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Clinical Practice Keywords Decision-making/Autonomy/ Information/Case law/Legal duties Discussion This article has been double-blind peer reviewed In this article... ● Duty to obtain informed consent from patients before giving treatment ● Salient law cases on patient decision making and informed consent ● Implications of the law on informed consent for nursing practice

Informed consent 1: legal basis and implications for practice

Key points Author Helen Taylor is visiting lecturer at the University of Birmingham and freelance Nurses must writer on health law. generally obtain the patient’s informed Abstract Nurses have a legal duty to ensure they obtain informed consent from consent before their patients before carrying out any intervention or treatment. This is one of proceeding with the requirements of the Nursing and Midwifery Council’s Code, which sets out a treatment mandatory framework of standards for practice. Nurses and midwives will all be aware of that requirement but they also need to understand exactly what informed Proceeding with consent is, how it is underpinned by law, and what it means for practice. This article – treatment without the first in a series of two – discusses why informed consent is fundamental to the the patient’s provision of person-centred care and explores the legal principles behind it. consent is, in most cases, unlawful Citation Taylor H (2018) Informed consent 1: legal basis and implications for practice. Nursing Times [online]; 114: 6, 25-28. The law on informed consent in adults was changed by a urses know they must have 2005; Thompson and Dowding, 2001; judgement of the their patients’ informed con- Hamm, 1988). Supreme Court in sent before giving any form of Regardless of the process used, the con- 2015 (Montgomery v Ncare or treatment but they may sensus is that decisions will be based on Lanarkshire) not be fully aware of the legal basis behind information of one kind or another, and this and the implications of not doing so. will influence the outcomes for patients Nurses must provide What is informed consent? Why is it (Taylor, 2005). It follows, therefore, that patients with the important? What does it mean for prac- the quality of the outcomes will depend information they tice? This article – the first in a two-part on the quality of the information upon need to make an series – explores the legal principles of which decisions were based. As such, informed decision informed consent in adults, considers why nurses must ensure their decisions are about their care it is fundamental to the provision of based on “the best evidence available” person-centred care, and explains how the (Nursing and Midwifery Council, 2015). If the necessary law relating to informed consent has information to recently changed. Person-centred care make an informed Evidence-based practice is considered fun- decision is not given, Clinical decision making damental to the delivery of good-quality consent may not Nurses make many clinical judgements person-centred care (Banner et al, 2016). be valid and nurses and decisions throughout the course of The concept of ‘person-centred care’ is may be acting their working day. They assess patients’ widely cited in the literature and applied in unlawfully if they health status and plan care based on their nursing practice. Although the term may proceed with observations, deciding which treatments be used interchangeably with ‘patient- treatment and interventions best meet patients’ centred care’ (Perez-Merino, 2014; McCrae, needs. The process of clinical decision 2013), there is some variance in how it is making has been widely explored and can defined in the literature. Sometimes be explained in a number of ways, ranging person-centred care is not defined but, from the intuitive to the analytical (Taylor, instead, is simply described in terms of

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patient autonomy, holistic care and pri- macy of patient need (Hayes, 2014). For the purpose of this article, person- centred care is defined as the: “approach to care that places the person at the centre of their own care. Individuals are supported, facilitated and enabled to contribute to their care through shared decision making, equality of communication and mutual respect” (Mitchell and Agnelli, 2015).

Person-centred care implies the cen- trality of the patient, who is seen as a key participant in care, rather than the passive recipient of it.

Accountability and best evidence The NMC’s (2015) code of conduct sets out a mandatory framework of professional standards for practice. All registered nurses, registered midwives, student nurses and student midwifes are account- able for their practice and must comply with the Code to ensure their practice meets the standards required not only by the NMC, but also by patients and the general public. Compliance with: “the professional standards that registered nurses and midwives must uphold [is] not negotiable or Nurses must give patients all the information that is necessary so they can make an discretionary” (NMC, 2015). informed decision about their care and any potential treatment

Some of the key legal principles of the evidence, they will be able to inform, As well as understanding the legal NMC Code are highlighted in Box 1. Nurses explain and account for these decisions framework that underpins care, nurses will be accountable for any deviation from (Aveyard and Sharp, 2017). need to be aware that the law can change these principles and must be able to justify Arguably, as well as informing the clin- quickly, even after long periods without their actions (Cornock, 2011). If they base ical element of care (for example, selecting changes. This is the case of the law relating their decisions on the best available the most appropriate wound dressing), the to consent to treatment. best available evidence must also inform Box 1. The NMC Code: the wider framework for decision making Autonomy key legal principles (for example, determining the legality of It is useful to start by considering consent providing treatment if the patient is from an ethical perspective and how it The Nursing and Midwifery Council’s unconscious and, as such, not able to give relates to the principle of autonomy. Code says that nurses must not only their consent). Autonomy recognises an individual’s right “act in the best interests of people at all to make choices on matters relating to times”, but also balance this with “the Understanding the legal basis themselves, unrestricted by factors – such requirement to respect a person’s right There is a legal principle that ignorance is as controls imposed by others or lack of to accept or refuse treatment”. This not a defence: if a law is not known or not information – that would limit the means nurses must “get properly understood, this does not remove any lia- freedom of their choice (Beauchamp and informed consent and document it bility that comes with it. To recognise and Childress, 2012). before carrying out any action”. The uphold their patients’ rights, nurses must This principle is upheld in the law, Code emphasises the need for nurses not only be aware of the standards set out which recognises that all adults generally to “keep to all relevant laws about in the Code, but also understand their legal have a presumed right to decide what hap- mental capacity that apply in the basis. However, although nurses may be pens to their body. The law not only pro- country in which [they] are practising, aware of broad legal concepts set out in the tects a person from any unwanted touch, and make sure that the rights and best Code, they do not always understand the but also from the fear of being touched. It interests of those who lack capacity detail of the law and how it affects their is unlawful to touch another person unless are still at the centre of the decision- practice (Taylor, 2016). This means that, they have agreed to it; their consent makes making process”. beyond the potential negative impact on lawful an act that would otherwise be Source: Nursing and Midwifery Council (2015) patient care, they may be in breach of the unlawful (Taylor, 2013), as highlighted in

ALAMY law without knowing it. Collins v Wilcock [1984] 3 All ER374.

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Non-consensual touching may breach Box 2. The Montgomery case both civil and criminal law. Mrs Montgomery, who had type 1 disability for Mrs Montgomery’s son. She Right to decide diabetes, was expecting her first baby; a sued the NHS trust, arguing that she This applies to all areas of life, including pre-natal assessment indicated that the should have been advised of the risks of healthcare (Re F (Mental Patient: Sterilisa- baby would be large. During the later vaginal delivery and that, if she had been tion) [1990] 2 AC 1) and means patients gen- stages of her pregnancy, she told her aware of those risks, she would have erally have the right to make decisions obstetrician about her concerns that the opted for an elective Caesarean section. about their care – for example, whether to baby’s size would make delivery difficult. When this case was first heard, the accept a treatment or intervention – even if The obstetrician recognised there was Scottish Court of Session followed the their “refusal may risk permanent injury a 9-10% risk of shoulder dystocia that approach taken in Sidaway v Board of to [their] health or even lead to premature would complicate the delivery, but Governors of the Bethlem Royal Hospital death”. The patient’s decision must be decided not to share that information and the Maudsley Hospital [1985] AC 871 respected even if it is considered foolish, with Mrs Montgomery. The obstetrician and concluded there was insufficient risk unfounded or irrational (Re T (Adult: felt the risk to Mrs Montgomery and her of significant harm to Mrs Montgomery to Refusal of Medical Treatment) [1992] baby was relatively small, and did not warrant a warning. The Supreme Court 4 All ER 649). warrant the elective Caesarean section disagreed and upheld Mrs Montgomery’s In Airedale NHS Trust v Bland [1993] that she would be likely to request if told appeal, recognising that there had been a AC 789, Lord Keith of Kinkel stated that: of the risk. She would have been given shift in the relationship between patients “it is unlawful, so as to constitute both this information only if she had asked and health professionals. Patients are: a and the crime of battery, to “specifically about exact risks” “now widely regarded as persons administer medical treatment to an (Montgomery v Lanarkshire Health holding rights, rather than as the passive adult, who is conscious and of sound Board [2015] UKSC 11). recipients of the care of the medical mind, without his consent”. Mrs Montgomery went into labour. profession. They are also widely treated Shoulder dystocia occurred and made as consumers exercising choices: a The NMC Code expands on this by vaginal delivery impossible, so an viewpoint which has underpinned stating that nurses must ensure that they emergency Caesarean section had to be some of the developments in the “get properly informed consent and docu- performed. Oxygen deprivation during provision of healthcare services” ment it before carrying out any action” birth resulted in severe and permanent (Montgomery [2015]). (NMC, 2015). Consent must be voluntary. It may not provide a valid legal defence if, for “All adults generally Sidaway v Board of Governors of the example, the patient felt obliged or was Bethlem Royal Hospital and the Maudsley persuaded by others to accept treatment. have a presumed right to Hospital [1985] AC 871 reflects the view that Some patients may be particularly vulner- decide what happens patients cannot be expected to have the able to pressure from others so nurses to their body” same level of knowledge as the doctors need to be alert to the possibility of coer- treating them, might not be able to objec- cion and make every effort to ensure tively balance the risks and benefits of a patients are supported to reach their own duty to a patient to warn him or her in gen- particular intervention, and might place decision (General Medical Council, 2008). eral terms of possible serious risks involved “undue significance” on certain elements in the procedure”. If there is doubt as to of the information they are given. It was Informing patients: whether consent was sufficiently informed, thought that giving the patient too much Chester v Afshar a decision will be made by the court (Mont- information might “prejudice the attain- What does informed consent mean? The gomery v Lanarkshire Health Board [2015] ment of the objective of restoring the concept is not explained in the NMC Code, UKSC 11; Chester v Afshar [2004]). The health patient’s health” and, therefore, conflict but the doctrine of informed consent as a professional would be found negligent if with the doctor’s duty to act in the patient’s principle in was clearly estab- they have not given the patient enough best interests (Sidaway [1985]). lished in Chester v Afshar [2004] UKHL 41. information to make an informed decision. The courts considered that patients In that case, the House of Lords made clear needed to be protected from making irra- that a practitioner would be negligent – Paternalistic approach tional decisions so the House of Lords and in breach of their duty of care to the Health professionals need to give patients extended the Bolam test – used to assess patient – if they failed to advise them of the sufficient information to make an informed – to the information doctors risks associated with a proposed treat- decision, but what does this mean in prac- were required to give or disclose to patients. ment. Although the case refers specifically tice? In the past, there was a paternalistic This meant doctors were able to withhold to surgical interventions, more recent approach to healthcare: doctors decided not information from their patients and would cases such as Gallardo v Imperial College only what treatment would best fit their not be deemed negligent provided they had: Healthcare NHS Trust [2017] EWHC 3147 (QB) patients’ needs, but also what information “acted in accordance with a practice show that the principle applies to treat- to give to them. Patients would be spared accepted as proper by a responsible ment more generally. information which their doctor thought body of medical men skilled in that Chester v Afshar [2004] does not specify they might find upsetting or otherwise did particular art” (Bolam v Friern the extent of the information doctors must not need to know – for example, a diagnosis Management Committee [1957] provide, other than saying there is a “legal of cancer or terminal illness (McCrae, 2013). 2 All ER 118).

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As such, although patients had the right Box 3. The Montgomery case: information has been given. Nurses will be to access the information they needed to implications for practice acting unlawfully, and contrary to the prin- make a balanced decision (including any ciples of person-centred care if they admin- “general dangers and […] any special dan- Nurses need to: ister care without a patient’s consent. gers […] without exaggeration or conceal- l Inform the patient of the advantages The second article in this series will ment”), doctors had the right to “decide and disadvantages of a particular consider what makes consent valid and what information should be given to the treatment, including any risks explains that this may depend on the cir- patient” and how that information should associated with it cumstances in which care is planned. It be presented (Sidaway [1985]). l Inform the patient of any other will also discuss situations in which treat- options or alternatives to that ments and interventions may be given law- A turning point: Montgomery treatment, and their pros and cons fully in the absence of consent. NT This remained the law until 2015, when a l Ensure that the information is landmark judgement was made by the presented in a way that the patient References will understand – for example, Aveyard H, Sharp P (2017) A Beginner’s Guide to Supreme Court in the Montgomery [2015] Evidence-Based Practice in Health and Social Care. case, which is described in Box 2. avoiding medical jargon London: Open University Press. Patients no longer have unquestioning l Give the patient time and space, as Banner D et al (2016) Making evidence-based faith in their doctors and nurses. In recent far as is reasonably practicable, to practice happen in ‘real world’ contexts: the years, their confidence in health profes- weigh up their options before arriving importance of collaborative partnerships. In: Lipscombe M (ed) Exploring Evidence-based sionals and the healthcare system has been at a decision Practice: Debates and Challenges in Nursing. eroded by a succession of scandals l Respect the patient’s decision, no Abingdon: Routledge. (McCrae, 2013). Patients are now more matter how much he or she may Beauchamp TL, Childress JF (2012) Principles of aware of their treatment options, more disagree with it Biomedical Ethics. New York: Oxford University aware of their rights as consumers of Press. Cornock M (2011) Legal definitions of healthcare, and prepared not only to com- responsibility, accountability and liability. Nursing plain about care they consider substandard they need to decide whether they want to Children and Young People; 23: 3, 25-26. but also to take legal action (McCrae, 2013). accept the risks that a particular treatment General Medical Council (2008) Consent: Patients Although not all patients want, or are may present (Montgomery [2015]). However, and Doctors Making Decisions Together. Bit.ly/GMCConsent able to, participate in decision making, this comes with three caveats: Hamm R (1988) Clinical intuition and clinical there has been a shift towards the active ● Practitioners may withhold any analysis: expertise and the cognitive continuum. In: involvement of patients in this area. information that they reasonably Dowie J, Elstein A (eds) Professional Judgement: A Generally, patients are no longer passive consider would “be seriously Reader in Clinical Decision Making. Cambridge: recipients but, rather, active partners in detrimental to the patient’s health” Cambridge University Press. Hayes AC et al (2014) Pathways through Care at their care. With this comes the duty for (Montgomery [2015]); the End of Life: A Guide to Person-Centred Care. practitioners: ● Practitioners may withhold London: Jessica Kingsley “to take reasonable care to ensure that information in circumstances where McCrae N (2013) Person-centred care: rhetoric and the patient is aware of any material the patient needs urgent treatment but reality in a public healthcare system. British Journal of Nursing; 22: 19, 1125-1128. risks involved in any recommended is either unconscious or has a condition Mitchell G, Agnelli J (2015) Person-centred care treatment, and of any reasonable that means that they are not able to give for people with dementia: Kitwood reconsidered. alternative or variant treatments”. valid consent (Montgomery [2015]); Nursing Standard; 30: 7, 46-50. ● Practitioners are not required to share Nursing and Midwifery Council (2015) The Code: Professional Standards of Practice and Behaviour The test to be applied is: information if the patient, after having for Nurses and Midwives. Bit.ly/NMCCode2015 “whether, in the circumstances of the been given the opportunity to receive Perez-Merino R (2014) Strategies for enhancing particular case, a reasonable person in it, makes clear their wish to remain the delivery of person-centred care. Nursing the patient’s position would be likely to uninformed. Standard; 28: 39, 37-41. attach significance to the risk, or the It must be noted that, although much of Taylor HJ (2016) What are ‘best interests’? A critical evaluation of ‘best interests’ decision- doctor is or should reasonably be aware the existing case law refers to doctors, the making in clinical practice. Medical Law Review; that the particular patient would be legal principles on informed consent apply 24: 2, 176-205. likely to attach significance to it” in just the same way to nurses and all other Taylor H (2013) What does consent mean in (Montgomery [2015]). health professionals (Young, 2009). It must clinical practice? Nursing Times; 109: 44, 30-32. - Taylor H (2005) Assessing the Nursing and Care also be noted that the law relating to con Needs of Older Adults: A Patient-Centred Implications of the case sent in children is different to that for Approach. Oxford: Radcliffe Publishing. The Montgomery case has a number of adults, and is not covered by this article. Thompson C, Dowding (2001) Decision making implications for nursing practice, which and judgement in nursing – an introduction. In: are outlined in Box 3. Nurses should be Conclusion Thompson C, Dowding D (eds) Clinical Decision Making and Judgement in Nursing. Edinburgh: aware that they will be accountable for the Other than in exceptional circumstances, Churchill Livingstone. decisions they make about disclosure, and nurses have both a legal and a professional should ensure that they carefully record obligation to ensure: the decision-making process and the l Their patients are informed about the Part two of this series appears in next month’s information shared. If they are uncertain proposed treatment; issue and, combined with this, will be a Journal Club article. For more information about any of this, they should seek advice. l They have their patients’ consent before about Nursing Times Journal Club, go to: Practitioners will be deemed negligent starting treatment. nursing times.net/NTJournalClub if they fail to give patients the information Consent will only be valid if that

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