CONSENT - HANDOUT (January 2015)

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1 CONSENT - HANDOUT (January 2015) Year Four Medical Ethics and Law, Thread Course CONTENTS: Aims of the Consent Session Section 1 Cases for Discussion Section 2 Background to Legal Issues Section 3 GMC Guidelines on Provision of Information for Adults with Capacity Section 4 Consent in English Law Section 5 Patients Lacking Capacity to Consent: The Mental Capacity Act 2005 Section 6 Consent and patients less than eighteen ETHOX: UNIVERSITY OF OXFORD 1

2 Aims of the Consent Session 1. To understand English common law, the Mental Capacity Act and GMC guidelines, relating to consent to medical treatment. 2. To be able to apply the law, and ethical reasoning about consent, to a range of practical situations that arise in clinical practice. Pre-session reading Consent in Hope T, Savelescu J, and Hendrick J Medical Ethics and Law : the Core Curriculum. Edinburgh: Churchill-Livingstone, 2007(2 nd edition), Chapter 6. ETHOX: UNIVERSITY OF OXFORD 2

3 Section 1. Cases for Discussion Case 1: A patient requests not to know relevant information A 55 year old post-menopausal woman comes to see you about whether she should take Hormone Replacement Therapy (HRT). You start to talk about the pros and cons of HRT but she stops you and says: I don t want to know about all the things that might happen to me do what you think is best and I ll go along with that. How should you respond? Case 2: A patient requests an option you disagree with A 45 year old woman has a malignant breast lump. A fine needle biopsy suggests the lump is locally invasive and that a total mastectomy will give a better prognosis than a lumpectomy. You fully inform the patient of the situation. The patient chooses lumpectomy but you strongly disagree with her choice. What should you do next? Case 3: A patient with a brain injury requires assistance with nutrition and hydration A 30 year old man has a traumatic brain injury following a car accident. Having spent several weeks in intensive care, he is now in a minimally conscious state a condition in which patients show signs of intermittent awareness of themselves and their surroundings. The man s wife has been distressed at her husband s current condition for some time, and has just recalled a time before the accident where she and her husband watched a TV documentary about head injury together. She remembers that her husband said that this was his idea of hell and that he wouldn t want to live in that state. The man s parents, who visit him every other day, are adamant that their son will recover and that everything be done to keep him alive. There is uncertainty amongst the clinical team about the best clinical course of action moving forward. How should a decision be made? Case 4: A teenage patient refuses life-saving treatment A 16 year old boy has Hodgkin s Lymphoma and requires a blood transfusion following high doses of chemotherapy. Without the transfusion, there is an 80% chance the boy will die of anaemia. The boy is fully informed about the options but chooses not to undergo the procedure. He says that his values do not allow him to receive blood products. Like his parents, he is a committed Jehovah s Witness, and says that his faith is more important to him than his health. On a board in his hospital room, the boy s father has written a scripture reference to abstaining from blood. What should be done? ETHOX: UNIVERSITY OF OXFORD 3

4 Section 2. Background to Legal Issues Introduction For any procedure or treatment in medicine, whether this is measuring blood pressure, giving a tablet or carrying out a large bowel resection, patients must, in general, give their consent. In many situations this consent can be implied from the patient s conduct as when the patient holds out her arm for her blood pressure to be measured. The mere fact that a patient has come to see the doctor, or come to hospital, does not imply consent for the doctor to touch the patient in any way. For consent to be valid it is now established in both civil and criminal law that the patient must: 1. Be informed: be given relevant information relating to the nature and purpose of the procedure and to its risks and benefits; 2. Be competent (have legal capacity): be able to understand what is proposed by way of treatment; and; 3. Be free to decide: be giving consent voluntarily, not subject to coercion or undue influence. It is wise to obtain evidence that consent has been given, in writing, for major procedures and operations. In law, the consent form could be used as evidence that the patient had, in fact, given consent in the event of the doctor being sued. It is not a contract. Patients may withdraw their consent at any time. If, after giving consent (and signing the form), a patient changes his mind and says that he no longer wishes to go ahead with the operation, then the doctor no longer has a valid consent to treatment. Judges have repeatedly said that one cannot infer legal incompetence simply from the fact that the patient s decision about treatment is utterly illogical. The following extracts from judgments illustrate this: "The patient is entitled to reject [the] advice for reasons which are rational, or irrational, or for no reason." 1 "It is established that the principle of self-determination requires that respect must 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 his care must give effect to his wishes, even...though they do not consider it to be in his best interests to do so..." 2 Thus the treatment of an adult is unlawful unless that adult gives consent. Special provisions apply to minors and others judged incapable of giving/withholding valid consent. 1 Per Lord Templeman in Sidaway v Board of Governors of Bethlem Royal Hospital, supra 2 Per Lord Goff in Airedale NHS Trust v Bland [1993] AC 789. ETHOX: UNIVERSITY OF OXFORD 4

5 Doctors accused of undertaking a medical procedure without valid consent often claim: I acted in good faith or The procedure was beneficial. Neither is a defence. The legal consequences of failing to obtain consent There are three possibilities: civil proceedings criminal proceedings disciplinary proceedings Civil proceedings There are two broad ways in which civil proceedings based on lack of consent can be framed: negligence and trespass to the person. Negligence In order for a doctor to be found liable in negligence, the plaintiff would need to prove: 1. that the doctor owed a duty of care to the relevant patient, 2. that the doctor was in breach of the appropriate standard of care, and 3. that the breach in the duty of care caused the patient harm. In order for patients to choose whether to have an operation, or a diagnostic test, they need information. In particular they need information about the benefits, risks and alternative treatments available. A doctor may be found negligent in not giving the patient certain relevant information before the patient gives consent for the procedure. A typical negligence action involving consent will occur when a surgeon, in his preoperative counselling, fails to tell the patient about the risk of a particular complication. The patient, in ignorance, gives his consent to the procedure. The complication occurs. The patient then sues the surgeon, saying that if he had known of the risk he would not have consented to the surgery. The measure of damages in such a case would be that representing compensation for the complication. How much information about risks and benefits should be given? The cornerstone authority is the House of Lords case of Sidaway. There is a lot of academic discussion about what Sidaway actually decides, but broadly it says: (a) (b) That the Bolam test applies to determination of liability. A doctor will escape liability if the pre-operative counselling he has given would be endorsed by a responsible body of medical opinion in the relevant specialty; and There will be cases where it is so blindingly obvious that a warning should have ETHOX: UNIVERSITY OF OXFORD 5

6 been given that, notwithstanding expert support for non-warning, the judges are perfectly capable of making up their own minds. Proposition (b) used to be regarded by some as inconsistent with (a), but it is not at all. All it is saying is that there are some cases which clearly demand a warning, and if any expert disagrees, he is simply not representing a responsible body of medical opinion. This second proposition was further developed in Bolitho v City & Hackney Health Authority, 3 where Lord Browne-Wilkinson emphasised the need for the body of medical opinion to have a logical basis in determining whether it is responsible. Bolitho represents a shift away from the courtroom declarations of medical experts, and towards the empirical evidence base underpinning good medical practice. In practice, the Courts will take close notice of the GMC guidelines in fleshing out the Bolam test. Therefore, it is important to be aware of the GMC s guidelines on the provision of information (see Section 2 below). These guidelines set very high standards for a doctor to provide information to patients. Trespass to the person The tort usually spoken of here is battery. This is touching without consent. The intention here is not to do a wrong, but simply intention to do the relevant act. Good faith is irrelevant. A good illustration is the recent English case of Miss B 4. Miss B was paralysed from the neck down, and so all her breathing was done for her by a ventilator. She wanted to die, and asked her treating clinicians to switch the ventilator off. They refused. She went to court, and the court found that she was competent. Accordingly the unwanted treatment amounted to an assault which should be compensated for in damages. Battery has some advantages for a claimant over negligence. The first is that in battery, unlike in negligence, no damage need be proved. If it is established that the defendant touched the claimant without consent, the claimant is entitled to damages, even if he is uninjured. Damage is assumed in the touching. The second advantage relates to the measure of damages. Damages in negligence are narrowly compensatory, and this does not normally take into account the mental distress which is caused by the defendant s motivation. But if battery is established there is the possibility of aggravated damages - damages representing precisely that additional outrage which comes from feeling that one has been exploited. That said, judges frown on the use of battery in a medical context, as expressed by Bristow J in Chatterton v Gerson: 5...it would be very much against the interests of justice if actions which are really based 3 [1998] AC232 4 B v An NHS Trust [2002] EWHC [1981] QB 432 at 443 ETHOX: UNIVERSITY OF OXFORD 6

7 on a failure by the doctor to perform his duty adequately to inform were pleaded in trespass. It is easier to avoid liability for battery than for negligence. If the doctor informs a patient in broad terms about the nature of the procedure which is intended, and the patient consents, the law of trespass will regard that consent as real. The law of negligence requires more detailed information to be given 6. A good modern example of battery in its natural legal habitat is the dental negligence case: Appleton v Garrett 7. The defendant dentist did lots of unnecessary work on several patients to enrich himself. No valid consent for that work had been given. Battery was therefore established, and the patients were found to be entitled to aggravated damages representing an additional 25 per cent of their purely compensatory damages. Criminal proceedings A doctor who does something without his patient s consent is also at risk of prosecution. Criminal proceedings against doctors for acting without consent are rare, and would not be instigated when the doctor has simply made an error. Such proceedings would require the doctor to have acted with the wrong intention. The two commonest examples which the courts see are: sexual molestation: such as when a doctor performs, for his sexual gratification, a breast or vaginal examination for which there is no clinical justification unnecessary treatment for financial gain: such as when a dentist does fillings which the patient does not need so that he can charge the patient a higher fee. Consent in the criminal law One might think that it is easy to know when, in circumstances like this, a patient has given consent. But the law does not always accord with common sense, and the development of the principle of consent in the criminal law has been different to its development in the civil law in important ways. For over a century the concept of consent in the criminal law was dogged by a case called R v Clarence 8. Clarence had gonorrhoea, and knew it. His wife did not. He slept with her, and she got infected. He was prosecuted under sections 47 and 20 of the Offences Against the Person Act causing actual (s. 47) and grievous (s.20) bodily harm. At the time (the law has since changed) it was thought necessary to establish an assault, and consent is a defence to assault. He said that his wife had consented to the act of sexual 6 In Chatterton v Gerson, supra, Bristow J said: Once a patient is informed in broad terms of the nature of the procedure which is intended, and gives her consent, that consent is real, and the cause of action on which to base a claim for failure to go into risks and implications is negligence, not trespass. See also Davis v Barking, Havering and Brentwood HA [1993] 4 Med LR 85 7 [1997] 8 Med LR 75 8 (1888) 22 QBD 23 ETHOX: UNIVERSITY OF OXFORD 7

8 intercourse, which indeed she had. The prosecution rejoined that there had been no true consent: if she had been told about his infection (a fact clearly material to the decision whether or not to sleep with someone) she would have withheld her consent. Clarence was convicted. He appealed. The appeal court allowed his appeal, saying that valid consent was consent to an act of the nature and quality of that which was done. Mrs. Clarence had consented to an act of the nature and quality of that which was done - namely sexual intercourse. She knew what sexual intercourse was, and had said yes to it. This decision had some strange results in medical law. For example: a dentist suspended from practice performed dental procedures on patients who assumed that he was properly registered. They said that they would not have consented had they known about the suspension. The dentist s conviction for assault occasioning actual body harm was quashed, the Court of Appeal saying that there was nothing tantamount to a mistake of identity, and that the patients knew perfectly the nature and quality of the acts they were subjected to. 9 a doctor inserted an instrument into a woman s vagina. He was motivated only by a desire for sexual gratification. The woman consented because she thought it was diagnostically justified. The Supreme Court of Victoria held that there was no assault: there was no fraud as to the nature and quality of the act. 10 The main objection to Clarence was the obvious one: sexual intercourse with an infected person is not an act of the same nature and quality as sexual intercourse with an uninfected one. That is particularly obviously so when the disease concerned is a dangerous one such as HIV. There is now another objection. Assault is no longer an element of s. 47 or s : why then should consent be a defence? Those, more or less, were the arguments which ushered Clarence into legal history. Mohammed Dica was HIV positive. He had unprotected sexual intercourse with two women who did not know that he was HIV positive, and said that they would not have slept with him if they had known. Both contracted HIV. Dica was convicted by a jury of causing grievous bodily harm. He appealed. The Court of Appeal said that Clarence was no longer good law, at least in the context of sexually transmitted disease. There was no true consent here. 12 The implications of Dica still have to be worked out, but it looks to have imported into English criminal law the idea of informed consent: that consent is only valid if given after provision of all information relevant to a responsible decision. Thus, the principle of consent in both criminal law and civil law now appear to be in close alignment. The criminal law contains an important exception to the general principle that you can consent to whatever you want. Public policy decrees that you cannot consent to serious 9 R v Richardson [1998] 2 Cr App Rep Mobilio [1991] 1 VR R v Wilson [1984] AC 242: see too R v Burstow; R v Ireland [1997] 3 WLR [2004] EWCA Crim 1103 ETHOX: UNIVERSITY OF OXFORD 8

9 bodily injury. Thus if you nail a man s genitals to a piece of plywood at his express invitation, the fact of the invitation will not save you from prison. 13 The limits of this prohibition have not been explored in a medical context. Lots of surgical procedures inevitably cause serious injury: amputating a person s leg, for instance, is certainly serious injury. If a surgeon who believes that there is no therapeutic justification for an amputation is talked into doing the procedure by an artist who asks the doctor to cut off her leg so she can use it in a forthcoming exhibit, it seems at least arguable that the surgeon might be criminally liable. Disciplinary proceedings The GMC takes consent issues very seriously. It has issued a number of guidelines, some of which have been referred to above. Some of the most notorious GMC disciplinary hearings have involved a failure to obtain proper consent. The best example is the Wisheart case: the GMC s inquiry into the Bristol paediatric cardiac surgeons. GMC proceedings are of course framed loosely in terms of failing to follow the GMC s own guidelines. The guidelines are broad. They allow the Fitness to Practise Panel to take action on the basis of ethical concern, but broadly the principles to be applied in deciding whether there has been impairment of fitness to practice are those applied in deciding whether there has been negligence. That should be a prerequisite of a finding of impaired fitness to practice, but mere negligence should not be enough. Unfortunately mere negligence has sometimes been enough: the GMC has sometimes taken its forensic cue more from the columns of outraged newspapers than from the columns of Sidaway. When is a patient s consent not required? (i) Necessity The common law recognises the doctrine of necessity. In an emergency, act to save the life of a patient or prevent him from suffering serious harm, unless it is possible to a) obtain consent, b) ensure that the consent or refusal of consent is valid, and c) adhere to the requirements of the Mental Capacity Act 2005 (see below, Section 4) when the patient lacks the capacity to give consent. If, in an emergency, a doctor has to restrain a person in order to prevent him/her from either doing serious harm to him/herself, or to others, or to prevent a crime, then this will normally be a defence to battery. (ii) The ordinary conduct of daily life It is not an offence to touch someone without their consent when that touching is physical contact which is generally acceptable in the ordinary conduct of daily life (Collins v Wilcock (1984)). A doctor giving a welcoming handshake or a reassuring pat on the arm to a patient would not be committing an offence, regardless of whether the patient had consented to being touched in this way. 13 R v Brown [1993] 2 All ER 75 ETHOX: UNIVERSITY OF OXFORD 9

10 (iii) Mental illness The Mental Health Act (1983) provides for treatment, of the mental illness only, without consent under certain defined circumstances. (iv) Public health If a patient is suffering from a notifiable disease, he can be ordered to be detained by a magistrate under the Public Health (Control of Disease) Act (v) Children and minors See below, Section 5: Consent and patients less than eighteen. ETHOX: UNIVERSITY OF OXFORD 10

11 Section 2. GMC Guidelines on Provision of Information to Adults with Capacity This is not the complete set of GMC guidelines, and guidelines are often updated, so it is important that you check the website: Patients have a right to information about their condition and the treatment options available to them. The amount of information you give each patient will vary, according to factors such as the nature of the condition, the complexity of the treatment, the risks associated with the treatment or procedure, and the patient's own wishes. The information which patients want or ought to know, before deciding whether to consent to treatment or an investigation, may include: details of the diagnosis, and prognosis, and the likely prognosis if the condition is left untreated; uncertainties about the diagnosis including options for further investigation prior to treatment; options for treatment or management of the condition, including the option not to treat; the purpose of a proposed investigation or treatment; details of the procedures or therapies involved, including subsidiary treatment such as methods of pain relief; how the patient should prepare for the procedure; and details of what the patient might experience during or after the procedure including common and serious side effects; for each option, explanations of the likely benefits and the probabilities of success; and discussion of any serious or frequently occurring risks, and of any lifestyle changes which may be caused by, or necessitated by, the treatment; advice about whether a proposed treatment is experimental; how and when the patient's condition and any side effects will be monitored or reassessed; the name of the doctor who will have overall responsibility for the treatment and, where appropriate, names of the senior members of his or her team; whether doctors in training will be involved, and the extent to which students may be involved in an investigation or treatment; a reminder that patients can change their minds about a decision at any time; a reminder that patients have a right to seek a second opinion; where applicable, details of costs or charges which the patient may have to meet. When providing information you must do your best to find out about patients' individual needs and priorities. For example, patients' beliefs, culture, occupation or other factors may have a bearing on the information they need in order to reach a decision. You should not make assumptions about patients' views, but discuss these matters with them, and ask them whether they have any concerns about the treatment or the risks it may involve. You should raise with patients the possibility of additional problems coming to light during a procedure when the patient is unconscious or otherwise unable to make a decision. You should seek consent to treat any problems which you think may arise and ETHOX: UNIVERSITY OF OXFORD 11

12 ascertain whether there are any procedures to which the patient would object, or prefer to give further thought to before you proceed. You must abide by patients' decisions on these issues. If in exceptional circumstances you decide, while the patient is unconscious, to treat a condition which falls outside the scope of the patient's consent, your decision may be challenged in the courts, or be the subject of a complaint to your employing authority or the GMC. You should therefore seek the views of an experienced colleague, wherever possible, before providing the treatment. And you must be prepared to explain and justify your decision. You must tell the patient what you have done and why, as soon as the patient is sufficiently recovered to understand. Responding to questions You must respond honestly to any questions the patient raises and, as far as possible, answer as fully as the patient wishes. In some cases, a patient may ask about other treatments that are unproven or ineffective. Some patients may want to know whether any of the risks or benefits of treatment are affected by the choice of institution or doctor providing the care. You must answer such questions as fully, accurately and objectively as possible. Withholding information You should not withhold information necessary for decision making unless you judge that disclosure of some relevant information would cause the patient serious harm. In this context serious harm does not mean the patient would become upset, or decide to refuse treatment. ETHOX: UNIVERSITY OF OXFORD 12

13 Section 3. Consent in English Law 18 yrs (i.e. adults) There is no proxy consent for adults (including incompetent adults unless the patient has a Lasting Power of Attorney under the Mental Capacity Act) Competent for the decision Incompetent for the decision Patient may refuse any, even life saving treatment. (i.e. patient s consent is needed, otherwise a battery) Patient should be given information about nature of procedure (otherwise battery); and information about common, or rare serious side effects; and benefits; and reasonable alternatives (otherwise negligence) Regulated by the Mental Capacity Act 2005 (see Section 4 below) Find out whether the patient has made an advance decision to refuse treatment (often referred to as an advance directive or living will ), and ascertain whether this advance decision is valid and applicable Find out whether patient has a Lasting Power of Attorney relating to matters of personal welfare Doctors should act in the best interests of patient. This is a professional judgement A patient s past and present wishes, feelings, beliefs and values are relevant in judging best interests (as is any advance statement that the person wrote to set out their wishes when they had capacity) Relatives and friends are to be treated as sources of information to judge best interests, and should be consulted. They cannot give or withhold consent unless designated as a Lasting Power of Attorney Act in the best interests of the patient in the least restrictive way. If the action to be taken in the patient s best interests involves a deprivation of liberty then the Deprivation of Liberty Safeguards must be used. ETHOX: UNIVERSITY OF OXFORD 13

14 Section 4. Patients Lacking Capacity to Consent: The Mental Capacity Act 2005 General points The majority of the Mental Capacity Act 2005 [MCA], which came into force from 2007, applies to those aged 16 years and over. Its application is primarily to those who lack capacity. The Act does require that 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. The Act also states that A person is not to be treated as unable to make a decision merely because he makes an unwise decision. A person of 16 years and over is presumed to have capacity unless it is shown to the contrary. For those who have a mental disorder the Mental Health Act may trump the MCA. Definition of incapacity The Act essentially puts into statute the position developed in common law. Someone is only unable to make a specific decision if he/she has an impairment of, or disturbance in the functioning of, mind or brain (s. 2(1)), which leads him/her to be unable to (i) understand the information relevant to the decision, (ii) retain that information, (iii) use or weigh up that information as part of the decision-making process, or (iv) communicate his/her decision whether by talking, using sign language or any other means (s. 3(1)). The fact that a person is able to retain the information relevant to a decision for a short period only does not prevent him from being regarded as able to make the decision (s. 3(3)). Best interests One of the main principles of the Act is that: an act done, or decision made, under this Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests. (s.1(5)). Certain medical interventions for a person lacking capacity are restricted under the Mental Capacity Act. Decisions concerning i) the withholding or withdrawing artificial nutrition and hydration from a patient in a persistent vegetative state, ii) donation of an organ or bone marrow, and iii) non-therapeutic sterilisation, are all thought to be so serious that only a judge sitting in the Court of Protection can make them. For all other decisions, the Act gives guidance on how those making decisions about treatment should make judgments about the patient s best interests. When it is determined that two or more actions would be in the patient s best interests, the action taken should be the least restrictive alternative. This principle of the MCA is designed to ensure that these adults are not inappropriately restrained when they could be treated or cared for in ways that were less restrictive of their freedoms. How are the best interests of the patient determined? ETHOX: UNIVERSITY OF OXFORD 14

15 Encourage participation in the decision The person making the determination of best interests (e.g. the doctor) must: consider whether it is likely that the person will at some time have capacity in relation to the matter in question, and if it appears likely that he will, when that is likely to be. He must, so far as is reasonably practicable, permit and encourage the person to participate, or to improve his ability to participate, as fully as possible in any act done for him and any decision affecting him. Criteria for best interests He must consider, so far as is reasonably ascertainable a) the persons past and present wishes and feelings, b) the beliefs and values that would be likely to influence his decision if he had capacity, and c) the other factors that he would be likely to consider if he were able to do so. A judgment of best interests must also take into account any advance statement that the person wrote setting out their wishes when they had capacity. Duty to consult He must take into account, if it is practicable and appropriate to consult them, the views of (a) anyone named by the person as someone to be consulted on the matter in question or on matters of that kind, (b) anyone engaged in caring for the person or interested in his welfare, (c) any donee of a lasting power of attorney granted by the person, and (d) any deputy appointed for the person by the court,as to what would be in the person s best interests and, in particular, as to the matters mentioned in subsection (5). Deprivation of Liberty Safeguards (DOLS) What are the DOLS? In April 2009, the Deprivation of Liberty Safeguards (DOLS) were introduced as an amendment to the Mental Capacity Act. The DOLS were introduced to ensure that care and treatment that is provided in the best interests of patients lacking capacity is compatible with human rights law. The DOLS are new legal safeguards that must be followed when patients who lack capacity might be deprived of their liberty when receiving care and treatment. What is a deprivation of liberty? The DOLS draw an important distinction between actions that restrict a patient s liberty and actions that deprive a patient of his liberty. This distinction has important consequences for medical practice although it remains unclear (see below). When a care or treatment plan to be provided in a patient s best interests involves restricting that patient s liberty, the DOLS do not need to be invoked, and the general principles of the ETHOX: UNIVERSITY OF OXFORD 15

16 MCA are applied. When a care or treatment plan to be provided in a patient s best interest involves a deprivation of that patient s liberty, the DOLS must be invoked. Because the DOLS are relatively new, it is not always clear when an action constitutes a deprivation rather than mere restriction of a patient s liberty. Developing case law clarifies that this distinction is one of the degree or intensity of the restraint to be used rather than its nature or substance. Understandably, the starting-point must be the specific situation of the individual concerned and account must be taken of a whole range of factors arising in a particular case such as the type, duration, effects and manner of implementation of the measure in question. 14 In practice, therefore, the same restraint technique might restrict a patient s liberty, or deprive a patient of his liberty, depending on the extent of its use, how it is used, and the degree to which it stops the patient doing something he would otherwise want to do. For a restraint to be merely restricting a patient s liberty, as opposed to depriving a patient of his liberty, there must be procedures in place to allow appropriate freedom. The following two examples illustrate how this distinction might be drawn: 1) The use of a baffle lock on a ward door: This intervention would constitute a restriction of a patient s liberty if procedures are in place for a patient to leave the ward, supervised by staff if necessary. It would constitute a deprivation of a patient s liberty if a patient is unable to open the door, spends all of the day in the ward, and no procedures are in place for the patient to leave the ward. 2) The use of mittens to prevent a patient removing a naso-gastric tube: This intervention would constitute a restriction of liberty if the mittens are used only when the patient cannot be closely supervised, and if they are removed occasionally to ensure that the patient can participate in activities he enjoys. It would constitute a deprivation of liberty if the mittens are used throughout the day, and not removed for the patient to participate in a range of activities. 15 When will the DOLS be applied? The DOLS are primarily relevant to the care provided to residents of care homes. However, the DOLS also cover patients in hospitals, and apply to all patients aged over 18. In hospitals, the DOLS are likely to applied when the care and treatment of patients involves significant restraint, such that doctors, nurses and health care assistants exercise almost total control over a patient s actions. The DOLS will normally be relevant only in the care and treatment of patients with significant learning or developmental disorders: for example if a patient has a genetic syndrome leading him to engage in skin picking or other self-injurious behaviours patients with dementia: for example a patient who wanders, and 14 HL v The United Kingdom (2004) 40 EHRR Adapted from Behrman, S. and Dunn, M. (2010) Physical restraint of medical inpatients: Unravelling the red tape, Clinical Ethics, 5: ETHOX: UNIVERSITY OF OXFORD 16

17 patients who have suffered a traumatic brain injury and who display challenging behaviours. What do the DOLS require? When it is established that a care or treatment plan to be provided in the best interests of a patient lacking capacity will involve depriving that patient of his liberty, doctors (or other healthcare practitioners) must obtain permission before providing the care or treatment. This involves seeking authorisation in advance from a supervisory body (a PCT in hospital settings). The authorisation process involves a series of six assessments that are designed to ascertain a) whether a patient meets the relevant criteria, and b) whether the provision of care or treatment in a way that constitutes a deprivation of liberty is justified Further information about the DOLS, and the specific legal procedures that must be followed, can be found in the Department of Health guidance leaflet, and the DOLS Code of Practice: h_ pdf gitalasset/dh_ pdf Advance decisions to refuse treatment An advance decision is one made by a person aged at least 18 years old who has capacity to make the decision. The decision relates to a refusal of treatment at a later time should the person then lack capacity to decide. The directive should specify the treatment and circumstances even though expressed in layman s terms. Except in the case of life-sustaining treatment (see below) advance decisions can be oral or written and have the same legal status as contemporaneous refusals of treatment. The directive is not valid if: i) the person has withdrawn the directive (and has capacity to do so); ii) the person has given authority to a donee with regard to the treatment to which the advance decision relates after the advance decision was made; iii) the person has done anything clearly inconsistent with the advance decision, iv) the treatment is not the treatment specified, or any circumstances specified in the advance decision are absent, or v) there are reasonable grounds for believing that there are circumstances not anticipated by the person and that would make a difference to the decision. Refusal of life sustaining treatment If the advance decision covers life-sustaining treatment then specific formalities must be followed. Life-sustaining treatment is treatment which in the view of the person providing health care is necessary to sustain life. According to the code of practice this ETHOX: UNIVERSITY OF OXFORD 17

18 would include artificial nutrition and hydration but not basic or essential care (such as warmth, shelter and hygiene measures to maintain body cleanliness and the offer of oral food and water). The formalities required for an advance decision refusing life-sustaining treatment are that: the advance decision must be in writing it must be signed by the maker (or by another person in the maker s presence and by his direction) the signature must be witnessed by a witness who must also sign the document (in the maker s presence) the document must be verified by a specific statement made by the maker expressly stating that the advance decision is to apply to the specified treatment even if life is at risk the specific statement must also be signed by the maker (or by someone else at his direction), in the presence of a witness who must also sign the statement. Protection for doctors A person does not incur liability for the consequences of withholding or withdrawing treatment from P [the person] if, at the time, he reasonably believes that an advance decision exists which is valid and applicable to the treatment. Nothing in an apparent advance decision stops a person: a) providing life-sustaining treatment, or b) doing any act he reasonably believes to be necessary to prevent a serious deterioration in P s condition; while a decision as respects any relevant issue is sought from the court. Lasting powers of attorney A person (the donor ) when competent may confer authority [to the donee(s) ] so that the donee can make decisions (if the donor becomes incompetent) about all or any of: specified matters of personal welfare; and specified matters of property. It is the first of these that is novel in English law and can include decisions about medical management. The donor must be at least 18 years old (as must the donee) and the process of conferring this authority must be properly registered. More than one donee may be appointed and in such a case the donor can specify whether they can act (or make decisions) only together or separately. If the lasting power of attorney authorises the donee to make decisions about the donor s personal welfare then this can extend to the giving or refusing of consent to the carrying out or continuation of treatment by a person providing health care (e.g. by a doctor). It would only authorise the donee in the giving or refusing of consent to life-sustaining treatment if this was specifically stated when the power was given. ETHOX: UNIVERSITY OF OXFORD 18

19 The powers that may be covered under matters of personal welfare include: deciding where the donor is to live (so may be relevant to decisions such as whether a person with dementia should live in a nursing home); prohibiting a named person from having contact with the donor; medical care; giving direction that a doctor should pass medical care to another doctor. ETHOX: UNIVERSITY OF OXFORD 19

20 Section 5. Consent and patients less than eighteen Minors (<18 years old) and consent The law is complex and not always clear. Do not allow a person under 18 years to come to serious harm on the grounds that the minor and the parents refuse consent for necessary and urgent treatment 16 and 17 year olds (governed by the Family Law Reform Act 1969) Are presumed to have capacity to give consent to medical procedures unless the contrary is shown. If they have capacity they can give consent. If the patient refuses consent then those with parental responsibility, or a court, can give consent to treatment which is in the child s best interests. Under 16 years old and Gillick competent (governed by common law) Children under 16 years old are presumed not to have capacity to consent unless they satisfy health professionals that they do have such capacity. In the case of Gillick the House of Lords decided that a minor has the capacity to consent to medical treatment:...when the child achieves a sufficient understanding and intelligence to enable him or her to understand fully what is proposed. 16. Whether the child has that understanding and intelligence is a question of fact in each case. 17 Ability to understand fully what is proposed involves ability to understand the consequences of a failure to treat - in other words to understand the risks-benefits equation which a competent medical practitioner will spell out. 18 If the patient refuses consent the legal situation is as for year olds above. Children who are not Gillick competent At least one person with parental responsibility should normally give consent. Those with parental responsibility are under a legal obligation to act in the child s best interests. If all those with parental responsibility refuse consent for a procedure that the doctors 16 Per Lord Scarman at p See too R (on the application of Sue Axon) v Secretary of State for Health EWCA (Admin). 18 : Per Lord Donaldson MR in Re R (a Minor) (Wardship: Medical Treatment) [1991] 4 All ER 177, 187: see too Mental Capacity Act 2005 s. 3(4). ETHOX: UNIVERSITY OF OXFORD 20

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