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 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 he be ‘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: patients have the right to decide their 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, such as 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.

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, 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 any complication.

  • 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 and document this. 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 the patient’s 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; 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

Three aspects of consent 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 4.1 . If the patient does not have capacity to make a decision, the doctor must involve the relatives, although the doctor is still making 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 making decisions about change of living circumstances.

Box 4.1
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 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 they 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 particular 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, such as 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 may 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, complications of a procedure to such an extent that the patient refuses treatment. This should not be the objective of discussing treatment and is rarely in the patient’s best interest. 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.

Consent law in the UK has recently been revised following a particular judgement in the case of Montgomery. The revision centres around the level of risk that needs to be explained to the patient. Previously it was assumed that risks that were rare did not need to be included in the explanation given prior to consent. Now doctors have a duty to take reasonable care to ensure that patients are aware of all ‘material risks’. When seeking consent to treatment, the question of what is a ‘material risk’ is judged from the perspective of what a reasonable person would consider material in the patient’s position. This makes understanding how patients would perceive the consequence of any risk particularly important (such as a tiny risk of blood transfusion being needed after a percutaneous biopsy procedure, or the tiny risk that laparotomy and colostomy may be needed after a colonoscopy perforation, which itself has a low risk of occurring).

Confidentiality

The fact that all aspects of the encounter are confidential forms the foundation for the consultation, because 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, may be used as evidence in court in both civil and criminal cases. Patients have the right to inspect their own medical records after making a written application. 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 the patient’s 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.

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