DLM - Module 10 PDF

Patients have a fundamental legal and ethical right to decide what happens to their bodies. Healthcare practitioners must ensure that patients have given informed and valid consent prior to any treatment, examination, investigation or intervention. This module provides an overview for the understand...

Patients have a fundamental legal and ethical right to decide what happens to their bodies. Healthcare practitioners must ensure that patients have given informed and valid consent prior to any treatment, examination, investigation or intervention. This module provides an overview for the understanding of the issues surrounding consent as it applies to adults, with reference to relevant case law and legislation. After successful completion of this module, you should be able to: Have a detailed knowledge and understanding of the law of consent as it applies to adults Understand the different types of consent and the requirements for consent to be deemed valid Describe how the issue of consent is addressed in mentally incapacitated adults From the syllabus [https://fflm.ac.uk/exam-regulations-guidance]: 8. CONSENT ii Candidates should have a detailed knowledge and understanding of the law and ethics relating to consent for medical treatment including: 8.1. Regulatory bodies’ and NHS guidance; 8.2. Requirements for consent to be valid; 8.3. Forms of consent; and 8.4. Consent and mentally incapacitated adults (including consent given by others e.g. welfare attorneys). ii Note that consent in children is included in “Children and Young People” 1. Introduction 2. Brief Historical Context of Consent 2.1 Early History 2.2 Nuremberg Code 1947 2.3 Declaration of Geneva 1948 2.4 Declaration of Helsinki 1964 2.5 Beauchamp and Childress 1985 3. Valid Consent 3.1 Capacity to Consent 3.2 Best Interests Decision-Making 3.3 Emergency Treatment 4. Types of Consent 5. Supporting People Who Lack Capacity 5.1 Attorneys Appointed Under Lasting Power of Attorney (England and Wales) 5.2 Continuing and Welfare Attorneys and Guardians (Scotland) 5.3 Enduring Power of Attorney (Northern Ireland) 5.4 Court Appointed Deputies 5.5 Independent Mental Capacity Advocate (IMCA) 6. Mental Health Act 1983 Relevant to Consent 7. NHS and Regulatory Body Guidance on Consent 8. Advanced Care Planning 9. Deprivation of Liberty Safeguards & Liberty Protection Safeguards 10. Case Law and Consent 10.1 Informed Consent and Negligence 10.2 Validity and Capacity to Consent to or Refuse Treatment (Adults) 10.3 Proxy Decision Makers and Consent 10.4 Emergency Treatment under the Mental Health Act 10.5 Advance Care Planning and Consent 10.6 What Constitutes Deprivation of Liberty 11. Self-Assessment SBA Questions Updated 28 July 2023 Adults have the right of autonomy over their own bodies, and the right to accept or decline any medical examination, intervention and treatment. All adults in the United Kingdom are presumed to have capacity to consent. This issue is central to all branches of medicine, but perhaps has a special significance in forensic medicine. Consider: Can a person in custody give free consent to medical examination/forensic examination? Does a complainant of sexual assault, who may be tired, injured or recently undergone trauma, have the capacity to consent to a forensic examination? What part of the examination? about the therapeutic The following quote from Molière’s “The Imaginary Invalid”, is a satire, but does convey the way consent was viewed by many medical practitioners in the past. In the play, depicting Argan, a fearful but miserly hypochondriac, the physician Dr Purgon addresses him as follows when Argan declines the doctor’s prescribed medication: “You have destroyed, at one stroke, a sacred obligation - the unquestioning obedience of a patient to his physician. That is rebellion. The revolt of Ignorance against Authority. And in Medicine, as in Society, such behaviour must bring chaos and disaster. It cannot be tolerated. It must be nipped in the bud. Here and now. At once. And without mercy.” 2.1 Early History In ancient Greece, patient participation in decision making for medical treatment was considered undesirable: essentially the physician's role was to inspire the confidence of the patient in the treatment and it was perceived that any disclosure of possible difficulties might erode patient trust. Beginning with the classic text of ancient medicine, the Hippocratic Corpus, as expressed in the Hippocratic Oath, the aim was to benefit the sick and keep them from harm and injustice. The pledge from the Hippocratic oath, written nearly 2500 years ago, forms part of the most famous text in Western medicine: Managing information in interactions with patients was really just a matter of prudence and discretion. By 1750, the Hippocratic Oath had been translated into several languages and was recited by graduating doctors. In medieval times, doctors were encouraged to offer comfort and hope coupled with emphasizing the need for obedience from patients. During the 1800's most physicians of the time still argued against informing patients of their condition. 2.2 Nuremberg Code 1947 This was developed following the atrocities of Nazi Germany, when doctors participated in torture. The Nuremberg military tribunals unequivocally condemned the sinister political motivation of Nazi experiments in their review of "crimes against humanity". Although not then legally binding, the Nuremberg Code outlined fundamental principles to govern research on humans. There are ten principles constituted in the Nuremberg Code, and Principle 1 of the code states that the primary consideration in research is the subject's voluntary consent, which is "absolutely essential". Indeed, at its heart was a requirement for consent that was voluntary, competent, informed and comprehended. Further information is available at https://history.nih.gov/research/downloads/nuremberg .pdf 2.3 Declaration of Geneva 1948 Following World War II, the World Medical Association (WMA) took responsibility for setting ethical guidelines for doctors to follow and further revised the Hippocratic Oath. The WMA oath contains the declaration: 2.4 Declaration of Helsinki 1964 This also came out of the wartime atrocities. It was made by physicians of the World Medical Association in 1964, and it relaxed the Nuremberg principles and simply required consent “if at all possible, consistent with patient psychology". The fundamental principle is respect for the individual (Article 8), their right to self-determination and the right to make informed decisions (Articles 20, 21 and 22 respectively). It applies to medical research and accepts the need for research, but states that the subject’s welfare must always take precedence over the interests of science and society. Further information available at: https://www.wma.net/policies-post/wma-declaration-of-helsinkiethical-principles-for-medical-research-involving-human-subjects/ 2.5 Beauchamp and Childress 1985 Beauchamp and Childress’s seminal book “Principles of Biomedical Ethics”now in its 8th edition – codified the four principles of ethics: Autonomy Beneficence Justice Non- maleficence These are NOT hierarchical, though in recent times there has sometimes been a false understanding that autonomy overrules the other three. Let us consider each in turn: Autonomy is another word for self-rule. Adults are free to make choices, but those choices must be: Informed – the person must have the information needed to make a valid choice. For illustration – imagine someone being asked to choose between two closed boxes without knowing the contents. Freely made – the person making the choice must be free to make the choice and not under any form of coercion. Consider someone in custody charged with rape – are they really free to choose NOT to have intimate samples taken, when their refusal may lead to an adverse impression by the court? With capacity – the person making the choice must have the capacity to do so. For example – is someone who is heavily intoxicated capable of making significant decisions? Beneficence is defined as “doing good”. Consider - Who decides “what is good”…? E.g. Compulsory vaccinations? Consider compulsory COVID vaccines for health workers? Fluoridation of water supplies? Sterilisation of people with severe learning difficulties? Justice does not mean that everyone is treated equally, but rather that “unequal people are treated unequally”. Imagine - People of unequal height wanting to see over a wall – the smaller would need something to stand on (unequal treatment) in order to achieve the aim of both being able to see. Non-maleficence or “doing no harm” may seem on the face of it to be merely the other side of the coin of beneficence, but it does have significant differences. It may be that in doing good, we also do harm (e.g. side effects of drugs, complications of an operation), but the harms need to be measured against the good. Consider Re A (conjoined twins) [2001] 2 WLR 480: “Mary” and “Jodie” were conjoined twins born in Manchester in 2010. The nature of their conjoined anatomy meant that both twins would die without separation. Separation would give Jodie a chance of a healthy life, but would inevitably cause the death of Mary. This dilemma (the parents were against the surgery as they knew this would cause the death of one of their daughters), led to a court case. The first ruling was by Mr Justice Johnson, who reasoned by analogy with the Airedale NHS Trust v Bland case that separation would not be murder, but “passive euthanasia”. This was rejected by the Court of Appeal. Lord Justice Ward invoked the concept of self-defence, while Lord Justice Brooke invoked R v Dudley and Stephens (a case of cannibalism in order to survive) which discusses “necessity as a defence to murder”. The Court of Appeal decided that the surgery should go ahead. This surgery caused good to “Jodie” but did, as expected, cause the death of “Mary.” For a fuller discussion on medical ethics, see Module 12 Ethics As previously stated, healthcare practitioners must ensure that patients have given informed and valid consent prior to any treatment, examination, investigation or intervention. For consent to be valid, it must be: 1. Given by a person with the capacity to make the decision in question 2. Given voluntarily by that person 3. Based on appropriate and adequate information (i.e. “informed”) and be understood. How much information is "enough" and how much is "too much"? If any of these factors are missing, then the patient is not considered to have given permission to proceed with the examination, investigation, treatment or intervention proposed. There are several examples of clinical research and practice that had a profound effect on public consciousness with respect to the ethics of research and medicine and shone a bright light on the need for valid consent. A classic example is the notorious Tuskegee study which resulted in a prolonged and knowing violation of subjects' rights. Summary of the Tuskegee syphilis experiment: This infamous clinical study was conducted between 1932 and 1972, by the US Public health system. The stated purpose of the study was to compare the health and longevity of an untreated syphilitic population with a non-syphilitic but otherwise similar population. These subjects, all African-American males, knew neither the name nor the nature of their disease. That they were participants in a nontherapeutic experiment also went undisclosed. They were informed only that they were receiving free treatment for "bad blood," a term local African-Americans associated with a host of unrelated ailments. The men were given free health care, meals, and free burial insurance, for participating in the scheme. After funding for the study was lost, the study continued, and the men were not informed that they had the disease and would never be treated. None of them were treated with penicillin, even after this had been shown to be successful. Although the study was reviewed several times between 1932 and 1970 and reported in prestigious medical and public-health journals, it continued uninterrupted and without serious challenge. It was not until 1972 that an advisory panel reviewed the study and found that there was no uniform or adequate policy for reviewing experimental procedures or securing subjects' consent. In 1993, President Clinton formally apologised to victims of the experiment. See section 10 below for relevant case law regarding informed consent: Hunter v Hanley 1955 S.C. 200 Bolam v Friern Hospital Management Committee 1957 Sidaway vs Bethlem Royal Hospital Governors 1985 Chester v Afshar 2004 Montgomery v Lanarkshire Health Board 2015 Duce v Worcestershire Acute Hospitals NHS Trust 2018 It is the treating clinician’s responsibility to assess the capacity of their patients to make decisions about their care. In this assessment, clinicians must comply with: A. the Mental Capacity Act 2005 (England or Wales), B. the Adults with Incapacity Act 2000 (Scotland), or C. the Mental Capacity (Northern Ireland) Act 2016 (when it comes fully into force) including the Codes of Practice that accompany them and the relevant regulatory guidance. All people over the age of 16 are presumed in law to have the capacity to consent to treatment unless there is evidence to the contrary: Family Law Reform Act 1969 (England and Wales), Age of Legal Capacity (Scotland) Act 1991 Age of Majority Act (Northern Ireland) 1969. A patient suffering with a mental disorder or impairment does not, necessarily, lack the competence to consent. Capacity is TIME specific – a patient may not have capacity right now but may regain capacity at a later stage. E.g., when the effects of intoxicants have worn off or following a period of sleep. DECISION specific – a patient may have the capacity to decide what to wear, but not have the capacity to decide to have, or not have, a specific procedure carried out. Patients may be competent to make some health care decisions, even if they are not competent to make others. Seemingly unwise or unexpected decisions do not prove the patient is incompetent - such decisions may indicate a need for further information or explanation. The patient's ability to make decisions should be optimised before concluding they are incapable of making a decision at a particular time, e.g., ensure they have adequate time to assimilate the information, repeat information as necessary, and use any appropriate communication aids available such as interpreters, sign language experts. There should be a presumption of capacity. See section 10 below for relevant case law regarding validity and capacity to consent: Re T (Adult, refusal of medical treatment) 1992 Re C (Adult, refusal of treatment) 1994 Re MB (Adult, medical treatment) 1997 St George's Healthcare NHS Trust v S; R v Collins and others, ex parte S 1998 A. Mental Capacity Act 2005: The Mental Capacity Act (MCA) 2005 covers England and Wales and applies to everyone involved in the care, treatment and support of people aged 16 years and over living in England and Wales who are unable to make all or some decisions for themselves. It is largely mirrored by the Adults with Incapacity (Scotland) Act 2000 and the Mental Capacity Act (Northern Ireland) 2016. The primary principle of the MCA is that every adult must be assumed to have capacity to do so unless it is proved otherwise and has the right to make his or her own decisions. The MCA provides the conditions under which people can be deemed to lack the capacity to make decisions regarding their care and provides the guidance under which treatment can be provided when people lack capacity and are thus unable to provide valid consent. It states that people must be provided with all reasonable help and support to enable them to make decisions for themselves or, where this is not possible, to maximise their participation in any decision-making process. It aims to balance the patient’s autonomy with the right to protection from harm for those patients who lack the capacity to make decisions for themselves. Any decision made on behalf of someone who lacks capacity must be made in their best interests and should, as far as possible, minimise any infringement of their basic rights and freedoms. To demonstrate capacity, a person must be able to: The MCA Two-Stage Functional Test of Capacity: The process of deciding whether an individual has the capacity to make a particular decision passes through two stages: Stage 1: Is there an impairment of or disturbance in the functioning of a person’s mind or brain? IF SO: Stage 2: Is the impairment or disturbance sufficient that the person lacks the capacity to make a particular decision at the time it needs to be made? Section 2(1) of the MCA 2005 states: ‘For the purposes of this Act, a person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain'. The impairment or disturbance of the functioning of the mind described in Section 2(1) refers to any disturbance that affects the person’s ability to make the specific decision in question at the specific time it needs to be made. This impairment does not need to be permanent and may only be partial. If an incompetent patient has clearly indicated in the past in an Advance Direction/Advance Directive (see section 8 below) when they were competent that they would refuse treatment in certain circumstances (i.e. an 'advance refusal' – see below) and those circumstances arise, you must abide by that refusal. Where the patient has never been competent, relatives, carers and friends may be best placed to advise on the patient's needs and preferences. Examples of impairment of brain or mind: Key points to remember - does the person: Understand what the decision is? Understand why the decision is needed? Understand the risks, the benefits, and the alternatives? Understand and retain enough information to make a choice? Understand how that information relates to them at this moment? Know they have a right to consent or refuse? Know how to refuse? Have the ability to communicate their decision? (This may require an interpreter, a signer, or materials specifically produced for those with learning disabilities) It is the responsibility of the clinician proposing the treatment to assess capacity, and this should not be delegated. If the person is judged not to have the capacity, a decision can be made on best interests (see below). B. Adults with Incapacity Act 2000 (Scotland) This act covers decisions for treatment of people over the age of 16 years who do not have the capacity to make some or all of the decisions about their treatment owing to mental disorder or communication difficulties. According to this Act, any intervention must be: necessary and benefit the person the minimum required to achieve the purpose Those making decisions must: take into account 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. C. Mental Capacity (Northern Ireland) Act 2016 The new legislation came into operation on 02 December 2019 but is still not fully in force. Legislates decisions made in relation to the care, treatment (for a physical or mental illness) or personal welfare of a person aged 16 or over, who lacks capacity to make the decision for themselves. There is a presumption of capacity in all persons over the age of 16. It emphasises that provision for proxy decision making for, or on behalf of, a person lacking mental capacity must be done or made in their best interests and with special regard to their past and present wishes and feelings. The presumption of capacity combined with the duty to provide support to individuals who may have capacity issues will be further elaborated by way of the Code of Conduct which is currently under development. The Act makes clear that a determination of capacity is not to be made merely on the basis of any condition that the person has, or any other characteristic of the person, which might lead others to make unjustified assumptions about his or her ability to make a decision: all the relevant circumstances must be considered, and the person assessing the individual must have “special regard” to: the individual’s past and present wishes and feelings (and, in particular, any relevant written statement made when the individual had capacity); the beliefs and values that would be likely to influence the individual’s decision if the individual had capacity; and the other factors that the individual would be likely to consider if able to do so. Best interests are not substituted judgement – i.e. NOT “What would I want in these circumstances?” but “What would this person want if they were able to decide for themselves?” In order to make a best interests decision, the clinician should take account of: the person’s known wishes and feelings (including religious, cultural and other non-medical views) and any advance decisions; views of family or those who know the person well (NB: they are not “giving consent” for the person); views of the parents, if the patient is a child; views of other clinicians looking after the patient; views of other people relevant to the patient, e.g. a donee of a lasting power of attorney granted by the patient, a deputy appointed for the patient by the court (England and Wales), a welfare attorney or court-appointed welfare guardian (Scotland). Consideration should be given to whether, and when, the person will regain capacity, and also the likelihood and extent of any degree of improvement in the patient's condition if treatment is provided. The pros and cons of making the decision (or doing the act) should be carefully documented, along with details of other people who have been consulted. Clinical judgement about the effectiveness of the proposed treatment, particularly in relation to other options, must be considered. Where there is more than one option, the option that is least restrictive of the patient's future choices should be adopted. A best interests decision can mean a decision to give, withhold or stop treatment. See section 5 below for details about the different bodies/roles available to support decision making when someone lacks capacity Sometimes, consent needs to be sought for emergency treatment. If consent cannot be obtained, healthcare practitioners should provide medical treatment that is in the patient's best interests and is immediately necessary to save life or avoid significant deterioration in the patient's health. This is in line with the common law doctrine of necessity. There may be clear evidence of a valid advance refusal of a particular treatment, indicating that treatment should not be given and that should be respected. If a patient has appointed a welfare attorney, or there is a courtappointed deputy or guardian (see below), this person, where practicable, must be consulted about treatment decisions. If the patient is a child under the age of 16 years and cannot consent (whether due to lack of capacity or illness), then someone with parental responsibility can provide consent for treatment. If no such person is available, then clinicians can treat the child in an emergency, provided the treatment is immediately necessary and in the patient’s best interests. Emergency ‘best interest’ decisions must not be determined merely on the basis of the person’s age or appearance, their condition, or an aspect of their behaviour which might lead others to make unjustified assumptions about what might be in his best interests. If the patient regains capacity during care, they should be told what has been done, and why, as soon as they are sufficiently recovered to understand. The hierarchy of decision-makers for emergency treatment when a person lacks capacity is: 1. Welfare Lasting Power of Attorney (LPA) or courtappointed deputy if no valid and applicable advanced decision and decision is not urgent 2. Healthcare staff in charge of care, using the best interests’ principles, if LPA is not available and/or situation is urgent. When taking consent, one must consider whether the patient has been given the information they want or need to make a decision, and how well they understand the details and implications of the treatment/investigation that is being proposed. This is more important than how their consent is expressed or recorded. It is always best for the person actually treating the patient to seek the patient's consent. However, consent may be sought on behalf of colleagues if that person is themselves capable of performing the procedure in question, or if they have been specially trained to seek consent for that procedure. Where the patient is an adult with mental capacity, the right to decide about medical treatment extends to refusing to undergo treatment, even if the treatment is needed to prevent harm or sustain life. GMC - Seven Principles of Consent (November 2020) 1. All patients have the right to be involved in decisions about their treatment and care, and be supported to make decisions if they are able. 2. Decision making is an ongoing process focused on meaningful dialogue: the exchange of relevant information specific to the individual patient. 3. All patients have the right to be listened to, and to be given the information they need to make a decision and the time and support they need to understand it. 4. Doctors must try to find out what matters to patients, so they can share relevant information about the benefits and harms of proposed options and reasonable alternatives, including the option of taking no action. 5. Doctors must start from the presumption that all adult patients have capacity to make decisions about their treatment and care. A patient can only be judged to lack capacity to make a specific decision at a specific time, and only after assessment in line with legal requirements. 6. The choice of treatment or care for patients who lack capacity must be of overall benefit to them, and decisions should be made in consultation with those who are close to them or advocating for them. 7. Patients whose right to consent is affected by law should be supported to be involved in the decision-making process, and to exercise choice if possible A forensic practitioner (doctor or nurse or paramedic) has a dual role in any interaction with a detainee/patient: a therapeutic role (caring for the patient’s injuries, safeguarding needs, assessing mental health, sexual health needs and emergency contraception) a forensic role (documenting the presence or absence of any injuries, collecting forensic samples. Consent for both these parts needs to be explicitly sought. Consider: How can detainees give informed consent? What about a complainant of sexual assault? The Mental Capacity Act MCA 2005 (England and Wales), the Adults with Incapacity (Scotland) Act 2000, and the Mental Health (Northern Ireland Order) 1986 provide a framework for making treatment decisions for patients who lack capacity. In Northern Ireland, most of the same principles from the MCA 2005 (England and Wales) currently apply but will be taken over by the Mental Capacity (Northern Ireland) Act 2016 when it comes fully into force. Medical professionals are responsible for determining what is in the patient’s best interests, but they need to consult and take into account the views of relevant associated persons and bodies that may have been assigned to support the patient in their decision-making process. People are also able to plan ahead for a time when they lack capacity by appointing attorneys and making advance directives (see section below). See section 10 below for relevant case law regarding proxy decision makers and consent: Airedale NHS Trust v Bland 1993 An NHS Trust and others (Respondents) v Y (by his litigation friend, the Official Solicitor) and another Appellant 2018 A lasting power of attorney (LPA) is a legal document that lets the person (“the donor”) appoint one or more people (known as “attorneys” or “donees”) to help them make decisions or to make decisions on their behalf should they lack mental capacity and be unable to make their own decisions. To make a LPA one has to be 18 years of age or over and have mental capacity at the time of making the LPA. The LPA must meet the requirements specified in the Mental Capacity Act 2005 (England and Wales) and the Mental Capacity (Northern Ireland) Act 2016 (when it comes fully into force), and be registered with the Office of the Public Guardian before it can be used. There are two types of LPA, and a person can make one or both types: 1. Health and welfare LPA 2. Property and financial affairs LPA 1. Health and Welfare LPA Can only be used when an individual is unable to make his/her own decisions. Appoints an attorney (i.e. someone) to make decisions about an individual’s welfare. Gives the attorney the power to make decisions about things such as the donor’s daily routine (e.g. washing, dressing, eating), where the person should live and who with, and moving into a care home. Includes healthcare decisions, and consenting on their behalf to treatment. The LPA may specify limits to the attorney’s authority and must specify whether or not the attorney has the authority to make decisions about lifesustaining treatment. Does not give the attorney the power to demand specific treatments, if the donor does not believe the treatment is necessary or appropriate. Attorneys have no authority to make decisions that result in the deprivation of an individual’s liberty. 2. Property and Financial Affairs LPA Gives the attorney the power to make decisions for the individual (i.e. donor) regarding money and property e.g. managing a bank or building society account, paying bills, collecting benefits or a pension, selling a house. They are separate from health and welfare attorneys and can be a different individual. Continuing and welfare powers of attorney were introduced by the Adults with Incapacity (Scotland) Act 2000. There are two types: 1. Continuing power of attorney – relating to property and/or finances; and 2. Welfare power of attorney – relating to personal welfare, including medical care. There is no statutory form for a continuing or a welfare power of attorney Scotland but the document must incorporate a certificate signed by a ‘prescribed person’ (a solicitor, a practicing member of the Faculty of Advocates or a medical practitioner) who must interview the person (“the granter”). This is to make sure the person fully understands the nature of the powers being given and the extent of them and are not acting under undue influence. Continuing and welfare powers of attorney also have to be registered before they can be used, with the Office of the Public Guardian (Scotland). 1. Continuing Power of Attorney Like a property and financial affairs LPA, a continuing power of attorney can be used straight away after registration, whilst the individual (in Scotland called “the granter”) still has capacity as well as after they become incapable. The individual (granter) can also restrict the attorney to act only when they become incapable. 2. Welfare Power of Attorney Can only be used when the individual/granter loses mental capacity. Allows for the appointment of a welfare guardian, with authority to act and make specific decisions over the long term on behalf of an adult who is unable to do so for him/herself. Section 5 of the Adults with Incapacity (Scotland) Act allows a medical practitioner (normally the doctor with overall clinical responsibility) to certify that a patient lacks capacity in relation to making decisions about medical treatment. The medical practitioner then has the authority to do what is reasonable in the circumstances, in relation to the medical treatment, to safeguard or promote the physical or mental health of the patient. A doctor’s authority to treat an adult under section 5 of the Act does not apply if a welfare guardian has been appointed, and has relevant powers relating to consent to medical treatment, and the doctor is aware of this. The Enduring Power of Attorney Order (Northern Ireland) 1987 protects and safeguards people who have or may go on to lose capacity (cf. the Mental Capacity Act 2005 in England and Wales). The Enduring Power of Attorney deals with the control of finance and property. Until the Mental Capacity (Northern Ireland) Act 2016 is fully in place, there is no Health and Welfare Power of Attorney in Northern Ireland. The current Enduring Power of Attorney role only covers decisions about finances and property. A general power of attorney (PoA) is a legal document giving someone (an attorney) the authority to take actions or make decisions on behalf of an individual. In N. Ireland, the EPA application is not registered until or just after the donor becomes mentally incapable (cf. England and Wales: the individual (donor) and the attorney register an LPA as soon as it is signed before the person has lost mental capacity). The Office of Care and Protection (OCP) manages powers of attorney (cf. Office of the Public Guardian England and Wales). Attorneys must give notice of an intention to register an EPA, to at least three relatives of the donor in strict order – beginning with the donor’s spouse, their children, their parents, and their blood siblings, followed by half-siblings and then aunts and uncles. If there is no EPA set up and the individual has already lost their mental capacity, then a Controllership is set up through the OCP. Controllers can be a friend or solicitor (as per Court Appointed Deputies in England and Wales). Deputies are appointed by the Court of Protection to make decisions about finances, property, health or welfare for someone above the age of 16 years who lacks capacity. Deputies are usually close relatives or friends of the person who needs help making decisions: they need to pay a fee to apply to be a deputy. If there is no one suitable or willing to act as a deputy, the Court can appoint a deputy from an approved panel of professionals. There are two types of deputy: i. Property and financial affairs deputy – e.g. pay the person’s bills or organise their pension. ii. Personal welfare deputy - make decisions about medical treatment and how someone is looked after. This role was introduced by the Mental Capacity Act (MCA) 2005 (England and Wales) and is legislated for in N. Ireland by the Mental Capacity (Northern Ireland) Act 2016 Part 4 (but not yet fully in force). They are a legal safeguard for people who lack capacity, where there is no one independent of a service (such as a family member or friend) that is able to represent the person. There is a requirement to appoint an IMCA where only paid carers are available and serious medical treatment decisions need to be made. They are there to ensure the MCA is being followed. Independent Mental Capacity Advocates (IMCAs) are instructed by local authorities or NHS organisations to help particularly vulnerable people who lack the capacity to make important decisions and who have no family or friends to consult. The functions of an IMCA are grouped into four areas: 1. Gathering information - meeting the patient, getting the views of professionals and carers, getting the views of anyone who can give information about the wishes and feelings of the patient; 2. Evaluating information - making sure the different options have been considered, checking the person has been supported to be involved in the decision; 3. Making representations – raising any issues and concerns with the decision-maker; 4. Challenging decisions - they may formally challenge the decision-making process if necessary. The Consent to Treatment Provisions are dealt with in Part 4 of the Mental Health Act (MHA)1983, which applies to: Treatments for mental disorder. All formal patients except those who are detained under sections 4, 5, 35, 135 and 136, and to individuals subject to Guardianship or Supervised Discharge, who have the right to refuse treatment, except in emergencies. [Section 37 (Hospital Orders made by the Courts) allows a Court to send a person to hospital for treatment, or to make the person subject to Guardianship, when the outcome might otherwise have been a prison sentence. The Order is instead of imprisonment, a fine or probation.] Patients detained under sections 5.2 and 5.4 can be treated for their mental disorder without consent if they lack capacity or in an emergency situation. If a patient with known or suspected mental disorder refuses a timecritical emergency intervention for a physical health need, a careful assessment of their capacity should be made. The more serious the consequences for non-treatment, the greater the capacity required to refuse the intervention. If there are doubts about the capacity of a patient, then it is good practice for another appropriately qualified clinician to assess the capacity of the patient. Patients who have severe eating disorders may well refuse treatment which would be aimed at increasing their body mass index (BMI): detention under the Mental Health Act enables a clinical team to treat them – using force/restraint if it is deemed necessary. Helpful guidance is available at https://www.rcpsych.ac.uk/docs/defaultsource/improving-care/better-mh-policy/college-reports/college-reportcr233---annexe-1. Where a person has been deemed to have given their consent to treatment under Section 57 or Section 58 (concerned with Treatment requiring consent and/or a second opinion), the person can withdraw that consent at any time. The treatment must then stop and the appropriate procedures be followed, unless discontinuing treatment would cause 'serious suffering' to the patient, in which case the treatment can be continued. Under Section 62 (Urgent treatment) the requirements of Section 57 and Section 58 do not have to be followed when urgent treatment is required to save the patient's life, prevent a serious deterioration in the patient's condition, and to alleviate serious suffering (so long as the treatment is neither irreversible nor hazardous). Physical health problems can be treated under section 63 of the MHA provided they are part of/ancillary to treatment for the mental disorder, i.e. treating wounds self-inflicted as a result of a mental disorder, or treating a potentially lethal drug overdose. The MHA cannot be used to justify treatment of patients for physical conditions unrelated to the mental disorder. Such treatment, if felt to be necessary and the patient is judged to lack capacity, may be provided if felt to be in the patient’s best interests, under the Mental Capacity Act. See section 10 below for relevant case law regarding emergency treatment for a patient detained under the MHA 1983: Cheshire & Wirral Partnership NHS Foundation Trust v Z 2016 The NHS guidance “Consent to Treat” states that consent to treatment means a person must give permission before they receive any type of medical treatment, test or examination, and that this must be done in the basis of an explanation by a clinician. For more information, For more information, see NHS “Consent to Treat” – www.nhs.uk Please be familiar with the specific regulatory guidance which is available from: Royal College of Nursing available at: https://qa.rcn.org.uk/-/media/royal-college-ofnursing/documents/publications/2017/june/pub-006047.pdf?la=en General Medical Council available at:https://www.gmcuk.org/ethical-guidance/ethical-guidance-for-doctors/decisionmaking-and-consent https://www.gmc-uk.org/ethical-guidance/ethical-guidance-fordoctors/decision-making-and-consent/the-seven-principles-ofdecision-making-and-consent Additional current guidance is also available at: GMC “Good Medical Practice” - www.gmc-uk.org NMC “The Code” – www.nmc.org.uk Also see the NICE guidelines: “Decision Making and Mental Capacity 2018” https://www.nice.org.uk/guidance/ng108/resources/decisionmaking -and-mental-capacity-pdf-66141544670917 Advance care planning choices are called an “Advance Decision” (previously known as a “Living Will”), and may also be called “Advance Directive". Advance care plans allow people who understand the implications of their choices to state in advance how they wish to be treated in the future, for a time when they may no longer have the capacity to make such decisions for themselves. Advance Decisions are covered by the Mental Capacity Act (MCA) 2005 in England and Wales. Northern Ireland currently largely follows the MCA, and under current common law in Northern Ireland, advance decisions to refuse treatment are legally recognised. The Mental Capacity Act (NI) 2016, provides for statutory recognition for advance decisions, but not a statutory provision. There is no current statutory definition in Northern Ireland as to what constitutes a valid advance decision. In Scotland, a person may make an advance directive in any area of medicine but only the Mental Health (Care and Treatment) (Scotland) Act 2003 provides a legal framework for recognition of ‘advance statements’ where a patient is subject to a compulsory order. For persons not subject to any orders under the 2003 Act, the common law prevails. Advance decisions are legally binding as long as they meet certain requirements: the patient was an adult when the decision was made (16 years old or over in Scotland, 18 years old or over in England, Wales and Northern Ireland) the patient had capacity to make the decision at the time it was made (UK wide) the patient was not subject to undue influence in making the decision (UK wide) the patient made the decision on the basis of adequate information about the implications of their choice (UK wide) if the decision relates to refusal of treatment that may prolong life it must be in writing, signed and witnessed, and include a statement that it is to apply even if the patient’s life is at stake (England and Wales only) the decision has not been withdrawn by the patient (UK wide) the patient has not appointed an attorney, since the decision was made, to make such decisions on their behalf (England, Wales and Scotland) more recent actions or decisions of the patient are not clearly inconsistent with the terms of their earlier decision, or in some way indicate they may have changed their mind A valid and applicable advance decision to refuse treatment must be specific to the treatment in question and has the same force as a contemporaneous decision. When it is in relation to life-sustaining treatments, it must be written, signed and witnessed, and must contain “a clear, specific written statement from the person making the advance decision that it is to apply to the specific treatment even if life is at risk” (Mental Capacity Act Code of Practice). It can be amended or withdrawn at any time. Advance requests or authorisations do not have the same binding status but should be taken into account in assessing best interests. In Scotland and Northern Ireland, advance decisions are not currently covered by statute but are covered by common law. An advance refusal of treatment is likely to be binding in Scotland and Northern Ireland if the patient was an adult at the time the decision was made, had capacity at the time the decision was made, and the circumstances that have arisen must be those that were envisaged by the patient. A valid and applicable Advance Decision overrules: the best interests provision, which would otherwise allow healthcare professionals to give treatment they believe is in the individual’s best interests; the decision of any personal welfare Lasting Power of Attorney (LPA) made before the advance decision was made; the decision of any court-appointed deputy. The Court of Protection has no power to overrule a valid and applicable advance decision to refuse treatment. Advance care plans can be overruled if the individual is being treated compulsorily under mental health legislation. However, a valid and applicable advance refusal of treatment for conditions that are not covered by the compulsory powers of the mental health legislation will be binding. In England and Wales, an advance decision is superseded if the patient subsequently gives someone lasting power of attorney to make that decision. If doubt exists about what the patient intended, the Court of Protection in England and Wales, the High Court in Northern Ireland and the Court of Session in Scotland can clarify the situation. When there is a disagreement about the validity of an advance decision, clinicians must take into consideration all available evidence, which will often involve consulting with the patient’s family, close friends of the patient, carers and the patient’s legal proxy (attorney). It may be worth considering also consulting with the staff involved in the patient’s care and also the patient’s GP. Details of these discussions should be recorded in the patient’s notes. If there is still doubt or disagreement, the clinical team refers the decision to the Court of Protection. The Court cannot overturn a valid and applicable advance decision. Whilst the Court comes to a decision, lifesustaining treatment and any treatment required to prevent the patient’s condition deteriorating should be provided. The Adults with Incapacity (Scotland) Act 2000 stipulates that decisions are made that benefit the person, and take into consideration their past and present wishes. People with mental ill health can make advance statements while they are well, in anticipation of a potential relapse. Their statements may include requests for treatment or care. There is no guarantee that requests made in the statement will be followed, but the Mental Welfare Commission for Scotland advises that they will be taken into account. In N. Ireland Advance Decisions were given legal effect under common law and will be legislated for in the Mental Capacity (Northern Ireland) Act 2016 when it comes fully into force. This means that a clear and specific Advance Decision must be followed. If a healthcare professional knows about an Advance Decision and chooses to ignore it, they can be taken to court. In N. Ireland however, there are currently no Health and welfare LPA (Lasting Powers of Attorney). This is legislated for in the Mental Capacity (Northern Ireland) Act 2016. Advance Decisions can be used to refuse any medical treatment including: life-sustaining treatment such as cardiopulmonary resuscitation and artificial ventilation being given food or fluids artificially, for example through a drip, a tube through the nose or through a tube directly into the stomach antibiotics for a life-threatening infection. Advance Decisions cannot be used to: request something illegal, such as assistance to end life refuse to be offered food and drink by mouth or to refuse care that keeps one clean and comfortable i.e. basic care which healthcare professionals have a duty to provide; choose someone else to decide about treatment on your behalf outside of a Lasting Power of Attorney for Health and Welfare; demand specific treatments. For more information see GMC guidance on end of life care: “Treatment and care towards the end of life: good practice in decision making” https://www.gmc-uk.org/ethical-guidance/ethical-guidance-fordoctors/treatment-and-care-towards-the-end-of-life See section 10 below for relevant case law regarding advance care planning and consent: Ms B v An NHS Hospital Trust 2002 Burke v GMC 2005 The Mental Capacity Act (MCA) 2005 (England and Wales) allows restraint and restrictions to be used – but only if they are in a person's best interests. The MCA includes the Deprivation of Liberty Safeguards (DoLS) – a set of checks that aims to make sure that any care that restricts a person’s liberty is both appropriate and in their best interests. DoLS only apply for people in care homes and hospitals. In other settings, e.g. people in ‘supported living arrangements’ where people live and receive care in the community, the Court of Protection can authorise a deprivation of liberty. In short, a deprivation of liberty for a person must be authorised in accordance with either the: Deprivation of Liberty Safeguards of the MCA or by the Court of Protection or, if applicable, under the Mental Health Act 1983 (MHA) The Deprivation of Liberty Safeguards is the procedure prescribed in law when it is necessary to deprive of their liberty a resident or patient who lacks capacity to consent to their care and treatment in order to keep them safe from harm. They are intended to: Protect people who lack mental capacity from being detained when this is not in their best interests; To prevent arbitrary detention; To give people the right to challenge a decision. The legislation sets out a procedure for care homes and hospitals to obtain authorisation to deprive someone of their liberty. Without that authorisation, the deprivation of liberty will be unlawful. These safeguards are intended to protect people from being deprived of their liberty unless it is in their best interests to protect them from harm and there is no other less restrictive alternative. The Mental Capacity Act (Northern Ireland) 2016 was enacted by the Assembly in May 2016, and the provisions in relation to Deprivation of Liberty commenced in December 2019. Specific training is required in order to carry out a Formal Assessment of Capacity and other specific functions. The Department of Health commissioned a Clinical Education Centre to develop and coordinate DoLS training. Specific further learning (level 5) is required for an individual to be able to sit on a Trust Panel. DoLS needs to also be considered from the perspective of Article 5 of the Human Rights Act which states that: 'Everyone has the right to liberty and security of person. No one shall be deprived of his or her liberty [unless] in accordance with a procedure prescribed in law'. Care homes or hospitals must ask a local authority if they can deprive a person of their liberty. This is called requesting a standard authorisation. There are six assessments which have to take place before a standard authorisation can be given. If a standard authorisation is given, one key safeguard is that the person has someone appointed with legal powers to represent them, called the relevant person's representative, who will usually be a family member or friend. Other safeguards include rights to challenge authorisations in the Court of Protection and access to Independent Mental Capacity Advocates (IMCAs). The DoLS state that deprivation of liberty: Should be avoided whenever possible Should only be authorised in cases where it is in the relevant person’s best interests and the only way to keep them safe Should be only for a particular treatment plan or course of action Should be for as short a time as possible “Acid Test”: The Supreme Court judgment of 19 March 2014, in the case of Cheshire West clarified an “acid test” for what constitutes a deprivation of liberty, stating that an individual is deprived of their liberty for the purposes of Article 5 of the European Convention on Human Rights if they: 1. Lack the capacity to consent to their care/treatment arrangements 2. Are under continuous supervision and control 3. Are not free to leave. All three elements must be present for the acid test to be met. See section 10 below for details on: P v Cheshire West & Chester Council; P & Q v Surrey County Council [2014] R(LF) v HM Senior Coroner for Inner London 2017 The Supreme Court further held that factors which are NOT relevant to determining whether there is a deprivation of liberty include: i. the person's compliance or lack of objection ii. the relative normality of the placement (whatever the comparison made) iii. the reason or purpose behind a particular placement But even with the 'acid test' it can be difficult to be clear when the use of restrictions and restraint in someone's support crosses the line to depriving a person of their liberty so each case must be considered on its own merits. Authorisation of DoLS Standard Authorisations: The managing authority i.e. the care home or hospital have to apply for authorisation from a supervisory body i.e. the local authority where the person is ordinarily resident. This can be done up to 28 days in advance of when they plan to deprive the person of their liberty. The supervisory body has to make a decision within 21 days and the body appoints assessors to see if the appropriate criteria have been met which include: The person is 18 or over (different safeguards apply for children). The person is suffering from a mental disorder. The person lacks capacity to decide for themselves about the restrictions which are proposed so they can receive the necessary care and treatment. The restrictions would deprive the person of their liberty. The proposed restrictions would be in the person’s best interests. Whether the person should instead be considered for detention under the Mental Health Act. There is no valid advance decision to refuse treatment or support that would be overridden by any DoLS process. If all conditions are met, the supervisory body must authorise the deprivation of liberty and inform the person and managing authority in writing. It can be authorised for up to one year. Urgent Authorisations: A person may need to be deprived of their liberty before the supervisory body can respond to a request for a standard authorisation. In these situations the managing authority can use an urgent authorisation: urgent authorisations are granted by the managing authority itself deprives a person of their liberty for up to seven days can only be extended (for up to a further seven days) if the supervisory body agrees to a request made by the managing authority to do this the managing authority must also make a request for a standard authorisation and must have a reasonable belief that a standard authorisation would be granted if using an urgent authorisation the managing authority should try to speak to the family, friends and carers of the person first as their knowledge of the person could mean that deprivation of liberty can be avoided the managing authority should make a record of their efforts to consult others. Liberty Protection Safeguards In July 2018, the Government published a Mental Capacity (Amendment) Bill, which if passed into law will reform the Deprivation of Liberty Safeguards (DoLS), and replace them with a scheme known as the Liberty Protection Safeguards. The expected implementation date is now October 2023. The relevant legislation is Mental Capacity (Amendment Act) 2019: Liberty Protection Safeguards. The key changes of the Liberty Protection Safeguards: Three assessments will form the basis of the authorisation of Liberty Protection Safeguards (LPS): A capacity assessment A ‘medical assessment’ to determine whether the person has a mental disorder A ‘necessary and proportionate’ assessment, to determine if the arrangements are NECESSARY to prevent harm, and PROPORTIONATE to the likelihood and seriousness of that harm. The assessment will be embedded into the existing care planning, and Local Authorities will be ‘Responsible Bodies’ under the LPS. Greater involvement for families There will be an explicit duty to consult those caring for the person, and those involved with the person’s welfare. A family member or someone else close to the person will be able to represent and support the person through the process as an “appropriate person”. Family members and others close to the person will also be able to raise concerns throughout the process. Involvement of an approved mental capacity professional (AMCP) An AMCP provides an additional protection, by considering cases where there are concerns about where the person might wish to receive care, for example. The Responsible Body can refer cases to the AMCP. Extension to 16 and 17-year-olds At present, applications must be made to the Court of Protection in order to deprive a 16 or 17 year old of their liberty. Under the LPS, Responsible bodies can authorise this arrangement without a Court order. Extension to domestic settings LPS will apply to people living in domestic settings, which includes the person’s own home/family home, shared homes, and supported living. Clinical commissioning groups (CCGs) NHS trusts and local health boards as Responsible Bodies In England, the Responsible Body for arrangements mainly taking place in hospital will normally be the NHS trust responsible for that hospital. In Wales, it will usually be the local health board. If the arrangements are mainly being carried out in the community, the Responsible Body will be the relevant CCG in England, and local health board in Wales. 10.1 Informed Consent and Negligence Clinicians have a duty of care to inform the patient about a procedure. If a patient is not properly informed and suffers harm as a result of the procedure, the clinician will be liable for negligence. Patients should be told of any possible significant adverse outcomes of a proposed treatment. Hunter v Hanley 1955 S.C. 200: The Scottish case that set the test for negligence The claimant was being given an injection but suffered an injury when the hypodermic needle broke. She alleged that the accident had been caused by the doctor who had failed to exercise the standard of care and competence which it was his duty to observe in giving the injection. More specifically it was alleged that the type of needle used by the doctor was not of suitable and adequate strength for that type of injection. It was held that in order for a claimant to succeed in establishing a claim for medical negligence against a health professional, all three of the following must be proven: i. that there is a usual and normal practice to be followed; ii. that this usual and normal practice was not adopted; and iii. the course that the medical professional did adopt was one that no ordinarily skilled practitioner in that position would have taken when acting with ordinary care. Deviation from ordinary professional practice is not necessarily evidence of negligence and it would hinder progress in medical treatment if the law were to hold otherwise. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582: The case that set the appropriate standard of care in negligence cases The Bolam test states that: “If a doctor reaches the standard of a responsible body of medical opinion, he is not negligent”. Mr. Bolam was a voluntary patient at a mental health unit. He agreed to undergo electro-convulsive therapy (ECT) as part of his treatment. He was not given any muscle relaxant and his body was not restrained during the procedure resulting in him violently flailing about and sustaining significant injuries. He sued for damages claiming negligence for not being given muscle relaxants, not being restrained and not receiving warning about the risks involved in this form of treatment. At the time, medical opinion was generally opposed to using muscle relaxants and restraint was thought to possibly i