Limitations of the Consent Model

Chapter 5
Limitations of the Consent Model

[S]tandard accounts of informed consent, standard arguments for requiring consent in clinical and research practice and standard ways of implementing consent requirements lead to intractable problems.¹

Laudable as the notion of consent to treatment is, there are limitations to its scope and effectiveness in protecting patient self-determination. Some of these limitations are intrinsic to the concept of consent as elaborated in bioethics, and scholars have sought to address this by reconceptualising or ‘rethinking’ consent,² and advancing alternative conceptions.³ Some limitations arise not necessarily from the concept per se but from how it is operationalised. These include difficulties (such as pressures of time)⁴ in applying the theoretical principles of consent in everyday clinical practice. These difficulties and related factors have resulted in discordance between the paradigm of consent espoused by bioethicists and the paradigm of consent that is actually practised by clinicians.⁵ Limitations also arise from the judicial constructions of consent.⁶ In this chapter, the dichotomy between theoretical and operational paradigms of consent is discussed. Other factors that limit the effectiveness of the consent model are discussed, and the alternative approaches proffered by Manson and O’Neill (‘genuine consent’)⁷ and Maclean (‘relational consent’)⁸ are considered. This sets the stage for a subsequent discussion of the possible role of a property approach in redressing the limitations of the consent model.

A convenient point from which to start this chapter is a discussion of the paradigms of consent. It is convenient to start at this point because in Chapter 4, it was argued that while the Manson/O’Neill reconceptualisation of consent is intellectually robust, it conflates the two paradigms that I have distinguished above. Their criticism of the current concept of consent applies mostly to the paradigm practised by clinicians, rather than to the ethically-espoused paradigm. If their criticism is upheld, then what needs changing is not the concept of consent but the way in which that concept is operationalised.

Similar to the way in which the concept of autonomy has many conceptions, the concept of consent has been interpreted in many ways and explained with various theoretical models.⁹ The various paradigms of consent can be categorised into three groups. The first group (Category 1 – which I term ‘bona fide consent’ or ‘authentic consent’) comprises paradigms of consent that are framed by both the law and bioethicists for the purpose of protecting the patient’s right to self-determination. The second group (Category 2 – which I term ‘contrived consent’) comprises paradigms of consent that are actually implemented most of the time in clinical practice. The third group (Category 3 – ‘null consent’ in my terminology) is one that can be readily dismissed from further analysis. This group comprises paradigms of consent that amount to no consent, what one may call null or invalid consent or, in some cases, mere assent. None of these three groups is homogenous; within each group there are variations in conception but, generally, the differences between the categories are stark except that sometimes the way consent is operationalised in clinical practice (contrived consent) actually amounts to no consent at all (null consent). Any criticism of consent and any proposals for revamping the mechanisms for protecting the right to self-determination should recognise these differences and make it clear which paradigm is being addressed.

Randall and Downie identify four conceptions of consent:¹⁰ (1) Consent as being told what is going to be done. This is the paternalistic approach, and it is arguable that this is not consent at all. From the legal perspective, this would be a null ‘consent’. (2) Consent as simply agreeing or acquiescing to a treatment proposal. In this conception, consent equates to mere assent. (3) Consent as joint investigation. The patient makes his/her own choice from a range of options, with help from the physician. It fits into Category 1 outlined above; it is also consonant with the ecological metaphor described in Chapter 1. (4) Consent as patient’s self-assertion¹¹ or freedom to choose. This conception is consonant with the narrow construction of self-determination. The nature of ‘choice’ in this model must be clarified – choice in this case does not mean selecting from a range of options offered by the doctor (as in Randall and Downie’s conception 3 above); rather it refers to the situation where the patient demands a form of treatment even if the doctor does not recommend it. An example would be Caesarean section performed at maternal request in the absence of a medical indication. Another example is that of a woman requesting (demanding?) hysterectomy for heavy menstrual bleeding when her doctor has offered less invasive but effective options such as ablation of the endometrium.¹²

One problem with this categorisation is that the true situation is not always as clear-cut as suggested by the four conceptions. For example, when a patient makes a choice it is not always clear whether he/she has done so within conception 3 or 4. If doctor and patient have jointly gone through options (including the risks, benefits and alternatives) and the well-informed patient has chosen an option different from the doctor’s preference, does this fall under ‘consent as joint investigation’ or ‘consent as self-assertion’? If the patient is requesting or demanding a treatment that is known to be ineffective or dangerous, then this would fall into conception 4 (and the doctor has professional and ethical issues to contend with). On the other hand, if he/she is demanding a treatment that is known to be effective but is not the doctor’s preferred option (because it is more invasive or costs more or is outwith his/her technical competence or does not fit with his/her life values) would this be conception 3 or 4? Such judgments often involve value as well as medical considerations, and it has been argued that while doctors can define the limits of medical factors, it is not for them to also define moral or non-medical limits.¹³ In any case, it is now well established not only by General Medical Council (GMC) guidance¹⁴ but also by judicial pronouncement¹⁵ that a doctor is not obliged to provide treatment that is ineffective or not in the best interests of the patient.

In summary, the first two conceptions in Randall and Downie’s list can be consigned to my Category 3 (null consent) and will not be discussed further. The third conception falls into Category 1 (bona fide consent). On the basis that respect for self-determination does not include an obligation to provide any treatment demanded by the patient, their fourth conception is also consigned to Category 3.

Concentrating now on Category 1, there are subtle or not so subtle differences between conceptions falling under this category. It is not surprising that this is the case, because as shown in Chapter 2, there is no standard model of doctor–patient relationship or consultation. The key point is that all conceptions in this category accord primacy to the patient’s right to self-determination. Where they differ is in the process for obtaining consent. In the Randall and Downie conception described above, the process is one of joint investigation. This process combines respect for the patient’s dignity and self-determination with respect for the physician’s dignity and professional autonomy, and the authors say that it offers ‘the best ethical-medical package’¹⁶ for patient and doctor.

There are other accounts that propose a similar process for obtaining consent, which view consent as ‘shared decision-making’.¹⁷ Shared decision-making has the following key characteristics: (1) at least two participants – physician and patient – are involved; (2) the parties share information; (3) both parties take steps to build a consensus about the preferred treatment; and (4) an agreement is reached on the treatment to implement.¹⁸ This conception of consent is advanced by the psychiatrist J Katz¹⁹ and the (US) President’s Commission,²⁰ but is opposed by Faden and Beauchamp, who say the essence of consent is that the patient authorises autonomously and not that patient and doctor reach a decision together.²¹ The American College of Obstetricians and Gynecologists (ACOG) hints at the provenance of this paradigm:

If in the 1970s informed consent was embraced as a corrective to paternalism, the 1980s and 1990s exhibited a growing sense of the need for shared decision making as a corrective to the exaggerated individualism that patient autonomy had sometimes produced.²²

The ACOG asserts that if persons are to be respected and their well-being promoted, consent must be seen as expressing a fuller notion of relationship.²³ Clements advocates minimum standards of dialogue between patient and doctor in the consent process.²⁴ These views are fundamentally the same as those expressed, albeit within a more theoretical framework, by ethicists such as Manson and O’Neill²⁵ and Randall and Downie²⁶ who see consent as more than mere disclosure of information. But does their richer conception of consent actually find application on the shop floor of medical practice? It appears not.

Ruth Faden and Tom Beauchamp distinguish between two conceptions of consent which they describe as consent as autonomous authorisation and consent as a policy-oriented ritual.²⁷ In the autonomous authorisation paradigm, a patient with (i) substantial understanding and (ii) in the substantial absence of control by others (iii) intentionally (iv) authorises a professional to undertake a particular intervention. A person whose act fulfils conditions i–iii but who refuses the intervention gives an informed refusal. The authors stress that only the patient authorises (that is the patient, not the doctor, makes the final decision) and it is not a prerequisite that agreement on the performance (or withholding) of the intervention should be reached through any particular method. By this emphasis, their intention is to clearly distinguish this paradigm from the ‘shared decision-making’ or ‘joint investigation’ paradigms. The authors go on to describe this notion of authorisation:

In authorizing, one both assumes responsibility for what one has authorized and transfers to another one’s authority to implement it. There is no informed consent unless one understands these features of the act and intends to perform that act. That is, one must understand that one is assuming responsibility and warranting another to proceed.²⁸ (emphasis mine)²⁹

In the Faden/Beauchamp policy-oriented conception of consent, effective authorisation is obtained from a patient through a procedure stipulated by institutional rules and regulations. Here, consent is ‘effective’ in the sense that it meets the regulations set by the hospital (or health-care facility) and is accepted by that institution as valid. Requirements for this paradigm of consent ‘typically do not focus on the autonomy of the act of giving consent … but rather on regulating the behavior of the consent-seeker’.³⁰

Writing a decade after Faden and Beauchamp, Irene Switankowsky also identifies two paradigms of consent: the harm avoidance model and the autonomy-enhancing model.³¹ She states that the harm avoidance paradigm is the common framework within which physicians operate. In this model consent is considered to be a mere legal formality and a minimalist approach is adopted to disclosure of risks. In the autonomy-enhancing model, all treatments must be disclosed and discussed in detail with the patient. The risks and benefits of each treatment are disclosed, not just the treatment that is preferred by the physician.

Swintankowsky’s two paradigms may appear similar to the Faden/Beauchamp paradigms but they are not identical. An important difference is the emphasis that Swintankowsky places on full disclosure in the autonomy-enhancing model. Faden and Beauchamp on the contrary decry such an emphasis; in their view it is understanding that counts, not disclosure – a patient can autonomously authorise an intervention in the absence of any disclosure, so long as the patient sufficiently understands the implications of the intervention (e.g. a general surgeon who needs to undergo a hernia operation does not need full disclosure before he/she can autonomously authorise it). This equates in legal terms to saying that the test for adequacy of information disclosure should be subjective.

The issue of disclosure of information and, in particular, the courts’ concentration on standards of disclosure was discussed in Chapter 3 and it was shown that the courts have gradually moved away from relying on doctors to set the standards. It was also shown that the tension between the ideal of a subjective test and the pragmatism of an objective one calls for a continual balancing act by the courts. This tension and its resolution are discussed again in Chapter 9.

Berg and colleagues recognise that consent as ‘autonomous authorisation’, consent as ‘institutional requirement’ and ‘consent as shared decision-making’ are interrelated, but they also emphasise that the distinctions between them are important and should be acknowledged:

Acknowledging them permits us to see that sometimes strict adherence to the rules governing informed consent may actually undermine the dialogue involved in the process of shared decision-making, or may fail to enable a particular patient autonomously to authorise a treatment plan. Alternatively, placing too much emphasis on sharing the decision may undermine the decisional authority of some patients; for example, if they over-value maintaining a good relationship and comfortable interaction with their physicians, at the expense of expressing their own views. These patients may eventually be disappointed when they find that they, not their physicians, bear responsibility for what they authorised their doctors to do. Like the hypothetical homeowner who would like to be able to blame her painters for her own paint colour choice, patients may want to blame their physicians for choices they later regret. Recognising that in authorising another to act on one’s behalf, one still retains responsibility for what is authorised, may help avoid misplacing blame. In order to be responsible for what they authorise, however, patients must be well informed and act autonomously.³²

The idea of patients taking responsibility when they consent to treatment is one that needs more emphasis in clinical and legal practice, and will be revisited in Chapter 9. Suffice to say at this point that the theoretical conceptions of consent espoused by most bioethicists are broadly grouped as the Category 1 paradigm described above, but it is widely acknowledged that this paradigm is not always operationalised in clinical practice. It is important to distinguish between Category 1 and Category 2 paradigms because consent that is valid in the first paradigm may not be valid in the other, and vice versa. Crucially, any analysis of consent in relation to self-determination must make clear which one of these two paradigms is the subject of analysis. Attention is now turned to the dichotomy between the theoretically envisioned paradigm and the operationalised one.

Contrived Consent

In this paradigm of consent the patient is presented with a menu of choices (sometimes ‘a menu of one item’³³) and a ‘yes or no’ response is elicited. The menu may be accompanied by a large quantity of information, most of it generic rather than specific to the patient, or little or no information. The emphasis is not on comprehension of information but on the signal which indicates that the doctor may proceed with treatment. In most consultations the signal is verbal but for surgical operations and other interventional treatment it is usually a signature. From a theories-of-consent perspective, this paradigm of consent has been classified as ‘Functionalist consent’.³⁴

In practice, this paradigm is heavily dependent on the consent form, and in the minds of many clinicians consent is a signature on the form.³⁵ This paradigm of consent is boosted by the UK Department of Health’s policy on consent, which appears to place undue emphasis on consent forms.³⁶ It appears that the current practice of health professionals in the UK matches this paradigm rather than what I have classified above as the bona fide or authentic paradigm of consent.³⁷ Clements paints this scenario:

The preoccupation with the form inhibits, not encourages, dialogue. It leads to the ludicrous caricature often encountered in the anaesthetic room just before the patient is wheeled into theatre. The consultant surgeon, arriving late, puts his head round the door and enquires of the anaesthetist ‘has she been consented?’ Leaving aside the abuse of the intransitive verb, the question speaks volumes for the surgeon’s understanding of the counselling process that should precede surgery.³⁸

In a similar scenario, a woman in the throes of labour pains who signs a consent form minutes before she is whisked to the operating theatre for a Caesarean section is deemed to have given an institutionally valid consent, but almost certainly has not autonomously authorised the operation – in other words, contrived ‘consent’ may have been obtained but not bona fide consent. In Figure 5.1 a case further illustrating the difference between these two categories of consent is described.

A patient listed for hysterectomy is taken to the operating theatre on the day of the operation. When she arrived in the anaesthetic room, the consent form (which she had signed on the ward) was missing. The unit managers and theatre staff were minded to cancel the operation, in the belief that there was no valid consent. The surgeon explained that he had discussed the operation comprehensively with the patient before and during her admission into hospital, and these discussions (including her agreement) were documented in the health records and in a letter to the patient’s general practitioner. In his opinion, the patient had given a valid consent and there was documentary evidence of this, even though there was no signed consent form. The managers and the theatre team then agreed that the operation should proceed. The institutional requirement for a consent form (Contrived or ‘functionalist’ consent) was not fulfilled but the operation was performed with the valid consent of the patient (Bona fide consent). In clinical audit of consent, this case would be flagged as bad practice, because it did not meet the institutional requirement for a signed consent form, and cases where a form was signed would be classified as good, regardless of the presence or absence of transactional communication between doctor and patient.

The British Medical Association has expressed concern that despite ‘a considerable amount of written guidance on consent, from regulatory, professional, and indemnifying bodies as well as government departments’,³⁹ the way in which consent was sought in practice was less than satisfactory.

Clearly this paradigm does not meet the requirements of the principles underlying Bona fide consent. This raises two questions: why is this so, and what can/should be done about it? The first question is addressed in this chapter and the second will be addressed in subsequent chapters.

There are barriers that circumscribe the potential application of the consent model in day-to-day clinical practice.⁴⁰ One of these is the difficulty in achieving optimal communication. Often there is not enough time or space for an adequate discussion, particularly in public sector hospitals (it must be stressed, however, that it is quality, not quantity of information that counts). At other times there may be language, cultural and social barriers inhibiting communication between clinicians and patients. These limiting factors are, however, relatively trivial compared to the factors discussed below.

There are a number of reasons why the operationalised paradigm of consent differs from the theoretical one. One of these is that doctors’ knowledge regarding consent law is shockingly poor⁴¹ and their perception of consent way off the mark established in bioethics. There is evidence that health professionals do not know enough about basic aspects of the law of consent, such as at what age can a child give consent or what happens when an adult is unable to give consent.⁴²

Reflecting and/or reinforcing this knowledge deficiency is a misdirected perception of consent, firstly as an event, secondly as primarily a shield against litigation. Consciously or subconsciously, obtaining consent is often perceived by clinicians as an event marked by the signalling of an agreement (this signal often but not always being the signing of a form). In its broad construction, obtaining consent is a process which begins with an open discussion of the purpose, benefits and risks of the proposed intervention and the alternatives (including the alternative of no treatment), and does not end until the treatment has been delivered or declined. These issues are explored between doctor and patient in the context of the patient’s values, goals and constraints.

The construction of consent as a process rather than an event, while accepted unequivocally by professional groups⁴³ and some academics,⁴⁴ has been challenged by Maclean who sees consent as a state of mind, and if it is a state of mind it should not also be regarded as a process.⁴⁵ In a sense, however, there is no conflict between the two sides, as they both accept that there is a process of communication between doctor and patient and that there is a signal given by the patient at the end of the process. The only difference is that while one school of thought uses the word consent to refer to the entire pathway from consultation to signal, the other regards only the signal as consent, everything else is ‘the process leading to consent’.⁴⁶

Doctors appear to be concerned principally with the signal, that is the event, and not so much with the process that precedes, informs and determines that signal. The signal is, of course, an expression of the patient’s state of mind.

The point about obtaining consent being a process rather than an event is more than a matter of semantics. The patient’s receipt, digesting and understanding of information is itself a process. When doctors take obtaining consent to be an event rather than a process, what they obtain is more likely to be an assent to what has been proposed (Category 3 paradigm) than a real consent to treatment. Also when the courts look at whether or not a valid signal (consent) has been given, they look at the preceding transaction.

The operational paradigm of consent tends to focus on the decision itself, paying insufficient attention to the process by which the decision is reached by patient and doctor. Any alternative model that takes due account of the communicative transaction leading up to the decision, rather than just focusing on the final decision, will meet the imperatives of cultural sensitivity while also upholding the principle of self-determination.

The other flawed perception is seeing consent as primarily a means of securing protection against litigation. Advising that it is time this perception was abandoned, Clements said:

It is high time for a change of emphasis; we should no longer be looking over our shoulder at the lawyers so as to escape a charge of battery; rather, we should be seeking to improve the dialogue with the patient to make sure that she has the information necessary to express her choice of treatment.⁴⁷

This misperception has been a longstanding attribute of the health professions, but there is evidence that it is beginning to change. In the first seven editions (1952–1971) of the iconic Myles Textbook for Midwives⁴⁸ there was no mention of consent, choice or information.⁴⁹ Consent was mentioned for the first time in the eighth edition, but what the author described is not a true consent:

It is customary and expedient for midwives to request women admitted in labour to sign a permission slip for the obstetrician-in-charge to carry out any treatment or operation which may be considered necessary, including an anaesthetic. This is a wise precaution … particularly at the present time when unscrupulous persons may initiate litigation against medical staff or Area Health Authorities on the slightest pretext When any treatment, operation, or anaesthetic is required, the doctor will explain the situation to the patient so that she understands what is involved. When she signs the permissions form, she gives her informed consent. This is a wise precaution.⁵⁰

In signing a ‘permissions form’ what the patient gave was not a bona fide consent but a null, or at best contrived, consent. Clearly, the purpose of ‘consent’ in this context was protection of the health-care professional from litigation. There was really no intention to uphold the patient’s right to self-determination.

Subsequent editions of the textbook showed a shift from ‘permissions’ to ‘choice’:

The midwife must take care not only to talk to the mother but to ask for her consent to what she plans to do and to invite her comments and questions. Promotion of informed choice is an essential element of contemporary midwifery care … It should be remembered that for some women their choice is to relinquish control and it should not … be assumed that all women desire or are capable of taking decisions about their care. They are, however, all entitled to information given in such a way as to assist their comprehension.⁵¹

The Consent Form

No distinction is made in this book between implied and expressed consent or between written and unwritten consent. Most clinical consultations do not entail the signing of a consent form but the doctor is still in these consultations required to obtain the patient’s consent to any treatment that is proposed. Nevertheless, in the minds of doctors, particularly in secondary and tertiary care, consent is commonly equated to a signature on a consent form.⁵² This is despite the fact that there is no requirement in common law, and only exceptionally in statute,⁵³ for consent to be written. Also, doctors and patients have different perceptions of what the form is about, with many patients thinking that the primary function of the consent form is to protect the hospital.⁵⁴

In one study, most patients (68 per cent) thought consent forms allowed doctors to assume control.⁵⁵ Less than half of patients believed that consent forms reflected their wishes. One in every five patients did not know whether they could change their mind after they had signed the form, and 16 per cent incorrectly thought that signing a consent form removed their right to compensation if things went wrong. One in 10 patients reported that they did not know what they had agreed to when they signed the consent form, and approximately one-third were unsure whether the operation could be performed if they refused to sign the consent form. Nearly a quarter did not know whether the operation could be performed if they were unable to sign the consent form, and some mistakenly assumed it could not. The majority of patients (71 per cent) did not know that their next of kin could not sign on their behalf if they were unable to sign for themselves.⁵⁶

Apart from failing to meet the requirements of patient self-determination, consent forms often fail the test of validity.⁵⁷ Consent may be valid in the absence of a signed consent form; on the other hand, consent may be invalid even though a consent form has been signed:

The most outstanding finding of this study was the fact that 40% of the consent obtained for treatment was not valid immediately after the consent form was signed.⁵⁸

Thus, for all of the attention focused on consent forms, the patients remained ill-informed and not in a position to assert their right to self-determination. This has led one clinician to suggest that the consent form should be binned:

… the consent form is the single most important obstacle to the proper dialogue between doctor and patient … Preoccupation with the form inhibits not encourages dialogue.⁵⁹