When is consent required?

Consent is required before any treatment, investigation or physical contact with a patient is undertaken. Consent is also required before involving patients in research, teaching or disclosure of confidential information (which may be written, pictorial or auditory).

In England and Wales there is no statute, as in some countries, stating the principles of consent. Failure to obtain informed consent may give rise to civil or criminal proceedings as any touching of the person, no matter how well intentioned, is a trespass. However, to protect against a claim of battery, consent only in the broadest terms has to be obtained.

By contrast, a much more demanding obligation to obtain informed consent arises from a duty of care to the patient by the health professional.

Failure to provide sufficient information prevents a patient making an informed choice. If, as a result, the patient agrees to a procedure she would have refused had she been fully informed and harm arises as a result, there would be grounds for a claim of negligence (even if the harm is a recognised hazard of the procedure rather than the product of poor management).

The case of Chester versus Afshar suggests that failing to provide relevant information to a patient and ensuring that information is understood in a timely manner, could lead to a successful claim, even if the patient would have chosen the treatment had they been informed of the risk.1 In this case, the patient developed cauda equina syndrome following discectomy (a recognised complication of this procedure). She claimed that her surgeon had not warned her of this complication. The court accepted this. She admitted that it was likely that she would have chosen to undergo surgery by the same surgeon, even if she had known, but she had been deprived of the ability to make an informed choice in the matter. The majority view, when this case was appealed in the House of Lords, was that being denied the opportunity to make a properly informed decision about whether to undergo surgery constituted the injury. The implications for English case law as a result of this ruling are profound and the NHS Litigation Authority has issued an alert on this subject.²

Obtaining consent should be a process begun as far in advance of a procedure as possible, but the doctor should recheck immediately prior to the procedure that the patient still consents. In obstetrics, information about potential complications and possible treatment options should be made available in the antenatal period. It is recognised that this will not be possible in the emergency situation and that those most at risk may not be accessible antenatally.³

The General Medical Council (GMC) suggests that obtaining informed consent is a process, not an isolated event. It suggests that, ‘When providing information you must do your best to find out about patients’ individual needs and priorities. You should respond honestly to any questions the patient raises.’ A whole section is devoted to withholding information: ‘You should not withhold information necessary for decision making unless you judge that disclosure of some relevant information would cause the patient serious harm. In this context serious harm does not mean the patient would become upset, or decide to refuse treatment.’⁴

Why is consent required? The legal and ethical considerations

The need for valid consent is not just a legal requirement but also an ethical principle that reflects respect for an individual’s autonomy and is a fundamental part of good practice. This is the view of both the Department of Health5 and the GMC.⁴

The traditional model of consent is the ‘harm-avoidance model’, in which the patient is informed of the risks of a procedure, described in general terms, but is otherwise excluded from the decision-making process. The patient is dealt with, ‘In an authoritarian but benevolent way, (e.g. by supplying all their needs but regulating their conduct).’⁶ This was considered acceptable in the case of Sidaway versus Board of Governors of the Bethlehem Royal Hospital. As the judge put it: ‘When telling a patient about an operation, the doctor has to decide what ought to be said and how it should be said.’⁷

The increased emphasis on the rights of individuals has led to the requirement for a more demanding form of consent. This is the so-called ‘autonomy enhancing model of consent’, in which the patient must be given all the information they require to make their own fully informed decision about a proposed course of action.

Consent may be implied or express. An example of implied consent is the action of a patient holding out an arm for venepuncture to be performed. Such implied consent would usually protect against a charge of battery.

Express consent is required for a procedure carrying a ‘material’ risk (see below). The validity of consent does not depend on the form in which it is given: a signature on a form will not necessarily make consent valid. Equally, if consent has been validly given, the absence of a signed consent form is no bar to treatment. Written consent is considered advisable when the procedure involved is complex or risky, research or screening rather than clinical care is involved or there may be, ‘Significant consequences for the patient’s employment, social or personal life.’⁴ It is a legal requirement for some treatments specified in the Human Fertilisation and Human Embryology Act 1990 and the Mental Health Act 1993.

What makes consent valid?

Sufficient information

This is an area of uncertainty with considerable changes occurring over time and between countries. Only the case in the UK will be discussed in detail.

In the UK in 1957, in the case of Bolam versus Friern Hospital it was established that a doctor’s practice would be judged against that of his medical peers – the Bolam principle or ‘reasonable doctor test’ – and this was specifically applied to what information to give a patient.⁸ This was challenged in 1985 in the case of Sidaway, when it was opined that there might be occasions when information about a particular risk was so obviously necessary that the court would decide that its omission was negligent even if this was not the opinion of a ‘responsible body of medical opinion’.⁹ In the cases of Bolitho and Pearce, the Bolam principle was overturned. The courts made it clear that the court itself would be the final arbiter of what was a reasonable amount of information to give a patient and not the medical profession. The reasonable doctor has been replaced by what the reasonable patient would expect to be told.¹⁰ The situation is different in the US where, in some states, the policy of ‘full disclosure’ is advocated (the patient is told as much as possible).

Material risk is a risk to which a person in the patient’s position would be likely to attach significance. A risk cannot be judged material on the basis of frequency alone.¹¹ The severity must be taken into account. The individual circumstances of the patient are also pertinent. For example, the risk of infertility following a procedure will be more significant to the primiparous woman than one who has completed her family. The type of information that patients should be told includes a description of the procedure and the incidence and severity of the risks involved (which should be mentioned even if they have not occurred in the practice of the particular doctor involved). There should be discussion on the likely or possible outcome of following or declining to follow a particular course of action and what the alternatives are (if any exist).⁴

The Association of Anaesthetists suggests that factors that might influence what the patient is told might include ‘the estimated capacity’ (see below) ‘of the patient to want to know and to be able to understand the risks’ and ‘the degree of urgency of the proposed treatment’.¹²

Occasionally, a patient might wish to know very little, or request that a relative make decisions for them (commonly the partner in obstetrics). In law, no-one may make decisions on behalf of an adult. In this situation, the GMC suggests trying to explain the importance of knowing what is happening to the patient and the Department of Health considers it ‘good practice’ to record in the notes if information is offered but declined. A relative of an adult cannot choose to withhold information; the patient must be consulted.

In obstetrics, the problem of how much to tell the patient can be particularly demanding. Obstetric patients are usually young and fit. Younger patients want more information.¹³ Women and their partners are often highly motivated to become informed. Several studies show that obstetric patients want more information than they are receiving.^14–16 There is evidence to suggest that providing more information does not increase anxiety levels in contrast to a common concern among the medical profession.¹⁷

Adversely influencing the opportunity to provide information that women want is lack of time: the majority of medical interventions in childbirth are unplanned, such as augmentation of labour, assisted vaginal delivery, episiotomy or manual removal of the placenta. Two-thirds of CS operations are nonelective. In a 2001 national audit, 16% of caesarean sections were considered to be category 1: when there is immediate threat to the life of the woman and her fetus and delivery within 30 minutes is considered mandatory.¹⁸ When trauma is involved, time is invariably at a premium. Most authorities suggest that women are given information about all the obstetric complications that might arise in the antenatal period. A combination of printed material with face to face question and answer sessions appear to be the most effective way of informing patients.¹⁹

Capacity

For a patient to have capacity (to be competent) to make a decision concerning medical treatment the following criteria must be met:

In the UK, anyone over the age of 18 years is assumed to be competent to choose or refuse treatment unless shown not to be (for 16–18-year-olds see below). This is ‘not a question of the degree of intelligence or education of the adult concerned’.²⁰ In order for a patient to be able to comprehend information, it must be presented in a form comprehensible to that patient (e.g. in a language they can understand or avoiding written material in the case of illiteracy). The Department of Health warns not to underestimate the capacity to consent by a patient with learning disabilities. Extra effort should be made to present information in a form comprehensible to such patients. Furthermore, the patient need not come to a decision that is seen as rational by others: ‘The patient’s right of choice exists whether the reasons for making that choice are rational, irrational, unknown or even non-existent’ (Lord Donaldson).²¹

No other person can consent to treatment on behalf of any adult, including incompetent ones, unless they are legally appointed with power of attorney.

Since 1969, those aged 16 or 17 years are entitled to consent to medical intervention (Section 8, Family Law Reform Act 1969). Unlike adults, however, their refusal of medical treatment may sometimes be overturned by an adult with parental responsibility. The power to overrule is based on the paramount importance of the welfare of the child. Refusal of treatment by a child or those with parental responsibility can be overruled by a court in the interests of the child’s welfare. This has obvious implications in the case of children of Jehovah’s Witnesses (this is not the case in Scotland, where a competent child’s refusal cannot be overturned).

Children under the age of 16 years may have the capacity to consent to medical treatment if they are judged to have capacity by their doctor, taking into account the complexity and risk of the procedure and the child’s state of health and mind. This process was known as assessing the child to be ‘Gillick competent’. The doctor should ensure that all relevant considerations pertaining to their decision are documented.

In the case of obstetrics, it is worth noting that, in the UK in 2000, over 41 000 girls under the age of 18 years became pregnant, of whom 8000 were under 16 years old. A high proportion of young girls seek to terminate their pregnancy. In such circumstances, there is potential for conflict between parents and children over whether to terminate the pregnancy and it is vital to establish whether the girl is ‘Gillick competent’.