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Does the General Medical Council’s 2020 guidance on consent advance on its 2008 guidance?
  1. Abeezar I Sarela
  1. Department of Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK
  1. Correspondence to Dr Abeezar I Sarela, Department of Surgery, Leeds Teaching Hospitals NHS Trust, Leeds LS9 7TF, UK; a.sarela{at}leeds.ac.uk

Abstract

The General Medical Council renewed its guidance on consent in 2020. In this essay, I argue that the 2020 guidance does not advance on the earlier, 2008 guidance in regard to treatments that doctors are obliged to offer to patients. In both, doctors are instructed to not provide treatments that are not in the overall benefit, or clinical interests, of the patient; although, patients are absolutely entitled to decline treatment. As such, consent has two aspects, and different standards apply to each aspect. To explore this paradigm, I propose the reconceptualisation of consent as a person’s freedom to achieve treatment, using Amartya Sen’s approach. Sen explains that freedom has two aspects: process and opportunity. Accordingly, a patient’s freedom to achieve treatment would comprise a process for the identification of proper treatment, followed by an opportunity for the patient to accept or decline this treatment. As per Sen, the opportunity aspect is to be assessed by the standard of public reason, whereas the standard for the process aspect is variable and contingent on the task at hand. I then use this reconceptualised view of consent to analyse case law. I show that senior judges have conceived the patient’s opportunity to be encompassed in information, which is to be decided by public reason. On the other hand, the process aspect relies on the private reason of medical professionals. Given the nature of professionalism, this reliance is inescapable, and it is maintained in the case law that is cited in both guidances.

  • autonomy
  • codes of/position statements on professional ethics
  • informed consent
  • law
  • political philosophy

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Introduction

The General Medical Council (GMC) has recently (2020) issued new guidance to doctors on how to seek and obtain consent for treatment from patients.1 The previous guidance on consent was published in 2008 (GMC 2008).2 Both sets of guidance assert compliance with contemporaneous case law. A critical question, then, is about the difference in the obligations that are placed on doctors by the 2020 guidance on consent (GMC 2020) as compared with GMC 2008. Unless doctors can understand the differences clearly, the practical significance of the new guidance is limited: without clarity, doctors will not be equipped to modify their practices in response to the new guidance and thereby remain compliant with current ethical and legal requirements. The present essay explores one of several differences between GMC 2008 and GMC 2020.

One significant difference is that GMC 2020 requires doctors to provide relevant information about the ‘proposed options and reasonable alternatives’, whereas GMC 2008 instructed doctors to inform patients about treatments that ‘are likely to result in overall benefit for the patient.’ GMC 2020 restricts the concept of ‘overall benefit’ to the selection of treatment for patients without decision-making capacity; for adults with capacity, GMC 2020 uses the term ‘available treatments’, which would include both proposed options and reasonable alternatives. At the same time, GMC 2020 advises doctors to not provide treatments that would not serve the patient’s ‘clinical interests’; and GMC 2008 had advised similarly about treatments that would not be of ‘overall benefit’. The explicit change in terminology—from ‘overall benefit’ to ‘reasonable’, ‘available’ and ‘clinical interests’—implies a corresponding change in a doctor’s obligation to identify treatment options; but, the GMC does not explain the nature of the change.

In this essay, I argue that the difference in the terminology between GMC 2008 and GMC 2020 is obscure; and that both sets of terminology reduce to what senior judges have earlier termed as ‘proper medical treatment’.3 My argument is organised in three parts. First, I distinguish two sequential stages in the model of consent in GMC 2008. I argue that each stage involves different standards for balancing bioethical principles, but these standards are not specified. Second, I explore these standards by proposing that consent is reconceptualised as a person’s freedom to achieve treatment, using Amartya Sen’s understanding of freedom. Sen’s ideas clarify the division of consent into two stages but do not provide distinct standards for each stage. Third, I turn to case law. I find an implicit acceptance of two stages in consent, and separate standards for each stage; but no clear difference between the legal standards that underpin GMC 2008 and GMC 2020 in regard to the identification of proper treatments.

Consent has two stages that engage distinct ethical principles

GMC 2008 sets out a four-step (1–4) model for consent: following an assessment of the patient’s condition and circumstances (1), the doctor identifies and explains treatments that ‘are likely to result in overall benefit for the patient’ (2), and the patient deliberates on the proposed options and makes a decision (3); but, there is no obligation to provide treatment that the doctor deems to not be of overall benefit to the patient (4).2 Implicitly, in this model, there are two stages in the doctor’s obligation: first, the doctor has to identify and propose treatments that would be of ‘overall benefit’ for the patient, in the context of their individual situation; and, second, the doctor has to communicate relevant information about these treatments, in a way that the patient can understand this information and make a decision.

Through the reliance on ‘overall benefit’, the first stage of consent requires doctors to exercise a principle of beneficence in the form that Beauchamp and Childress describe as ‘utility’, which ‘requires that agents balance benefits, risks and costs to produce the best overall results’ (pg. 202).4 In other words, doctors have to exercise their professional expertise and experience to evaluate the benefits and harms of various treatments that might be possible, in order to locate the treatments for which the anticipated benefits are likely to outweigh potential harms. It is only after the first stage—identifying treatments which are of overall benefit—has been completed, that the second stage—informing the patient about these treatments—can be undertaken.

Beauchamp and Childress have been prominent advocates of conceptualising doctors’ obligations in consent as practices of the principle of respect for a patient’s autonomy. They define that ‘An informed consent is an individual’s autonomous authorisation of a medical intervention’ (pg. 122).4 They explain further that ‘A person gives an informed consent to an intervention if (and perhaps only if) he or she is competent to act, receives a thorough disclosure, comprehends the disclosure, acts voluntarily and consents to the intervention’ (pg. 124).4 Notably, in this paradigm of consent to ‘an intervention’, the focus is on the disclosure of information about the intervention, or treatment, that is being proposed by the doctor; and not on the selection of the intervention, itself. Hence, it would seem that Beauchamp and Childress’s reliance on the principle of respect for autonomy as the basis for consent pertains only to the second stage of consent that emerges from GMC 2008.

In Beauchamp and Childress’s widely respected theory of bioethics, a doctor’s obligation to identify appropriate treatments is not underpinned by the principle of respect for autonomy. Rather, as pointed out earlier, this latter obligation pivots on the principle of beneficence. In discussing beneficence, Beauchamp and Childress clarify that ‘physicians do not have a moral obligation to carry out their patients’ wishes when they are incompatible with accepted standards of medical practice or are against the physicians’ conscience’ (pg. 226).4 The model of consent in GMC 2008 follows Beauchamp and Childress in enjoining doctors to not offer, or concede to requests for, treatments that would not be of overall benefit to the patient. By inference, GMC 2008 accepts that doctors have to exercise the principle of beneficence, rather than respect for autonomy, in identifying treatments of overall benefit.

Beauchamp and Childress acknowledge that beneficence as utility is evaluative, that is, it involves the placement of values on benefits and harms in order to arrive at an assessment of overall benefit. In conceiving overall benefit, the doctor’s values would seem to take precedence over those of the patient, since doctors are not required to provide treatments that they do not deem to be of overall benefit, even if the patient thinks otherwise. At the same time, the doctor is absolutely forbidden to constrain a competent patient from declining treatment and thereby remaining in, or entering into, a condition that the patient chooses, regardless of the doctor’s views. Here, the patient’s values trump those of the doctor. Implicitly, different systems of values, or standards, apply to balancing ethical principles in the identification of treatments that would be of overall benefit (the first stage of consent) versus the decision making about whether, or not, the identified treatment should be implemented (the second stage of consent).

For the first stage of consent, beneficence takes priority over respect for autonomy; for the second stage, it is the converse. Neither the GMC nor Beauchamp and Childress explain the difference in the standards for balancing ethical principles between the two stages; more fundamentally, neither makes explicit the critical distinction between the two stages of consent. It would seem that the widespread emphasis on respect for autonomy conflates the distinction between the two stages of consent. Yet, as pointed out by Neil Manson and Onora O’Neill, it is not sufficient to justify consent simply on the basis of respect for patients’ autonomy5; instead, a more nuanced justification is necessary. In the next section, I propose a justification that is based on a particular understanding of freedom, and I suggest that consent practices are reconceptualised as respect for a patient’s freedom to achieve treatment.

Reconceptualisation of consent as freedom to achieve medical treatment

While there are several expositions of freedom,6 I rely, here, on Amartya Sen. In his view, freedom has two aspects: ‘process’ and ‘opportunity’. He explains that freedom ‘involves both the processes that allow freedom of actions and decisions, and the actual opportunities that people have, given their personal and social circumstances’ (pg. 17).7 The process aspect encompasses the means, or resources, that are available to people in order for them to achieve the ends, or goals, that they have reason to value.8 The opportunity aspect, on the other hand, pertains to the real or effective possibilities for people to convert these means into their valued ends. In this way, Sen makes a critical distinction between means and opportunities; and he envisages that opportunities derive from the underlying means, but the assertion of opportunities does not shape the means.

For example, consider that a person’s valued end is to travel to certain destination, and she has the means (say, a car) to accomplish this travel; yet, if she is disabled and cannot drive, then it is not really possible for her to achieve her end. Here, the process aspect of the person’s freedom to travel is satisfied; but, her opportunity aspect would not be satisfied—she would not truly be free to travel—unless some additional actions were taken (say, providing a driver). Similarly, the availability of a treatment constitutes the means, and supplies the process aspect of a patient’s freedom to medical treatment.1 For example, in case of prostate cancer at an early stage, both radiotherapy and surgery may be available as potentially curative treatment options, and these options would constitute the process aspect of the patient’s freedom to achieve treatment for prostate cancer. The doctor’s explanation of these treatments then supplies the patient with the opportunity to choose the option that really achieves his valued ends, based on his individual weightage of the pros and cons of each treatment. On the other hand, if the prostate cancer was at an advanced stage, then hormonal therapy might be the only available treatment. Now, the process aspect would not include radiotherapy or surgery; and the opportunity aspect, however stringent, could not culminate in either of these treatments. In this latter case, the patient’s opportunity would be limited to accepting or declining hormonal therapy. Thus, both aspects of a person’s freedom are important, but the two aspects are distinct and important in different ways.

In Sen’s paradigm, the same standard does not apply for determining the adequacy of both aspects of freedom. For the opportunity aspect, Sen insists on the standard of public reason.9 Essentially, as per John Rawls, public reason involves justifications that would be acceptable to a reasonable person.10 The proposed reconceptualisation of consent would oblige the doctor to exercise public reason in discharging the opportunity aspect of the patient’s freedom to achieve treatment; that is, the doctor would have to be able to justify the provision of information to a reasonable person in the patient’s position.2 For example, if the doctor had not disclosed the risk of impotence from prostate surgery, then the doctor would have to be able to justify her or his reason for excluding this information to a reasonable person. If the doctor’s reasoning was not acceptable to this reasonable person, then the doctor would not have provided the patient with an adequate opportunity to achieve treatment. Thus, the standard for assessing the second stage of consent—the patient’s opportunity to accept or decline the proposed treatment—is that of a reasonable person.

However, Sen does not argue that the process aspect of freedom should be decided by public reason; his focus is on the opportunity aspect. Public reason cannot be extended to the process aspect of freedom to achieve medical treatment. Public reason is the centrepiece of Rawls’s theory of justice, which assumes that all people remain in normal health over their lifetime; and Rawls explicitly excludes considerations of health and healthcare (pg. 184).10 Norman Daniels has extended Rawls’s theory to healthcare; but, in doing so, Daniels advances Rawls’s idea of procedural justice, and not of public reason.11 In brief, Daniels discusses that, since healthcare resource is inescapably finite, some limits have to be set on treatments that are made available to individuals; and the limit-setting criteria may not be acceptable to a reasonable person to whom a certain treatment was denied. As such, Daniels proposes that the availability of medical treatment should be decided according to a fair procedure—procedural justice—rather than public reason.3

Healthcare-resource apart, it does not seem that the identification of proper treatment could be a matter for public reason, because medicine has a transcendental purpose, or ‘internal morality’, that is independent of its acceptability to an external audience, reasonable or otherwise.12 The standard for deciding the process aspect of a person’s freedom to achieve treatment, then, depends on a combination of a fair procedure for resource-allocation and an expression of medicine’s purpose in the context of any individual patient’s situation. In the next section, I will analyse case law to locate how judges have employed this combination as the relevant standard. The legal analysis will also expose the tacit acknowledgement of two stages in consent, and the acceptance of public reason for the opportunity aspect of consent.

Consent in case law

GMC 2008 cites the judgement of the House of Lords in Chester 13 as the legal basis for the doctor’s duty to inform the patient. The standard of the doctor’s duty in Chester is to be inferred through its approval of the judgement of Lord Woolf MR in Pearce.4 Lord Woolf had instructed that ‘if there is a significant risk which would affect the judgement of a reasonable patient, then in the normal course 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.’14 By invoking the ‘reasonable patient’, Lord Woolf implicitly demands public reason; which, then, might seem to be the standard for the entirety of the doctor’s obligations in consent. However, as I will discuss below, this call on public reason is nuanced.

Moving ahead from GMC 2008, GMC 2020 relies on the judgement of the Supreme Court in Montgomery.15 Here, it is held that doctors should communicate ‘material’ information to patients and the ‘test of materiality’ is that ‘a risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it’ [para 72].15 By relying on a ‘reasonable person’ the Supreme Court, too, calls for public reason as the standard for supplying information (although, by including the ‘particular patient’ the Supreme Court extends Lord Woolf’s test5). However, as pointed out in a judicial analysis of Montgomery, ‘material’ was not ‘the qualification applied to provision of information as to alternative treatments. The concept of materiality has an obvious application to risks, but the question of what is a reasonable treatment is a different one, and the concept of materiality is not such an easy fit.’16 In other words, the test of materiality applies only to informing the patient about the proposed treatment, that is, the second stage of consent or the opportunity aspect of the patient’s freedom to achieve treatment. The Montgomery test of materiality does not encompass the identification of proper treatments, that is, the first stage of consent or the process aspect of the patient’s freedom.

The Supreme Court alludes separately to the process aspect as follows: ‘the treatment which they (doctors) can offer is now understood to depend not only on their clinical judgment, but on bureaucratic decisions as to such matters as resource allocation, cost containment and hospital administration’ [75].15 The Court explains that bureaucratic decisions are governed by public law. If policy-makers have lawfully excluded a certain treatment, say chemotherapy X, then doctors cannot offer it to anyone. The critical element, then, for the selection of ‘available’ treatments for individual patients is the doctor’s ‘clinical judgement’. For example, a doctor would have to exercise clinical judgement to determine whether chemotherapy Y, which is approved by policy-makers, is appropriate, and therefore ‘available’, for a certain patient in their unique clinical context.

What is the standard for assessing a doctor’s clinical judgement? The Supreme Court explains that ‘the doctor’s role when considering possible investigatory or treatment options’[82]15 is ‘a matter falling within the expertise of members of the medical profession’[83].15 Thus, the Court relies on medical expertise, and not on the reasonable person, to identify available treatment options.6 In other words, the Supreme Court does not hold that the availability of treatment is a matter for public reason. Instead, the identification of available treatments rests on the private reason of medical professionals. Private reason requires that actions are justified to a restricted audience only, such as the members of a particular profession or a specialty within that profession.17 The restricted audience is justified, in turn, by a particular sociological understanding that professionalism involves certain, complex knowledge and skills; consequently, only members of that profession, and none others, are competent to make proper professional judgements.18 It follows that only the doctors in any specialty, and no one else, can make proper clinical judgements about the availability of medical treatments for illnesses related to that specialty.

Furthermore, unlike public reason, private reason may provide several, different answers to the same problem. The subject of public reason—a reasonable person—is a philosophical ideal that includes all members of society.19 Public reason, then, supplies justifications that ought to be acceptable to this ideal; regardless of whether, or not, the justifications are actually accepted by real people. As such, as emphasised by Rawls, public reason can result in only one correct outcome for any problem (pg. 220).10 Private reason, on the other hand, may result in multiple outcomes for the same problem, because it targets real people, who may segregate into different ideological groups; for instance, different schools of opinion and practice within the same medical specialty. As observed by Lord Scarman, ‘Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgement.’20

The legal locus classicus for the assessment of medical activity—the Bolam test21—is grounded in the private reason of medical professionals. As explained by Lord Scarman, ‘The Bolam principle may be formulated as a rule that a doctor is not negligent if he acts in accordance with a practice accepted at the time as proper by a responsible body of medical opinion even though other doctors adopt a different practice.’22 By the Bolam paradigm, the standard of all aspects of medical practice becomes an exclusive matter of medical professional judgement. In Montgomery, the Supreme Court explicitly rejects the Bolam test for assessing the standard of information provision, that is, the opportunity aspect of the patient’s freedom to achieve treatment. Yet, as discussed above, the Court implicitly retains the Bolam principle—the private reason of medical professionals—for determining the process aspect, that is, the availability of treatment options.7 Lord Scarman had done so explicitly in Sidaway,22 which preceded Pearce; and, in Pearce, Lord Woolf does not, in any way, modify Lord Scarman’s dicta.

As such, the standard for the process aspect of freedom would not seem to be different in Montgomery from that in Chester. By implication, notwithstanding the change in terminology from ‘overall benefit’ to ‘available treatments’ and ‘reasonable alternatives’, there would not seem to be any difference between GMC 2008 and GMC 2020 in the standard for assessing the process aspect; in both, the standard is the private reason of medical professionals.

Conclusions

There are two stages to consent, and each stage is subject to different standards. The reconceptualisation of consent as a patient’s freedom to achieve treatment supplies the critical conceptual distinction between these two stages. The first stage—the process aspect of the patient’s freedom—is concerned with the identification of proper medical treatment. The second stage—the opportunity aspect—covers the doctor’s communication with the patient about the proper treatments that have been identified in the first stage. The second stage is sequential to, and contingent upon, the first stage. While the second stage is momentous, it is not determinative of the first stage. The first stage is independent of, and prior to, the second stage; increasing the rigour, and expanding the standard, of the second stage does not alter the standard of the first stage. The standard for the first stage remains the private reason of medical professionals, which emerges from case law that is relied on in both GMC 2008 and GMC 2020. It remains to be determined whether this private reason can be externally assessed (that is, by non-members of the medical profession); and, if so, how? It does not seem that GMC 2020 advances on GMC 2008 in relation to this question. Further work is required so that clarity can be supplied to both doctors and the public.

Data availability statement

There are no data in this work.

Ethics statements

Patient consent for publication

References

Footnotes

  • Twitter @AbeezarSarela

  • Contributors This paper is the sole work of AIS.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Other means, such as proper time and competency of the doctor, as well as the absence of disadvantageous influences on the patient, could also form part of the process aspect. However, the present focus is on the availability of treatment.

  • In Rawls’s theory, the reasonable person is a not an actual person but a philosophical ideal, and the construction of this ideal is a normative exercise that does not involve public discourse.

  • Public reason might demand discussion about treatments that were not available, and the reasons for unavailability (what Rawls terms as the ‘duty of civility’ pg. 217).10 But, this explanation would not alter the scope of the process aspect of a person’s freedom to achieve treatment.

  • In Chester, it was conceded that the surgeon had not disclosed the risk of paralysis from an operation on the spine, and that he should have explained this risk. The debate revolved around causation: on the likely outcome but for the failure to disclose this risk.

  • Accordingly, it could be argued that the Supreme Court, and GMC 2020, advance the opportunity aspect of a patient’s freedom to achieve treatment. I will discuss the advance in the opportunity aspect in another essay; the present focus is on the distinction between the process aspect and the opportunity aspect.

  • Montgomery asserts the requirement for a ‘dialogue’ between the doctor and the patient. Yet, within this dialogue, the doctor retains the obligation to exercise her or his expertise to identify proper treatments.

  • Following Montgomery, the reliance on Bolam for identifying available treatment is made explicit in the case of AH v Greater Glasgow Health Board [2018] CSOH 57, 169 BMLR 120.