Policy Document Control Page Title Title: Consent to Examination or Treatment Policy Version: 7 Reference Number: CL2 Keywords: Consent, Examination, Treatment, Capacity, Fraser, Competency, Parental Responsibility, Zone of Parental Control, Statement, Preferences, Wishes, Advance, Decisions, Lasting Power of Attorney, Deputies, Mental Capacity Act, Research, photography, life sustaining treatment, consent form, video recording, tissue, court of protection, refusals Supersedes Supersedes: Consent to Examination or Treatment Policy v6 Description of Amendment(s): Policy reflects and signposts health care professionals regarding consent requirements set in the case of Montgomery v Lanarkshire Health Board (Scotland) [2015] UKSC 11. This case has provided the Supreme Court with the opportunity to firmly state that the need for “informed consent” is now part of English law. This landmark ruling clearly illustrates the Court’s growing appreciation of patients’ selfdetermination and ability to understand the consequences and risks of a particular treatment. Doctors, and other healthcare professionals, are now under a clear duty to take reasonable care to ensure that patients are aware of all material risks. This judgment aligns the law with the guidance on consent set out by the General Medical Council. Significant detail added around information giving including material risks to allow patients to make informed decisions around giving or withholding consent Appendix 9 updated Online Resources for Clinicians Appendix 14 Revised Mental Capacity Assessment Form Appendix 15 Powers of Restraint and Detention – updated guidance Electronic recording of consent Originator Originated By: Mental Health Law Manager Designation: On behalf of the Mental Health Law Scrutiny Group Equality Impact Assessment (EIA) Process Equality Relevance Assessment Undertaken by: Mental Health Law Manager ERA undertaken on: 3rd February 2016 CL2 Consent to Examination or Treatment Policy V7 Page 1 of 75 ERA approved by EIA Work group on: 4th February 2016 Where policy deemed relevant to equalityEIA undertaken by Mental Health Law Manager EIA undertaken on EIA approved by EIA work group on Approval and Ratification Referred for approval by: Mental Health Law Manager Date of Referral: 10/02/2016 Approved by: Mental Health Law Scrutiny Group Approval Date: 12/02/2016 Date Ratified by Executive Directors: 14th March 2016 Executive Director Lead: Medical Director Circulation Issue Date: 15th March 2016 Circulated by: Performance and Information Issued to: An e-copy of this policy is sent to all wards and departments Policy to be uploaded to the Trust’s External Website? YES Review Review Date: October 2018 Responsibility of: Mental Health Law Manager Designation: On behalf of the Mental Health Law Scrutiny Group This policy is to be disseminated to all relevant staff. This policy must be posted on the Intranet. Date posted: 15th March 2016 CL2 Consent to Examination or Treatment Policy V7 Page 2 of 75 SECTION 1 2 3 4 5 TABLE OF CONTENTS INTRODUCTION SCOPE DEFINITIONS AND TERMINOLOGY, RESPONSIBILITIES PROCESS FOR SEEKING CONSENT When consent is refused Withdrawal of Consent Advance Decisions to refuse treatment Has consent been given voluntarily? 6 INFORMATION Provision for patients whose first language is not English Access to more detailed or specialist information Access to health professionals between formal appointments Open access clinics 7 DOCUMENTATION Completing consent forms / Electronic recording 8 SEEKING CONSENT FOR ANAESTHESIA 9 EMERGENCIES 10 MENTAL CAPACITY ACT AND PATIENTS LACKING CAPACITY PROCESSES Does the person have capacity? Duration of lack of Capacity Consent of Adults who lack capacity Statements of Preferences and Wishes / Where a patient lacks capacity and continues to refuse treatment Lasting Power of Attorney (LPA) Court Appointed Deputies Independent Mental Capacity Advocates Referral to Court Withdrawing and withholding life sustaining treatment: General guidance Withdrawing and withholding life sustaining treatment: Adults and Children with Capacity Withdrawing and withholding life sustaining treatment: Adults and Children lacking Capacity 11 SELF HARM 12 TREATMENT OF CHILDREN AND YOUNG PEOPLE Children or Young People with capacity refusing treatment Children under 16 (the concept of Fraser Guidelines) Children Lacking Capacity Who has Parental Responsibility? Young People 13 TISSUE 14 CLINICAL PHOTOGRAPHY AND CONVENTIONAL OR DIGITAL VIDEO RECORDING 15 IMPACT OF POLICY ON CQC REGISTRATION 16 MONITORING 17 IMPLEMENTATION ANDPolicy TRAINING CL2 Consent to Examination or Treatment V7 PAGE 5 7 8 9 10 13 14 14 16 16 20 20 20 20 21 21 22 23 23 Page 3 of 75 23 25 25 25 27 27 28 28 29 30 31 31 32 33 33 34 35 35 37 38 38 39 41 18 Training REFERENCES 41 42 APPENDIX 1 CONSENT FORM 1 - Patient Agreement to Investigation or Treatment APPENDIX 2 CONSENT FORM 2 - Parental agreement to Investigation or treatment for a child or young person APPENDIX 3 CONSENT FORM 3 - Parental/Patient agreement to Investigation or treatment (procedures where consciousness not 43 45 47 impaired) APPENDIX 4 CONSENT FORM GUIDANCE TO HEALTH PROFESSIONALS – To be read in conjunction with consent form 1-3 APPENDIX 5 CONSENT FORM 4 - Form for adults who are unable to consent to investigation or treatment APPENDIX 6 CONSENT FORM GUIDANCE TO HEALTH PROFESSIONALS – To be read in conjunction with consent form 4 APPENDIX 7 Questions to ask health professionals APPENDIX 8 Case Law Summary – Consent APPENDIX 9 Online Resources for Clinicians APPENDIX 10 GUIDANCE NOTE ADVANCE DECISIONS APPENDIX 11 ADVANCE DECISION TEMPLATE APPENDIX 12 GUIDANCE NOTE WRITTEN STATEMENTS APPENDIX 13 WRITTEN STATEMENT TEMPLATE APPENDIX 14 MENTAL CAPACITY ASSESSMENT FORM APPENDIX 15 BEST INTEREST CHECKLIST APPENDIX 16 MCA DECISION MAKING PATHWAY APPENDIX 17 MCA BEST INTEREST PATHWAY APPENDIX 18 GUIDANCE POWERS OF RESTRAINT AND DETENTION APPENDIX 19 SEEKING CONSENT REMEMBERING THE PATIENTS PERSPECTIVE CL2 Consent to Examination or Treatment Policy V7 Page 4 of 75 48 49 51 52 53 56 58 60 62 64 66 68 70 71 72 75 Consent to Examination and Treatment Policy 1 Introduction 1.1 Pennine Care NHS Foundation Trust is committed to ensuring patient’s legal rights are protected and they can expect healthcare professionals to work in an ethical and lawful manner. In terms of providing treatment, physical investigation and personal care, the Trust believes a patient’s autonomy to determine what happens to their body should be the paramount consideration. 1.2 Although recognising that a failure to comply with the principles of consent and examination could lead to legal challenge, the overriding aim of the Trust is promoting participation and respecting a patient’s right to choose what treatments and interventions we provide to them. 1.3 The purpose of this document is to provide healthcare professionals with procedures and information relating to the consent of living patients. 1.4 The aim of this policy is to: Ensure staff understand the legal requirements relating to obtaining consent Encourage participation and respect of patient’s rights particularly relating to physical interventions and clinical procedures Establish clear processes for seeking and documenting consent 1.5 This policy also aims to be compliant with the legal requirement for the general principles of consent including the Trust obligations under the Human Rights Act1. Statute does not deal with consent although case law (‘common law’) has established that physical intervention with a patient without valid/informed consent may constitute the civil or criminal offence of assault or battery. The availability of Trust guidance in this area aims to prevent legal claims of negligence or complaints from patients either to the Trust or to professional bodies. 1.6 In order to ensure that staff work in partnership with patients they must: Listen to patients and respect their views about their health Discuss with patients what their diagnosis, prognosis, treatment or care involves (dependent upon your role in their care) Articles which impact upon medical case law are usually; Article 2 – Protection of the right to life, Article 3 – Prohibition of torture and inhuman or degrading treatment or punishment, Article 5 – The right to liberty and security, Article 8 – The right to respect for private and family life, Article 9 – Freedom of thought, conscience and religion, Article 12 – The right to marry and found a family and Article 14 – Prohibition of discrimination in the enjoyment of Convention Rights. 1 CL2 Consent to Examination or Treatment Policy V7 Page 5 of 75 1.7 Share with patients all relevant information they want or need (to allow them to make informed decisions based on a sufficient knowledge of the purpose, nature, likely effects and risks of that treatment, including the likelihood of its success and any alternatives to it. Permission given under any unfair or undue pressure is not consent. Maximise patients’ opportunities, and their ability, to make decisions for themselves. Respect patients’ decisions. When there is doubt regarding a proposed intervention or patients consent, staff must seek further information and access legal advice from the Trust’s legal team. This policy complements (and when appropriate should be read in conjunction with) the following Trust policies available on the intranet (please note that this is not an exhaustive list and all health care professionals have a duty to ensure that the principles of obtaining valid and applicable consent or applying the principles of the Mental Capacity Act (2005) is evident in their practice in relation to providing care and treatment and intervention to patients): CL1 Patient Identification Policy CL5 Observation & Engagement Policy CL6 Patients Absent Without Leave Policy CL8 Co-Morbidity Strategy CL9 Resuscitation Policy CL14 Rapid Tranquilisation Policy CL19 Clinical Risk Assessment & Management Policy CL20 Guideline for Physical Examination & Assessment on Admission CL21 Section 136 MHA 1983 - Removal to a Place of Safety Policy CL25 Protocol for Mental Health Inpatient Service Users Who Require Care in the Pennine Acute Hospital CL26 Policy for Seclusion, Time Out & Other Restriction of Patients Movement CL27 Procedure of Venepuncture CL32 Community Treatment Order Policy CL36 Section 132, 132A, and 133 MHA (provision of information) Policy CL39 Unified Cardiopulmonary Resuscitation Policy CL42 Mental Health Services Physical Health Policy For Service Users Aged 18 Years and Over CL43 Non Medical Prescribing Policy CL46 Complementary Therapies Policy CL48 Falls Prevention & Management Strategy CL49 Mental Health Act 1983 Section 117 Policy CL54 Guidance for the Management of Pornography & Sensitive Materials on In-patient Units CL58 Treatment of patients subject to the Mental Health Act 1983 Part 4 & Part 4a V3 CL61 Admission, Entry & Exit Policy for Mental Health Ward CL62 Mobile Phone Policy for Service Users and Visitors CL63 Patients' Property Policy and Procedure CL73 Specimens Policy CL2 Consent to Examination or Treatment Policy V7 Page 6 of 75 CL74 Management of Head, Body and Public Lice CL80 Management of Scabies Policy CL81 Electro Convulsive Therapy Policy CL83 Research and Development Policy CL87 Victims Policy CL89 Clinical Audit Policy CL90 Procedure for Specialist CMHN Assessments CL91 Nearest Relative Policy CL93 Bealey Community Discharge Policy CL94 Practice Guidelines for Clinical Risk Assessment & Management Policy CL95 Butler Green Community Hospital Discharge Policy CL97 Butler Green Enhanced Intermediate Care Admissions Policy CL99 Guidance for Staff on Disclosure/Discovery of Assisted Suicide CL111 Newborn Bloodspot Screening Policy CL104 Children’s Speech and Language Therapy Access & Discharge Policy CL106 Bealey Community Hospital Admission Policy CL110 Policy for the Management of Adults with Acquired Dysphagia CL112 Health of Looked After Children Policy CL114 Paediatric Dysphagia Policy CL115 Client Focused Physical Intervention Policy for Adults and Children (L D Directorate) CO4 Confidentiality Policy CO10 Incident Reporting, Management and Investigation Policy CO23 Inclusive Involvement and Participation of Service Users and Carers Policy CO64 Privacy & Dignity Policy CO65 Guidelines for Supporting Service Users with Management of Personal Money CO104 Non Access to a Clients Home/Non-attendance at Clinic Appointments Policy GL1 Ear Care Guidance Including Irrigation and Otoscopy for Adults GL3 Wound Care Photography Procedure GL4 Nephrostomy Tube Care Guidelines for Adults and Children GL5 Safeguarding Children and Domestic Abuse Guidelines (Part of Safeguarding Children Policy) GL9 Earwax Clearance by Suction Guidelines GL13 Continence Promotion and Management of Urinary and Faecal Incontinence for Adults GL14 Trial Without Catheter (TWOC) in the Community Setting for Adults GL18 Digital Rectal Examination Guidance for Adult GL16 Maternal Perinatal Mental Health Guidelines for Community Services GL20 The Insertion and Management of Urinary Catheters in Adult Patients Guidelines 2 Scope 2.1 This policy applies to all staff working for and on behalf of Pennine Care NHS Foundation Trust, including bank/agency workers. CL2 Consent to Examination or Treatment Policy V7 Page 7 of 75 2.2 This policy covers both treatment and examination although throughout only the term treatment is used. Staff must adhere to the requirements of the policy for both types of intervention as well as the requirements and standards set by their own professional Codes of Conduct, professional membership bodies/council in relation to obtaining consent, for example, General Medical Council, Nurse and Midwifery Council, Health and Care Professionals Council. 2.3 The scope of this policy does not extend to: Participation in observational studies The use of personal information The use of organs or tissue after death 3 Definitions and Terminology 3.1 Consent: Consent is “the voluntary and continuing permission of a patient to be given a particular treatment, based on a sufficient knowledge of the purpose, nature and likely effects and risks of that treatment, including the likelihood of its success and any alternatives to it” (Department of Health, 2015). 3.2 For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. Voluntary consent: This means that the decision to either consent or not to consent to treatment must be made by the person themselves, and must not be influenced by pressure from medical staff, friends or family. Informed consent: This means that the person must be given all of the information in terms of what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments and what will happen if treatment does not go ahead (NHS Choices, 2015). 3.3 Case law on consent has evolved significantly over recent years. Further legal developments may occur after this guidance has been issued and all healthcare professionals must remember their duty to keep themselves informed of legal developments that may have a bearing on their practice. 3.4 Capacity: A person’s capacity relates to their ability to understand the matter in question at the time and to make decisions for themselves. A person lacks capacity in relation to the matter if at the material time they are unable to make a decision for themselves in relation to the matter due to an impairment, or a disturbance in the functioning of their mind or brain (Department of Health, 2015). 3.5 The Mental Capacity Act 2005: The Mental Capacity Act 2005, which came fully into force on 1 October 2007, sets out a statutory framework for making care and treatment decisions for people who lack the capacity to make such decisions themselves. The Act establishes overarching statutory principles governing these decisions, setting out who can make them and when. It also sets out the legal requirements for assessing whether or not a person lacks the capacity to make a decision. CL2 Consent to Examination or Treatment Policy V7 Page 8 of 75 3.6 Where a person lacks the capacity to make a decision for themselves, any decision must be made in that person’s best interests. The Mental Capacity Act introduced a duty on NHS bodies to instruct an independent mental capacity advocate (IMCA) in serious medical treatment decisions when a person who lacks the capacity to make a decision has no one who can speak for them, other than paid staff. The Act allows people to plan ahead for a time when they may not have the capacity to make their own decisions: it allows them to appoint a personal welfare attorney to make health and social care decisions, including medical treatment, on their behalf or to make an advance decision to refuse medical treatment. Further guidance is available in the Mental Capacity Act (2005) Code of Practice2. 3.7 Patient: The term patient has been used throughout this policy although it is accepted other terminology may be appropriate such as service user. 3.8 Healthcare Professional: The term Healthcare Professional includes all staff who may be involved in a patient’s care and has been used to encompass non-qualified staff. 3.9 Must: The term must is used to indicate the requirement is a legal or overriding duty or principle. Where staff are unable to complete this requirement they must report this to their line manager and request advice as to alternative ways to comply with the legislation. 3.10 Should: The term should is used where the duty or principle may not apply in all situations and circumstances, if there are factors outside the control of staff that may affect how you comply with the policy then any departures should be documented and recorded in the patients notes. 4 Responsibilities 4.1 The Trust Board remain responsible for ensuring appropriate consent procedures are in place. The Trust Board delegate the monitoring and responsibility of this policy to the Mental Health Law Scrutiny Group who may request the advice and involvement of other departments i.e. Audit, Medical Staffing, as necessary. 4.2 The Trusts Mental Health Law Manager, and all policy holders and subject matter experts have responsibility for ensuring consent legislation is embedded within their relevant training, audit and policy requirements where consent applies. The Trusts Mental Health Law Manager has the responsibility for updating and implementing this policy on at least a bi-annual basis. 4.3 Line Managers are responsible for ensuring that staff who may be delegated the role of obtaining consent are appropriately trained in respect to this policy and the consent process and that this is recorded in their supervision records. Line Managers are also responsible for reviewing consent related incidents and addressing any identified performance issues through the appropriate escalation structures. 2 The Mental Capacity Act (2005) Code of Practice can be accessed here: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/497253/Mental-capacity-actcode-of-practice.pdf CL2 Consent to Examination or Treatment Policy V7 Page 9 of 75 4.4 Line Managers must ensure staff under their charge are aware of this policy and the principles of seeking valid consent and that this is apparent in working practices. Any incidents or breaches of policy should be reported in accordance with the Trust Incident Reporting policy and any investigations or actions supported by Line Managers. Line Managers are also required to report any practical issues to the Trust Mental Health Law Manager to facilitate policy change if necessary. 4.5 Staff including agency, contractors or anyone providing a service on behalf of the Trust in clinical and non-clinical settings have a responsibility to ensure appropriate consent is obtained and that is documented in the patient’s health records. In addition, all health care professionals are responsible for seeking valid consent for any examination, investigation, care and or treatment that they provide or carry out themselves. Where responsibility for any aspect of the consent process is delegated to another person, the overall responsibility remains with the person carrying out the procedure. In some cases, professional codes of conduct will also expect staff to work to a higher standard than the requirements of this policy and the professionals must refer to those codes for instruction. All practical issues in implementing this policy should be reported and discussed with Line Managers. A failure to comply with this policy may result in disciplinary action. 4.6 The clinician in charge is responsible for ensuring the person has given valid consent before the treatment begins. In some cases this may be delegated to another person although they must be suitably trained and qualified. This person must have a sufficient knowledge of the various options available purpose, nature, likely effects and risks of that treatment, including the likelihood of its success and any alternatives to it. In addition they must be familiar with and able to apply the Mental Capacity Act (MCA). 5 Process for Seeking Consent 5.1 Valid consent must be given voluntarily by an appropriately informed person who has capacity to consent to the intervention in question. This may be: The patient Someone with parental responsibility for under 18’s where this is considered appropriate and is applicable A Lasting Power of Attorney (LPA) Court Appointed Deputy 5.2 For consent to be voluntary it must be given freely and without pressure. This pressure may come from healthcare professionals or family and carers. Permission given under any unfair or undue pressure is not consent. All staff are responsible for alerting the relevant/appropriate team to any possibility of coercion or pressure they become aware of. The clinician in charge should then make arrangements to see the patient on their own to establish the decision is a valid one. This discussion is to be documented in the patients’ healthcare records. 5.3 The clinician in charge of the treatment is responsible for ensuring the person has given valid consent before the treatment begins. In some cases this may be delegated to another person although they must be suitably trained and qualified. This person must have a sufficient knowledge of the purpose, nature, likely effects CL2 Consent to Examination or Treatment Policy V7 Page 10 of 75 and risks of that treatment, including the likelihood of its success and any alternatives to it. In addition they must be familiar with and able to apply the Mental Capacity Act (MCA). The clinician in charge remains responsible for making sure the patient is allowed time to consider a decision, given information relating to that decision and has given consent. 5.4 It is the responsibility of each Line Manager to ensure staff who may be delegated the role of obtaining consent has access to procedure specific training on the consent process and are aware of this policy and this should be recorded in their supervision records. This training may be delivered by other staff who are capable of doing so, as identified by their Line Managers, but staff should be offered access to the Trust training programme in addition to this. 5.5 Where consent is obtained by a member of staff not authorised to do so this must be recorded using the Trust Incident Reporting system and addressed by the Line Manager through supervision (either individually or with the team in accordance with the nature of the incident). 5.6 Consent should be sought as soon as possible prior to the proposed treatment and/or investigation. This allows time to respond to questions and sufficient information to be provided to the patient. Healthcare professionals should allow time for discussions, seek consent, document this and then ask the patient to signify their consent again prior to the treatment commencing where appropriate. 5.7 It should be noted that when consent is formally given this is the endpoint of the process but the whole process needs to be completed; information giving, discussion and decision-making for it to be valid consent. 5.8 When consent is given to treatment or examination this remains valid for an indefinite period unless it is withdrawn. If new information becomes available then the patient must be informed and asked to reconfirm their consent. It is good practice where a considerable amount of time has passed3 that the person is asked to reconfirm as well. 5.9 Where a patient has capacity, including an incapacitated patient who has a Lasting Power of Attorney or Court Appointed Deputy, the process that applies for examination or treatment is: Healthcare professional in charge of treatment identifies the treatment options based on patient’s condition, medical history, views, experience and knowledge. It may be necessary to consult with other members of the team at this stage but overall responsibility lies with the professional in charge. The healthcare professional then discusses the options with the patient, setting out potential benefits, risks, burdens and side effects of each option, including the option of not having the treatment. Recommendations may be made to the patient for what they feel best but they should not put pressure on the patient. The patient must be offered information relating to the treatment and provided with time to consider the options given to them where possible. The patient should be asked to consent or refuse the proposed treatment. They may provide answers that seem irrational or unwise or they may choose to give 3 In some services this may be a period of 6 months but this should be service dependent and can be decided locally CL2 Consent to Examination or Treatment Policy V7 Page 11 of 75 no reason for their decision (please refer to part 10 of this policy on the Mental Capacity Act (MCA)). Where a patient asks for treatment that the healthcare professional doesn’t believe is of overall benefit they must discuss with the patient their reasons for that belief and explain other options to them. Dependent upon the seriousness of the decision the patient may then provide their consent either orally or in writing using the forms in this policy or by signing health records. Before accepting a patient’s consent, you must consider whether they have been given the information they want or need, and how well they understand the details and implications of what is proposed. This is more important than how their consent is expressed or recorded. Patients can give consent orally or in writing, or they may imply consent by complying with the proposed examination or treatment, for example, by rolling up their sleeve to have their blood pressure taken. In the case of minor or routine investigations or treatments, if you are satisfied that the patient understands what you propose to do and why, it is usually enough to have oral or implied consent. In cases that involve serious or higher risk treatment, it is important that you get the patient's written consent. This is so that everyone involved understands what was explained and agreed. 5.10 Examples of this are: The treatment is complex or with significant risk There may be significant consequences for the patient’s employment, social or personal life. Clinical care is NOT the primary purpose Is part of a research programme or is an innovative treatment. 5.11 Where a patient has a valid and applicable advance decision in place healthcare professionals MUST follow this, even if it results in the person’s death. If an advance decision is not followed criminal prosecution or civil liability may be possible. If there is genuine doubt or disagreement regarding the existence of an advance decision or the validity of this the Mental Health Law Manager must be contacted. Disagreements may need to be referred to the Court of Protection so the Trust’s legal team need to be involved at the earliest possible stage. 5.12 Where it has been identified that the patient may lack capacity the process is as follows: The healthcare professional begins discussions with the patient, setting out the purpose, nature, likely effects and risks of that treatment, including the likelihood of its success and any alternatives to it including the option of not having the treatment and the effect of this. Discussions should focus on the patient’s ‘individual situation and risk to them’. If the healthcare professional believes the patient lacks capacity regarding this decision then follow the legal framework contained within the MCA (see part 10 of this policy) in line with the assessments set out in this section. Healthcare professional in charge of treatment identifies the treatment options based on patient’s condition, medical history, views, experience and knowledge. It may be necessary to consult with other members of the team at this stage but overall responsibility lies with the professional in charge. CL2 Consent to Examination or Treatment Policy V7 Page 12 of 75 Information should be presented to the patient in different formats in line with the legal requirement to take all practicable steps to involve the patient in the decision. Discussion should take place regarding the different formats that may be available including consideration of asking for specific assistance to be commissioned i.e. learning disabilities input. Consent Form 4 should be completed to document processes and assessments have been completed for capacity, best interests, consultation with others and second opinions where necessary. When consent is refused 5.13 If an adult with capacity makes a voluntary and appropriately informed decision to refuse treatment (whether contemporaneously or in advance), this decision must be respected, except in certain circumstances as defined by the Mental Health Act 1983. This is the case even where this may result in the death of the person (and/or the death of an unborn child, whatever the stage of the pregnancy). 5.14 If, after discussion of possible treatment options, a patient refuses all treatment, this fact should be clearly documented in their notes. If the patient has already signed a consent form, but then changes their mind, you (and where possible the patient) should note this on the form. 5.15 Where a patient has refused a particular intervention, you must ensure that you continue to provide any other appropriate care to which they have consented. You should also ensure that the patient realises they are free to change their mind and accept treatment if they later wish to do so. Where delay may affect their treatment choices, they should be advised accordingly. 5.16 If a patient consents to a particular procedure but refuses certain aspects of the intervention, you must explain to the patient the possible consequences of their partial refusal. If you genuinely believe that the procedure cannot be safely carried out under the patient’s stipulated conditions, you are not obliged to perform it. You must, however, continue to provide any other appropriate care. Where another health professional believes that the treatment can be safely carried out under the conditions specified by the patient, you must on request be prepared to transfer the patient’s care to that health professional. You should formally record in the notes any decision made and the justifications for it. 5.17 For an adult to refuse consent they must be: 18 or over Must have the capacity to make such a decision The person must make clear which treatments they are refusing 5.18 If the advance decision refuses life-sustaining treatment, it must be in writing (it can be written by someone else or recorded in healthcare notes), it must be signed and witnessed and it must state clearly that the decision applies even if life is at risk. A person with capacity can withdraw their advance decision at any time. 5.19 For issues concerning refusal of treatment by those under the age of 18 see the DoH’s Seeking Consent: Working with children (2001) and the section of this policy covering children and young people for more detail. CL2 Consent to Examination or Treatment Policy V7 Page 13 of 75 Withdrawal of Consent 5.20 A person with capacity is entitled to withdraw consent at any time, including during the performance of a procedure. Where a person does object during treatment, it is good practice for the practitioner, if at all possible, to stop the procedure, establish the person’s concerns and explain the consequences of not completing the procedure. At times, an apparent objection may in fact be a cry of pain rather than withdrawal of consent, and appropriate reassurance may enable the practitioner to continue with the person’s consent. If stopping the procedure at that point would genuinely put the life of the person at risk, the practitioner may be entitled to continue until that risk no longer applies. 5.21 Assessing capacity during a procedure may be difficult and factors such as pain, panic and shock may diminish capacity to consent. The practitioner should try to establish whether at that time the person has capacity to withdraw a previously given consent. If capacity is lacking, it may sometimes be justified to continue in the person’s best interests but this should not be used as an excuse to ignore distress. Advance Decisions to refuse treatment 5.22 A person may have made an advance decision to refuse particular treatment in anticipation of future incapacity (sometimes previously referred to as a ‘living will’ or ‘advance directive’). A valid and applicable advance decision to refuse treatment has the same force as a contemporaneous decision to refuse treatment. This is a well-established rule of common law, and the MCA 2005 which puts advance decisions on a statutory basis. The Act sets out the requirements that such a decision must meet to be valid and applicable. Further details are available in chapter 9 of the MCA 2005 (2005) Code of Practice, but in summary these are: 5.23 The person must be 18 or over The person must have the capacity to make such a decision The person must make clear which treatments they are refusing if the advance decision refuses life-sustaining treatment, it must be in writing (it can be written by someone else or recorded in healthcare notes), it must be signed and witnessed and it must state clearly that the decision applies even if life is at risk A person with capacity can withdraw their advance decision at any time. Healthcare professionals must follow an advance decision if it is valid and applicable, even if it may result in the person’s death. If they do not, they could face criminal prosecution or civil liability. The MCA 2005 protects a health professional from liability for treating or continuing to treat a person in the person’s best interests if they are not satisfied that an advance decision exists which is valid and applicable. The Act also protects healthcare professionals from liability for the consequences of withholding or withdrawing a treatment if at the time they reasonably believe that there is a valid and applicable advance decision. If there is genuine doubt or disagreement about an advance decision’s existence, validity or applicability, the case should be referred to the Court of Protection via the Mental Health Law Managers office. The court does not have the power to overturn a valid and applicable advance decision. While a decision is awaited from the courts, CL2 Consent to Examination or Treatment Policy V7 Page 14 of 75 healthcare professionals can provide life-sustaining treatment or treatment to stop a serious deterioration in the patient’s condition. 5.24 If an advance decision is not valid or applicable to current circumstances, healthcare professionals must consider the advance decision as part of their assessment of the person’s best interests. Advance decisions made before the MCA 2005 came into force may still be valid if they meet the provisions of the Act. There are transitional arrangements for advance decisions to refuse life-sustaining treatment made before 1 October 2007. Further information is available from the Mental Health Law Manager. 5.25 Some healthcare professionals may disagree in principle with a person’s right to refuse life-sustaining treatment. The MCA 2005 does not change the current legal position. Healthcare professionals do not have to act in a way that goes against their beliefs; however, they must not simply abandon patients or cause their care to suffer. A patient should have the option of transferring their care to another healthcare professional or, if the patient lacks capacity, arrangements should be made for the management of the patient’s care to be transferred to another healthcare professional. 5.26 Patients should always be offered measures that are essential to keeping them comfortable. This is sometimes referred to as ‘basic’ or ‘essential’ care, and includes warmth, shelter, actions to keep a person clean and free from distress and the offer of food and water by mouth. The BMA’s guidance advises that basic care should always be provided unless it is actively resisted by a patient, and that ‘refusals of basic care by patients with capacity should be respected, although it should be continued to be offered’. Advance decisions made under the MCA 2005 cannot refuse actions that are needed to keep a person comfortable. The Act allows healthcare professionals to carry out these actions in the best interests of a person who lacks capacity. An advance decision can refuse artificial nutrition and hydration. 5.27 However, although basic/essential care would include the offer of oral nutrition and hydration, it would not cover force feeding an individual or the use of artificial nutrition and hydration. The courts have recognised that an individual with capacity has the right to choose to refuse food and drink, although this may be qualified if the person has a mental disorder. Towards the end of such a period an individual is likely to lose capacity, and the courts have stated that if the individual has, while they have capacity, expressed the desire to refuse food until death supervenes, the person cannot be force fed or fed artificially when they lack capacity. If the person is refusing food as a result of mental disorder, then detention and treatment without consent may be a possibility under certain provisions/sections of the Mental Health Act 1983, different considerations may apply and more specialist guidance should be consulted. 5.28 Where clinicians have concerns or queries regarding the validity of an Advance Decision these should be escalated to the Mental Health Law Manager in the first instance. This should be in line with the Trust processes for accessing legal advice. CL2 Consent to Examination or Treatment Policy V7 Page 15 of 75 Has consent been given voluntarily? 5.29 To be valid, consent must be given voluntarily and freely, without pressure or undue influence being exerted on the person either to accept or refuse treatment. Such pressure can come from partners or family members, as well as health or care practitioners. Practitioners should be alert to this possibility and where appropriate should arrange to see the person on their own in order to establish that the decision is truly their own. 5.30 The test of capacity is set out in the MCA 2005. Once it has been determined that a person has the capacity to make a particular decision at a particular time, a further requirement (under the common law) for that consent to be valid is that it must be given voluntarily and freely, without pressure or undue influence being exerted upon them. 5.31 When people are seen and treated in environments where involuntary detention may be an issue, such as prisons and mental hospitals, there is a potential for treatment offers to be perceived coercively, whether or not this is the case. Coercion invalidates consent, and care must be taken to ensure that the person makes decisions freely. Coercion should be distinguished from providing the person with appropriate reassurance concerning their treatment, or pointing out the potential benefits of treatment for the person’s health. However, threats such as withdrawal of any privileges, loss of remission of sentence for refusing consent or using such matters to induce consent may well invalidate the consent given, and are not acceptable. 6 Information 6.1 The provision of information and the dialogue between the health care professional and patient is central to the consent process. Before patients can come to a decision about treatment, they need comprehensible information about their condition the purpose, nature, likely effects and risks4 of that treatment, including the likelihood of its success and any alternatives to it (including the risks/benefits of doing nothing). Discussions should focus on the patient’s ‘individual situation and risk to them’. The law now demands a standard of consent broadly similar to that required by the professional guidance of the GMC. For example doctors must now ensure that patients are aware of any “material risks” involved in a proposed treatment, and of reasonable alternatives, following the judgment in the Supreme Court case of Montgomery v Lanarkshire Health Board (Scotland) [2015] UKSC 11. The case of Montgomery clarifies the correct test to consent. Mrs Montgomery (The Claimant) suffered from insulin dependent diabetes mellitus. It was agreed between the parties that the risk of shoulder dystocia occurring during vaginal delivery was 9 -10% in the case of diabetic mothers. The Claimant was not told of the risk of shoulder dystocia, as, in the doctor’s opinion, the possibility of it causing a serious problem for the baby was very small. The doctor also suggested that advising of the risk would lead to most women electing for a caesarean section. During the vaginal delivery the umbilical cord was completely or partially occluded, thereby depriving the baby of oxygen. After his birth, he was diagnosed as suffering from dyskinetic cerebral palsy. It was the Claimant’s case that had she been told of CL2 Consent to Examination or Treatment Policy V7 Page 16 of 75 the risk of shoulder dystocia she would have elected for a caesarean section. The Supreme Court felt that there was a duty for a doctor to warn a patient of a material risk inherent in the treatment. The Supreme Court reiterated that there was a duty for the doctor to discuss with the patient the material risks involved in the medically preferred treatment and any alternative treatment options. The test for materiality was whether a reasonably person in the position of a patient would think the risk significant. In the Claimant’s case it was found that the risk of shoulder dystocia was substantial and should have been disclosed. The Claimant was entitled to consider this risk against the relatively low risk to both mother and baby of a caesarean section. The Supreme Court found that had the risks been discussed the Claimant would have elected to have a caesarean. This case has provided the Supreme Court with the opportunity to firmly state that the need for “informed consent” is now part of English law. This landmark ruling clearly illustrates the Court’s growing appreciation of patients’ self-determination and ability to understand the consequences and risks of a particular treatment. Doctors, and other healthcare professionals, are now under a clear duty to take reasonable care to ensure that patients are aware of all material risks. This judgment aligns the law with the guidance on consent set out by the General Medical Council. 6.2 6.3 Health care professionals need to consider the following; Does the patient know about the material risks of the treatment you are proposing? What sort of risks would a reasonable person in the patient’s circumstances want to know? What sorts of risks would your particular patient want to know? Does the patient know about the reasonable alternatives and the comparative risks (even very rare risks)? Have you taken reasonable care to ensure the patient actually knows this? Do any of the exceptions to your duty to disclose apply here? Have you properly documented the consent process? How you discuss a patient’s diagnosis, prognosis and treatment options is often as important as the information itself. Discussions should focus on the patient’s ‘individual situation and risk to them’. You should: (a) share information in a way that the patient can understand and, whenever possible, in a place and at a time when they are best able to understand and retain it (b) give information that the patient may find distressing in a considerate way (c) involve other members of the healthcare team in discussions with the patient, if appropriate (d) give the patient time to reflect, before and after they make a decision, especially if the information is complex or what you are proposing involves significant risks CL2 Consent to Examination or Treatment Policy V7 Page 17 of 75 (e) make sure the patient knows if there is a time limit on making their decision, and who they can contact in the healthcare team if they have any questions or concerns. 6.4 You may need to support your discussions with patients by using written material, or visual or other aids. If you do, you must make sure the material is accurate and up to date. 6.5 You should check whether the patient needs any additional support to understand information, to communicate their wishes, or to make a decision. You should bear in mind that some barriers to understanding and communication may not be obvious; for example, a patient may have unspoken anxieties, or may be affected by pain or other underlying problems. You must make sure, wherever practical, that arrangements are made to give the patient any necessary support. This might include, for example: using an advocate or interpreter; asking those close to the patient about the patient’s communication needs; or giving the patient a written or audio record of the discussion and any decisions that were made. 6.6 You should accommodate a patient’s wishes if they want another person, such as a relative, partner, friend, carer or advocate, to be involved in discussions or to help them make decisions. 6.7 To help you give patients as much information or support in making decisions consider the role of other members of the healthcare team might play, and what other sources of information and support are available. These may be, for example, patient information leaflets, advocacy services, expert patient programmes, or support groups for people with specific conditions. 6.8 You should do your best to make sure that patients with additional needs, such as those with disabilities, have the time and support they need to make a decision. In all cases, you must treat patients fairly and not discriminate against them. 6.9 You must give patients the information they want or need about: The diagnosis and prognosis Any uncertainties about the diagnosis or prognosis, including options for further investigations Options for treating or managing the condition, including the option not to treat The purpose of any proposed investigation or treatment and what it will involve The potential benefits, risks and burdens and the likelihood of success for each option. Discussions should focus on the patient’s ‘individual situation and risk to them’. 6.10 In order to have effective discussions with patients about risk, you must identify the adverse outcomes that may result from the proposed options. 6.11 This includes the potential outcome of taking no action. Risks can take a number of forms, but will usually be: CL2 Consent to Examination or Treatment Policy V7 Page 18 of 75 (a) side effects (b) complications (c) failure of an intervention to achieve the desired aim 6.12 Risks can vary from common but minor side effects, to rare but serious adverse outcomes possibly resulting in permanent disability or death. 6.13 In assessing the risk to an individual patient, you must consider the nature of the patient’s condition, their general health and other circumstances. These are variable factors that may affect the likelihood of adverse outcomes occurring. 6.14 You should do your best to understand the patient's views and preferences about any proposed investigation or treatment, and the adverse outcomes they are most concerned about. You must not make assumptions about a patient's understanding of risk or the importance they attach to different outcomes. You should discuss these issues with your patient. 6.15 You must tell patients if an investigation or treatment might result in a serious adverse outcome, even if the likelihood is very small. You should also tell patients about less serious side effects or complications if they occur frequently, and explain what the patient should do if they experience any of them. 6.16 You must give information about risk in a balanced way. You should avoid bias, and you should explain the expected benefits as well as the potential burdens and risks of any proposed investigation or treatment. 6.17 You must use clear, simple and consistent language when discussing risks with patients. You should be aware that patients may understand information about risk differently from you. You should check that the patient understands the terms that you use, particularly when describing the seriousness, frequency and likelihood of an adverse outcome. You should use simple and accurate written information or visual or other aids to explain risk, if they will help the patient to understand. 6.18 You must keep up to date with developments in your area of practice, which may affect your knowledge and understanding of the risks associated with the investigations or treatments that you provide. 6.19 You should explore these matters with patients, listen to their concerns, ask for and respect their views, and encourage them to ask questions. You should check whether patients have understood the information given, and whether or not they would like more information before making a decision. You must make it clear that they can change their mind about a decision at any time. 6.20 You should discuss with patients the possibility of additional problems coming to light during an investigation or treatment when they might not be in a position to make a decision about how to proceed. If there is a significant risk of a particular problem arising, you should ask in advance what the patient would like you to do if it does arise. You should also ask if there are any procedures they object to, or which they would like more time to think about. The Trust wishes to make it clear that removal of tissue is not routinely undertaken although may be a result of dental procedure or podiatry surgery. Once a decision to have a particular treatment/investigation has been made, patients need information about what will CL2 Consent to Examination or Treatment Policy V7 Page 19 of 75 happen: where to go, how long they will be in hospital, how they will feel afterwards and so on. 6.21 Patients and those close to them will vary in how much information they want. However, the presumption must be that the patient wishes to be well informed about the material and comparative risks and benefits to them as an individual of the various options available. Where the patient makes clear (verbally or nonverbally) that they do not wish to be given this level of information, this should be clearly documented. You should not withhold information necessary for making decisions for any other reason, including when a relative, partner, friend or carer asks you to, unless you believe that giving it would cause the patient serious harm. In this context ‘serious harm’ means more than that the patient might become upset or decide to refuse treatment. If you withhold information from the patient you must record your reason for doing so in the patient’s medical records, and you must be prepared to explain and justify your decision. You should regularly review your decision, and consider whether you could give information to the patient later, without causing them serious harm. Provision for patients whose first language is not English 6.22 The Trust is committed to ensuring that patients whose first language is not English receive the information they need and are able to communicate appropriately with healthcare staff. It is not appropriate to use children to interpret for family members who do not speak English. 6.23 Details on the Trust’s translation and interpreting service access arrangements are available on the Trust intranet and can be accessed by following this link: http://portal/search/Pages/Results.aspx?k=language%20empire 6.24 The DOH has a list of translated consent forms available on its website5. Access to more detailed or specialist information 6.25 Patients may sometimes request more detailed information about their condition or about a proposed treatment than that provided in general leaflets. The Trust recommends that teams and clinicians examine methods of obtaining detailed information and advise their clients accordingly. Access to health professionals between formal appointments 6.26 After an appointment with a health professional in primary care or in Outpatients, patients will often think of further questions which they would like answered before they take their decision. Where possible, it will be much quicker and easier for the patient to contact the healthcare team by phone than to make another appointment. To this end contact details should be provided to patients when discussing their treatment options and they should be advised to call with any further questions they may have. 5 http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/Publichealth/Scientificd evelopmentgeneticsandbioethics/Consent/Consentgeneralinformation/DH_4001986 CL2 Consent to Examination or Treatment Policy V7 Page 20 of 75 Open access clinics 6.27 Where patients access clinics directly, it should not be assumed that their presence at the clinic implies consent to particular treatment. You should ensure that they have the information they need before proceeding with an investigation or treatment. 7 Documentation 7.1 All decisions to proceed with treatment must be documented using the patient’s healthcare records or the consent forms within this policy. It is essential that the documentation includes both a patients’ agreement to the intervention and a record of the discussions which led to that agreement. 7.2 It should be borne in mind that a patient’s signature on a consent form will not be sufficient evidence of valid consent. This is the reason a record of the discussions must accompany all records of consent. If the consent has been provided verbally then the fact they cannot physically sign is not a bar to treatment. Signatures provided on the consent forms are evidence of their consent at that time and not a binding contract as they may still withdraw consent if they choose to do so. 7.3 Although not a legal requirement to seek written consent healthcare professionals should do so wherever possible. This is particularly important where; • • • • • • The treatment or procedure is complex, or involves significant risks (the term ‘risk’ is used throughout to refer to any adverse outcome, including those which some health professionals would describe as ‘side-effects’ or ‘complications’) The procedure involves general/regional anaesthesia or sedation Providing clinical care is not the primary purpose of the procedure There may be significant consequences for the patient’s employment, social or personal life The treatment is part of a project or programme of research approved by the Trust Written consent is not required for intrauterine and subdermal implant procedures 7.4 Completed forms should be kept with the patient’s healthcare records. Any changes to a form, made after the form has been signed by the patient, should be initialled and dated by both patient and health professional. 7.5 It will not usually be necessary to document a patient’s consent to routine and lowrisk procedures, such as providing personal care or taking a blood sample. However, if you have any reason to believe that the consent may be disputed later or if the procedure is of particular concern to the patient (for example if they have declined, or become very distressed about, similar care in the past), it would be helpful to do so. 7.6 It is good practice to also record an assessment of the patient’s capacity prior to signing any consent forms or records. This will establish they have both the capacity to consent and they have received enough information. Details of the CL2 Consent to Examination or Treatment Policy V7 Page 21 of 75 assessment and the conclusion reached should be recorded by the assessor in the patient’s healthcare records. 7.7 In some cases the patient may be unable to read or write and it is acceptable for them to mark on the form that they consent. It would be good practice for this to be witnessed by a person other than the healthcare professional in charge of the treatment. 7.8 Consent may be expressed verbally or non-verbally: an example of non-verbal consent would be where a person, after receiving appropriate information, holds out an arm for their blood pressure to be taken. However, the person must have understood what examination or treatment is intended, and why, for such consent to be valid. It is good practice to obtain written consent for any significant procedure, such as a surgical operation or when the person participates in a research project or a video recording (even if only minor procedures are involved). 6 7.9 Where a patient is detained under certain sections of the Mental Health Act, the appropriate procedure for obtaining consent for treatment of mental illness should be followed in line with the provisions of that particular section of the MHA. Staff should refer to the separate policy on the treatment of patients subject to the Mental Health Act, CL58. 7.10 Standard consent forms and forms for adults who are unable to consent for themselves are reproduced in Appendix B and are available from the Mental Health Law offices. There are three versions of the standard consent form: form 1 for adults or competent children, form 2 for parental consent for a child or young person and form 3 for cases where it is envisaged that the patient will remain alert throughout the procedure and no anaesthetist will be involved in their care. The use of form 3 is optional but may be thought more appropriate than form 1 in situations where patients do not need to be made aware of issues surrounding general or regional anaesthesia and do not need to make any advance decision about additional procedures because they will be in a position to make any such decisions at the time if necessary. 7.11 Where the treatment is Electro Convulsive Therapy clinicians should refer to that policy for further guidance, CL81. Completing consent forms 7.12 The standard consent forms provide space for a health professional to provide information to patients and to sign confirming that they have done so. The health professional providing the information must be competent to do so: either because they themselves carry out the procedure, or because they have received specialist training in advising patients about this procedure, have been assessed, are aware of their own knowledge limitations and are subject to audit. 7.13 Following the introduction of the new electronic care system (Paris) the system will remain that in all cases, the practitioner should document decisions to proceed with treatment including the patient’s agreement and the discussions that led to the Department of Health - Reference guide to consent for examination or treatment (second edition) 7.12 – 7.15 6 CL2 Consent to Examination or Treatment Policy V7 Page 22 of 75 agreement. If a signature of consent is required then the form must be scanned and uploaded onto the patient’s electronic record. 8 Seeking consent for anaesthesia 8.1 Where an anaesthetist is involved in a patient’s care, it is their responsibility (not that of a surgeon) to seek consent for anaesthesia, having discussed the benefits and risks. However, in elective treatment it is not acceptable for the patient to receive no information about anaesthesia until their pre-operative visit from the anaesthetist: at such a late stage the patient will not be in a position genuinely to make a decision about whether or not to undergo anaesthesia. Patients should therefore either receive a general leaflet about anaesthesia in outpatients, or have the opportunity to discuss anaesthesia in a pre-assessment clinic. The anaesthetist should ensure that the discussion with the patient and their consent is documented in the anaesthetic record, in the patient’s notes or on the consent form. Where the clinician providing the care is personally responsible for anaesthesia (eg where local anaesthesia or sedation is being used), then he or she will also be responsible for ensuring that the patient has given consent to that form of anaesthesia. 8.2 In addition, where general anaesthesia or sedation is being provided as part of dental treatment, the General Dental Council currently holds dentists responsible for ensuring that the patient has all the necessary information. In such cases, the anaesthetist and dentist will therefore share that responsibility. 9 Emergencies 9.1 Clearly in emergencies, the two stages (discussion of options and confirmation that the patient wishes to go ahead) will follow straight on from each other, and it may often be appropriate to use the patient’s notes to document any discussion and the patient’s consent, rather than using a form. The urgency of the patient’s situation may limit the quantity of information that they can be given, but should not affect its quality. 10 Mental Capacity Act and Patients Lacking Capacity Processes Does the person have capacity? 10.1 The MCA (2005) came fully into force in 2007 and applies to everyone who works in health and social care and is involved in the care, treatment or support of people over 16 years of age who may lack capacity to make decisions for themselves. It is largely based on previous common law and creates a single, coherent framework for decision-making, including decisions about treatment. The Act imposes a duty on health professionals (and other healthcare staff) to have regard to the Code of Practice. The Act makes it clear that when determining what is in a person’s best interests a healthcare professional must not make assumptions about someone’s best interests merely on the basis of the person’s age or appearance, condition or any aspect of their behaviour. A healthcare professional must consider all the relevant circumstances relating to the decision in question. These are described as factors that the healthcare professional is aware of and which are reasonable to take into account. CL2 Consent to Examination or Treatment Policy V7 Page 23 of 75 10.2 The MCA defines a person who lacks capacity as a person who is unable to make a decision for themselves because of an impairment or disturbance in the functioning of their mind or brain. It does not matter if the impairment or disturbance is permanent or temporary. A person lacks capacity if: • • 10.3 They have an impairment or disturbance (for example a disability, condition or trauma or the effect of drugs or alcohol) that affects the way their mind or brain works, and That impairment or disturbance means that they are unable to make a specific decision at the time it needs to be made. An assessment of a person’s capacity must be based on their ability to make a specific decision at the time it needs to be made, and not their ability to make decisions in general. A person is unable to make a decision if they cannot do one or more of the following things: Understand the information given to them that is relevant to the decision Retain that information long enough to be able to make the decision Use or weigh up the information as part of the decision-making process Communicate their decision – this could be by talking or using sign language and includes simple muscle movements such as blinking an eye or squeezing a hand. 10.4 People may have capacity to consent to some interventions but not to others, or may have capacity at some times but not others. Under the MCA 2005, a person must be assumed to have capacity unless it is established that they lack capacity. If there is any doubt, then the healthcare professional should assess the capacity of the patient to take the decision in question. This assessment and the conclusions drawn from it should be recorded in the patient’s notes. Guidance on assessing capacity is given in chapter 4 of the MCA (2005) Code of Practice. 10.5 A person’s capacity to consent may be temporarily affected by factors such as communication difficulties e.g. language barriers or impairment; confusion, panic, shock, fatigue, pain or medication. However, the existence of such factors should not lead to an automatic assumption that the person does not have the capacity to consent. 10.6 Capacity should not be confused with a healthcare professional’s assessment of the reasonableness of the person’s decision. Under the MCA 2005 and the common law, a person is not to be treated as unable to make a decision merely because they make an unwise decision. A person is entitled to make a decision which may be perceived by others to be unwise or irrational, as long as they have the capacity to do so. 10.7 However, if the decision that appears irrational is based on a misperception of reality, as opposed to a different value system to that of the health practitioner – for example a patient who, despite the obvious evidence, denies that his foot is gangrenous, or a patient with anorexia nervosa who is unable to comprehend their failing physical condition – then the patient may not be able to comprehend, weigh or make use of the relevant information and hence may lack the capacity to make the decision in question. CL2 Consent to Examination or Treatment Policy V7 Page 24 of 75 10.8 The MCA 2005 also requires that all practical and appropriate steps are taken to enable a person to make the decision themselves. These steps include the following: Providing relevant information. For example, if there is a choice, has information been given on the alternatives? Communicating in an appropriate way. For example, could the information be explained or presented in a way that is easier for the person to understand? Making the person feel at ease. For example, are there particular times of the day when a person’s understanding is better? Supporting the person. For example, can anyone else help or support the person to understand information and to make a choice? Duration of lack of Capacity 10.9 It is possible for capacity to fluctuate. Capacity may be temporary or permanent. In such cases, it is good practice to establish, while the person has capacity, their views about any clinical intervention that may be necessary during a period of anticipated incapacity, and to record these views. The person may wish to make an advance decision to refuse treatment or a statement of their preferences and wishes. If the person does not make a relevant advance decision, decisions about that person’s treatment if they lack capacity must be made in accordance with the MCA 2005. This would include considering whether the person is likely to regain capacity and, if so, whether the decision can wait, as well as the statutory principle that all practical steps must be taken to enable the person to make their own decision. Consent of Adults who lack capacity 10.10 In law, no one is able to give consent to the examination or treatment of an adult who lacks the capacity to give consent for them self, unless they have been authorised to do so under a Lasting Power of Attorney or they have the authority to make treatment decisions as a court appointed deputy. Therefore, in most cases, parents, relatives or members of the healthcare team cannot consent on behalf of such an adult. However, the MCA 2005 sets out the circumstances in which it will be lawful to carry out such examinations or treatment. 10.11 In general, the refusal to an intervention made by a person when they had capacity cannot be overridden if the advance decision is valid and applicable to the situation. There are certain statutory exceptions to this principle, including treatment for mental disorder under certain sections of the Mental Health Act 1983. 10.12 The legal requirements in the MCA 2005 are underpinned by five statutory principles set out in Section 1 of the Act. One of these key principles is that any act done for, or any decision made on behalf of, a person who lacks capacity must be done, or made, in that person’s best interests. This principle applies to health professionals as it does to anyone working with and caring for a person who lacks capacity. The Act also creates a new offence of ill treatment or wilful neglect of someone who lacks capacity by someone with responsibility for their care or with decision-making powers. The 5 statutory principles are summarised as: CL2 Consent to Examination or Treatment Policy V7 Page 25 of 75 1) A presumption of capacity – every adult has the right to make his or her own decisions and must be assumed to have capacity unless it is proved otherwise; 2) The right for individuals to be supported to make their own decisions – people must be given all appropriate help before anyone concludes that they cannot make their own decisions; 3) Individuals must retain the right to make what may be seen as eccentric or unwise decisions; 4) Best Interests – anything done for or on behalf of people without capacity must be in their best interests; and 5) Least restrictive intervention – anything done for or on behalf of people without capacity should be the least restrictive of their basic rights and freedoms. 10.13 In considering the relevant circumstances, the Act rules that the healthcare professionals must take the following steps: Consider whether the person is likely to regain capacity and if so whether the decision can wait. Involve the person as fully as possible in the decision that is being made on their behalf. 10.14 As far as possible consider: The person’s past and present wishes and feelings (in particular if they have been written down) Any beliefs and values (e.g. religious, cultural or moral) that would be likely to influence the decision in question, and any other relevant factors, and The other factors that the person would be likely to consider if they were able to do so. 10.15 As far as possible, consult other people if it is appropriate to do so and take into account their views as to what would be in the best interests of the person lacking capacity, especially: Anyone previously named by the person lacking capacity as someone to be consulted Anyone engaging in caring for or interested in the person’s welfare Any attorney appointed under a Lasting Power of Attorney Any deputy appointed by the Court of Protection to make decisions for the person 10.16 For decisions about serious medical treatment, where there is no one appropriate other than paid staff, healthcare professionals have to instruct an Independent Mental Capacity Advocates (IMCA). If the decision concerns the provision or withdrawal of life-sustaining treatment, the person making the best interests decision must not be motivated by a desire to bring about the person’s death. 10.17 Healthcare professionals should demonstrate in their record-keeping that the decision has been based on all available evidence and has taken into account any conflicting views. What is in a person’s best interests may well change over time. This means that even where similar actions need to be taken repeatedly in connection with the person’s care or treatment, the person’s best interests should be reviewed regularly. CL2 Consent to Examination or Treatment Policy V7 Page 26 of 75 10.18 In cases of serious doubt or dispute about an individual’s mental capacity or best interests, an application can be made to the Court of Protection for a ruling via the Mental Health Law Managers Office. Statements of Preferences and Wishes / Where a patient lacks capacity and continues to refuse treatment 10.19 A healthcare professional must take all statements of a person’s preferences and wishes into consideration as part of a best interest assessment. Written statements which request specific treatments made by a person before losing capacity should be given the same consideration as those made by people who currently have capacity to make treatment decisions. However, a healthcare professional would not have to follow a written request if they thought that the specific treatment would be clinically unnecessary or not appropriate for the person’s condition, and therefore not in the person’s best interests. If the decision is different to a written statement, a healthcare professional should keep a record of this and be prepared to justify the decision if challenged. There is an important legal distinction between a written statement expressing treatment preferences, which a healthcare professional must take into account when making a best interests decision, and a valid and applicable advance decision to refuse treatment which healthcare professionals must follow. Healthcare professionals cannot ignore a written statement that is a valid and applicable advance decision to refuse treatment. Lasting Power of Attorney (LPA) 10.20 The MCA 2005 enables a person aged 18 or over to appoint an attorney to look after their health and welfare decisions if they should lack the capacity to make such decisions in the future. Under a personal welfare LPA, the attorney – if they have the authority to do so – can make decisions that are as valid as those made by the person themselves. The LPA must be made in the form, and meet the criteria, set out in the regulations, and it must be registered with the Office of the Public Guardian before it can be used. 10.21 The LPA may specify limits to the attorney’s authority, and the LPA must specify whether or not the attorney has the authority to make decisions about life-sustaining treatment. Healthcare practitioners directly involved in the care or treatment of a person who lacks capacity should not agree to act as that person’s attorney other than in exceptional circumstances (for example if they are the only close relative of the person). If the person lacks capacity and has created a personal welfare LPA, the attorney will have the authority to make decisions and consent to or refuse treatment as set out in the LPA. Healthcare practitioners should read the LPA if it is available, in order to understand the extent of the attorney’s power. 10.22 The attorney must follow the statutory principles under the MCA 2005 and make decisions in the best interests of the person lacking capacity. If the decision is about life-sustaining treatment, the attorney must not be motivated by a desire to bring about the person’s death. Attorneys also have a legal duty to have regard to the guidance in the MCA 2005 Code of Practice. If there is a dispute that cannot be resolved, e.g. between the attorney and a doctor, it may have to be referred to the Court of Protection. CL2 Consent to Examination or Treatment Policy V7 Page 27 of 75 Court Appointed Deputies 10.23 If a person lacks capacity to make a decision relating to their personal welfare, then the Court of Protection can make an order making a decision on their behalf. Alternatively, the Court of Protection can appoint a deputy to make decisions on behalf of the person who lacks capacity. The MCA 2005 makes it clear that in such situations it is preferable for the Court of Protection to make the decision if at all possible, and that if a deputy is appointed, then their powers should be limited in scope to what is absolutely necessary. 10.24 The court must ensure that any deputy appointed has the necessary skills and abilities and is prepared to take on the duty and responsibility of the role. Both the court and any deputy must follow the statutory principles of the Act and make decisions in the person’s best interests. 10.25 Deputies for personal welfare decisions will only be required in the most difficult cases, where important and necessary actions cannot be carried out without the court’s authority or where there is no other way of settling the matter in the best interests of the person who lacks capacity. For example, a deputy could be appointed to make ongoing decisions, having consulted all relevant parties. This could be useful where there is a history of family disputes. 10.26 If a deputy has been appointed to make treatment decisions on behalf of a person who lacks capacity then it is the deputy rather than the healthcare professional who makes the treatment decision. A deputy cannot go against a decision of an attorney under an LPA made before the person lacks capacity. Deputies must follow the MCA 2005’s statutory principles and must make decisions in the person’s best interests. A deputy cannot refuse consent to the provision of life-sustaining treatment. Independent Mental Capacity Advocates 10.27 The MCA 2005 introduced a duty on NHS bodies to instruct an IMCA in serious medical treatment decisions when a person who lacks capacity to make a decision has no one who can speak for them, other than paid staff. In matters that meet the definition of serious medical treatment, IMCAs are only able to represent and support people whose treatment is arranged by the NHS. They have the right to information about an individual and can see relevant healthcare records. 10.28 The duties of an IMCA are to: support the person who lacks capacity and represent their views and interests to the decision-maker obtain and evaluate information, both through interviewing the person and through examining relevant records and documents obtain the views of professionals providing treatment for the person who lacks capacity identify alternative courses of action obtain a further medical opinion, if required, and prepare a report (that the decision-maker must consider). CL2 Consent to Examination or Treatment Policy V7 Page 28 of 75 10.29 IMCAs are not decision-makers for the person who lacks capacity. They are there to support and represent that person and to ensure that decision-making for people who lack capacity is done appropriately and in accordance with the MCA 2005. More information is given at www.dh.gov.uk/imca and in chapter 10 of the MCA 2005 (2005) Code of Practice. Referral to Court 10.30 The MCA 2005 established the Court of Protection to deal with decision-making for adults (and children in a few cases) who may lack the capacity to make specific decisions for themselves. The Court of Protection deals with serious decisions affecting personal welfare matters, including healthcare, which were previously dealt with by the High Court. In cases of serious dispute, where there is no other way of finding a solution or when the authority of the court is needed in order to make a particular decision or take a particular action, the court can be asked to make a decision. These proceeding can only be commenced via the Trust’s legal team. 10.31 The courts have identified certain circumstances when referral should be made to them for a ruling on lawfulness before a procedure is undertaken. These are: Decisions about the proposed withholding or withdrawal of artificial nutrition and hydration (ANH) from patients in a permanent vegetative state Cases involving organ, bone marrow or peripheral blood stem cell donation by an adult who lacks the capacity to consent Cases involving the proposed non-therapeutic sterilisation of a person who lacks the capacity to consent to this (e.g. for contraceptive purposes), and All other cases where there is a doubt or dispute about whether a particular treatment will be in a person’s best interests. 10.32 Other cases likely to be referred to the court include those involving ethical dilemmas in untested areas or where there are otherwise irresolvable conflicts between healthcare staff, or between staff and family members. The courts have stated that neither sterilisation which is incidental to the management of the detrimental effects of menstruation nor abortion need automatically be referred to court if there is no doubt that this is the most appropriate therapeutic response. However, these procedures can give rise to special concern about the best interests and rights of a person who lacks capacity. The need for such procedures occasionally arises in relation to women with a severe learning disability. It is good practice to involve as part of the decision-making process a consultant in the psychiatry of learning disability, the multidisciplinary team and the patient’s family, and to document their involvement. Less invasive or reversible options should always be considered before permanent sterilisation. Where there is disagreement as to the patient’s best interests, a reference to court may be appropriate. 10.33 It should be noted that, in the future, the courts may extend the list of procedures concerning which referral to the court is good practice. 10.34 Although some procedures may not require court approval, their appropriateness may give rise to concern. For example, some patients with learning disability may exhibit challenging behaviour, such as biting or self-injury. If such behaviour is severe, interventions such as applying a temporary soft splint to the teeth or using CL2 Consent to Examination or Treatment Policy V7 Page 29 of 75 arm splints to prevent self-injury are exceptionally considered, within a wider therapeutic context. As with hysterectomies undertaken for menstrual management purposes, great care must be taken in determining the best interests of such patients as distinct from dealing with the needs of carers and others who are concerned with the individual’s treatment. Withdrawing and withholding life sustaining treatment: General guidance 10.35 A healthcare professional’s legal duty is to care for a patient and to take reasonable steps to prolong their life. Although there is a strong presumption in favour of providing life-sustaining treatment, there are circumstances when continuing or providing life-sustaining treatment stops providing a benefit to a patient and is not clinically indicated. There is no legal distinction between withdrawing and withholding life-sustaining treatment. A person with capacity may decide either contemporaneously or by a valid and applicable advance decision that they have reached a stage where they no longer wish treatment to continue. If a person lacks capacity, this decision must be taken in their best interests and in a way that reflects their wishes (if these are known). 10.36 The legal principles around consent are the same for all medical interventions, including decisions to withdraw or withhold life-sustaining treatment, but the issues surrounding seriously ill or dying patients are necessarily more grave and sensitive. Persons with the capacity to do so can make such decisions for themselves. If the person is an adult who lacks capacity to make such decisions then the provisions of the MCA will apply to these, as to other decisions. When making a best-interests decision in relation to life-sustaining treatment, healthcare professionals should be aware that the MCA 2005 requires that the healthcare professional must not be motivated by a desire to bring about the person’s death. 10.37 Sometimes decisions will need to be made immediately – for example whether it is appropriate to attempt resuscitation after severe trauma. In an emergency situation, where there is doubt as to the appropriateness of treatment, there should be a presumption in favour of providing life-sustaining treatment. When more time is available and the patient is an adult or child without capacity, all those concerned with the care of the patient – relatives, partners, friends, carers and the multidisciplinary team – can potentially make a contribution to the assessment. The discussions and the basis for decisions should be recorded in the notes. 10.38 Legally, the use of artificial nutrition and hydration (ANH) constitutes medical treatment. Thus the legal principles that apply to the use of ANH are the same as those that apply to all other medical treatments, such as medication or ventilation. Decisions about the proposed withholding or withdrawal of ANH from a patient in a permanent vegetative state should be referred to court. 10.39 There is an important distinction between withdrawing or withholding treatment that is of no clinical benefit to the patient or is not in the patient’s best interests, and taking a deliberate action to end the patient’s life. A deliberate action that is intended to cause death is unlawful. Although there is a strong presumption in favour of providing life-sustaining treatment, there are circumstances when continuing or providing life-sustaining treatment stops providing a benefit to a patient and is not clinically indicated. Healthcare professionals should discuss the situation with a patient with capacity and agree if and when the patient no longer CL2 Consent to Examination or Treatment Policy V7 Page 30 of 75 wishes treatment to continue. If the patient lacks capacity, this decision must be taken in their best interests and in a way that reflects their wishes, beliefs and values (if these are known). Suitable care should be provided to ensure that both the comfort and dignity of the patient are maintained. Withdrawing and withholding life sustaining treatment: Adults and Children with Capacity 10.40 Except in circumstances governed by the Mental Health Act 1983, if an adult with the capacity to make the decision refuses life-sustaining treatment, or requests that it be withdrawn, practitioners must comply with the person’s decision, even if it may result in the person’s death. If a refusal is ignored, they will be treating the person unlawfully. 10.41 An adult patient with capacity does not have the legal right to demand treatment that is not clinically indicated. Where a patient with capacity indicates his or her wish to be kept alive by the provision of ANH, the doctor’s duty of care will require them to provide ANH while such treatment continues to prolong life. A patient cannot demand that a healthcare professional do something unlawful such as assisting them to commit suicide. 10.42 If a child with capacity makes such a request or refusal it is possible that such a refusal could be overruled if it would in all probability lead to the death of the child or to severe permanent injury. Moreover, the courts consider that to take a decision which may result in the individual’s death requires a very high level of understanding, so that many young people who would have the capacity to take other decisions about their medical care would lack the capacity to make such a grave decision. 10.43 Refusal of treatment by a child with capacity must always be taken very seriously, even though legally it is possible to override their objections. It is not a legal requirement to continue a child’s life-sustaining treatment in all circumstances. For example, where the child is suffering an illness where the likelihood of survival even with treatment is extremely poor, and treatment will pose a significant burden to the child, it may not be in the best interests of the child to continue treatment. Withdrawing and withholding life sustaining treatment: Adults and Children lacking Capacity 10.44 If a child lacks capacity, it is still good practice to involve the child as far as is possible and appropriate in the decision. The decision to withdraw or withhold lifesustaining treatment must be made in the best interests of the child. The best interests of a child in the context of the withholding of medical treatment should be interpreted more broadly than medical interests, and should include emotional and other factors. There is a strong presumption in favour of preserving life, but not where treatment would be futile, and there is no obligation on healthcare professionals to give treatment that would be futile. If there is disagreement between those with parental responsibility for the child and the clinical team concerning the appropriate course of action, a ruling should be sought from the court as early as possible, to action this the clinician in charge must contact the Mental Health Law Manager. CL2 Consent to Examination or Treatment Policy V7 Page 31 of 75 10.45 A person with parental responsibility for a child or young person is legally entitled to give or withhold consent to treatment. A person with parental responsibility cannot demand a particular treatment to be continued where the burdens of the treatment clearly outweigh the benefits for the child. If agreement cannot be reached between the parent(s) and the healthcare professionals, a court should be asked to make a declaration about whether the provision of life-sustaining treatment would benefit the child. In exceptional cases, the court may be willing to authorise the withdrawal of life-sustaining treatment against the parents’ wishes. However, the views of the parents are given great weight by the courts and are usually determinative unless they conflict with the child’s best interests. 10.46 If an adult lacks capacity, and has not made a valid and applicable advance decision to refuse life-sustaining treatment, the provisions of the MCA (2005) will apply and the decision must be based on the best interests of the adult, again involving the person as far as this is possible. As with all decisions made under the MCA (2005), before deciding to withdraw or withhold life-sustaining treatment, the healthcare professional must consider the range of treatment options available in order to work out what would be in the person’s best interests. All of the factors set out in the MCA (2005) Code of Practice should be considered, and in particular the healthcare professional should consider any statements that the person has previously made about their wishes and feelings about life-sustaining treatment. Healthcare professionals should also refer to relevant professional guidance when making decisions regarding life-sustaining treatment. 10.47 Where a patient had indicated, while they had capacity, his or her wish to be kept alive by the provision of ANH, the doctor’s duty of care will require the doctors to provide ANH while such treatment continues to prolong life. Where life depends upon the continued provision of ANH, ANH will be clinically indicated. If the patient lacks capacity, all reasonable steps that are in the person’s best interests should be taken to prolong their life. Although there is a strong presumption in favour of providing life-sustaining treatment, there are circumstances when continuing or providing life-sustaining treatment stops providing a benefit to a patient and is not clinically indicated. 10.48 Where treatment is provided to a person who lacks capacity following a best interests decision, any consent form should not be signed by someone else unless they have a personal welfare LPA that authorises them to make the decision in question, or they are a court appointed deputy with similar authority. It is good practice to note either in the records or on a ‘patient unable to consent’ form why the treatment was decided to be in the patient’s best interests. 11 Self Harm 11.1 Where the person is able to communicate, an assessment of their mental capacity should be made as a matter of urgency. If the person is judged not to have capacity, then they may be treated on the basis of temporary incapacity. Similarly, patients who have attempted suicide and are unconscious should be given emergency treatment if any doubt exists as to either their intentions or their capacity when they took the decision to attempt suicide. 11.2 However, patients with capacity do have the right to refuse life-sustaining treatment (other than treatment for mental disorder under the Mental Health Act 1983) – both CL2 Consent to Examination or Treatment Policy V7 Page 32 of 75 at the time it is offered and in the future. Making a decision which, if followed, may result in death does not necessarily mean that a person is or feels suicidal. Nor does it necessarily mean that the person lacks the capacity to make the decision now or in advance. If the person is clearly suicidal, this may raise questions about their capacity to make the decision. If a patient with capacity has harmed themselves, a prompt psychosocial assessment of their needs should be offered. However, if the person refuses treatment and use of the Mental Health Act 1983 is not appropriate, then their refusal must be respected. Similarly, if practitioners have good reason to believe that a patient genuinely intended to end their life and had capacity when they took that decision, and are satisfied that the Mental Health Act is not applicable, then treatment should not be forced upon the person, although clearly attempts should of course be made to encourage them to accept help. 12 Treatment of Children and Young People 12.1 Acknowledging that the requirement for healthcare professionals to gain written consent from a child’s parent prior to vaccination and immunisation. Forms are available for this specific purpose and the forms within this policy should not be used but the principles and processes within this document still remain applicable. 12.2 Within a school health service there is a standard operating procedure for informed positive consent by adults with parental responsibility. DOH guidance 7 provides for one exception to the need for positive consent for the monitoring of a child’s height and weight at reception year 5 and 6, under the National Child Measurement Programme. 12.3 For the purposes of this policy ‘children’ refers to people aged below 16 and ‘young people’ refers to people aged 16–17. 12.4 Although a child or young person may have the capacity to give consent, this is only valid if it is given voluntarily. This requirement must be considered carefully. Children and young people may be subject to undue influence by their parent(s), other carers or a sexual partner (current or potential), and it is important to establish that the decision is that of the individual him or herself. Children or Young People with capacity refusing treatment 12.5 Where a young person of 16 or 17 who could consent to treatment, or a child under 16 with Fraser competency refuses treatment, it is possible to gain a court order that such a refusal could be overruled if it would in all probability lead to the death of the child/young person or to severe permanent injury. 12.6 The courts have, in the past, ruled that parents can consent to their competent child being treated even where the child/young person is refusing treatment. However, there is no post-Human Rights Act 1998 authority for this proposition, and it would therefore be prudent to obtain a court declaration or decision if faced with a competent child or young person who is refusing to consent to treatment, to determine whether it is lawful to treat the child. Where the treatment involved is for mental disorder, consideration should be given to using mental health legislation. 7 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/487707/NCMPguidance20151 6FINAL.PDF CL2 Consent to Examination or Treatment Policy V7 Page 33 of 75 The changes made to section 131 of the Mental Health Act 1983 by section 43 of the Mental Health Act 2007 mean that when a young person of 16 or 17 has capacity (as defined in the MCA 2005) and does not consent to admission for treatment for mental disorder (either because they are overwhelmed, do not want to consent or refuse to consent), they cannot then be admitted informally on the basis of the consent of a person with parental responsibility. 12.7 A life-threatening emergency may arise when consultation with either a person with parental responsibility or the court is impossible, or the person with parental responsibility refuses consent despite such emergency treatment appearing to be in the best interests of the child. In such cases the courts have stated that doubt should be resolved in favour of the preservation of life, and it will be acceptable to undertake treatment to preserve life or prevent serious damage to health. Children under 16 (the concept of Fraser Guidelines) 12.8 In the case of Fraser Guidelines, children who have sufficient understanding to enable them to understand fully what is involved in a proposed intervention will also have the capacity to consent to that intervention. This is sometimes described as being ‘Fraser competent’. A child of under 16 may be Fraser competent to consent to medical treatment, research, donation or any other activity that requires their consent. 12.9 The concept of Fraser Guidelines is said to reflect a child’s increasing development to maturity. The understanding required for different interventions will vary considerably. Thus a child under 16 may have the capacity to consent to some interventions but not to others. The child’s capacity to consent should be assessed carefully in relation to each decision that needs to be made. 12.10 In some cases, for example because of a mental disorder, a child’s mental state may fluctuate significantly, so that on some occasions the child appears Fraser competent in respect of a particular decision and on other occasions does not. In cases such as these, careful consideration should be given as to whether the child is truly Fraser competent the time that they need to take a relevant decision. 12.11 If the child is Fraser competent and is able to give voluntary consent after receiving appropriate information, that consent will be valid and additional consent by a person with parental responsibility will not be required. It is, however, good practice to involve the child’s family in the decision-making process, if the child consents to their information being shared. 12.12 Where advice or treatment relates to contraception, or the child’s sexual or reproductive health, the healthcare professional should try to persuade the child to inform his or her parent(s), or allow the medical professional to do so. If however the child cannot be persuaded, advice and/or treatment should still be given if the healthcare professional considers that the child is very likely to begin or continue to have sexual intercourse with or without advice or treatment, and that unless they receive the advice or treatment then the child’s physical or mental health is likely to suffer. If the child seeks advice or treatment in relation to abortion and cannot be persuaded to inform her parent(s), every effort should be made to help the child find CL2 Consent to Examination or Treatment Policy V7 Page 34 of 75 another adult (such as another family member or a Specialist Young People’s Worker) to provide support to the child. Children Lacking Capacity 12.13 Where a child under the age of 16 lacks capacity to consent (i.e. is not Fraser competent), consent can be given on their behalf by any one person with parental responsibility (if the matter is within the ‘zone of parental control) or by the court. As is the case where patients are giving consent for themselves, those giving consent on behalf of child patients must have the capacity to consent to the intervention in question, be acting voluntarily and be appropriately informed. The power to consent must be exercised according to the ‘welfare principle’: that the child’s ‘welfare’ or ‘best interests’ must be paramount. Even where a child lacks capacity to consent on their own behalf, it is good practice to involve the child as much as possible in the decision-making process. 12.14 Where necessary, the courts can overrule a refusal by a person with parental responsibility. It is recommended that certain important decisions, such as sterilisation for contraceptive purposes, should be referred to the courts for guidance, even if those with parental responsibility consent to the operation going ahead. 12.15 Treating a child contrary to his parent’s wishes, without a court order is not only a breach of professional guidance but also potentially a breach of the European Convention on Human Rights. In situations where there is continuing disagreement or conflict between those with parental responsibility and Practitioners, and where the child is not competent to provide consent, the court should be involved to clarify whether a proposed treatment, or withholding of treatment, is in the child’s best interests. Parental refusal can only be overridden in an emergency. Who has Parental Responsibility 12.16 The Children Act 1989 sets out persons who may have parental responsibility. The Act defines parental responsibility as ‘all rights, duties, powers, responsibilities and authorities which by law a parent or child has in relation to the child and his property. These include: The child’s mother (biological) or by adoption The child’s father, by adoption or if he was married to the mother at the time of birth Unmarried fathers, who can acquire parental responsibility in several different ways CL2 Consent to Examination or Treatment Policy V7 Page 35 of 75 For children born before 1 December 2003, unmarried fathers will have parental responsibility if they: - marry the mother of their child or obtain a parental responsibility order from the court; - register a parental responsibility agreement with the court or by an application to court For children born after 1 December 2003, unmarried fathers will have parental responsibility if they: - register the child’s birth jointly with the mother at the time of birth - re-register the birth if they are the natural father - marry the mother of their child or obtain a parental responsibility order from the court - register with the court for parental responsibility The child’s legally appointed guardian (Parents with parental responsibility may also appoint a guardian in the event of their own death) A person in whose favour the court has made a residence order concerning the child A local authority designated in a care order in respect of the child A local authority or other authorised person who holds an emergency protection order in respect of the child. Section 2(9) of the Children Act 1989 states that a person who has parental responsibility for a child ‘may arrange for some or all of it to be met by one or more persons acting on his or her behalf’. Such a person might choose to do this, for example, if a childminder or the staff of a boarding school have regular care of their child. As only a person exercising parental responsibility can give valid consent, in the event of any doubt then specific enquiry should be made. Foster parents do not automatically have parental responsibility. 12.17 Consent given by one person with parental responsibility is valid, even if another person with parental responsibility withholds consent. However, the courts have stated that a ‘small group of important decisions’ should not be taken by one person with parental responsibility against the wishes of another, citing in particular nontherapeutic male circumcision and immunisation. 12.18 Where persons with parental responsibility disagree as to whether these procedures are in the child’s best interests, it is advisable to refer the decision to the courts. It is possible that major experimental treatment, where opinion is divided as to the benefits it may bring the child, might also fall into this category of important decisions. 12.19 Where there is doubt about whether a parent is acting in the interest of the child or young person, then the healthcare practitioner would be unwise to rely on the parent’s consent, for example if a child alleges abuse and the parent supports psychiatric treatment for the child. The Government’s guidance Working Together to Safeguard Children covers situations involving parental consent where abuse or neglect is suspected8. 8https://www.gov.uk/government/publications/working-together-to-safeguard-children--2 http://www.childrenscommissioner.gov.uk/publications/young-person-guide-working-together-safeguardchildren CL2 Consent to Examination or Treatment Policy V7 Page 36 of 75 12.20 In order to consent on behalf of a child, the person with parental responsibility must themselves have capacity. Where the person with parental responsibility for a child is them self under 18, they will only be able to give valid consent for the child’s treatment if they themselves are Fraser Guidelines competent. Whether or not they have capacity may vary, depending on the seriousness of the decision to be taken. 12.21 Where a child is a ward of court, no important step may be taken in the life of the child without the prior consent of the court. This is likely to include more significant medical interventions but not treatment for minor injuries or common diseases of childhood. In an emergency, it is justifiable to treat a child who lacks capacity without the consent of a person with parental responsibility, if it is impossible to obtain consent in time and if the treatment is vital to the survival or health of the child. Young People 12.22 By virtue of section 8 of the Family Law Reform Act 1969, people aged 16 or 17 are presumed to be capable of consenting to their own medical treatment, and any ancillary procedures involved in that treatment, such as an anaesthetic. As for adults, consent will be valid only if it is given voluntarily by an appropriately informed young person capable of consenting to the particular intervention. However, unlike adults, the refusal of a competent person aged 16–17 may in certain circumstances be overridden by either a person with parental responsibility or a court. 12.23 The Act does not apply to an intervention that is not potentially of direct health benefit to the young person, such as blood donation or non-therapeutic research on the causes of a disorder. However, a young person may be able to consent to such an intervention under the standard of Fraser Guidelines. 12.24 In order to establish whether a young person aged 16 or 17 has the requisite capacity to consent to the proposed intervention, the same criteria as for adults should be used. If a young person lacks capacity to consent because of an impairment of, or a disturbance in the functioning of, the mind or brain then the MCA (2005) will apply in the same way as it does to those who are 18 and over. If however they are unable to make the decision for some other reason, for example because they are overwhelmed by the implications of the decision, then the Act will not apply to them and the legality of any treatment should be assessed under common law principles. It may be unclear whether a young person lacks capacity within the meaning of the Act. In those circumstances, it would be prudent to seek a declaration from the court. More information on how the Act applies to young people is given in chapter 12 of the MCA (2005) Code of Practice 12.25 If the 16/17-year-old is capable of giving valid consent then it is not legally necessary to obtain consent from a person with parental responsibility for the young person in addition to the consent of the young person. It is, however, good practice to involve the young person’s family in the decision-making process – unless the young person specifically wishes to exclude them – if the young person consents to their information being shared. CL2 Consent to Examination or Treatment Policy V7 Page 37 of 75 13 Tissue 13.1 The Human Tissue Act came into force on 1st September 2006, having been passed as law in 2004.It replaces a variety of existing laws and establishes an updated legislative framework for regulating body donation and the removal, storage, and use of human organs and tissues. Informed consent is now the fundamental principle underpinning the lawful removal, storage and use of human tissue and organs. Non-compliance with the Act can lead to severe penalties, ranging from fines through to imprisonment of up to three years. The Human Tissue Act sets out detailed requirements for obtaining consent in different situations, including obtaining consent from adults who lack the capacity to consent, children, and from the deceased or their relatives/representatives. Further guidance on consent and codes of practice are available on the HTA’s website, these should be consulted to ensure compliance as well as chapter 11 of the MCA Code of Practice. At present, the Trust requires that patients must be given the opportunity to refuse permission for tissue taken from them during surgery or other procedure to be used for education or research purposes. This should be undertaken using the consent forms provided. The removal of tissue from a person as part of their diagnosis or treatment does not fall within the scope of the Act and is covered by the usual legal and ethical requirements for consent to treatment 13.2 Explicit consent is not necessary for public health surveillance using the unlinked anonymous method, but a well-publicised opt-out policy must apply. 13.3 The Department of Health believes that tissue samples may be used for quality assurance purposes without requiring specific patient consent provided there is an active policy of informing patients of such use. This is essential to ensure the high quality of service which all patients have the right to expect. Wherever possible, samples of tissue used in this way should be anonymised or pseudonymised. 13.4 It should be noted that the guidance above is for information purposes only. The Trust does not routinely take tissue samples for research purposes, however blood samples are taken and in some instances these may fall into the category of ‘tissue sample’ 14 Clinical photography and conventional or digital video recording 14.1 Photographic and video recordings made for clinical purposes form part of a patient’s record. Although consent to certain recordings, such as X-rays, is implicit in the patient’s consent to the procedure, health professionals should always ensure that they make clear in advance if any photographic or video recording will result from that procedure. 14.2 Photographic and video recordings which are made for treating or assessing a patient must not be used for any purpose other than the patient’s care or the audit of that care, without the express consent of the patient or a person with parental responsibility for the patient. If you wish to use such a recording for education, publication or research purposes, you must seek consent in writing, ensuring that the person giving consent is fully aware of the possible uses of the material. In particular, the person must be made aware that you may not be able to control future use of the material once it has been placed in the public domain. If a child is CL2 Consent to Examination or Treatment Policy V7 Page 38 of 75 not willing for a recording to be used, you must not use it, even if a person with parental responsibility consents. 14.3 Photographic and video recordings, made for treating or assessing a patient and from which there is no possibility that the patient might be recognised, may be used within the clinical setting for education or research purposes without express consent from the patient, as long as this policy is well publicised. However, express consent must be sought for any form of publication. 14.4 If you wish to make a photographic or video recording of a patient specifically for education, publication or research purposes, you must first seek their written consent (or where appropriate that of a person with parental responsibility) to make the recording, and then seek their consent to use it. Patients must know that they are free to stop the recording at any time and that they are entitled to view it if they wish, before deciding whether to give consent to its use. If the patient decides that they are not happy for any recording to be used, it must be destroyed. As with recordings made with therapeutic intent, patients must receive full information on the possible future uses of the recording, including the fact that it may not be possible to withdraw it once it is in the public domain. 14.5 The situation may sometimes arise where you wish to make a recording specifically for education, publication or research purposes, but the patient is temporarily unable to give or withhold consent because, for example, they are unconscious. In such cases, you may make such a recording, but you must seek consent as soon as the patient regains capacity. You must not use the recording until you have received consent for its use, and if the patient does not consent to any form of use, the recording must be destroyed. 14.6 If a patient is unable to give consent for a recording to be made then it may still be possible to continue, provided that the provisions and principles of the Mental Capacity Act 2005 and Code of Practice are followed. You should not make, or use, any recording if the purpose of the recording could equally well be met by recording patients who are able to give or withhold consent. 15 Impact of Policy on CQC Registration 15.1 This policy and adherence to this policy has a direct impact on the Trusts registration with the CQC. The areas covered within this policy are directly linked to the Core Quality and Safety Standards. The key outcomes are: Outcome 1 - Respecting and involving people who use services Outcome 2 - Consent to care and treatment Outcome 4 - Care and welfare of people who use services 15.2 Outcome 1 specifies the following expectations which should be observed in line with this policy: People who use services: Understand the care, treatment and support choices available to them. Can express their views, so far as they are able to do so, and are involved in making decisions about their care, treatment and support. CL2 Consent to Examination or Treatment Policy V7 Page 39 of 75 Have their privacy, dignity and independence respected. Have their views and experiences taken into account in the way the service is provided and delivered. Those acting on behalf of people who use services: Understand the care, treatment and support choices available to the people who use services. Can represent the views of the person using the service by expressing these on their behalf, and are involved appropriately in making decisions about their care, treatment and support. This is because providers who comply with the regulations will: Recognise the diversity, values and human rights of people who use services. Uphold and maintain the privacy, dignity and independence of people who use services. Put people who use services at the centre of their care, treatment and support by enabling them to make decisions. Provide information that supports people who use services or others acting on their behalf, to make decisions about their care, treatment and support. Support people who use services or others acting on their behalf, to understand the care, treatment and support provided. 15.3 Outcome 2 specifies the following expectations which should be observed in line with this policy; People who use services: Where they are able, give valid consent to the examination, care, treatment and support they receive. Understand and know how to change any decisions about examination, care, treatment and support that has been previously agreed. Can be confident that their human rights are respected and taken into account. This is because providers who comply with the regulations will: Have systems in place to gain and review consent from people who use services, and act on them. 15.4 Outcome 4 specifies the following expectations which should be observed in line with this policy: People who use services: Experience effective, safe and appropriate care, treatment and support that meets their needs and protects their rights. This is because providers who comply with the regulations will: Reduce the risk of people receiving unsafe or inappropriate care, treatment and support by: – Assessing the needs of people who use services – Planning and delivering care, treatment and support so that people are safe, their welfare is protected and their needs are met – Taking account of published research and guidance CL2 Consent to Examination or Treatment Policy V7 Page 40 of 75 – Making reasonable adjustments to reflect people’s needs, values and diversity – Having arrangements for dealing with foreseeable emergencies. 16 Monitoring 16.1 The application of this policy will be overseen by the Mental Health Law Scrutiny Group. 16.2 The processes and principles of this policy where applicable will be included in clinical audits where this is considered appropriate. 16.3 The requirements of this policy will be used as a standard for investigations in to complaints and investigations relating to the examination and treatment of people coming in to contact with our services. 17 Implementation and Training Implementation 17.1 This policy will be issued and implemented to staff to ensure employees have access to and are able to comply with the processes within by way of; Lists of all new policies are published in the Trust’s Corporate Brief including a brief description and its intended audience. All policies are held on the Trusts intranet to which all staff have access. Staff should always consult the intranet for the latest version available. Ward and Clinical area’s should have the latest version on file and the responsibility for monitoring this is the Ward Manager / Team Leader. The Mental Health Law Manager is responsible for distributing the latest version of this policy through the existing governance structures to healthcare professionals Ward Managers / Team Leaders /Line managers are responsible for cascading details of the policy to staff they supervise. All employees are responsible for ensuring they understand the contents of this policy and associated procedures and act accordingly. Training 17.2 Information on and training in the procedures for consent to examination and treatment appear within the Mental Health Law Training programmes. These are delivered through the induction training and Principles of Governance training. 17.2 The Trust Training Needs Analysis incorporates the Mental Health Law format and minimum delivery standards. 17.3 Mental Health Law is used to encompass the Mental Health Act, Mental Capacity Act and consent law provision across the Trust for all services. Training sessions will be clearly identified where they are specific to one service of the Trust i.e. Mental Health staff only. All other sessions will be advertised and available to all staff with booking through the Learning and Development Team. CL2 Consent to Examination or Treatment Policy V7 Page 41 of 75 18 References Department of Health (2001) Seeking Consent: Working with children. London: Department of Health). GMC (2008) Consent: patients and doctors making decisions together. London: GMC Department of Health (2009) Reference guide to consent for examination or treatment, second edition 2009 Office of the Public Guardian 2013 Mental Capacity Act Code of Practice 2005 Department of Health (2015) Mental Health Act 1983 Code of Practice. London: The Stationery Office. NHS Choices (2015) Consent to treatment. Web page content http://www.nhs.uk/conditions/consent-to-treatment/pages/introduction.aspx CL2 Consent to Examination or Treatment Policy V7 Page 42 of 75 APPENDIX 1 Consent Form 1 Patient Agreement to Investigation or Treatment Patient Surname Date of Birth First Name NHS Number Special Requirements? Male / Female Responsible Health Professional (PRINT NAME) Job Title Contact Number Name of proposed procedure or course of treatment (include brief explanation if medical term not clear) Statement of health professional (to be filled in by health professional with appropriate knowledge of proposed procedure, as specified in consent policy) I have explained the procedure to the patient. In particular, I have explained: The intended benefits Risks including any material risks (as specified in the policy) Blood Transfusion Any extra procedures Other (specify) which may become necessary during the procedure I have also discussed what the procedure is likely to involve, the benefits and risks of any available alternative treatments (including no treatment) and any particular concerns of this patient. I have provided the patient with the following leaflets, tape or printed information: This procedure involves General or regional anaesthesia Signed Local anaesthesia Sedation Date Contact Details (for patient if they wish to discuss options later) Statement of Interpreter (where appropriate) I have interpreted the information above to the patient to the best of my ability and in a way in which I believe s/he can understand. Signed Date Name (Print) Top Copy Accepted by Patient: Yes / No (please circle) CL2 Consent to Examination or Treatment Policy V7 Page 43 of 75 Statement of Patient Please read this form carefully. If your treatment has been planned in advance, you should already have your own copy of page 1 which describes the benefits and risks of the proposed treatment. If not, you will be offered a copy now. If you have any further questions, do ask – we are here to help you. You have the right to change your mind at any time, including after you have signed this form. I agree to the procedure or course of treatment described on this form. I understand that you cannot give me a guarantee that a particular person will perform the procedure. The person will, however, have appropriate experience. I understand that I will have the opportunity to discuss the details of anesthesia with an anesthetist before the procedure, unless the urgency of my situation prevents this. (This only applies to patients having general or regional anesthesia.) I understand that any procedure in addition to those described on this form will only be carried out if it is necessary to save my life or to prevent serious harm to my health. I have been told about additional procedures which may become necessary during my treatment. I have listed below any procedures which I do not wish to be carried out without further discussion Signature Name (PRINT) Date A witness should sign below if the patient is unable to sign but has indicated his or her consent. Young people/children may also like a parent to sign here (see notes). Signature Name (PRINT) Date Confirmation of consent (to be completed by a health professional when the patient is admitted for the procedure, if the patient has signed the form in advance) On behalf of the team treating the patient, I have confirmed with the patient that s/he has no further questions and wishes the procedure to go ahead. Signature Date Name (PRINT) Job Title Important notes: (tick if applicable) See also advance decision/living will (eg Jehovah’s Witness form) Patient has withdrawn consent (ask patient to sign /date here) ……………...………. CL2 Consent to Examination or Treatment Policy V7 Page 44 of 75 APPENDIX 2 Consent Form 2 Parental agreement to investigation or treatment for a child or young person Patient Surname Date of Birth Male / Female Age Responsible Health Professional (PRINT NAME) Job Title First Name NHS Number Special Requirements? Contact Number Name of proposed procedure or course of treatment (include brief explanation if medical term not clear) Statement of health professional (to be filled in by health professional with appropriate knowledge of proposed procedure, as specified in consent policy) I have explained the procedure to the patient. In particular, I have explained: The intended benefits Risks including any material risks (as specified in the policy) Blood Transfusion Any extra procedures Other (specify) which may become necessary during the procedure I have also discussed what the procedure is likely to involve, the benefits and risks of any available alternative treatments (including no treatment) and any particular concerns of this patient. I have provided the patient with the following leaflets, tape or printed information: This procedure involves General or regional anaesthesia Signed Local anaesthesia Sedation Date Contact Details (for child / parent if they wish to discuss options later) Statement of Interpreter (where appropriate) I have interpreted the information above to the child and his or her parents to the best of my ability and in a way in which I believe they can understand. Signed Date Name (Print) Top Copy Accepted by Patient: Yes / No (please circle) CL2 Consent to Examination or Treatment Policy V7 Page 45 of 75 Statement of Parent Please read this form carefully. If the procedure has been planned in advance, you should already have your own copy of page 2 which describes the benefits and risks of the proposed treatment. If not, you will be offered a copy now. If you have any further questions, do ask – we are here to help you and your child. You have the right to change your mind at any time, including after you have signed this form. I agree to the procedure or course of treatment described on this form and I confirm that I have ‘parental responsibility’ for this child. I understand that you cannot give me a guarantee that a particular person will perform the procedure. The person will, however, have appropriate experience. I understand that my child and I will have the opportunity to discuss the details of anaesthesia with an anaesthetist before the procedure, unless the urgency of the situation prevents this. (This only applies to children having general or regional anaesthesia.) I understand that any procedure in addition to those described on this form will only be carried out if it is necessary to save the life of my child or to prevent serious harm to his or her health. I have been told about additional procedures which may become necessary during my child’s treatment. I have listed below any procedures which I do not wish to be carried out without further discussion Signature Name (PRINT) Date Relationship to Child Child’s agreement to treatment (if child wishes to sign) I agree to have the treatment I have been told about. Signature Name (PRINT) Date Confirmation of consent (to be completed by a health professional when the child is admitted for the procedure, if the parent/child have signed the form in advance) On behalf of the team treating the patient, I have confirmed with the child and his or her parent(s) that they have no further questions and wish the procedure to go ahead. Signature Date Name (PRINT) Job Title Important notes: (tick if applicable) See also advance decision/living will (e.g. Jehovah’s Witness form) Parent has withdrawn consent (ask parent to sign /date here ……………...………. CL2 Consent to Examination or Treatment Policy V7 Page 46 of 75 APPENDIX 3 Consent Form 3 Patient/parental agreement to investigation or treatment (procedures where consciousness not impaired) Patient Surname Date of Birth Male / Female Responsible Health Professional (PRINT NAME) Job Title First Name NHS Number Special Requirements? Contact Number Statement of health professional (to be filled in by health professional with appropriate knowledge of proposed procedure, as specified in consent policy) I have explained the procedure to the patient. In particular, I have explained: The intended benefits Risks including any material risks (as specified in the policy) I have also discussed what the procedure is likely to involve, the benefits and risks of any available alternative treatments (including no treatment) and any particular concerns of this patient. I have provided the patient with the following leaflets, tape or printed information: This procedure involves General or regional anaesthesia Local anaesthesia Sedation Signed Date Contact Details (for patient if they wish to discuss options later) Statement of patient/person with parental responsibility for patient I agree to the procedure described above. I understand that you cannot give me a guarantee that a particular person will perform the procedure. The person will, however, have appropriate experience. I understand that the procedure will/will not involve local anaesthesia. Signature Date Name (PRINT) Relationship to Patient Confirmation of consent (to be completed by a health professional when the patient is admitted for the procedure, if the patient/parent has signed the form in advance) I have confirmed that the patient/parent has no further questions and wishes the procedure to go ahead. Signature Date Name (PRINT) Job Title Top Copy Accepted by Patient: Yes / No (please circle) CL2 Consent to Examination or Treatment Policy V7 Page 47 of 75 APPENDIX 4 Consent Forms - Guidance to Health Professionals (to be read in conjunction with consent policy, Consent Form 1 -3) What a consent form is for This form documents the patient’s agreement to go ahead with the investigation or treatment you have proposed. It is not a legal waiver – if patients, for example, do not receive enough information on which to base their decision, then the consent may not be valid, even though the form has been signed. Patients are also entitled to change their mind after signing the form, if they retain capacity to do so. The form should act as an aide-memoire to health professionals and patients, by providing a check-list of the kind of information patients should be offered, and by enabling the patient to have a written record of the main points discussed. In no way, however, should the written information provided for the patient be regarded as a substitute for face-to-face discussions with the patient. competent to give consent but is physically unable to sign a form, you should complete this form as usual, and ask an independent witness to confirm that the patient has given consent orally or non-verbally. When NOT to use this form If the patient is 18 or over and is not legally competent to give consent, you should use form 4 (form for adults who are unable to consent to investigation or treatment) instead of this form. A patient will not be legally competent to give consent if: they are unable to comprehend and retain information material to the decision and/or they are unable to weigh and use this information in coming to a decision. You should always take all reasonable steps (for example involving more specialist colleagues) to support a patient in making their own decision, before concluding that they are unable to do so. Relatives cannot be asked to sign this form on behalf of an adult who is not legally competent to consent for himself or herself. Information The law on consent See the Department of Health’s Reference guide to consent for examination or treatment for a comprehensive summary of the law on consent (also available at www.doh.gov.uk/consent). Who can give consent Everyone aged 16 or more is presumed to be competent to give consent for themselves, unless the opposite is demonstrated. If a child under the age of 16 has “sufficient understanding and intelligence to enable him or her to understand fully what is proposed”, then he or she will be competent to give consent for himself or herself. Young people aged 16 and 17, and legally ‘competent’ younger children, may therefore sign this form for themselves, but may like a parent to countersign as well. If the child is not able to give consent for himself or herself, some-one with parental responsibility may do so on their behalf and a separate form is available for this purpose. Even where a child is able to give consent for himself or herself, you should always involve those with parental responsibility in the child’s care, unless the child specifically asks you not to do so. If a patient is mentally CL2 Consent to Examination or Treatment Policy V7 Information about what the treatment will involve, its benefits and risks (including side-effects and complications) and the alternatives to the particular procedure proposed, is crucial for patients when making up their minds. The courts have stated that patients must be told about ‘significant risks which would affect the judgement of a reasonable patient’. ‘Significant’ has not been legally defined, but the GMC requires doctors to tell patients about ‘serious or frequently occurring’ risks. In addition if patients make clear they have particular concerns about certain kinds of risk, you should make sure they are informed about these risks, even if they are very small or rare. You should always answer questions honestly. Sometimes, patients may make it clear that they do not want to have any information about the options, but want you to decide on their behalf. In such circumstances, you should do your best to ensure that the patient receives at least very basic information about what is proposed. Where information is refused, you should document this on page 1 of the form or in the patient’s notes. Page 48 of 75 APPENDIX 5 Consent Form 4 Form for adults who are unable to consent to investigation or treatment Patient Surname Date of Birth Male / Female Date of Birth Responsible Health Professional (PRINT NAME) Job Title First Name NHS Number Special Requirements? NHS Number Contact Number Name of proposed procedure or course of treatment (include brief explanation if medical term not clear) Assessment of Capacity I confirm that the patient lacks capacity to give or withhold consent to this procedure or course of treatment because: the patient is unable to comprehend the information relevant to the decision and/or retain information material to the decision; and/or the patient is unable to use or weigh this information in the decision-making process; or The patient is unable to communicate their decision Further details (excluding where patient unconscious): for example how above judgements’ reached; which colleagues consulted; what attempts made to assist the patient make his or her own decision and why these were not successful. Assessment of Patients Best Interests To the best of my knowledge, the patient has not refused this procedure in a valid advance directive. Where possible and appropriate, I have consulted with colleagues and those close to the patient, and I believe the procedure to be in the patient’s best interests because: The treatment cannot wait until the patient recovers capacity because: (Where incapacity is likely to be temporary, for example if patient unconscious, or where patient has fluctuating capacity) CL2 Consent to Examination or Treatment Policy V7 Page 49 of 75 Involvement of the patient’s family and others close to the patient The final responsibility for determining whether a procedure is in an incapacitated patient’s best interests lies with the health professional performing the procedure. However, it is good practice to consult with those close to the patient (eg spouse/partner, family and friends, carer, supporter or advocate) unless you have good reason to believe that the patient would not have wished particular individuals to be consulted, or unless the urgency of their situation prevents this. “Best interests” go far wider than “best medical interests”, and include factors such as the patient’s wishes and beliefs when competent, their current wishes, their general well-being and their spiritual and religious welfare. (To be signed by a person or persons close to the patient, if they wish) I/We have been involved in a discussion with the relevant health professionals over the treatment of……………………………(patient’s name). I/We understand that he/she is unable to give his/her own consent, based on the criteria set out in this form. I/We also understand that treatment can lawfully be provided if it is in his/her best interests to receive it. Any other comments (including any concerns about decision) Name Address Signed Relationship to Patient Date If a person close to the patient was not available in person, has this matter been discussed in any other way (e.g. over the telephone?) Details Signature of health professional proposing treatment The above procedure is, in my clinical judgement, in the best interests of the patient, who lacks capacity to consent for himself or herself. Where possible and appropriate I have discussed the patient’s condition with those close to him or her, and taken their knowledge of the patient’s views and beliefs into account in determining his or her best interests. I have/have not sought a second opinion. Signature Name (PRINT) Date Job Title Where second opinion sought, s/he should sign below to confirm agreement: Signature Name (PRINT) Date Job Title CL2 Consent to Examination or Treatment Policy V7 Page 50 of 75 APPENDIX 6 Guidance to health professionals (to be read in conjunction with consent policy and Consent Form 4) This form should only be used where it would be usual to seek written consent but an adult patient (18 or over) lacks capacity to give or withhold consent to treatment. If an adult has capacity to accept or refuse treatment, you should use the standard consent form and respect any refusal. Where treatment is very urgent (for example if the patient is critically ill), it may not be feasible to fill in a form at the time, but you should document your clinical decisions appropriately afterwards. If treatment is being provided under the authority of Part IV of the Mental Health Act 1983, different legal provisions apply and you are required to fill in more specialised forms (although in some circumstances you may find it helpful to use this form as well). If the adult now lacks capacity, but has clearly refused particular treatment in advance of their loss of capacity (for example in an advance directive or ‘living will’), then you must abide by that refusal if it was validly made and is applicable to the circumstances. For further information on the law on consent, see the Department of Health’s Reference guide to consent for examination or treatment (www.doh.gov.uk/consent). When treatment can be given to a patient who is unable to consent For treatment to be given to a patient who is unable to consent, the following must apply: • the patient must lack the capacity (‘competence’) to give or withhold consent to this procedure AND • the procedure must be in the patient’s best interests. Capacity A patient will lack capacity to consent to a particular intervention if he or she is: • unable to comprehend or retain information material to the decision, especially as to the consequences of having, or not having, the intervention in question; and/or • unable to use or weigh this information in the decision-making process. Before making a judgement that a patient lacks capacity you must take all steps reasonable in the circumstances to assist the patient in taking their own decisions (this will clearly not apply if the patient is unconscious). This may involve explaining what is involved in very simple language, using pictures and communication and decision-aids as appropriate. CL2 Consent to Examination or Treatment Policy V7 People close to the patient (spouse/partner, family, friends and carers) may often be able to help, as may specialist colleagues such as speech and language therapists or learning disability teams, and independent advocates or supporters. Capacity is ‘decision-specific’: a patient may lack capacity to take a particular complex decision, but be quite able to take other more straightforward decisions or parts of decisions. Best interests A patient’s best interests are not limited to their best medical interests. Other factors which form part of the best interests decision include: • the wishes and beliefs of the patient when competent • their current wishes • their general well-being • their spiritual and religious welfare Two incapacitated patients, whose physical condition is identical, may therefore, have different best interests. Unless the patient has clearly indicated that particular individuals should not be involved in their care, or unless the urgency of their situation prevents it, you should attempt to involve people close to the patient (spouse/partner, family and friends, carer, supporter or advocate) in the decision-making process. Those close to the patient cannot require you to provide particular treatment which you do not believe to be clinically appropriate. However they will know the patient much better than you do, and therefore are likely to be able to provide valuable information about the patient’s wishes and values. Second opinions and court involvement Where treatment is complex and/or people close to the patient express doubts about the proposed treatment, a second opinion should be sought, unless the urgency of the patient’s condition prevents this. Donation of regenerative tissue such as bone marrow, sterilisation for contraceptive purposes and withdrawal of artificial nutrition or hydration from a patient in PVS must never be undertaken without prior High Court approval. High Court approval can also be sought where there are doubts about the patient’s capacity or best interests. Page 51 of 75 Questions to ask health professionals As well as giving you information health professionals must listen and do their best to answer your questions. Before your next appointment, you can write some down in the space below. Questions may be about the treatment itself, for example: • • • • • • • • What are the main treatment options? What are the benefits of each of the options? What are the risks, if any, of each option? What are the success rates for different options – nationally, for this unit or for you (the surgeon)? Why do you think an operation (if suggested) is necessary? What are the risks if I decide to do nothing for the time being? How can I expect to feel after the procedure? When am I likely to be able to get back to work? Questions may also be about how the treatment might affect your future state of health or style of life, for example: • • • • • • • Will I need long-term care? Will my mobility be affected? Will I still be able to drive? Will it affect the kind of work I do? Will it affect my personal/sexual relationships? Will I be able to take part in my favourite sport/exercises? Will I be able to follow my usual diet? Health care professionals should welcome your views and discuss any issues so they can work in partnership with you for the best outcome. The Mental Capacity Act also provides you with the ability to make Advance Decisions refusing treatments or allows you to appoint a deputy to make these decisions for you if you become incapacitated. If you would like to find out more about this then you should speak to a Health Care Professional who can get you more details. CL2 Consent to Examination or Treatment Policy V7 Page 52 of 75 THIS CASE LAW APPENDIX IS FOR TRAINING PURPOSES ONLY Case Law Summary – Consent Ms B v An NHS Hospital Trust [2002] 2 All ER 449 Respect a capacitated patient’s wishes Ms B was tetraplegic and reliant on an artificial ventilator. Following her request to switch off the ventilator she claimed continuing to keep it on was an unlawful trespass. The court held that Ms B did have capacity and had been treated unlawfully. Where a patient has capacity they have the right to refuse treatment even when the consequences lead to their death. If Healthcare Professionals involved are unable to carry out the wishes of their patients their duty is find another professional to do so. St George's Healthcare NHS Trust v S; R v Collins and others, ex parte S [1998] 3 All ER 673 The right of a competent pregnant woman to refuse treatment even if that refusal may result in harm to her or her unborn child/Application of the Mental Health Act 1983. Whilst detained under Section 2 – Assessment, of the Mental Health Act S was diagnoses with preeclampsia and required induction of labour. S refused the treatment on the grounds she did not agree with medical intervention during pregnancy. A judge made a declaration overriding the need for her consent and the baby was delivered by caesarean. S appealed the decision and the Appeal Court found that her right to autonomy had been violated and her detention unlawful. The court held that a competent pregnant woman can refuse treatment even if that may result in harm to her or her unborn child. Re MB (Adult, medical treatment) [1997] 38 BMLR 175 CA Capacity to refuse treatment This case involved a patient who required a caesarean section but had a needle phobia. The patient refused to consent and the hospital sought a judicial declaration that it would be lawful to continue the procedure and MB appealed against this. The court upheld the view that MB had not, at the time, been competent to refuse treatment as a result of her fear and panic. This had meant her capacity was impaired and she was unable to understand the information or weigh it as a result (Re: C test applied). This case established that an individuals capacity to make particular decisions may fluctuate or be temporarily affected by factors such as pain, fear, confusion or the effects of medication. Assessments of capacity should also be time and decision specific (now set out in Section 2 of the MCA) Chester v Afshar [2004] UKHL 41 Pt 2 The duty to warn patients about risk Ms Chester had surgery for lumbar disc protrusion and was left partially paralysed. The court found that Dr Afshar had not warned Ms Chester about the risk (1-2%) of the surgery. In their findings the House of Lords concluded that although the failure to warn was not a direct cause of the injury, it was negligence and a doctor has a duty to warn patients of possible serious risks. There may be wholly exceptional cases where in the best interests of the patient the surgeon is excused from giving a warning. A patient’s prima facie right to be informed of small, but well established risks was upheld by the court. Staff working in healthcare should make sure patients are told of any possible significant adverse outcomes of treatment. CL2 Consent to Examination or Treatment Policy V7 Page 53 of 75 Re C (Adult, refusal of treatment) [1994] 1 All ER 819 The right of a competent adult to refuse medical treatment/The principle that mental illness does not automatically call a patient's capacity into question. The case of C established the capacity test of those who are able to understand, believe, retain and weigh the necessary information can refuse treatment. This applies even where their decision may appear irrational to the doctor or places their health or life at risk. C was detained at Broadmoor under the Mental Health Act with a diagnosis of schizophrenia. After developing gangrene in his leg he refused the amputation that doctors believed was needed to save his life. The court upheld the decision and C survived the gangrene. Some years after this case was reported C’s solicitor released an article following C’s death (from natural causes not related to the gangrene). C’s solicitor had visited C shortly after the court case to discuss the writing of a will. C replied that he wanted to take his finances with him when he passed. Although the court had relied upon C’s knowledge that his refusal may lead to his death, his desire to take the money with him seemed to indicate he did not fully understand the finality of death or at least the lack of ability to spend money that comes with it. Re T (Adult) [1992] 4 All ER 649 The effect of coercion/pressure on patient consent The patient’s mother was a Jehovah’s Witness and after the patient had been injured in a car accident had spoken with her and coerced her into refusing a blood transfusion. The Court of Appeal found that T had been pressured by her mother and that her capacity was further impaired by medications she had been given at the time. This case established that a patients consent may not be valid if it is given under pressure or duress. Mr Leslie Burke v GMC [2005] EWCA Civ 1003 Refusing a patients request for treatment This case covered a range of issues but the key point is the Courts ruling that if doctors don’t believe a treatment is in a patients best interests they have no legal or ethical obligation to proceed. Gillick v West Norfolk and Wisbech AHA [1986] AC 112 Children and young people’s competence to consent to treatment Gillick had challenged the lawfulness of the DOH guidance on doctors providing contraceptive advice or treatment to under 16’s without parental consent or knowledge. The case came before the House of Lords who held that a doctor could do this if; the patient is of sufficient maturity and intelligence to understand the nature and implications of the treatment, they cant be persuaded to tell their parents or allow the doctor to do so, they are likely to begin or continue having sex without using contraceptive, their physical and mental health are likely to suffer without the advice or treatment and it is in their best interests. In 2006 the case of Axon, R (on the application of) v Secretary of State for Health made it clear that the principles established in Gillick will apply across treatment and care for sexually transmitted infections and abortions as well. The Gillick case is now used to establish competence in a young person under 16. CL2 Consent to Examination or Treatment Policy V7 Page 54 of 75 Glass v United Kingdom (61827/00) [2004] 1 FLR 1019 European Court of Human Rights Parental Responsibility and Article 8 of the ECHR In a case before the European Court of Human Rights it was held a decision of health professionals to override the wishes of a mother of a seriously ill child breached Article 8 of the ECHR. The court was critical of the fact they had not been involved at an earlier stage. In the event of continued disagreement between parents and doctor, the courts should be consulted, and particularly before the matter reaches an emergency situation. The facts of the case were the doctors decision to administer diamorphine to the child, David, and to place a Do Not Resuscitate Notice in his notes without her knowledge. Montgomery v Lanarkshire Health Board (Scotland) [2015] UKSC 11 The case of Montgomery clarifies the correct test to consent. Mrs Montgomery (The Claimant) suffered from insulin dependent diabetes mellitus. It was agreed between the parties that the risk of shoulder dystocia occurring during vaginal delivery was 9 -10% in the case of diabetic mothers. The Claimant was not told of the risk of shoulder dystocia, as, in the doctor’s opinion, the possibility of it causing a serious problem for the baby was very small. The doctor also suggested that advising of the risk would lead to most women electing for a caesarean section. During the vaginal delivery the umbilical cord was completely or partially occluded, thereby depriving the baby of oxygen. After his birth, he was diagnosed as suffering from dyskinetic cerebral palsy. It was the Claimant’s case that had she been told of the risk of shoulder dystocia she would have elected for a caesarean section. The Supreme Court felt that there was a duty for a doctor to warn a patient of a material risk inherent in the treatment. The Supreme Court reiterated that there was a duty for the doctor to discuss with the patient the material risks involved in the medically preferred treatment and any alternative treatment options. The test for materiality was whether a reasonably person in the position of a patient would think the risk significant. In the Claimant’s case it was found that the risk of shoulder dystocia was substantial and should have been disclosed. The Claimant was entitled to consider this risk against the relatively low risk to both mother and baby of a caesarean section. The Supreme Court found that had the risks been discussed the Claimant would have elected to have a caesarean. This case has provided the Supreme Court with the opportunity to firmly state that the need for “informed consent” is now part of English law. This landmark ruling clearly illustrates the Court’s growing appreciation of patients’ self-determination and ability to understand the consequences and risks of a particular treatment. Doctors, and other healthcare professionals, are now under a clear duty to take reasonable care to ensure that patients are aware of all material risks. This judgment aligns the law with the guidance on consent set out by the General Medical Council. CL2 Consent to Examination or Treatment Policy V7 Page 55 of 75 Online Resources for Clinicians The following websites may be accessed by clinicians who are working with patients lacking capacity to self assess your practice. This can be a useful learning resource and could be used in your clinical supervision to promote discussion of legal issues; Mental Health Law Online: a site run by Jonathan Wilson that is about much more than mental health law. It has pretty much all the primary and secondary legislation relating to both mental health and mental capacity law in England and Wales, together with statutory guidance and transcripts of hundreds of cases related to both fields of the law. http://www.mentalhealthlaw.co.uk/Main_Page British and Irish Legal Information Institute: this hosts transcripts of decisions from a range of courts including, increasingly, the Court of Protection. http://www.bailii.org/ COP Cases online: this is the database of the case comments that have been produced over the past 4 years for purposes of the 39 Essex Chambers Mental Capacity Law Newsletter http://www.39essex.com/cop_cases/ Community Care: this online only (free) news service is extremely useful for providing insights into mental capacity law from the social services perspective. It is possible to subscribe to a daily email service. http://www.communitycare.co.uk/ Local Government Lawyer: online only (free) news service helpful for ensuring awareness of wider developments in the local government field. A very useful weekly newsletter service is available. http://www.localgovernmentlawyer.co.uk/index.php?option=com_content&vie w=article&id=648&Itemid=85 SCIE: the website of the Social Care Institute for Excellence includes a number of really important and useful resources, in particular the directory of online MCA resources and this sub-site devoted to the Care Act (including guidance on powers of entry in cases of suspected abuse and neglect). http://www.scie.org.uk/ The Local Government Ombudsman website contains, in particular, reports into investigations conducted into maladministration and the (non) application of the MCA 2005. It is possible to sign up for weekly emails. http://www.lgo.org.uk/ CL2 Consent to Examination or Treatment Policy V7 Page 56 of 75 Other useful resources The GMC maintains a learning disabilities resource which is aimed at doctors, but which is actually of far greater use – it is, in particular, rammed to the gills with useful techniques to enable effective communications with those with learning disabilities. http://www.gmc-uk.org/learningdisabilities/ http://www.amcat.org.uk/ This site has been developed to help staff working in health and social care, to improve the way they assess mental capacity. The Assessment of Mental Capacity Audit Tool (AMCAT) is a simple online tool to help staff and others evaluate, reflect and learn about an assessment of mental capacity they have done. Audit an assessment using AMCAT. Once you have completed the tool you will be given a report of approximately 5 pages that evaluates your assessment. This could be added to a patients medical records to provide additional evidence of the teams practice and decision making processes. http://www.bestinterests.org.uk/ This site is designed to help staff working in health and social care, to improve the way they determine the best interests of people who lack capacity to make a decision. The Best Interests Determination General Research and Evaluation Tool (BRIDGET) allows you to evaluate a best interests process that you have been involved in. Completing the online tool allows you to download a report that indicates how closely the process followed the Mental Capacity Act and its Code of Practice. BRIDGET is a companion tool the Assessment of Mental Capacity Audit Tool (AMCAT) Visit our what is mental capacity? and what is best interests? pages for more information. CL2 Consent to Examination or Treatment Policy V7 Page 57 of 75 Guidance Note for Staff and Patients APPENDIX 10 Advance Decisions What are they? The Mental Capacity Act 2005 (MCA) allows for an Advance Decision (also referred to as Advance Directives or Living Wills) to refuse treatment to be made by any person who has capacity to make that decision. It is a statement by that person setting out a refusal of future treatment in the event they lose capacity at a later time. It should be noted they cannot be used to request a particular treatment and you may wish to refer to the Trust guidance note on Written Statements of Wishes and Feelings for more information on requests. Who can make an Advance Decision? Anyone over the age of 18 who has capacity. If an Advance Decision is being considered it would be best to discuss this with a healthcare professional or an Advocate so the person understands all the implications of making the Advance Decision. How do you make an Advance Decision? There are two types of Advance Decision. The first is a verbal Advance Decision that does not apply to a life-sustaining treatment. To ensure people know this has been made it is best to do this with a healthcare professional. Staff should then take a record of the treatment being refused, the person’s capacity and who was present when it was said. A template for this has been developed at the end of this guidance. If it is refusing life-sustaining treatment this has to be a written Advance Decision that is signed and witnessed (the witness can be a member of staff). This needs to include a statement that it applies even if the person’s life is at risk. Appropriate advice should be sought from legal or advocacy services if a decision of this type is needed. What can be included in an Advance Decision? Advance Decisions can be made about any type of treatment but it must be specific. A refusal of ‘all anti-psychotic’ drugs may not be specific enough and the individual names of medication should be included to avoid confusion. Do they have to be followed? Yes, the MCA provides that a valid Advance Decision has to be followed if it applicable to the treatment plan. It is the same as someone with capacity refusing treatment and takes precedence over a court decision, lasting power of attorney decision and best interests decision made by healthcare staff if these are made before the Advance Decision. If staff ignored a valid Advance Decision they could face legal charges either criminal or civil. There are exceptions to this: If a Lasting Power of Attorney is made after the Advance Decision. They would be able to accept or refuse treatment and their decisions take precedence although they don’t invalidate the Advance Decision. If the person has since acted in a way contrary to the Advance Decision i.e. in the case of a Jehovah’s witness refusing blood but has since changed faith. Although in these situations it may be that a court has to decide and advice should be sought from the Mental Health Law Office declaring it invalid. CL2 Consent to Examination or Treatment Policy V7 Page 58 of 75 If circumstances have changed for the person to an extent that their decision may be affected i.e. if new medications are available and if the person had known about this they wouldn’t have refused If the treatment is to be provided under the Mental Health Act. With the exception of Electro Convulsive Therapy any treatment given under the Mental Health Act can be continued regardless of an Advance Decision although this would form part of the information a consultant has to consider when deciding the treatment plan. All queries relating to the applicability of an Advance Decision should be referred to the Mental Health Law office in the first instance. Can an Advance Decision be changed or cancelled? Yes, the person who made the Advance Decision can withdraw or change the details at anytime as long as they still have capacity to do so. Staff should record any cancellation and although it doesn’t have to be in writing (even if it was for a refusal of life-sustaining treatment) staff should ask the person to sign to say they wish to cancel. If it is a change to the details then it doesn’t need to be in writing either unless it is now a refusal of life-sustaining treatment. Again to ensure people are clear about the changes made it would be preferable if this was signed and dated by the person making the change. Where are they kept? Any type of Advance Decision should be communicated as widely as possible. It is the responsibility of the person making the Advance Decision to make sure people are aware of this. Staff should advise and assist the person to send the Advance Decision to their consultant (medical records), Care Co-ordinator (community records) and Mental Health Law office. This should also be sent to the persons GP and they should keep a copy for themselves and give to any other people involved i.e. family members, legal representatives or advocates. This will avoid the situation where people do not adhere to the Advance Decision because they are not aware of its existence. Staff are not obliged to delay any treatment that is provided while checking whether there is an Advance Decision so to avoid that treatment being given steps must be taken before the person loses capacity. It is good practice for all staff to ask patients whether they have an Advance Decision in place. Any Advance Decisions should form part of the persons care plan and records should clearly state there is an Advance Decision in place. How long do they last for? The Advance Decision will remain in place unless cancelled or changed. It is recommended they are reviewed and updated at least once a year. This would also prevent anyone challenging that the persons views have changed since the Advance Decision was made. CL2 Consent to Examination or Treatment Policy V7 Page 59 of 75 APPENDIX 11 THIS TEMPLATE IS INTENDED AS A GUIDE ONLY THIS IS NOT INTENDED FOR USE FOR THE REFUSAL OF LIFE-SUSTAINING TREATMENT AND FURTHER ADVICE SHOULD BE SOUGHT IF THAT IS THE PURPOSE OF YOUR ADVANCE DECISION Advance Decision Template Name: Address: Date of Birth: Contact number: Consultant Psychiatrist: GP Name: Care Coordinator: GP Surgery: Next of Kin: Contact Number: Treatment Advance Decision I declare that if I ever lack capacity to make decisions for myself, this advance decision should be followed. Treatment Refusal Medication and Treatment that I don’t want including the type, circumstances and route of administration if applicable (Be as detailed and specific as possible) Any other information I would like to be known and anyone I wish to be contacted or involved in treatment decisions about me CL2 Consent to Examination or Treatment Policy V7 Page 60 of 75 Statement I confirm that I am over 18 years of age or over, I currently believe myself to have capacity to make this decision and understand that this will remain effective until I change or withdraw this decision. I also understand that it is my responsibility to ensure people are aware of my decision and that I should review this document regularly and let people know if I need to change the details of my refusal. Signed: Date: Witness (Optional) I am signing below to confirm that I witnessed the making of this Advance Decision and believe they have capacity regarding their decision at this time. Signed: Date: Role: Copy to be sent / stored in: Care Plan Mental Health Law Office Community Notes Medical Notes General Practitioner Family Member _____________________ REVIEWS Date of Review Signed Date of Next Review Review Sent to all parties (as above) CL2 Consent to Examination or Treatment Policy V7 Page 61 of 75 Guidance Note for Staff and Patients Written Statements of Wishes and Feelings APPENDIX 12 What are they? The Mental Capacity Act 2005 requires professionals to take account of people’s previous wishes and feelings regarding their healthcare and treatment choices. Unlike an Advance Decision which is a refusal of treatment (see Guidance Note on Advance Decisions) and is legally binding in most circumstances, a written statement can be a statement of general beliefs and values. They are also sometimes referred to as an Advance Statement. It is not limited to medication or interventions and can cover a range of topics. The Written Statement will then help to inform decisions that professionals and carers may have to make when that person doesn’t have capacity. Who can make a Written Statement? Anyone can complete a statement although they must have capacity regarding the decisions they are recording at the time. Advance Decisions are limited to those above 18 years of age but because a statement isn’t legally binding those under 18 could also record their preferences and wishes for staff information. Why should a Written Statement be made? Written statements can help people to think about, plan and inform decisions that may be made when people can’t decide for themselves. This allows people to still have input into their care and treatment. It also means you are able to set out how you would like to be treated and things you would like to be done or not done when you become unwell, distressed or need to be admitted to hospital. How do you make a Written Statement? A record of your wishes and feeling can be documented within your care plan or you can record it separately and give this to a member of staff to place in your notes. There is no specific format or form for this to be documented and you are free to use terminology and language of your choosing. You should discuss this with a member of staff so they can help you to make sure the statement is clear and accurately reflects your wishes. What can be included in a Written Statement? The advantage of a written statement is that its not limited to just medication options although you can record treatments that you prefer or have worked in the past and ones that haven’t. You can also list the people that you want to be told details about your care and treatment even if at the time of your illness you are saying you don’t want them involved. This helps staff and carers because the Data Protection Act says we need your consent to release information so it will make it clear who and what information you are happy for us to share. You could include arrangements for your home if admitted including any children (although some formal arrangements may need to be made your statement will inform any decisions taken by others) or pets and what you would like to happen to them. Other things you may want to include are dietary requirements, religious preferences, and visitors whilst in hospital and things that you enjoy doing or that you think helps to relax you. CL2 Consent to Examination or Treatment Policy V7 Page 62 of 75 Do they have to be followed? They are not legally binding on your care team but when they need to make decisions about your care and treatment they must take account of any statements you have made. Section 4 of the Mental Capacity Act says that any decision taken in your best interests should include consideration so far as possible of your past and present wishes and feeling including any relevant statements made when you had capacity. If they aren’t able to adhere to those statements they will make a record in your notes of the reasons they couldn’t and this will be discussed with you when you are well enough to understand. When should a Written Statement be made? You can make a written statement at any time but you could particularly consider making one when you are being discharged from hospital or when completing or reviewing your care plan with your Care Coordinator. These are often the times when all aspects of your care are being discussed and would be a good opportunity to raise any concerns or issues you may have had during your admission or worries you have about future care options. Where are they kept? Any type of written statement should be communicated as widely as possible. It is the responsibility of the person making the written statement to make sure people are aware of this. Staff should advise and assist the person to send this to their consultant (medical records), Care Co-ordinator (community records) and Mental Health Law office. This should also be sent to the persons GP and they should keep a copy for themselves and give to any other people involved i.e. family members, legal representatives or advocates. This will avoid the situation where people do not consider to the written statement because they are not aware of its existence. It is good practice for all staff to ask patients whether they have a written statement in place. Any written statements should form part of the persons care plan and records should clearly state there is a written statement in place and what it relates to. How long do they last for? The written statement will remain in place unless cancelled or changed. It is recommended they are reviewed and updated at least once a year. If any changes are made you will need to redistribute it to everyone who needs a copy. Further Information If you would like to make a written statement you can speak to any member of staff, advocate or legal representative. CL2 Consent to Examination or Treatment Policy V7 Page 63 of 75 APPENDIX 13 THIS TEMPLATE IS INTENDED AS A GUIDE ONLY Written Statement of Wishes and feelings Template Name: Address: Consultant Psychiatrist: GP Name: Date of Birth: Contact number: Care Coordinator: GP Surgery: Next of Kin: Contact Number: Advance statement regarding wishes and feelings I declare that if I ever lack capacity to make decisions for myself, this written statement should be considered by those making choices for me: Treatment Medication and Treatment that have helped me or not in the past (Be as detailed and specific as possible) Caring Responsibilities Arrangements I would like to be made for people and children Home Responsibilities Arrangements I would like to be made for my home and pets CL2 Consent to Examination or Treatment Policy V7 Page 64 of 75 Hospital Admission If I am in hospital people I would or wouldn’t like to visit me and people I want you to share or not share information with Any other information I would like to be known and anyone I wish to be contacted or involved in treatment decisions about me Statement I currently believe myself to have capacity to make this statement and understand that this will remain effective until I change or withdraw this statement. I also understand that it is my responsibility to ensure people are aware of my statement and that I should review this document regularly and let people know if I need to change the details of my statement. Signed: Date: Witness (Optional) I am signing below to confirm that I witnessed the making of this written statement and believe they have capacity regarding their decision at this time. Signed: Date: Role: Copy to be sent / stored in: Care Plan Community Notes General Practitioner _____________________ REVIEWS Date of Review Signed Mental Health Law Office Medical Notes Family Member Date of Next Review Review Sent to all parties (as above) CL2 Consent to Examination or Treatment Policy V7 Page 65 of 75 APPENDIX 14 Mental Capacity Assessment Form Patient Name: Completed by: Reason for Assessment: What triggered the need for assessment? What is the decision to be made? (decision specific i.e. a “matter… at the material time”) Who needs to be consulted? Functional Test of Capacity Is there an impairment of, or disturbance in, the functioning of the person’s mind or brain? Permanent Temporary No Does the person have the ability to UNDERSTAND information relevant to the decision? Comment: YES NO Is the person able to RETAIN that information? Comment: YES NO Can the person USE or WEIGH that information as part of the process of making the decision? Comment: YES NO Can they COMMUNICATE their decision? i.e. talk, sign language or any other means. Comment: YES NO Not likely to regain Delay Not appropriate If yes comment on the impairment or disturbance: Can the decision be delayed because they are likely to regain capacity in the near future? Comment: YES CL2 Consent to Examination or Treatment Policy V7 Page 66 of 75 Support in Decision Making Does the person have ALL the relevant information about the decision and what practicable steps have been taken to enable the person to make the decision? Has the information been explained or presented in a way that is easier for the person to understand and are there times of day or environmental factors that make decision making easier for the person? Can anyone else help or support the person to understand the information or make a choice? Additional Assessment Required Clinical Psychology Reason for referral (e.g. assessment of IQ, memory & concentration, information processing, reasoning, problem solving, fluctuating capacity, behaviour, mood) Communication Therapy Reason for referral (e.g., assessment of communications skills, and alternative ways to support communication) Other Advanced Decisions Does the person have an advance decision relevant to the decision? Yes No If Yes: Advance Decision Type Similar Treatment? Written Verbal Similar Circumstances? Date Location What was the decision? Is this still applicable? AD Withdrawn Unexpected Circumstances Detained under the MHA Yes No If No, Why not? Lasting Power of Attorney Inconsistent Behaviours Other Reasons FINAL DECISION Yes No If they do not have capacity then proceed to Best Interests Meeting Checklist for Decision Makers Signed: Date: The person has capacity to make this decision CL2 Consent to Examination or Treatment Policy V7 Page 67 of 75 APPENDIX 15 Best Interest Checklist for Decision Makers Service User Name Completed by: There is documented assessment and evidence that the individual has: An impairment of, or a disturbance in the functioning of, the mind or brain disturbance, AND Lacks capacity to make the decision/s for themselves at this time What is the decision that needs to be made? If more than one then define each separately here Who is involved in considering this best interest decision? Provide Name, Designation, Relationship to individual and what information it is expected they will bring Can the decision be delayed because they are likely to regain capacity in the near future? Yes Not likely to regain Delay Not appropriate Have steps been taken to permit and encourage the person to participate or improve their ability to participate as fully as possible in terms of the act being done or decisions being made that affect them? Yes Comments: No Has the decision maker considered as far as reasonably ascertainable the service users past or present wishes or feelings? Yes Comments: No Has the person got a valid and applicable Advance Decision or Lasting Power of Attorney? Yes Comments: No CL2 Consent to Examination or Treatment Policy V7 Page 68 of 75 Have issues around non-discrimination been considered? Yes Comments: No Is there a least restrictive option? Yes Comments No Have you considered what beliefs or values would be likely to influence the decision if the person had capacity? Yes Comments No Is there a need to involve an IMCA? Yes Comments No What are the views of the relevant people? Yes Comments No Have all the considerations been fully recorded and all relevant circumstances taken into account? Yes Comments No FINAL AGREED BEST INTEREST DECISION If someone involved in the meeting did not agree with the final decision then please record the reasons and their signature below: Signed: CL2 Consent to Examination or Treatment Policy V7 Page 69 of 75 Mental Capacity Act (2005) Decision Making Pathway All adults should be presumed to have capacity unless the opposite has been demonstrated. Consent must be obtained by the person undertaking the procedure and is specific to the decision to be made Legal/Statutory requirements of the Mental Capacity Act (2005) Issue requiring person to give informed consent Test for Capacity: Understand the information given to them Retain the information long enough to make the decision Weigh up the information available to make the decision Communicate the decision Do you think the person has the capacity to consent? Yes No Respect the wishes of the person Following assessment of capacity – still NO A person with capacity has the right to make what might be seen to be eccentric or unwise decisions Assess capacity to consent Is there an Advance Statement/Directive? Is there a Lasting Power of Attorney or deputy? See Test for Capacity Clarify what is Valid Consent Yes No You must seek legal advice Does the decision involve a serious medical treatment OR The NHS arranges Hospital stay for 28 days or more OR The arrangement of accommodation for 8 weeks or more No Every person has the right to be supported to make their own decision Unsure Have (ensure that) all practicable steps been taken to ensure understanding Yes You may need an IMCA Ensure that all who are involved in the person’s welfare are consulted No Arrange a best interests meeting Yes Is there an alternative No Consider best interests? Yes Is this in the person’s best interests? Yes: Go ahead Valid Consent is: Given by a competent person Be given voluntarily Given following receipt of adequate information All practicable steps: Consider use of real objects or photographs/hierarchy of symbolic development Arrange visits to treatment areas Develop information packages that are accessible Give the person extra time Best Interests: Anything done for and/or on behalf of a person without capacity must be in the person’s best interests A best interests meeting should include all relevant parties - the person, medic (GP / Doctor), advocate/IMCA, carers, nurse, social worker, Allied Health Professional and or people who know the person well Least restrictive option: Anything done for or on behalf of the person without capacity should be the least restrictive to their basic rights and freedoms An Independent Mental Capacity Advocate (IMCA) must be involved if the person lacks capacity and has no relatives or close friends and requires: Serious medical treatment involves providing, withdrawing or withholding treatment in specific circumstances OR in what is being proposed, there is a fine balance between the likely benefits and the risks to the person, OR where there is a choice of treatments, and a decision as to which one to use is finely balanced OR what is proposed would be likely to involve serious consequences for the person OR the NHS arranges a hospital stay for 28 days or more OR the NHS or Local Authority arrange accommodation for 8 weeks or more Deprivation of Liberty Order IMCA may be instructed for review of care, and for any Safeguarding Adult Procedure Version Dec 2008 CL2 Consent to Examination or Treatment Policy V7 Page 70 of 75 APPENDIX 17 Mental Capacity Act (2005) Best Interest Pathway Principle 4 - Anything done for, or on behalf of a person who lacks capacity must be done in the person’s best interests Test for Capacity has found the person lacks the capacity to consent therefore a best interests meeting must be arranged Is it likely that the person may have capacity in the future? Yes No Can the decision or act wait until that time; consider if it is likely that the person will at some time have capacity to the matter in question. Does the decision involve serious medical treatment or a care home move? Yes No No Yes Delay the decision until that time. Can you identify when the person may have the capacity? Document and discuss with relevant others You will need to evidence your decision making Arrange the best interest meeting / consultation and invite / consult with all relevant parties Is there a relative /friend of individual nominated by the person to consult? Yes As decision maker follow the checklist opposite No Instruct an IMCA Is there agreement that the proposal is in the person’s best interests? No Yes Is there a dispute? Evidence decision making using agreed decision record Try to resolve locally Agreement reached No Proposed action, treatment goes ahead, with evidence via the Decision Record that the action is in the persons best interests Yes Seek Court of Protection ruling The decision maker takes the responsibility to ensure that the proposed action is in the best interests of the person The decision maker needs to check if there is an advance directive, LPA or Deputy or if there is a friend/carer of person nominated by the person to consult All relevant parties; the person, GP/Doctor, carers, nurse, allied health professional, social care staff, advocate, IMCA, or people who know the person really well The decision maker must: Consult with all relevant others i.e. the person, medic/GP, advocate / IMCA, carers and others involved with the person i.e. LPA/Deputy/EPA Identify the views of all relevant people in the persons life Not make assumptions about a persons best interests based upon the persons age, or appearance, condition or any aspect of their behaviour Consider all the relevant circumstances relating to the decision in question Involve the person as fully as possible Ensure that the decision concerns the preservation of withdrawing of life sustaining treatment, the decision maker must not be motivated by a desire to bring about death Be able to justify and evidence their decision making Ensure that other least restrictive options are always explored (please complete best interests decision record) As far as possible the decision maker must consult with other people as appropriate to do so and take into account their views as to what would be in the best interests of the person lacking capacity, especially anyone previous named by the person as some one to be consulted, carers, and close relatives or friends or others involved in the persons welfare, LPA or deputy appointed by the court of protection. If it has not been possible to contact people, give details why not possible Record keeping; it is important that you accurately record and evidence any decisions made with regards to best interests To access Court of Protection refer to Public Guardian Version Dec 2008 CL2 Consent to Examination or Treatment Policy V7 Page 71 of 75 Powers of Restraint and Detention APPENDIX 18 For staff working within Mental Health Services there are times when it may be necessary to restrain or detain a person for their own health or for the protection of others. Primarily this would be dealt with by the Mental Health Act, including the implied powers of restraint contained within that statute9. However, there will be occasions where the Mental Health Act is not immediately available – an example of this that is occurring more frequently is where a Community Treatment Order (CTO - s17A MHA) patient is informally admitted to a mental health ward and they attempt to leave and ward staff have serious concerns around their mental health/risk to self and or others. Section 5 (holding powers under the MHA) are not available to detain a CTO patient on the ward so a recall under s17E (statutory form CTO3) of the MHA is needed. Recalls (form CTO3) can only be completed by the Responsible Clinician so it may be necessary in this situation of emergency to prevent the person from leaving if there are serious concerns about the person’s mental health and risk to self or others until the statutory powers of recall can be invoked and served on the patient. Another example is in non-inpatient settings such as a clinic or Emergency Department, when a patient that is presenting as a risk tries to leave but staff believe they may need to be assessed and detained under the MHA. Case law suggests that it is unlikely in the ordinary case that there will be a false imprisonment at common law or deprivation of liberty if there is no undue delay during the processing of an application for admission under s.2 or s.3 for instance, and if that process is considered too slow then s.4 of the MHA must be considered. Further, if this process is considered too slow and the person is in an area the public have access to (such as an Emergency Department for example) then staff can consider contacting the police to apply their powers under s.136 of the MHA to allow for lawful detention. 10 There exists both common law and statutory powers of detention to detain and restrain in situations of emergency but it can be complex for staff to be aware of what legal authority they are acting within. This guidance has been prepared to offer staff information on their rights although further details on individual situations can be sought from your local Mental Health Law Office. Common law, also known as case law or precedent, is law developed by judges through decisions of courts rather than through statutes. This can only be relied upon when there isn’t statute to address the issue so we will begin with powers in statute then move on to case law. 9 It is common ground that the power to seclude a patient within the hospital is implied from the power to detain as a “necessary ingredient flowing from a power of detention for treatment”: see Auld LJ in R v Broadmoor Special Hospital Authority, Ex p S, H and D (5 February 1998, unreported) 10 In R. (on the application of Sessay) v South London and Maudsley NHS Foundation Trust) [2011], the Divisional Court held that the MHA provides a complete statutory code for the detention of non-compliant mentally incapacitated patients and that the common law doctrine of necessity does not apply during the period when a patient is being assessed for detention under the Act). However the courts said it is unlikely in the ordinary case that there will be a false imprisonment at common law or deprivation of liberty if there is no undue delay during the processing of an application for admission under s.2 or s.4 MHA for admission. CL2 Consent to Examination or Treatment Policy V7 Page 72 of 75 Mental Capacity Act Restraint can be authorised by the MCA11 and specifically section 6. The restraint must be necessary to prevent the patient from causing himself harm not for the protection of others. For this to apply the staff member restraining the patient must reasonably believe12 it is necessary to prevent harm13, it must be a proportionate response to the likelihood of harm and the seriousness of that harm14 and it must be in their best interests15. The restraint can only be the minimum and for the shortest possible period. The person’s liberty of movement can also be (temporarily) restricted, whether or not they resist16. Criminal Law Act Section 3(1) of the Criminal Law Act can be used when reasonable force is necessary to restrain a patient or seclude him in self defence or to protect other people or property. Staff may not apply this power if they do not believe the patient has capacity to understand the crime he is about to commit17. Case Law – R (on the application of Munjaz) v Mersey Care NHS Trust18 L.J. Hale stated in this case that ‘there is a general [common law] power to take such steps as are reasonably necessary and proportionate to protect others from the immediate risk of significant harm. This applies whether or not the patient lacks capacity to make decisions for himself.’ Staff would need to believe they were protecting others from the immediate risk of significant harm. Case Law – Black v Forsey19 This case set a precedent that confers upon a private individual the power to lawfully detain, in a situation of necessity, a person of unsound mind who is a danger to himself or others. The person who applies this must be able to justify their actions and if challenged prove the mental disorder of the detainee and the necessity of detention. This should only be a temporary restraint of a mentally disordered person who presents as a danger – in a situation as obvious to a lay person as it would be to a clinician. 11 Authorisation must be subject to Section 1 to 4 of the MCA also being satisfied. Staff must be able to identify objective reasons to justify the necessity of acting to prevent harm. Harm is not restricted to physical harm but could include financial or psychological harm. 13 Section 6(2) MCA 14 Section 6(3)(a) and (b) MCA 15 Section 1(5) MCA 16 Section 6(4)(b) MCA 17 M’Naghten rules – test of insanity established by the House of Lords in the M’naughten case [1843-60] All E.R. 229 is that: ‘it must be clearly proved that, at the time of committing the act, the party accused was labouring under such a defect of reason, from disease of mind, as not to know the nature and quality of the act he was doing was wrong, or, if he did know it, that he did not know he was doing what was wrong’ 18 [2003] EWCA Civ 1036; [2003] M.H.L.R 362 19 1987 S.L.T 681 12 CL2 Consent to Examination or Treatment Policy V7 Page 73 of 75 Case Law - R (on the application of Laporte) v. Chief Constable of Gloucestershire Constabulary20 This is a power to prevent a breach of the peace. Lord Bingham in the case said ‘every constable, and also every citizen, enjoys the power and is subject to the duty to seek to prevent, by arrest or other action short of arrest, any breach of the peace occurring in his presence, or any breach of the peace which (having occurred) is likely to be renewed, or any breach of the peace which is about to occur’. A breach of the peace can be in public or private property and would involve actual harm done either to a person or property. Staff working within healthcare settings should be aware of these powers when working with service users. In applying these powers staff should pay regard to the Statutory Principles contained within the Mental Capacity Act and the Guiding Principles within the Mental Health Act. 20 [2006] UKHL 55; [2007] 2 All E.R. 529 CL2 Consent to Examination or Treatment Policy V7 Page 74 of 75 APPENDIX 19 Seeking consent: Remembering the patient’s perspective Maybe I’d like to talk it over with my family before I decide. What do they think is wrong with me? What treatment might help? Can I drive/ work/ look after my family afterwards? Will I have to stay in hospital? How long for? How would it help me? PATIENT What are the risks and benefits of the alternatives? Are there any alternatives? What about the risks? What would it involve? Will it hurt? CL2 Consent to Examination or Treatment Policy V7 Page 75 of 75
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