GUIDANCE FOR OBTAINING INFORMED CONSENT

Transcription

1 GUIDANCE FOR OBTAINING INFORMED CONSENT Emergency treatment may be provided to patients without consent provided that the treatment is necessary to preserve life or to prevent a serious deterioration in the patient s condition. See Emergency Section 1.9 for details page 10. October 2012 Next Review Date Oct 2015 Page 1 of 48

2 CONTENTS 1. CONSENT PROCESS 1.1 Introduction 1.2 What is consent? 1.3 Who should obtain consent? 1.4 Providing information 1.5 Consent Forms 1.6 Scope of consent 1.7 Timing of Consent 1.8 Withholding of consent 1.9 Emergency Treatment 2. COMPETENCE AND ADULTS WITH INCAPACITY 2.1 Introduction 2.2 Incapacity 2.3 The General Authority to Treat and Core Principles of the 2000 Act 2.4 Certificate of Incapacity 2.5 Proxy - Welfare Power of Attorney, Intervention Orders and Welfare Guardianship orders 2.6 Advance Directives/Statements (Living Wills) 2.7 Frequently asked questions from this section CHILDREN 3.1 Obtaining consent for children 3.2 Who has the right to consent on behalf of a child? 3.3 Looked after children 3.4 Child freed for adoption 3.5 Where no one is able to give consent 3.6 Where staff and those with parental responsibilities do not agree 3.7 Making sure children are involved in decision-making 4.0 MENTAL HEALTH 4.1 Obtaining consent from patients detained under the Mental Health (Care and Treatment) (Scotland) Act Advance Statements in the Mental Health (Care and Treatment) (Scotland) Act PHOTOGRAPHIC/AUDIO MATERIAL 5.1 Consent for photography, video or audio recordings Next Review Date Oct 2015 Page 2 of 48

3 5.2 Children and photographic image consent (see 3.2 for children treatment consent) and long running treatment or assessment Next Review Date Oct 2015 Page 3 of 48

4 6. ASKING FOR AGREEMENT FOR A POST MORTEM 7. NON SURGICAL INTERVENTIONS 7.1 Medical interventions 7.2 Immunisation 7.3 Interventions by Registered Health Care Professionals who are not Registered Medical Practitioners 8. RESEARCH 8.1 Introduction 8.2 Research - Voluntary withdrawal 8.3 Research Information 8.4 Competence 8.5 Written Consent to research participation 9. Accessible documents and links for consent related patient information materials 10. References and related documents 11. APPENDICES Next Review Date Oct 2015 Page 4 of 48

5 1. CONSENT PROCESS 1.1 Introduction Patients have a fundamental right to: receive sufficient verbal and written information to enable an informed decision to be made grant or withhold consent prior to any examination or treatment unless: o the patient has been assessed as lacking capacity (See section 2) o they are a child (See section 3) o the patient is detained under the Mental Health (Care and Treatment) (Scotland) Act 2003 and certain conditions apply regarding treatment related to his/her mental disorder. (See section 4) Consent is only legally valid if certain conditions are satisfied. This means that in any particular case a clinician must satisfy him/herself that any consent obtained from a patient meets the following conditions: The patient is legally competent (i.e. capable of consenting). (See section 2) The consent is given freely (i.e. no coercion). The patient is adequately informed and has understood the information given. (See section 1.4 and also reference section for translations into other languages/formats) The patient is given sufficient time to reflect on the information provided before giving consent. If a significant period of time (6 months or more) has elapsed between consent and the procedure, consent will be reaffirmed by a member of the healthcare team If there has been a significant change in the patient s condition, new consent should be obtained (See section 1.7) If the treatment proposed has changed significantly, new consent will be sought. Consent is a process rather than a one off decision. The steps in the process include discussions with patients, the giving of verbal and written information and the explanation of risks Next Review Date Oct 2015 Page 5 of 48

6 and benefits. All of these steps should be formally documented. Successful relationships between clinicians and patients depend on trust. A patient must be properly informed about the risks, benefits and consequences of any proposed treatment and any possible alternative before signing a consent form. A fully informed patient is less likely to have cause to complain or to resort to litigation. A signature on a consent form is normally the concluding part of the consent process. It is important to realise that if the patient has not been given appropriate information then consent may not be valid even with a signature on the form. Completed consent forms are evidence of a process not the process itself. 1.2 What is consent? Consent is the voluntary and continuing permission of the patient to: Receive a particular treatment or procedure based upon adequate knowledge and understanding of the: 1. purpose 2. nature 3. likely effects 4. significant risks of that treatment including the likelihood of its success and outcomes 5. consequences of either no treatment or alternative treatment. Permission given under unfair or undue pressure is not consent. 1.3 Who should obtain consent? It is the responsibility of the clinician providing the treatment, carrying out an investigation or performing a surgical operation or other procedure, to discuss it with the patient, provide information necessary for the patient s understanding and to obtain consent. Whoever is seeking a patient s consent and ensuring the completion of the consent form should: be suitably trained and qualified have sufficient knowledge of the proposed investigation or treatment (including knowledge of the risk involved) Next Review Date Oct 2015 Page 6 of 48

7 act in full accordance with the NHS Fife Consent Policy and their professional guidance. Additionally, there are situations in which it may be regarded as standard practice for one clinician to refer a patient to a colleague to carry out a particular procedure or investigation or aspect of treatment. An example could be referral of a patient by a surgeon for diagnostic or interventional radiology. In such circumstances, the referring clinician could explain the general need for the proposed referral, possibly using information provided by the receiving clinician. It would be for the receiving clinician to provide any further specialist information necessary to secure the patients full understanding and obtain consent. Where an anaesthetic is to be administered as part of treatment, the anaesthetist undertaking the procedure should obtain separate consent. If, due to illness or other circumstance, the clinician carrying out the procedure is not the same clinician that has previously obtained consent, then the clinician carrying out the procedure should seek reconfirmation of consent from the patient. Regardless of who has provided the information and obtained consent, all discussions and consent should be recorded in the patient record. It remains the responsibility of the person performing the procedure to ensure: 1. that the patient has been given sufficient time and information to make an informed decision 2. that all the other requirements of the NHS Fife Consent policy have been met. 1.4 Providing information Obtaining valid consent requires provision of accurate and relevant information regarding the nature, consequences and alternatives to the treatment proposed in an understandable format. It is of particular importance that provision is made for patients whose first language is not English or who have a communication difficulty. Further guidance with regard to this is included within NHS Fife Equality and Diversity resources on the NHS Fife website, and in the references section. Appendix 1 details services available to assist patients who have difficulty communicating for reasons other than due to deafness or blindness. Guidance on the production of patient Next Review Date Oct 2015 Page 7 of 48

8 information is also available to staff (see references section). There will be wide variations in the amount and complexity of information required by individual patients or that is relevant to particular procedures. As a minimum, the following information should be available: i Details of diagnosis and prognosis ii Details of investigation or treatment proposed iii Named clinician with overall responsibility iv Ability of patient to retract consent at any time i Diagnosis and prognosis Patients should be told the name and nature of the condition for which treatment or investigation is planned. If the diagnosis is unclear this should be stated and information as to the range of diagnoses and their likelihood provided. Information as to prognosis and other consequences with and without treatment may influence whether consent is granted and should be as accurate as reasonably possible. ii Proposed investigation or treatment Clinicians should explain the purpose and nature of the proposed procedure so patients have a clear idea of what is involved and what will be experienced. It is also necessary to include information as to adjunctive procedures including use of anaesthesia and analgesia. A separate information leaflet ( You and your anaesthesia ) is available and should be given to all patients where an anaesthetic is to be administered as part of their treatment. Where the extent or nature of a procedure may be influenced by operative findings, the range of possibilities should be explored with the patient and clear limitations as to the maximal extent of the procedure to which the patient is required to consent, emergency treatment being excepted. For each option considered, the patient should understand the likely benefits and probabilities of success. Significant risks should be explained and clinicians must form their own view as to what it is appropriate to tell patients, guided by what other reasonable clinicians would do in the same situation. Serious, frequently occurring, or individually relevant risks should be explained having considered the patient s beliefs, occupation and lifestyle. Next Review Date Oct 2015 Page 8 of 48

9 iii Responsible clinician The senior clinician responsible for overall treatment should be clearly identified. It may also be relevant to specify other senior members of his or her team and whether and to what extent doctors or other health professionals in training will be involved. iv Withdrawal of consent The patient should be reminded that at any stage up to and during the procedure, they can withdraw consent without prejudice to future treatment. Patients should also be reminded of their right to obtain a second opinion. Comprehension After providing such information, the clinician is expected to ensure patients have understood what has been presented and whether they would like more information before making a decision. It is also important to ensure patients have a mechanism and timescale in which to reflect on and review their decisions Nature of information presented Individual clinicians and specialties should consider the following factors in how information is presented: Use of additional written material or visual aids. These should be kept up to date and be applicable to and accurately reflect local practice Ensure language and other communication needs are met with access to translators, interpreters, other patient representative or technical aids Involvement of other members of the health care team in providing and discussing information relevant to the consent process. 1.5 Consent Forms NHS Fife generic (Appendix 3, 4) or procedure specific consent forms must be used. All newly developed forms must meet the NHS Fife consent form standards (Appendix 2) and be registered with the NHS Fife Clinical Governance Steering Group. All writing on the consent form must: be legible Next Review Date Oct 2015 Page 9 of 48

10 be unambiguous contain no abbreviations be signed and dated by the patient and clinician. Alterations are not permitted after the patient has signed the consent form. If alterations are needed, a new form must be used. Clinicians must seek express (written) consent for: procedures that carry a significant risk any procedure to be carried out under general anaesthesia, sedation or regional anaesthesia (exclusions to this are anaesthesia administered topically, by simple infiltration or dental local anaesthetic) any procedure which could be considered new, novel or experimental (Please refer to NICE Guidance on introduction of new or novel procedures and NHS Fife New Interventional Procedures Policy) any situation where there are implications for third parties e.g. in relation to genetic studies or HIV testing. If the clinician is in any doubt about the need for written consent then it is preferable to obtain consent or at the very least record any discussion with the patient in the patient notes. 1.6 Scope of consent Following the provision of appropriate information, a patient consents to a specific investigation, procedure or treatment being carried out. Additional or alternative procedures must only be carried out on anaesthetised or sedated patients where this is unequivocally in the patient s best interests for the procedure to be performed immediately. The desire to spare a patient a second anaesthetic is definitely not sufficient justification in itself. Procedures unconnected with that for which specific consent has not been obtained are very unlikely to be justifiable. The consent form provides an opportunity for the patient to note procedures that the practitioner may not carry out without discussing the matter further with the patient. Next Review Date Oct 2015 Page 10 of 48

11 1.7 Timing of Consent The timing of consent will depend on the degree of urgency of the procedure. Whilst there is no recognised absolute minimum period of time which should elapse between giving information, obtaining consent and carrying out the procedure, it is appropriate that there be sufficient time for the patient to reflect. This is particularly necessary where the information provided is complex and/or the risks are significant. In such cases, more than one session may be necessary to inform the patient adequately. For elective surgery, consent should ideally be obtained at the time the patient s name is placed on the waiting list. If a significant time (6 months or more) has elapsed between obtaining the consent and the procedure, the consent should be reaffirmed. If there has been a significant change in the patient s condition, new consent should be obtained. It is not possible or permissible to obtain informed consent from a patient who has been administered premedication. Consent must be reaffirmed with the patient prior to the procedure to ensure that he or she has not had a change of mind. 1.8 Withholding of consent A patient s decision not to consent, with the reasons for refusal, must be fully documented in the patient s record. 1.9 Emergency Treatment Healthcare professionals may provide emergency treatment to patients without consent provided that the following criteria are met:- The patient is assessed as being incapable of providing informed consent The treatment is urgent and is limited to that which is necessary to preserve life or to prevent a serious deterioration in the patient s condition. In these circumstances no certificate of incapacity is necessary. If a patient refuses emergency treatment and there is doubt about his / her capacity then the clinicians should take whatever steps are necessary to prevent deterioration in the patient s condition and then consider issues of capacity. These steps should also be taken if a proxy Next Review Date Oct 2015 Page 11 of 48

12 refuses consent but the healthcare professional judges that treatment would be in the patient s best interests. Next Review Date Oct 2015 Page 12 of 48

13 2. COMPETENCE AND ADULTS WITH INCAPACITY 2.1 Introduction The law of Scotland generally presumes that adults (those aged 16 or over) are legally capable of making personal decisions for themselves and managing their own affairs. That presumption can only be overturned on evidence of impaired capacity. The Adults with Incapacity (Scotland) Act 2000 ( The 2000 Act') sets out a framework for regulating interventions in the affairs of adults who have impaired capacity, in the circumstances covered by the Act. Part 5 of the 2000 Act, and its associated Code of Practice (3 rd edition), deals with medical treatment and research. The common law doctrine of necessity allows medical practitioners to give life saving treatment to patients who cannot consent and in these circumstances there is no need to invoke the mechanisms in Part 5 of the 2000 Act.. Part 5 covers non-emergency medical treatment and includes any procedure or treatment designed to safeguard or promote physical or mental health, including treatment for mental disorder. In the absence of consent, either from the adult patient, or from any proxy authorised under the 2000 Act to consent on his or her behalf, the 2000 Act confers a general authority to treat on the medical practitioner primarily responsible for the medical treatment of the adult and to any other person authorised by him or her and acting on his behalf under instructions, or with his or her approval and agreement. This authority is certified by a Section 47 Certificate of Incapacity (see 2.4 and Appendix 7): it authorises the treatment for the condition in question and can usually last for up to one year, although can last up to three years in certain circumstances. Registered Nurses, Ophthalmic Opticians and Dentists (who have all undergone specialist training) can now also authorise certain treatments without the need for the medical practitioner to issue a certificate of incapacity. 2.2 Incapacity For the purposes of the Act, 'incapable' means incapable of: a. acting or b. making decisions or c. communicating decisions or d. understanding decisions or e. retaining the memory of decisions Next Review Date Oct 2015 Page 13 of 48

14 in relation to any particular matter, by reason of mental disorder or due to an inability to communicate because of physical disability. A person cannot be presumed to lack capacity due only to a lack or deficiency of communication if that can be made good by human or mechanical aid (whether of an interpretative nature or otherwise). It is central to the 2000 Act that adults must not be labelled as incapable because of some circumstances or condition. The assessment of capacity must be made in relation to the particular matter or matters about which a decision or action is required. Incapacity is not an 'all or nothing' concept. A person may be legally capable of making some decisions and not of others. The decision to intervene has to be taken by the medical practitioner primarily responsible for the proposed medical treatment. This may be the adult's consultant in Care of Older People, Learning Disabilities or Psychiatry or the family doctor. In the case of an acute admission to hospital, it may be a consultant who has never before met the adult but who still must reach a view on whether or not the adult is capable in relation to a decision about the medical treatment. In practical terms, to demonstrate capacity, an adult should be able to: understand in simple language what the proposed medical treatment is, its purpose and nature and why it is being proposed; understand its principal risks, benefits and alternatives; understand in broad terms what will be the consequences of receiving the proposed treatment; retain the information; make the choice freely. The 2000 Act accepts that no pre-determined, single model of assessment of capacity exists at present. In determining if an intervention is to be made, it is expected that relatives and carers and other professionals will be consulted and involved in decisions about incapacity. 2.3 The General Authority to Treat and Core Principles of the 2000 Act There are exceptions to the general authority to treat. Treatments dealt with under Part 16 of the Mental Health (Care and Treatment) (Scotland) Act 2003 are not covered by the general authority to treat (see Section 4). Next Review Date Oct 2015 Page 14 of 48

15 The 2000 Act requires that any planned medical intervention should adhere to the following core principles: Provide a benefit to the person which cannot be reasonably achieved without the proposed medical intervention. Be the minimum intervention, consistent with the purpose of the intervention and the freedom of the individual. Should take account of the person's past and present wishes, so far as they can be determined. Include consultation with relevant others, so far as is reasonable, taking account of the views of the nearest relative, primary carer, any guardian or welfare attorney or any person nominated by a sheriff with powers relating to the proposed intervention, other persons with a legitimate interest in the welfare of the patient and who have made their views known. Encourage, as far as is reasonable, the person to exercise residual capacity. 2.4 Certificate of Incapacity (section 47 certificate) In the event that the person is deemed incapable of giving or withholding consent to medical treatment, a Certificate of Incapacity (7) must be completed and signed by the medical practitioner (or other registered healthcare professional as previously described in section 2.1) primarily responsible for the proposed treatment. It is essential that the medical practitioner who has undertaken the assessment of capacity completes the Certificate of Incapacity. This may be the General Practitioner, Consultant Psychiatrist, Consultant in Care of Older People or other Consultant in an acute specialty, dependent on who specifies and will be responsible for undertaking the medical intervention. A Certificate of Incapacity must be in the prescribed form and must specify the period during which the authority remains valid, being a period which: a) the medical practitioner primarily responsible for the medical treatment considers appropriate to the condition or circumstances of the patient; but b) does not exceed 12 months (in some circumstances this is extended to three years) from the date of the examination and assessment on which the certificate is based. Next Review Date Oct 2015 Page 15 of 48

16 A single Certificate of Incapacity is entirely appropriate when a person requires a single procedure, e.g. an operation. The certificate will provide authority to do what is reasonable in the circumstances, in relation to the medical treatment, to safeguard or promote the physical or mental health of the person. This could cover not only the operation but also post-operative medical care and pain relief. Careful completion of a Certificate of Incapacity is required for a person who needs multiple medical interventions and a possible way to complete the certificate in such circumstances would be by reference to a treatment plan. Patients incapable of giving or withholding consent who are being cared for in a continuing care setting will require a certificate of incapacity to authorise their general treatment and care provided by medical and other staff. Such certificate requires to be regularly reviewed as the treatment plan requires, and at least on an annual basis. Specific guidance is available in the Code of Practice for Persons Authorised to Carry out Medical Treatment or Research under Part 5 of the Act. 2.5 Proxy - Welfare Power of Attorney, Intervention Orders and Welfare Guardianship Orders Under the Act, an adult with capacity may at any time grant powers to someone to act as their attorney. A Welfare Attorney, with powers over personal welfare, may have the authority to consent to medical treatment or research; these powers only commence on the adult s incapacity. It is important to note that an adult has wide scope to grant to their Welfare Attorney whatever powers they choose, but unless powers are expressly in the written document, these cannot be implied. It is possible that a Welfare Attorney may have been appointed with powers over other matters of welfare, but without the authority to consent to medical treatment or research. The role of a Welfare Attorney is not to be confused with that of a Continuing Attorney, who is appointed and granted powers only over property and financial affairs. Where an adult has lost capacity to make his/her own decisions, and where no welfare attorney has been appointed, a relative, carer or other individual with an interest in the welfare of the adult, or the Local Authority which has statutory obligations under the 2000 Act, may apply to the Sheriff to appoint someone as Welfare Guardian. This person would then be entitled to make decisions about welfare matters, including consenting to medical treatment and/or research. In a Next Review Date Oct 2015 Page 16 of 48

17 one-off, clearly-defined situation an Intervention Order may be sufficient, but for an ongoing welfare matters, a Welfare Guardianship would be required. Such powers are subject to the same exceptions as apply to Welfare Attorneys. The Public Guardian, an office based on the Accountant of Court, registers powers of attorneys, intervention orders and guardianship orders and can help with enquiries arising from powers of attorney, intervention orders and guardianship. They can be contacted through their website Procedures are laid down in the Act for handling situations where there is dispute between the medical practitioner primarily responsible for medical treatment, any appointed proxy, and anyone else having an interest. The advice and assistance of the Legislation Manager (Clinical Services), the Legal Services Manager and NHS Fife's nominated solicitors are available when required. 2.6 Advance Directives/Statements (Living Wills) A patient's past and present wishes must be taken into account insofar as they can reasonably be ascertained. An Advance Directive, sometimes colloquially referred to as a 'living will', made orally or in writing to a clinician, solicitor or other health professional would be a strong indication of a patient's previously expressed wishes about medical treatment, but should not be viewed in isolation from surrounding circumstances. The status of the statement should be judged in light of its age, its relevance to the clinical situation now presenting, medical developments since the time it was made, and the patient's current wishes and feelings. If possible, the patient should be asked directly whether they still maintain the position stated in relation to the proposed treatment. It is noted that advance directives do not have any statutory legal authority (they are not covered by any statute, unlike advance statements in mental health legislation (see Section 4). Their common law authority has never been tested in Scotland as there is no Scottish case law on advance directives or living wills, but English case law may be persuasive. Medical practitioners may have occasion to override an advance directive if they believe the patient to have been incapable of decision-making about medical treatment when the Advance Directive was made, or where they believe the patient may have been subject to undue influence Next Review Date Oct 2015 Page 17 of 48

18 by another party. In these cases it would be prudent to seek legal advice. However, the doctor and other healthcare professionals should view the Advance Directive as a strong indication of the patient s wishes when they were capable and should take them very seriously into account. In any event, an Advance Directive cannot bind a clinician to provide treatment which is futile, unethical or illegal. Further advice with regard to Advance Directives/Statements can be found in the Operational Divisional policy 'Guidance to health professionals dealing with advance statements/directives about medical treatment (Living Wills)' see references section. For further details on advance directives consult the appropriate National or local policies or guidance. Next Review Date Oct 2015 Page 18 of 48

19 2.7 Frequently asked questions regarding this section Q: Can people set up Welfare Power of Attorney for some time in the future for example if someone has Motor Neurone Disease and they know they will in incapacitated at some stage in the future and would wish such arrangements to be set up at that time but not just yet while they are still able? If this is possible, how does a doctor know when that might come into effect? Welfare power of attorney must be made when the person still has capacity and unlike the continuing Power of Attorney can only come into effect when the attorney reasonably believes the adult has lost capacity to take the relevant welfare decision. Certain points should be addressed: The adult (Granter) signing the Power of Attorney document should consider what steps (if any) the attorney should take to establish incapacity The Adults with Incapacity (Scotland) Act 2000 (AWIA) does not require the attorney to obtain a medical certificate of incapacity (although solicitors often ask for one), however, it must incorporate a certificate by a practising solicitor, a practising member of the Faculty of Advocates or a registered medical practitioner which certifies that he or she: - has interviewed the granter immediately before the s/he signed the document; - is satisfied, either because of knowledge of the granter or because of consultation with another person who has knowledge of the granter, that at the time of granting the power, the granter understands its nature and extent; and - has no reason to believe that the granter is acting under undue influence. The attorney may seek medical advice, especially if there are disputes about whether the adult has lost capacity From 5th October 2007 a new incapacity clause was introduced and a failure to include wording which indicates that the granter has considered how they would wish their incapacity to be determined will result in the document failing against the Office of the Public Guardian s registration criteria and thus being returned. In other words the granter must state this has been thought about and hopefully discussed when the document was drawn up, however, the granter is not required to include the Next Review Date Oct 2015 Page 19 of 48

20 outcome of their considerations, i.e. they do not need to state the actual methods to be employed to determine their incapacity, although the Public Guardian advocates a reference to this as best practice; but the document will not fail against the registration criteria if reference to 'how' is omitted There is no prescribed wording for the new incapacity clause; any wording which indicates that the granter has considered how their incapacity shall be determined will be accepted Power of Attorneys executed before 5th October 2007, even if submitted after that date, do not require this clause Next Review Date Oct 2015 Page 20 of 48

21 Q: What if a Welfare Power of Attorney was issued in England is it legally binding in Scotland? This question is slightly more complicated in its answer since the laws are different in relation to power of attorney and this is further complicated by the English Mental Capacity Act 2005 recently coming into effect. The English Mental Capacity Act 2005 introduced Lasting Powers of Attorney (LPAs), certain conditions apply: Enduring powers of attorney, which related to the management of property and affairs, have been replaced under the Act by LPAs which extend to health and welfare decisions. An individual can nominate another person to make health care decisions on his or her behalf when he or she loses the capacity to make such decisions; this is similar to the Scottish WPoA. This transfer of health decision-making authority has to be indicated in the LPA, and does not extend to refusing life-sustaining treatment unless this is explicitly stated. The individual creating the LPA can also set a variety of conditions on the exercise of the powers. Anyone acting under the powers of an LPA is constrained by the basic principles of the Act and has to make decisions in the best interests of the incapacitated person. When a health professional has a significant concern relating to decisions taken under the authority of an LPA about serious medical treatment, the case can be referred for adjudication to the Court of Protection. Both Acts and their respective Codes of Practice are silent on any cross-border issues. While both Acts are similar in their WPA/LPA provisions, there are some important Next Review Date Oct 2015 Page 21 of 48

22 differences, e.g. age of an adult: 16 years in Scotland, 18 in England; differences in the principles of each Act, etc. NHS Fife advice to medical practitioners would be to invoke the authorisation of medical treatment through a section 47 certificate of the AWIA for adults who have English Power of Attorneys and who have lost decision-making capacity as well as getting agreement from the English attorney for proposed treatment. This is will ensure that the doctor is not treating the patient unlawfully under Scottish legislation. 3. CHILDREN 3.1 Obtaining consent for children Young people of 16 years and over have the right to consent or refuse to consent to medical, dental or surgical procedures or treatments, as any adult does. Children and young people UNDER the age of 16 are entitled to consent to medical, surgical, dental procedures or treatment where, in the opinion of a qualified practitioner attending him/her, he or she is capable of understanding the nature and possible consequences of the procedure or treatment. Good practice suggests that the child s parents/carers should be involved when discussing consent and carrying treatment forward. However if a doctor, dentist or other medical practitioner takes the view that the child has the capacity to consent then only the child can consent or not consent. The consent or refusal of someone else, such as the parent, is legally irrelevant. If the child has the capacity he or she is entitled to patient confidentiality unless you can justify disclosure on the grounds that you have reasonable cause to suspect that the child or other children are suffering, or are likely to suffer significant harm. In cases where confidentiality issues were to arise then the personnel involved must maintain the patient s trust but in most cases would look to resolve any dispute between the child and their parents so that a satisfactory agreement can be achieved. Assessing competence: For young people to have the capacity (be competent) to take a particular decision they must be able to: Comprehend and retain information material to the decision, especially as to the consequences of having or not having the intervention in question: and Next Review Date Oct 2015 Page 22 of 48

23 Use and weigh information in the decision making process. It should never be automatically assumed that a child with learning disabilities is not competent to take his or her own decisions: many children will be competent if information is presented in an appropriate way and they are supported through the decision making process. 3.2 Who has the right to consent on behalf of a child? If a doctor takes the view that the child does not have the capacity to understand the nature and consequences of treatment, then it is necessary to consider who has parental responsibilities and rights to consent on the child s behalf. Legally, consent is only required from one person with parental responsibility. The Children (Scotland) Act 1995 sets out who has parental responsibility and this includes: The child s mother whether married to the father or not. The child s natural father if married to the mother at the time of conception or birth. The child s natural father, even if divorced from the mother. Unmarried fathers who have entered and registered a formal Parents Responsibilities and Parental Rights Agreement with the mother. (NB: except for babies born after 4th May 2006, where, if the fathers name is on the birth certificate then parental rights and responsibilities are automatically assumed) The child s legally appointed guardian appointed either by a court or by parents with parental responsibility in the event of their own death. A person holding a Residence Order in relation to the child, or any other court order giving the right to consent on a child s behalf. Individuals who are normally the carers of a child may also consent to medical treatment in certain circumstances under section 5 of the 1995 Act. Where a person 16 years or over has control of a child under that age but no parental responsibility or rights they may consent to medical treatment if the child is incapable or they have no knowledge that a parent of the child would refuse. Parents may also for example give authority for someone who cares for the child on a regular basis, such as grandparents, foster carer or child minder, to give consent for Next Review Date Oct 2015 Page 23 of 48

24 medical treatment under defined circumstances i.e. in emergencies or for routine treatments. 3.3 Looked after children If a child is looked after this does not normally give the local authority the right to consent to treatment on behalf of a child. Regardless of whether the child is at home or away from home, parental responsibilities and rights remain with the parents. The only clear exception is where a child is looked after because they are subject to a Parental Rights Order (PRO) under section 86 of the 1995 Act. In that situation parental responsibilities and rights to consent to treatment are passed to the local authority. Another exception for looked after children is when the child is subject to a Child Protection Order, Child Assessment Order, a warrant or a supervision requirement which has a condition authorising medical treatment. In those situations it is presumed to be safe for the doctor to take that authority in place of the consent from the parent. 3.4 Child freed for adoption If a child has been freed for adoption in terms of section 18 of the Adoption (Scotland) Act 1978 then the local authority has all parental responsibilities and rights. Where a person exercising parental responsibility is giving consent for a child s treatment or care, it is important that they have the necessary information about the proposed procedure in order to take a proper view as to the child s best interests. 3.5 Where no one is able to give consent Where no one is able to give consent to treatment because the child is unconscious after an accident, needs treatment urgently, and no one with parental responsibility can be contacted. In such circumstances it is lawful to provide immediate necessary treatment on the basis that it is in the child s best interests. When the person with parental responsibility may be available but not competent to give or withhold consent. For example if the person is under the influence of drugs or alcohol, or the mother of a child is herself under 16 and the treatment cannot wait, it will be lawful to provide it in the child s best interest. Next Review Date Oct 2015 Page 24 of 48

25 3.6 Where staff and those with parental responsibilities do not agree Parental responsibilities and rights are subject to a qualification that their exercise must be in the best interests of the child. Parents have no right to insist on treatment, which is clearly not going to benefit the child or to withhold treatment that would benefit the child. Occasions will inevitably arise when clinicians are confronted either with disputes over consent or purported refusals of consent which (in their view) are contrary to the best interest of the patient. At all times, clinicians will principally be guided by their duty to act in the best interests of their patient. Most disputes can be resolved by negotiation and compromise, and the case that cannot is very much the exception. Next Review Date Oct 2015 Page 25 of 48

26 3.7 Making sure children are involved in decision-making Even when children are not able to consent themselves, it is important to involve them as much as possible in decisions about their own health. Even very young children will have opinions about their health and care and methods should be used appropriate to their age and understanding to enable these views to be taken into account. Decision making in older children is often a matter of negotiation between the child, those with parental responsibility and health care professionals. Further advice is available in Advocating for children, from the Royal College of Paediatrics and Child health. (RCPH 2000) 3. MENTAL HEALTH 4.1 Obtaining consent from patients detained under the Mental Health (Care and Treatment) (Scotland) Act 2003 The Mental Health (Care and Treatment) (Scotland) Act 2003 (the 2003 Act) is concerned with the care and treatment of individuals with a mental disorder including those who may be subject to compulsory treatment and detention. Mental disorder is defined in the 2003 Act as mental illness, personality disorder or learning disability, however caused or manifested. Mental disorder is not defined by any of the following alone: Sexual orientation Deviancy Acting as no prudent person would act Behaviour that causes or is likely to cause harassment, alarm or distress to any other person Dependence on alcohol and/or drugs, Detention under the terms of the 2003 Act does not affect the fundamental right of an individual to receive sufficient verbal and written information to enable an informed decision to be made, nor does it interfere with the fundamental right to grant or withhold consent prior to any examination or treatment. In some circumstances, subject to proper procedures in the Act being applied, a patient may be given compulsory treatment against their will. This relates only to treatment for their mental Next Review Date Oct 2015 Page 26 of 48

27 disorder or treatment for a physical disorder directly related to a mental disorder, for example giving antibiotics for an infection which is causing delirium. The 2003 Act does not apply to treatments for physical conditions unrelated to the mental disorder. Accordingly, in relation to treatment for physical or medical conditions a patient subject to compulsory detention under the 2003 Act would be dealt with as any other individual who has not been detained. Where the patient lacks capacity due to his/her mental disorder and requires treatment for a physical condition, then this should be dealt with under the Adults with Incapacity (Scotland) Act 2000 as described in section 2. Neither Act alters the underlying common law duty of care that compels medical practitioners to treat in certain circumstances. Emergency treatment can be given to any patient, who does not or cannot consent, to save life, to prevent harm or to alleviate serious suffering. 4.2 Advance Statements in the Mental Health (Care and Treatment) (Scotland) Act 2003 An advance statement is a written statement of how a patient would or would not wish to be treated for a mental disorder should his or her decision-making become significantly impaired. Any person providing medical treatment for a mental disorder must take account of a valid advance statement. Further information on advance statements in mental health and learning disabilities can be found at 4. PHOTOGRAPHIC/AUDIO MATERIAL 5.1 Consent for photography, video or audio recordings Photographic, video and audio recordings made for clinical purposes form part of a patient s medical record. Although consent to certain recordings, such as X-rays, is implicit in the patient s consent to the procedures, patients should be warned in advance if any photography, video or audio recording will be any part of the procedure/consultation. Photographic, video or audio recordings made for treating or assessing the patient must not be used for any purpose other than the patient s care, or audit of that care, without the express consent of the patient or person with parental responsibility for the patient. Photographic, video or audio recordings made for treating or assessing the patient and even when there is no possibility that the patient might be recognised must still have Next Review Date Oct 2015 Page 27 of 48

28 the consent of the patient for those images to be used in the clinical setting for educational or research purposes. Forms are available from the Department of Medical Illustration. When consent is sought for any form of publication, the clinician must ensure that the person giving consent is fully aware of the possible uses for the material. In particular, it must be made clear that there may not be any control over future use of the material once it is in the public domain. If a photographic, video or audio recording of a patient is being made specifically for education, publication or research purposes their written consent must be sought both to make the recording, and, to permit use of the recording. Patients must be informed that they are free to stop the recording at any time and that they are entitled to view/listen to the recording before deciding to give consent for its use. If the patient withdraws consent for the recording to be used then it must be destroyed. In cases where the patient is temporarily unable to give consent because they are, for example, unconscious, the health care professional may make the recording, but consent must be sought as soon as the patient is able to make a decision. The recording must not be used until consent has been obtained. If the patient does not give consent then the recording must be destroyed. If the patient is likely to be permanently unable to give or withhold consent then agreement should be sought from the next-of-kin. The recording should not be used in any way which might be against the interests of the patient. If an alternative patient is able to give consent then this route should be pursued instead. A separate consent form is available for babies that die and for those with abnormalities. Permission for the taking of these images, their storage and subsequent use are individually selected using this form. (Refer to Women and Children s Health Directorate policy and guidance) Further advice is available from the Department of Medical Illustration. 5.2 Children and photographic image consent (see 3.2 for children treatment consent) and long running treatment or assessment In the case of children where there is the requirement for photographic image recording for a whole course of treatment (such as orthodontics) the child may often be unaccompanied; Consent is required for each attendance for photographic images. If a child is not willing for a recording to be used, it must not be used, even if a person with parental responsibility consents. Next Review Date Oct 2015 Page 28 of 48

29 6. ASKING FOR AGREEMENT FOR A POST MORTEM The death of a patient can be a difficult time for the healthcare professionals involved as well as for relatives. Asking relatives to agree to a post mortem is a delicate and challenging task and the production of suitable guidance is outwith the scope of this document. Full guidance is available from the Pathology Department in the Adult Authorisation Form: Guidance for Clinical Staff and also in the Relatives Leaflet produced by NHS Fife. 7. NON SURGICAL INTERVENTIONS 7.1 Medical interventions Many medical (drug therapy) interventions carry risks equal to or greater than surgical procedures yet consent to use such treatments is rarely sought. It is, however, expected that informed consent to receive medical therapy is obtained by responsible clinicians in appropriate settings. It is not necessary that a consent to treatment form is signed by a patient but it should be evident from clinical records that a process of informing the patient and obtaining consent has taken place. The same information needs apply to patients receiving medical therapy with regard to the diagnosis being treated and regarding prognosis with and without treatment. Details of the treatment proposed should include information as to the type and duration of treatment and any serious or frequently occurring adverse effects. Alternatives to the proposed treatment and their relative risks and benefits should also be discussed. The clinician with overall responsibility should be identified and the ability of the patient to retract consent at any time emphasised, particularly where protracted or repeated treatments are required. One example of this is specific consent forms for chemotherapy which have been developed and are available in the haematology units. Important exceptions to the above include emergency treatment and treatments in the context of a clinical trial where separate consent procedures exist. All forms developed must meet the Consent Form Standards and be registered with the NHS Fife Clinical Governance Steering Group. Next Review Date Oct 2015 Page 29 of 48

30 7.2 Immunisation The general principles of obtaining consent apply to the administration of vaccination by either a Registered Nurse or a medical practitioner. Further guidance is available in the NHS Fife Code of Practice for Medicines. 7.3 Interventions by Registered Health Care Professionals who are not Registered Medical Practitioners Guidance on obtaining informed consent is provided by individual professional bodies (e.g. Nursing and Midwifery Council, College of Occupational Therapy, British Dietetic Association, etc) which follow the spirit of the recommendations laid out in the Department of Health guidance Good practice in consent implementation guide: consent to examination or treatment. In general it is considered adequate to obtain oral consent for most interventions which are considered not to involve risk or substantial risk. For procedures which have been identified as involving risk or substantial risk written consent is required and the generic NHS Fife Consent form should be used to record this. If a clinician is left with any doubt then written consent should be obtained. 8. RESEARCH 8.1 Introduction Informed consent should be requested for research which involves interventions, observations or interviews with patients or healthy volunteers (including NHS employees) and/or their tissue or data relating to them. Valid informed consent for participation in research must be given voluntarily in light of sufficient information by legally competent individuals. Requests for informed consent for research should avoid any form of coercion. The process must be recorded in writing. 8.2 Research - Voluntary withdrawal Potential participants should understand that they are free to withhold consent and that doing so will not affect the standard of treatment they receive or upset the people responsible for their health care. Assurance should be given that once enrolled in a research study participants may withdraw at any time, without having to give a reason. Next Review Date Oct 2015 Page 30 of 48