LEARNING OUTCOMES
After completing this module, the paramedic will be able to:
Paramedics know it is essential to obtain a patient’s consent before proceeding with any form of diagnostic or therapeutic intervention. They will ask the patient’s permission before undertaking a 12-lead electrocardiogram (ECG) or taking a finger-prick blood sample to evaluate blood glucose levels. It is expected that the patient will ordinarily be asked for their agreement before clothing is cut away to enable comprehensive assessment in the trauma setting, or being transferred to hospital for further investigations.
The need to obtain the patient’s informed consent is stipulated by the Health and Care Professions Council (HCPC) within both its Standards of Proficiency—Paramedics (HCPC, 2014) and the Standards of Conduct, Performance and Ethics (HCPC, 2016). Why is this so important and what does ‘informed consent’ (HCPC, 2014: 7) actually mean?
Given the general imperative for evidence-based healthcare (Banner et al, 2016; Taylor, 2018a) and the professional regulatory requirement for paramedics to ensure their practice has a sound and justifiable evidence base (HCPC, 2014; 2016), the objectives of this article are to: give practitioners a range of opportunities to reflect on their understanding of informed consent; identify any gaps in their knowledge; and to provide a basis for developing the level of comprehension necessary to ensure that their future practice is based on up-to-date, appropriate knowledge.
It should be noted that during the COVID-19 pandemic, there are likely to be continuing changes, which may affect policy and law relating to consent in healthcare, as well as variations in provision between England, Wales, Scotland and Northern Ireland. Consideration of these is beyond the scope of this article, but readers are directed to a website managed by Alex Ruck Keene (2020a) (barrister with expertise in mental health and mental capacity law), which provides regular updates to law and policy relating to COVID-19 and mental capacity.
Informed consent and why it is important
Individual autonomy is both a legal (Collins v Wilcock, 1984) and ethical (Beauchamp and Childress, 2013) principle, which means that people generally have the right to choose not only who touches their body, but the nature and circumstances in which that contact takes place (see, for example, the legal case of R v Tabassum (2000)).
The decision must be free from constraints caused by factors such as a lack of information (Montgomery v Lanarkshire, 2015), or coercion by others (Beauchamp and Childress, 2012). This principle applies in all areas of an individual’s life, including healthcare (Re F (mental patient: sterilisation), 1990). Touching or putting an individual in fear of being touched may be a breach of both civil and criminal law (Airedale NHS Trust v Bland, 1993).
Obtaining the patient’s consent will give the paramedic permission to proceed with a specified intervention. Consent, therefore, provides a defence and makes lawful what would otherwise be unlawful (Taylor, 2013; 2018a). This means that other than in certain circumstances (see ‘Inability to give consent during an emergency’ on p. 5), care may not go ahead without the patient’s consent, and any treatment provided ‘without the informed consent of the patient is unlawful’ (Chester v Afshar, 2004: para 14).
This right to choose is regarded as so important that it must be upheld ‘whether the reasons for making that choice are rational, irrational, unknown or even non-existent’, per Lord Donaldson in Re T (an adult: refusal of medical treatment), 1992: 662. Following this, Dame Butler- Sloss went further in the case of re MB (medical treatment) (1997) and asserted that:
‘A mentally competent patient has an absolute right to refuse to consent to medical treatment for any reason, rational or irrational, or for no reason at all, even where that decision may lead to his or her own death.’
This means that if the patient has not given or has refused consent (subject to the conditions below in relation to the Mental Capacity Act 2005 and provisions relating to children and young people), any assessment, monitoring or other intervention that does not comply with the patient’s wishes would be unlawful (Re W (adult: refusal of treatment), 2002).
Guide for reflection and review
Consider the following to guide your reflections and wider reading on consent to treatment:.
Valid consent
Consent will only be valid if the patient gives it voluntarily after having been appropriately informed about the proposed intervention and has the requisite mental capacity. The intervention must also fall within the scope of what has been agreed between the patient and practitioner (Re T (an adult: refusal of medical treatment), 1992).
Informing patients
Until relatively recently, while practitioners had a legal duty to ensure patients were informed about their treatment options, the law supported the practitioner’s right to make what could be regarded as a paternalistic approach to informing patients about their options. Indeed, in the legal case of Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital (1985: 905), Lord Templeman indicated that while doctors were under an obligation to ensure that patients were warned about any specific or ‘general dangers … [related to the proposed treatment] … without exaggeration or concealment’, there was legal justification for the doctor to decide not only how that information might be presented to the patient, but also the exact nature of that information.
This position changed with the supreme court’s judgment in the case of Montgomery v Lanarkshire (2015: para 88), which provided that unless the information could ‘be seriously detrimental to the patient’s health’ or that urgent treatment was necessary but the patient’s condition meant they could not give consent, the paramedic would be acting negligently (as per Bolam v Friern Hospital Management Committee, 1957) if they failed to provide the patient with the information necessary to decide if they would be willing to accept the potential risks associated with a specified intervention. Lord Reed made it clear in this judgment, saying the health professional’s duty was to disclose any information that the patient would attach significance to.
From this, Taylor (2018a) indicates that paramedics must ensure:
In summary, treatment may generally not proceed without the patient’s informed consent and their decision must be respected even if it appears irrational, unwise or unjustified.
Capacity to consent
Although this article has emphasised the importance of obtaining a patient’s consent before starting any form of intervention, paramedics need to understand that the person giving consent must have capacity to do so. The law differentiates between children, young people and adults in relation to capacity to make healthcare decisions (Department of Health and Social Care (DHSC), 2009; Taylor, 2018b).
Reflective activity
It is late Friday night and you have been called out to Dave Smith, who has collapsed in the high street. It is evident that he is experiencing alcohol intoxication, and you suspect a fracture of his left ankle. You tell Mr Smith that you would like to take him to hospital for further assessment of his ankle, but he becomes agitated and forcefully tells you to get off his leg and leave him alone with his friends. Unfortunately, the friends appear equally intoxicated.
Variations in law between legal jurisdictions in the UK
Although there are broad correlations between the Mental Capacity Act 2005 (England and Wales) and the Adults with Incapacity (Scotland) Act 2000 (Scotland), there are some fundamental differences. While the English legislation levels the justification for non-consensual treatment on what constitutes a patient’s best interests (MCA, 2005: sections 4, 5; Taylor, 2016), Scottish law emphasises a ‘general authority to treat’ and confers authority on the practitioner to ‘safeguard or promote the physical or mental health of the adult’ (Adults with Incapacity (Scotland) Act 2000: section 47(1) and (2)). The relevant legislation in Northern Ireland is the Mental Capacity (Northern Ireland) Act 2016, which has generally followed the English legislation in its approach.
Adults
The Mental Capacity Act 2005 provides a statutory basis for the presumption that adult patients will have the mental capacity to provide valid consent for their care. However, it also recognises that there are circumstances in which an adult patient may lack capacity to consent, and provides a framework for decision-making in those circumstances.
A detailed overview of the framework for assessing mental capacity and decision-making in the case of an incapacitated patient has been published in the Journal of Paramedic Practice (Gaisford, 2018).
Young people aged 16–17 years
Like adults, young people aged 16–17 years have presumed capacity to consent to their own medical treatment under section 8 of the Family Law Reform Act 1969. Unlike adults, if a young person refuses their consent for a treatment considered to be in their best interests, this refusal may be overridden by someone with parental responsibility or by the court under its parens patriae jurisdiction (Re R (A minor) (wardship: medical treatment) 1991). Paramedics should seek further advice before proceeding with any care in the absence of a young person’s consent (Taylor, 2018b).
Children aged under 16 years
Children aged under 16 years may have capacity to consent to medical treatment, and this depends on a range of factors, including the nature and complexity of the proposed intervention, and the child’s level of understanding and stage of development (DHSC, 2009).
The court’s ruling in the case of Gillick v West Norfolk and Wisbech AHA (1986) determined that provided a child had the intelligence and understanding to fully understand what is involved in an identified intervention, they would have the capacity to consent to it. This means that a child might have capacity to consent to some procedures but not others.
However, unlike the concept of capacity for adults (as set out in the Mental Capacity Act 2005), ‘Gillick competence’ does not ‘fluctuate upon a day to day or week to week basis … [instead it] is an assessment of mental and emotional age, as contrasted with chronological age’, per Lord Donaldson in Re R (a minor) (wardship: consent to treatment) (1992: 25–26).
On this basis, the General Medical Council (GMC) (2018: 11) provides the following guidance: children will have capacity to consent ‘[o]nly 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’; and the practitioner is responsible for ensuring that the child has been provided with the appropriate information before assessing that child’s capacity to consent.
While there is a fundamental presumption in law that an adult (or young person aged 16 years or older) has the requisite mental capacity to make a decision, paramedics should be are aware that the position in relation to children is different.
Reflective activity
May Brown is 79 years old and has fallen at home; there are no injuries reported. When you arrive, she declines any assistance or referral to primary care services. While you are with her, you note she has had frequent falls in the past and you are worried she is not coping at home. From the information available, you are alert to the possibility that Ms Brown is living with the early stages of dementia, which is having an impact on her ability to care for herself. Her son Nigel then arrives at the address and starts berating you and your colleague, and tells you that it is clear that his mother is vulnerable and it is not appropriate for her to be left at home alone. Although you advise Nigel that there is no evidence of an injury requiring hospital treatment and May repeats her refusal of any referral, Nigel says that if you don’t take her to hospital and she suffers an injury, he will sue you.
Responsibility for assessing decision-making capacity
The practitioner providing care will generally be the individual responsible for assessing the patient’s capacity to consent where:
Practitioners will be accountable for their assessment of capacity and decisions based upon this (Department for Constitutional Affairs, 2007; Ruck Keene et al, 2020b), so should seek advice if they are uncertain about any element of this process (GMC, 2018).
Does the intervention fall within the scope of what has been agreed?
The person being touched must understand what they are agreeing to—both the nature and the quality of the act (R v Tabassum 2000). So, if a patient agrees to receiving analgesia, they should understand how and what is being administered; consent for an injection of morphine would not be valid for an intravenous infusion of paracetamol.
Evidence of patient consent
Given that the paramedic will be accountable for deciding what information they should share with the patient (and should document their decision- making), it would be reasonable to consider what evidence of consent the paramedic might rely on. Two relatively recent legal cases have explored this issue (Montgomery v Lanarkshire 2015; Gallardo v Imperial College Healthcare NHS Trust, 2017), with both endorsing guidance published by the GMC (2008).
It should be noted that the GMC (2020) has published some supplementary guidance on consent during the COVID-19 pandemic, which provides a valid framework for obtaining and evidencing consent in healthcare practice (Taylor, 2018a).
The GMC (2008) provides useful guidance for healthcare practitioners, including paramedics. This indicates that, except where interventions are complex or carry great risk, the paramedic may rely on implied or oral consent provided they can be satisfied that the patient fully understands the planned intervention (GMC, 2008). For example, a patient may voluntarily adjust their clothing to permit a paramedic to apply adhesive ECG contact pads or roll up a sleeve for blood pressure monitoring. The paramedic should document fully circumstances where interventions are more complex and the patient has refused consent or is unable to consent.
Paramedics should be aware that the process of consent ‘is a continuing process, rather than a one-off decision and patients can change their mind about treatment at any time’ (BMA, 2019: 3). This means that if at any point the patient withdraws their consent—for example by telling the paramedic to ‘stop’ or signalling non-verbally (e.g. moving their hand away to indicate withdrawal of consent for cannulation), the paramedic must stop that intervention immediately.
Inability to give consent during an emergency
While the Mental Capacity Act 2005 provides a statutory presumption that adults have decision- making capacity, it also provides a framework for the provision of care where there is cause to reject the presumption of capacity, and a patient is found to lack the capacity required to make a particular decision (Department for Constitutional Affairs, 2007). In these circumstances, care may be delivered provided it satisfies the statutory provisions and has been evaluated as being in the patient’s best interests (Mental Capacity Act 2005: section 5).
The British Medical Association (BMA) (2019) has provided guidance on how practitioners may lawfully proceed with care in emergencies where they are not able to obtain the patient’s consent; for example, because they are already have cognitive impairment arising from conditions such as dementia or are unconscious following trauma. The first point made by the BMA is that if a patient has capacity to consent, this must be obtained before proceeding with treatment—even in an emergency.
The BMA (2019: 16) goes on to state that in emergencies where obtaining the patient’s consent is not possible, that treatment that ‘is in the patient’s best interests and is immediately necessary to save life or avoid significant deterioration to the patient’s health’ should be provided. However, it adds a caveat:
‘If the patient is an adult, and there is clear evidence of a valid and applicable advance refusal of a particular treatment, that treatment should not be given (for example, a refusal of a blood transfusion by a Jehovah’s Witness). If the patient has appointed a welfare attorney, or there is a court-appointed deputy or guardian, this person must be consulted about treatment decisions, where practical.’
Reflective activity
Sami Green, a MotoX rider, falls off during a race and fractures her right tibia and fibula, causing an open fracture with vascular compromise to the extremity requiring emergency realignment, analgesia, packaging and transport. She screams at you to leave her leg alone and refuses any analgesia. She is clearly experiencing psychological distress and is so overcome with pain that you question her mental capacity to make decisions about her treatment.
Conclusion
While the overriding principle is that no treatment or other care intervention should proceed in the absence of the patient’s informed consent, there are complex requirements for valid consent.
Paramedics are accountable for decision-making in both routine and emergency care, so must understand the principles underpinning the delivery of care in wide-ranging circumstances, including where a patient has capacity but refuses consent or in an emergency where the patient is not able to give their consent.