Consent to examination or treatment
Contents
Section
1 Introduction
2 Capacity to consent
Assessing capacity
Assessing best interests (patients who lack capacity)
IMCA Service
Disagreement
3 When to seek consent
4 Recording consent
Duration of consent
Withdrawal of consent
5 Providing sufficient information to obtain consent
6 Who is responsible for seeking consent?
7 Consent in relation to patients who are under 18 years old
Parental Responsibility
8 Refusal of medical treatment
Advance Decisions
9 Human Tissue
10 Clinical photography and video/digital recordings
11 Training
12 Consent to involvement of students
13 Consent for clinical audit or research programmes
14 Use of treatment contracts
15 Disclosing information to third parties
16 Consent in an emergency
Appendix A - Consent forms
1 Introduction
Why consent is crucial?
Patients have a legal and ethical right to determine what happens to their own bodies. Healthcare professionals have a legal and professional duty to obtain valid consent before providing any treatment. Valid consent is necessary to avoid legal action for battery, breach of human rights or successful clinical negligence claims (where a patient has not been made aware of a risk of the treatment and the risk has occurred causing harm). Consent is therefore a requirement for all forms of healthcare, from providing personal care to undertaking surgery.
This policy
This policy sets out the standards and procedures required within this Practice. This document is primarily aimed at healthcare professionals. However social care colleagues should also be aware of their obligations to obtain consent before providing any care which involves touching or feeding a patient, providing or withholding any medication, disclosing confidential information or taking any action in relation to a patient’s property. If there is any doubt about how to comply with this policy, concerns should be discussed with the line manager. Health professionals must also be aware of any guidance on consent issued by their own regulatory bodies.
The Equality, Diversity and Human Rights context
Coventry Road Medical Centre recognises and values diversity, and strives to ensure that policies incorporate and address issues of difference. This policy guides staff to consider issues of consent, and the context is one of equality, diversity and human rights. The application/implementation of this policy should ensure that all patients and their carers are treated with dignity and respect, have a clear understanding of what they are consenting to, and where necessary and applicable, support is provided to facilitate patients and their carers making informed choices and decisions. The Practice is keen to ensure that through policy development and service delivery all staff create an environment where human rights are respected.
What is consent?
Consent is a patient’s agreement, which allows a health professional to provide care. A patient may indicate consent non-verbally (for example by presenting their arm for their pulse to be taken), or in writing on a consent form. Consent is an on-going process, and a patient may change their mind at any time and withdraw consent.
The requirement for consent can arise in many different circumstances, ranging from a proactive request by a patient for a particular treatment, to the acceptance of a health professional’s clinical advice. Seeking consent is better described as ‘joint decision-making’: the patient and health professional need to come to an agreement on the best way forward, based on the patient’s values, preferences and understanding, and the health professional’s clinical knowledge and advice.
It is important to understand that for consent to be valid, the patient must:
o Have capacity to make that particular decision;
o Have received sufficient information to make the decisions; and
o Not be acting under duress.
This policy guides staff about how to assess capacity, what information should be provided and how to be mindful that a patient is not acting under duress.
Wherever possible verbal discussion should be supported by written information i.e. leaflets. If these are provided, this should also be recorded. All leaflets should show the date of issue. Whenever a leaflet is withdrawn the date of withdrawal should be recorded by the Practice manager and a copy retained for medico-legal purposes. Guidance for archiving of patient records and other items associated with patient care are laid out in [1]HSC 1998.
2 Capacity to consent
Valid consent can only be provided by;
a. a patient who has capacity to make that decision, or
b. an Attorney as a result of a valid and applicable lawful Lasting Power of Attorney document, or a Deputy appointed by the Court of Protection acting under an applicable court order.
The Mental Capacity Act 2005 and the associated Code of Practice sets out the law in more detail in relation to assessing capacity and assessing what is in a patient’s best interests, if they do not have capacity to make the decision for themselves.
It is important to remember that capacity is the ability to make a specific decision at a specific time; a patient may have the capacity to make a decision about whether to take their routine medication or eat their meal, but may not have the capacity to make more complex decisions about other medical treatment. In addition, they may be able to understand information and make decisions at a specific time of day, or for example before they take pain medication.
The law requires that;
o A person must be assumed to have capacity unless it is established that they lack capacity.
o A person is not to be treated as unable to make a decision unless all practicable steps to help him to do so have been taken without success.
o A person is not to be treated as unable to make a decision merely because he makes an unwise decision.
o An act done, or decision made on behalf of a person who lacks capacity must be done in his best interests.
o Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action.
Assessing Capacity
If there is suspicion that a person may not have the capacity to make a decision, the two-stage test must be used (from section 3 Mental Capacity Act 2005);
i. Is there an impairment of, or a disturbance in the functioning of, the mind or brain?
ii. If so, is the patient unable to make a decision for himself because of the impairment?
The law states that a patient is considered unable to make a decision if they are unable to;
a. Understand the information relevant to the decision, or
b. Retain that information, or
c. Use or weigh that information as part of the process of making the decision, or
d. Communicate the decision (whether by talking, using sign language or any other means).
Any health professional can assess a patient’s capacity using the test set out above. Which healthcare provider will make this assessment will depend on the type of healthcare being provided; a nurse who attends to change dressings may need to assess a patient’s capacity to consent to this procedure; a care assistant may need to assess a patient’s capacity to consent to being undressed or washed.
An apparent lack of capacity to give or withhold consent may in fact be the result of communication difficulties rather than actual incapacity. Appropriate colleagues should be involved 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. All reasonable steps should be taken to improve a patient’s capacity to enable them to make a decision if possible.
The person who has assessed a patient’s capacity to make a decision should record this in the medical records, along with the specific decision that was being considered.
Assessing best interests (patients who lack capacity to consent)
If a patient does not have the capacity to make the specific decision about treatment (and capacity has been assessed and recorded), the relevant healthcare professional will then usually make the decision in the patient’s best interests.
The main exceptions to this rule are where;
a. The patient has made a valid Advance Decision to refuse treatment, or
b. There is an Attorney as a result of a valid and applicable lawful Lasting Power of Attorney document, or a Deputy appointed by the Court of Protection acting under a an applicable court order.
If there is no valid Advance Decision to refuse treatment, and there is no relevant Attorney as a result of a formal and lawful Lasting Power of Attorney document, or Deputy appointed by the Court of Protection, the healthcare professional must make the decision in the patient’s best interests.
The most relevant healthcare professional should make the best interest decision e.g. if a GP is considering providing treatment, the GP should determine the patient’s best interests, if a nurse is considering providing an injection, the nurse should determine the patient’s best interests.
Best Interest Checklist
In order to determine the best interests of the patient, the law requires that a specific process is followed. The Mental Capacity Act includes a checklist (section 4), which sets out the issues that must be considered and actions taken, before any decision is made in a patient’s best interests;
1. You must not make assumptions or discriminate i.e. you must not decide what is in a patient’s best interests only on the basis of the person’s age, appearance, a condition, or an aspect of their behaviour.
2. You must consider all of the relevant circumstances in relation to the treatment, not simply the clinical risks and benefits and alternatives.
3. You must decide whether it is likely that the person will have capacity to make the decision at some time in the future, and if so, when that is likely to be.
4. You must, so far as reasonably practicable, encourage the patient to participate in any decision affecting him, even if he does not have capacity to make the decision himself. You should ensure that all reasonable steps are taken to facilitate the patient to understand and provide their views.
5. In relation to life-sustaining treatment, you must not be motivated by a desire to bring about the patient’s death.
6. You must consider, so far as is reasonably possible, the patient’s past and present wishes and any relevant written statement made by him when he had capacity, eg an advance decision.
7. You have a legal duty to consult, family, friends, unpaid carers, any Attorney or a Deputy appointed by the court, and to take their views into account before reaching a decision on “best interests” (unless it is not practicable or appropriate to do so).
Where a decision-maker makes a decision on behalf of a patient who does not have capacity, the decision-maker must apply the checklist above and record the reasons why they believe that the decision is in the best interests of the patient.
IMCA Service (Independent Mental Capacity Advocate)
In some cases, where the patient does not have capacity and has no relevant family or unpaid carers to consult in relation to their best interests, an IMCA must be instructed before a decision is made.
The law requires that an IMCA must be instructed if;
a. an NHS body is proposing to provide serious medical treatment, or
b. an NHS body or local authority is proposing to arrange accommodation in hospital or a care home, and;
i. the person will stay in hospital for longer than 28 days, or
ii. they will stay in the care home for more than eight weeks.
An IMCA may also be instructed where there are safeguarding issues. In these cases, seek advice from your line manager.
The IMCA will then provide their opinion on what they believe is in the patient’s best interests. The decision-maker has a duty to take this opinion into account.
If the decision is urgent, so that there is not time to make a referral (in that there is a risk of harm to the patient if the treatment is not provided urgently), this should be recorded in the patient’s notes. If it is not urgent but time is short, staff should contact the IMCA service, who may be able to prioritise the case accordingly.
Disagreement
In some cases where the patient lacks capacity to make a decision, there may be disagreement between the treating team and the family or IMCA as to whether the treatment is in the patient’s best interests. If this occurs steps should be made to reach a consensus. If agreement cannot be reached, it should be discussed with the line manager, and legal advice sought before providing the treatment.
In some cases, if agreement cannot be reached, it will be necessary to seek a court declaration that the treatment is in the patient’s best interests; this will protect those who provide the treatment. If a member of staff thinks it might be appropriate to seek a declaration, the Practice Clinical Lead should be contacted; advice may be sought from the Practice solicitors.
3 When to seek consent
When a patient formally gives their consent to a particular intervention, this is only the endpoint of the consent process. It is helpful to see the whole process of information provision, discussion and decision-making as part of ‘seeking consent’. This process may take place at one time, or over a series of meetings and discussions, depending on the seriousness of what is proposed and the urgency of the patient’s condition.
Single stage process
In many cases, it will be appropriate for a health professional to initiate a procedure immediately after discussing the procedure with the patient. For example, during an ongoing episode of care a General Practitioner may suggest a joint injection and explain how it might help the patient’s condition and whether there are any significant risks. If the patient is willing for the treatment to be used, they will then give their consent and the procedure can go ahead immediately.
If a proposed procedure carries significant risks, health professionals must take into consideration whether the patient has had sufficient chance to absorb the information necessary for them to make their decision and provide consent. As long as it is clear that the patient has capacity and has had sufficient information to provide consent and does so, the health professional may then proceed.
Two or more stage process
In most cases where treatment is being considered that carries significant risks or is complex, treatment options will generally be discussed well in advance of the actual procedure being carried out. This may be on just one occasion (either within primary care or in a hospital out-patient clinic), or it might be during a series of consultations with a number of different health professionals. The consent process will therefore have a number of stages: information will be provided (including leaflets if appropriate), options will be discussed, the patient may wish to think about the options at home and return to discuss it further, the patient may provide consent and the treatment is then arranged.
While administrative arrangements will vary, it should always be remembered that for consent to be valid, the patient must feel that it would have been possible for them to refuse, or change their mind.
Duration of Consent
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 capacity) still wishes the intervention to proceed, even if no new information needs to be provided or further questions answered.
Patients receiving elective treatment or investigations should be familiar with the contents of the consent form before they arrive for the actual procedure. The patient should have received a copy of the page documenting the decision-making process. The patient may be invited to sign the form, confirming that they wish treatment to go ahead, at any appropriate point before the procedure: in out-patients, at a pre-admission clinic, or when they arrive for treatment. If a form is signed before patients arrive for treatment, a member of the healthcare team must check with the patient at this point whether they have any further concerns, whether their condition has changed and whether they still consent to the procedure. This is particularly important where there has been a significant lapse of time between the form being signed and the procedure. When confirming the patient’s consent and understanding, it is advisable to use a form of words which requires more than a yes/no answer from the patient: for example beginning with “can you explain to me what you are expecting to happen today”, rather than “is everything all right?”. If the patient signs the form in advance of the procedure, a health professional involved in their care on the day should sign the form to confirm that the patient still wishes to go ahead and has had any further questions answered.
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.
4 Recording Consent
It is good practice to make a brief record whenever consent is given, or information which feeds into consent is discussed. Recording consent may be done either through the use of a consent form, which the patient can sign or through documenting the discussions in the patient’s notes.
Consent is often wrongly equated with a patient’s signature on a consent form. A signature on a form is evidence that the patient may have 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, or that it has been recorded by the clinician, 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 at that time, not a binding contract.
It is rarely a legal requirement to seek written consent[2]. However, careful records can assist both patients and clinicians if any difficulties arise in the future. All clinical staff should be able to advise staff on which specific procedures require written consent. 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 there is 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 distressed about, similar care in the past), it would be helpful to do so.
It is good practice to make a record of the consent process if any of the following circumstances apply:
· There is any concern that the patient may lack capacity to provide consent
· The treatment or procedure involves any significant clinical risks (the term ‘risk’ is used throughout to refer to any adverse outcome, including those which some health professionals would describe as ‘side-effects’ or ‘complications’)
· the procedure involves general/regional anaesthesia or sedation
· providing clinical care is not the primary purpose of the procedure
· there may be significant consequences for the patient’s employment, social or personal life
· the treatment is part of a project or programme of research approved by the Practice
· there is any disagreement about the proposed treatment
· the patient has refused a similar treatment in the past, or become distressed when the treatment has been given.
· The patient has declined to be informed of any significant risks.
Where the consent process is recorded due to any of the above circumstances, the record should reflect the discussion about all of the possible significant risks and benefits of the treatment in addition to the patients’ agreement. It is also essential that any alternative treatments are discussed and recorded; a patient cannot provide valid consent to a particular treatment if they are not aware of possible alternative treatments. Any written information which is given to the patient should also be recorded. If the patient has declined to be informed about any significant risks of a procedure, this should be carefully recorded.
Whenever there is any concern about a patient’s capacity to consent to treatment, the assessment of capacity should be recorded along with a detailed explanation of the best interests decision. Please refer to the relevant section of this policy in relation to assessing capacity and making best interests decision in line with the law.
Completed consent forms should be kept in the clinical records. Any changes to a form, made after the form has been signed by the patient, should be avoided. However, if a change is required to amend an error, it should be initialled, timed and dated by both the patient and the health professional. It should be clear which clinician has documented, checked or amended the consent form.
Availability of forms
Department of Health standard consent forms and forms for adults who are unable to consent for themselves are reproduced in Appendix A.
There are four versions of the standard consent form:
· Form 1 for adults or competent children
· Form 2 for parental consent for a child or young person
· 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
· Form 4 For adults who are unable to consent to investigation or treatment
The use of form 3 is optional. It may be 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.
For patients who lack capacity please use do not use Form 4. Please use the attached form entitled ‘Assessing capacity and assessing best interests’.
5 Providing sufficient information to obtain valid consent
The law recognises that patients require sufficient information in order to provide valid consent – agreeing to a procedure while not knowing about the possible risks, or alternative treatment options, is not providing valid consent.
Therefore, the practitioner must ensure that the patient receives sufficient information, in a manner that they understand, in relation to all of the treatment or possible treatments, the significant risks, benefits, likely consequences and alternatives of any proposed treatment (or of non-treatment). The patient must be informed if any additional procedures are likely to be necessary as part of the procedure, for example a blood transfusion, or the removal of particular tissue.
Different patients will want to have different information about proposed treatment; some patients will not want to know the details of each procedure or alternative, whereas some will want to know specific details about risks and the likelihood that they might occur. The first presumption must be that the patient wishes to be well informed about all of the significant risks, benefits and alternatives.
A patient who has capacity to make their own decision to consent to a procedure, may make it clear that they do not wish to know some of the information which would usually be provided in order to obtain consent. There will always be an element of clinical judgment in determining what information should be given. If a patient chooses not to receive information, this should be carefully explored and recorded.
Open access clinics
Where patients access clinics directly, it should not be assumed that their presence at the clinic implies consent to particular treatment, or that they have all of the necessary information in order to consent. It should be ensured that they have sufficient information before proceeding with an investigation or treatment.
Access to more detailed or specialist information
Individual services have information available for the patients and carer in relation to investigations and treatment.
Patients may sometimes request more detailed information about their condition or about a proposed treatment than that provided in general leaflets. The healthcare professional who recommended the treatment shall be contacted for further information in the first instance.
In addition, the patient may contact the following for advice on how to access additional information on their condition:
o NHS Direct - 0845 4647.
o NHS Direct online — www.nhsdirect.nhs.uk
Access to health professionals between formal appointments
After an appointment with a health professional in primary care or in outpatients, patients will often think of further questions which they would like answered before they make their decision. Where possible, it will be quicker and easier for the patient to contact the relevant healthcare team by phone, rather than to make another appointment or to wait until the date of an elective procedure by which time maybe too late for the information to be fully considered.
The Practice Information Leaflets includes details of how to access appointments with a healthcare professional in the surgery.
Providing information to patients and their carers with language support needs
· Patients for whom English is not their first language
This Practice is committed to ensuring that patients whose first language is not English receive the information they need to provide consent and are able to communicate appropriately with healthcare staff. It is not appropriate to use family members to interpret for those who do not speak English in order to obtain consent. Translating via family members is inappropriate as in some cases information is not translated accurately or appropriately to the patient. In addition, family dynamics can also affect translation in relation to the consent process, particularly the questions and concerns which may not be raised by the patient if the information has to be translated via a family member.
· Patients who have a hearing impairment
The Practice is committed to ensuring that patients with a disability, including a hearing impairment, receive the information they need to provide consent and are able to communicate their needs to a health care professional.
6 Who is responsible for seeking consent?
The health professional carrying out the procedure is responsible for ensuring that the patient is validly consenting: it is they who will be held responsible in law.
Where oral or written consent is being sought at the point at which the procedure will be carried out, this will naturally fall to the health professional responsible. However, teamwork is a crucial part of the way the NHS operates, and it may be appropriate for other members of the team to participate in the process of seeking consent. It is essential that all of those involved in seeking consent understand all of the relevant information about the significant, risks, benefits and alternatives.
Completing consent forms
The health professional providing the information on a consent form must be competent to do so, either because they themselves carry out the procedure, or because they have received specialist training in advising patients about this procedure, have been assessed, are aware of their own knowledge limitations and are subject to audit.
It will be appropriate for any member of the healthcare team to provide the second signature on a consent form, as long as they have access to appropriate colleagues to answer questions that they cannot answer themselves
Responsibility of health professionals
It is a 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; and
· to work within their own competence and not to agree to perform tasks which exceed that competence.
If a clinician feels that they are being pressured to seek consent when they do not feel competent to do so, they may contact the Practice Clinical Lead, Dr Nishat Ahmad.
7. Consent in relation to patients who are under 18 years old
The legal position concerning consent and refusal of treatment by those under the age of 18 is different from the position for adults. For the purposes of this policy “children” refers to people aged below 16 and “young people” refers to people aged 16-17.
By virtue of section 8 of the Family Law Reform Act 1969, people aged 16 or 17 are presumed to be capable of consenting to their own medical treatment, and any ancillary procedures involved in that treatment, such as anaesthesia. As in the care of adults, consent will only be valid if it is given voluntarily by an appropriately informed young person capable of consenting to the particular intervention. However, unlike adults, the refusal of a person aged 16-17 may in certain circumstances be overridden by either a person with parental responsibility or a court.
Young people (under the age of 18 years old) may have the capacity to make their own decision as to whether to consent to, or refuse, medical treatment. If children are competent to give consent for themselves, consent should be sought directly from them. The legal position regarding “competence” is different for children aged over and under 16 (see below).
If a person under 18 years old does not have capacity, only people with ‘parental responsibility’ are entitled to give consent on behalf of their children. It should be remembered that all parents have parental responsibility for their children. If there is any doubt about whether the person with the child has parental responsibility for that child, verification must be sought.
16 & 17 year olds
Once children reach the age of 16, they are presumed to be competent, in law, to give consent themselves for their own medical, surgical or dental treatment, including any related procedures such as nursing care, anaesthesia or investigations. It is still good practice to encourage competent children to involve their families in the decision-making process.
Sometimes, as with adults, children aged 16 and 17 may not be competent to make certain decisions. For example, they may be unconscious, or be unable to make a decision due to the effects of medication, pain or fatigue. If a child of 16 or 17 is not competent to make a particular decision, then a person with parental responsibility (see below) can make that decision for them, although the child should be involved as much as possible.
Alternatively, once a child reaches the age of 16, the general principles of the Mental Capacity Act 2005 apply (but not Lasting Powers of Attorney or Advance Decisions), and so decisions may be taken in accordance with the best interests checklist where the young person lacks capacity.
Under 16 years old
Children under 16 are not automatically presumed to be legally competent to make decisions about their healthcare. The Courts have stated that children under 16 will be competent to give valid consent to a particular intervention if they have “sufficient understanding and intelligence to enable him or her to understand fully what is proposed” (known as Gillick competence).
There is no specific age at which a child becomes competent to consent to treatment; it depends on the child and on the complexity and seriousness of the treatment being proposed. If a child under 16 is competent, it is still good practice to involve their family in the decision-making process unless the child asks for this not to be done and cannot be persuaded otherwise.
Disagreement
There will be occasions where children and persons with parental responsibility do not agree. The decision of a competent child to accept treatment cannot be over-ridden by a person with parental responsibility. However, the courts have said that, in exceptional cases, if the child refuses treatment, those with parental responsibility may consent on their behalf, and treatment can lawfully be given. This power should be used very rarely and should, at all times, be guided by the best interests of the child. Where a child is refusing treatment which his or her parents want to accept, and the consequences of refusal are potentially very serious, consideration should be given to seeking a court ruling on what would be in the best interests of the child.
The following link to the Department of Health website has leaflets for parents and children:
Parental Responsibility?
The Children Act 1989 sets out who has parental responsibility and these include:
a. The child’s parents, if married to each other at the time of conception or birth.
b. In relation to unmarried parents, mothers automatically have Parental Responsibility.
c. The position in relation to unmarried fathers changed on 1 December 2003. Up to then, if the father was not married to the mother, he could only acquire Parental Responsibility by a formal agreement with the mother in a prescribed form (parental responsibility agreement), by a Court Order or if he subsequently married the child’s mother.
After 1 December 2003, an unmarried father acquires Parental Responsibility if he registers the birth jointly with the mother. This is not a retrospective law and therefore an unmarried father whose name appears on the birth certificate where registration took place before 1 December 2003 does not automatically have Parental Responsibility.
d. The child’s legally appointed guardian, appointed either by a court or by a parent with parental responsibility in the event of their own death.
e. A person in whose favour a court has made a residence order, parental responsibility order, adoption order or a special guardianship order concerning the child.
f. A local authority designated in a care order in respect of the child (but not where the child is being looked after under section 20 of the Children Act 1989).
g. A local authority or other authorised person who holds an emergency protection order in respect of the child.
h. Step-parents, or civil partners, may now obtain parental responsibility for their partner’s child if both birth parents (or anyone else with parental responsibility) agree, or by Court Order.
The Children Act also allows a person who does not have parental responsibility but who “has care” of a child to “do all that is reasonable in the circumstances of the case for the purpose of safeguarding or promoting the child’s welfare”. (section 3(5) Children Act 1989).
8 Refusal of medical treatment
In line with the Practice commitment to equality, diversity and human rights, staff should have an awareness of people’s religious observance and or belief when applying this policy.
If the process of seeking consent is to be a meaningful one, refusal must be one of the patient’s options. An adult patient is entitled to refuse any medical treatment, except in certain circumstances (as governed by the Mental Health Act 1983).
Advance Decisions to refuse medical treatment
If a patient who is 18 years or older has capacity and wishes to refuse specific medical treatment in the future (in case they do not have the capacity to consent or refuse the treatment in the future), the patient should be encouraged to make an Advance Decision. A valid and applicable Advance Decision is legally binding and a healthcare professional must not treat a patient in breach of a valid Advance Decision. A valid and applicable Advance Decision should make the patient’s decision to refuse treatment clear, and therefore protects the treating health professionals by making it clear they do not have the necessary consent to provide the specific treatment.
In general, an Advance Decision does not need to be in writing (see below re: life-sustaining treatments) and healthcare professionals should therefore record details of any discussion on healthcare records. It is important that a verbal Advance Decision is recorded accurately and clearly, so that it can be identified and followed by other healthcare professionals.
An Advance Decision;
- must state precisely what treatment is to be refused – a statement giving a general desire not to be treated is not enough
- may set out the circumstances when the refusal should apply – it is helpful to include as much detail as possible
- will only apply at a time when the person lacks capacity to consent to or refuse the specific treatment
To establish whether an advance decision is valid and applicable, healthcare professionals must try to find out if the person:
a. has done anything that clearly goes against their advance decision
b. has withdrawn their decision
c. has subsequently conferred the power to make that decision on an attorney, or
d. would have changed their decision if they had known more about the current circumstances.
Advance Decisions to refuse life sustaining treatment
The law imposes particular legal requirements on advance decisions to refuse life-sustaining treatment. Advance decisions to refuse life-sustaining treatment must meet specific requirements:
a. They must be in writing.
b. The person must sign the advance decision.
c. The person making the decision must sign in the presence of a witness to the signature. The witness must then sign the document in the presence of the person making the advance decision.
d. The advance decision must include a clear, specific written statement from the person making the advance decision that the advance decision is to apply to the specific treatment even if life is at risk.
If there is any doubt as to whether an Advance Decision is valid or not, guidance should be sought from senior managers. However, healthcare professionals will be protected from liability if they:
a. stop or withhold treatment because they reasonably believe that an advance decision exists, and that it is valid and applicable, or
b. treat a person because, having taken all practical and appropriate steps to find out if the person has made an advance decision to refuse treatment, they do not know or are not satisfied that a valid and applicable advance decision exists.
If the patient has already signed a consent form, but then changes their mind, this should be noted on the form by the practitioner (and where possible the patient). Where a patient has refused a particular intervention, health professionals must ensure that they continue to provide any other appropriate care to which the patient has consented. They should also ensure that the patient understands that they are free to change their mind and accept treatment if they later wish to do so. Where delay may affect their treatment choices, they should be advised accordingly.
If a patient consents to a particular procedure but refuses certain aspects of the intervention, the possible consequences of their partial refusal must be explained to them. If it is genuinely believed that the procedure cannot be safely carried out under the patient’s stipulated conditions, health professionals are not obliged to perform it. They 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, on request the patient must be allowed to transfer their care to that health professional.
9 Human Tissue
All those involved in the removal, storage and use of human tissue in any form should be aware of the following statutory requirements for consent as outlined in the Human Tissue Authority’s Code of Practice – Consent.
Living patients
Under the Human Tissue Act 2004, tissue may be taken in a variety of circumstances. For example:
· In the course of diagnostic procedures e.g. taking a blood or urine sample, tissue biopsy, cervical screening etc.
· In the course of a treatment procedure e.g. removing tissue (organs, tumours etc.) during surgery
· When removed specifically for the purpose of research
Consent from living patients is needed for storage and use of tissue for:
· Obtaining scientific or medical information that may be relevant to any other person, now or in the future (i.e. where the purpose is storage or use in relation to another person, rather than where it might incidentally, be of future relevance to another person)
· Research in connection with disorders, or the functioning, of the human body (although there are some exceptions)
· Public display
· Transplantation
Consent from the living is not needed for storage and use of tissue for:
· Clinical audit
· Education or training relating to human health
· Performance assessment
· Public health monitoring
· Quality assurance
Further information on the Human Tissue Act 2004, The Human Tissue Authority and guidance around consent can be found at www.hta.gov.uk.
10 Consent to clinical photography and video/digital recordings
Photographic and video recordings made for clinical purposes form part of a patient’s record. Although consent to certain recordings, such as X-rays, is implicit in the patient’s consent to the procedure, health professionals should always ensure that they make clear in advance if any photographic or video recording will result from that procedure.
Photographic and video recordings which are made for treating or assessing a patient must not be used for any purpose other than the patient’s care or the audit of that care, without the express consent of the patient or a person with parental responsibility for the patient.
However, photographic and video recordings, made for treating or assessing a patient and from which there is no possibility that the patient might be recognised, may be used within the clinical setting for education or research purposes without express consent from the patient, as long as this policy is well publicised. However, express consent must be sought for any form of publication.
If a recording is to be used for education, publication or research purposes, explicit consent must be sought and given 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 it may not be possible 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 it must not be used, even if a person with parental responsibility consents.
If a health professional wishes to make a photographic or video recording of a patient specifically for education, publication or research purposes, they must first seek their written consent (or where appropriate that of a person with parental responsibility) to make the recording, and then seek their consent to use it. Patients must know that they are free to stop the recording at any time and that they are entitled to view it if they wish, before deciding whether to give consent to its use. If the patient decides that they are not happy for any recording to be used, it must be destroyed. As with recordings made with therapeutic intent, patients must receive full information on the possible future uses of the recording, including the fact that it may not be possible to withdraw it once it is in the public domain.
The situation may sometimes arise where a health professional wishes 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, such a recording may be made, but consent must be sought as soon as the patient regains capacity. The recording should be kept until 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, the agreement of the patients family or unpaid carer must be sought. A patient recording must only be made if it is believed it is in the patients’ best interests, and use of the recording must only be made if it is in the patients’ best interests. No such recording should be made if the purpose of the recording could be equally met by recording patients who are able to give or withhold consent.
There are some very rare cases where recording and photography might be lawful without consent, however legal advice should be sought if this is felt to be appropriate.
11 Training
Training around consent is a priority for the Practice, in keeping with its commitment to continuous professional development for all staff to ensure patients’ interests are safeguarded.
Staff training on the understanding and implementation of this policy will be available via a rolling programme based on clinical staff training need.
12. Consent to involvement of students
Patients with capacity should be asked if they consent to being observed or treated by students. It should be clearly stated that all patients have the right to refuse consent, without detriment to the care that they received.
It is good practice to include this information in patient information leaflets, appointment cards etc and on posters on waiting and ward areas, if services regularly take students.
Patients must also know the identity and status of the student(s) who are carrying out the assessment or treatment. If a student is required to see a patient on an unsupervised one to one basis, he\she must introduce him\herself and first gain the permission of the patient to the consultation.
Patients should be advised in good time that the member of staff would like to bring students and have the opportunity to refuse.
13. Consent for clinical audit or research programmes
In general, the clinical audit process requiring access to personal data (including patient records), may be carried out within the Practice, without explicit consent from the patient, provided that the staff operate within a robust Confidentiality Code of Conduct.
The Department of Health guidance HSG (96)18 ‘Protection and Use of Patient Information’ suggests that patients must be informed about what will happen to information obtained from them. This might include information which is to be passed internally to other health service departments which may be involved in the patient’s care and which would be in the interests of the patient to be shared. If it is well known where information will be passed to, this should be explained to patients.
Written consent is required from each patient taking part in a research project. The nature and purpose and what is known about the effects of any procedure(s) involved must be explained fully to the patient and written information provided. The fact that the patient is participating in the project and the information that has been given to them, must be noted in the case notes. All research must have been approved by an NHS Research Ethics Committee.
If research involves patients who do not have capacity to provide consent, health professionals should refer to The Mental Capacity Act 2005 and Chapter 11 of the associate Code of Practice and also seek approval from their line manager.
14 Use of treatment contracts
Some healthcare professions find the use of a treatment contract useful, not only to inform the consent process, but also as a means of increasing the accountability of the clinician and patient to each other and clarifying and formulating their expectations with regard to treatment. It is suggested that if such a contract is used it could include the following:
· A descriptions of the condition to be treated
· An explanation of the treatment; risks, benefits and alternatives
· An explanation of the treatment aims
· The criteria for the attainment of successful treatment
· An estimation of when the treatment will start and the duration of treatment
· An explanation as to how progress will be assessed
· A statement regarding the clinician’s expectations of the patient
· A statement that the patient has read the contract, understanding it and has been informed that the contract can be terminated or re-negotiated at the request of either party.
· The signature of the clinician and the patient
15. Consent to disclosing information to third parties
Information provided by patients to healthcare professionals is generally provided under a duty of confidence. For further details, please refer to the Practice Confidentiality Policy. However, in general, when patient information is required by a third party agency e.g. the Police, Education Authority or Social Services, the possible disclosure should be discussed with the patient, so that the patient has an opportunity to provide consent for the disclosure.
However, where discussing this possible disclosure with the patient might place a vulnerable adult or child at risk of significant harm, or prevent the detection of a crime, consent is not required for the disclosure. In any case where disclosure of information to a third party, without the consent of the patient is being considered, advice should be sought from the Practice Caldicott Guardian. Dr Nishat Ahmad.
16. Consent in an emergency
Clearly in an emergency, the consent process cannot take place over a number of consultations, and records may be made after the event rather than contemporaneously. For a patient who has capacity, the responsible healthcare professional, who will be providing the treatment or undertaking the procedure, should provide as much information about the risks, benefits and alternatives as is reasonably possible in the circumstances.
For a patient without capacity; as long as the treating clinician reasonably believes that the patient does not have capacity (in accordance with the legal test) and acts in the patients best interests, he will be protected.
Appendix A
Consent Forms
The Department of Health has produced model consent to treatment forms that can be ordered or downloaded via the website www.dh.gov.uk/consent.
However, for patients who lack capacity to consent, the attached form entitled ‘Assessment of Capacity and Assessment of Best Interests’ should be used.
ASSESSMENT OF CAPACITY & ASSESSMENT OF BEST INTERESTS
SUMMARY
name of patient…………………………………………………………………………………….
date of birth
address………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
..................................................................................................................................................
COVENTRY ROAD Medical Centre…………………………………date ……………………..
Clinician responsible for the patient …………………………………………………….
details of decision to be made……………………………………………………………..
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………..
details of decision maker(s)
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
conclusion (made as a result of completing the entire assessment form)
as at the date above, does the patient have capacity to make the decision above?
o yes o no
Assessment of capacity
Does the patient:
- Have an impairment of, or a disturbance in, the functioning of the mind or brain?
o Yes o No (if no, go to v)
If yes please provide details:……………………………………………………………………..
…………………………………………………………………………………………………
…………………………………………………………………………………………………
If yes, Is the patient able to:
- Understand the information relevant to the decision o yes o no
Details ……………………………………………………………………………………………..
and
- Retain that information o yes o no
Details ……………………………………………………………………………………………..
and
- Use or weigh that information as part of the process of making the decision?
o yes o no
Details ……………………………………………………………………………………………
Please provide further information, if appropriate/necessary:
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
and/or
v. Is the patient unable to communicate their decision, whether by talking, using sign language or any other means o yes o no
Please provide details …………………………………………………………………………………….
……………………………………………………………………………………………………………
…………………………………………………………………………………………………………….
DECISION RE: CAPACITY
As a result of the above, I consider the patient [has*] or [does not have*] capacity to make this decision. (* delete as appropriate)
SIGNED…………………………………………………………
JOB TITLE …………………………..
NAME IN CAPITALS………………………………………………. DATE…………………………..
If the patient is assessed as not having capacity to make this decision, you must consider the best interests checklist below, before deciding what is in the patient’s best interests.
Alternatively, if the patient has made a relevant applicable Lasting Power of Attorney the Attorney may be able to provide consent.
Where the patient has made a valid applicable Advance Decision refusing the treatment concerned, the Advance Decision should be respected. In any case of uncertainty, further guidance should be sought.
BEST INTERESTS CHECKLIST (please tick when task completed)
a) I have encouraged and assisted the patient to participate in the decision o
b) I have considered all factors relevant to the decision o
c) I have attempted to find out the views of the patient, including their past and present wishes and feelings, and taken these into account o
d) I have not based my assessment solely on the patient’s age, appearance, condition or behaviour o
e) I have considered whether the patient might regain capacity and if so whether the decision can be delayed o
Please provide details of how you have applied factors a) – e) and what factors have taken into account:
……………………………………………………………………………………………………….
………………………………………………………………………………………………………..
………………………………………………………………………………………………………..
…………………………………………………………………………………………………………
………………………………………………………………………………………………………..
………………………………………………………………………………………………………….
………………………………………………………………………………………………………….
…………………………………………………………
[continue on another sheet if necessary]
f) I have consulted the following relevant individuals in coming to my decision:
…………………………………………………………………………………………………………
……………………………………………………………………………………………………….
…………………………………………………………………………………………………………
Their views were as follows
…………………………………………………………………………………………………………
………………………………………………………………………………………………………..
…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
……………………………………………………………………………………………………….
It was not practicable/appropriate* to consult for the following reasons:
(*delete as appropriate)
………………………………………………………………………………………………………
……………………………………………………………………………………………………….
………………………………………………………………………………………………………..
Independent Mental Capacity Advocate Service (tick one)
i) A referral to the IMCA service is not necessary as:
§ I have been able to consult relevant individuals under the best interests checklist o
§ the decision needs to be taken on an urgent basis* o
Reason for urgency……………………………...............................................
ii) A referral has been made to the IMCA service and I have taken the IMCA’s view into account o
(Attach the written view of the IMCA)
Life sustaining Treatment
g) My decision is not motivated by a desire to bring about the patient’s death. o
DECISION RE: BEST INTERESTS
Taking into account all of the above, I have decided that it is in the patient’s best interests to:
………………………………………………………………………………………………………
………………………………………………………………………………………………………
DETAILS OF INDIVIDUALS TO BE INFORMED OF DECISION:
………………………………………………………………………………………………………
………………………………………………………………………………………………………
SIGNED…………………………………………………………
JOB TITLE ……………………
NAME IN CAPITALS……………………………………………….
DATE…………………………
Version: 1.1
Date Reviewed: April 2025
Implementation Responsibility: Surjit Kaur and Dr Nishat Ahmad
References
Giving someone power of attorney - Social care and support guide - NHS
Consent to treatment - Assessing capacity - NHS
Consent to treatment - Children and young people - NHS
Regulation 11: Need for consent - Care Quality Commission
Consent to care and treatment - Care Quality Commission
Best interests decision making for adults who lack capacity toolkit
Guidance for doctors on patient consent
Green Book: Chapter 2 - Consent
Decision making and consent - professional standards - GMC
Mental Capacity Act Code of Practice - GOV.UK
Mental Capacity Act - Social care and support guide - NHS
Gillick competence and Fraser guidelines | NSPCC Learning
GP mythbuster 8: Gillick competency and Fraser guidelines - Care Quality Commission
Parental rights and responsibilities: Apply for parental responsibility - GOV.UK
0-18 years - professional standards - GMC
Consent_Guidance_Revised_Jan2018.pdf
[2] The Mental Health Act 1983 and the Human Fertilisation and Embryology Act 1990 require written consent in certain circumstances.
Page created: 19 August 2025