Consent to Examination or Treatment Policy and Guidelines

Transcription

1 Consent to Examination or Treatment Policy and Guidelines Policy Reference Number PCD017 Status Ratified Version 9 Implementation Date April 2002 Current/Last Review Dates July 2005, Oct 2006, Feb 2008, June 2009, May 2010, May 2011, August 2011, May 2016 Next Formal Review September 2019 Sponsor Medical Director Sponsor Signature Author Assistant Director of Governance Where available Governance Department, Trust Intranet and internet Target audience All Clinical Staff Ratification Record Procedural Document Sub Group (Clinical Governance and Risk Committee) June 2009 Approval Record Committee Name Chairperson Date Clinical Governance & Risk Committee Medical Director July 2009 Consultation Date Consultants July 2009; June 2010 General Managers and Heads of Clinical Services July 2009; June 2010 Medical Staffing Department July 2009; June 2010 Senior Practice Development Department June 2010 Staff Development (Education) Department June 2010 Director of Nursing June 2010 Director of Human Resources June 2010 Regulators Requirements DH model consent policy and good practice in consent guidance Research Governance framework for health and social care NHSLA Risk Management Standard for Acute Trusts 4.3 HCC Standards for Better Health C13 Document Control / History Version No Reason for change 9 No changes to main policy. NHS organisation names updated, EIA updated. 8 References updated. 7 To comply with DH 2 nd Edition i.e. update on legislation relating to obtaining valid consent the Human Tissue Act 2004, the Mental Capacity Act 2005 and recent legal cases. 6 No changes to main policy. Section X monitoring register for (non medical staff) obtaining consent will be kept by Senior Nurse Practice Development. 5 Implementation of Mental Capacity Act 2005 and compliance with new NHSLA risk management standards.

2 Ref: PCD017 (v9) Status: Ratified Section Document Summary 3 Page No 1. Introduction 4 2. Purpose 4 3. Definitions 4 4. Duties (Roles and Responsibilities) 4 5. Process for Obtaining Consent 5 6. Refusal of Treatment 7 7. Withdrawal of Consent 9 8. Mental Capacity 9 9. Research and Innovation Children and Young People Process for Recording Consent Provision of Information Tissue Consent to Visual and Audio Recordings Training and Implementation Equality Impact Assessment Monitoring Compliance with this Procedural Document Associated Document/Further Reading References 19 Appendix A Current forms in use in this organisation 20 Appendix B How to seek a court declaration 21 Consent Form 1 For Adults or Competent Children 23 Consent Form 2 For Parental Consent for a Child or Young Person 27 Consent Form 3 For procedures where the patient will remain alert and an anaesthetist is not involved Consent Form 4 For persons not competent to consent 34 Patient Information Leaflet About the Consent Form 40 31

3 Document Summary This policy and guidance describes the process of seeking consent, the importance of establishing whether the person has capacity to give consent, what constitutes valid consent, the form that consent might take and the duration of that consent. It highlights the need to ensure that the consent is given voluntarily and that sufficient information has been imparted to allow valid consent to be made. It deals with consent issues arising from additional procedures that may be required during treatment and are not covered by the original consent, consent relating to the subsequent use of removed tissue, consent to visual and audio recordings, and the requirements for research and innovative treatment. The Mental Capacity Act now puts advance decisions on a statutory basis. This guide clearly sets out that healthcare professionals must follow an advanced decision where it is valid and applicable, what they must consider if it is not valid and what they must consider if they disagree with a person s right to refuse life-sustaining treatment. Main Imperatives of the policy 1. For consent to be valid, the patient must: a. be competent to take the particular decision b. have sufficient information to take it; and c. not be acting under duress 2. Consent may be written or verbal, express or implied. 3. Consent must be obtained by a person capable of performing the intervention or by a person who has been specifically trained to take consent for the intervention. 4. Comprehensible information must be provided to the patient the presumption is that the patient wishes to be well informed and the patient should be provided with the opportunity to ask further questions outside outpatient appointments. 5. If a patient refuses all treatment this should be clearly recorded in their notes. 6. Where a patient has refused a particular intervention other appropriate care must be provided. 7. Relatives cannot consent on behalf of an adult who is unable to consent themselves treatment is provided in the patient s best interests. If a patient is unable to consent this should be recorded in their notes, together with an assessment of the patient s capacity, why the treatment is in the best interests of the patient and the involvement of people close to the patient. Dartford and Gravesham NHS Trust Page 3 of 44

4 1. Introduction Patients have a fundamental legal and ethical right to determine what happens to them. Valid consent to treatment is therefore absolutely central in all forms of healthcare, from providing personal care to undertaking major surgery. Seeking consent is also a matter of common courtesy between health professionals and patients. The Trust will ensure that the process of obtaining consent for examination and treatment complies with current legislation and NHS England (NHSE) Guidance and is properly focussed on the rights of individual patients and their relatives. For patients lacking capacity (even if temporary) the policy must be implemented in conjunction with the Mental Capacity Act The test of capacity is set out in the Mental Capacity Act. 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, 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. 2. Purpose NHS England and previously the Department of Health has issued a range of guidance documents on consent and these should be consulted for details of the law and good practice requirements on consent. This policy sets out the standards and procedures in Dartford and Gravesham NHS Trust which aim to ensure that health professionals are able to comply with the NHSE guidance. While this document is primarily concerned with healthcare, social care colleagues should also be aware of their obligations to obtain consent before providing certain forms of social care, such as those that involve touching the patient. 3. Definitions Valid Consent - For consent to be valid, it must be given voluntarily by an appropriately informed person who has the capacity to consent to the intervention in question (this will be the patient or someone with parental responsibility for a patient under the age of 18, someone authorised to do so under a Lasting Power of Attorney (LPA) or someone who has the authority to make treatment decisions as a court appointed deputy. Acquiescence where the person does not know what the intervention entails is not consent. 4. Duties (Roles and Responsibilities) The health professional providing the treatment or investigation is responsible for ensuring the patient has given valid consent before treatment begins, although the consultant responsible for the patients care will remain ultimately responsible for the quality of medical care provided. Where oral or non-verbal consent is being sought at the point the procedure will be carried out, this will naturally be done by the health professional responsible. However, team work is a crucial part of the way the NHS operates, and where written consent is being sought it may be appropriate for other members of the team to participate in the process of seeking consent. Dartford and Gravesham NHS Trust Page 4 of 44

5 The GMC guidance states that the task of seeking consent may be delegated to another person, as long as they are suitably trained and qualified. In particular they must have knowledge of the proposed investigation or treatment and understand the risks involved, in order to be able to provide any information the patient may require. (Please refer to section 15 for further information on consent training) 4.1 Process for identifying staff not capable of performing the procedure but are authorised to obtain consent for that procedure Dartford and Gravesham NHS Trust advocates that consent is not obtained by the most junior doctors in training i.e. FY1s Where it is necessary to delegate consent it is the health professional s own responsibility to ensure that when they require colleagues to seek consent on their behalf they are confident that the colleague is competent to do so by: requesting to see the individuals competency records as outlined in section 15 checking the register of those authorised to take consent held by the Senior Nurse Practice Development Manager (non medical staff) or the departments own records It is further recommended that senior staff (i.e. the health professional who wish to delegate consent), meet with new intakes as soon as possible to ascertain their level of competency and previous experience. If there is any doubt about an individual s level of experience and competency consent must not be delegated to that individual until they can satisfy the requirements of training and clinical tutor or the Senior Nurse Practice Development Manager should be advised to update the register of persons trained. This process will be regularly evaluated through audit of the consent forms to identify the designation of the health professional obtaining consent against the register of persons trained to obtain consent for specific procedures. If any individual feels pressurised to seek consent when they do not feel competent to do so please contact the Director of Nursing, Extension 8658 or Medical Director, Extension 8653 or your manager to seek advice. Inappropriate delegation (for example where the clinician seeking consent has inadequate knowledge of the procedure) may mean that the consent obtained is not valid. Clinicians are responsible for knowing the limits of their competence and should seek the advice of appropriate colleagues when necessary. The healthcare professional who eventually carries out the investigation or treatment must also be able to determine whether the person has capacity to make that decision (Please refer to section 8 for further information on Mental Capacity). 5. Process for Obtaining Consent The seeking and giving of consent is usually a process, rather than a one-off event. For major interventions, it is good practice where possible to seek the person s consent to the proposed procedure well in advance, when there is time to respond to the person s questions and provide adequate information (please refer to section 12 on Patient Information). Clinicians should then check, before the procedure starts that the person still consents. If a person is not asked to signify their consent until just before the procedure is due to start, at a time when they may be feeling particularly vulnerable, there may be real doubt as to its validity. In no circumstances should a person be given Dartford and Gravesham NHS Trust Page 5 of 44

6 routine pre-operative medication before being asked for their consent to proceed with the treatment. 5.1 Emergencies Clearly in emergencies, the 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. 5.2 Form of Consent The validity of consent does not depend on the form in which it is given. Written consent merely serves as evidence of consent: if the elements of voluntariness, appropriate information and capacity have not been satisfied, a signature on a form will not make the consent valid. Although completion of a consent form is in most cases not a legal requirement the use of such forms is good practice where an intervention such as surgery is to be undertaken. Where there is any doubt about the person s capacity, it is important, before the person is asked to sign the form, to establish both that they have the capacity to consent to the intervention and that they have received enough information to enable valid consent to be given. Details of the assessment of capacity, and the conclusion reached, should be recorded in the case notes. If the person has capacity, but is unable to read or write, they may be able to make their mark on the form to indicate consent. It would be good practice for the mark to be witnessed by a person other than the clinician seeking consent, and for the fact that the person has chosen to make their mark in this way to be recorded in the case notes. Similarly, if the person has capacity, and wishes to give consent, but is physically unable to mark the form, this fact should be recorded in the notes. Or, the person can direct someone to sign the form on their behalf, but there is no legal requirement for them to do so. If consent has been given validly, the lack of a completed form is no bar to treatment, but a form can be important evidence of such consent. 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). 5.3 Duration of Consent When a person gives valid consent to an intervention, in general that consent remains valid for an indefinite duration, unless it is withdrawn by the person. However, if new information becomes available regarding the proposed intervention (for example new evidence of risks or new treatment options) between the time when consent was sought and when the intervention is undertaken, the clinician should consider whether the new information should be drawn to the attention of the patient and the process of seeking consent repeated on the basis of this information. Similarly, if the patient s condition has changed significantly in the intervening time it may be necessary to seek consent again, on the basis that the likely benefits and/or risks of the intervention may also have changed. If consent has been obtained a significant time before undertaking the intervention, it is good practice to confirm that the person who has given consent (assuming that they retain Dartford and Gravesham NHS Trust Page 6 of 44

7 capacity) still wishes the intervention to proceed, even if no new information needs to be provided or further questions answered. 5.4 Seeking consent for anaesthesia 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 out-patients, or have the opportunity to discuss anaesthesia in a preassessment 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 (e.g. 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. Information for patients, relatives and friends on anaesthesia has been produced by the Royal College of Anaesthetists and Association of Anaesthetics of Great Britain and Northern Ireland. 5.5 Additional Procedures During an operation it may become evident that the person could benefit from an additional procedure that was not within the scope of the original consent. If it would be unreasonable to delay the procedure until the person regains consciousness (for example because there is a threat to the person s life) it may be justified to perform the procedure on the grounds that it is in the person s best interests. However, the procedure should not be performed merely because it is convenient. For example, a hysterectomy should never be performed during an operation without explicit consent, unless it is necessary to do so to save life. If a person has refused certain additional procedures before the anaesthetic (for example, specifying that a mastectomy should not be carried out after a frozen section biopsy result), then this must be respected if the refusal is applicable to the circumstances. The GMC guidance states that it is good practice to seek the views of the patient on possible additional procedures when seeking consent for the original intervention. 6. Refusal of treatment 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 1 ). Refusal of treatment by those under the age of 18 is covered in section 10 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 1 Re B [2002] FLR 1090 Dartford and Gravesham NHS Trust Page 7 of 44

8 wish to do so. Where delay may affect their treatment choices, they should be advised accordingly. 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. 6.1 Advanced Decisions to Refuse Treatment 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 Mental Capacity Act 2005 now 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 Mental Capacity Act (2005) Code of Practice 2, but in summary these are: 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 Mental Capacity Act 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. The court does not have the power to overturn a valid and applicable advance decision. While a decision is awaited from the courts, healthcare professionals can provide life-sustaining treatment or treatment to stop a serious deterioration in the patient s condition. 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 Mental Capacity Act 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 Further information is available on the Department of Health website. 2 Dartford and Gravesham NHS Trust Page 8 of 44

9 7. Withdrawal of Consent 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. Assessing capacity during a procedure may be difficult and, as noted above, 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 (see chapter 2), but this should not be used as an excuse to ignore distress. 8. Mental Capacity The Mental Capacity Act 2005 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: 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 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 Mental Capacity Act, 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 Mental Capacity Act (2005) Code of Practice Dartford and Gravesham NHS Trust Page 9 of 44

10 The Mental Capacity Act 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? Guidance on how people should be helped to make their own decisions is given in chapter 3 of the Mental Capacity Act (2005) Code of Practice and further guidance on obtaining consent for adults without capacity is given in Chapter 2 in the DH Reference guide to consent for examination or treatment 2 nd Edition. 9. Research and Innovation The same legal principles apply when seeking consent from a person for research purposes as when seeking consent for investigations or treatment. GMC guidance advises that patients should be told how the proposed treatment differs from the usual methods, why it is being offered, and if there are any additional risks or uncertainties. Clinical trials are covered by the Medicines for Human Use (Clinical Trial Regulations) Children and Young People The legal position concerning consent and refusal of treatment by those under the age of 18 is different from the position for adults (Please refer to Chapter 3 in the DH Reference guide to consent for examination or treatment 2 nd Edition). 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. In the case of Gillick 5, the court held that children who have sufficient understanding and intelligence 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 Gillick competent. A child of under 16 may be Gillick competent to consent to medical treatment, research, donation or any other activity that requires their consent 4 Medicines for Human Use (Clinical Trials) Regulations 2004, SI Gillick v West Norfolk and Wisbech AHA [1986] AC112 Dartford and Gravesham NHS Trust Page 10 of 44

11 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. 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 Treatment of young children When babies or young children are being cared for in hospital, it will not usually seem practicable to seek their parents consent on every occasion for every routine intervention such as blood or urine tests or X-rays. However, you should remember that, in law, such consent is required. Where a child is admitted, you should therefore discuss with their parent(s) what routine procedures will be necessary, and ensure that you have their consent for these interventions in advance. If parents specify that they wish to be asked before particular procedures are initiated, you must do so, unless the delay involved in contacting them would put the child s health at risk. Only people with parental responsibility are entitled to give consent on behalf of their children. You must be aware that not all parents have parental responsibility for their children (for example, unmarried fathers do not automatically have such responsibility although they can acquire it). If you are in any doubt about whether the person with the child has parental responsibility for that child, you must check. The Children Act 1989 sets out the persons who may have parental responsibility. 11. Process for Recording Consent For significant procedures, it is essential for health professionals to document clearly both a patient s agreement to the intervention and the discussions which led up to that agreement. This may be done either through the use of a consent form (with further detail in the patient s notes if necessary), or through documenting in the patient s notes that they have given oral consent Written consent Consent is often wrongly equated with a patient s signature on a consent form. A signature on a form is evidence that the patient has given consent, but is not proof of valid consent. If a patient is rushed into signing a form, on the basis of too little information, the consent may not be valid, despite the signature. Similarly, if a patient has given valid verbal consent, the fact that they are physically unable to sign the form is no bar to treatment. Patients may, if they wish, withdraw consent after they have signed a form: the signature is evidence of the process of consent-giving, not a binding contract. Dartford and Gravesham NHS Trust Page 11 of 44

12 It is rarely a legal requirement to seek written consent 6 but it is good practice to do so if any of the following circumstances apply: 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 Dartford & Gravesham NHS Trust Completed forms should be kept with the patient s notes. 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. It will not usually be necessary to document a patient s consent to routine and low-risk 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 Documentation where patients lack capacity to give or withhold consent Where an adult patient does not have the capacity to give or withhold consent to a significant intervention, this fact should be documented in form 4 (form for adults who are unable to consent to investigation or treatment), along with the assessment of the patient s capacity, why the health professional believes the treatment to be in the patient s best interests, and the involvement of people close to the patient. The standard consent forms should never be used for adult patients unable to consent for themselves. For more minor interventions, this information should be entered in the patient s notes. An apparent lack of capacity to give or withhold consent may in fact be the result of communication difficulties rather than genuine incapacity. You should involve appropriate colleagues in making such assessments of incapacity, such as specialist learning disability teams and speech and language therapists, unless the urgency of the patient s situation prevents this. If at all possible, the patient should be assisted to make and communicate their own decision, for example by providing information in non-verbal ways where appropriate. Occasionally, there will not be a consensus on whether a particular treatment is in an incapacitated adult s best interests. Where the consequences of having, or not having, the treatments are potentially serious, a court declaration, decision or order may be sought. The new Court of Protection (under the Mental Capacity Act 2005) deals with decisions concerning health and welfare decisions as well as property and affairs. See Appendix D for details of how to do this Availability of forms 6 The Mental Health 1983 and the Human Fertilisation and Embryology Act 1990 require written consent in certain circumstances. Dartford and Gravesham NHS Trust Page 12 of 44

13 Standard consent forms and forms for adults who are unable to consent for themselves are reproduced in Appendix B and are available from Supplies Department, extension 8212 in Darent Valley Hospital. 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 decisions about additional procedures because they will be in a position to make any such decisions at the time if necessary. Form 4 is for adults who are unable to consent to treatment or care. 12. Provision of information To give valid consent, the patient needs to understand the nature and purpose of the procedure. Any misrepresentation of theses elements will invalidate consent. Where relevant, information about anaesthesia should be given alongside information about the procedure itself. The provision of information is central to the consent process. Before patients can come to a decision about treatment, they need comprehensible information about their condition and about possible treatments/investigations and their risks and benefits (including the risks/benefits of doing nothing). They also need to know whether additional procedures are likely to be necessary as part of the procedure, for example a blood transfusion, or the removal of particular tissue. Once a decision to have a particular treatment/investigation has been made, patients need information about what will happen: where to go, how long they will be in hospital, how they will feel afterwards and so on. It is particularly important that a patient is aware of the situation when students or trainees carry out procedures to further their own education. It is not a legal requirement to tell the patient the person is a trainee although it would always be good practice to do so. However if the purpose is to conduct a physical examination that is not part of the patients care and is to further the trainees education then consent has to be sought for that to take place. Patients and those close to them will vary in how much information they want: from those who want as much detail as possible, including details of rare risks, to those who ask health professionals to make decisions for them. There will always be an element of clinical judgement in determining what information should be given. However, the presumption must be that the patient wishes to be well informed about the risks and benefits of the various options. Where the patient makes clear (verbally or non-verbally) that they do not wish to be given this level of information, this should be documented in the healthcare record. Although informing people of the nature and purpose of procedures enables valid consent to be given as far as any claim is concerned, case law 7 has proved this is not sufficient to fulfil 7 Sidaway v Board of Governors of the Bethlem Royal Hospital [1985] AC871 Bolam v Friern Hospital Management Committee [1957] 2 All ER 118 Dartford and Gravesham NHS Trust Page 13 of 44

14 the legal duty of care to the person. Failure to provide other relevant information may render the practitioner liable to an action for negligence if a person subsequently suffers harm as a result of the treatment received. It is therefore, advisable to inform the patient of any material or significant risks or any unavoidable risks, even if small, in the proposed treatment; any alternatives to it; and risks incurred by doing nothing. In the very rare event that the healthcare professional believes it will cause the patient serious harm to not follow this guidance, this must be discussed with the team, give reasons for it and record in the patients notes. The mere fact that a patient might become upset by hearing the information or might refuse treatment, is not sufficient to act as a justification. The following sources of patient information are available in the Dartford & Gravesham NHS Trust: Patient information leaflets are available within the ward, department, clinic and on the Trust intranet and internet. Each department maintains a patient information folder containing the most updated information that is held on record by the Communications Department Extension All versions of leaflets are archived according to the Patient Information Policy. As Patient Information leaflets are revised this information is recorded centrally by the Communications Department, Extension For those who, for reasons of disability or otherwise, would not find printed information particularly accessible, arrangements for large print, Braille or taped information can be made available by contacting the Communications Department, Extension Information on the top 10 most frequently performed surgical procedures within the Trust are readily available in large text, audio and the 3 most popular translated languages. Further information and advocacy for patients in accessing and understanding information can be obtained from the Trust s PALS Officer, Extension Provision for patients whose first language is not English The Dartford and Gravesham NHS 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. Patient Information leaflets for the top 10 surgical procedures are available in the 3 most popular as determined by the translation service. These are available on the Trust intranet and internet. It is not appropriate to use children to interpret for family members who do not speak English. Translation and interpreting services can be accessed from the Bexley Interpreting Service contacted directly on Guidelines for the use of interpreting services are held on the Trust intranet. Guidelines for interpreting services are held on each ward and department to aide basic communication in 28 languages until an interpreter can be located. More information on interpreting services can be obtained from the Trust s Communication Manager, Extension Helpful guidance is found in the toolkit Bridging the Gap produced by Sheffield Health Authority and the Commission for Racial Equality 8 Chester v Afshar [2004] UKHL 41 8 Contact David Codner (Senior Manager Black & Minority Ethnic Health Issues) at Sheffield Health Authority for details. Dartford and Gravesham NHS Trust Page 14 of 44

15 12.2 Access to more detailed or specialist information Patients may sometimes request more detailed information about their condition or about a proposed treatment than that provided in general leaflets. Dartford & Gravesham NHS Trust has made the following arrangements to assist patients to obtain such information The Trust has a Patient Advice & Liaison Service (PALS) who can assist patients to access NHS Direct online and the National Electronic Library for Health, which links with local medical libraries. The PALS officer can be contacted on Extension Access to health professionals between formal appointments After an appointment with a health professional in primary care or in out-patients, 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 or to wait until the date of an elective procedure (by which time it is too late for the information genuinely to affect the patient s choice). Many of the Trusts information leaflets contain contacts of an appropriate health professional such as a specialist nurse. Alternatively the PALS Manager on Extension 8382 will be pleased to help Open access clinics 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. Such information can be obtained directly from the clinic at Darent Valley Hospital Documenting the discussion and provision of information to patients It is important that the discussion regarding the risks, benefits and alternatives of the procedure you are seeking consent for is documented. There is provision for this to be recorded on the appropriate consent form alongside details of any additional information (written, tapes DVDs etc) provided to the patient. If more specialised information is required or provided this should be documented in the patients medical record. An annual audit will be undertaken to ensure the provision of information is recorded. This will also include a patient survey regarding the satisfaction of the information received. 13. Tissue Dartford and Gravesham NHS Trust requires that patients should be given the opportunity to refuse permission for tissue (including blood samples and other bodily fluids provided for testing) taken from them during surgery or other procedure to be used for education or research purposes. As agreed by the Kent & Medway Pathology Network an opt out clause has been added to the consent forms stating TISSUE CONSENT REFUSED if the patient refuses permission. The same clause has been added to all pathology request forms. It remains the responsibility of the requester to ensure that the patient is aware of the options for education and research. Explicit consent is not necessary for public health surveillance using the unlinked anonymous method, but a well-publicised opt-out policy must apply. 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. This information has been added to the patient information leaflets and on posters within the pathology department. Dartford and Gravesham NHS Trust Page 15 of 44

16 13.1 The Human Tissue Act The Human Tissue Act 2004 Act makes consent the fundamental principle underpinning the lawful retention and use of body parts, organs and tissue from the living or the deceased for specified health-related purposes and public display. It also covers the removal of such material from the deceased. (It does not cover removal of such material from living patients this continues to be dealt with under the common law and the Mental Capacity Act 2005.) The 2004 Act regulates removal, storage and use of human tissue. This is referred to in the Act as relevant material and is defined as material that has come from a human body and consists of, or includes, human cells. Cell lines are excluded, as is hair and nail from living people. Live gametes and embryos are excluded as they are already regulated under the Human Fertilisation and Embryology Act 1990 as amended by the Human Fertilisation and Embryology Act The Human Tissue Act 2004 lists the purposes for which consent is required in Schedule 1, and they are referred to as scheduled purposes. The consent required under the Act is called appropriate consent, which means consent from the appropriate person, as identified in the Act. Where there has been a failure to obtain or misuse of consent, penalties of up to three years imprisonment or a fine, or both, are provided for in the Act. Full details on the requirements of the Human Tissue Act 2004 and the HTA s codes of practice are on the HTA s website at These should be consulted to ensure compliance Requirements for Living Donation The HTA is responsible for the regulation, through a system of approvals, of the donation from living people of solid organs, bone marrow and peripheral blood stem cells for transplantation into others. Information on the legal requirements and how to proceed is available from the HTA. 14. Consent to Visual and Audio Recordings Photographic, audio and video recordings (personal devices for the recording of images i.e. mobile phones must not be used) made for treatment 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, audio or video recording will result from that procedure. Photographic, audio 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. The one exception to this principle is set out in paragraph 3 below. 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 not willing for a recording to be used, you must not use it, even if a person with parental responsibility consents. Photographic, audio 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. Dartford and Gravesham NHS Trust Page 16 of 44

17 If you wish to make a photographic, audio 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 be aware that they can refuse without their care being compromised and that when required or appropriate it can be anonymised. 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. 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..if the patient is likely to be permanently unable to give or withhold consent for a recording to be made, you should seek the agreement of some-one close to the patient. You must not make any use of the recording which might be against the interests of the patient. You should also not make, or use, any such recording if the purpose of the recording could equally well be met by recording patients who are able to give or withhold consent. For further information please refer to the Trusts Consent for the Taking of Visual and Audio Recordings Policy 15. Training and Implementation 15.1 Generic training on the consent process Regular training on the law of consent and adherence to this policy is available and training is organised by the Trust s Staff Development Centre. Additionally training seminars are organised by the Medical Staffing Department from the Medical Defence Union. The programme is scheduled for the junior doctor s intake; this is an open seminar for doctors of all grades, and is open to other health professionals to attend Procedure specific training on consent for staff whom the consent process is delegated and who are not capable of performing the procedure Dartford & Gravesham NHS Trust and the Medical Staffing department advocate and support that all consent should be taken by the senior clinician capable of undertaking the procedure and advocate that consent should not be delegated to the most junior doctors in training i.e. FY1s, however If consent is to be delegated to junior staff e.g. FY2s or to healthcare professionals not capable of performing the procedure the Consultant must train the staff member in the taking of consent for every procedure (known as procedure-specific training) which they wish them to take consent for. The senior clinician must demonstrate that they have a training programme in place which includes the risks, benefits and alternatives of that procedure. The training must not just be theoretical but must include observation of the junior doctor or of the healthcare professional undertaking the consent to demonstrate they are competent. This may require the senior clinician to continue to supervise and assess their capability. Dartford and Gravesham NHS Trust Page 17 of 44