In this article you will learn:
- How rules around patient consent have changed
- What to ask patients to ensure consent is valid
- How to ensure a patient is competent to give consent
After a landmark ruling in the case of Montgomery v Lanarkshire Health Board at the UK Supreme Court in March 2015, patients must now be given information about any risks associated with their treatment for their consent to be legally valid
. This means information that would enable the patient to make an informed decision should not be selective, even if a healthcare professional believes this is a reasonable judgement based on guidance from their professional body, or what a ‘reasonable patient’ needs to know
This article gives an overview of legally valid consent in the UK, what health professionals need to inform patients to allow them to give consent to treatment, and how the law applies to vulnerable groups.
Montgomery v Lanarkshire Health Board, 2015
On 1 October 1999, Nadine Montgomery gave birth at Bellshill Maternity Hospital, Lanarkshire. As a result of complications during delivery, her baby was born with severe disabilities. Montgomery had diabetes; patients with diabetes are more likely to have large babies and have a 9–10% risk of shoulder dystocia during vaginal delivery. The doctor responsible for her care did not advise her of this possibility as she believed the risk was very small. If Montgomery had been aware of this risk she may have opted for a caesarean section, which was not, in the doctor’s opinion, in her interest. Montgomery sought damages alleging negligence.
The Supreme Court judgment ruled that the doctor should have advised Montgomery of the substantial risk of shoulder dystocia. The doctor made a value judgement about whether a caesarean section was in the patient’s interest; the patient was entitled to make her own value judgement, be given information enabling her to make the decision, and her choice should have been respected.
Legally valid consent
Courts currently test whether consent is legally valid by looking for evidence that:
- The patient had capacity to give or refuse consent;
- There was no pressure or coercion on the patient to give consent;
- The patient was fully informed about the nature of the intervention, the material risks and the implications of giving or refusing consent.
Courts use the tests for legally valid consent when a patient complains about not being informed appropriately about the risks and outcomes prior to undergoing a healthcare intervention (which also includes taking medicines). Often, the patient is seeking compensation for unexpected harm and may protest that, had they known about the risk of harm, they might have refused the intervention or would have sought advice on alternatives.
The recent Supreme Court judgement affects the third test, and offers a clearer definition of ‘material risk’
‘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.’
This statement emphasises a move towards increasing collaboration and open discussion between the health professional and patient in order to determine and agree on how to proceed with treatment and management. Government policy documents
and guidance offered by official bodies
on respecting patients’ rights and involving them in decisions about their healthcare reflect this advance in terms of the phrases used (e.g. ‘no decision about me without me’).
What to ask
The Supreme Court ruling
emphasises the importance of never assuming a patient has provided consent. If there is any doubt surrounding consent, the patient should be asked again. Patients may fail to fully understand the intervention when it is explained for the first time, may forget details, change their mind about the treatment, or may want to understand more about their options and the possible alternative treatments.
It may take days or even weeks for a patient to provide consent, as they must reach their own decision on what risks they are willing to accept. As stated in the Supreme Court judgement
‘There is something unreal about placing the onus of asking upon a patient who may not know that there is anything to ask about.’
A recent article in The BMJ proposes questions that should be posed by healthcare professionals to the patient
(see ‘Questions to ask to ensure the patient is giving legally valid consent’).
Documentation of consent is important. While consent may often be implied (e.g. with a nod of the head, offering the affected limb for treatment) rather than explicit (e.g. through the completion of a consent form), it is the process that matters. The courts would look for the following components when deciding if the consent is legally valid:
- Has all of the information about what might happen been explained?
- Does the patient have any further questions?
- Has the patient been told that they could refuse?
- Have any alternative interventions been explained?
Health professionals should work towards ensuring that the patient is as fully informed as possible. This will involve rulings from other case law
, which establish that you should be able to demonstrate that the patient is able to ‘comprehend… and retain… the treatment information, believe [it] and weigh it in the balance to make a choice’.
Questions to ask to ensure the patient is giving legally valid consent
- Does the patient know about the material risks of the treatment that is being proposed?
- What sort of risks would a reasonable person in the patient’s circumstances want to know?
- What sort of risks would this particular patient want to know?
- Does the patient know about reasonable alternatives to this treatment?
- Has reasonable care been taken to ensure that the patient actually knows all of this information?
- Do any of the exceptions to my duty to disclose information apply?
- Have I properly documented the consent process?
Source: The BMJ
Also referred to as ‘competence’, capacity refers to the ability of a person to make their own decisions; in this context, to give or refuse consent. In English law, a person over the age of 18 years is presumed to have full capacity as an adult, and no one else can give consent on behalf of a competent adult. For patients who are adults but lack some or all capacity, or for those who are still minors, UK law has a number of safeguards to protect their interests while allowing them to be treated where necessary.
Even when an adult patient is unconscious, no one else can give consent on their behalf. Instead, civil law in the UK allows the health professional responsible for their care to make a decision on whether treatment is absolutely necessary based on the best interests of the patient (e.g. could treatment be delayed until the patient regains consciousness?). Any information the health professional can obtain about what the patient would have wanted, if they were able to give or refuse consent, would also be taken into account. This information can be gleaned directly from the patient’s wishes, such as views on resuscitation in the form of an advance directive or lasting power of attorney, or by asking relatives or friends for details of any conversations they may have had with the patient on this topic. If no other information is available, the health professional must make the decision and take responsibility for it.
Unless unconscious, adults rarely lack all capacity, although capacity can fluctuate, reduce or depend on the nature of the decision being made. For example, patients with learning disabilities may struggle to give valid consent to medical treatment but often have very clear views on what they would like to eat or wear. Where capacity is failing because of mental impairment, the Mental Health Act 2007 covers those with a legally defined ‘mental disorder’ and provides details on when their rights to refuse treatment can be overruled. Where mental impairment is temporary, less severe, or anticipated (e.g. because of advancing dementia), the Mental Capacity Act 2005 in England and Wales sets out the principles by which capacity must be promoted and which must underpin determination of a patient’s best interests.
Children generally acquire increasing capacity with age. As a child gets older and enters adolescence, the position becomes more fluid. Much will depend on the nature of the decision, the capacity of the child to understand what is involved and whether they can develop their own opinions about what they would or would not like to happen to them. A landmark case, Gillick v West Norfolk and Wisbech Area Health Authority and Department of Health and Social Security, concerned contraceptive treatment for a girl under 16 years of age without the consent of a parent
. The judge ruled that this could be lawful where ‘the child achieves a sufficient understanding and intelligence to fully understand what is proposed’. The ruling can be extrapolated to many situations where children might reasonably expect to take part in decisions about their treatment.
Gillick v West Norfolk and Wisbech Area Health Authority and Department of Health and Social Security, 1985
Victoria Gillick had five daughters. She asked the health authority for assurance that they would not be given advice and treatment on contraception without her prior knowledge and consent while aged under 16 years. The authority refused. Gillick brought a case alleging health authority guidance was unlawful as it would mean doctors could cause or encourage unlawful sexual intercourse.
Initially, a judge held that a doctor prescribing contraceptives to a girl under 16 years of age would not be causing an offence, and that a parent’s interest in his or her child was not a right but a duty. This was overturned at the Court of Appeal. However, the judges ruled it could be lawful to give advice on contraception to a girl under 16 years of age if she could understand it, could not be persuaded to involve her parents, was likely to have sex irrespective of advice, if her health was at risk, and if it was in her best interests.
A competent adult always has the right to refuse treatment, regardless of personal opinions on whether the patient is making the right or wrong decision. A patient should not agree to a treatment because of subtle pressures (e.g. they want to please the treating healthcare professional, or want to avoid being seen as awkward or stupid because they do not understand what has been said). Patients can be overawed in a hospital environment — they may be frightened as to what is wrong with them, they may see that everyone is busy and just think it will save time to be passive and compliant. If the consequences of the patient’s choice could be dangerous or damaging, then it should be determined that they realise this, but if they say ‘no’, that is their choice.
Conversely, if a patient does not wish to make a decision and wants to trust the advice of the healthcare professional, that is acceptable too. In this situation it would be prudent to fully document and record the patient’s wishes.
The same tests apply when considering consent to disclosure of information. Wherever possible, the patient’s consent should be obtained; it should not be assumed that the patient is happy for their health information to be shared with anyone. If the patient explicitly requests that their health information is not shared, that wish must be respected. In certain circumstances (e.g. HIV positive status), strenuous efforts may be made to change the patient’s mind but ultimately a refusal must be respected, unless there are overriding public interests in disclosing information without consent
. In cases of some infectious diseases (e.g. cholera, plague, relapsing fever, smallpox and typhus), statutory law requires compulsory disclosure
but HIV/AIDS is not included.
Joy Wingfield is honorary professor of pharmacy law and ethics at the University of Nottingham.
 Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland) 2015. UKSC 11.
 Bolam v Friern Hospital Management Committee 1957. 2 All ER 118.
 Pearce v United Bristol Healthcare Trust  48 BMLR 118 (CA).
 Department of Health. Liberating the NHS: no decision about me without me. Government response to the consultation. London: DH 2012.
 General Pharmaceutical Council.Guidance on consent. London: GPhC 2012.
 Sokol DK. Update on the UK law on consent.The BMJ 2015;350:h1481.
 Re C. (adult: refusal of treatment)  1 All ER 819 (Fam Div);  1 FLR at 33E; 1 WLR 290.
 Gillick v West Norfolk and Wisbech Health Authority  3 All ER;  AC 11, HL.
 General Medical Council. Should a doctor override a patient’s objection to disclosure of their HIV status? Available at: www.gmc-uk.org.
 Public Health (Control of Disease) Act 1984. Available at: www.legislation.gov.uk/ukpga/1984/22.