Ethical considerations

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3 Ethical considerations

William M. Drake

Introduction

The cornerstone of a good relationship between doctor and patient is trust. In primary care, this relationship (often in the context of caring for the whole family) may be built up over several years, but in hospital practice or in an emergency, the patient and the doctor may be meeting for the first time. Patients expect a high standard of behaviour and care when they seek medical help. This includes the following expectations:

They will be consulted about decisions bearing on their treatment.

They will be informed about their illness.

They will be informed about the likely outcome of any treatment offered.

Their right to confidentiality will be respected.

Always assume that a patient is able fully to understand the nature of the medical problem and its implications, regardless of your impression of their educational level. Some patients like to discuss what they would like to know early in a consultation, and many will say clearly what information they would like to be given to the family. Occasionally, family members may feel that the patient would not be able to comprehend medical information; or ask that they are ‘protected’ from the full details of a serious illness. Patients may insist that they do not wish the family to know about their medical problems or, sometimes, that they themselves do not wish to know the diagnosis. In all such instances, the needs and rights of each individual patient should be considered paramount, over and above those of the family, in the event of conflict.

Autonomy

The fundamental principle underlying medical ethics is autonomy: the patient has the right to decide his or her own medical destiny. This gives rise to the concept of seeking the patient’s consent for medical interventions, for research and for teaching. Only in the case of a minor or a mentally disturbed person may consent be sought from the patient’s lawful parents or guardians. Assent, but not consent, may be sought from relatives, for example in the case of an unconscious patient in an intensive care unit. The doctor therefore has a duty not only to advise, but also to explain. This principle crosses all religious and cultural boundaries.

Consent

The patient’s consent should be sought for any treatment, however minor, even when that consent might appear implicit as, for example, by attendance at an emergency unit with injury. Sometimes assessment of a minor symptom discloses a separate, more serious issue. In such circumstances, consent to investigate the new problem is required.

In order to give consent, a patient must have sufficient, accurate information about the illness in order to make an informed judgement about whether its investigation and treatment are justified. There are four requirements of the doctor discussing an intervention with a patient:

1 The procedure itself must be described, including the technique and its implications, and the intended benefit of doing it.

2 Information about the risks and complications must be given, which usually means all the risks, as well as some information about the consequences of the complication (e.g. perforation at colonoscopy is a rare occurrence but, if it happens, a laparotomy and colostomy may be needed).

3 Associated risks (e.g. from anaesthesia or from other drugs that may be necessary) should be described.

4 Alternative medical or surgical investigations or treatments should be discussed, so that the reasons for the specific advice given are clear. In addition, the implications of the ‘do nothing’ option should be discussed.

Obtaining consent

The amount of information divulged will vary according to the context of the discussion and according to the needs of the patient as they emerge in the consultation. The objective is not to place the patient in the situation of having to decide between conflicting medical data, but to explain why a particular investigation or treatment is being recommended. The patient must not feel under duress.

Setting the scene

Discussions regarding consent for investigation and treatment should be conducted in a suitable environment that is quiet, free of interruptions and away from unnecessary observers, such as other patients or unfamiliar nurses or students. Make time for the discussion and turn off pagers or mobile phones which, if they interrupt a discussion, can give the impression that you are rushed and fitting the patient into a busier, more important schedule. Use simple language that the patient can understand. Be patient. If necessary, and with the patient’s permission, involve relatives. If there is likely to be a language problem, make sure that an interpreter (not a relative) is available. At the end of the discussion, check that the patient has actually understood. A written summary of the information supplied should be given to the patient for later consideration.

Implications of consent or refusal

Some patients, after detailed discussion, decline the recommended investigation or treatment. This should not result in the doctor being any less committed to their welfare. Discussions regarding alternative strategies should commence within the framework of what has been agreed and what is acceptable to the patient.

If explicit consent is given, the patient and doctor should both sign an appropriate consent form. This procedure should be followed for all serious interventions. In hospital, this will be a standardized form, and a similar form should be used in family or private practice to verify that the discussion took place. The act of both parties signing the form does not constitute proof that consent has been lawfully given but merely documents that a discussion took place. It is good practice to make a separate, contemporaneous note describing what was discussed.

Legal requirements for consent

There are three aspects of consent that are required in law:

1 The patient must be mentally and legally competent to give consent.

2 The patient must have been sufficiently well-informed to be able to give consent.

3 Consent must have been given voluntarily, and not under duress.

Competence and capacity for consent

The definition of mental capacity is given in Box 3.1. If the patient does not have capacity to make a decision, the doctor must involve the relatives, although the doctor is still taking the final decision. If the patient does not have capacity and has no relatives, in the UK the doctor must involve an independent mental capacity advocate (IMCA) to help with decision-making, particularly if consenting for surgery or for decisions about change of living circumstances.

Box 3.1 Criteria for having mental capacity

The patient can understand what has been explained

The patient can recall and repeat what has been explained

The patient can discuss what has been explained and weigh up information

The patient can communicate the decision that he has made

Special difficulties with consent arise when the patient is unconscious. If treatment is necessary in order to save life, it can and must be given without waiting for consent. If relatives are available, they should be consulted, but their wishes are not necessarily paramount in the decision to initiate life-saving therapy. The relatives may thus assent to treatment, but cannot legally consent to it (in the UK). This limitation also means that relatives cannot legally refuse treatment that is medically in the best interests of the patient, although a conflict of this kind should be reason to consider, carefully and in detail with the relatives, the reasons for disagreement.

Consent for the treatment of children requires special consideration. In general, a minor (i.e. a person under the age of 16 years) can be treated without parental consent, provided that care has been taken to ensure the child understands the nature of the treatment proposed and its possible risks, adverse effects and consequences. However, this should be a most exceptional decision. In practice, the parents’ agreement should almost always be sought. An obvious exception would be in an emergency, such as after a life-threatening head injury, or when non-accidental injury is suspected. Difficult decisions sometimes arise, for example when the prescription of contraceptive drugs to a young girl is requested in circumstances she does not wish her parents to know, or parents refusing to allow a bleeding child to have a blood transfusion for religious reasons.

Appropriately informed

The point at which a patient can be considered to be appropriately informed is a matter of judgement. Some patients make it clear that they do not wish for long and involved discussions whereas others are comfortable only when very full explanations have been given. It is often necessary to strike a balance. It is easy to frighten a patient by reciting unwelcome, but rare, possible complications of a procedure to such an extent that he refuses treatment. This should not be the objective of discussing treatment. If a procedure is so risky that the doctor feels it is not justified, and is therefore futile, the patient should be advised accordingly rather than being asked to decide for himself.

Confidentiality

The fact that all aspects of the medical consultation are confidential forms the foundation for the consultation, as it allows the patient freedom of expression in the knowledge that disclosures made within the confines of the consulting room will not be made available to others.

The principle of confidentiality applies also to the medical records. These are held by the doctor or the group practice or, in the case of hospital records, by the hospital itself. Medical records are not available to anyone other than the medical and nursing staff treating the patient, and are immune from police powers of search. They are made available, however, with the permission of the patient and, once disclosed, can be used in evidence in court in both civil and criminal cases. Patients have the right to inspect their own medical records after seeking access in writing. In the UK, the principle of confidentiality is rigorously supported by the General Medical Council and its breach is regarded as a serious matter.

The main situations in which confidentiality can be relaxed include the following:

When the patient or his legal adviser allows it.

When it is in the patient’s interests.

If there is an overriding duty to society as a whole.

In cases of statutory disclosure.

Sometimes after death.

With permission

A common example of relaxation of confidentiality with the patient’s permission occurs when a consultation is witnessed (e.g. by medical students or a nurse). The patient should be given the opportunity to ask that others leave.

In the patient’s interests

When it is necessary that another family member be informed about the nature of a patient’s illness, for example in order to obtain information essential for effective treatment, it may be judged in the patient’s best interests to break confidentiality. Another example might arise if a patient was judged mentally incompetent and it became necessary to involve a legal adviser to handle their financial and legal affairs during a severe illness. This generally requires permission from a court.

An overriding duty to society

Occasionally confidentiality may be relaxed in the context of a known or possibly pending violent crime. In the case of an illness such as epilepsy or coronary heart disease that might impair the ability to control a vehicle, the responsibility to inform the authorities rests with the patient. Voluntary disclosure is encouraged, maintaining the principle of confidentiality between doctor and patient, but if the patient clearly does not make the disclosure, the clinician does have discretion to break this principle in circumstances that entail serious public risk (e.g. a patient having regular seizures who clearly has not informed the driving licensing authority).

Statutory disclosure

Confidentiality is breached in the case of certain infectious diseases, such as tuberculosis, that are statutorily notifiable to the public health authorities. There is also a statutory duty for a doctor to help in the identification of a driver involved in a road traffic accident who, for example, might have attended a surgery or accident and emergency department after the accident. The doctor in the witness box is in a state of privilege, and is protected against any action for breach of confidentiality when instructed by a court to disclose potentially confidential information. Similarly, a court can ask that medical documents be released to it if they are regarded as necessary for the completion of a fair trial of an accused person.

Inspection of medical records

Patients have a lawful right to inspect their own medical records, and can see any reports concerning their own medical condition that have been prepared before they are released to another party. Such reports can only be prepared with the permission of the patient or at the request of a statutory body, as in the context of an order under the Mental Health Act, or in the jurisdiction of a recognized court. Generally, persons other than the patient have no right to inspect the medical records of an individual in the absence of written permission or when the records are subject to a subpoena from a recognized court.

After death

Generally, the principle of confidentiality should extend to patients who have died. In the cases of a number of deceased public figures of recent years (e.g. Winston Churchill and John F. Kennedy), this principle was not adhered to on the grounds (not universally accepted) that there were matters of public interest involved.

Organ donation

When a tissue that can be replaced by the donor’s own tissues, such as blood or bone marrow, is given to another patient, no special ethical problem arises. When a living donor gives an irreplaceable organ, such as a kidney, difficulties arise. The donor must be of sound mind, not under duress and must not be placed in a position to gain financially by the gift. The sale of organs for transplantation is forbidden in all developed countries, and is rapidly becoming illegal in all countries. Similar considerations apply to the acquisition of donor organs from a minor, a practice about which it is particularly difficult to issue sound guidelines.

Resuscitation

Resuscitation is generally available in hospitals in the event that cardiopulmonary arrest occurs unexpectedly. However, this is not always successful, and many patients, recognizing the terminal nature of their illness, may request that resuscitation not be attempted. This is an entirely valid request, which should be respected once it is certain that the options are clearly understood by the patient.

Not for resuscitation

Sometimes a patient is so seriously ill that resuscitation is deemed inappropriate by medical and nursing staff. Clearly, this implies a value judgement by those concerned that, in some way, the patient’s life is not worth saving. The situation most frequently arises when a patient has terminal cancer; resuscitation followed by a few hours or days of further pain and discomfort might be regarded as an unnecessary prolongation of the illness.

The decision to withhold resuscitation is a matter for which it is proper always to seek the patient’s full, informed consent. The patient’s views are paramount, and should be respected whatever the views of the clinicians and nurses or even the relatives. Relatives have no legal rights in a decision about the possible resuscitation of another individual. Although they may be consulted, and their views noted, they should not be allowed to influence a decision once it has been made by the individual, unless it is decided that the patient is not competent by reason of dementia, or some other impairment of judgement, to reach a decision. Overt depression, for example, might be a reason for not accepting a patient’s expressed wish not to be resuscitated.

Although it might be thought not helpful to a patient to discuss this issue openly, in fact the reverse is usually the case. Most patients near to death are aware of their situation and welcome the opportunity for full discussion of the issues. The agreement of the patient and medical staff should be signed in the case record and most hospitals now use a formal protocol to document this procedure. Patients should always be resuscitated when cardio-pulmonary collapse is unexpected and their wishes are unknown.

Consent for autopsy

Explicit consent is required for autopsy, as tissue samples will be taken and examined and some may be retained for future use. If this is intended, or is likely to occur, permission to retain the samples must be obtained as part of the consent for autopsy. This process of consent implies that the family will be given some idea of what studies might be undertaken on the retained samples in the future. It may be considered appropriate to consider whether any circumstances might develop in which the family might reasonably expect to be informed of the results of any such studies. For example, if information of a predictive or genetic nature were to be obtained in relation to the risk of vascular disease, or of specific cancers, then the family might wish to know of this.

Principles of medical ethics

Several modern attempts have been made to encapsulate the principles of ethical medical behaviour in a series of simple statements. The Declaration of Geneva (Box 3.2) represents a modern attempt to restate the Hippocratic Oath in contemporary language. The International Code of Medical Ethics (Box 3.3) was derived from these principles, and restates them in more direct terms. The Declaration of Helsinki (1975) sets out recommendations for the guidance of doctors wishing to undertake biomedical research involving human subjects. The recommendations of the Declaration of Helsinki are generally recognized as relevant to the design of research protocols. The UK General Medical Council’s duties of doctors are listed at the end of Chapter 1.

Box 3.2 Declaration of Geneva propounded by the World Medical Association in Sydney (1968)