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Consent I Notes

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Consent I Introduction Learning Objectives: how much information must be provided to patients before they can consent to medical treatment, and what recourse might patients have if they are not provided with enough?
Learning Goals:

* what are the ethical justifications for informing patients about their medical treatment

* how does the law protect patient's interests in medical disclosure

* describe the alternatives to the law of tort in protecting patient consent Central Issues:

* if a patient has capacity, treatment should not take place without her consent. The difficult question is working out how much information patients need in order to be properly informed.

* a failure to inform the patient in broad terms about the medical treatment she is about to receive could lead to an action in battery.

* a patient who claims to have been inadequately informed might bring a claim in negligence, in that the failure to warn her about a particular risk was a breach of the doctor's duty of care to inform about material risks.

* information is material if a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor should reasonably be aware that the particular patient would be likely to attach significance to it.

* causation raises particular difficulties in 'informed consent' cases because the patient has to prove that if she had been told about the risk which has now materialised, she would have refused treatment.

* professional guidance appears to impose more onerous duties of information disclosure upon doctors than tort law, but because a 'reasonable doctor' will follow professional guidelines, these more stringent standards might be directly incorporated into the doctor's duty of care.

Why inform patients?
In the past, the Hippocratic oath assumed the treatment decisions are for doctors alone. As a result of growing importance re patient autonomy, giving patients more information redressed the imbalance of knowledge between doctor and patient. Of course, this is not to say that doctors are allknowing, meaning that telling patients the truth sometimes involves explaining to them what is not known and uncertain. This is particularly the case re alternative treatment options, as there is very rarely a 'best solution' in medicine. Few treatments have no risks or side effects, it may be necessary to weigh the advantages and disadvantages of different treatment options, as well as the possibility of doing nothing. In this regard, although doctors can diagnose problems and explain/carry out procedures, the patient is the only one who has the expertise to judge the suitability of a particular treatment, and its side
effects of their life. The Hippocratic model has been replaced by the partnership model of decision making, where both the patient and doctor have specialist knowledge which must be shared in order to ensure that the patient makes the best possible choice for themselves.

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What is informed consent?
For a patient to be capable giving informed consent, they must be competent, must understand the information disclosed to them and appreciate its significance, and must give consent freely. What is focused on in this set of notes is the information which must be disclosed to the patient, and how to facilitate their understanding of it. In particular, one of the major concerns is what doctors choose to disclose to patients because doctors approach their jobs with a certain value framework, they may be inclined to reveal or withhold certain information based on an assumption of shared values held by the patient. However, this is dangerous, and as we will see, the law now regulates to some extent the bare minimum which must be disclosed to a patient this bare minimum standard covers the four critical elements of disclosure: (1) the nature of the procedure; (2) the proposed risks; (3) alternatives; and (4) the benefits of the procedure. Of course, like all general rules, there are exceptions to where informed consent is not necessary. For example, where consent is waived, in cases of emergency, or therapeutic privilege. All these exceptions must be allowed within reason so as to prevent abuse (e.g. duress in signing waiver forms, or doctor's exercising paternalistic judgement re therapeutic privilege). Challenges faced by informed consent The most basic and persistent challenge is the balancing act between overly demanding criteria of consent, and under demanding criteria for consent i.e. how much consent is necessary to protect the rights which we think are protected by consent? This manifests itself in the legal decisions over the years, which have changed positions (as will be seen below). It also manifests itself in discussions around the quality of consent how much explaining should a doctor have to do, and how far should the doctor go to ensuring that the patient is genuinely informed?
Another more recent challenge is that the concept of informed consent is too narrow to account for modern medical advances, especially in the field of biomedical ethics. Negligence may be a good model for understanding what has gone wrong in some cases, but this rationale provides an inadequate framework for determining what we ought to be doing in soliciting consent in institutions for research, and what degree of consent is sufficient. Arguably, the law's focus now is on what is illegal, as opposed to growing concerns in recent medical advances re what is unethical. This precipitates the further question of whether a distinction between treatment and research should be drawn so sharply in terms of consent. Perhaps today patients are overprotected in research and under protected in treatment. Ethical basis for patient information There are both deontological and consequentialist justifications for the twin elements of informed consent: (a) to seek the patient's consent prior treatment; and (b) to ensure the patient has sufficient information. The deontological justification is obviously to respect the patient's autonomy and selfdetermination. The consequentialist justification would instead emphasise the beneficial consequences which flow from involving patients in the decision making process. Criticisms of informed consent First, the informed consent expression is both ambiguous and misleading. What does 'informed' actually mean? Is it sufficient for the doctor to have done his part in explaining it to the patient, or does the patient's state of mind have to be clear about what they have been informed? This leads to the misleading binary nature of 'informed consent' its not just 'informed' or 'uninformed', but

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rather a question of degree. PDG Skegg has suggested that the phrase 'sufficiently informed consent' is more apt. Simply providing a patient with information does not ensure they have understood it, especially where their illness affects their capacity to digest information (as when most people get sick, autonomy is not their primary focus, whereas dependence on others is a reality). Secondly, there is a danger doctors might feel obliged to overdisclose so as to avoid a negligence suit. Presenting patients with lengthy and complex consent forms may very well inhibit rather than promote genuine communication between doctors and patients. There is in fact some evidence to suggest that a patient's understanding of consent forms is inversely related to their length. Moreover, giving patients detailed information takes time, and therefore costs money. If doctors had to disclose everything, NHS resources might be diverted to obtaining consent, as opposed to actual treatment. In practise, the process of obtaining consent is commonly limited to one or two encounters before the procedure takes place. The doctor will first give the patient some information about risks and benefits, and then ask the patient to sign a consent form. This model in itself is unsatisfactory for two reasons:

1. consent forms exacerbate the false perception that consent is a oneoff event, rather than a process that takes place over time. A doctor's duty to communicate information is as present pretreatment as it is during treatment, and posttreatment. Interestingly, Heywood et al. found in a study that many doctors actually perceive the consent form to be driven by bureaucratic and legalistic reasons, rather than actually encouraging a dialogue between the doctor/patient. A signature on a form in no way indicates that a discussion whatsoever has taken place between the doctor and patient about the procedure.

2. some patients may wrongly believe that signing a consent form binds them to its contents. In fact, consent need not even be in writing, so long as the elements are there and satisfied e.g. voluntariness, information, and capacity. Empirical evidence also suggests that patients have misunderstandings about the purpose of consent forms (e.g. being that it is legally necessary to sign one before surgery, or because it protected the hospital from litigation, or that it gave doctors control over everything). Interestingly, based on a study by Heywood, Macaskill and Williams, patients didn't even think that openness or proper communication of information had anything to do with he consent process. Thirdly, giving patient's too many decisions is not necessarily conducive to obtaining informed consent. Patients may suffer from decision fatigue and a consequent decline in the quality of their decision making. The context in which informed consent is typically sought by doctors is stressful, and for patients who are unwell, their cognitive resources may not allow them to make significant decisions properly. To refrain from giving patients assistance in making their decisions (as opposed to dictating their decisions for them) is not respecting autonomy, but undermining it. This may involve doctors raising their voice etc. just to make sure the patient understands what the best options are, but if autonomy is to be taken seriously, it ought to be able to stand up to the professional's vigorously expressed factbased opinions. Fourthly, there is a question as to how justifiable informed consent is in the context of decisions which have wider implications e.g. public health (i.e. decisions to vaccinate your children), food safety and environmental concerns. This reflects the increasing view of medicine as requiring consumer consent, and the corresponding downfalls of that narrow view. In this vein, Stirrat & Gill have argued that individualistic accounts of informed consent are fundamentally flawed because they are not set in the context of relationships and the wider community. These above criticisms give rise to at least two more sharp questions:

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1. What exactly does protecting autonomy entail?
Looking back at the writings of Mill and Kant, autonomy was never used in the sense of individualistic freedom of choice. A proper understanding of Kant would reveal that an individual's autonomy is necessarily limited by the autonomy of others. In this vein, Coggon & Miola argue that courts have actually failed to distinguish between political concepts of liberty, and moral concepts of autonomy, and that there is an excessive commitment to ostensible rather than substantive protection of autonomy. Autonomy denotes selfgovernment. It is an empirical question, as opposed to a normative one. Importantly, autonomy is free will, as contrasted with liberty, which is freedom to act without interference from a third party (e.g. consider the Diane Pretty case). In this sense, Kantian autonomy is closer to true autonomy, whereas Millian autonomy is closer to liberty. In medical jurisprudence, autonomy demands a focus on assuring the agent has the rational acumen to reach a decision (mental capacity) whereas liberty demands a focus on establishing that the person is in the rightful position to reach that decision (legal capacity). Rational acumen may be judged either according to the person's own values, or an objectively true value (the former is what the law ideally protects, and the latter may be used as a brake by the law to limit excessive individualism). Crucial to autonomy is the exercise of reason, and crucial to reason is a good ground of knowledge and understanding (e.g. reflected in the law through informed consent and capacity rules). Maximisation of autonomy is not necessarily coherent with maximisation of liberty. For example, although we might seek to enhance autonomy, and have good reason to ensure that decisions
especially serious decisions are reached in accordance with a maximum of autonomy, we must limit autonomous actions that impinge on the deserved liberty of others. Mediating the demands of each is made harder with a commitment for valuepluralism (i.e. balancing the excesses of autonomy with the excesses of liberty). Stirrat & Gill are proponents for a modern model of patient autonomy. In this model, a patient is fully entitled to take an active role in decision making regarding treatment. This involves the provision of sufficient and understandable information and space for patients, who have the capacity to make a settled choice about medical intervention on themselves, to do so responsibly and in a manner considerate to others.

2. To what extent do informed consent procedures actually protect autonomy?
O'Neill argues that the triumph of autonomy is mostly a triumph of informed consent. In particular, that f (given the number of situations in which a patient is unable to consent). Fundamentally, there is a limitation to how much justification informed consent procedures can offer to the taking of a choice. Consent is a propositional attitude: people consent to the proposition of the intended treatment. Therefore, they may not necessarily consent to equivalent or closely related propositions, nor the consequences of the proposition of intended treatment. All this is on top of the practical limitations of obtaining informed consent e.g. time, and money, and resource scarcity. Put in this perspective, O'Neill argues that consent can only be seen as generally, and not invariably necessary for justifying medical treatment, and by extension, can only offer limited protection of autonomy. For example, in situations concerning public health mentioned above, individual autonomy plays a limited role. Coggon & Miola argue that the idea of autonomy is partly protected via informed consent, but more so, the law has supported liberty instead (move from paternalism to libertarianism). The main thrust of their argument is that the law is assuming that so long as the patient is properly informed with the relevant risks, and that the choice is theirs to make, they are protecting their autonomy. In

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fact, what protection of autonomy also requires is ensuring that the patient understands the information presented to them. Otherwise, what the law is doing is just protecting liberty (in the sense that the decision to undertake treatment is made by the right person, being the patient, not the doctor). Arguably, this criticism is weakened in light of the decision in Montgomery, but whether in practice, there will be any difference remains to be seen. This opens up the further question whether patient autonomy in medical practice is even appropriate if it requires doctors to make sure patients understand.

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Legal protection for patients' interests in information disclosure Battery Trespass to the person can be a tort and crime. The patient's consent will absolve the medical practitioner from liability in battery for unlawful touching as long as the consent is 'real' i.e. patient informed of what the doctor is going to do, and the doctor doesn't do anything other than that. Proof need not be required of any harm battery is strict liability. It is not a defence to battery that the doctor was acting in the best interest of their patient, or that they exercised reasonable care and skill. Evidence of accepted medical practice is also irrelevant. There is also no 'therapeutic privilege' in the sense that, if certain information is required for consent to be 'real' and it is not revealed, the doctor will not be exempt from liability. Courts have been reluctant to use battery in order to protect a patient's interests in information disclosure. Provided the patient agreed to the procedure that was in fact carried out, their consent will be effective and there will be no cause of action in battery. The leading case of Chatterton v Gerson held that consent would be real so long as the patient had been informed in 'broad terms' about the nature of the procedure. If information is withheld in bad faith however, consent is vitiated. Judicial hostility flows from the connotations of a charge of battery because battery is often also assault, judges are reluctant to criminalise by association well meaning but misguided decisions to withhold information from patients. In Wells v Surrey, a sterilisation operation was first suggested to the claimant after she had gone into labour, and the operation was performed at the same time as the caesarian. The court found the doctor had been negligent in failing to give the claimant proper advice about sterilisation. Given the circumstances in which her consent was given, it is hard to believe the claimant understood all the implications of the operation. Despite this, the court held the consent to be real, arguably because the court was struggling to avoid the conclusion that it was battery. There have been a handful of successful cases though. For example, in Appleton v Garrett, a dentist who deliberately carried out extensive and wholly unnecessary dental treatment for personal financial gain, was struck off the dentistry board, and held to have committed battery. Note: battery has its limitations however. There can only be battery if there has been physical contact, but much of medical decision making does not involve touching. The prescription of medication for example. Negligence Two main situations which can give rise to negligence in the context of informed consent: 1 failure to obtain consent; and

3. failure to warn. The former will be briefly dealt with here. In Border v Lewisham, the judge accepted the claimant's evidence that the doctor did not discuss whether to insert a cannula into her left arm. Immediately before inserting the cannula, the claimant told the doctor that she had recently undergone a procedure which made it risky to cut her left arm. The court held clearly that the doctor had inserted the cannula without the patient's consent, and had breached his duty of care.

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