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Consent: how to get it and what to do if you cannot
Current Anaesthesia and Critical Care
(1998) 9, 274-277
© 1998 Harcourt Brace & Co. Ltd
F o c u s on: M e d i c o - l e g a l issues in a n a e s t h e s i a - p a r t 2
Consent: how to get it and what to do if you cannot
D. M a s o n and K. Peters
' A n adult patient w h o ... suffers f r o m no m e n t a l i n c a p a c i t y has an absolute right to c h o o s e w h e t h e r to c o n s e n t to m e d i c a l treatment, to refuse it or to c h o o s e one rather than the other o f the treatments b e i n g offered.' 1
Introduction
Valid c o n s e n t
We start this article by attempting to define the concept of consent and the reason why it is necessary. We explore the components which constitute 'valid' consent and the options available if consent is refused.
Valid consent must encompass three elements: 1. the patient must have the capacity to consent to the treatment offered 2. the patient must have sufficient information to be able to make a balanced decision to consent 3. the patient' s consent must be given voluntarily
W h a t is consent? Consent has been described as 'an aspect of respect for autonomy' and is essentially an expression of selfdetermination. 2 Since the time of St Thomas Aquinas, there has been a principle that every adult o sound mind has the right to decide what should - or should not - be done to his own body. ~ A patient will often have total faith in a doctor's knowledge and skill, and may not even consider the possibility of any inherent risk in their treatment. The superior knowledge of the clinicians can lead to a risk of paternalism and result in a patient accepting treatment without fully understanding its consequences. Consent is a question of power and control. 4
Capacity Capacity to give legal effective consent depends upon capacity to understand and come to a decision on what is involved, and the capacity to communicate that decision. 11 Consent will not be valid unless a patient has capacity to make a decision. If a patient is able to comprehend and retain the material treatment information, believes it and able to weigh it in the balance as part of the process of arriving at a decision, then he will have capacity. If he fails any part of this test, then he does not have capacity. 12 Essentially, every adult is presumed to have the capacity to consent unless proven otherwise. Minors aged between 16 and 18 years are presumed to have the same capacity to consent to treatment as if they were adults. 13 Under 16 year olds may be deemed to have the capacity to consent, if they are able to fully appreciate the nature and consequences of the treatment which is proposed for,them. 14 There is no fixed age below which a minor cannot consent to treatment, but clinicians have to be careful and must determine that the minor does have a full understanding of the risks and
W h y is c o n s e n t necessary? Any unpermitted invasion of the body is technically a criminal offence of battery, even if there is no tangible injury. 5
David Mason MA(Oxon),Dip L, FSALS, Partner,Katy Peters LLB Hon, Trainee Solicitor, Capsticks Solicitors, 77-83 Upper Richmond Road, London SW15 2TT, UK. 274
CONSENT 275 potential outcome of the treatment. If there is any doubt about a minor's capacity, consent should also be sought from one person with parental responsibility. ~5 A refusal of treatment by a person under 18 years can be overridden by the consent of a person with parental responsibility or the court, provided that the proposed treatment is necessary in the best interests of the young person_ Since it is the capacity to make a decision which is crucial to the issue of consent, problems may arise where a patient has a learning and/or communication disability. It should never be assumed that such patients do not have the capacity to consent to or refuse treatment, because often they do, but, clearly, particular care needs to be taken when assessing capacity. Patients who are being treated under the Mental Health Act 1983 will not necessarily be incapable of consenting to treatment_ Patients detained under Sections 2 and 3 of the Act may be treated without a need for obtaining consent only for the mental disorder for which they were detained. They do not, by virtue of the detention, necessarily lack the capacity to give consent to or refuse other medical treatment. Capacity may also be invalidated by a patient's confusion, shock, pain or fatigue; the ability to make a decision may also be inadvertently affected by any drugs which the patient has been given_ A patient who has just been informed that he is suffering from cancer, for example, may be too numb and shocked to be able to fully comprehend the information necessary for him to make a decision about his treatment. 16 A patient's fear can also lead to the need for a judgment call on capacity. It could be that the patient's fear of a particular treatment or procedure has paralysed his will and destroyed his capacity to make a decision. Alternatively, it could be that the patient had a rational reason for his fear and this would mean that although he was capable of consenting, he had chosen to refuse treatment. This refusal would be perfectly valid. It will be important to look at the evidence in each individual situation to decide whether any factors which might erode capacity have done so to such a degree that the patient has no capacity to decide. In one case, a pregnant woman, who was quite happy to consent to a Caesarean section for her child's well-being, suffered from a needle phobia. Although she accepted and consented to the incision by the surgeon's scalpel, she would not consent to the prick of the anaesthetist's needle. The court found that the w o m a n ' s fear of the anaesthetist's needle dominated her thinking and made her quite unable to consider anything else. This meant that she was incapable of making any decision at all and was temporarily incompetent and the doctors were, therefore, free to administer the anaesthetic if that was in her best interests, despite her lack of consent. It is important to bear in mind, however, that this case involved a very specific phobia. I7
Information _.. for consent to be real the patient must be told what operation is to be performed and why it is to be done. 18
Even if the patient is better off in the long run as a result of the invasion, he could still recover damages if he proved that there had been actual physical contact to which he had not consented. In Canada, a doctor who had injected a patient in her left arm, when she had asked to be injected in her right arm, was convicted of battery. The woman had only consented to an injection in her right arm and the injection in her left arm was, therefore, unlawful. 6 The courts in England are generally reluctant to find surgeons liable for battery] A doctor might still be sued, however, if he were to infringe a patient's non-clinical right of self-determination. In one case, a woman who had consented to a hysterectomy successfully sued the surgeon for trespass when he also removed her ovaries, an act to which she had not consented. If a doctor carries out any surgery over and above what the patient has agreed to, it must be seen to be immediately necessary to preserve that patient's health. In effect, the doctor would probably need to prove that his actions had averted a potentially life-threatening condition. 9 The most common claim against clinicians who act without a patient's consent is of course one of negligence. If a doctor fails to disclose a material risk to a patient, then he is abusing the patient's right to be involved in its clinical decision, l° Consent on its own will not provide a defence to an allegation of clinical negligence, but it will, if it has been well documented, act as evidence that the patient was aware of the implications of the treatment which had been proposed. For a patient to give valid consent, he must be in possession of an adequate amount of information about the treatment. This need not necessarily mean that he fully understands a particularly technical procedure, but he should fully appreciate the nature and consequences of it.19 When deciding how much information to disclose, it is important for the clinician to consider the individual patient and his needs. In some cases, the sheer technicality and complexity of a procedure can mean that a patient will not fully understand its implications even after they have been explained to him. It has been suggested that it is sufficient for the patient to be informed in broad terms of the nature and the procedure which is intended. 2° Too much information could simply frighten a patient into refusing much needed treatment, but it is important that a patient should be aware of any significant risks inherent in a procedure. 21 The case of Sidaway, 2~ suggested that a doctor had a certain amount of therapeutic privilege in determining how much information to give to a patient. In this case, a woman underwent electro-convulsive therapy without being told about the risks involved. It was held that the doctors had a defence of therapeutic privilege, as disclosing the risks to this patient would have been to her psychological detriment. Balanced against this, however, is the fact that a patient must have sufficient kiaowledge to be able to make an informed decision. This will vary according to the individual. A pianist undergoing hand surgery, for example, would need to know of any
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risk which might affect his career. A telephone operator undergoing the same operation, may not need such a detailed explanation of the specific risks to her hands. 'Significant' risks must be discussed with the patient: generally this would mean any risks which are likely to occur in _> 1% of cases. The test will be whether a reasonable body of medical opinion would have informed the patient of the same risks in a given situation. 23 It is important that the person explaining the treatment to the patient is sufficiently skilled to be able to answer any questions which the patient might have. As it is so important for the plaintiff to have sufficient knowledge to be able to give informed consent, it is important that the person who explains the procedure to him is sufficiently skilled to be able to understand it. This means that the anaesthetist should visit the patient sometime before surgery, in order to explain the planned procedures and possible hazards. 24 For this reason, the act of gaining a patient's consent should not be delegated to a junior staff member or to someone who is not an anaesthetist. The possible need for naso-gastric tubes, chest drains or blood transfusions in the postoperative period should be explained before the procedure. The Court of Appeal has held that wherever possible, consent should be obtained by the person who actually carries out the procedure and, if this is not possible, by someone who is appropriately qualified and 'familiar with all the details and the risks of the proposed procedure, and any alternatives'.25 Equally, consent should be obtained as near to the time of the actual treatment as possible) 6 Any discussions and the patient's final consent or refusal, should be recorded in the clinical notes. Any explanation given should be in comprehensible language, so that the patient is not overwhelmed with technicalities and has a good grasp of the risks involved) 7 If the language used is too technical, then the patient may not be able to make an informed decision and his confusion will mean that any consent which he does give will not be valid. A doctor is under an obligation to answer any questions which the patient might have in a truthful manner. 28 However_ the doctor is under no obligation to divulge remote risks which the patient has not enquired a b o u t . 29 General risks, such as those from anaesthesia, are common to most operations. If a patient would be unable to cope with the facts relevant to the more specific aspects of the treatment, the doctor may be justified in generalizing the information which he gives) ° The personality of the patient, the likelihood of misfortune and the best way of expressing any explanation of the risks must be decided according to a particular patient's welfare, but doctors should beware of being too paternalistic. ~
Voluntary The real question in such a case is 'does the patient really mean what he says or is he merely saying it for a quiet life, to satisfy someone else or because the advice or persuasion to which he has been subjected is such that he can no longer think and decide for himself?' In other words 'Is a decision expressed in form only, not in reality?' t2
Any patient with capacity is as entitled to refuse treatment as he is to consent to it. Jehovah's Witnesses, because of their faith, will often refuse to have blood transfusions. As long as they understand and accept the nature and consequences of such a decision, then their refusal will be valid even if it leads to their death. 3~ However, problems may arise where a patient is being pressurized by his family, friends or religious leaders into refusing treatment that he might otherwise agree to. In one case, a pregnant patient's decision to refuse a blood transfusion was invalidated by the fact that it was the result of undue influence from her mother. It transpired that, although the patient's mother was a Jehovah's Witness, the patient was not and it was held that her refusal was due solely to pressure from her mother and was, therefore, invalid. 34 Consent will not be valid if the patient has been forced or coerced into giving it. This is where consent forms can be crucial evidence. They are not in themselves evidence of the fact that a patient has been given sufficient information, but they may be evidence of the voluntary nature of the consent procedure in a particular case. The voluntary nature of any refusal to consent is also a crucial factor.
Advance directives Living wills (or advance directives) allow patients to express their wishes in advance about what treatment they will accept if they become too ill or mentally confused to express their wishes in the futureY There is no specific legislation governing advance directives, although advance refusal of treatment is binding on doctors. A schizophrenic man from Broadmoor, who refused to allow his gangrenous leg to be amputated, was granted an injunction forbidding his doctors from removing the leg in the future. The judge found that he had understood the information given to him about the treatment - including the fact that without it he might die - and had made a clear choiceJ 6 The case of Annie Lindsell, ~7 a woman with motor neurone disease with weeks to live, brought the issue of 'living wills' into the limelight. She wanted to be able to permit her GP to administer intensive diamorphic treatment in her final days, if she should need it for pain relief, even though a secondary effect of the drug would be to hasten her death. It is illegal to administer such treatment if the sole intention is to hasten death, that would be euthanasia. The doctrine of 'double effect', however, allows for the administration of pain-relieving drags where the clinician's intention is to ease suffering, despite the fact that a secondary effect will be to speed up death. An advance directive can be either oral or in writing, but to be legally binding, it must satisfy three criteria: 1. the patient must have had the capacity to refuse or to consent to treatment at the time of making the decision 2_ the patient must have anticipated and intended the
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decision to apply to the situation in which he now finds himself 3. the patient must have made his decision voluntarily, with no undue influence from anyone else.
information from the clinician, and a voluntary decision from the patient, must all be present_ If any of them are missing, the patient's consent will not be valid.
Failure to adhere to a valid advance directive could result in a charge of assault.
References
Best interests If a patient is incapable of consent, for example, if they are unconscious or mentally incapacitated, then they should be treated in their best interests_ 3s This usually means that they must be given any treatment which is necessary to preserve their life, health and well-being. 39 However, the case of Tony Bland established that it is not always in a patient's best interests to keep him alive at all costs_ In some cases it may be in his best interests to allow him to die. 4° In one case, a D o w n ' s Syndrome child was born with an intestinal blockage which required an operation if she were to live for more than a few days. If successful, then her life expectancy would be 20-30 years. She was unable to consent to the operation herself and her parents refused to consent on her behalf. The court decided that it had not been demonstrated that her life was so intolerable that she should be allowed to die and, therefore, found that it would be in her best interests to have the operation, despite the lack of consent. 4I At the opposite end of the spectrum, Tony Bland, who was left in a permanent vegetative state (PVS), having suffered catastrophic brain damage at the Hillsborough Football Stadium disaster, had his artificial feeding and hydration withdrawn as tt was not considered to be in his best interests to keep him alive. The court agreed that it was lawful to withdraw artificial feeding and hydration as he had no further interest in being kept alive, and the doctors were under no duty to continue to give him medical treatment to keep him alive. 42 Such cases are controversial and clinicians should be very cautious when deciding that it would be in the patient's best interests for treatment to be discontinued altogether. Withdrawal of feeding and hydration from patients in PVS must be authorised by the court.
Conclusions Consent should be a vital part of the preoperative procedure. Consent must be obtained by someone with sufficient knowledge of the procedure and risks and the consent must be fully and clearly completed. The three elements of consent: the patient's capacity, sufficient
1. Re T [1992] 4 All ER 649, per Donaldson MR2. Kennedy I. Treat me right: law & medical ethics. Oxford: OUP, 1991. 3. SchIoendorff v Society of New York Hospital, [1914] 211 NY125 per Cardozo J. 4. Eekelaar J. Consent to treatment. In: Dingwall (eds) Medical negligence, compensation and accountability. Sweet & Maxwell, 1988. 5. Brazier M. Medicine, patients & the law (2nd edn). Harmonsworth: Penguin, 1992. 6. Allan v New Mount Sinai Hospital [1980] 109 DLR (3d) 634. 7. Wilson v Pringle, [1986] 2 All ER 440. 8. Bartley v Studd, (unreported) Dally Telegraph 12th July 1995 and 27th September 1997 9. Brazier, supra. 10. McHaIe J, Fox M. Health care law: texts cases and materials. Sweet & Maxwell, 1997. 11. Skegg P. Law, ethics and medicine. Oxford: OUP, 1984. 12. Re MS [1998] 1 FLR 790. 13. $8(1) Family Law Reform Act 1969. 14. Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER402. 15. Children Act, 1989. 16. Skegg, supra_ 17 Re MB (Casearean Section) [1997] 2 FLR 426. 18. Brazier, supra. 19. Skegg, supra. 20. Chatterton v Gerson [1981] QB 432. 21. Brazier, supra. 22. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] 1 All ER 643. 23. Blyth v Bloomsbury Health Authority [1993] 4 Med LR 151, following the decision in Bolam v Friem Hospital Management Committee [1957] 2All ER. 24. Hull C J, Brennan D. The anaesthetists duty of care: a British perspective. In: Healey T E J, Cohen P J (eds) Davidson's a practice of anaesthesia. London: Whylie and Chmchill, 1995. 25. Whitefield T D. Consent to anaesthesia. Healthcare Risk Report, February 1998. 26. Blundell C. Informed consent and the extension of treatment under a general anaesthetic. Healthcare Risk Report, March 1998. 27. Kennedy, Supra. 28. Rogers v Whittaker [1992] 67AJLR 47 (Australian case). 29 O'Malley Williams v Board of Governors of the National Hospital for Nervous Diseases [ 1975] 1 EMJ 635. 30. Reibl v Hughes [1980] 114 DLR (3d) 1 per Lasldncjc. 31. Chatteron v Gerson, supra. 32. Re T, supra. 33. Malette v Shulmann [1990] 2 Meal LR 162. 34. Re T, supra. 35. Dyer C. UK public calls for legislation over living wills. BMJ 1998; 316: 959. 36. Re C (adult: refusal of treatment) [1994] 1 WLR 290. 37. Dally Telegraph, 3 December 1997. 38. R v Boumewood Community and Mental Health Trust ex p L, [1998] 3 WLR 107. 39. F v West Berkshire Health Authority [1990] 2 AC 1. 40. Airedale NHS Trust v Bland [1993] 1 All ER 821. 41. Re B (A minor) (Wardship: Medical Treatment) [1981] 1 WLR 1421. 42. Airedale NHS Trust v Bland, supra.
(1998) 9, 274-277
© 1998 Harcourt Brace & Co. Ltd
F o c u s on: M e d i c o - l e g a l issues in a n a e s t h e s i a - p a r t 2
Consent: how to get it and what to do if you cannot
D. M a s o n and K. Peters
' A n adult patient w h o ... suffers f r o m no m e n t a l i n c a p a c i t y has an absolute right to c h o o s e w h e t h e r to c o n s e n t to m e d i c a l treatment, to refuse it or to c h o o s e one rather than the other o f the treatments b e i n g offered.' 1
Introduction
Valid c o n s e n t
We start this article by attempting to define the concept of consent and the reason why it is necessary. We explore the components which constitute 'valid' consent and the options available if consent is refused.
Valid consent must encompass three elements: 1. the patient must have the capacity to consent to the treatment offered 2. the patient must have sufficient information to be able to make a balanced decision to consent 3. the patient' s consent must be given voluntarily
W h a t is consent? Consent has been described as 'an aspect of respect for autonomy' and is essentially an expression of selfdetermination. 2 Since the time of St Thomas Aquinas, there has been a principle that every adult o sound mind has the right to decide what should - or should not - be done to his own body. ~ A patient will often have total faith in a doctor's knowledge and skill, and may not even consider the possibility of any inherent risk in their treatment. The superior knowledge of the clinicians can lead to a risk of paternalism and result in a patient accepting treatment without fully understanding its consequences. Consent is a question of power and control. 4
Capacity Capacity to give legal effective consent depends upon capacity to understand and come to a decision on what is involved, and the capacity to communicate that decision. 11 Consent will not be valid unless a patient has capacity to make a decision. If a patient is able to comprehend and retain the material treatment information, believes it and able to weigh it in the balance as part of the process of arriving at a decision, then he will have capacity. If he fails any part of this test, then he does not have capacity. 12 Essentially, every adult is presumed to have the capacity to consent unless proven otherwise. Minors aged between 16 and 18 years are presumed to have the same capacity to consent to treatment as if they were adults. 13 Under 16 year olds may be deemed to have the capacity to consent, if they are able to fully appreciate the nature and consequences of the treatment which is proposed for,them. 14 There is no fixed age below which a minor cannot consent to treatment, but clinicians have to be careful and must determine that the minor does have a full understanding of the risks and
W h y is c o n s e n t necessary? Any unpermitted invasion of the body is technically a criminal offence of battery, even if there is no tangible injury. 5
David Mason MA(Oxon),Dip L, FSALS, Partner,Katy Peters LLB Hon, Trainee Solicitor, Capsticks Solicitors, 77-83 Upper Richmond Road, London SW15 2TT, UK. 274
CONSENT 275 potential outcome of the treatment. If there is any doubt about a minor's capacity, consent should also be sought from one person with parental responsibility. ~5 A refusal of treatment by a person under 18 years can be overridden by the consent of a person with parental responsibility or the court, provided that the proposed treatment is necessary in the best interests of the young person_ Since it is the capacity to make a decision which is crucial to the issue of consent, problems may arise where a patient has a learning and/or communication disability. It should never be assumed that such patients do not have the capacity to consent to or refuse treatment, because often they do, but, clearly, particular care needs to be taken when assessing capacity. Patients who are being treated under the Mental Health Act 1983 will not necessarily be incapable of consenting to treatment_ Patients detained under Sections 2 and 3 of the Act may be treated without a need for obtaining consent only for the mental disorder for which they were detained. They do not, by virtue of the detention, necessarily lack the capacity to give consent to or refuse other medical treatment. Capacity may also be invalidated by a patient's confusion, shock, pain or fatigue; the ability to make a decision may also be inadvertently affected by any drugs which the patient has been given_ A patient who has just been informed that he is suffering from cancer, for example, may be too numb and shocked to be able to fully comprehend the information necessary for him to make a decision about his treatment. 16 A patient's fear can also lead to the need for a judgment call on capacity. It could be that the patient's fear of a particular treatment or procedure has paralysed his will and destroyed his capacity to make a decision. Alternatively, it could be that the patient had a rational reason for his fear and this would mean that although he was capable of consenting, he had chosen to refuse treatment. This refusal would be perfectly valid. It will be important to look at the evidence in each individual situation to decide whether any factors which might erode capacity have done so to such a degree that the patient has no capacity to decide. In one case, a pregnant woman, who was quite happy to consent to a Caesarean section for her child's well-being, suffered from a needle phobia. Although she accepted and consented to the incision by the surgeon's scalpel, she would not consent to the prick of the anaesthetist's needle. The court found that the w o m a n ' s fear of the anaesthetist's needle dominated her thinking and made her quite unable to consider anything else. This meant that she was incapable of making any decision at all and was temporarily incompetent and the doctors were, therefore, free to administer the anaesthetic if that was in her best interests, despite her lack of consent. It is important to bear in mind, however, that this case involved a very specific phobia. I7
Information _.. for consent to be real the patient must be told what operation is to be performed and why it is to be done. 18
Even if the patient is better off in the long run as a result of the invasion, he could still recover damages if he proved that there had been actual physical contact to which he had not consented. In Canada, a doctor who had injected a patient in her left arm, when she had asked to be injected in her right arm, was convicted of battery. The woman had only consented to an injection in her right arm and the injection in her left arm was, therefore, unlawful. 6 The courts in England are generally reluctant to find surgeons liable for battery] A doctor might still be sued, however, if he were to infringe a patient's non-clinical right of self-determination. In one case, a woman who had consented to a hysterectomy successfully sued the surgeon for trespass when he also removed her ovaries, an act to which she had not consented. If a doctor carries out any surgery over and above what the patient has agreed to, it must be seen to be immediately necessary to preserve that patient's health. In effect, the doctor would probably need to prove that his actions had averted a potentially life-threatening condition. 9 The most common claim against clinicians who act without a patient's consent is of course one of negligence. If a doctor fails to disclose a material risk to a patient, then he is abusing the patient's right to be involved in its clinical decision, l° Consent on its own will not provide a defence to an allegation of clinical negligence, but it will, if it has been well documented, act as evidence that the patient was aware of the implications of the treatment which had been proposed. For a patient to give valid consent, he must be in possession of an adequate amount of information about the treatment. This need not necessarily mean that he fully understands a particularly technical procedure, but he should fully appreciate the nature and consequences of it.19 When deciding how much information to disclose, it is important for the clinician to consider the individual patient and his needs. In some cases, the sheer technicality and complexity of a procedure can mean that a patient will not fully understand its implications even after they have been explained to him. It has been suggested that it is sufficient for the patient to be informed in broad terms of the nature and the procedure which is intended. 2° Too much information could simply frighten a patient into refusing much needed treatment, but it is important that a patient should be aware of any significant risks inherent in a procedure. 21 The case of Sidaway, 2~ suggested that a doctor had a certain amount of therapeutic privilege in determining how much information to give to a patient. In this case, a woman underwent electro-convulsive therapy without being told about the risks involved. It was held that the doctors had a defence of therapeutic privilege, as disclosing the risks to this patient would have been to her psychological detriment. Balanced against this, however, is the fact that a patient must have sufficient kiaowledge to be able to make an informed decision. This will vary according to the individual. A pianist undergoing hand surgery, for example, would need to know of any
276
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risk which might affect his career. A telephone operator undergoing the same operation, may not need such a detailed explanation of the specific risks to her hands. 'Significant' risks must be discussed with the patient: generally this would mean any risks which are likely to occur in _> 1% of cases. The test will be whether a reasonable body of medical opinion would have informed the patient of the same risks in a given situation. 23 It is important that the person explaining the treatment to the patient is sufficiently skilled to be able to answer any questions which the patient might have. As it is so important for the plaintiff to have sufficient knowledge to be able to give informed consent, it is important that the person who explains the procedure to him is sufficiently skilled to be able to understand it. This means that the anaesthetist should visit the patient sometime before surgery, in order to explain the planned procedures and possible hazards. 24 For this reason, the act of gaining a patient's consent should not be delegated to a junior staff member or to someone who is not an anaesthetist. The possible need for naso-gastric tubes, chest drains or blood transfusions in the postoperative period should be explained before the procedure. The Court of Appeal has held that wherever possible, consent should be obtained by the person who actually carries out the procedure and, if this is not possible, by someone who is appropriately qualified and 'familiar with all the details and the risks of the proposed procedure, and any alternatives'.25 Equally, consent should be obtained as near to the time of the actual treatment as possible) 6 Any discussions and the patient's final consent or refusal, should be recorded in the clinical notes. Any explanation given should be in comprehensible language, so that the patient is not overwhelmed with technicalities and has a good grasp of the risks involved) 7 If the language used is too technical, then the patient may not be able to make an informed decision and his confusion will mean that any consent which he does give will not be valid. A doctor is under an obligation to answer any questions which the patient might have in a truthful manner. 28 However_ the doctor is under no obligation to divulge remote risks which the patient has not enquired a b o u t . 29 General risks, such as those from anaesthesia, are common to most operations. If a patient would be unable to cope with the facts relevant to the more specific aspects of the treatment, the doctor may be justified in generalizing the information which he gives) ° The personality of the patient, the likelihood of misfortune and the best way of expressing any explanation of the risks must be decided according to a particular patient's welfare, but doctors should beware of being too paternalistic. ~
Voluntary The real question in such a case is 'does the patient really mean what he says or is he merely saying it for a quiet life, to satisfy someone else or because the advice or persuasion to which he has been subjected is such that he can no longer think and decide for himself?' In other words 'Is a decision expressed in form only, not in reality?' t2
Any patient with capacity is as entitled to refuse treatment as he is to consent to it. Jehovah's Witnesses, because of their faith, will often refuse to have blood transfusions. As long as they understand and accept the nature and consequences of such a decision, then their refusal will be valid even if it leads to their death. 3~ However, problems may arise where a patient is being pressurized by his family, friends or religious leaders into refusing treatment that he might otherwise agree to. In one case, a pregnant patient's decision to refuse a blood transfusion was invalidated by the fact that it was the result of undue influence from her mother. It transpired that, although the patient's mother was a Jehovah's Witness, the patient was not and it was held that her refusal was due solely to pressure from her mother and was, therefore, invalid. 34 Consent will not be valid if the patient has been forced or coerced into giving it. This is where consent forms can be crucial evidence. They are not in themselves evidence of the fact that a patient has been given sufficient information, but they may be evidence of the voluntary nature of the consent procedure in a particular case. The voluntary nature of any refusal to consent is also a crucial factor.
Advance directives Living wills (or advance directives) allow patients to express their wishes in advance about what treatment they will accept if they become too ill or mentally confused to express their wishes in the futureY There is no specific legislation governing advance directives, although advance refusal of treatment is binding on doctors. A schizophrenic man from Broadmoor, who refused to allow his gangrenous leg to be amputated, was granted an injunction forbidding his doctors from removing the leg in the future. The judge found that he had understood the information given to him about the treatment - including the fact that without it he might die - and had made a clear choiceJ 6 The case of Annie Lindsell, ~7 a woman with motor neurone disease with weeks to live, brought the issue of 'living wills' into the limelight. She wanted to be able to permit her GP to administer intensive diamorphic treatment in her final days, if she should need it for pain relief, even though a secondary effect of the drug would be to hasten her death. It is illegal to administer such treatment if the sole intention is to hasten death, that would be euthanasia. The doctrine of 'double effect', however, allows for the administration of pain-relieving drags where the clinician's intention is to ease suffering, despite the fact that a secondary effect will be to speed up death. An advance directive can be either oral or in writing, but to be legally binding, it must satisfy three criteria: 1. the patient must have had the capacity to refuse or to consent to treatment at the time of making the decision 2_ the patient must have anticipated and intended the
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decision to apply to the situation in which he now finds himself 3. the patient must have made his decision voluntarily, with no undue influence from anyone else.
information from the clinician, and a voluntary decision from the patient, must all be present_ If any of them are missing, the patient's consent will not be valid.
Failure to adhere to a valid advance directive could result in a charge of assault.
References
Best interests If a patient is incapable of consent, for example, if they are unconscious or mentally incapacitated, then they should be treated in their best interests_ 3s This usually means that they must be given any treatment which is necessary to preserve their life, health and well-being. 39 However, the case of Tony Bland established that it is not always in a patient's best interests to keep him alive at all costs_ In some cases it may be in his best interests to allow him to die. 4° In one case, a D o w n ' s Syndrome child was born with an intestinal blockage which required an operation if she were to live for more than a few days. If successful, then her life expectancy would be 20-30 years. She was unable to consent to the operation herself and her parents refused to consent on her behalf. The court decided that it had not been demonstrated that her life was so intolerable that she should be allowed to die and, therefore, found that it would be in her best interests to have the operation, despite the lack of consent. 4I At the opposite end of the spectrum, Tony Bland, who was left in a permanent vegetative state (PVS), having suffered catastrophic brain damage at the Hillsborough Football Stadium disaster, had his artificial feeding and hydration withdrawn as tt was not considered to be in his best interests to keep him alive. The court agreed that it was lawful to withdraw artificial feeding and hydration as he had no further interest in being kept alive, and the doctors were under no duty to continue to give him medical treatment to keep him alive. 42 Such cases are controversial and clinicians should be very cautious when deciding that it would be in the patient's best interests for treatment to be discontinued altogether. Withdrawal of feeding and hydration from patients in PVS must be authorised by the court.
Conclusions Consent should be a vital part of the preoperative procedure. Consent must be obtained by someone with sufficient knowledge of the procedure and risks and the consent must be fully and clearly completed. The three elements of consent: the patient's capacity, sufficient
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