The legal principles can be seen to derive from some of the ethical principles discussed in the previous section.

It is illegal to actively bring about someone’s death, either with or without the person’s consent. This covers both physician assisted suicide and the situation of giving a lethal injection to an incompetent patient.
An omission to act that (intentionally) results in the patient’s death is permissible where it is not in the patient’s interests to continue treatment (Airedale NHS Trust v Bland [1993] 1 All ER 821).
Court approval should be sought in all cases where treatment is proposed to be withheld / withdrawn from a patient in Permanent Vegetative State (Airedale NHS Trust v Bland [1993] 1 All ER 821).
Withholding and withdrawing treatment are both considered omissions to act.
A competent patient can refuse treatment, including requesting that ongoing treatment is withdrawn, even if that results in the patient’s death (Re B Consent to treatment: Capacity, 2002). The clinician would not be assisting a suicide. Treatment given in the face of a refusal would amount to battery.
A competent patient cannot request that a positive act is taken to end his/her life (R (on the Application of Pretty) v DPP [2002] 1 All ER 1). This would amount to assisted suicide. No right of self-determination in relation to death is created by the Human Rights Act 1998.
Where a clinician owes a duty of care to provide treatment to a patient then failure to do so will be a culpable omission. However the duty to provide life sustaining treatment is not absolute. There are exceptions including when a patient refuses such treatment or when the patient is incompetent and it is not considered in the best interests of the patient to be kept alive, for example, patients in persistent vegetative state or when life involves extreme pain, discomfort or indignity (R (on the application of Burke) and the General Medical Council. [2005]EWCA. Civ 1003).
If, as a side effect of giving pain - relieving drugs, the life of a terminally ill patient is thereby shortened, this is lawful under the doctrine of double effect (see above) where the intention is to relieve pain.

Bland (Airedale NHS Trust v Bland [1993] 1 All ER 821)

Anthony Bland was 21 years old when overcrowding at the Hillsborough football stadium lead to him being badly crushed. He was left permanently unconscious, in persistent vegetative state. Three years later the hospital Trust applied to the court for a ruling whether it would be lawful to discontinue artificial hydration and nutrition, resulting inevitably in his death.

The House of Lords considered that:

Artificial nutrition and hydration is regarded as a form of medical treatment.
There is no distinction between an omission to treat a patient (withholding) and discontinuance of treatment once commenced (withdrawing).
In making the decision whether or not to provide medical treatment the question to be asked is whether it is in the best interests of the patient that his life should be prolonged.
Previously stated wishes of the patient should be taken into account in the assessment of best interest.

Pretty (Pretty v UK (Application 2346/02) [2002] 2 FLR 45)

Dianne Pretty suffered from motor neurone disease which left her paralysed. She wanted her husband to be able to assist her suicide without fear of prosecution (assisting a suicide is a crime under the Suicide Act 1961) so that she could choose the time of her death and die with dignity. She argued that Article 2 (right to life) of the European Convention on Human Rights protects the right to life and the right to choose the manner of death.

However the House of Lords and the European Court did not find that Article 2 created a right to die and indeed that the need to protect vulnerable citizens justified the prohibition of assisted suicide.

In the past ten years there has been ongoing debate on the issue of physician assisted suicide. The Assisted Dying (terminally ill) Bill Joffe Bill calling for legalisation of PAS was blocked by the House of Lords in the UK Parliament in 2006. In 2010 a similar Bill (the End of Life Assistance (Scotland) Bill)was submitted to the Scottish Parliament. Also in 2010 the Director of Prosecutions in England published a policy on prosecution of assisted suicide. The policy sets out public interest factors in favour of and against prosecution in such cases.

Ethical Considerations

A number of ethical theories and principles are relevant when considering treatment decisions at the end of life.

Sanctity of Life Doctrine

The argument underpinning this doctrine is that all human life has worth and therefore it is wrong to take steps to end a person’s life, directly or indirectly, no matter what the quality of that life. This is in keeping with both traditional codes of medical ethics and a general perception of what doctors and other health professionals should do, that is save and preserve life. One challenge to this principle in the context of health care is to ask should life be preserved at all costs. Is there no place for consideration of quality of life? One of the problems with considering quality of life is the question of how this is defined and by whom. An objective view of someone’s life may be very different to the view of the person who is living that life. However, this problem does not remove the challenge to the sanctity of life doctrine. There may be some circumstances where a person’s quality of life, however defined, is so poor that it should not be maintained even if it is possible to do so. Some ethical arguments have been developed to address this challenge.

Acts /omissions distinction

This distinction argues that there is a difference between actively killing someone and refraining from an action that may save or preserve that person’s life. Thus it is morally wrong to push someone into a river to their death but we may not have a moral duty to leap into the river to save someone who is drowning. In a medical context this distinction would mean that a doctor could not give a patient a lethal injection to end his/her life, whatever the circumstances, but could, withhold treatment that may sustain it. Withholding treatment would only be permissible if the patient’s quality of life was so poor, and the burden of treatment so great, that it would not to be in the patient’s best interests to continue treatment. For example, it might be permissible not to ventilate a patient if he/she was in chronic respiratory failure, or not to use tube feeding if he/she was in a permanent vegetative state.

Doctrine of Double Effect

The doctrine of double effect argues that there is a moral distinction between acting with the intention to bring about a person’s death and performing an act where death is a foreseen but unintended consequence.

The doctrine of double effect allows that performing an act that brings about a good consequence may be morally right even though the good consequence can only be achieved at the risk of a harmful side effect. Prescribing pain relieving drugs which in large doses shorten the life of a terminally ill patient is often used as an example of double effect. The intention is to relieve pain and the foreseen but unintended consequence is that the patient’s life will be shortened. Current practice in palliative medicine and the range of drugs available may reduce the appropriateness of this doctrine.

Respect for autonomy

The principle for respect for autonomy acknowledges the right of a patient to have control over his or her own life, including decisions about how his/her life should end. Thus a competent person should be able to refuse life saving treatment in both current situations and future foreseeable situations. Should respect for autonomy mean that a person can request assistance in ending his/her life? Some would argue that this is the case but as assisted suicide is currently illegal in the UK this is not an issue that a clinical ethics committee should need to consider. Does respect for autonomy mean that a patient can request treatment that the clinician does not think is in his/her best interests, or treatment that is futile? In these situations the principle of respect for autonomy comes into conflict with other ethical considerations, such as preventing or avoiding harm, or distributive justice.

A duty to act in the patient’s best interest (Beneficence)

The duty of beneficence, that is to act in a way that benefits the patient, is an important ethical principle in health care. In treatment decisions at the end of life the dilemma often revolves around what course of action will be in the patient’s best interests. It is difficult to see how death can be a benefit or in the patient’s interests, but in some circumstances, if existing quality of life is so poor, or treatment is very burdensome, then the balance of harms and benefits may suggest that continuing treatment is not a benefit to the patient.

A duty not to harm (Nonmaleficence)

The concept of nonmaleficence - an obligation not to inflict harm intentionally, is distinct from that of beneficence - an obligation to help others. In codes of medical practice the principle of nonmaleficence (primum non nocere) has been a fundamental tenet. However, in the context of health care it can sometimes be difficult to comply with this principle depending on the definition of harm. Many medical treatments may have harmful side effects but save or improve lives. In end of life decisions the question of how much harm is caused by the treatment needs to be considered, as does the question of whether death itself is always a harm.

Introduction

Decisions about medical treatment that have consequences for the timing and nature of a person’s death engender strong emotions in both health professionals and the public and raise difficult ethical issues for all concerned. They can often be a source of conflict between health professionals and patients’ families, or between health professionals within a health care team. Ethical dilemmas arise when there is a perceived conflicting duty to the patient, such as a conflict between a duty to preserve life and a duty to act in a patient’s best interests, or when an ethical principle such as respect for autonomy conflicts with a duty not to harm. Decisions at the end of life are among the most frequently discussed issues in a clinical ethics committee, in the context of both individual cases and in determining Trust policy. In this section we provide a brief overview of the ethical and legal approaches to end of life decisions and then look at some specific issues that may be brought to committees by clinicians. We illustrate these with some hypothetical cases. The section concludes with some suggested further reading on the issues.

This section does not provide a comprehensive overview of the issues around end of life decisions, and does not make recommendations about what an ethics committee should do. It highlights issues that a committee may wish to consider and provides some ethical and legal frameworks for approaching the subject.

Issues that may present to a clinical ethics committee

The issue of resource allocation is beginning to come to Clinical Ethics Committees for consideration.

Below we use hypothetical cases to illustrate the ethical principles a committee needs to consider in approaching requests for advice on issues of resource allocation.

Case One: Who should have the intensive care bed?

Most choices regarding resource allocation are made at a managerial level. However, clinicians are faced with difficult decisions about determining priorities within the limited resources available in their area. For example, what should you do if the intensive care unit is full and a patient that requires intensive care is admitted to the hospital?

Barry is a 32 year old man with meningitis and is brought into the A&E department of hospital A. He is unconscious with an extremely low blood pressure and evidence of renal failure. His condition is grave and without intensive care support he is almost certain to die. With intensive care support he may make a full recovery. Until this illness he has been fit and well. The Intensive Care Unit (ICU) in hospital A is full, with some patients critically ill and some in a relatively stable condition but for who optimum care would still require the facilities of an ICU. There is evidence that moving a patient from an ICU early increases their chances of complications and may increase mortality. There is an available bed in an ICU in hospital B, which is fifty miles away. The intensive care consultant on call must decide if Barry should be moved to hospital B or if a patient already in ICU should be transferred to allow Barry to be admitted. The clinical ethics committee is asked to review the case retrospectively and advise on how such cases should be approached in the future.

Questions for the committee to consider

Does the clinical team, or the institution, which the CEC is advising owe an equal duty of care to both patients?
If each patient is owed the same duty of care, should the aim be to maximise the chance that both patients live, or minimise the chance that both patients die.
In contrast to 2, should the sickest patient be given any greater priority in receiving best possible care?
If the patient in ICU is owed a greater duty of care, is this sufficient to justify the decision not to admit the other patient, given the foreseeable probable outcome?
Is patient autonomy relevant in this situation?
Keep in mind that it is not possible to provide the best care to both patients

Discussion of the issues

The first step in considering such a dilemma is to establish the clinical facts and clarify the concepts used. This process may involve seeking expert opinion from sources outside the clinical team treating the patient and / or outside the Trust. This is an important part of the process of any ethical discussion, but is particularly important in issues of resource allocation when underlying ethical principles include terms such as benefit and need that may be open to interpretation. Thus information such as what will be the benefit of a certain course of action, and to whom it will accrue, and the relative need of the individuals involved, is essential to inform the ethical debate.

Maximising benefit

One way of looking at the dilemma would be to consider the relative benefit of different courses of action. The benefit to Barry of being admitted to ICU is clear; he will die if he is not given intensive care. However, the actual benefit will depend on the likelihood of his surviving even with intensive care. If his chances of making a full recovery are 80% the potential benefit will be greater than if his chance of surviving, even with intensive care, is 10%. The effect of transferring Barry to another hospital on his likely survival would also be important. For a patient already in ICU in hospital A, there can be no benefit from moving them out of ICU and transferring them to another hospital. The assessment here would be of the possible risk of such a move and the likely effect on their long-term recovery. If the risk is small, and the risk of moving Barry is great, then a utilitarian calculation of the overall benefit may support the transfer of a stable patient in hospital A to provide a bed for Barry. However, a greater risk of transfer for patients already in ICU combined with only a small chance of benefit to Barry from admission (a high likelihood that he will not survive even with treatment) may give a different answer if the criterion for the decision is overall benefit.

Responding to need

Another way of looking at this dilemma is from the point of view of the relative need for intensive care treatment. Barry is in urgent need because without intensive care treatment he will die. One can argue that we have a moral responsibility to respond to such urgent need even if the chances of success are small and it involves a small risk of potential harm to others.

Respecting autonomy

Respecting a patient’s autonomous wishes is an important ethical principle in health care. What weight should be given to the refusal of a patient, or their relatives, to agree to a transfer to another hospital to allow a very sick patient to have their bed? What about the autonomous wish of the patient in the casualty department to have appropriate care in the hospital to which they have been brought? In terms of acceding to patients’ or relatives’ wishes, the principle of autonomy is not particularly helpful in this situation.

Duty of care

Health professionals in an ICU have a duty of care to their patients and must act in their patients’ best interests. Therefore it may be very difficult for them to make a decision that is not entirely in their patient’s best interest. The question arises as to whether the intensive care team also has a duty of care to a patient who is currently physically elsewhere in the hospital but who is in need of intensive care treatment. A further question is whether the hospital management has an equal duty of care to both patients, and if so how does this fit with the clinician’s duty of care?

Case two: Should a clinician prescribe a new treatment that is more expensive than the standard treatment?

Dr Z is consultant at a specialist cancer unit. A new cancer treatment has recently become available for use in patients who have reached the end of conventional treatment for a particular type of cancer. Without further treatment less than 5% of patients will survive for 6 months. With the new treatment 40% of patients survive for six months and 5% are still alive at one year after treatment.

40% of patients survive for 6 months
If we treat 100 people we will gain 20 life years (40 multiplied by 0.5)
Cost of treating 100 patients is £500,000
Cost per life year gained is £25,000 (500,000 divided by 20)

5% of patients survive one year
If we treat 100 patients we will gain 5 life years
Cost of treating 100 patients is £500,000
Cost per life year gained is £100,000 (500,000 divided by 5)

Thus, the cost of one life year gained with this treatment is £25,000 if we use 6 month survival figures and £100,000 if we use one year survival figures.

Dr Z has a patient for whom he wishes to prescribe the new treatment. Alice is a 27 year old mother of two young children. Dr Z argues that an extra 6 to 12 months of life will make a huge difference to Alice and her children, and it is possible that within those 12 months further advances in treatment may be made. Furthermore, if she is one of the 5% of patients who survive for one year, she may go on to survive for much longer as there is little experience of this drug in the longer term. The Trust managers are concerned that they will not be able to meet the total cost of treating all patients who may benefit from this drug without cutting other services or treatments. They ask the clinical ethics committee to consider the ethical implications of this request for treatment.

This issue could come to a CEC of an acute trust where a clinician is asking the acute trust to fund such treatment.
If the acute trust says that it cannot afford the treatment, then the issue could go to the local PCT as a request for further funding to the acute trust.

Questions for the Committee to consider

If this treatment were funded, how many other patients would have a claim on this drug?
Is the cost per life year gained greater than that normally funded by the Trust? If so, from which budget should the funding come? From the envelope of resources for cancer care, or from other services? In which case, is this fair?
Does the fact that this patient has dependent children affect the decision? If it does, and if it provides a reason for giving greater priority, does this have implications for allocation decisions elsewhere in the Trust?
Does the increase in probability of extended life, and the predicted extent of extended life, justify paying more for a treatment than the Trust can normally afford? Are there other examples within the Trust of expensive interventions being used because of a chance of saving someone’s life?

Discussion of the issues

Maximising benefit

A utilitarian approach to this dilemma would be to consider the cost effectiveness of the new treatment compared to other treatments currently provided by the cancer unit and by the trust as a whole. Money used to fund the new treatment would need to come from other treatments or services, assuming that the trust was fully committed financially. Therefore, to maximise benefit to all patients across the Trust it is necessary to have a threshold for cost effectiveness of treatments or services that the Trust will fund. This allows different treatments or services to be compared directly on cost effectiveness terms and ensure that resources are used efficiently. Inefficient use of resources will reduce the overall benefit that can be achieved. If the Trust had a threshold of £20,000 per QALY or per life year extended, then the new treatment proposed by Dr Z would not fulfil the cost effectiveness criterion. One problem with only considering the cost effectiveness of the new drug is that other treatments already available may be less cost effective.

Responding to need

Are there reasons other than cost effectiveness to fund this new treatment? A persuasive argument would be the pressing need of Alice for treatment, without which she will die very soon. Even if the treatment only extends her life by six months that is a significant length of time for someone who is otherwise likely to die in a few weeks. In comparison, other treatments that are funded within the trust may not extend life but simply improve the quality of life for those having treatment. Is extending life always more important than improving the quality of life?

Fairness and morally relevant differences

If it were not possible to provide funding for every patient who might benefit from this treatment, could Dr Z argue that the fact that Alice has two small children who would benefit from having their mother around for even a short amount of time, gives her a stronger case than others without children for receiving treatment? This raises the question of whether having children is a morally relevant difference and justifies ‘unequal’ treatment. What if, rather than having dependent children, Alice is the main carer for her elderly mother?

Autonomy:

How much account should be taken of Alice’s views of what treatment she wants? Respecting patient autonomy is important but the wishes of individual patients must also be balanced against the interests of others. In the context of limited resources, as we saw in case one, the principle of individual autonomy is not particularly helpful.

Case three: Prevention or treatment?

Decisions about setting priorities for treatments and services on a larger scale raise difficult ethical issues for PCTs. A PCT may seek advice on the ethical issues arising from these ‘macro-level’ decisions from a priorities forum, or a PCT may develop their own ethics committee to inform these decisions.

Metroville PCT has a sum of recurring money that has been ring-fenced for use in the area of ischaemic heart disease. The PCT has two proposals for developing services in this area and must decide which proposal to fund.

Proposal 1 is from the local acute trust and is for an increase in angiography and angioplasty services. The proposal cites evidence from research studies to show that reducing waiting times for angioplasty will save lives and is a cost effective use of resources.

Proposal 2 is from the local diabetes group and is for a project that will focus on the small Asian community within the population. This community has a high prevalence of diabetes and ischaemic heart disease and traditionally has tended to use health care services only when they are acutely ill rather than attending for regular care of their chronic diseases. The proposal is to provide a specialist diabetes nurse and health advocate for this population and an educational programme for the whole community focusing on prevention of diabetic complications and promotion of life-style changes to reduce the incidence of new cases of diabetes. There is no research evidence for this intervention but there is some anecdotal evidence from other areas that this approach has some success.
The PCT must choose one of these proposals.

Questions for a priorities forum to consider

Should the aim of the PCT be to provide the best value health care for the whole population by always funding the most cost effective treatments, or are there other considerations that would outweigh the cost effectiveness argument?
If overall value to the whole population is the most important consideration, how does the PCT compare the value of different interventions when different levels of evidence are available for each?
Is providing a service that is equally accessible to everyone in the population who could benefit from it (angioplasty and angiography) fairer than providing a service that will only benefit a specific section of the population who could benefit (diabetes intervention for minority ethnic group)?
Should the PCT put more resources into services for specific groups that are currently disadvantaged in health terms, compared to the general population, to redress the balance, even if these services are less cost effective than those usually funded by the PCT?
Should services that have an immediate impact in terms of saving lives always be preferred over those that may reduce the risk of future death (and thus save lives in the future)?

Discussion of the issues

As with individual clinical cases, the first step in considering such an issue is to obtain as much relevant information as possible about the two interventions, including the views of users of the services as well as providers.

Maximising benefit

An important consideration for a PCT is how to use its limited budget in an efficient manner in order to provide as much overall benefit as possible for the community it serves. A utilitarian perspective of maximising benefit will require an assessment of the evidence of how effective each intervention is and the cost of obtaining that benefit. QALY calculations, if available, would be useful in this context. However, not all health care interventions have robust research evidence, including economic data. Some interventions are difficult to assess in a randomised controlled trial, and some medical conditions are less attractive to researchers or funders of medical research. A lack of evidence about the effectiveness of an intervention is not the same as good evidence that the intervention is not effective. Making a decision that was informed only by evidence of cost effectiveness of the competing interventions would tend to favour interventions for which evidence was available and could lead to unfair treatment of patients with equal need. The priorities forum of Metroville PCT may wish to consider evidence of effectiveness for the diabetes intervention other than that from formal research studies to obtain a more balanced view of the likely overall benefit to its population.

Reducing inequity

A different approach to this difficult decision would be to consider what would be a just distribution of resources in the context of existing health inequalities within the population served by the PCT. If the Asian community was particularly disadvantaged in terms of its health compared to the population as a whole, then one could argue that targeting resources at this group will reduce inequality in health between it and the general population.

Responding to need

One argument for funding the increased angioplasty service could be that those patients who will benefit from this service are in more acute need than those who will benefit from the diabetes intervention. Even if more lives could be saved in the long term from a preventive service, there are identifiable individuals on the angioplasty waiting list who may die very soon if not treated. Is it more important morally to save the lives of identifiable patients in the short term or to save the lives of as yet unidentified patients in the long term?

Equal access to treatment

What if waiting times for angioplasty were longer in this PCT than in other areas of the country? If this were the case one could argue that this is unjust and that the resources should be used to redress this inequality. A similar argument could be made for the diabetes intervention. How do we balance the demand of equal access to a specific treatment for all who would benefit, and equal access to appropriate treatment for people with different conditions but equal need?

How much weight is given to the different principles and perspectives will affect the outcome of the decision. There is no ranking formula for this process. What is important is that members of the committee or forum consider carefully all relevant facts and values in deliberating the issue. As PCTs will be expected to justify their decisions to their population, a fair and transparent process that is followed for each decision will also be of great importance.

Professional guidance

Any professional guidance will set the benchmark for ethical thinking on a particular topic. In general there is little professional guidance for health professionals in making decisions about allocation of resources. Guidance issued by the GMC identifies that a doctor should consider the needs of his patients individually, whilst also taking into account that treatment for a particular patient may impact on the availability of treatment for his other patients.

General Medical Council (GMC)

The GMC states that while the duty of a doctor is to his or her individual patient, there is also a duty to other patients and the wider community.

The duties of a doctor registered with the General Medical Council

“Patients must be able to trust doctors with their lives and well-being. To justify that trust we as a profession have a duty to maintain a good standard of practice and care and to show respect for human life. In particular as a doctor you must:
- make the care of your patient your first concern”

Duties of a doctor GMC

However, there may be a conflict between the doctor’s duty to a particular patient and his or her duty to other patients and the wider community.

The GMC document ‘Priorities and Choices’ directly addresses the issue of determining priorities in the context of limited resources.

Priorities and Choices, July 2000 paragraph 8

“In determining priorities between individuals for a limited resource, clinicians should have regard for the three duties of care [to protect life and health, to respect autonomy and to treat justly]. In many cases this assessment will give priority to the need to protect life and health, so that those whose healthcare needs are greatest or most urgent on clinical assessment will receive priority.”

www.gmc-uk.org/guidance/library/priorities_choices.asp

The GMC recognises the particular difficulties that face clinicians who also have a managerial role within health care (for example medical and nursing directors or clinical members of PCT executives).

Management in Health Care - The Role of Doctors, May 1999, paragraph 7.

“Conflicts may arise when doctors are called upon to make decisions about the use of resources and about patients’ care, when the needs of an individual patient and the needs of a population of patients cannot both be fully met. Dilemmas of this kind have no simple solution. When taking such decisions, doctors should take into account the priorities set by Government and the NHS and/or their employing or funding body. But they must also be clear about their own role. As clinicians, doctors must make the care of their patients their first concern, bearing in mind the effects of their decisions on the resources and choices available for other patients. As managers, doctors must allocate resources in the way that best serves the interests of a community or population of patients. In both roles, doctors should use evidence from research and audit to make the optimum use of the resources available”
National Institute for Clinical Excellence (NICE)
www.nice.org.uk
The National Institute for Clinical Excellence (NICE) was set up as a Special Health Authority for England and Wales on 1 April 1999. It is part of the National Health Service (NHS) and its stated role is to
“provide patients, health professionals and the public with authoritative, robust and reliable guidance on current ‘best practice’.”
NICE guidance and funding implications
NICE sets out the obligations of health professionals to provide treatment which it has recommended to be provided. This is set out in ‘A Guide to NICE’ (page 6):
“Once NICE guidance is published, health professionals are expected to take it fully into account when exercising their clinical judgment. However, NICE guidance does not override the individual responsibility of health professionals to make appropriate decisions according to the circumstances of the individual patient in consultation with the patient and/or their guardian or carer.”
However there seems to be some contradiction about who is responsible for any increased funding implications of NICE recommendations. On one reading of A Guide to NICE the NHS is responsible through its technology appraisals:
“Since January 2002, the NHS has been obliged to provide funding and resources for medicines and treatments recommended by NICE through its technology appraisals work programme.”
On another reading the responsibility would fall to local NHS organisations e.g. PCTs:
“Local NHS organisations are expected to meet the costs of medicines and treatments recommended by NICE out of their general allocations”.
The issue of funding NICE recommendations has received attention recently with the publication of NICE guidance on provision of infertility treatments.
NICE guidance recommends that the NHS funds up to three cycles of IVF treatment for those couples meeting specific criteria. However, NICE guidance will not yet be fully implemented and the Health Secretary has said that couples will only be offered 1 cycle of IVF treatment and there is no deadline for full implementation of the guidance. There is a question for PCTs about how they will implement this recommendation within their limited healthcare budget.
CG11: Fertility: assessment and treatment for people with fertility problems.
www.nice.org.uk/pdf/CG011niceguideline.pdf
This issue was considered in:
NICE, the draft fertility guideline and dodging the big question, J R McMillan, J. Med. Ethics, Dec 2003; 29: 313 - 314.
Legal considerations
We consider below the legal implications of some topical issues relating to resource allocation in the National Health Service.
Is there a right to medical treatment?
Going abroad for treatment
Does the European Convention on Human Rights (incorporated into UK law by the Human Rights Act 1998) provide a right to medical treatment?
Article 2 states that there is a ‘right to life’. There is a positive obligation upon the State to ensure that this right is respected. Does this mean that there is a right to medical treatment? The positive obligation under Article 2 must be interpreted in a way that does not impose an impossible or disproportionate burden on the authorities. Therefore, although the State cannot be expected to fund every treatment, it must act reasonably in allocating resources.
The European Court in Osman v UK ((1998) 29 EHRR 245) said that there will be a range of policy decisions relating to the use of state resources which it will be up to the contracting states to assess on the basis of their aims and priorities, subject to these being compatible with the values of democratic societies and the fundamental rights guaranteed in the Convention.
Article 8 provides a right to respect for private and family life. This does not impose an obligation upon the State to provide medical treatment. Article 8(2) allows the state to restrict the right to respect for private and family life in the interests of the protection of health or morals, or the protection of the rights and freedoms of others. This requires a balance to be struck between the interests of the community and those of the individual.
A refusal to fund medical treatment because of the advanced age of the patient could be a breach of Article 2 and Article 14 (prohibition on discrimination). Article 14 would also be relevant where resources are not allocated for treatment on the grounds of gender.
Treatment in EU Member States
E112 authorisation is a Department of Health scheme whereby prior authorisation can be obtained for a patient to receive treatment abroad where he/she would otherwise face ‘undue delay’.
If approved, payment under the NHS would be made by the PCT.
Watts v Bedford PCT and the Department of Health [2004] EWCA Civ 166.
Mrs Watts suffered constant hip pain and had limited mobility. She was on an NHS waiting list for a hip replacement and given a waiting time of approximately one year. She applied to have the operation performed in France under E112 authorisation. The PCT refused, one of the reasons given was that as she would receive the operation within the normal waiting time she would not suffer undue delay.
The normal NHS waiting time for the treatment had been used as a threshold, but the Court said that this could not be the sole determinant of what constitutes ‘undue delay’. The fact that a waiting time is normal (in the UK) does not necessarily mean that it is reasonable. Other relevant factors that should be taken into account are: whether the patient is in pain, has had repeated delays in treatment or will suffer deterioration if treatment is delayed, in assessing whether there has been undue delay.
The original waiting time for Mrs Watts of one year would have amounted to undue delay despite the fact that this fell within NHS Target waiting times. However, she was reassessed about three months later and, because her condition had deteriorated she was reclassified as an urgent patient to be provided treatment within 3 to 4 months time, thus there was no undue delay
The attitude of the Courts to resource allocation
A patient who has been refused treatment may appeal to the court by way of judicial review. In reviewing the decision to refuse treatment the court does not look at the merits of the decision but rather whether it was taken lawfully, e.g. did the decision-maker have the power to make the decision, were the correct procedures followed, were relevant considerations taken into account and was it reasonable and proportionate. The court would then decide whether the PCT has acted lawfully in refusing to fund treatment. Traditionally the courts have been reluctant to involve themselves in the allocation of resources as they consider that judges lack the expertise to make such decisions and that those charged with the duty, i.e. managers in Health Authorities (now PCTs) should be left to make the decision. The court does have the right to find that a decision is unlawful.
It is true that the NHS does have a statutory duty to provide medical treatment. But that is not and, because resources are finite, cannot be, a duty to provide all conceivable treatments in all circumstances. In R v East Devon Health Authority ex p Coughlan, [2000] 3 All ER 850, the Court of Appeal said that, in exercising judgments about resource allocation, the Secretary of State for Health (and therefore all bodies which took their powers from him) had “to bear in mind the comprehensive service which he is under a duty to promote….However, as long as he pays due regard to that duty, the fact that the service will not be comprehensive does not mean that he is necessarily contravening [his statutory duty]. The truth is that, while he has the duty to continue to provide a comprehensive free health service and he must never….disregard that duty, a comprehensive health service may never, for human, financial and other resource reasons, be achievable….In exercising his judgment the Secretary of State is entitled to take into account the resources available to him and the demands on those services. In R v Secretary of State for Social Services and others ex p Hincks (1980) 1 BMLR 93 the Court of Appeal held that s. 3(1) of the Health Act does not impose an absolute duty to provide the specified services. [He] is entitled to have regard to the resources made available to him under current government policy.”
In R v North West Lancashire Health Authority ex p A and others [2000] 1 WLR 977, which concerned the legality of a refusal to fund gender reassignment surgery, the Court of Appeal said this about the general principles to be applied in making decisions about resource allocation:
“As illustrated in the Cambridge Health Authority and Coughlan cases, it is an unhappy but unavoidable feature of state funded health care that Regional Health Authorities have to establish certain priorities in funding different treatments from their finite resources. It is natural that each Authority, in establishing its own priorities, will give greater priority to life-threatening and other grave illnesses than to others obviously less demanding of medical intervention. The precise allocation and weighting of priorities is clearly a matter of judgment for each Authority, keeping well in mind its statutory obligations to meet the reasonable requirements of all those within its area for which it is responsible. It makes sense to have a policy for the purpose - indeed, it might well be irrational not to have one - and it makes sense too that, in settling on such a policy, an Authority would normally place treatment of transsexualism lower in its scale of priorities than, say, cancer or heart disease or kidney failure. Authorities might reasonably differ as to precisely where in the scale transsexualism should be placed and as to the criteria for determining the appropriateness and need for treatment of it in individual cases.
It is proper for an Authority to adopt a general policy for the exercise of such an administrative discretion, to allow for exceptions from it in “exceptional circumstances” and to leave those circumstances undefined; see In re Findlay [1985] 1 AC 318, HL, per Lord Scarman at 335H-336F. In my view, a policy to place transsexualism low in an order of priorities of illnesses for treatment and to deny it treatment save in exceptional circumstances such as overriding clinical need is not in principle irrational, provided that the policy genuinely recognises the possibility of there being an overriding clinical need and requires each request for treatment to be considered on its individual merits”.
R v Cambridge HA ex p B [1995] 2 All E.R. 129
A ten year old girl had non Hodgkin’s lymphoma with common acute lymphoblastic leukaemia. She was receiving palliative care only. Her father had sought other medical opinions recommending other treatments. He wanted the Health Authority to fund a further course of chemotherapy and a bone marrow transplant. It refused on the grounds that the proposed treatment was unproven and that the cost was disproportionate to the likely benefit.
In the court of first instance Laws J. said that where a life was at stake then a health authority must ‘do more than toll the bell of tight resources’ and must explain the priorities that led them to decline to fund the treatment. He referred to the fundamental right to life and that the Health Authority should justify any limitation on that right if it refused to fund treatment.
However, the Court of Appeal did not invoke the right to life. The court said that in reviewing the decision of the Health Authority it must only look at the lawfulness of its decision and not the merits.
“Difficult and agonising judgments have to be made as to how a limited budget is best allocated to the maximum advantage of the maximum number of patients. That is not a judgment which the court can make.”
Has the law moved on? Now that the Human Rights Act 1998 is in force could an individual argue that a decision to refuse to fund treatment infringes his right to life? The English courts’ reluctance to adjudicate in disputes about the allocation of resources is mirrored in the jurisprudence of the European Court of Human Rights at Strasbourg. Probably, in relation to resource allocation questions, the European Convention on Human Rights adds little to the position under purely domestic public law. If a decision about funding is made irrationally (for instance taking into account irrelevant factors or not taking into account obviously relevant factors), then the court is likely to interfere. But irrationality is hard to show. It is no easier simply because the argument is framed in terms of Article 2. Although Article 2 does give an absolute right to life, it does not follow that it confers an absolute right to have whatever is necessary to maintain life. The courts recognise that resources are limited. If person X could go to court saying: “It is a breach of my Article 2 right not to have this treatment”, person Y could equally go to court saying: “My Article 2 right to have treatment has been breached because the resources needed were all used up on person X.” The only way out of that sort of bickering is to resort, in Article 2 debates about resource allocation, to the old public law principles. And that is what the courts have done. If a decision not to fund treatment is based on factors that are relevant e.g. clinical effectiveness of treatment and is made as a result of an explicit and transparent process, then the refusal would probably be justifiable. Courts are likely to regard PCTs as acting reasonably if they refuse to fund treatment where the cost is high and the prospects of success or benefit are limited.

Where decisions about allocation of resources have been made on the grounds (for example), of race, colour or creed, Article 14 of the ECHR is quick to strike them down, (although the public law principles of impartiality and irrationality would produce the same result).
If a decision not to fund treatment is based on factors that are relevant e.g. clinical effectiveness of treatment and is made as a result of an explicit and transparent process, then the refusal would probably be lawful. Courts are likely to regard PCTs as acting reasonably if they refuse to fund treatment where the cost is high and where there is limited prospect of success or benefit of the treatment.
Priorities Forums
Clinical ethics committees may be asked for advice on resource allocation issues at the level of individual patient care or in relation to setting priorities within an acute trust. In the UK, decisions about distributing resources for larger communities and populations lie within the remit of PCTs or health authorities. Many PCTs either have, or are considering developing, a committee or forum to advise on commissioning priorities for the PCT. Some of these priorities forums were originally developed within area health authorities prior to the reorganisation of the NHS in 2003. PCTs also have committees or panels that consider requests for individual patient treatments that fall outside the broad range of services routinely commissioned by the PCT. Some priorities forums have developed an ethical framework to inform their decision-making. The use of such a framework helps to achieve consistency and transparency of decision-making.
An example of a priorities forum that has developed an ethical framework is the forum first established within Oxfordshire Area Health Authority, and now hosted by Oxfordshire PCTs.
The ethical framework of the Oxfordshire Priorities Forum is structured around three main components:
effectiveness of treatment - the extent to which the healthcare intervention achieves the desired effect - and value of a particular treatment - a judgement on how valuable that effect is for the relevant individual, relative to the value of other treatments
equity - people in similar situations should be treated similarly. There should be no discrimination on grounds of employment status, family circumstances, lifestyle, learning disability, age, race, sex etc.
patient choice - patients can choose between treatments of similar efficiency.

T.Hope, N. Hicks, D.J.M. Reynolds, R. Crisp, S. Griffiths, Rationing and the health authority, British Medical Journal, Oct 17, 1998.
The need for health authorities (or PCTs) to have a framework within which to make decisions about treatment priorities was recognised by the Court of Appeal in 1999.
R v North West Lancashire HA ex p A, D and G (1999) 53 BMLR 148, [2000] 1 WLR 977
The Court of Appeal said that a decision regarding the provision of treatment must be taken within a proper framework.
Although it is appropriate for a Health Authority to have a policy for establishing certain priorities in funding different treatments, in establishing priorities - comparing the respective needs of patients suffering from different illnesses and determining the respective strengths of their claims to treatment - it is vital for the Health Authority to:
accurately assess the nature and seriousness of each type of illness
determine the effectiveness of various forms of treatment for it, AND
give proper effect to that assessment and that determination in the formulation and individual application of its policy
Ethical considerations
Maximising Welfare / Benefit

In many ethical dilemmas in health care, for example informed consent, confidentiality or end of life decisions, the focus is on the individual patient. However, in considering how to make the best use of limited health care resources, the focus of the decision shifts from the individual patient to a group of patients or potential patients, which may be the national population, a local community, or users of a specific service in an a hospital. One ethical theory that lends itself to community or population level decisions is utilitarianism. For a utilitarian, the ethically correct action will be that which results in the maximum overall benefit.
Thus, in making decisions about health care this theory requires consideration of the benefit to be gained from the various competing options in terms of the improvement in health for an individual and also the number of individuals who could benefit. In the context of the allocation of limited healthcare resources a key issue is the cost of the benefit achieved by the healthcare intervention. This approach would tend to favour resources being allocated to less expensive treatments or services that provide the greatest benefit. This may be a treatment that produces a large benefit for a small number of people or a small benefit for a large group of patients.
A criticism of this theory is that it fails to take into account the ‘need’ for healthcare intervention and relies rather on cost effectiveness. For example, it may favour preventative treatment such as cholesterol lowering agents to prevent future deaths from heart disease compared to renal dialysis for end stage renal disease.
The practical application of utilitarian theory in allocation of health care resources can be seen in the use of Quality Adjusted Life Years (QALYs) as a means of quantifying the net benefit from health care interventions to allow comparison of different interventions.
QALYS
QALY stands for Quality Adjusted Life Year.
Alan Williams has described the thinking behind the development of QALYs thus:
“The essence of a QALY is that it takes a year of healthy life expectancy to be worth 1, but regards a year of unhealthy life expectancy as worth less than 1. Its precise value is lower the worse the quality of life of the unhealthy person (which is what the ‘quality adjusted’ bit is all about).”
A. Williams, ‘The Value of QALYs’, Health and Social Service Journal July (1985), 3.
Health care interventions are measured both by the number of extra years of life, and by the increased quality of life, that they can achieve. Thus an intervention that provides 10 years of extra life at full health would have a QALY value of 10, and an intervention that improves quality of life from 0.5 to 0.8 for a person with a predicted further life expectancy of 30 years, would have a QALY value of 9. [0.3 (0.8-0.5) multiplied by 30]. Once the QALY value of a health care intervention is calculated and its cost is known it is then possible to calculate the cost per QALY of each intervention and provide a direct comparison between interventions. The general idea is that a high priority health care activity is one where the cost per QALY is as low as it can be.
Some examples of Cost per QALY calculations:

Hospital dialysis for end-stage renal disease for patients aged 55 – 64 years (compared with no treatment) £45, 000
Coronary artery bypass graft for patients with mild angina (compared with medical management) £26,000
Breast cancer screening programme £6,800
Cervical cancer screening (women aged 20-59 years) £200
Reproduced from Medical Ethics and Law, the core curriculum. T. Hope, J. Savulescu and J. Hendrick, (Churchill Livingstone) 2003 Chapter 13 (table 13.2).
Several objections have been made against QALYs. These include:
1. Many healthcare interventions are not the subject of a QALY assessment and direct comparisons between the cost -effectiveness of different treatments is not possible.
2. QALYs are based on population-level information. They do not take into account the personal response of individuals to their illness and their views of their need for treatment.
3. QALYs are ageist. Ageism is unfair discrimination against a person on the grounds of their age. Some would consider QALYs ageist under this definition because providing treatment for younger people is likely to give a better QALY calculation. Individuals who have a greater span of life ahead of them, typically a younger person, would gain more from treatment on the basis of their predicted life expectancy in comparison with an older person who would have fewer years to benefit from a particular healthcare treatment. So a one -off life-saving intervention performed on a one-year old with a life expectancy of 80 years has a better QALY rating than the same intervention performed on a 70 year old. This would not apply to all treatments. If the treatment needs to be continued indefinitely then the cost per QALY calculation may not favour the younger person because the cost would be greater the longer the patient continued to live.
There are conflicting views about whether QALY calculations are ageist. Most supporters of QALYs argue that QALYs are not ageist because the age of the patients is not taken directly into account. An urgent life-saving treatment for an 80 year old, who was then expected to live 5 years would have the same priority, under the QALY method, as a 40 year old whose life-expectancy was 5 years (because of some underlying, untreatable illness). Michael Lockwood argues that QALYs “are not ageist enough”. He thinks the 40 year old should have greater priority than the 80 year old (in the above example) on the basis of a ‘fair innings’ argument, that is, the older person has already had the advantage of a long life and that treatment should be preferentially given to a younger person.
(Lockwood M, “Quality of life and resource allocation”, in Philosophy and Medical Welfare, edited by J. M. Bell and S. Mendus, Cambridge: Cambridge University Press 1988).
4. Patients who suffer a disability unconnected with the medical condition requiring treatment would be disadvantaged; John Harris calls this ‘double jeopardy’. Those who have a disability would be considered to have a lower quality of life and therefore would benefit less from treatment for an independent separate condition than those who, with treatment could be returned to full health. (Harris J. “Qualifying the Value of Life” Journal of Medical Ethics, Vol 13, Issue 3 117-123, Harris, J. Double Jeopardy and the Veil of Ignorance - A Reply. Journal of Medical Ethics 21:151-157).
Example:
A PCT has to decide on whether to allocate resources to neonatal intensive care services or to increase provision of coronary artery bypass grafts.
A QALY assessment will look at the relative cost of the different treatments and the change in quality of life and life expectancy that will result if the treatment is provided. Neonatal intensive care and coronary artery bypass grafts will both save lives. Some patients who require neonatal intensive care will go on to have healthy lives (QALY value of 1 for each year of life) while others may have diminished quality of life. Patients having coronary artery bypass grafts may not be completely healthy following treatment and will therefore not achieve a QALY value of 1 for each year of life. As heart disease is more common in the elderly, the average life expectancy for patients having coronary artery bypass grafts is likely to be less than that for patients requiring neonatal intensive care. Assuming for the sake of this example that the cost of neonatal intensive care and the cost of coronary artery bypass grafts are the same, then even though some babies will not survive intensive care, the potential life expectancy of the survivors will tend to weigh in favour of this intervention, and against the intervention that is aimed at an older age group.
Equity and Distributive Justice
A possible criticism of the utilitarian or QALY based approach to resource allocation is that it does not provide an equitable or fair way of distributing resources.
Aristotle, explaining his view of distributive justice, says, in effect, that equals should be treated equally, and unequals treated unequally in proportion to the relevant inequalities. This is known as Aristotle’s “formal principle of equality”. Its value lies in its implicit demand that we spell out the criteria we are using when we call people equal or unequal. Aristotle’s own criteria were based on merit; modern criteria may (or may not) be based more on need.(Nichomachean Ethics 1131a-1131b. See for example the edition of Crisp R, Cambridge, CUP, 2000 pp 85-87). The utilitarian or QALY based approach could be said to treat unequals equally, in that it does not take account of differences in need for health care but focuses entirely on the benefit gained from an intervention. Some individuals or groups of patients will have poorer health than others, or more serious diseases, and will have a greater need of health care. If degree of need is a main criterion, a just distribution of health care resources may require that these individuals or groups have more resources, even if the benefit gained by treatment is small compared to that achieved by a different treatment in patients who are less sick.
One ethical theory that considers equity, or fairness, rather than overall benefit is John Rawls’ ‘Theory of Justice’ (Rawls J. A Theory of Justice, The Belknap Press, 1971, revised edition 1999). Norman Daniels has applied this theory to the context of health care. For Rawls, a just system of distribution of ‘goods’ within a society is one in which those members of society who are worst off will be better off under this system than any other. Thus, in the context of health care we should allocate resources to ensure that those in poorest health, or greatest need, are as well off, in terms of health, as they can be.
Assessing and addressing inequity
Reducing health inequalities is seen as an important aim of the National Health Service. But there are different ways of looking at inequality, and some inequalities may be easier to address than others. Which inequalities are inequitable, that is, unfair? The concern about ‘post code prescribing’ relates to inequality of access to treatment across different parts of the country for all those with the same condition, for example access to fertility treatment for all women who meet specific criteria. Other types of inequality arise when comparing access to treatments for different conditions. How does one compare the need for hip replacement with the need for smoking cessation clinics, or the need for a new cancer therapy with the need for a treatment for multiple sclerosis? Even within the context of a specific medical condition, some patients may have a greater need for treatment because of more severe disease. Thus providing equal treatment without some assessment of health status or healthcare need is not always a just or equitable approach in health care.
Considering the social determinants of health
Non-medical factors may produce inequalities between individuals or groups with the same medical conditions such that more resources are required to achieve the same benefit in health. For example, greater resources per person may be needed to improve mortality and morbidity from diabetes or ischaemic heart disease in groups with a high degree of social deprivation than in affluent middle class patients. Is it equitable (fair) to provide greater resources for the more disadvantaged group.
‘The veil of ignorance’
In trying to make decisions about allocation of resources in the context of different needs, it may be helpful to use the concept of the ’ veil of ignorance’ put forward by John Rawls in his Theory of Justice. Faced with a range of possible societies (or possible methods of healthcare resource allocation) you must decide which society you would wish to live in given that you would not know your position in that society, whether you would be old or young, rich or poor sick or healthy. Rawls would argue that a rational person would choose the society (or to allocate resources) so that the most disadvantaged were as well off as they could be.
Determining morally relevant reasons for treating people differently
In considering equitable distribution of health care resources, care must be taken to ensure that any differences between individuals or groups that are used to justify different treatment are morally relevant differences. Thus, differences in race, sex or income are not seen as morally relevant. More controversial issues include whether factors such as personal responsibility for health and the presence of dependents are morally relevant in decisions about priority - setting in health care.
The influence of targets on resource allocation decisions
The recent introduction of targets into the NHS, with penalties for trusts that do not meet those targets, and rewards for those that do, may have an effect on decisions around resource allocation and priority setting. If failure to meet a target would result in fewer resources for future patient care, then it could be argued that maximum overall benefit will be achieved by always meeting targets. However, depending on how targets are set, the focus on achieving targets may result in patients with conditions not the subject of targets being treated unfairly.
Patient Autonomy
To what extent should a patient’s wishes regarding the choice of the course of treatment be respected?
Respect for patient autonomy is a fundamental ethical principle that has assumed greater prominence in the healthcare setting over recent years. The emphasis on informed consent to treatment and shared decision-making within health care highlights the importance of this ethical principle. However, in considering how to allocate scarce health care resources for the whole community, or for all patients with a particular condition, respect for the autonomy of a specific individual may conflict with other values such as equity or the need to benefit the whole community or group, or with the autonomous choices of other individuals. Does respecting a person’s autonomy to make decisions about their treatment mean that they should be able to choose an expensive treatment over a cheaper treatment? If the consequence of complying with such a choice is that treatment will be unavailable to other patients because of the limited available resources this may not be fair.
A balance needs to be struck between respect for individual autonomy, benefiting the whole population and fair distribution of limited resources.
Process of Decision Making
The lack of agreement on basic theory underpinning resource allocation has led to a focus on the process of decision-making. One example of an ethical approach to the process of resource allocation decision-making is that of Daniels and Sabin. (Daniels N. Sabin JE., Limits to health care: fair procedures, democratic deliberation and the legitimacy problem for insurers, Philosophy and Public Affairs, 1997; 26: 303- 350.) This approach is known as accountability for reasonableness. It focuses particularly on macro-level decision-making; that is decisions about treatments and services for populations, such as those made by a PCT. However, the rationale for a process of accountability would be just as relevant for decisions affecting individual patients. Acknowledging the competing ethical principles involved, Daniels and Sabin suggest that for such decisions to be ethical they must satisfy four criteria:
1. Publicity - Decisions and their rationales must be publicly accessible.
2. Reasonableness -The rationales for decisions should appeal to reasons and principles that are accepted as relevant by people who are disposed to finding terms of cooperation that are mutually justifiable.
3. Appeals - There is a mechanism for challenge and dispute resolution.
4. Enforcement - There is either voluntary or public regulation of the process.
A summary by Daniels appeared in Daniels, N. (2000) “Accountability for reasonableness”, British Medical Journal 321, 1300-1301.
Introduction
In the UK, Clinical Ethics Committees (CECs) have until recently focussed very much on individual patient care and many have not specifically considered issues of resources. However, as they become more established in acute trusts and develop in primary care trusts (PCTs) they will be more likely to consider issues that have resource implications, as some already have done.
The distribution of limited healthcare resources, be they money, time, equipment, staff, or organs for transplantation, requires setting of priorities. This is so throughout the health service, both at the level of individual patient care (should a patient be prescribed a particular drug?), and at the level of populations (should a PCT spend more on renal dialysis services than prevention of heart disease?).
Questions of allocation of resources involve a range of ethical considerations including fairness, respect for individual autonomy, responding to individual need and benefiting the whole population.
Difficult choices have to be made where pressing claims are made upon a limited budget. For example, should preference be given to:
Those who are young and have a longer expected time of survival / good health with treatment?
Those who are parents with dependent children?
Treating a greater number of patients rather than fewer patients with a greater need?
Treatment that prolongs life or treatment that improves the quality of life?
Established treatments rather than experimental treatments?
Issues of resource allocation and priority setting are likely to present to clinical ethics committees in both acute trusts and PCTs. As a generalisation, committees in acute trusts are more likely to consider issues involving individual patient treatment, whereas CECs in PCTs will consider issues around strategic priority setting. There will be much in common between the two settings, both in terms of issues, and of the principles and values underlying the decisions.
On these pages we explain some of the ethical theories that underpin thinking on resource allocation and consider their application to practical problems. We also look at some topical legal issues. We have listed relevant professional guidance and have suggested some reading material so you can examine these issues in more depth.
This section does not provide a comprehensive overview of the issues around resource allocation, and does not make recommendations about what an ethics committee should do. It highlights issues that a committee may wish to consider and provides some ethical and legal frameworks for approaching the subject.
CARE (Shneider and Schnell 2000)
(Schneider GW Snell CARE: an approach for teaching ethics in medicine. Social Science and Medicine. 2000; 51:1563-7)
This framework is drafted for individuals but could be used by an ethics committee.
What are my Core beliefs and how do they relate to this situation?
How have I Acted in the past when faced with similar situations? (What do I like about what I have done, what do I not like?)
What are the Reasoned opinions of others about similar situations? (What does our culture say about this situation?)
What has been the Experience of others in the past when faced with similar situations? (What do I like about what they have done, what do I not like?)
The four principles of biomedical ethics
(Beauchamp and Childress; Principles Biomedical Ethics, OUP, 5th edition 2001)
Beauchamp and Childress’ Four Principles 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 are general guides that 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: this considers the balancing of benefits of treatment against the risks and costs; the healthcare professional should act in a way that benefits the patient
Non maleficence: avoiding the causation of harm; the healthcare professional should not harm the patient. All treatment involves some harm, even if minimal, but the harm should not be disproportionate to the benefits of treatment.
Justice: distributing benefits, risks and costs fairly; the notion that patients in similar positions should be treated in a similar manner.
To get some feel for how the Four Principles could be used by a clinical ethics committee consider the following hypothetical case study.
Mrs Y is 56 years old and has a learning disability. She is admitted to hospital with an ovarian cyst. The cyst is blocking her ureter and if left untreated will result in renal failure. Mrs Y would need an operation to remove the cyst. Mrs Y has indicated quite clearly that she does not want a needle inserted for the anaesthetic for the operation to remove the cyst- she is uncomfortable in a hospital setting and is frightened of needles.
The clinician is concerned that if the cyst is not removed Mrs Y will develop renal failure and require dialysis which would involve the regular use of needles and be very difficult to carry out given her fear of needles and discomfort with hospitals. The anaesthetist is concerned that if Mrs Y does not comply with the procedure then she would need to be physically restrained. Mrs Y’s niece visits her in the care home every other month. The niece is adamant that her aunt should receive treatment.
Should the surgeon perform the operation despite Mrs Y’s objections?
Consideration of the ethical issues using the Four Principles framework
Respect for autonomy:
The principle of respect for autonomy entails taking into account and giving consideration to the patient’s views on his/ her treatment. Autonomy is not an all or nothing concept. Mrs Y may not be fully autonomous (and not legally competent to refuse treatment) but this does not mean that ethically her views should not be considered and respected as far as possible. She has expressed her wishes clearly; she does not want a needle inserted for the anaesthetic. An autonomous decision does not have to be the ‘correct’ decision from an objective viewpoint otherwise individual needs and values would not be respected. However an autonomous decision is one that is informed – has Mrs Y been given enough information, in a manner that she can comprehend?
Beneficence:
The healthcare professional should act to benefit his/her patient. This principle may clash with the principle of respect for autonomy when the patient makes a decision that the healthcare professional does not think will benefit the patient – is not in her best interests. Here we should consider both the long term and short -term effects of overriding Mrs Y’s views. In the short - term Mrs Y will be frightened to have a needle inserted in her arm and to be in hospital – this may lead her to distrust healthcare professionals in the future and to be reluctant to seek medical help. In the long term there will be a benefit to Mrs Y in having her autonomy overridden on this occasion. Without treatment she will suffer serious and long-term health problems that would require greater medical intervention (ongoing dialysis) than the treatment required now (operation).
The benefits of acting beneficently would need to be weighed against the dis-benefits of failing to respect Mrs Y’s autonomy. (From a legal point of view the wishes of a competent patient cannot be overridden in his best interests).
Non maleficence:
Do no harm to the patient. Here, Mrs Y would be harmed by forcibly restraining her in order to insert the needle for anaesthesia. On the other hand if she is not treated now she will require ongoing dialysis a number of times per week. If she does not comply with dialysis it would be impractical to administer and may require restraint. Which course of action would result in the greatest harm? This assessment relies on assumptions: how successful is the operation likely to be; how likely will Mrs Y comply with dialysis?
Justice:
It would be relevant to consider cost effectiveness of the treatment options for Mrs Y, and the impact the decision about her treatment has on the availability of treatment for others (awaiting dialysis).
The four quadrant approach
Jonsen, Siegler and Winslade; Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine (3rd edition McGraw-Hill 1992)
The following questions should be worked through in order.
Indications for medical intervention - establish a diagnosis, what are the options for treatment, what are the prognoses for each of the options.
Preferences of patient - is the patient competent- if so what does he / she want? If not competent then what is in the patient’s best interest?
Quality of life - will the proposed treatment improve the patient’s quality of life?
Contextual features - do religious, cultural, legal factors have an impact on the decision?
Consideration of the ethical issues in a case using the four quadrant approach
Mrs Y is 56 years old and has a learning disability. She is admitted to hospital with an ovarian cyst. The cyst is blocking her ureter and if left untreated will result in renal failure. Mrs Y would need an operation to remove the cyst. Mrs Y has indicated quite clearly that she does not want a needle inserted for the anaesthetic for the operation to remove the cyst- she is uncomfortable in a hospital setting and is frightened of needles.
The clinician is concerned that if the cyst is not removed Mrs Y will develop renal failure and require dialysis which would involve the regular use of needles and be very difficult to carry out given her fear of needles and discomfort with hospitals. The anaesthetist is concerned that if Mrs Y does not comply with the procedure then she would need to be physically restrained. Mrs Y’s niece visits her in the care home every other month. The niece is adamant that her aunt should receive treatment.
Should the surgeon perform the operation despite Mrs Y’s objections?
Medical Indications:
Mrs Y has been diagnosed with an ovarian cyst and so the options for treatment should be considered. What is the prognosis with the operation, considered against the prognosis without treatment (or with ongoing dialysis)? If she does not have the operation and requires dialysis, is this going to be manageable; will she be able to get to hospital many times a week and will this interfere with work or caring commitments she may have?
Patient preferences:
Mrs Y has a learning disability. This does not mean that she is automatically incompetent to make a decision about her treatment. Her competence would need to be assessed using the Re C test (see Consent and Refusal pages). If she is incompetent (and this is not temporary incompetence) then the decision about treatment should be taken in her best interests. It is in her medical best interests to have the operation but it is not in her interests to forcibly restrain her in order to carry out the treatment. These benefits and disadvantages need to be balanced to arrive at a decision about which course of treatment to follow.
Quality of Life:
Will the operation improve the Mrs Y’s quality of life? It is a one –off treatment that, if all goes to plan, will return her to her previous standard of health.
Contextual features:
Are there any religious or cultural factors here that may be relevant? What care will she receive after the operation? To what extent will Mrs Y’s niece continue to provide support? It would be useful to know if there is any particular reason why Mrs Y is so frightened of needles and why she feels uncomfortable in hospitals?
Issues that may present to a CEC
A competent patient refuses treatment
An incompetent patient refuses treatment
The following worked examples of hypothetical case studies show how ethical principles would apply to practical problems.
A competent patient refuses treatment
Mrs Xis 35 and is in need of dialysis. She is refusing treatment because she is scared of the treatment which she believes is invasive. She has been counseled about the nature of the treatment - there are no alternatives that would be of practical benefit. She is competent to make treatment decisions. She understands that if she refuses dialysis she will die. She has a daughter of 15 years who lives at home. The clinician feels very strongly that she should receive dialysis but despite numerous attempts to persuade her she refuses.
Can the clinician treat her?
Issues that a clinical ethics committee / group may consider:
Mrs X is competent and so has autonomy to make treatment decisions. If the principle of respect for autonomy is given the highest value then her refusal should be respected despite the resulting harm. It is clear that she considers invasive long term treatment not to be in her best interests.
It is important however that Mrs X is making an informed and voluntary decision - a decision made in ignorance could not be said to be an autonomous one (although arguably a patient makes an autonomous choice if he delegates his decision to the clinician/ healthcare professional). Mrs X has received dialysis counseling but she still believes it to be invasive. Could more be done to inform her - perhaps she could be taken around a dialysis ward? Are some types of dialysis less invasive or more acceptable to Mrs X? Can a compromise be reached? If she has been sufficiently informed then does she need to make an objectively ‘rational’ decision? This seems unduly paternalistic and not respectful of autonomy which is the expression of individual wishes. However it is important to consider whether an irrational fear, for example of needles, might be interfering with her free choice in this matter. Any causes of coercion should be identified and where possible steps taken to alleviate these.
The clinician may feel that he is not protecting his patient from harm or acting in her best interests if he allows her to die for lack of dialysis. But forced dialysis will also be harmful to Mrs X. In addition, to what extent are the interests of Mrs X’s daughter to be considered? Her exercise of autonomy has enormous repercussions for her daughter - has she been involved in discussions / expressed a view?
If Mrs X has capacity her refusal must be respected - otherwise a battery may be committed. If through lack of treatment her condition deteriorates and she becomes incompetent through illness, then her previously expressed wishes, made when competent, should be respected. If she really does not want treatment even if this results in her death she should be encouraged to complete an advance refusal of treatment.
An incompetent patient refuses treatment
Mrs Y is 56 years old. She has a learning disability and lives in a care home. She is admitted to hospital with an ovarian cyst. The cyst is blocking her ureter and if left untreated will result in renal failure. Mrs Y would need an operation to remove the cyst. Mrs Y has indicated quite clearly that she does not want a needle inserted for the anaesthetic for the operation to remove the cyst - she is uncomfortable in a hospital setting and is frightened of needles.

The clinician is concerned that if the cyst is not removed Mrs Y will develop renal failure and require dialysis which would involve the regular use of needles and be very difficult to carry out given her fear of needles and discomfort with hospitals. The anaesthetist is concerned that if Mrs Y does not comply with the procedure then she would need to be physically restrained. Mrs Y’s niece visits her in the care home every other month. The niece is adamant that her aunt should receive treatment.
Should the surgeon perform the operation despite Mrs Y’s objections?
Issues that the clinical ethics committee may consider:
An initial step may be to clarify all the facts in the case, for example does Mrs Y have any understanding of the risks of not having this treatment? Her learning disability means that she is unlikely to be competent to consent or refuse the operation, but an attempt should be made to explain to her, in terms that she could understand, what the treatment would involve and what the outcome would be without treatment. Have alternative forms of anaesthetic and ameliorating strategies such as local anaesthetic cream or a sedative drink prior to injection been discussed? Has her autonomy been enhanced as much as is possible? If the conclusion is that she is unable to understand the consequences of non treatment, or that her fear of needles is stopping her evaluating the risks, then she will not be competent to make a decision. However, this does not mean that her fears and concerns should not be acknowledged.
The consequences of the various courses of action need to be considered. If she is not treated then she is likely to develop renal failure. Dialysis would cause her repeated distress as it is an ongoing treatment. If dialysis cannot be maintained she will die. Treatment will involve some degree of force or deception, which could cause increased distress, possible physical harm, and have long term effects on her future cooperation with health care professionals. A balancing of the harms and benefits of the various options is required to determine what would be in Mrs Y’s best interests. In this case, in view of the serious and prolonged harm of not treating her, and the circumscribed nature of the harm of treatment, it would seem to be in her best interests to be treated. If dialysis is the proposed treatment the balance of harms and benefits may be such that treatment would not be in her best interests if it causes severe distress on a regular basis such that her life is intolerable. If the decision is to perform the operation on Mrs Y, then once again respect for her wishes and concerns should influence the approach to treatment so that her fears are mitigated as much as possible.
This approach reflects that it would not be ethical simply to assess Mrs Y as incompetent and then proceed to treatment in the most convenient manner for the health professionals without regard for Mrs Y as a person.
The views of Mrs Y’s niece should be acknowledged but they can only be given weight in the decision if they contribute to the assessment of what would be in her best interests. Legally, no person can give consent or refuse treatment on behalf of another adult unless they have been given Lasting Power of Attorney.
Suggested reading
Hope, Savulescu and Hendrick, Medical Ethics and Law, the core curriculum,
Churchill Livingstone 2008, Chapter 6
O’Neill O. Some limits of informed consent.. J Med Ethics. 2003 Feb;29(1):4-7.
Mason JK, Laurie GT. Law and Medical Ethics. 7th edition. Oxford. Oxford University Press. 2006. Ch 10.
O’Neill O. Autonomy and Trust in Bioethics. Cambridge. Cambridge University Press. 2002.Chapter 7
Delany C. Making a difference: incorporating theories of autonomy into models of informed consent J Med Ethics 2008;34:e3
Hope T, Slowther A, Eccles J. Best interests, dementia and the Mental Capacity Act. J Med Ethics 2009;35:733-738
Slowther A Determining best interests in patients who lack capacity Clinical Ethics 2007;2(1)
Slowther A. Refusal of treatment by patients Clinical Ethics 2(3): 121-123
Professional guidance
General Medical Council
Consent: Patients and doctors making decisions together. 2008
The guidance provides a comprehensive overview of a doctor’s duties with regard to sharing information with patients, obtaining appropriate consent, respecting patients’ wishes regarding information disclosure, and treating people who lack capacity to consent. Paragraph 2 sets out the principles on which the guidance is based.
Whatever the context in which medical decisions are made, you must work in partnership with your patients to ensure good care. In so doing, you must:
a. listen to patients and respect their views about their health
b. discuss with patients what their diagnosis, prognosis, treatment and care involve
c. share with patients the information they want or need in order to make decisions
d. maximise patients’ opportunities, and their ability, to make decisions for themselves
e. respect patients’ decisions.
0-18 years: guidance for all doctors (2007)
This guidance covers all aspects of treating children and young people under the age of 18. Paragraphs 22-33 specifically look at issues of consent
The GMC website’s interactive section GMP in action has a set of case studies relating to issues of consent Waiting room 2
British Medical Association
The BMA has a range of publications and guidance in relation to consent and capacity. These can be found on the ethics pages of the BMA website
The fifth edition of the BMA Consent toolkit ( 2009) consists of a series of cards relating to specific areas of consent such as providing treatment to children, consent and research, obtaining consent for teaching purposes, assessing competence and determining best interests.
The Department of Health has published a range of guidance on consent for both clinicians and patients Key documents
The Nursing and Midwifery Council
The Council’s Professional Code has a section on consent
Ethical considerations
Respect for Autonomy
The principle of respect for autonomy underpins the requirement for valid consent to treatment. This principle acknowledges the right of a person to determine how his or her life should be lived and to make choices that are consistent with his/her life’s plan. While respect for autonomy is often associated with deontological theories, utilitarian philosophers such as John Stuart Mill also stress the importance of an individual’s right to determine how he/she lives his/her life, free from coercion:
“the only purpose for which power can be rightfully exercised over any member of a civilised community, against his will, is to prevent harm to others. His own good, either physical or moral, is not a sufficient warrant. He cannot rightfully be compelled to do or forbear because it will be better for him to do so, because it will make him happier, because, in the opinion of others to do so would be wise, or even right”
(Mill JS, On Liberty, 1982, Harmondsworth: Penguin, p 68).
Autonomy is not all or nothing. Very few of us are able to make fully autonomous choices all the time. Some of us, in certain situations, will not have the ability to understand and evaluate the options in order to make a choice. The more complex the choice and the more impaired our ability to understand, the less we are likely to be able to make an autonomous decision. This has implications for respecting autonomy in the context of health care, specifically in relation to consent to treatment. First, health professionals have an obligation to endeavour to enhance autonomy and facilitate the likelihood of a patient being able to make an autonomous decision. Second, where a patient is unable to make an autonomous decision, it is the duty of the health professional to act in the patient’s best interests. However, even in these situations, an effort should be made to discover any previous preferences of the patient, or current wishes, in order to respect his/her autonomy as far as possible.
Rationality, competence and autonomy
Does an autonomous decision have to be rational?
“In the ideal of autonomy day - to -day decisions should be rational, i.e. consistent with the person’s life plans” (Hope, Savulescu and Hendrick, Medical Ethics and Law, the core curriculum, Churchill Livingstone 2003 p 34).
However this internal rationality may not be viewed as rational by an external view. A health professional may judge the rationality of a patient’s decision by its consistency with the professional’s view of what would be in the best interests of the patient. A decision that is seen as contrary to the patient’s best interests may be interpreted as irrational by the health professional and therefore the patient may be seen, erroneously, as not competent to make an autonomous choice. It is the internal rather than the external rationality that is important here. A patient is not necessarily incompetent simply because he/she doesn’t agree with the health professional about the suggested treatment. A good example of this is the case of a Jehovah’s Witness who refuses a life saving blood transfusion. The decision appears irrational to the health care professional but is internally consistent with the beliefs of the patient.
Beneficence and Best Interests
The principle of beneficence highlights the moral importance of doing good to others. When a patient is unable to make an autonomous choice the health professional has a duty of beneficence. Beneficence is usually considered to rely on an objective view of what would be best for the patient whereas respect for autonomy identifies what the patient subjectively considers to be in his/her best interests.
The concept of ‘best interests’ is linked to well-being / beneficience but includes considerations wider than purely medical risks and benefits such as the religious and cultural interests of the patient. This implies a duty to discover if possible what the patient would have wanted or what is likely to be appropriate in the context of this patient’s particular life. Thus respecting the patient as an individual person (or respecting his/her autonomy) is an intrinsic part of the process of determining best interests.
There is generally no conflict between beneficence and the principle of respect for autonomy - most patients would choose the course of treatment that is objectively considered to be in his/her best interests. However difficulties arise where the view of a competent adult patient as to what is in his/her best interests conflicts with medical opinion - for example where a Jehovah’s Witness patient refuses treatment using blood products. The principle of respect for patient autonomy overrides the principle of beneficence in a competent patient. If the patient is unconscious, then knowledge of what he/she would have wanted in the circumstances is part of the assessment of what is in his/her best interests. If the patient is able to communicate but is not competent to make the particular decision, the health professional should still seek to ascertain any wishes, preferences and values of the patient that may be relevant to the decision.
It may be helpful to consider how judges in legal cases have used the concept of best interests.
Re F [1990] 2 AC 1
The House of Lords considered whether it was in the best interests of an incompetent adult female patient to be sterilized to prevent her becoming pregnant. The court took the view that treatment would be in the best interests of a patient if it is carried out to:
A) save the life of the patient, or to
B) ensure improvement / prevent deterioration in the patient’s physical or mental health.
This would cover basic care such as dental care and washing and dressing the patient.
The concept of best interests is wider than a consideration of purely medical issues:
Re Y [1996] 35 BMLR 111
The patient (Y) was 25 years old, severely mentally and physically handicapped. She lived in a nursing home but had a close relationship with her family. One of her three sisters suffered from leukaemia and needed a bone marrow transplant. The patient was the only suitable donor. The court considered that it was in Y’s best interests to donate bone marrow to her sister even though there was no therapeutic medical benefit to Y (and a minimal risk to Y from the procedure). The court considered that it was in Y’s emotional, social and psychological interests, since, if Y’s sister died, Y’s mother would have to look after the sister’s daughter and therefore be unable to spend as much time visiting Y in the nursing home.
There is much discussion in ethics literature about the interpretation of best interests. If a wide interpretation is given to “best interests” then the interests of those other than the patient may be taken into account in determining the interests of the patient and there is a danger of moving away from the patient as a focus for legal / ethical decision-making.
Legal considerations
In England and Wales the Mental Capacity Act (2005) sets out the legal position relating to determination of capacity and the principles for treating adults who lack capacity. The Act is applicable to people aged 16 years and older and states that capacity should be assumed unless it is established that he or she lacks capacity. A similar Act (Adults with Incapacity (Scotland) Act 2000) sets out the legal framework in Scotland. There is no statutory legislation governing consent in children under the age of 16 years but there is clear case law to guide practitioners (see below). A further key piece of statutory legislation in relation to consent to treatment is the Mental Health Act (2007) which provides the legal framework for treating adults without their consent in carefully specified circumstances of mental illness.
A comprehensive review of the Mental Capacity Act for clinical ethics committees can be found on this here.

Form of Consent (Express / Implied)
Consent provides lawful justification for treatment. If valid consent is not given, any treatment which involves touching e.g. physical examination, surgery, dressing a wound, would amount to a battery.
There is no legal requirement that consent should be written, or be in a particular form - oral consent is valid (or it may be implied from circumstances, where for example a patient undresses prior to examination). However a written consent form provides evidence of consent and is recommended for major interventions such as surgical procedures. The Department of Health has produced standardized consent forms.
Consent may be withdrawn at any time, even after signing of a consent form, and to proceed with treatment where consent has effectively been withdrawn would constitute a battery.
In order for consent to be valid it must be:
given by someone who is competent (has legal capacity)
sufficiently informed
freely given
Battery
Battery is any non-consensual touching - it does not have to harm the patient. A doctor can commit a battery even though the doctor considers he is acting in the best interests of his patient by treating him/her. To avoid liability in battery the patient should be informed in broad terms of the nature of the procedure that is intended to be carried out and give consent to it.
There are very few cases where a doctor has been successfully sued for battery.
Devi v West Midlands RHA [1980] C.L.Y. 687
A woman underwent a hysterectomy to which she did not consent (she had given consent to repair her uterus). The Court found the surgeon liable in battery as there was total lack of consent to the nature of the operation.
Negligence

If the patient claims that he has not been sufficiently informed about the risks inherent in the treatment and alternatives to the treatment then liability does not lie in battery but rather in negligence. In deciding whether non-disclosure is negligent it is necessary to determine whether there is a responsible body of clinicians in the relevant field who would warn of the relevant risks (the Bolam test). In the area of disclosure of risk, however, the judges are more ready than in other areas of clinical negligence to go against expert medical evidence in deciding what amounts to “responsible” practice.
Past judgments in legal cases have suggested that a patient should be informed of risks if:
the incidence of the risk is sufficiently high - for example a 1% risk of stroke
if the risk materialised it would have serious consequences for the patient (It is worth noting that identifying serious consequences for the patient requires knowledge of what might be important consequences for the patient)
the patient specifically asks about a risk
Chatterton v Gerson [1981] 1 ALL ER 257
Mrs Chatterton suffered intractable pain as a result of a trapped nerve following a hernia operation. Dr Gerson, a pain specialist, performed an operation to relieve the pain, but this resulted in permanent immobility of her right leg. Mrs. Chatterton said that she should have been informed of this risk and claimed in battery.
It was held that she had been informed in broad terms of the nature of the procedure ie. she had been informed and consented to an operation to her right leg. The fact that she may not have been informed of the risks of paralysis to her leg could not amount to battery but any claim would have to be made in negligence.
Capacity to consent to treatment
Capacity is treatment specific - it depends on the treatment to be performed. If the treatment is risky / has potential serious side effects / is complicated, it may require a greater degree of understanding to make a decision than is necessary for treatment that is straightforward or less invasive. Thus a patient can have capacity to consent to one procedure, but not to another. Capacity can also fluctuate.
Tests of capacity
People aged 16 years and over
The Mental Capacity Act sets out the criteria for capacity.
A patient has capacity to consent / refuse medical treatment if he/she can:
Understand the information relevant to the decision
Retain the information long enough to make a decision
Weigh the information and make a choice
Communicate the decision
Young people aged under 16 years
For young people under 16 there is precedent in case law governing consent to treatment. The law was set out in the case of Gillick (Gillick v West Norfolk and Wisbech AHA [1986] AC 112).

This states that if a minor has sufficient intelligence and understanding to enable him / her to understand the treatment and implications of treatment then he / she is ‘Gillick competent’ and can consent to treatment. (However a refusal of treatment may be treated differently - see below). The Gillick case referred specifically to consent regarding contraceptive treatment and the guidance set out by Lord Fraser in the House of Lord’s Judgment in the case has been used as the template for determining whether to treat a young person without obtaining the consent of his or her parents. These are as follows:
The young person understands all aspects of the advice and its implications
The health care professional cannot persuade the young person to tell their parents or to allow the health professional to tell them
In relation to contraception and STIs, the young person is very likely to have sex with or without such treatment
Their physical or mental health is likely to suffer unless they receive such advice or treatment, and
It is in the best interests of the young person to receive the advice and treatment without parental knowledge or consent.
For babies, young children and teenagers who are not competent in law someone else must consent on their behalf. This can be a proxy or the Court. A proxy is usually a parent or another person with parental responsibility. In making a decision about medical treatment the proxy must act in the child’s best interests and if this is not the case then the decision can be overridden by the court. Usually consent need be obtained from only one parent (although if treatment involves an operation that is irreversible and not medically necessary e.g. male circumcision and if the two parents disagree it is advisable to seek advice from the court). If there is a difference of opinion between the parent (s) and the clinician regarding best interests the matter can be referred to the Official Solicitor who is likely to make an application to the court. In an emergency situation, where a parent cannot be contacted, the child can be treated without consent, but only where treatment is immediately necessary.
Where consent cannot be obtained from an adult patient
The Mental Capacity Act 2005 and in Scotland the Adults with Incapacity (Scotland) Act 2000 provide that competent individuals over 18 (over 16 in Scotland) can appoint someone to make decisions about medical treatment on their behalf if they become unable to do so. (Lasting Power of Attorney) If no such power of attorney has been executed then no-one can consent to or refuse treatment on behalf of an adult (over 18 in England, over 16 in Scotland).
There are two categories of situation where decisions about medical treatment need to be taken for incompetent patients:
When a patient is temporarily incompetent, e.g. if he/she is unconscious following an accident or acute medical event.
When a patient is unlikely ever to be able to make a competent decision about treatment, e.g. severe dementia or learning disability or permanent vegetative state.
In the first situation the healthcare professional should do no more than is necessary in the circumstances. This does NOT justify treatment that is against the known wishes of the patient. In both situations the health professional act in the best interests of the patient. The principle of best interests also governs decisions made by Donees of Lasting Power of Attorney.
When Consent may not be needed - s63 Mental Health Act 1983
A patient who has been sectioned under the Mental Health Act may be treated without the requirement for consent. This is only applicable for treatment for the mental illness. www.doh.gov.uk/mentalhealth/
A more in depth discussion of treating adults who cannot consent can be found in the section on the Mental Capacity Act.
Refusal of Treatment
Adults
A competent adult may refuse treatment even if his/her life depends on it. The right to refuse treatment also applies to a pregnant woman even though the exercise of the right to refuse treatment may result in the death of her unborn child.
The English courts protect strenuously the right to be self-endangeringly eccentric, as these extracts from judgments illustrate:
“The patient is entitled to reject [the] advice for reasons which are rational, or irrational, or for no reason.” Per Lord Templeman in Sidaway v Board of Governors of Bethlem Royal Hospital [1985] 1 AC 171
“It is established that the principle of self-determination requires that respect must be given to the wishes of the patient, so that, if an adult patient of sound mind refuses, however unreasonably, to consent to treatment or care by which his life would or might be prolonged, the doctors responsible for his care must give effect to his wishes, even….though they do not consider it to be in his best interests to do so….” Per Lord Goff in Airedale NHS Trust v Bland [1993] AC 789.
Children
A child who is competent can consent to treatment. However, a refusal of treatment may be overridden by a parent or the Court where such a refusal would be likely to result in the death or permanent disability of the child. Then the wishes of the child may be overridden to preserve his or her long-term interests.
Re M [1999] 2 FLR 1097
M was a competent 15 ½ year old who sustained acute heart failure and required a heart transplant. She stated that she did not want someone else’s heart and refused to give consent. It was considered to be in her best interests to have the transplant and (although she ultimately consented to the operation) it is clear that treatment would have been declared lawful despite a refusal.
Advance Statements
Advance statements about future medical treatment can be made by those who understand the implications of their choices in order to anticipate situations where they may lose mental capacity.
See End of life section and Mental Capacity Act section.

Introduction
Consent to treatment lies at the heart of the relationship between the patient and the health care professional. The patient relies on the professional’s expertise, knowledge and advice, but it is up to the patient to decide whether he/she will accept or reject treatment, or in some circumstances request that the professional make the decision. The focus on patient centred care and shared decision making highlights the importance of informed consent, and this is reinforced by professional guidelines and the law. However, the issue of consent to treatment is not quite as straightforward as it may seem on initial inspection. For consent to treatment to be meaningful a person must be able to understand the information he/she is given, which must be sufficient for him/her to evaluate the available choices, and he/she must feel free to make that choice. Determining the appropriate amount of information or a person’s ability to understand and evaluate it can be difficult in a health care context, and the very nature of the health care relationship and health care setting can lead to implicit if not explicit coercion. Thus issues around consent can lead to ethical dilemmas that may be brought to a clinical ethics committee. In this section we provide a brief overview of the ethical and legal approaches that apply to consent and then look at some specific issues that may present to clinical ethics committees illustrated by hypothetical cases. The section concludes with some suggested further reading on the issues.
This section does not provide a comprehensive overview of the issues around consent and refusal, and does not make recommendations about what an ethics committee should do. It highlights issues that a committee may wish to consider and provides some ethical and legal frameworks for approaching the subject.
Suggested reading
Beauchamp and Childress, Principles of Biomedical Ethics, Fifth Edition, Oxford University Press 2001, p 303
Hope, Savulescu and Hendrick, Medical Ethics and Law, the core curriculum, Churchill Livingstone 2008, chapter 7
Slowther A, Kleinman I. Confidentiality. In Eds Singer P, Viens A. Bioethics for Clinicians. Cambridge. Cambridge University Press. 2007 pp43-48
Symposium on Consent and Confidentiality.
Consent and confidentiality – where are the limits? An introduction, P J Lachmann. J Med Ethics 2003; 29: 2
Consent and confidentiality in genetics: whose information is it anyway?, A. Kent. J Med Ethics 2003; 29: 16 – 18
The requirements of the Data Protection Act 1998 for the processing of medical data. P. Boyd. J Med Ethics 2003; 29: 34-35
Confidentiality and the duties of care. J O’Brien, C Chantler, J Med Ethics 2003; 29: 36-40
Patient privacy and confidentiality, Jim Chalmers and Rod Muir, BMJ 2003; 326: 725-726.
Confidentiality and cognitive impairment : professional and philosophical ethics. JC Hughes and SJ Louw. Age and Ageing, 2002; 31 (2): 147 - 150
The criminalisation of HIV transmission. J Chalmers J Med Ethics 2002; 28: 160 - 163
Wife wins case against GPs who did not disclose husband’s HIV status, Christopher Zinn, BMJ; 326: 1286
Sharing patient information electronically throughout the NHS, Nick Booth, BMJ 2003; 327: 114-115
New consent form designed for release of medical records, Clare Dyer, BMJ 2003; 327: 122
Case study
The following is a worked example of a hypothetical case study showing how ethical principles would apply to a practical problem.
Bob has attended the genito-urinary clinic at his local Trust hospital. Bob is seen by Dr Gomez who informs him that he is HIV positive. Dr Gomez counsels Bob to contact his sexual partners to inform them of his status. Bob starts a course of treatment.
For the last 18 months Bob has been in a relationship with Sue. They are expecting a baby in 2 months time. Before this relationship Bob had a series of sexual partners.
On a subsequent visit to the clinic it becomes clear to Dr Gomez that Bob has not told Sue of his HIV status. Dr Gomez is aware of the impending arrival of their baby and tells Bob that steps should be taken to assess whether Sue is HIV positive and whether the baby is at risk so that if necessary treatment may be started.
Bob adamantly refuses to tell Sue and says that if she is told without his consent then he will stop his course of treatment.
What should Dr Gomez do? Can / should he inform Sue, or Bob’s GP?
Issues to consider
The principle of respect for autonomy requires that personal information should not be disclosed without consent. However, in some cases the autonomy of another person may also be at issue (in this case Sue and previous sexual partners, as well as the baby when born). Not disclosing information may limit their ability to make decisions as to treatment and lifestyle.
Although maintaining confidence in personal information may be the starting point, a balance of the benefits and harms of disclosure / non-disclosure leads to consideration of the consequences of a course of action.
In this scenario the harms of non-disclosure can be identified as:
The risk that Sue may be HIV positive. The consequence of not providing information to enable her to be tested is that she is harmed by not knowing her HIV status and not receiving a course of treatment.
If Sue is HIV positive and is not aware of the risk the consequences are that she will not take steps to minimise the risk of infection to the baby eg. obtaining treatment during pregnancy, baby born by caesarean section, knowing not to breastfeed, prophylactic treatment.
If Sue did later find out that there was a risk to her and that she was not informed she may lose trust in her doctor or the healthcare system.
Risks to Bob’s former identifiable sexual partners who could be contacted and informed.
The harms of disclosure would include:
If the clinician informs others without Bob’s consent then as a consequence he may lose trust in Dr Gomez, and perhaps the medical profession in general.
He has indicated that he will end his course of treatment thus risking relapse and severe health problems including death.
There is also a risk that he could go on to infect future sexual partners.
Bob may be stigmatized by others who get to know and may have problems with future employment because of discrimination
Applying ethics and law - balancing competing interests and values
It is necessary to balance the potential harms of non -disclosure with the harms that might result from disclosure without consent in breach of the duty of confidentiality.
Paragraph 53 of the GMC guidance Confidentiality(2009) states that disclosure of confidential information without the patient’s consent can be justified to prevent risk of death or serious harm to a third party.
“53. Disclosure of personal information about a patient without consent may be justified in the public interest if failure to disclose may expose others to a risk of death or serious harm. You should still seek the patient’s consent to disclosure if practicable and consider any reasons given for refusal.”
If Sue were to become infected with HIV she would be harmed by contracting a serious disease which if untreated is ultimately life threatening. In addition she could transmit the virus to her child again with potentially life threatening consequences.
In its supplementary guidance on confidentiality (2009) the GMC considers specifically the issue of disclosing information about serious communicable diseases. Section 8 states

“If a patient refuses to allow you to inform someone outside the healthcare team of their infection status, you must respect their wishes unless you consider that failure to disclose the information will put other healthcare workers or other patients at risk of infection. But such situations are likely to be very rare, not least because of the use of universal precautions to protect healthcare workers and patients, particularly during exposure prone procedures”
The particular risk of becoming infected from a sexually transmitted disease (or by vertical transmission from mother to child, cannot be prevented by universal precautions taken by healthcare workers. The GMC advises in these situations, where a person with a sexually transmitted disease refuses to disclose information to their sexual partner, that a doctor may disclose information to the sexual partner “if you have reason to believe they are at risk of infection and that the patient has not informed them or has refused to do so”. This would appear to be the case in this scenario.
A useful comparison could be made with disclosure of genetic information. Genetic information may have great relevance for the health of relatives. Nevertheless, if the patient refuses to allow relatives to be informed confidence should be maintained unless the health interests’ of family members to be given such information outweighs the duty of confidentiality.
The GMC guidance considers the disclosure of genetic and other shared information (paragraphs 67-69). Essentially the advice is to encourage patients to share information that would be relevant to a family member, for example of the knowledge could be used to receive prophylaxis or other preventative treatments. However should a patient refuse to disclose the health professional must then make a judgement based on the public interest principle described above.
BMA guidance (Human genetics: choice and responsibility 1998) states that a healthcare professional should consider the following factors in deciding whether to disclose:
Severity of the disorder
Level of predictability
Action relatives could take
Harms / benefits in giving or withholding information
What about the interests of the child to be born? In Re C (HIV testing) [1999] 2 FLR 1004 the court considered that it was in the best interests of a baby to undergo testing for HIV (where the mother was HIV positive and had refused interventions to prevent transmission of the virus) despite the fact that the parents refused their consent. Clinicians were of the view that if the child was infected measures could be taken to manage the condition. The court said that the child had interests that were separate from those of its parents (a foetus does not have legal rights but rights do crystallize at birth).
In the case study scenario it would be necessary to consider the likelihood of HIV risk to the baby to determine whether breach of confidentiality is justified. Sue would need to be informed in order to consent to testing / treatment.
Should Bob’s GP be informed? Paragraph 25 of GMC guidance Confidentiality (2009) states that, “Most patients understand and accept that information must be shared within the healthcare team in order to provide their care.”
However, should a patient object to information being shared with another health professional then their wish should be respected unless there is a public interest justification for disclosure. Thus, if Bob still refuses his wishes must be respected unless failure to disclose would put a health care worker or other patient at serious risk of death or serious harm. As the GMC supplementary guidance points out this is unlikely to be the case if universal precautions are followed. One situation where there may be an increased risk to a healthcare professional is if a needle stick injury has occurred. In this situation the GMC guidance advises that it may be appropriate to disclose information if this is needed for decisions about post exposure prophylaxis (Supplementary Guidance paragraph 18)
It would appear, in balancing the harm to Bob with harms to others that the harm to Bob in disclosing without his consent is outweighed by the harmful consequences of not disclosing. However health professionals working in this area may consider that more weight should be given to the loss of trust that might result from breaching confidences.
“Compelling ethical reasons exists for protecting the privacy of persons with HIV infection. An important justification for privacy resides in the principle of respect for autonomy. To respect the privacy of persons with HIV/AIDS is to respect their wishes not be observed or to have intimate information about themselves made available to others. Privacy also enhances the development of trust in the physician. One of the defining characteristics of the doctor/patient relationship involves the sharing - freely given - of private information. Failure to respect the confidentiality of patients drives patients away from HIV testing, counseling, and treatment, and discourages patients from confiding in their physicians. Healthcare facilities that treat persons with HIV argue fiercely that compelling physicians to disclose HIV infection to sexual or needle-sharing partners would mean they would lose the trust of their clients.”
Lawrence O. Gostin, JD, from the September, 1995 issue of the JIAPAC.
Clinical Ethics Committees and access to health records
Patients, or their relatives, may want access to the written record of the deliberations of the committee, assuming that they have been informed.
What is the responsibility of a Clinical Ethics Committee to provide access to minutes of a committee meeting?
Data Protection Act 1998
The subject access provisions of the Data Protection Act 1998 provide that an individual having submitted a request in writing is entitled to be provided with a copy of the personal data held about him or her. “Personal data” is defined as information that relates to a living individual who can be identified from the data. This would therefore include health records and possibly minutes of Clinical Ethics Committee meetings.
Information need not be disclosed however, where another individual can be identified from that information (except where that individual is a health professional who has contributed to the care and treatment of the patient). This data should be withheld unless the other individual has consented to the disclosure.
Where the treatment and care of a patient has been subject to discussion by a clinical ethics committee the patient could have access to notes / minutes of the meeting if he /she could be identified from them. However access may be denied if individual members of the committee who are not healthcare professionals (legal, lay, religious members) could be themselves identified from the minutes (and they do not consent to such disclosure). It is therefore relevant whether the minutes identify comments from individual members of the committee or give an opinion of the committee as a whole.
Freedom of Information Act 2000
Relevant information about the requirements of the Freedom of Information Act can be found on the website.
The Freedom of Information Act gives a general right of access to all types of recorded information held by public authorities (NHS bodies are public authorities). The right of access to information under this Act does not come into force until the 1st January 2005.
Any person who makes a request to a public authority for information will have to be told whether information is held and that information must be supplied. However there are a number of exemptions.
Public Authorities are also required to proactively make some of the information they hold available through a publication scheme. The publication scheme must organise the information to be published into classes and then set out how that information is to be published. Model publication schemes have been approved for various health sector bodies.
The Network is considering the applicability of the provisions of the Act to minutes of Clinical Ethics Committees.
Caldicott guardians
In 1997 the Department of Health published the Caldicott Report (‘On the Review of Patient-Identifiable Information’). It considered the flow of identifiable patient information and recommended that confidentiality should be safeguarded by anonymising health data, where possible. Each NHS organisation must have a ‘guardian’ (normally a senior health professional) to oversee all procedures affecting access to person-identifiable information.
Professional guidance
The General Medical Council (GMC) has published guidance on confidentiality, including supplementary guidance on specific situations such as reporting concerns about patients to the DVLA or DVA. (Although they do not have the force of law, the courts do consider such guidance to have persuasive authority).
GMC: Confidentiality: 2009
‘There is a clear public good in having a confidential medical service. The fact that people are encouraged to seek advice and treatment, including for communicable diseases, benefits society as a whole as well as the individual. Confidential medical care is recognised in law as being in the public interest. However, there can also be a public interest in disclosing information: to protect individuals or society from risks of serious harm, such as serious communicable diseases or serious crime; or to enable medical research, education or other secondary uses of information that will benefit society over time.’ - GMC Para 36
The GMC has interactive case scenarios to illustrate how their guidance can be applied in practice. Some scenarios related to their guidance on confidentiality are available.
GMP in action
The Nursing and Midwifery Council (NMC) has a section on confidentiality in their Code of Conduct. NMC.
The Code: Standards of conduct, performance and ethics for nurses and midwives. 2008
Confidentiality
Confidentiality: NHS Code of Practice 2003.
The code is a guide to required practice for those who work within or under contract to NHS organisations - it deals with confidentiality and patients’ consent to the use of their health records.
The code can be downloaded from the Department of Health website
Legal considerations
The Human Rights Act, which encompassed the European Convention on Human Rights into UK law, recognises the importance of confidentiality under Article 8 of the Convention, the right to respect for private and family life which states:
Everyone has the right to respect for his private and family life, his home and his correspondence.
There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection.
There is a public interest in health professionals maintaining patient confidentiality - this encourages patients to fully divulge relevant information so that the healthcare professional can make a proper assessment of the patient’s condition. On the other hand there may, occasionally, be circumstances where the interest in maintaining confidentiality is outweighed in the public interest (disclosure to prevent a crime, for the health interests of others etc) and this justifies disclosure of confidential patient information without consent. The health professional will have to balance these competing public interests in deciding whether or not to disclose. Assistance can be gleaned from legal cases and professional guidance (the courts do take account of these).
W v Edgell [1990] 1 ALL ER 835
The patient was a prisoner in a secure hospital following convictions for killing five people and wounding several others. He made an application to a mental health tribunal to be transferred to a regional unit. An independent psychiatrist, Dr Edgell, was asked by W’s legal advisors to provide a confidential expert opinion that they hoped would show that W was no longer a danger to the public. However Dr Edgell was of the opinion that in fact W was still dangerous. W’s application was withdrawn. Dr Edgell, knowing that his opinion would not be included in the patient’s notes, sent a copy to the medical director of the hospital and to the Home Office.
The patient brought an action for breach of confidence.
The Court of Appeal held that the breach was justified in the public interest, on grounds of protection of the public from dangerous criminal acts. However, the Court said the risk must be ‘real, immediate and serious’.
X v Y [1988] 2 ALL ER 648
A Health Authority sought an injunction to prevent a national newspaper publishing the names of two practising doctors who were receiving treatment for AIDS. The Court balanced the public interest in freedom of the press against the public interest in maintaining hospital records confidential. The Court found that lack of publication of the information would be of minimal significance since there was a wide ranging public debate about AIDS generally.
In balancing these competing interests it should be noted that disclosure should in any event only be made to a relevant party - there should be no blanket disclosure.
See also: H (a Healthworker) v Associated Newspapers Ltd [2002] EWCA civ 195. Times, March 19, 2002 in which again the Court of Appeal reiterated the strong public interest in maintaining the confidentiality of health workers infected with HIV.
In Axon, R (on the application of) v Secretary of State for Health & Anor [2006] EWHC 37 (Admin) the Court addressed the issue of confidentiality in relation to minors under the age of 16 years. This case concerned disclosure of information regarding termination of pregnancy but the principle can be applied to confidentiality in other situations. The court emphasised that a young person is entitled to the same standard of confidentiality as an adult provided that they are competent. (see our commentaries pages for a summary of this case).
Statues requiring disclosure
Some statutes require disclosure of confidential information where this would otherwise be a breach of confidentiality. These include:
Police and Criminal Evidence Act 1984
The police can access medical records for the purpose of a criminal investigation by making an application to a circuit judge.
Public Health (Control of Disease) Act 1984 and Public Health (Infectious Diseases) Regulations 1988
A doctor must notify the relevant local authority officer (usually a public health consultant) if he suspects a patient of having a notifiable disease. AIDS and HIV are not notifiable diseases.
Abortion Regulations 1991
A doctor carrying out a termination of pregnancy must notify the relevant Chief Medical Officer including giving the name and address of the woman concerned.
Births and Deaths Registration Act 1953
The doctor or midwife normally has a duty to inform the district medical officer of a birth within six hours. Stillbirths (a baby born dead after 24th week of pregnancy) must be registered. Doctors attending patients during their last illness must sign a death certificate, giving cause of death.
Road Traffic Act 1988
All citizens, including doctors, must provide the police, on request, with information (name, address), which might identify a driver alleged to have committed a traffic offence. This would not normally justify providing clinical information without the patient’s consent, or a court order. A doctor may have a legal obligation to inform the DVLA if he has concerns that a patient has a medical disability that could affect his driving.
DVLA
Human Fertilisation and Embryology Act 1990
The Human Fertilisation and Embryology Authority maintains a register of individuals receiving fertility treatment.
NHS (Venereal Diseases) Regulations 1974
Allows limited disclosure of information for contact-tracing in the case of sexually transmitted diseases. Such disclosure can only be made to a doctor, or to someone working on a doctor’s instruction in connection with treatment or prevention. It forbids those working in a genito-urinary clinic to inform an insurance company of a patient’s sexually transmitted disease – even with the patient’s consent. GP’s are not routinely informed of the patient’s attendance at such clinics, although the patient may request that the GP be informed.
Children Act 1989
Regulates many aspects of childcare including professionals’ duties when there is suspicion of child abuse.
Prevention of Terrorism (Temporary Provisions) Act 2000
All citizens, including doctors, must inform police, as soon as possible, of any information that may help to prevent an act of terrorism, or help in apprehending or prosecuting a terrorist.

Ethical considerations
Confidentiality can be considered from a number of different ethical perspectives
Respect for patient autonomy
The principle of respect for patient autonomy acknowledges the right of a patient to have control over his or her own life – and this would include the right to decide who should have access to his/her personal information. Can there be a breach of confidentiality if a patient never knows that the healthcare professional has disclosed the information? Where the basis for the duty of confidentiality is the principle of respect for autonomy any breach of confidentiality means that the patient’s autonomy has not been respected, whether or not the patient is aware of the breach.
Implied promise
The health professional-patient relationship could be seen as having elements of an implied contract and this could include an implied promise that health professionals keep information about their patients confidential. It is reasonable for patients to expect that information they divulge to their doctors or other health professionals will be kept confidential. If confidentiality is subsequently breached the patient may feel that a promise has been broken. This view of confidentiality is different from that of patient autonomy because it depends on the concept of the doctor-patient relationship rather than what the patient wants or believes.
Virtue Ethics
Virtue ethics focuses on the position of the doctor rather than that of the patient (as is the case with respect for autonomy). This approach asks what a virtuous doctor would do in the particular circumstances - what issues would a virtuous doctor take into account in deciding whether or not to disclose confidential information?
Consequentialism
From a consequentialist position the question of whether it is wrong to breach confidentiality is determined by the consequences of the breach. One of the consequences of a breach of confidentiality could be that the patient will lose trust in his/her doctor, and perhaps doctors generally, resulting in him/her not accessing healthcare in the future with a detrimental effect on his/her (and others?) health. On the other hand there may be situations where there are bad consequences of not breaching confidentiality, for example third parties may be denied information which would have serious implications for their health and treatment
Introduction
Confidentiality is seen as a fundamental ethical principal in health care and a breach of confidentiality can be a reason for disciplinary action. Dilemmas around confidentiality arise when the principle of confidentiality is in possible conflict with other ethical principles such as avoiding harm to the patient or others. Issues around confidentiality may be brought to a clinical ethics committee or group in the form of individual cases or in considering hospital policies. There are also issues of confidentiality for the ethics committee itself. In this section we provide a brief overview of the ethical and legal approaches to confidentiality and then look at some specific issues that may present to ethics committees. We describe a hypothetical case to illustrate the issues that might be brought to a committee by health professionals, and then look at the duties of the committee regarding confidentiality and access to records in health care. The section concludes with some suggested further reading on the issues.
This section does not provide a comprehensive overview of the issues around confidentiality, and does not make recommendations about what an ethics committee should do. It highlights issues that a committee may wish to consider and provides some ethical and legal frameworks for approaching the subject.

In which situation would the nurse be justified in overriding a patient's right to confidentiality?

The clearest situations in which confidentiality can be justifiably overridden are those in which the patient places another person or the community at significant risk of serious harm. Confidentiality is a prima facie duty.

Which ethical principle is demonstrated when an adult child is legally?

Which ethical principle is demonstrated when an adult child is legally given the right to make medical decisions for a cognitively impaired parent? Paternalism is when one individual assumes the right to make decisions for another.

Which definition best describes moral distress in the nursing environment?

According to Andrew Jameton's influential definition, first published in 1984, moral distress occurs when a nurse “knows the right thing to do, but institutional constraints make it nearly impossible to pursue the right course of action” [1].

What initiative is most likely to promote open communication between clients and practitioners quizlet?

What initiative is most likely to promote open communication between clients and practitioners? One way to promote open communication between clients and practitioners is involving health-care consumers as active members of the health-care team.

The principle of autonomy would have the greatest bearing on what clinical situation

Ethical Frameworks

Further Reading

Issues that might present to a CEC

Professional guidance

Legal Considerations

Ethical Considerations

Introduction

Suggested reading

Issues that may present to a clinical ethics committee

Case One: Who should have the intensive care bed?

Case two: Should a clinician prescribe a new treatment that is more expensive than the standard treatment?

Discussion of the issues

Case three: Prevention or treatment?

Discussion of the issues

Professional guidance

General Medical Council (GMC)

National Institute for Clinical Excellence (NICE)

Legal considerations

Treatment in EU Member States

The attitude of the Courts to resource allocation

Priorities Forums

Ethical considerations

Maximising Welfare / Benefit

QALYS

Equity and Distributive Justice

Assessing and addressing inequity

Considering the social determinants of health

‘The veil of ignorance’

Determining morally relevant reasons for treating people differently

Patient Autonomy

Process of Decision Making

Introduction

CARE (Shneider and Schnell 2000)

The four principles of biomedical ethics

Consideration of the ethical issues using the Four Principles framework

Respect for autonomy:

Beneficence:

Non maleficence:

Justice:

The four quadrant approach

Consideration of the ethical issues in a case using the four quadrant approach

Medical Indications:

Patient preferences:

Quality of Life:

Contextual features:

Issues that may present to a CEC

Suggested reading

Professional guidance

Ethical considerations

Legal considerations

Introduction

Suggested reading

Case study

Clinical Ethics Committees and access to health records

Data Protection Act 1998

Freedom of Information Act 2000

Caldicott guardians

Professional guidance

Confidentiality: NHS Code of Practice 2003.

Legal considerations

Ethical considerations

Respect for patient autonomy

Implied promise

Virtue Ethics

Consequentialism

Introduction

In which situation would the nurse be justified in overriding a patient's right to confidentiality?

Which ethical principle is demonstrated when an adult child is legally?

Which definition best describes moral distress in the nursing environment?

What initiative is most likely to promote open communication between clients and practitioners quizlet?

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