People have the fundamental right to grant, or withhold consent to any examination, investigation or treatment, or to involvement with teaching or research. They must receive information to the extent they desire, so that their decisions are truly informed, taking into account their legal capacity.

NHS Ayrshire & Arran will provide information in a way that the patient can understand and will, where applicable, supplement verbal information with booklets, audio, video or web-based content.

NHS Ayrshire & Arran will provide training to health professionals on informed consent. Our intent is for staff to work with patients collaboratively, to achieve the best achievable outcome for that individual. The clinician brings clinical expertise and experience to the table, and the patient brings knowledge of their own attitudes, wishes and lifestyle.

With specific exceptions, the legal basis for consent is mostly common law rather than statute. The General Medical Council’s latest publication on the topic, Decision Making and Consent, in effect from 9th November 2020, outlines the principles, and supporting legal framework. The Scottish Government also provides guidance in HDL (2006)34, A good practice guide on consent for health professionals in NHSScotland, with further guidance published in 2018: Shared decision-making and consent: good practice  We expect our health professionals to be familiar with, and to follow the General Medical Council (GMC) and Scottish Government guidance, as well as this policy.

A 2017 thematic report by the Scottish Public Services Ombudsman analysed complaints received regarding healthcare, and found that inadequate or poor consent was a topic which was repeatedly raised – often as part of a broader complaint about the care received by a patient rather than a specific complaint about consent processes.

Consent is a patient’s continuing agreement for a health professional to provide care. For consent to be valid, patients must:

• have capacity to take a particular decision
• have received sufficient information to take the decision
• give consent voluntarily.

Consent is only valid if all three elements are satisfied.

Mental disorder does not necessarily make a patient incapable of giving consent. Capacity to consent may be variable in patients with mental disorder and should be assessed with regard to the particular patient, at the particular time, and with regard to the particular treatment.

Voluntary consent to treatment for mental disorder should be sought, according to the principles above, wherever possible. In cases where there is purely a lack of capacity, no sign of any resistance to the proposed intervention, and where detention is not an issue, consideration can and should be given to applying the Adults with Incapacity Act rather than the Mental Health (Care and Treatment) (Scotland) Act 2003 .

If treatment for mental disorder is being given to a patient without their consent, the provisions of Part 16 of the Mental Health Act must be followed. In all cases, advice should be sought from specialist mental health practitioners. This advice should also encompass advance directives, named person rights and advocacy.

The Mental Health Act does not apply to treatments for physical disorders.

Section 243 of the Act allows for medical treatment to be given to a patient who, refuses to consent to or is incapable of consenting to, that treatment even if the patient is detained due to an Emergency Detention Certificate (issued under section 36).

Urgent medical treatment for mental disorder can only be provided, even if the patient does not consent or is incapable of consenting, where the purpose of the treatment is to:

• save the patient's life
• prevent serious deterioration of the patient’s health
• alleviate the patient's suffering
• prevent the patient from harming self or others.

Section 243 however limits the circumstances in which medical treatment can be given, except for life saving treatment medical treatment can only be given if:

• the treatment is not likely to entail unfavourable, and irreversible, physical or psychological consequences
• the purpose of the treatment is to alleviate serious suffering or prevent the patient from harming himself or others
• the proposed treatment must also not entail significant physical hazard to the patient.

An adult who usually has capacity may become temporarily incapable, for example, whilst under a general anaesthetic or sedation, or after a road accident. Other temporary factors can remove or reduce capacity include confusion, shock, fatigue, pain, drugs.

Unless a valid advance refusal of treatment is applicable to the circumstances, the law permits interventions to be made which are necessary and no more than is reasonably required for the patient’s benefit pending the recovery of capacity. If a medical intervention is thought to be to the patients benefit but can be delayed until the patient recovers capacity and can consent to (or refuse) the intervention, it must be delayed until that time. For example, it would not be justifiable to perform an additional procedure without consent, simply to avoid a second anaesthetic for the patient.z

6.1 Emergency situations

In unconscious patients where treatment is immediately necessary to save life and avoid significant deterioration in the patient’s health, or alleviate pain or suffering treatment may proceed under the common law principle of “necessity”. However, this may not be justifiable when it is contrary to the known wishes of the patient. In any event, the health professional should do no more than is reasonably required in the best interests of the patient. Advice may be sought from the Medical Director, the Nurse Director or the Central Legal Office.

6.2 Determining best interests

The following factors should be taken into account when determining best interests:

• the patient's own wishes, if these can be determined including any Living Will
• clinical judgment about the effectiveness of any proposed treatment and alternatives
• where there is more than one option, which is least likely to restrict the patient’s future choices
• the degree of urgency of the treatment, e.g. lifesaving treatment
• the views of people close to the patient especially close relatives, partners, carers, and proxy decision-makers (Welfare Guardian or Attorney) about what the patient is likely to see as beneficial
• any knowledge of the patient’s religious, cultural or non-medical views that may have an impact on the patient’s wishes
• the views of the parent, if the patient is a child.

7.1 The age of legal capacity

The Age of Legal Capacity Act presumes that young people over the age of sixteen are competent to give consent for themselves for their own surgical, medical or dental treatment, and any associated procedure, such as investigations, anaesthesia or nursing care.

7.2 Young people under the age of sixteen years

The Age of Legal Capacity Act states that children under the age of sixteen years shall have legal capacity to consent on their own behalf to any surgical, medical or dental procedure or treatment when a qualified medical practitioner states that he or she is capable of understanding the nature and the possible consequences of the procedure or treatment.

Although the Act states “a qualified medical practitioner” will make the decision as to ability to consent, in practice, the health professional treating the child can make this decision given s/he is competent to do so.

Assessment of the young person’s ability to make decisions will depend on several things, including:

• the patient's age
• the maturity of the patient
• the complexity of the proposed intervention, its likely outcome and the risks associated.

If the responsible health professional feels unable to take this decision, the professional should seek advice from a senior member of his/her profession.

It is good practice for the health professional to encourage children to involve their parents in the healthcare decision-making process. There may be a difference of opinion between the parent and child. Acting in a professional and tactful way may help them to reach an agreement.

The Age of Legal Capacity Act requires that when the child has capacity to make health care decisions then the child’s decision should be respected even if it differs from the parents` views or the views of the health professional. It is also important to note that young people under sixteen years of age also have the right to withhold consent to treatment.

If the child is not capable of understanding the nature of the healthcare intervention and its consequences, then the health professional should ask the child’s parent or guardian to consent to the treatment.

7.3 Children with cognitive impairment

It should not be assumed that a child with cognitive impairment 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.

7.4 Parental responsibility

Only people with ‘parental responsibility’ are entitled to give consent on behalf of their children. 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 the parent or guardian who has parental responsibility for the child is not available and the procedure cannot be postponed until the health professional can speak to the parent, section 5 of the Children (Scotland) Act 1995  allows a person who has care or control of the child, but has no parental rights or responsibilities in relation to the child, the power to do what is reasonable in all circumstances to safeguard the child’s health, development and welfare. This could include persons such as:

• the child’s father (where the parents are unmarried and even if there is no parental responsibilities agreement)
• step-parent
• relative
• child minder who is looking after the child during the day
• partner of an adoptive parent
• civil partner of a child’s parent or guardian.

This person may consent to surgical, medical or dental treatments or procedures if the child cannot give consent on his own behalf and it is not within the knowledge of the person that the person with parental responsibility would refuse the treatment.

This provision does not apply to teachers and others having care and control of a child in school.

When babies, children or young people are being cared for in hospital, it will not usually be practicable to seek their parents’ consent on every occasion for every routine intervention such as blood or urine tests or x-rays. Where a child is admitted, it should therefore be discussed 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, this must be done, unless the delay involved in contacting them would put the child’s health at risk.

The child must be fully involved in all aspects of care and treatment and consent should be explicitly elicited regardless of age. It is a common mistake to assume that parental consent for someone under sixteen years of age is satisfactory on its own to allow medical or other treatments to proceed; the law makes it clear that this is not the case (Age of Legal Capacity Act).

7.5 Emergency situations

If the child is unable to consent and treatment cannot be delayed until the person with parental rights is consulted then the position as discussed in section 6.1 of this policy with regard to emergency situations will apply to children under the age of sixteen.

7.6 Children in local authority care

If the child is looked after or accommodated by a local authority the same general principles apply. If the child is capable of giving consent and understanding the nature and possible consequences of the procedure or treatment then no further consent is required.

If a Court has made a parental responsibilities order in favour of a local authority then, if the child lacks the capacity to consent, the consent should be sought from the authority.

7.7 Treatment under the Children Act

The health professional may be involved in the examination or treatment ordered under the Children (Scotland) Act 1995 by a Children’s Hearing. If the child has the necessary capacity the health professional must obtain the child’s consent or, if the child lacks that capacity, then parental consent should be obtained.

If consent is refused by or on behalf of a child it may be overridden by the courts. Under section11 (2) of the Children (Scotland) Act 1995 the Courts may authorise medical treatment if it is deemed to be in the child’s best interests. Any person with an interest, which could include a medical practitioner, can apply to the court for such an order to be considered. However circumstances in which such an application will be appropriate are limited but could arise in a life threatening situation.

7.8 Criminal proceedings

In cases of criminal proceedings, when consent to examination for purposes of obtaining evidence is refused by the parent or guardian, the Procurator Fiscal may obtain a warrant for this purpose, but if the child who has legal capacity to consent declines, the Procurator Fiscal cannot seek a warrant.

7.9 Refusal of parental consent to urgent or life-saving procedures

When a child lacks the capacity to consent in urgent situations, if time permits, consent should be sought from the Court of Session. If time does not permit, the consultant should wherever possible obtain a written supporting opinion from another colleague (usually another consultant) that the patient’s life is in danger and there is clear risk of permanent harm if treatment is withheld. The need for treatment should be discussed with the parents in the presence of a witness. The discussion should be clearly recorded in the case notes and counter-signed by the witness. However, advice should always be sought from the Medical Director or Deputy, who, in turn, will seek advice from the Central Legal Office.

8.1 Advance refusal/living wills

Patients may have a living will specifying how they would like to be treated in the case of future incapacity for example Jehovah's Witness (and some other patients) who do not wish to receive a transfusion of blood products. An Advanced Refusal/Living Will is a document, which specifically refuses particular treatments or categories of treatment.

Such documents may be binding, therefore, when a medical practitioner contemplates overriding such a directive, appropriate legal guidance should be sought.

NHS Ayrshire & Arran will recognise a patient’s valid Advance Refusal/Living Will and therefore treatment, which would breach the terms of such a directive, may not be given without seeking legal advice. The onus is on the patient/relative to produce the document at the time of treatment.

A clear statement of refusal of treatment in advance by a competent adult, acting free from pressure, has potential legal force. General statements of preferences should always be taken into account, if appropriate, but are not legally binding. Any Advance Refusal/Living Will is superseded by a clear and competent contemporaneous decision by the individual concerned.

An Advance Refusal / Living Will is legally binding providing that the patient was competent and properly informed when reaching the decision, the directive is clearly applicable to the present circumstances and there is no reason to believe that the patient has changed his or her mind.

Although the issue has not yet come before a court, it has been suggested that, as a matter of public policy, individuals should not be able to refuse care which is essential to keep a patient comfortable in advance directives. This is sometimes referred to as “basic” or “essential” care and includes keeping the patient warm and clean and free from distressing symptoms such as breathlessness, vomiting, and severe pain.

Basic/essential care includes the offer of oral nutrition and hydration; however, it does not cover feeding an individual against their will or the use of artificial nutrition and hydration. Towards the end of such a period, an individual is likely to lose capacity (become incompetent) and the courts have stated that if the individual has, whilst competent, expressed the desire to refuse food until death supervenes, the person cannot be force fed or fed artificially when incompetent. However, if the patient is refusing food as a result of mental disorder and is detained under the Mental Health Act, different considerations may apply and specialist guidance should be sought.

8.2 Ascertaining the patient's present wishes

The health professional must take into account the present wishes and feelings of the adult in so far as they can be ascertained by any means of communication. The best person to give an account of his or her wishes or feelings is the adult him or herself. Non-verbal communication may be taken into account, for example, if the patient shows unusual distress at the mention of a particular kind of treatment, or the sight of particular apparatus or instruments, even after attempts to reassure have been made.

8.3 Additional evidence about the patient's wishes

Medical records may record the past wishes of the adult from earlier contacts with the medical profession. Where possible the health professional should try to ascertain the adult’s past wishes and feelings from those who know him or her. Whilst these reports should be taken into account, the health professional should guard against taking at face value everything that relatives or carers say about the adult’s past wishes and feelings in case these have been misunderstood or misrepresented. If time allows and it is feasible to do so, it may be appropriate to contact the patient’s solicitor, or other advisor to ascertain whether the patient at any time in the past expressed wishes or feelings on the subject of his or her future medical treatment.

8.4 Considering the evidence

The status of an advance directive will depend upon the age of the statement, its particular relevance to the patient’s current health care needs, medical progress since the time it was made which might affect the patient’s attitude and the patient’s current wishes and feelings. An advance directive cannot bind a health professional to do anything illegal or unethical.

8.5 Withdrawal of treatment

Where life-sustaining treatment or other medical treatment is withdrawn or discontinued for patients who are incapable of consenting to such withdrawal or discontinuation, legal advice will be required. A living will cannot authorise the withdrawal or discontinuation of treatment in those circumstances.

It is necessary to seek the approval of the Court of Session to the withdrawal of life sustaining treatment from a patient who is in a permanent or persistent vegetative state before doing so. It is only on this basis that the Lord Advocate has confirmed that he will not prosecute should the patient subsequently die.

NHS Ayrshire & Arran is involved in the training of student health professionals, and such training may involve examination of patients. Verbal consent should always be sought for the involvement of students in patient care, or teaching.

Students should explain to the patient in terms the patient could understand what the examination involves and the reason for it. The patient should have the opportunity to ask questions and be given the opportunity to refuse consent for the examination.

For intimate examinations, a qualified doctor rather than the student must obtain specific consent.

Intimate examinations under anaesthesia by students must be performed only when the staff member supervising the student has obtained specific written consent from the patient.

Occasionally, non-NHS staff may be present in the clinical environment (for example, company representatives advising on the use of new equipment). Verbal consent must be sought from the patient beforehand. If the patient will be under anaesthetic or sedated, specific written consent must be obtained.

All research within the NHS must comply with the UK statutory instrument Medicines for Human Use (Clinical Trials) Regulations SI No. 1031 2004 and amendments  and the UK Policy Framework for Health and Social Care Research . Before a piece of research can commence the study must be granted a favourable opinion by the appropriate Research Ethics Committee (REC) to ensure that the ethical issues associated with the study have been reviewed.

Studies which involve participants who are unable to give informed consent under the Adults with Incapacity Act must be submitted to the REC with designation for the Act for an ethical opinion. All research must comply with the provisions of the Act. In addition the host Board area must review the proposal to ensure that the service demands of the research are appropriately addressed.

10.1 Obtaining consent for research studies

When obtaining consent researchers must ensure that all potential participants are informed of all the requirements and consequences of participating in the study. It is particularly important that it is explained to the participant the importance of the work when a piece of research will not be of direct clinical benefit to the individual. The potential participant should be clearly informed that at any point during the study the participant could withdraw with no consequences for current or future clinical care.

10.2 Research Ethics Committee guidance

Research Ethics Committees provide detailed guidance on the layout and contents of the participant information sheet and consent form to ensure that these issues are properly dealt with.

Video, audio recordings and clinical photographs may be collected as part of routine clinical practice and audit, and used as part of the medical record. Verbal consent is sufficient for this use, although sensitive recordings may warrant more formal written consent.

Prior to undertaking video or audio recordings or clinical photography for teaching, research or publication, the reason and purpose for doing so must be explained clearly to the patient and his/her consent sought.

At a later date, should the health professional wish to use the recordings or photographs for any purpose other than that to which the patient has consented, the health professional must seek additional consent for this specific use from the patient.

12.1 Individual

This policy outlines the practice in relation to patient consent expected of health professionals employed by NHS Ayrshire & Arran. In addition, it is the duty of all health professionals working in NHS Ayrshire & Arran to ensure that they are aware of their professional body’s code of practice in relation to patient information and consent. Health professionals are expected to practice according to the principles of these codes at all times.

12.2 Departments

Clinical directors and clinical nurse managers (and other equivalent professional line management roles) must ensure that all health professionals within their department are aware of this policy, and understand its contents. They must ensure that new clinical staff joining the department are made aware of the policy through local induction procedures.

If departments opt to use information leaflets other than those provided by the organisation, they are responsible for the distribution, version control and revision of those leaflets.

If departments wish to use procedure-specific or other non-standard consent forms, they must seek approval from the Surgical Division Clinical Governance Group, after agreeing the need within their own clinical governance meeting.

Departments who have made special arrangements to allow consent on the same day as the procedure, must perform an audit every three years, which assesses if patients who underwent the procedure found the approach and information provided satisfactory, and in line with the principles of consent.

Departments are responsible for agreeing which ward-based interventions require written consent, and ensuring their staff are aware of the requirement. Where the procedure is carried out in more than one department, it may be appropriate to escalate this decision to the Surgical Division Clinical Governance Group to ensure consistency across the organisation.

12.3 Organisation

The Combined Surgical/Medical Clinical Governance Group has delegated responsibility for the Consent Policy on behalf of the organisation. The Committee will ensure the policy is revised every three years, or earlier if required. The Committee must consult with the other Clinical Governance Committees (Women, Children and Diagnostics; Mental Health; Health and Social Care) before issuing a revised policy.

The Combined Surgical/Medical Clinical Governance Group will consider approval of any applications:

• to seek consent on the day of a procedure, and will receive three yearly reports on the acceptability to patients of any same day consent form.
• to use a procedure-specific or non-standard consent form.

The Director of the Acute Directorate and the three Integrated Joint Boards, as guided by the Associate Medical and Nursing Directors and AHP Director, will ensure:

• provision of adequate training for health professionals on seeking consent.
• provision of patient information leaflets on common treatments and ensuring these are written in plain English, are accurate, relevant and supportive.
• that all information is provided in a format that the patients can comprehend.
• provision of interpreter and other communication services, and ensuring that all staff know how to access these services.
• availability of Speech and Language services to assist with communication.

This policy has been impact assessed using the NHS Ayrshire & Arran Equality and Diversity Impact Assessment Tool Kit.

It should be noted that information has been included in this document to cover requirements around appropriate communication.

In addition at Section 7.4 explicit mention has been added around adoptive parents and civil partners.

NHS Health Research Authority. UK policy framework for health and social care research. Updated 2020. Available from: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

The Scottish Government. (2006) HDL(2006)34: A good practice guide on consent for health professionals in NHSScotland. http://www.sehd.scot.nhs.uk/mels/HDL2006_34.pdf

The Scottish Government. (2018) Shared Decision-Making and Consent: Good Practice. Available from:https://www.gov.scot/publications/good-practice-shared-decision-making-consent/

Scottish Parliament, SPICe Briefing. (2019). Informed Consent in Healthcare Settings. Available from: https://digitalpublications.parliament.scot/ResearchBriefings/Report/2019/1/10/Informed-Consent-in-Healthcare-Settings

Scottish Public Services Ombudsman. (2017). Informed Consent: Learning from Complaints. Available from: https://www.spso.org.uk/sites/spso/files/csa/InformedConsent_SPSOMarch2017.pdf

General Medical Council. (2020) Decision Making and Consent. Available from:https://www.gmc-uk.org/-/media/documents/updated-decision-making-and-consent- guidance_pdf-84160128.pdf

British Medical Association. (2019) Seeking Patient Consent Toolkit. https://www.bma.org.uk/media/2481/bma-consent-toolkit-september-2019.pdf

Adults with Incapacity (Scotland) Act 2000 Code of Practice (Third Edition). (2010) For practitioners authorised to carry out medical treatment or research under part 5 of the Act. http://www.gov.scot/Resource/Doc/327864/0105906.pdf

Medical and Dental Defence Union of Scotland. (2011) Essential guide to consent. http://www.mddus.com/media/1679/essentialguideconsent03-11.pdf

Montgomery v Lanarkshire Health Board (Scotland) [2015] UKSC 11. https://www.supremecourt.uk/cases/uksc-2013-0136.html

Legislation

Age of Legal Capacity (Scotland) Act 1991 http://www.legislation.gov.uk/ukpga/1991/50/contents

Children (Scotland) Act 1995 http://www.legislation.gov.uk/ukpga/1995/36/contents

Adults with Incapacity (Scotland) Act 2000 http://www.legislation.gov.uk/asp/2000/4/contents

Mental Health (Care and Treatment) (Scotland) Act 2003 http://www.legislation.gov.uk/asp/2003/13/contents

The Medicines for Human Use (Clinical Trials) Regulations 2004 http://www.legislation.gov.uk/uksi/2004/1031/made

Smoking, Health and Social Care (Scotland) Act 2005 http://www.legislation.gov.uk/asp/2005/13/contents

Adult Support Protection (Scotland) Act 2007 http://www.legislation.gov.uk/asp/2007/10/contents

NHS Ayrshire & Arran consent for operation form

The consent forms listed below are available from the appropriate service.