A doctor and a patient talking while sat at a desk.

Consent Guide

PREMIUM

Risk Management Strategies for Informed Consent

Introduction

A doctor working in partnership with a patient to make good clinical decisions goes to the heart of good medical practice. It is essential for the therapeutic relationship of mutual respect and trust between doctor and patient to exist. It is a fundamental principle of medical law and necessary to protect a patient’s autonomy. Doctors must respect that a patient must give permission for any medical treatment or examination to be carried out.

The concept of informed patient consent is too often mistakenly viewed as a rote process by which practitioners obtain a patient’s signature on a template form or make notes in a patient’s medical records. This oversimplification mischaracterises the spirit of informed consent. Further, it fails to acknowledge the benefits available to practitioners and their patients when true informed consent is obtained.

This PMP guidance provides a brief overview of the principles underlying the concept of consent and offers clinicians practical tips regarding informed consent issues.


The framework for informed consent

1. Scope of informed consent

The thoroughness and complexity of the informed consent process will depend on the type of procedure or treatment involved. The process does not always need to be formal or time-consuming. For some non-invasive procedures, such as examinations, it is reasonable to rely on a patient’s non-verbal consent, following an explanation and reason for carrying out the intervention. However, as procedures become more complex or have a greater degree of risk, the consent process should be more comprehensive.

Doctors should tailor the consent process to each patient and their specific condition or situation. When determining which treatment or procedural risks should be disclosed to the patient, it is imperative that a doctor endeavours to find out what matters to each patient and discuss risks and benefits, such as those that:

  • are recognised risks of the intervention
  • the patient might consider important or significant to them individually
  • may affect the patient’s individual circumstances
  • might affect the patient’s decision to accept or reject the intervention
  • may cause significant harm, however unlikely to occur.

When obtaining consent from a patient, a doctor must have sufficient knowledge and experience of the intervention, its associated benefits and potential risks, as well as any alternative options, and be in a position to inform the patient accordingly.

Regardless of the complexity of the procedure and the scope of the informed consent process, doctors must always document full details of the consent discussions, including the decisions made and actions agreed. Related consent forms should be saved in the patient’s medical records. A copy of the consent form should be given to the patient.

2. The process of informed consent

A common misperception is that a signed consent form demonstrates informed consent. It does not. By itself, a consent form does not verify that true informed consent was obtained; it merely documents one phase of the informed consent process. Consent forms can be a useful way of recording a decision.

More important in the process is a meaningful discussion with the patient, tailored to their individual needs.

For the patient to be truly ‘informed,’ they must understand and retain the information that the healthcare provider has shared with them.

There are three components to the consent process:

  1. Informed
    The patient must have sufficient information to ‘make a decision’, as, without adequate information, they are unable to make decisions about their treatment.
    The clinician should also consider:
    • Cultural factors, personal values and beliefs, and other considerations that may impact the patient’s decision making. The clinician should seek out and discuss issues that are important to the patient.
    • Any language or communication barriers that could impede the consent process.
  2. Voluntary
    There should be no coercion.
    • The patient must be able to give their consent freely; pressuring patients into consenting to treatment invalidates the consent. This also includes the patient’s family and friends. Be cognisant that they may also try to exert their influence on the patient, openly or subtly, which can be just as powerful.
    • The patient should be provided with adequate time to ask questions, voice concerns, and clarify information with the treating clinician.
  3. Capacity
    The patient must have the capacity to understand and make the decision in question. Please refer to the section ‘Informed consent in cognitively impaired patients’.

When should consent be taken?
For some procedures, such as elective surgery, consent should be obtained from the patient during an outpatient consultation prior to admission for surgery. This may be several weeks prior to the surgery. Whilst there is no specific time limit on consent taken in advance, the patient may have further questions and dilemmas regarding the surgery or treatment.

It is best practice, therefore, to confirm consent prior to the procedure, eg, at the patient’s admission to the clinic/hospital, using this as an opportunity to find out if there have been any changes since consent was first taken and to ask the patient if they have any further questions.

Record in the patient’s medical records, confirmation of their consent, including date and time, and add a supplementary note on the original consent form.

Who should take consent?
Ideally, the clinician carrying out the intervention should undertake the consent process with the patient. However, it may be necessary on occasions to delegate the process to another doctor providing they:

  • are suitably trained and competent
  • have sufficient knowledge of the proposed surgical intervention or treatment
  • understand the associated benefits and risks, as well as alternatives.

If consent has been taken by a colleague, consent should be confirmed prior to the procedure by the consultant undertaking the procedure. This confirmation should be recorded in the patient’s medical record.

Exception: It is important to note that consent for cosmetic interventions must only be undertaken by the clinician who will be carrying out the procedure. It must not be delegated to another healthcare professional. Please refer to para 16 of the GMC, Guidance for doctors who offer cosmetic interventions (2016).

Verbal versus written consent
Patients can give consent orally or in writing, or they may imply consent by complying with the proposed examination or treatment, for example, lying on the couch for an examination. The GMC states in Decision making and consent (2020) para 7:

“For some quick, minimally or non-invasive interventions – particularly examinations – it would be reasonable to rely on a patient’s non-verbal consent. Examinations are a necessary part of diagnosis, and it’s reasonable to believe that a patient presenting for a consultation wants to be diagnosed. However, even for such routine procedures, you should:

  • explain what you’re going to do and why
  • make clear the patient can say no, and stop immediately if they do
  • be alert for any sign that they may be confused or unhappy about what you are doing.”

For physical examinations, doctors should always explain what is involved and obtain verbal consent before proceeding. Doctors should be aware of the obligations incumbent upon them regarding offering a chaperone for any intimate examinations. Please see the PMP factsheet Chaperones for Examinations.

When carrying out minor or routine interventions, if a doctor is satisfied that the patient understands what is proposed and the reasons for it, it is usually sufficient to have verbal consent.

Consent forms are a helpful prompt to share key information with the patient. They are also a useful standard way to record a decision, making a regular review easier. They can be used as a tool to review decisions made at an earlier stage. However, filling in a consent form is not a substitute for a meaningful dialogue tailored to the individual patient’s needs on the risks and benefits of the proposed treatment. It is merely a record of the actual consent process.

Patients should be asked to sign a consent form where:

  • there are significant risks or side effects associated with the proposed treatment or procedure, eg, for invasive or serious procedures
  • the patient’s lifestyle, employment or personal relationships could be adversely affected by the outcome of the treatment or procedure
  • the main purpose of the proposed intervention is not for the patient’s clinical care, eg, cosmetic surgery
  • the treatment or procedure is being undertaken as part of a research programme.

The patient should be provided with a copy of the consent form.

3. The essentials of informed consent

Although the information provided during informed consent should be tailored to each individual patient and their clinical condition, key essentials include:

  • the patient’s name
  • the name of the hospital or clinic
  • the treatment/procedure name (both in medical and layman’s terms)
  • a description of the procedure
  • the names of all practitioners performing the intervention and the significant tasks of each
  • the risks and benefits of the proposed intervention, with evidence that this has been discussed in the context of the individual patient. For example, patient A is in employment but has severe back pain. The patient understands that the outcome of the surgery might make the pain worse or no better but is willing to take that risk.
  • alternatives to the proposed intervention, including doing nothing
  • a statement that the procedure was explained to the patient (or patient’s guardian)
  • the name and signature of the person who explained the procedure to the patient or their guardian
  • the patient’s signature, confirming understanding and providing consent
  • the date and time at which consent was obtained.

Discussing risks and benefits
To support the patient to assess the risks and benefits of an intervention, the clinician should consider techniques such as:

  • Employing communications that use plain language.
  • Using open questions about work and family to explore what might be important to the individual patient.
  • Avoiding descriptive terms (such as low risk) to explain risks; try to supplement with numerical data.
  • Using absolute numbers or percentages.
  • Avoid using relative risk or percentage improvements.
  • Using visual aids, eg, pictographs wherever possible, to maximise understanding.

The provision of information leaflets to a patient may be a useful means by which to augment a detailed discussion of the risks and benefits associated with a particular course of treatment. However, they should never be regarded as a substitute for such a discussion. If explanatory literature is given to a patient, this should be recorded in the patient’s records, in conjunction with details of the leaflets/booklets given (including version numbers).

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Legal position

Respect for patients’ autonomy is expressed in consent law; to impose care or treatment on patients without respecting their wishes and right to self-determination is not only unethical, it is illegal.

Montgomery and informed consent
Although the principles of involving patients in their treatment and sharing information with them had been in place for some time, the Montgomery v Lanarkshire Health Board case of March 2015 changed the legal landscape of informed consent. It shifted the focus from a traditional paternalistic model of consent towards a more patient-centred approach.

Nadine Montgomery, a lady of small stature (five feet tall) and also a diabetic (which often results in a larger foetus), delivered her son vaginally. The baby experienced complications owing to shoulder dystocia, which resulted in hypoxia. After his birth, he was diagnosed as suffering from cerebral palsy, which had been caused by the deprivation of oxygen.

Evidence available at the time showed a 9-10% risk of dystocia where a diabetic woman delivered vaginally, but Mrs Montgomery’s obstetrician did not disclose the increased risk of this complication in vaginal delivery, despite Mrs Montgomery asking if the baby’s size was a potential problem. She was not offered a caesarean section as an alternative.

Mrs Montgomery claimed for negligence, arguing that if she had known of the increased risk associated with vaginal delivery in her circumstances, she would have requested a caesarean section.

She was awarded in excess of £5 million in damages following an appeal to the Supreme Court.

Historically a doctor’s duty to warn of risks was based on the Bolam test, ie, whether a doctor had acted in line with a responsible body of medical opinion. However, case law has moved a long way beyond this and towards patient involvement and autonomy.

Following the Montgomery case, doctors must now provide information about all material risks associated with a course of treatment or procedure, as well as any to which it would be reasonable for them to think the individual patient would attach significance.

The Montgomery judgment details what a patient would consider to be material risk. In para 87, it states:

“The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”

The law on consent has progressed from doctor focused to patient focused. The Royal College of Physicians and Surgeons of Glasgow (RCPSG), in The Montgomery Case, states:

“The practice of medicine has moved significantly away from the idea of the paternalistic doctor who tells their patient what to do, even if this was thought to be in the patient’s best interests. A patient is autonomous and should be supported to make decisions about their own health and to take ownership of the fact that sometimes success is uncertain and complications can occur despite the best treatment.”

The Montgomery ruling requires that all reasonable options are discussed with the patient to help them make a decision. The RCPSG, in The Montgomery Case, states:

  • “This does not mean that you are required to discuss all options available if they are not all appropriate/reasonable in a particular patient’s case.
  • You are not expected to be able to offer any and all treatments that can be found globally/in research settings.
  • If a patient requests a treatment/procedure that you do not think is a reasonable or appropriate option, you can refer on to another clinician for a second opinion.”

If a patient does not want to know all the risks:

  • Establish, through discussion with the patient, if there is anything underlying this decision.
  • If the patient genuinely does not wish to know and they understand that they may not be able to make a balanced decision as a result, they do not have to be told.
  • Document all discussions in the patient’s medical records.

The GMC states in Decision making and consent (2020):
“66 If a patient has chosen an option but doesn’t want to discuss the details, you should explain they will need to have some information about what it would involve before you can proceed, such as:

  • whether the procedure is invasive
  • what level of pain or discomfort they might experience and what can be done to minimise this
  • anything they should do to prepare for the intervention
  • if it involves any risk of serious harm.

67 You should try to find out why they don’t want to be involved in decision making and explore whether you can do anything to reassure and support them. They might be anxious about the decision or overwhelmed by the information and need time or support to process it.

68 If, after trying to discuss options with them along the lines set out above, your patient insists that they don’t want even this basic information, you will need to judge whether their consent is valid so that you can proceed. This is more likely to be the case if the proposed option is a well-established intervention commonly used for treating the condition they have, and there’s reason to believe the patient wants to be treated or cared for rather than take no action. You should consider seeking advice from your medical defence body or professional association in these circumstances.”

Professional obligations

Taking into account the changes in the law following the Montgomery ruling, the GMC updated the consent guidance – published November 2020, some 12 years after the previous 2008 version.
GMC, Decision making and consent (2020)

The guidance sets out a framework for decision making to assist doctors in complying with the law and practising ethically. It details seven key principles of decision making and consent, on which good clinical decisions should be based. It places greater emphasis on doctors and patients making decisions together based on the exchange of relevant information specific to the individual patient.

It expands on the guidance in Good medical practice, which “requires doctors to be satisfied that they have consent from a patient, or other valid authority, before undertaking any examination or investigation, providing treatment, or involving patients in teaching and research.”

The seven key principles of decision making and consent are:

  • Patients should be involved in decisions about their care, ie, personal autonomy and be supported to make informed choices if able to do so.
  • Decision making is not static but rather an ongoing process.
  • Doctors must listen to the views of their patients and provide them with sufficient information.
  • Doctors must establish what matters to the patient as an individual based on their circumstances.
  • Doctors must start from the premise that all adult patients have capacity to make decisions about their treatment and care. A patient can only be judged to lack capacity after assessment in line with legal requirements.
  • The choice of treatment or care for patients who lack capacity must be of overall benefit to them, and decisions should be made in consultation with those who are close to them or advocating for them.
  • Patients whose right to consent is affected by law should be supported to be involved in the decision-making process, and to exercise choice if possible.

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Informed consent in cognitively impaired patients

The GMC and legislation emphasise that doctors should presume that adults over the age of 16 have the capacity to make decisions (consent) about their own medical treatment. Under legislation, ie, the Mental Capacity Act (2005) and Mental Capacity (Amendment) Act 2019 (England and Wales), Adults with Incapacity Act (Scotland) 2000Mental Capacity Act (Northern Ireland) 2016, a person lacks capacity to make a decision if they are unable to:

  • understand the information relevant to the decision
  • retain that information long enough to make a voluntary choice
  • use or weigh that information as part of the process of making the decision, or
  • communicate their decision (whether by talking, writing, using sign language, assistive technology, or any other means).

The GMC states, in Decision making and consent, para 82:
“Assessing capacity is a core clinical skill and doesn’t necessarily require specialist input (eg, by a psychiatrist). You should be able to draw reasonable conclusions about your patient’s capacity during your dialogue with them. You should be alert to signs that patients may lack capacity and must give them all reasonable help and support to make a decision.”

Clinicians have a duty to assist patients to make decisions for themselves by giving them information in a clear and comprehensible manner and by ensuring that they have appropriate help and support. The patient is also entitled to be accompanied during any such discussion by an advocate of their own choice.

There are instances where a person’s capacity to provide consent can be affected by infirmity. In this regard, the GMC states in para 88, of the above guidance:
“If you are the treating doctor, before concluding that it is your responsibility to decide which option(s) would be of overall benefit to a patient who lacks capacity, you should take reasonable steps to find out:

  1. whether there’s evidence of the patient’s previously expressed values and preferences that may be legally binding, such as an advance statement or decision
  2. whether someone else has the legal authority to make the decision on the patient’s behalf or has been appointed to represent them.”

Records

  • Doctors should ensure that they record why there is uncertainty about the patient’s capacity, as well as details of their assessment and conclusions.
  • The record should clearly evidence how any decision about the patient’s best interests was reached, the reasons for the decision, who was consulted, and what factors were considered.

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Patients aged 16 years or over are entitled to consent to their own treatment. This can only be overruled in exceptional circumstances. Young patients (aged 16 and 17) are presumed to have sufficient capacity to consent to their own treatment unless there is significant evidence to suggest otherwise.

Children under the age of 16 can consent to their own treatment if they are able to understand information about their treatment, appreciate what is involved and the implications of either proceeding with the intervention or doing nothing.

The rights of a child under the age of 16 to consent to medical examination and treatment, was decided by the House of Lords in Gillick v West Norfolk and Wisbech AHA [1986] where a mother of a girl, under 16, objected to Department of Health advice that allowed doctors to give contraceptive advice and treatment to children without parental consent. Their Lordships held that a child under 16 had the legal competence to consent to medical examination and treatment if they had sufficient maturity and intelligence to understand the nature and implications of that treatment. This is now often referred to as ‘Gillick’ competence.

The GMC explains this in the guidance 0-18 Years: Guidance for Doctors:

“24 You must decide whether a young person is able to understand the nature, purpose and possible consequences of investigations or treatments you propose, as well as the consequences of not having treatment. Only if they are able to understand, retain, use and weigh this information, and communicate their decision to others can they consent to that investigation or treatment. That means you must make sure that all relevant information has been provided and thoroughly discussed before deciding whether or not a child or young person has the capacity to consent.

25 The capacity to consent depends more on young people’s ability to understand and weigh up options than on age. When assessing a young person’s capacity to consent, you should bear in mind that:

  1. at 16 a young person can be presumed to have the capacity to consent (see paragraphs 30 to 33)
  2. a young person under 16 may have the capacity to consent, depending on their maturity and ability to understand what is involved.

26 It is important that you assess maturity and understanding on an individual basis and with regard to the complexity and importance of the decision to be made. You should remember that a young person who has the capacity to consent to straightforward, relatively risk-free treatment may not necessarily have the capacity to consent to complex treatment involving high risks or serious consequences. The capacity to consent can also be affected by their physical and emotional development and by changes in their health and treatment.”

When assessing whether a child is ‘Gillick’ competent, consider the following:

  • The child’s age, maturity (physical and mental) and intellect.
  • Do they understand the problem or issue and what it involves?
  • Do they understand the risks, implications and any consequences that may arise from their decision?
  • Do they understand the advantages and disadvantages to any course of treatment or interventions suggested?
  • Do they understand any advice or information they have been given?
  • Do they understand any alternative options (if available)?
  • Can they articulate a rationale around their reasoning and decision making?

Clinicians should satisfy themselves that the child has come to the decision without any form of coercion, exploitation or influence from a third party.

If the doctor believes that the child is ‘Gillick’ competent and is able to give voluntary consent after receiving appropriate information, additional consent by a person with parental responsibility will not be required. It is, however, good practice to involve the child’s parents or those with parental responsibility in the decision-making process if the child consents to their information being shared.

The doctor must ensure that the consent of the child is given voluntarily, ie, children may be subject to undue influence by their parent(s), other carers or a sexual partner (current or potential), and it is important to establish that the decision is that of the individual child.

Child lacking capacity
Where a child under the age of 16 lacks capacity to consent, ie, is not ‘Gillick’ competent, consent can be given on their behalf by any one person with parental responsibility or by the court. This could be:

  • the child’s mother or father (please refer to parental responsibility below)
  • the child’s legally appointed guardian
  • a person with a residence order concerning the child
  • a local authority designated to care for the child
  • a local authority or person with an emergency protection order for the child.

The consent must always be exercised according to the ‘best interests’ of the child. Even where a child lacks capacity to consent on their own behalf, it is good practice to involve the child as much as possible in the decision-making process.

The courts, where necessary, can overrule a refusal of consent by a person with parental responsibility, for example, when the parents are in disagreement either between themselves or with the doctor. Indeed, the paramount consideration in such cases is always that any action taken or not taken should be in the best interest of the child.

The courts can also overrule a ‘Gillick’ competent child who refuses treatment if deemed not in their best interests.

Parental responsibility
Parental responsibility is a legal concept that consists of the rights, duties, powers, responsibilities and authority that most parents have in respect of their children. It includes the right to give consent to medical treatment, although as detailed above, it is not absolute.

The mother of a child, unless she lacks capacity herself, has automatic parental responsibility, throughout the UK.

The father has parental responsibility if:

  • The child’s birth was registered from 15th April 2002 in Northern Ireland, 1st December 2003 in England and Wales and 4th May 2006 in Scotland, and the father is named on the birth certificate.
  • He is married to the mother of the child or was married to her when the child was born
  • He acquires a court order granting him parental responsibility. Married step-parents and registered civil partners can acquire parental responsibility in the same ways. Parental responsibility awarded by a court can only be removed by a court.
  • He makes a parental responsibility agreement with the mother.

Parents do not lose parental responsibility if they divorce, neither can a separated or divorced parent relinquish parental responsibility. This remains the case even if the parent without custody does not have contact with the child and does not make any financial contribution.

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Every adult with capacity is entitled to refuse medical treatment, except where compulsory treatment for a patient’s psychiatric disorder is authorised by mental health legislation. The basis of informed refusal is identical to that of informed consent. This process ensures that the patient who is refusing the clinician’s recommended treatment or procedure is informed about the potential risks and complications that may occur as a result of their refusal.

In these circumstances, a doctor should explain clearly to the patient the possible consequences of refusing treatment and, where possible, offer the patient a second medical opinion. It is crucially important to make detailed notes of any such discussions with a patient.

Doctors must respect a patient’s decision to refuse treatment or withdraw consent, even if they disagree with that decision or when it could lead to permanent injury or death. For example, a Jehovah’s Witness can refuse a blood transfusion even where this is essential for survival. Providing treatment without informed consent, and in the face of a competent refusal, would leave a doctor open to potential criminal, civil and regulatory sanctions.

However, if the patient’s choice of option seems out of character or inconsistent with their beliefs and values, the doctor should check the patient’s understanding of expectations about the likely outcome of this option and reasonable alternatives. If it is unclear whether the patient understands, the doctor should offer further support to help the patient understand the information and consequences of their decision. The doctor should not assume a lack of capacity just because, in the doctor’s opinion, the patient’s decision is unwise.

The GMC states in Personal beliefs and medical practice:
Para 24 “You must respect a competent patient’s decision to refuse an investigation or treatment, even if you think their decision is wrong or irrational. You may advise the patient of your clinical opinion, but you must not put pressure on them to accept your advice. You must be careful that your words and actions do not imply judgement of the patient or their beliefs and values.”

A refusal of treatment should not be interpreted as a refusal of all treatment or care. It is essential that steps are taken to keep the patient comfortable and that any symptoms or distress are appropriately managed.

Patients also have the right to change their minds and withdraw consent for treatment they have previously authorised, even when the treatment has already started. When a patient refuses treatment or wants to abandon a treatment plan, consider the following:

  • Was the patient given adequate information about the diagnosis and treatment options that meet the current standard of care?
  • Were the risks and benefits of treatment options discussed with the patient?
  • Did the clinician and patient discuss and agree upon their mutual expectations for a satisfactory outcome?
  • Was the patient encouraged to ask questions and voice their concerns? Were these questions and concerns addressed to the patient’s satisfaction?
  • Did the clinician explain the risks associated with refusing treatment? Risks might include:
    • fewer treatment options as the condition deteriorates
    • lower probability of a successful or optimal outcome
    • higher probability of complications
    • remaining treatment options that are more expensive than the treatment that was initially recommended.
  • Did the clinician ask for the patient’s reason for the decision? An understanding of the patient’s reason for refusal might help the doctor propose an alternative acceptable treatment.

If the patient has received adequate information and education, but still refuses treatment, the clinician should carefully document the decision in the patient’s medical records. Documentation should include the patient’s diagnosis, recommended treatment options and associated benefits and risks, the outcomes that might occur if the condition isn’t treated, and all patient education efforts.

The Royal College of Surgeons of England in Caring for patients who refuse blood (2016) states:
“Surgeons have the right to choose not to treat patients if they feel that the restrictions placed on them by the refusal of blood products are contrary to their values as a doctor. If a surgeon is not prepared to treat a patient who refuses blood they must refer them to a doctor who is suitably qualified and prepared to take on the patient knowing the circumstances of this refusal of blood.”

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Patient comprehension

Health information and services are often unfamiliar, complicated and technical, even for people who have high levels of education. Taking steps to ensure that patients understand information is a critical component of the informed consent process.

Strategies that support patient comprehension include the following:

  • Involve patients’ families and significant others in the patients’ care (with permission).
  • Use simple language and explain medical terms when communicating with patients verbally. Explain to patients why the information is important.
  • Present information in a simple, organised way; discuss the most important information first.
  • Ensure that patient education materials are written in plain language. Developing or using easy-to-understand materials may increase the likelihood that patients will understand and use the information correctly.
  • Allow time for questions at the end of each patient encounter and restate information as needed.
  • Carefully consider whether cultural factors, personal values or beliefs, or other considerations might influence the patient’s decision-making.
  • Provide comprehensive language access services and assistive technologies to meet the needs of diverse patient communities.

Clinicians should evaluate patient comprehension and the effectiveness of consent discussions. Two techniques that can assist clinicians with evaluation are the ‘Teach back’ and ‘Show-me’ methods. These techniques involve asking patients to explain in their own words or demonstrate the information that has been shared with them.

The ‘Teach back’ method is a useful way to confirm that the information provided to the patient has been understood. This is more than just saying “do you understand?” and is more a check of how the clinician has explained things, rather than the patient/client understanding.

The ‘Show-me’ method can be used when showing patients how to carry out an action, eg, where or how to apply a cream.

Clinicians should document in patient health records their use of the ‘Teach back’ and ‘Show-me’ techniques as part of patient education to support the informed consent process.

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Advance care planning

An advance request, advance decision (living will) is a decision a patient with capacity can make to refuse a specific type of treatment at some time in the future if they become unable to express their views about treatment.

Advance requests for treatment are not legally binding but will be taken into account, once capacity is lost, as part of the best interests assessment.

However, a patient may decide to make a formal advance decision to refuse treatment (ADRT), sometimes called living wills, which are legally binding in England and Wales and are likely to be binding in Scotland and Northern Ireland.

Patients who wish to plan for a future loss of capacity can formally appoint someone as an attorney with the power to make health and care decisions on their behalf.

Patients who have made an advance decision should be encouraged to provide a copy to be stored as part of their medical records. They should also ensure that those family members or friends who are likely to be consulted in an emergency are aware of its existence and can locate it easily. It is the patient’s responsibility to ensure that the document is available when needed and doctors do not need to spend time searching for an ADRT if there is no indication that one exists.

If doctors are informed of the existence of an ADRT, they must take steps to find it. Doctors who receive enquiries about the existence of an advance decision from another health professional should provide them with a copy of the document without delay.

The GMC states in Treatment and care towards the end of life: good practice in decision making (2020):

“68 When advance refusals are binding
If a patient lacks capacity and information about a written or verbal advance refusal of treatment is recorded in their notes or is otherwise brought to your attention, you must bear in mind that valid and applicable advance refusals must be respected. A valid advance refusal that is clearly applicable to the patient’s present circumstances will be legally binding in England and Wales (unless it relates to life-prolonging treatment, in which case further legal criteria must be met). Valid and applicable advance refusals are potentially binding in Scotland and Northern Ireland, although this has not yet been tested in the courts.

69 Non-binding advance refusals
Written and verbal advance refusals of treatment that are not legally binding should be taken into account as evidence of the person’s wishes when you are assessing whether a particular treatment would be of overall benefit to them.”

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Screening tests

It is important to realise that consent does not only apply to procedures but also to other forms of treatment and investigations, such as screening tests, eg, genetic screening, prostate-specific antigen levels (PSA).

Prior to undertaking a screening test, the patient’s informed consent should be obtained. The patient should be fully informed about the implications of having the test, the possible causes of abnormal levels and the likely management should the investigation highlight any concerns. Providing the patient with a leaflet would be helpful. Informed consent should be documented in the patient’s medical record along with the advice given to the patient, including reference to any information leaflets provided.

Audio, visual or photographic recordings

Any audio, visual or photographic recordings of a patient or relative of a patient, in which the person is identifiable, should only be made with the express consent of that person. Recordings made as part of the patient’s care form part of the medical record and should be treated in the same way as written material in terms of security and decisions about disclosures. The recordings should be kept confidential as a part of the patient’s records. Doctors should be aware of security risks when sharing information by electronic means and do all that’s reasonably practical to protect confidentiality which may include encryption measures.

When a patient is going to be photographed or videotaped as part of a procedure or surgery, the GMC guidance Making and using visual and audio recordings of patients (2013) reminds clinicians:
“To respect important ethical principles of consent and confidentiality.

That a recording made as part of the patient’s care is part of their medical record and must be treated in the same way as any other part of the medical record.”

Consent for teaching purposes

When technicians or healthcare professionals plan to observe a patient during a procedure or surgery for educational or technical support, the doctor carrying out the consultation should explain to the patient that an observer would like to sit in on the consultation, who that person is and why they would like to observe.

Patients should feel able to say no, knowing that it will not impact on their treatment in any way. Wherever possible, patients should be given the option of considering the request before the arrival of the observers.

Consent for research

The GMC Good practice in research and consent to research (2013), sets out the good practice principles that doctors are expected to understand and follow if they are involved in research.

Paras 28 and 29 states:
“You must get consent from participants before involving them in any research project. You must have other valid authority before involving in research adults who lack capacity, or children or young people who cannot consent for themselves.

You must make sure that people are informed of, and that you respect, their right to decline to take part in research and to withdraw from the research project at any time, with an assurance that this will not adversely affect their relationship with those providing care, or the care they receive.”

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Conclusion

The informed consent process creates many challenges for doctors as they seek to ensure that patients understand the information they receive and are able to make fully informed decisions about their healthcare.

Careful planning and development of consent protocols can help practitioners provide patients with appropriate information to facilitate a patient-centred approach, hold meaningful discussions with patients and potentially mitigate risks related to allegations of inadequate informed consent.

If you have any queries or concerns surrounding the issues raised in this publication, please do not hesitate to call the PMP medicolegal helpline, which is available 24/7.

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Reviewed and updated February 2024

Originally published February 2022

This document does not constitute legal or medical advice and should not be construed as rules or establishing a standard of care. We recommend that you seek independent legal and/or professional advice in relation to your legal or medical obligations or rights. Premium Medical Protection Limited is the owner of this material and its contents are protected by copyright law © 2022. All such rights are reserved.

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