GMC, seeking patients′ consent: the ethical considerations (1998)

The language used in the guidance is important because where it is stated that a doctor must do something this is a requirement and doctors' registrations may be at risk if they do not do it. Should is used when the GMC is ‘providing an explanation of how you will meet the overriding duty’ and is distinct from must because ‘the duty or principle will not apply in all situations or circumstances’ (see, for example, GMC, 2008, p5).1 Must is thus an overarching, universal duty, whereas there are situations in which it might not be appropriate to follow the explanations using should, although a doctor may have to justify non-compliance. The should remains, prima facie, something that a doctor ought to think carefully about before departing from, but it is less compelling than must.

It was not until late in 1998 that the GMC issued specific guidance on consent.2 Before that, the 1995 and 1998 editions of Good Medical Practice dealt with consent as bullet points of generic guidance.4 5 But, importantly, paragraph 12 of the 1998 edition required doctors to ‘be satisfied that, wherever possible, the patient has understood what is proposed’. Paragraph 1 of Seeking Patients' Consent, published in November 1998, made clear that autonomy, defined as a patient's ‘right to decide whether or not to undergo any medical intervention even where a refusal may result in harm to themselves or in their own death,’ was a central concept. Patients must be given ‘sufficient information’ in a way they can understand ‘to enable them to exercise their right to make informed decisions about their care’ (GMC, 1998, para 6).2 Shared decision-making and communication were emphasised and doctors required to ‘do [their] best to find out about patients' individual needs and priorities,’ including their beliefs, culture or other factors that might affect the information needed to make a decision (GMC, 1998, para 6).2 Assumptions should not be made about patients' views, but doctors should discuss these with them and ask about concerns regarding the treatment. Patients should be provided with ‘appropriate information … [including] an explanation of any risks to which they may attach particular significance’ (our emphasis) (GMC, 1998, para 6).2 Doctors should ‘ask patients whether they have understood the information and whether they would like more before making a decision’ (GMC, 1998, para 6)2 and ‘make arrangements, wherever possible, to meet particular language and communication needs’ by, for example, using independent interpreters, signers or the patient's representative (GMC, 1998, para 13).2 Communicating via suitable means and mediums was thus appropriate and there was a requirement to discover patients' needs and priorities. Therefore, despite equating autonomy with information transfer and patients' rights to make their own decisions, the 1998 guidance required an interaction and communication between doctors and their patients. In this regard, it asked for more than required under the common law at that time.

The common law

From the mid-1980s to mid-1990s, the courts were grappling with the question of what constituted a material risk. Ideas of joint decision-making were absent from the judgements, as the focus was on what and how much information the doctor should give to the patient. The process was viewed as one-way—the doctor spoke, and the patient listened and then decided what to do. Dialogue was not explicitly encouraged. This approach is evident in the leading case of Sidaway v Bethlem Royal Hospital Governors [1985] where the House of Lords held that the doctor should decide what risks the patient should be told about, based on those a reasonable doctor would inform a patient of.6–8 A reasonable doctor would not have warned Mrs Sidaway of a less than 1% risk of paralysis from the waist down. Although Lord Templeman acknowledged the importance of providing information because ‘[a] patient may make an unbalanced judgement … [if] deprived of adequate information’ (p666),6 he warned of the dangers of providing too much information.

The law thus focused on the doctor, with the courts not appearing to view informed decision-making as an issue of patient autonomy, and patient's interests were rarely, if ever, mentioned. For example, in Blyth v Bloomsbury Health Authority, decided in 1987 but only reported in 1993, Mrs Blyth complained that she had asked specific questions about the risks inherent in receiving the oral contraceptive Depo-Provera and had not been given full answers.9 The Court of Appeal, rejecting her claim, held she had no automatic right to be fully informed because the decision in Sidaway did not mean that ‘where questions are asked … or doubts are expressed, a doctor is under an obligation to put the patient in possession of all the information on the subject which may have been available in the files of a consultant, who may have made a special study of the subject’; rather, ‘[t]he amount of information to be given must depend on the circumstances, and as a general proposition it is governed by … the Bolam test’ (p160 per Neill LJ).9 Similarly, in Gold v Haringey Health Authority [1988], the Court of Appeal, applying Sidaway, held that there was no distinction between the amount of information to be given in therapeutic and non-therapeutic procedures, and Lloyd LJ defined information disclosure as a matter of technical medical skill (p489).10 In neither Blyth nor Gold was the notion of a patient's right to information raised, much less the idea of patient autonomy. The test for disclosing risks was doctor-based; thus, ‘the non-observance of patient autonomy … [was] notorious in English law’.11

During the 1990s, there were signs of change in the common law, with the driver being the courts' recognition of what they termed patients' rights to autonomy and self-determination. In Smith v Tunbridge Wells Health Authority [1994],12 Morland J approvingly quoted passages from Lord Templeman in Sidaway (p662)6 that recognised the right of patients to make their own decisions and suggested that patient autonomy was best protected by providing information. He emphasised Lord Templeman's statement, noted above, about the risk of inadequate information leading to a patient making an unbalanced judgement (p337).12 Morland J also said ‘the doctor … must take reasonable care to ensure that his explanation … is intelligible to his particular patient. The doctor should use language, simple but not misleading, which the doctor perceives from what knowledge and acquaintanceship that he may have of the patient (which may be slight), will be understood by the patient so that the patient can make an informed decision as to whether or not to consent’ (our emphasis) (p339).12

The importance of communicating information was thus recognised, as was the fact that ‘[s]imply telling the patient about the risks without making any attempt to see if the patient has understood the information can be negligent’ (Jones, 1997, p118).13 This idea has been supported in other decisions, including Smith v Salford Health Authority [1994]14 and Lybert v Warrington Health Authority [1996].15 Despite this change in approach, the courts' focus on disclosing material risks has remained, with this redefined first as a risk that the reasonable patient would wish to be informed of16 and then as a question for the courts and not the medical profession.17 The belated recognition of the centrality of the patient is identifiable in Pearce v United Bristol Healthcare NHS Trust,16 and in Chester v Afshar [2004] the court recognised that the law relating to informed decision-making should prioritise and protect patient autonomy (para 14 per Steyn LJ).17 In Pearce the court emphasised the importance of providing information and equated this to patient autonomy: ‘if there is a significant risk which would affect the judgement of a reasonable patient, then … it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt (p59, per Woolf LJ, MR).16

The House of Lords went further in Chester viewing patient autonomy as fundamental: ‘The starting point is that every individual of adult years and sound mind has a right to decide what may or may not be done with his or her body. Individuals have a right to make important medical decisions affecting their lives for themselves: they have the right to make decisions which doctors regard as ill advised’ (para 14 per Steyn LJ),17 In this important case, their Lordships dispensed with the well-established legal rule that in order to prove negligence it has to be shown that the breach of duty of care owed by the doctor to the patient (failing to warn of a material risk) had caused harm to the patient (normally meaning the patient consented to a procedure that the patient would otherwise have refused). In this case, the latter was legally contentious because Ms Chester admitted that although she might have taken more time to think about the issues if she had been informed of the 1–2% risk that the surgery might lead to a seriously adverse result even if correctly performed, she would probably still have consented to the procedure. In dispensing with this requirement, their Lordships essentially compensated Ms Chester for the autonomy she had lost in not receiving that information, rather than any tangible, physical harm that she ultimately suffered.

Does the common law meet the GMC's 1998 standard?

Although the common law does not directly highlight the importance of communication and shared decision-making, as the GMC's 1998 guidance did, ideas of patient autonomy and its centrality to information provision and consent are now recognised. In Chester, for example, patient autonomy was accepted as underpinning the law and given precedence even though a well-established legal rule had to be modified to do so. Indeed, Lord Justice Steyn said ‘Her right of autonomy and dignity can and ought to be vindicated by a narrow and modest departure from traditional causation principles (paragraph 14)17 But the common law has not yet reached the standard of the GMC's 1998 guidance, and the courts have not considered what autonomy means nor how it might be legally defined. Unfortunately, despite Lord Templeman's cautionary words in Sidaway (p666),6 there is a sense that judges are equating more information with more autonomy. In Chester (para 58),17 Lord Hope drew attention to Jones's comment that ‘[p]art of the imbalance between doctor and patient is due to the patient's lack of information, and, on one view, it is the function of the law to redress the imbalance by providing patients with the ‘right’ to be given that information, or perhaps more accurately imposing a duty on doctors to provide it’ (Jones, 1999, p129).13 Thus, volume of information and not its value, communication or shared decision-making may be viewed as the panacea to protect patients' rights.

There are at least two problems with this view of autonomy. First, if the duty of doctors is simply to impart information and not to communicate it, then the focus returns to the doctors' conduct and is not a genuine attempt to encourage patients to make the decision they wish to make. Consequently, there is a danger of ‘abandoning’ patients to their decisions.18 These points are illustrated in Al Hamwi v Johnston and the North West London Hospitals NHS Trust,19 where Mrs Al Hamwi, who did not speak much English and wanted to undergo amniocentesis, was left, after counselling, under the impression that there was a 75% chance of harming the fetus. She thus refused her consent and gave birth to a child with a genetic abnormality that would have been detected by the test. The court, in rejecting her claim, found that the doctor had explained the issues to her correctly, provided leaflets (in English) and had satisfied her legal duty to inform. It would be ‘too onerous’ to require the doctor to ensure the patient had understood the information (para 69).19 This decision did not protect Mrs Al Hamwi's autonomy and emphasised that doctors only need to ensure that information is imparted and not that it is understood by the patient. In this case, the idea that Mrs Al Hamwi's autonomy would be protected by (more) information is clearly flawed—she could not understand the information and made a decision different to the one that she would have made had she correctly understood the information given to her. She was abandoned to her so-called choice. Yet the decision in Al Hamwi is a logical extension of the approach taken by the courts.

Thus, despite statements in Smith v Tunbridge Wells Health Authority12 to the contrary, the common law has tended to view the process of providing information as one-way—a list of risks imparted by the doctor to the patient. The disadvantages of this approach are clear. If the law required genuine communication in a way that patients could understand, as in the GMC's 1998 guidance, Mrs Al Hamwi's case might have been decided differently. In imagining discussion, genuine interaction and an attempt to find out what the patient wanted, the 1998 guidance set a standard of disclosure higher than that demanded by the law, and undoubtedly preferable to it. The guidance also advocated an approach that sought to maximise patient autonomy in a more sophisticated, effective way than the common law has yet to achieve. It can thus be said to define (and protect) a different definition of autonomy. While both the common law and GMC imagine autonomy as requiring information about risks and the right of patients to make their own decisions, only the GMC emphasises communication between doctor and patient as a fundamental part of this interaction. It is thus unfortunate that this guidance is no longer valid, as we suggest that the 2008 guidance now requires less of doctors and thus represents a step backward in seeking informed decision-making.

GMC Consent: Patients and Doctors Making Decisions Together (2008)

On 2 June 2008 the GMC's new guidance on consent came into force.1 It moves away from the approach in Seeking Patients' Consent.2 Doctors are told that they should tailor their discussions with patients depending on ‘(a) their needs, wishes and priorities, (b) their level of knowledge about, and understanding of, their condition, prognosis and the treatment options, (c) the nature of their condition, (d) the complexity of the treatment, and (e) the nature and level of risk associated with the investigation or treatment’ (paragraph 7). Doctors should have regard to a patient's level of understanding, and there are 12 categories of medical information that a patient might want—including prognosis, alternative options and whether the procedure is part of a research programme—which doctors must provide (paragraph 9). Doctors should ‘explore these matters with patients, listen to their concerns, ask for and respect their views, and encourage them to ask questions’ (paragraph 10) and should check that the patient has understood the information and does not require more (paragraph 11).

There thus appears to be a distinction between the medical information in paragraph 9 and the information that the patient might want (see para 7, 8, 10 and 11). In other words, the communicative aspect of the 1998 guidance that crucially differentiates its definition of autonomy from that of the common law has been weakened. Indeed, paragraph 9 is the only one to be preceded by the invocation that the doctor must comply, and the problem with this is twofold. First, aspects surrounding the patient's own needs and wishes have been downgraded to should, whereas paragraph 6 of the 1998 guidance stated that doctors must try to find out about patients' individual needs and priorities. Even if the effect of this relegation is only symbolic, it represents a change of the duty from one to be followed under all circumstances to one that is not. The fact that the relegated elements are those that relate to discussion and communication is disappointing and represents a step backwards towards the legal position. Second, this downgrading cannot be seen as consistent with the more recent approach of the courts which, Al Hamwi apart, have attempted, however imperfectly, to prioritise the autonomy of patients and their rights to have their wishes and priorities respected. In the past, the demanding nature of the 1998 guidance mitigated the courts' lack of coherence with regard to how patient autonomy might be protected. The new guidance, with its subtle changes to wording, may serve to undermine the very points—commitment to dialogue, personalisation of care and information provision—that had placed the GMC's requirements so far above the law in its treatment of patients as individuals.

Moreover, the information process as imagined in Part 1 of the 2008 guidance runs the risk of abandoning patients to their decision in some cases. Paragraph 5 sets out the way in which consent will work. First the doctor will ‘make an assessment of the patient's condition, taking into account the patient's medical history, views, experience and knowledge’; then the doctor will explain the relative risks and benefits of the various options available to the patient and recommend an option, but ‘must not put pressure’ on the patient to accept that advice. After that, patients are left to their own devices: ‘The patient weighs up the potential benefits, risks and burdens of the various options as well as any non-clinical issues that are relevant to them. The patient decides whether to accept any of the options and, if so, which one. They also have the right to accept or refuse an option for a reason that may seem irrational to the doctor, or for no reason at all’ (our emphasis). The doctor is only advised to discuss matters with a patient if the decision made is one that is not ‘of overall benefit’ to the patient. Thus, the interaction envisaged consists of the doctor explaining the risks and the patient then making a decision. There is minimal encouragement for discussion, communication or shared decision-making, despite the title of the 2008 guidance. The risk of abandonment lies in patients having access to information, without perhaps fully understanding it, and being left to make decisions they may not have been, or not feel, adequately counselled to make. This is an inherent danger of the non-directive provision of information.20