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Informed consent
MEDICO-LEGAL
Informed consent
their doctors to provide all the information they require so that they themselves can make the best decision for them. Sixty years ago in the case of Hatcher v Black,1 the court found in favour of a surgeon who had lied to reassure a patient. She was to undergo a partial thyroidectomy and was concerned about potential adverse effects on her voice as she worked as a BBC announcer. The surgeon said that there was nothing to worry about. The judge, Lord Denning, said that: “His peers did not condemn him and neither should we”, giving judicial endorsement to a dishonest approach with doctors shouldering the burden of deciding what patients should know, whether their patients wanted them to do so or not. In 1972, jurisprudence moved on. The Californian case of Canterbury v Spence2 was a landmark decision introducing the doctrine of informed consent. A 19-year-old patient consulted Dr. Spence because of severe pain between his shoulder blades. Surgery was recommended. Prior to the procedure, the patient did not ask any questions about the procedure, and was not told about potential complications. Post-operatively he suffered from incontinence and experienced difficulty in walking, and sued for failure to warn of the risks of serious disability inherent in the laminectomy. The Court found for the claimant. The Judge stated: “In our view, the patient’s right of self decision shapes the boundaries of the duty to reveal. That right can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The scope of the physician’s communications to the patient then must be measured by the patient’s need, and that need is the information material to the decision. Thus the test of determining whether a particular peril must be divulged is the materiality of that risk to the patient’s decision. All risks potentially affecting the decision must be unmasked. To safeguard the patient’s interests in achieving his own determination on treatment, the law itself must set the standard for adequate disclosure.” In 1985, the House of Lords rejected the doctrine of informed consent by a majority in the case of Sidaway.3 Mrs Sidaway consulted a neurosurgeon as she was suffering from persistent pain, and was advised to undergo surgery. She claimed that she was informed of the risks of damage to the nerves emerging from the spinal column, but not of the risk of spinal vein thrombosis, thought to be less than 1%. She developed a post-operative hemiplegia due to spinal vein thrombosis, and sued, on the grounds that had the risk been disclosed she would have declined surgery. The House of Lords ruled that determining what information should be given to the patient was primarily a matter of clinical judgement and therefore for the doctor to decide. In 1998 the General Medical Council (GMC) published its first guidance for doctors on consent, entitled Seeking patients’ consent e the ethical considerations.4 This set out in explicit terms the information which doctors ought to provide to patients before seeking consent to treatment and adopted into the UK the previously alien doctrine of informed consent. The GMC’s guidance has been regularly updated, the latest version published in 2008 is entitled Consent: patients and doctors making decisions together.5 In October 2004, the case of Chester v Afshar6 was considered by the House of Lords. Miss Chester had a discectomy for low back pain. The procedure was undertaken competently, but Miss Chester was left with cauda equina syndrome, a complication thought to occur in under 2% of cases. She sued, claiming that there was a failure to warn about this risk and was awarded
Gerard Panting
Abstract The term ‘informed consent’ has been in common usage since the case of Canterbury v Spence was decided in the Californian courts in the 1970s. The basic principle is straightforward: to be in a position to make an informed choice you need to know all the material facts. However, the law is not static and as new situations are presented so the law is developed through cases decided in the courts, in some instances influenced by guidance issued by the General Medical Council, and new statutes enacted by Parliament. This paper reviews the current law on consent in the United Kingdom, taking into account variations in the devolved administrations, the principles that underlie obtaining valid consent, in situations ranging from elective procedures in competent adults to lifethreatening emergencies and the treatment of the temporarily or permanently incompetent patient as well as the rights of spouses, relatives and other interested parties. A sound knowledge of the basic principles and how they should be applied is essential for all surgeons and failure to warn is a common component of clinical negligence claims.
Keywords competence; consent; information; proxies; voluntary decisions
Introduction Consent is a fundamental tenet of medical law, protecting all of us against unwelcome intrusion. The basic rule is simple; no-one has the right to touch anyone else without lawful excuse: to do so may amount to a battery and/or negligence. For consent to examination, investigation or treatment to be valid, three conditions must be satisfied: first, the patient must be competent; second, he or she must have sufficient information to make an informed choice and lastly, the consent must be given voluntarily. The term informed consent emphasizes the importance of providing patients with all the information material to their decision, but remains as just one element of what is required for valid consent. Unless there is reason to believe otherwise, it is assumed that adult patients are competent. The fact that a patient does not agree with the doctor’s recommendation or makes a decision which appears irrational, does not automatically condemn the patient as incompetent. Nor does the existence of chronic mental illness, even where the patient is detained as a result of that illness. Consent to medical interventions may be given by the patient, or by someone authorized to act on behalf of the patient, for example a parent, or authorized proxy.
A brief history of consent law Consent law has evolved over time, moving from patients relying on their doctors to do what is best for them, to patients expecting
Gerard Panting MA MBBS FFFLM DMJ Director of TWG Resources, The Garden House, Blackhall Lane, Sevenoaks, Kent, UK.
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compensation, as there was no documentation to demonstrate that any warning had been given. Chester v Afshar emphasizes the need to ensure patients are fully informed, understand the information, are given sufficient time, where possible, to reflect on their decision, and that the consent process, including warnings, is properly recorded.
questioned, even though arriving at a rational decision is no part of assessing competence. If there is any doubt about an individual’s competence, a more formal assessment is required which may involve psychiatrists, or if there are communication difficulties, speech therapists and others. Competence is not an all or nothing phenomenon e patients can have the capacity to consent to one procedure, but not to others, so a patient’s capacity to decide may vary depending on the situation, complexity of the decision-making process and may also fluctuate with time. If an adult patient is not competent, authority to proceed with treatment may be provided in England, Wales and Scotland (but not Northern Ireland), by someone authorized to consent on the patient’s behalf as discussed in more detail below.
Advance refusal of treatment Two cases, Re T (Adult: Refusal of Medical Treatment)7 and Airedale NHS Trust v Bland,8 gave judicial backing to the concept of advance refusals of treatment, or living wills, provided that refusal is both ‘clearly established’ and ‘applicable in all the circumstances’ being as effective as the decision of a capable adult. Statutory provision for advance refusals of treatment in England and Wales was included in the Mental Capacity Act 2005, which came into force in 2007. The Act also provides for lasting powers of attorney, which allow competent individuals to appoint others to make treatment decisions on their behalf, should they become incompetent to make those decisions for themselves. In Scotland the Adults with Incapacity (Scotland) Act 2000 makes similar provisions to the Mental Capacity Act. The Adults with Incapacity (Scotland) Act safeguards the welfare and finances of people over 16, who lack capacity to take some or all decisions for themselves because of a mental disorder or an inability to communicate. The Act allows others such as relatives, friends or partners to make those decisions for them. The Act also allows patients to make arrangements for another person or persons to make decisions and manage affairs on their behalf if they lose capacity in the future. Currently there is no equivalent provision in Northern Ireland, so decisions about medical treatment and care when individuals lack capacity must be made in accordance with that individual’s best interests. How the term best interests should be interpreted was clarified in two cases: Re A (Medical Treatment: Male Sterilisation)9 and F v West Berkshire Health Authority10 [1990] 2 AC 1. The best interests of a mentally incapacitated person are not limited to best medical interests, but also encompass medical, emotional and all other welfare issues. Any treatment provided should be in accordance with standard treatments for that condition, bearing in mind any individual idiosyncrasies of the patient; incompetent patients should not be denied treatment open to competent patients.
Information The provision of information is the key to obtaining valid consent. The GMC guidance states that the exchange of information between doctor and patient is central to good decision-making. Exactly how much information is disclosed to the patient will vary, but the default position should be to provide full disclosure. The GMC expects doctors to give patients the information they want or need about: 1. diagnosis and prognosis 2. uncertainties about the diagnosis or prognosis, including options for further investigations 3. options for treating or managing the condition, including the option not to treat 4. the purpose of any proposed investigation or treatment and what it will involve 5. potential benefits, risks and burdens, and the likelihood of success, for each option; this should include information, if available, about whether the benefits or risks are affected by which organization or doctor is chosen to provide care 6. whether a proposed investigation or treatment is part of a research programme or is an innovative treatment designed specifically for their benefit 7. people who will be mainly responsible for and involved in their care, what their roles are, and to what extent students may be involved 8. their right to refuse to take part in teaching or research 9. their right to seek a second opinion 10. any bills they will have to pay In addition, the GMC expects doctors to answer patients’ questions honestly and, as far as is practical, answer as fully as they wish. If, however, patients do not want detailed information, the doctor should try to find out why. If, after discussion, the patient still does not want to know in detail about their condition or treatment, their wishes should be respected, but the GMC still requires that patients are provided with the information they need in order to give consent to the proposed investigation or treatment. This may include what the investigation or treatment aims to achieve and what is involved; the likely level of pain or discomfort; anything they should do to prepare for the investigation or treatment; and if it involves any serious risks. GMC guidance states that: “if a patient insists that they do not want even this basic information, you must explain the potential consequences of them not having it, particularly if it might mean
Competence Capacity or competence is the ability to make a choice. The test of competence was set out in the case of Re C,11 a chronic schizophrenic detained under the Mental Health Act, who had developed gangrene of his foot. Surgeons recommended amputation but he refused, and applied successfully for an injunction restraining the surgeons from amputating his foot against his will. The basis for the court’s decision was that he did understand the treatment information, believed that information to be true, and was able to process it to arrive at a choice. He was also able to communicate his decision and was therefore competent and entitled to accept or reject treatment, even though his choice jeopardized his health and life. Competence is usually not formally assessed. In practice, provided a patient appears to comprehend what is being said and the decision appears rational, competence will not normally be
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that their consent is not valid. You must record the fact that the patient has declined this information. You must also make it clear that they can change their mind and have more information at any time.” The only justification for withholding information is that disclosure would be likely to cause serious harm to the patient’s physical or mental health. In this context ‘serious harm’ does not include the risk that the patient might become upset or decide to refuse treatment. Where information is withheld, the reason for doing so must be recorded in the clinical records.
In law, written consent is required for certain treatments, such as fertility treatment and organ donation. But the GMC also expects doctors to obtain written consent if: the investigation or treatment is complex or involves significant risks; there may be significant consequences for the patient’s employment, or social or personal life; clinical care is not the primary purpose of the investigation or treatment, or if the treatment is part of a research programme or is an innovative treatment designed specifically for their benefit. In addition NHS trusts and independent sector providers usually have internal policies which doctors are expected to adhere to. However, a consent form is, at best, only some evidence that a valid consent has been obtained and will not in itself rebut all allegations of failure to warn about potential risks. The validity of the consent always depends upon being able to demonstrate competence, the provision of sufficient information and the voluntary nature of consent. In law, there is no specified time limit on the validity of a patient’s consent to treatment, but where there has been a delay between obtaining consent and the procedure, it makes sense to “refresh” the consent by going through the main points again and providing an opportunity for the patient to ask any questions they may have. As with all aspects of patient care this discussion should be recorded in the clinical records. In emergencies and some other situations it is not always possible to obtain written consent, but insofar as is possible patients should still be given the information they need to make a decision.
Voluntariness Unless consent is given freely it is not valid. Any degree of coercion, fear, force or fraud may invalidate an otherwise apparently valid consent. This point is illustrated by the case of Re T (adult: refusal of medical treatment).12 Miss T was 20 years old and 34 weeks pregnant. She was not herself a Jehovah’s Witness but had been brought up as one by her mother. The day following admission Miss T announced that she did not want a blood transfusion because of her religious beliefs. At that time, no transfusion had been contemplated but later on it was decided to deliver the baby by Caesarean section. A blood transfusion was subsequently necessary. Miss T was in a sedated and critical condition. It was held that her refusal was not valid as at the time she made her comments as she had not anticipated the specific complication that she now faced. In the Court of Appeal, it was held that apparent consent or apparent refusal to treatment may not be true consent or true refusal and may not be valid for one of three reasons: 1. There may be such degree of external influence as to persuade the patient to depart from her own wishes to an extent that the law regards it as undue influence. 2. An apparent consent or apparent refusal to consent may not have been made with reference to the particular circumstances in which it turns out to be relevant. 3. At the time the patient may not for the time being be a competent adult or understanding may be seriously reduced by drugs or other circumstances although she is not actually unconscious. The decision of a doctor as to the existence or refusal of consent will not protect him if the law subsequently decides otherwise. It is also important to ensure that the environment does not embarrass patients into going ahead with treatment when they would prefer not to undergo the treatment. Patients are also free to change their mind at any stage.
Incompetent adults e England and Wales: The Mental Capacity Act 2005 The Mental Capacity Act 2005 came into force in England and Wales in 2007, allowing competent adults to appoint others to make limited treatment decisions on their behalf should they become incompetent at a later date, and provides statutory backing to advance treatment decisions. The Act sets out a number of principles (see Box 1). It is presumed adults are competent unless it can be demonstrated that they are incompetent. Furthermore, a patient should not be regarded as incompetent unless all practicable steps have been taken to help the patient come to a decision without success. The fact that a decision appears unwise, even if life-threatening, cannot be taken as evidence of incapacity. If the patient is incompetent, any treatment should be provided on the basis of promoting his or her best interests. An individual’s best interests depend upon their specific circumstances and cannot be confined to purely medical considerations: all relevant factors, for example, religious beliefs or values expressed by the patient when competent, should be considered together. This may require consultation with relatives, carers, and those with lasting powers of attorney or appointed by the court. Decisions cannot be made merely on the basis of age, appearance or behaviour, and even if incapable, patients must be encouraged to participate in the process.
The consent process The consent process is an integral part of medical management. Consent may be given orally or in writing, or may simply be implied by complying with the proposed examination or treatment, for example, by taking off a shoe and sock to allow examination of a foot. It is usually enough to have oral or implied consent for physical examinations and for minor or routine investigations or treatments provided that the patient understands the nature and purpose of what is proposed. But for procedures involving higher levels of risk, written consent is preferred.
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Incompetent adults e Scotland: Adults with Incapacity (Scotland) Act 2000 This Act provides ways to help to safeguard the welfare of people aged 16 and over, who lack the capacity to take some or all
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Advance decisions Advance decisions are also referred to as advance directives or living wills. The treatment of patients who are competent will be governed by their consent or refusal of treatment. Furthermore, patients who are incompetent but who have made an advance directive, in effect refusing certain forms of medical treatment in advance, should have their wishes respected provided they were competent at the time the advance directive was signed. This was a point which again emerged in the Bland8 case. Lord Goff stated: “. It is established that the principle of self-determination requires that respect be given to the wishes of the patient, so that, if an adult patient of sound mind refuses, however unreasonably, to consent to treatment or care by which his life would or might be prolonged, the doctors responsible for the care must give effect to his wishes, even though they do not consider it to be in his best interests to do so.”
1. A person must be assumed to have capacity unless it is established that he lacks capacity. 2. A person is not to be treated as unable to make a decision unless all practicable steps to help him to do so have been taken without success. 3. A person is not to be treated as unable to make a decision merely because he makes an unwise decision. 4. An act done, or decision made, under the Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests. 5. Before the act is done, or the decision made, regard must be had to whether the purposes for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action.
“Moreover, the same principle applies where the patient’s refusal to give his consent has been expressed at an earlier date, before he became unconscious or otherwise incapable of communicating it; though in such circumstances, especial care may be necessary to ensure that the prior refusal of consent is still properly to be regarded as applicable in the circumstances which have subsequently occurred.” Section 24 of the Mental Capacity Act 2005 allows competent individuals to make advance decisions about specified treatments, which should not be carried out or continued in certain circumstances. These decisions do not apply to life-sustaining treatment unless it is verified by a written statement signed by the patient and witnessed by another person. There is a further safeguard in the Act allowing health professionals, who are not sure about the validity or applicability of an advance decision, not to be liable for providing treatment in these circumstances. No liability is incurred for withholding or withdrawing treatment if those responsible for care believe that a valid and applicable advance decision exists.
Box 1
decisions for themselves, because of a mental disorder or inability to communicate. It also allows other people to make decisions on their behalf. The Act provides various methods of intervening (that is, taking decisions or action) on behalf of an adult who lacks capacity, including in relation to healthcare. The Act sets out the principles that must be followed when deciding whether to intervene. Any intervention must be: necessary and must benefit the person the minimum necessary to achieve the purpose. Those making decisions must: Take account of the person’s present and past wishes and feelings, and must try every possible means of communicating with the person to find out what these are. Take into account the views of the person’s nearest relative and primary carer, and of any other person with powers to intervene in the person’s affairs or personal welfare, or with an interest in the person, so far as it is reasonable and practical to do so. Encourage the person to use any skills they have to make decisions. Consider whether it would be possible to intervene without using the Act. In this Act, incapacity means being incapable of acting on, making, communicating, understanding, or remembering decisions by reason of mental disorder or inability to communicate due to physical disorder. The Act is supported by Codes of Practice setting out guidance for those acting under the legislation, including doctors and other healthcare professionals who are treating adults with incapacity. Part 5 of the Code of Practice covers decisions about medical treatment and research.
Proxy decision makers Both the Mental Capacity Act 2005 (England and Wales) and the Adults with Incapacity (Scotland) Act 2000 provide for individuals to be given authority to make decisions about an incapacitated individual’s welfare, property and affairs. Under the Mental Capacity Act, competent adults can grant lasting powers of attorney to others. But there are a number of restrictions so where a lasting power of attorney includes the power to make decisions about personal welfare, this does not extend to refusing, carrying out or continuing life-sustaining treatment unless the patient expressly gave authority to that effect. The Adults with Incapacity (Scotland) Act 2000 created welfare attorneys with similar proxy decision-making powers. The Mental Capacity Act also created Independent Mental Capacity Advocates. The Independent Mental Capacity Advocates’ (IMCAs) Service came into operation in April 2007. IMCAs support vulnerable people who lack capacity to make important decisions, where there are no friends or family members available to consult. An IMCA must be instructed and then consulted, for patients lacking capacity whenever an NHS body is proposing to provide
Incompetent adults: Northern Ireland There is currently no primary legislation on capacity covering Northern Ireland. Decisions about medical treatment and care when people lack capacity must be made in accordance with the common law, which requires decisions to be made in a person’s best interests.
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serious medical treatment such as chemotherapy or major surgery. The IMCA should represent the patient in discussions to work out whether a proposed decision is in the patient’s best interests. In an emergency with no time to arrange for an IMCA, treatment should go ahead but an IMCA should be instructed for any serious medical treatment which follows, or if there is likely to be a stay in hospital for more than 28 days or other accommodation for more than eight weeks.
Other potential scenarios are where parents refuse treatment that is clearly in the best interests of a child or young person who lacks capacity or if both a young person with capacity and their parents all refuse treatment that is clearly in their best interests. Again in these circumstances expert advice should be sought at an early stage. Research The GMC guidance on consent for research is predictably, and rightly, more stringent than for day-to-day medical care. The key is information. The GMC say that research subjects should be aware that they are under no commitment to agree to participate in any research project and that if they decline to do so or withdraw from the research project at any time, their relationship with the clinical team and their care will not be adversely affected. However, where therapeutic agents are only available to research subjects, a caveat will be required to that assurance, together with an explanation of the treatment options available to them if they withdraw from the research project. The information people need to decide whether or not to take part in a research project is included in the participant information sheet. Advice on the design of information sheets and consent forms is available from the National Research Ethics Service. In the context of medical research on competent adult patients, full disclosure of all aspects of the project should be provided to the subjects, and all their questions answered as fully as they require. They should also have access to a copy of the protocol approved by a research ethics committee, subject to considerations of confidentiality, commercial privilege or the possible undermining of the purpose of the study. But where one of these conditions applies this, too, should be explained. Subjects should also have access to an individual or organization they can contact to discuss the research project and obtain further information. It is a legal requirement to get written consent from participants in clinical trials of investigational medicinal products. Further considerations apply to studies involving subjects who cannot consent for themselves, and the GMC provides detailed guidance in Good practice in research and Consent to research, available on the GMC website, with annexes providing useful explanations of the legal requirements. The Mental Capacity Act also includes specific provision for research. Section 30 makes intrusive research unlawful unless it is part of a research project approved by an Ethics Committee and has the potential of benefiting the patient without posing a disproportionate burden, or if the research is intended to shed light on the causes or treatment of their medical condition or something similar. Under these circumstances the risks associated with participating in the research must be viewed as negligible and that it will not be unduly invasive or restrictive or interfere with the patient’s freedom of action or privacy in a significant way.
Emergencies When an emergency arises in a clinical setting and it is not possible to find out a patient’s wishes, treatment can go ahead without their consent, provided the treatment is immediately necessary to save their life or to prevent a serious deterioration of their condition. The treatment provided must be the least restrictive of the patient’s future choices. If the patient regains capacity while in your care, you should tell them what has been done, and why, as soon as they are sufficiently recovered to understand. Children The Family Law Reform Act 1968 Section 8 (1) states that the consent of a minor who has attained the age of 16 years to any medical or surgical treatment which “. should be as effective as if he were of full age; [and] . it shall not be necessary to obtain consent for it from his parent or guardian”. For competent patients between the age of 16 and 18 the law is clear; they can give valid consent to treatment. What was less clear until the Gillick13 case in 1986 was whether competent children under the age of 16 could also give consent to treatment. The House of Lords ruled that a child under the age of 16 who was capable of understanding the proposed treatment, of expressing his or her own wishes, could lawfully consent to treatment. So the capacity to consent in children under 16 years of age depends on their ability to understand and weigh up options, not their age, always bearing in mind that a young person may have the capacity to consent to easily understood relatively risk-free treatment, such as the reduction of a fractured arm, but may not necessarily have the capacity to consent to more complex treatment potentially involving more serious consequences. Even if a child or young person is not able to make decisions about their own care, the expectation is they will be involved as much as possible. Detailed guidance is given in the GMC publication 0e18 years: guidance for all doctors.14 It contains advice on involving children and young people in decisions, assessing capacity and best interests, and refusal of treatment. It also details the different legal requirements across the UK for decision-making involving children and young people. The position of parents is frequently misunderstood. Parents cannot override the decision of a competent child or young person to treatment considered to be in his or her best interests. But parents can provide consent for a child who lacks the capacity to consent. More difficult is the situation where a competent child refuses consent but the parent wishes to override that decision. In Scotland, parents cannot authorize treatment a competent young person has refused. In England, Wales and Northern Ireland, the law on parents overriding young people’s competent refusal is complex, and may require referral to the courts. In these rare circumstances it is worth obtaining expert advice on the facts of the specific case.
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Legal liability Doctors are subject to numerous forms of accountability. One clinical incident can in theory give rise to a multitude of investigations, but consent cases are usually pursued as clinical negligence claims (often pleaded together with other allegations of negligence), GMC inquiries or both. In a clinical negligence claim, the claimant must prove three things. First, that the doctor owed the patient a duty of care,
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which is present in every therapeutic relationship. Second, the standard of care was inadequate, which in consent cases boils down to failure to warn the claimant of a potential complication. And third, that the patient suffered harm as a result. In other words, the claimant says that he or she suffered from a complication that they did not know about, and that had he or she been warned about the presence of that particular risk, consent to the procedure would have been declined and so the damage caused by that complication would have been avoided. Although it is relatively uncommon for “failure to warn” claims to be brought in isolation, between 20% and 30% of all surgical claims have a consent or failure to warn element to them. The GMC investigates complaints where, if proved, cast doubt on a doctor’s fitness to practise, which can include serious or persistent failure to follow the GMC’s guidance on consent and other issues. The sanctions available to the GMC include issuing a warning, placing restrictions on practice and suspension or erasure from the medical register.
clinical records, and if they are inadequate the doctor’s position will be prejudiced. One definition of an adequate medical record is one which enables reconstruction of the consultation without reference to memory, including adequate details of the history; answers to relevant direct questions; a record of all systems examined, noting all positive findings and important negative findings as well as objective measurements such as blood pressure, peak ventilatory flow, etc.; the clinical impression formed; any investigations ordered; treatment prescribed or referral made and arrangements for follow-up or admission.
Risk management Risk management is about preventing problems for the benefit of patients and their doctors. Broadly, risk management can be broken down into a number of categories: awareness of legal responsibilities; sound clinical management; competent administration; clear communication; and comprehensive contemporaneous records. The primary purpose of clinical records is continuity of care, but good notes are also invaluable from an evidential perspective. The GMC defines in detail how it expects doctors to provide information to patients and approach consent issues. Ignorance of these requirements will not provide a defence so, being familiar with the GMC’s guidance, and implementing it, are essential elements of sound clinical care. Reinforcing the information given to patients during a consultation by providing information leaflets or copying the patient in on correspondence to GPs and other healthcare professionals is helpful in proving that the patient was properly informed. Complaints, claims of negligence and other forms of investigation may not materialize for weeks, months or even years after the events in question, by which time the doctor is unlikely to remember exactly what happened at a given consultation, particularly where there has been a sequence of consultations over a period of time. Even if only for corroboration, the doctor must be able to refer to contemporaneous
REFERENCES 1 Hatcher v Black. Times; 2 July 1954 (QBD). 2 Canterbury v Spence 464 F 2d 772 (DC, 1972). 3 Sidaway v Governors of Royal Bethlem Hospital [1985] AC 871, [1985] 1 Al ER 643. 4 Seeking patients’ consent: the ethical considerations. Regent’s Place, 350 Euston Road, London, NW1 3JN: The General Medical Council, 1998. 5 Consent: patients and doctors making decisions together. Regent’s Place, 350 Euston Road, London, NW1 3JN: The General Medical Council, 2008. 6 Chester v Afshar [2004] UKHL 41; [2005] 1 AC 134; [2004] 3 WLR 927; [2004] 4 All ER 587. Times; October 19, 2004. 7 Re T (Adult: Refusal of Medical Treatment) [1992] 4 All ER 649, 30 July 1992. 8 Airedale Hospital Trustees v Bland [1992] UKHL 5 (04 February 1993), [1993] 2 WLR 316, [1993] 1 All ER 821, [1992] UKHL 5, [1993] AC 789. 9 Re A (Medical Treatment: Male Sterilisation) [2000] 1 FLR 549, [2000] 1 FCR 193. 10 F v West Berkshire Health Authority [1990], 2 AC 1. 11 Re C (1993) NLJR 1642. 12 Re T (Adult: Refusal of Medical Treatment) [1992] 4 All ER 649. 13 Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402 (HL). 14 0e18 years: guidance for all doctors. Regent’s Place, 350 Euston Road, London, NW1 3JN: The General Medical Council, 2007.
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Summary The theory of consent is straightforward, but its application in practice generates complex problems and is time-consuming. It is worth seeking advice sooner rather than later. A
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Informed consent
their doctors to provide all the information they require so that they themselves can make the best decision for them. Sixty years ago in the case of Hatcher v Black,1 the court found in favour of a surgeon who had lied to reassure a patient. She was to undergo a partial thyroidectomy and was concerned about potential adverse effects on her voice as she worked as a BBC announcer. The surgeon said that there was nothing to worry about. The judge, Lord Denning, said that: “His peers did not condemn him and neither should we”, giving judicial endorsement to a dishonest approach with doctors shouldering the burden of deciding what patients should know, whether their patients wanted them to do so or not. In 1972, jurisprudence moved on. The Californian case of Canterbury v Spence2 was a landmark decision introducing the doctrine of informed consent. A 19-year-old patient consulted Dr. Spence because of severe pain between his shoulder blades. Surgery was recommended. Prior to the procedure, the patient did not ask any questions about the procedure, and was not told about potential complications. Post-operatively he suffered from incontinence and experienced difficulty in walking, and sued for failure to warn of the risks of serious disability inherent in the laminectomy. The Court found for the claimant. The Judge stated: “In our view, the patient’s right of self decision shapes the boundaries of the duty to reveal. That right can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The scope of the physician’s communications to the patient then must be measured by the patient’s need, and that need is the information material to the decision. Thus the test of determining whether a particular peril must be divulged is the materiality of that risk to the patient’s decision. All risks potentially affecting the decision must be unmasked. To safeguard the patient’s interests in achieving his own determination on treatment, the law itself must set the standard for adequate disclosure.” In 1985, the House of Lords rejected the doctrine of informed consent by a majority in the case of Sidaway.3 Mrs Sidaway consulted a neurosurgeon as she was suffering from persistent pain, and was advised to undergo surgery. She claimed that she was informed of the risks of damage to the nerves emerging from the spinal column, but not of the risk of spinal vein thrombosis, thought to be less than 1%. She developed a post-operative hemiplegia due to spinal vein thrombosis, and sued, on the grounds that had the risk been disclosed she would have declined surgery. The House of Lords ruled that determining what information should be given to the patient was primarily a matter of clinical judgement and therefore for the doctor to decide. In 1998 the General Medical Council (GMC) published its first guidance for doctors on consent, entitled Seeking patients’ consent e the ethical considerations.4 This set out in explicit terms the information which doctors ought to provide to patients before seeking consent to treatment and adopted into the UK the previously alien doctrine of informed consent. The GMC’s guidance has been regularly updated, the latest version published in 2008 is entitled Consent: patients and doctors making decisions together.5 In October 2004, the case of Chester v Afshar6 was considered by the House of Lords. Miss Chester had a discectomy for low back pain. The procedure was undertaken competently, but Miss Chester was left with cauda equina syndrome, a complication thought to occur in under 2% of cases. She sued, claiming that there was a failure to warn about this risk and was awarded
Gerard Panting
Abstract The term ‘informed consent’ has been in common usage since the case of Canterbury v Spence was decided in the Californian courts in the 1970s. The basic principle is straightforward: to be in a position to make an informed choice you need to know all the material facts. However, the law is not static and as new situations are presented so the law is developed through cases decided in the courts, in some instances influenced by guidance issued by the General Medical Council, and new statutes enacted by Parliament. This paper reviews the current law on consent in the United Kingdom, taking into account variations in the devolved administrations, the principles that underlie obtaining valid consent, in situations ranging from elective procedures in competent adults to lifethreatening emergencies and the treatment of the temporarily or permanently incompetent patient as well as the rights of spouses, relatives and other interested parties. A sound knowledge of the basic principles and how they should be applied is essential for all surgeons and failure to warn is a common component of clinical negligence claims.
Keywords competence; consent; information; proxies; voluntary decisions
Introduction Consent is a fundamental tenet of medical law, protecting all of us against unwelcome intrusion. The basic rule is simple; no-one has the right to touch anyone else without lawful excuse: to do so may amount to a battery and/or negligence. For consent to examination, investigation or treatment to be valid, three conditions must be satisfied: first, the patient must be competent; second, he or she must have sufficient information to make an informed choice and lastly, the consent must be given voluntarily. The term informed consent emphasizes the importance of providing patients with all the information material to their decision, but remains as just one element of what is required for valid consent. Unless there is reason to believe otherwise, it is assumed that adult patients are competent. The fact that a patient does not agree with the doctor’s recommendation or makes a decision which appears irrational, does not automatically condemn the patient as incompetent. Nor does the existence of chronic mental illness, even where the patient is detained as a result of that illness. Consent to medical interventions may be given by the patient, or by someone authorized to act on behalf of the patient, for example a parent, or authorized proxy.
A brief history of consent law Consent law has evolved over time, moving from patients relying on their doctors to do what is best for them, to patients expecting
Gerard Panting MA MBBS FFFLM DMJ Director of TWG Resources, The Garden House, Blackhall Lane, Sevenoaks, Kent, UK.
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compensation, as there was no documentation to demonstrate that any warning had been given. Chester v Afshar emphasizes the need to ensure patients are fully informed, understand the information, are given sufficient time, where possible, to reflect on their decision, and that the consent process, including warnings, is properly recorded.
questioned, even though arriving at a rational decision is no part of assessing competence. If there is any doubt about an individual’s competence, a more formal assessment is required which may involve psychiatrists, or if there are communication difficulties, speech therapists and others. Competence is not an all or nothing phenomenon e patients can have the capacity to consent to one procedure, but not to others, so a patient’s capacity to decide may vary depending on the situation, complexity of the decision-making process and may also fluctuate with time. If an adult patient is not competent, authority to proceed with treatment may be provided in England, Wales and Scotland (but not Northern Ireland), by someone authorized to consent on the patient’s behalf as discussed in more detail below.
Advance refusal of treatment Two cases, Re T (Adult: Refusal of Medical Treatment)7 and Airedale NHS Trust v Bland,8 gave judicial backing to the concept of advance refusals of treatment, or living wills, provided that refusal is both ‘clearly established’ and ‘applicable in all the circumstances’ being as effective as the decision of a capable adult. Statutory provision for advance refusals of treatment in England and Wales was included in the Mental Capacity Act 2005, which came into force in 2007. The Act also provides for lasting powers of attorney, which allow competent individuals to appoint others to make treatment decisions on their behalf, should they become incompetent to make those decisions for themselves. In Scotland the Adults with Incapacity (Scotland) Act 2000 makes similar provisions to the Mental Capacity Act. The Adults with Incapacity (Scotland) Act safeguards the welfare and finances of people over 16, who lack capacity to take some or all decisions for themselves because of a mental disorder or an inability to communicate. The Act allows others such as relatives, friends or partners to make those decisions for them. The Act also allows patients to make arrangements for another person or persons to make decisions and manage affairs on their behalf if they lose capacity in the future. Currently there is no equivalent provision in Northern Ireland, so decisions about medical treatment and care when individuals lack capacity must be made in accordance with that individual’s best interests. How the term best interests should be interpreted was clarified in two cases: Re A (Medical Treatment: Male Sterilisation)9 and F v West Berkshire Health Authority10 [1990] 2 AC 1. The best interests of a mentally incapacitated person are not limited to best medical interests, but also encompass medical, emotional and all other welfare issues. Any treatment provided should be in accordance with standard treatments for that condition, bearing in mind any individual idiosyncrasies of the patient; incompetent patients should not be denied treatment open to competent patients.
Information The provision of information is the key to obtaining valid consent. The GMC guidance states that the exchange of information between doctor and patient is central to good decision-making. Exactly how much information is disclosed to the patient will vary, but the default position should be to provide full disclosure. The GMC expects doctors to give patients the information they want or need about: 1. diagnosis and prognosis 2. uncertainties about the diagnosis or prognosis, including options for further investigations 3. options for treating or managing the condition, including the option not to treat 4. the purpose of any proposed investigation or treatment and what it will involve 5. potential benefits, risks and burdens, and the likelihood of success, for each option; this should include information, if available, about whether the benefits or risks are affected by which organization or doctor is chosen to provide care 6. whether a proposed investigation or treatment is part of a research programme or is an innovative treatment designed specifically for their benefit 7. people who will be mainly responsible for and involved in their care, what their roles are, and to what extent students may be involved 8. their right to refuse to take part in teaching or research 9. their right to seek a second opinion 10. any bills they will have to pay In addition, the GMC expects doctors to answer patients’ questions honestly and, as far as is practical, answer as fully as they wish. If, however, patients do not want detailed information, the doctor should try to find out why. If, after discussion, the patient still does not want to know in detail about their condition or treatment, their wishes should be respected, but the GMC still requires that patients are provided with the information they need in order to give consent to the proposed investigation or treatment. This may include what the investigation or treatment aims to achieve and what is involved; the likely level of pain or discomfort; anything they should do to prepare for the investigation or treatment; and if it involves any serious risks. GMC guidance states that: “if a patient insists that they do not want even this basic information, you must explain the potential consequences of them not having it, particularly if it might mean
Competence Capacity or competence is the ability to make a choice. The test of competence was set out in the case of Re C,11 a chronic schizophrenic detained under the Mental Health Act, who had developed gangrene of his foot. Surgeons recommended amputation but he refused, and applied successfully for an injunction restraining the surgeons from amputating his foot against his will. The basis for the court’s decision was that he did understand the treatment information, believed that information to be true, and was able to process it to arrive at a choice. He was also able to communicate his decision and was therefore competent and entitled to accept or reject treatment, even though his choice jeopardized his health and life. Competence is usually not formally assessed. In practice, provided a patient appears to comprehend what is being said and the decision appears rational, competence will not normally be
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that their consent is not valid. You must record the fact that the patient has declined this information. You must also make it clear that they can change their mind and have more information at any time.” The only justification for withholding information is that disclosure would be likely to cause serious harm to the patient’s physical or mental health. In this context ‘serious harm’ does not include the risk that the patient might become upset or decide to refuse treatment. Where information is withheld, the reason for doing so must be recorded in the clinical records.
In law, written consent is required for certain treatments, such as fertility treatment and organ donation. But the GMC also expects doctors to obtain written consent if: the investigation or treatment is complex or involves significant risks; there may be significant consequences for the patient’s employment, or social or personal life; clinical care is not the primary purpose of the investigation or treatment, or if the treatment is part of a research programme or is an innovative treatment designed specifically for their benefit. In addition NHS trusts and independent sector providers usually have internal policies which doctors are expected to adhere to. However, a consent form is, at best, only some evidence that a valid consent has been obtained and will not in itself rebut all allegations of failure to warn about potential risks. The validity of the consent always depends upon being able to demonstrate competence, the provision of sufficient information and the voluntary nature of consent. In law, there is no specified time limit on the validity of a patient’s consent to treatment, but where there has been a delay between obtaining consent and the procedure, it makes sense to “refresh” the consent by going through the main points again and providing an opportunity for the patient to ask any questions they may have. As with all aspects of patient care this discussion should be recorded in the clinical records. In emergencies and some other situations it is not always possible to obtain written consent, but insofar as is possible patients should still be given the information they need to make a decision.
Voluntariness Unless consent is given freely it is not valid. Any degree of coercion, fear, force or fraud may invalidate an otherwise apparently valid consent. This point is illustrated by the case of Re T (adult: refusal of medical treatment).12 Miss T was 20 years old and 34 weeks pregnant. She was not herself a Jehovah’s Witness but had been brought up as one by her mother. The day following admission Miss T announced that she did not want a blood transfusion because of her religious beliefs. At that time, no transfusion had been contemplated but later on it was decided to deliver the baby by Caesarean section. A blood transfusion was subsequently necessary. Miss T was in a sedated and critical condition. It was held that her refusal was not valid as at the time she made her comments as she had not anticipated the specific complication that she now faced. In the Court of Appeal, it was held that apparent consent or apparent refusal to treatment may not be true consent or true refusal and may not be valid for one of three reasons: 1. There may be such degree of external influence as to persuade the patient to depart from her own wishes to an extent that the law regards it as undue influence. 2. An apparent consent or apparent refusal to consent may not have been made with reference to the particular circumstances in which it turns out to be relevant. 3. At the time the patient may not for the time being be a competent adult or understanding may be seriously reduced by drugs or other circumstances although she is not actually unconscious. The decision of a doctor as to the existence or refusal of consent will not protect him if the law subsequently decides otherwise. It is also important to ensure that the environment does not embarrass patients into going ahead with treatment when they would prefer not to undergo the treatment. Patients are also free to change their mind at any stage.
Incompetent adults e England and Wales: The Mental Capacity Act 2005 The Mental Capacity Act 2005 came into force in England and Wales in 2007, allowing competent adults to appoint others to make limited treatment decisions on their behalf should they become incompetent at a later date, and provides statutory backing to advance treatment decisions. The Act sets out a number of principles (see Box 1). It is presumed adults are competent unless it can be demonstrated that they are incompetent. Furthermore, a patient should not be regarded as incompetent unless all practicable steps have been taken to help the patient come to a decision without success. The fact that a decision appears unwise, even if life-threatening, cannot be taken as evidence of incapacity. If the patient is incompetent, any treatment should be provided on the basis of promoting his or her best interests. An individual’s best interests depend upon their specific circumstances and cannot be confined to purely medical considerations: all relevant factors, for example, religious beliefs or values expressed by the patient when competent, should be considered together. This may require consultation with relatives, carers, and those with lasting powers of attorney or appointed by the court. Decisions cannot be made merely on the basis of age, appearance or behaviour, and even if incapable, patients must be encouraged to participate in the process.
The consent process The consent process is an integral part of medical management. Consent may be given orally or in writing, or may simply be implied by complying with the proposed examination or treatment, for example, by taking off a shoe and sock to allow examination of a foot. It is usually enough to have oral or implied consent for physical examinations and for minor or routine investigations or treatments provided that the patient understands the nature and purpose of what is proposed. But for procedures involving higher levels of risk, written consent is preferred.
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Incompetent adults e Scotland: Adults with Incapacity (Scotland) Act 2000 This Act provides ways to help to safeguard the welfare of people aged 16 and over, who lack the capacity to take some or all
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Advance decisions Advance decisions are also referred to as advance directives or living wills. The treatment of patients who are competent will be governed by their consent or refusal of treatment. Furthermore, patients who are incompetent but who have made an advance directive, in effect refusing certain forms of medical treatment in advance, should have their wishes respected provided they were competent at the time the advance directive was signed. This was a point which again emerged in the Bland8 case. Lord Goff stated: “. It is established that the principle of self-determination requires that respect be given to the wishes of the patient, so that, if an adult patient of sound mind refuses, however unreasonably, to consent to treatment or care by which his life would or might be prolonged, the doctors responsible for the care must give effect to his wishes, even though they do not consider it to be in his best interests to do so.”
1. A person must be assumed to have capacity unless it is established that he lacks capacity. 2. A person is not to be treated as unable to make a decision unless all practicable steps to help him to do so have been taken without success. 3. A person is not to be treated as unable to make a decision merely because he makes an unwise decision. 4. An act done, or decision made, under the Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests. 5. Before the act is done, or the decision made, regard must be had to whether the purposes for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action.
“Moreover, the same principle applies where the patient’s refusal to give his consent has been expressed at an earlier date, before he became unconscious or otherwise incapable of communicating it; though in such circumstances, especial care may be necessary to ensure that the prior refusal of consent is still properly to be regarded as applicable in the circumstances which have subsequently occurred.” Section 24 of the Mental Capacity Act 2005 allows competent individuals to make advance decisions about specified treatments, which should not be carried out or continued in certain circumstances. These decisions do not apply to life-sustaining treatment unless it is verified by a written statement signed by the patient and witnessed by another person. There is a further safeguard in the Act allowing health professionals, who are not sure about the validity or applicability of an advance decision, not to be liable for providing treatment in these circumstances. No liability is incurred for withholding or withdrawing treatment if those responsible for care believe that a valid and applicable advance decision exists.
Box 1
decisions for themselves, because of a mental disorder or inability to communicate. It also allows other people to make decisions on their behalf. The Act provides various methods of intervening (that is, taking decisions or action) on behalf of an adult who lacks capacity, including in relation to healthcare. The Act sets out the principles that must be followed when deciding whether to intervene. Any intervention must be: necessary and must benefit the person the minimum necessary to achieve the purpose. Those making decisions must: Take account of the person’s present and past wishes and feelings, and must try every possible means of communicating with the person to find out what these are. Take into account the views of the person’s nearest relative and primary carer, and of any other person with powers to intervene in the person’s affairs or personal welfare, or with an interest in the person, so far as it is reasonable and practical to do so. Encourage the person to use any skills they have to make decisions. Consider whether it would be possible to intervene without using the Act. In this Act, incapacity means being incapable of acting on, making, communicating, understanding, or remembering decisions by reason of mental disorder or inability to communicate due to physical disorder. The Act is supported by Codes of Practice setting out guidance for those acting under the legislation, including doctors and other healthcare professionals who are treating adults with incapacity. Part 5 of the Code of Practice covers decisions about medical treatment and research.
Proxy decision makers Both the Mental Capacity Act 2005 (England and Wales) and the Adults with Incapacity (Scotland) Act 2000 provide for individuals to be given authority to make decisions about an incapacitated individual’s welfare, property and affairs. Under the Mental Capacity Act, competent adults can grant lasting powers of attorney to others. But there are a number of restrictions so where a lasting power of attorney includes the power to make decisions about personal welfare, this does not extend to refusing, carrying out or continuing life-sustaining treatment unless the patient expressly gave authority to that effect. The Adults with Incapacity (Scotland) Act 2000 created welfare attorneys with similar proxy decision-making powers. The Mental Capacity Act also created Independent Mental Capacity Advocates. The Independent Mental Capacity Advocates’ (IMCAs) Service came into operation in April 2007. IMCAs support vulnerable people who lack capacity to make important decisions, where there are no friends or family members available to consult. An IMCA must be instructed and then consulted, for patients lacking capacity whenever an NHS body is proposing to provide
Incompetent adults: Northern Ireland There is currently no primary legislation on capacity covering Northern Ireland. Decisions about medical treatment and care when people lack capacity must be made in accordance with the common law, which requires decisions to be made in a person’s best interests.
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serious medical treatment such as chemotherapy or major surgery. The IMCA should represent the patient in discussions to work out whether a proposed decision is in the patient’s best interests. In an emergency with no time to arrange for an IMCA, treatment should go ahead but an IMCA should be instructed for any serious medical treatment which follows, or if there is likely to be a stay in hospital for more than 28 days or other accommodation for more than eight weeks.
Other potential scenarios are where parents refuse treatment that is clearly in the best interests of a child or young person who lacks capacity or if both a young person with capacity and their parents all refuse treatment that is clearly in their best interests. Again in these circumstances expert advice should be sought at an early stage. Research The GMC guidance on consent for research is predictably, and rightly, more stringent than for day-to-day medical care. The key is information. The GMC say that research subjects should be aware that they are under no commitment to agree to participate in any research project and that if they decline to do so or withdraw from the research project at any time, their relationship with the clinical team and their care will not be adversely affected. However, where therapeutic agents are only available to research subjects, a caveat will be required to that assurance, together with an explanation of the treatment options available to them if they withdraw from the research project. The information people need to decide whether or not to take part in a research project is included in the participant information sheet. Advice on the design of information sheets and consent forms is available from the National Research Ethics Service. In the context of medical research on competent adult patients, full disclosure of all aspects of the project should be provided to the subjects, and all their questions answered as fully as they require. They should also have access to a copy of the protocol approved by a research ethics committee, subject to considerations of confidentiality, commercial privilege or the possible undermining of the purpose of the study. But where one of these conditions applies this, too, should be explained. Subjects should also have access to an individual or organization they can contact to discuss the research project and obtain further information. It is a legal requirement to get written consent from participants in clinical trials of investigational medicinal products. Further considerations apply to studies involving subjects who cannot consent for themselves, and the GMC provides detailed guidance in Good practice in research and Consent to research, available on the GMC website, with annexes providing useful explanations of the legal requirements. The Mental Capacity Act also includes specific provision for research. Section 30 makes intrusive research unlawful unless it is part of a research project approved by an Ethics Committee and has the potential of benefiting the patient without posing a disproportionate burden, or if the research is intended to shed light on the causes or treatment of their medical condition or something similar. Under these circumstances the risks associated with participating in the research must be viewed as negligible and that it will not be unduly invasive or restrictive or interfere with the patient’s freedom of action or privacy in a significant way.
Emergencies When an emergency arises in a clinical setting and it is not possible to find out a patient’s wishes, treatment can go ahead without their consent, provided the treatment is immediately necessary to save their life or to prevent a serious deterioration of their condition. The treatment provided must be the least restrictive of the patient’s future choices. If the patient regains capacity while in your care, you should tell them what has been done, and why, as soon as they are sufficiently recovered to understand. Children The Family Law Reform Act 1968 Section 8 (1) states that the consent of a minor who has attained the age of 16 years to any medical or surgical treatment which “. should be as effective as if he were of full age; [and] . it shall not be necessary to obtain consent for it from his parent or guardian”. For competent patients between the age of 16 and 18 the law is clear; they can give valid consent to treatment. What was less clear until the Gillick13 case in 1986 was whether competent children under the age of 16 could also give consent to treatment. The House of Lords ruled that a child under the age of 16 who was capable of understanding the proposed treatment, of expressing his or her own wishes, could lawfully consent to treatment. So the capacity to consent in children under 16 years of age depends on their ability to understand and weigh up options, not their age, always bearing in mind that a young person may have the capacity to consent to easily understood relatively risk-free treatment, such as the reduction of a fractured arm, but may not necessarily have the capacity to consent to more complex treatment potentially involving more serious consequences. Even if a child or young person is not able to make decisions about their own care, the expectation is they will be involved as much as possible. Detailed guidance is given in the GMC publication 0e18 years: guidance for all doctors.14 It contains advice on involving children and young people in decisions, assessing capacity and best interests, and refusal of treatment. It also details the different legal requirements across the UK for decision-making involving children and young people. The position of parents is frequently misunderstood. Parents cannot override the decision of a competent child or young person to treatment considered to be in his or her best interests. But parents can provide consent for a child who lacks the capacity to consent. More difficult is the situation where a competent child refuses consent but the parent wishes to override that decision. In Scotland, parents cannot authorize treatment a competent young person has refused. In England, Wales and Northern Ireland, the law on parents overriding young people’s competent refusal is complex, and may require referral to the courts. In these rare circumstances it is worth obtaining expert advice on the facts of the specific case.
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Legal liability Doctors are subject to numerous forms of accountability. One clinical incident can in theory give rise to a multitude of investigations, but consent cases are usually pursued as clinical negligence claims (often pleaded together with other allegations of negligence), GMC inquiries or both. In a clinical negligence claim, the claimant must prove three things. First, that the doctor owed the patient a duty of care,
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which is present in every therapeutic relationship. Second, the standard of care was inadequate, which in consent cases boils down to failure to warn the claimant of a potential complication. And third, that the patient suffered harm as a result. In other words, the claimant says that he or she suffered from a complication that they did not know about, and that had he or she been warned about the presence of that particular risk, consent to the procedure would have been declined and so the damage caused by that complication would have been avoided. Although it is relatively uncommon for “failure to warn” claims to be brought in isolation, between 20% and 30% of all surgical claims have a consent or failure to warn element to them. The GMC investigates complaints where, if proved, cast doubt on a doctor’s fitness to practise, which can include serious or persistent failure to follow the GMC’s guidance on consent and other issues. The sanctions available to the GMC include issuing a warning, placing restrictions on practice and suspension or erasure from the medical register.
clinical records, and if they are inadequate the doctor’s position will be prejudiced. One definition of an adequate medical record is one which enables reconstruction of the consultation without reference to memory, including adequate details of the history; answers to relevant direct questions; a record of all systems examined, noting all positive findings and important negative findings as well as objective measurements such as blood pressure, peak ventilatory flow, etc.; the clinical impression formed; any investigations ordered; treatment prescribed or referral made and arrangements for follow-up or admission.
Risk management Risk management is about preventing problems for the benefit of patients and their doctors. Broadly, risk management can be broken down into a number of categories: awareness of legal responsibilities; sound clinical management; competent administration; clear communication; and comprehensive contemporaneous records. The primary purpose of clinical records is continuity of care, but good notes are also invaluable from an evidential perspective. The GMC defines in detail how it expects doctors to provide information to patients and approach consent issues. Ignorance of these requirements will not provide a defence so, being familiar with the GMC’s guidance, and implementing it, are essential elements of sound clinical care. Reinforcing the information given to patients during a consultation by providing information leaflets or copying the patient in on correspondence to GPs and other healthcare professionals is helpful in proving that the patient was properly informed. Complaints, claims of negligence and other forms of investigation may not materialize for weeks, months or even years after the events in question, by which time the doctor is unlikely to remember exactly what happened at a given consultation, particularly where there has been a sequence of consultations over a period of time. Even if only for corroboration, the doctor must be able to refer to contemporaneous
REFERENCES 1 Hatcher v Black. Times; 2 July 1954 (QBD). 2 Canterbury v Spence 464 F 2d 772 (DC, 1972). 3 Sidaway v Governors of Royal Bethlem Hospital [1985] AC 871, [1985] 1 Al ER 643. 4 Seeking patients’ consent: the ethical considerations. Regent’s Place, 350 Euston Road, London, NW1 3JN: The General Medical Council, 1998. 5 Consent: patients and doctors making decisions together. Regent’s Place, 350 Euston Road, London, NW1 3JN: The General Medical Council, 2008. 6 Chester v Afshar [2004] UKHL 41; [2005] 1 AC 134; [2004] 3 WLR 927; [2004] 4 All ER 587. Times; October 19, 2004. 7 Re T (Adult: Refusal of Medical Treatment) [1992] 4 All ER 649, 30 July 1992. 8 Airedale Hospital Trustees v Bland [1992] UKHL 5 (04 February 1993), [1993] 2 WLR 316, [1993] 1 All ER 821, [1992] UKHL 5, [1993] AC 789. 9 Re A (Medical Treatment: Male Sterilisation) [2000] 1 FLR 549, [2000] 1 FCR 193. 10 F v West Berkshire Health Authority [1990], 2 AC 1. 11 Re C (1993) NLJR 1642. 12 Re T (Adult: Refusal of Medical Treatment) [1992] 4 All ER 649. 13 Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402 (HL). 14 0e18 years: guidance for all doctors. Regent’s Place, 350 Euston Road, London, NW1 3JN: The General Medical Council, 2007.
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Summary The theory of consent is straightforward, but its application in practice generates complex problems and is time-consuming. It is worth seeking advice sooner rather than later. A
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Ó 2010 Gerard Panting. Published by Elsevier Ltd. All rights reserved.