VERIFIABLE CPD PAPER

Consent CLINICAL

Patient choice: the shape of consent post-Montgomery

Shaun Sellars*1 and Lauren Sutherland2

Key points
Provides an overview of the current legal position Describes the consent process in detail. Introduces a unique workflow to aid in gaining
regarding consent to treat. valid and informed consent in practice.

Abstract
The law relating to consent and the process dentists need to go through to gain valid and informed consent to treat
patients changed significantly following the landmark ruling of Montgomery v Lanarkshire Health Board. In this paper,
we revisit the history of patient consent, give an update on the current legal situation in the UK, and produce a unique
‘consent workflow’ to aid in the process of gaining valid and informed consent to treat. The aim is to clarify the legal
standing and provide a framework that dentists and other healthcare professionals can adapt to their current clinical
practice while increasing the confidence of those involved in the consent process; both professionals and patients.

Introduction Sidaway was never a full endorsement of the obtain consent from the patient with capacity.
professional practice test, but the House did In 2015, the UK Supreme Court issued
For many years, the UK law on information not embrace a patient-focused test in this area the landmark decision in Montgomery v
disclosure to patients was governed by the of the law. Lanarkshire Health Board and at last clarified
ruling of the House of Lords in Sidaway v Pre-Montgomery,3 the UK law provided that the UK law on information disclosure to
Board of Governors of the Bethlem Royal a patient who asked questions was entitled to patients.3 This was a unanimous decision of the
Hospital.1 Although information disclosure a truthful answer. The reality of this situation court, which gave effect to the consent guidance
was a central part of the argument in Bolam, was that the patient who did ask questions issued by the General Medical Council (GMC)
Sidaway was the first opportunity for the could be provided with more information than and the General Dental Council (GDC). This
highest court in the UK to define the law on a patient who did not. guidance has been available and updated since
patient consent.2 While the decision in Bolitho v City and the 1990s. It also brought the UK law in line
The Members of the House in Sidaway Hackney Health Authority did permit the with other common law jurisdictions, such as
provided that the Bolam test should be applied court to consider the logic and reasonableness Canada and Australia.8,9,10
when considering information disclosure to of a view expressed on a professional practice, Following Montgomery, the focus is now
patients, that is, a practitioner would not be this decision did nothing to advance the right on the right of the competent person to make
held to be negligent if they acted in accordance of a patient to make their own choice about informed choices about their own health care.
with a responsible body of professional their health care needs.4 To facilitate this choice, the patient requires
opinion. However, the decision did permit a Pearce v United Bristol Healthcare NHS information, and the practitioner should
departure from the professional practice test Trust moved towards the recognition of the provide this. This paper reviews the legal
in certain defined circumstances. In this sense, rights of patients.5 Lord Woolf MR indicated changes in the consent process following the
that it was the doctor’s responsibility to warn Montgomery ruling. It investigates the reaction
patients of significant risks to make informed to this ruling throughout several healthcare
1
General Dental Practitioner, Alvington House Dental
treatment decisions. This ruling was referred to professions while concentrating on dentistry.
Practice, 112 Northgate Street, Bury St Edmunds, IP33 1HP,
UK; 2Ampersand Advocates, Parliament House, Edinburgh, in Wyatt v Curtis and approved of in Chester We will also introduce a ‘consent workflow’
EH1 1RF, UK. v Afshar, where Lord Steyn emphasised that to enable practitioners to be confident in
*Correspondence to: Shaun Sellars
Email address: s.sellars@alvington-house.co.uk medical paternalism no longer rules.6,7 He was obtaining valid consent ‘post-Montgomery’.
Refereed Paper.
of the view that a patient had a prima facie right We have identified many published papers,
Submitted 27 August 2022 to be informed of a small but well-established in both healthcare and legal journals, along
Revised 28 December 2022 risk of injury. Lord Steyn recognised that with guidance from professional bodies and
Accepted 6 January 2023 patient autonomy and dignity were the legal indemnity companies relevant to the changes
https://doi.org/10.1038/s41415-023-5752-6
interests to be protected by the obligation to in the law regarding consent.

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 CLINICAL Consent

The consent process • ‘Patients are now widely recognised as A practitioner should disclose a risk where the
persons holding rights, rather than as the incidence of the risk is high or if the incidence
There are three parts to the consent process. passive recipients of the care of the medical of the risk is low, but the consequences of the
The patient must have the capacity to give profession. They are also widely regarded as risk materialising are serious.10,27
consent, which must be given voluntarily, and consumers exercising choices’ In Montgomery, the Supreme Court
the patient must have the appropriate level • ‘The social and legal developments which provided: ‘…the assessment of whether a risk is
of information regarding the procedure or we have mentioned point away from a material cannot be reduced to percentages. The
treatment they are consenting to undergo. model of the relationship between the significance of a given risk is likely to reflect
A competent adult has the capacity to doctor and the patient based upon medical a variety of factors besides its magnitude:
consent, and patients who lack mental capacity paternalism’ for example, the nature of the risk, the effect
can be provided with treatment that is in their • ‘It is now well-recognised that the interest which its occurrence would have upon the life
best interests, as set out in Section 2(1) of which the law of negligence protects is a of the patient, the importance to the patient
the Mental Capacity Act 2005.11 The courts person’s interest in their own physical and of the benefits sought to be achieved by the
have warned against too strict an approach psychiatric integrity, an important feature treatment, the alternatives available and the
to capacity.12 The question to be addressed is of which is their autonomy, their freedom risks of those alternatives’.
whether the person has the capacity to decide to decide what shall and shall not be done
on the particular issue in question.13 with their own body’. Arguments against the
If there are questions regarding the capacity Montgomery test
to consent to treatment, in England and The patient is now an active participant
Wales, the assessment of capacity relies on a in decisions about their health care. Patient The Supreme Court thoroughly considered
‘diagnostic test’ and a ‘functional test’.14,15 The autonomy can only be protected where a patient the arguments for and against introducing
‘diagnostic test’ asks if the patient is suffering can make a meaningful choice based on adequate a patient-focused test into the law.24 One of
from a long- or short-term impairment or information on the available treatments and the main arguments has always been that
disturbance of the functioning of the brain. therapies and the risks and benefits of each. there will be cases where a frightened patient
Under the ‘functional test’, the question is In developing the legal test for information capriciously refuses the necessary treatment,
whether, as a result of the disturbance, the disclosure following Montgomery, the which would not be in their best interests.
person is unable to make a decision, and there Supreme Court adopted the approach of Lord This decision allows for a significant increase
must be a link between the impairment and the Scarman in Sidaway and Lord Woolf MR in in patient autonomy at the risk of a reduction
inability to make a decision.16,17 Pearce, subject to the refinement made by the in ideal outcomes from treatment.
Assessment of capacity is unchanged by High Court of Australia in Rogers v Whitaker, It is important to note that the decision in
the decision in the Montgomery ruling and and provided that a doctor is under a duty Montgomery does not require that a patient is
it is well-documented by numerous sources, to take reasonable care to ensure that the force-fed information. It permits the patient
including the British Medical Association patient is aware of any material risks involved who wishes to receive information to do so
(BMA)’s Mental capacity act toolkit.18 The in any recommended treatment, and of any unfiltered by a profession collectively deciding
standing regarding capacity in Scotland and reasonable alternative or variant treatments.5,10 what the patient should be told. However, a
Northern Ireland varies from that in England The two-limbed test of materiality is replicated patient’s right not to seek complete information
and Wales. Local legislation and guidelines are from the decision in Rogers v Whitaker. A risk must be equally respected. A patient who
available and should be followed.19,20,21 is material if it satisfies either the objective limb elects to entrust all necessary decisions to the
It has always been the law that to obtain valid or the subjective limb. The objective limb asks practitioner is permitted to do so, although this
consent there must be no coercion from the if, in the particular case, a reasonable person in should be clearly recorded.
practitioner proposing treatment or any outside the patient’s position would be likely to attach Some still adhere to the view that the decision
sources.22 A practitioner may recommend a significance to that risk if warned of the risk. is one for the doctor based on their experience
course of treatment but should not pressure The subjective limb questions if the medical and knowledge. Montgomery emphasises that
a patient to accept the practitioner’s preferred practitioner is or should reasonably be aware the decision is one for the patient to make,
treatment. that the particular patient would be likely to assisted by the practitioner’s expertise. The
The final component of the consent process attach significance to the risk if warned of it.10 practitioner uses their professional experience
is that of ‘informed patient choice’ and it is in In the first instance, this test applies objective and communicates the available options for
this area of the law where the decision of the criteria and focuses on the requirements of a treatment to the patient, with the risks and
Supreme Court in Montgomery has a significant reasonable or ordinary person in the patient’s benefits of those options. The informed patient
impact. In Montgomery, the Supreme Court position. The second subjective limb allows the then makes a decision on treatment that meets
validated the concept of patient autonomy or court to consider the particular person and their their needs.
self-determination, first set out by Cardozo J in needs of fears (reasonable or unreasonable). The Many feel that the decision in Montgomery
Schloendorff v Society of New York Hospital.23 second limb of the test is subject to the caveat has made the consent process significantly
The court recognised the right of the that the medical practitioner is or ought to be more difficult. It is arguable that given that
individual patient to make their own choices aware of them.24,25,26 In Canada and Australia, a patient self-determination is one of the most
and health care decisions based on their distinction is made between the likelihood of basic human rights, the issue of whether
personal beliefs and values. It was said that: the risk occurring and the gravity of the risk. the process is made more difficult has no

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 Consent CLINICAL

Fig. 1 Consent workflow

Explain diagnosis Reasonable treatment options

Understand patient
No treatment Recommended treatment and Valid alternative treatment
wants and needs
associated costs options and associated costs

Benefit assessment Risk analysis

Benefits of no treatment General risks Treatment specific risks Patient specific risks

Benefits of recommended Failure of treatment Common risks Medical

treatment

Anatomical
Benefits of alternative
Future treatment needs
treatment options
Job related

Risks of no treatment Uncommon high significance risks Social

Explain consent Time for Examine patient’s Discuss Provide any Ensure
process deliberation if needs & wishes compromises necessary further understanding Individualised consent
required information form signed

Valid consent

relevance. Delivery of information requires essential in gaining valid consent.26,29 Indeed, experienced registrants are either less aware
dialogue between patient and practitioner. The a patient cannot weigh the risks of treatment of the importance of the consent process or
conversation’s aim should be to understand the without considering the positive and negative that younger practitioners have a better grasp
specific patient’s needs and requirements. Only outcomes. This line is echoed in the Royal of consent in a modern setting.
through dialogue can there be an assessment College of Surgeons’ (RCS’) guidelines on There is no standard set of guidelines on
of the risks and benefits the particular obtaining valid consent, and guidelines of both how to gain valid and informed consent for
patient would attach significance to.3,26 Many the GMC and GDC.30,31,32 dental treatment. With this in mind, we have
practitioners were initially fearful that the produced a dual-purpose consent workflow.
ruling in Montgomery would require them to Consent workflow Firstly, the workflow will help ensure that,
disclose every possible risk to patients. These if followed correctly, patients can exercise
worries were subsequently relieved, and it is There is still considerable confusion within informed choices about their dental treatment.
now clear that so-called theoretical risks, those the profession regarding the changes to the It will also help practitioners gain confidence
in which the odds of occurring are vanishingly law on consent. Over 40% of doctors may be in their ability to obtain consent.
small, are not required to be disclosed.28 unaware of the change to the law on consent, We have started with the RCS’ Consent:
In reality, the ruling in Montgomery should and around 82% are unsure if their consent supported decision-making guidelines as
not change the process of gaining consent from process meets current legal standards.33 It has a basis. 30 They clearly indicate how the
a patient. The GMC’s and GDC’s respective been suggested that the ongoing confusion consent process should proceed, including
standards of care have held this approach for regarding the consent process is compounded the importance of benefits, risks and patient
many years. The Montgomery decision merely by the lack of patient understanding of what dialogue. Notably, the RCS guidelines consider
raises the legal standard for consent to treat the consent process entails.34 the recommendations of the GDC and Dental
to that already expected by the appropriate Gaining valid consent is also an issue Protection.32,36 We have also incorporated ideas
healthcare regulators. from a regulatory viewpoint. GDC figures from the BMA’s Consent toolkit and applied
Early commenters concentrate on the show that consent is a consideration in 7.1% them to the specifics of the dental surgery.37
risk disclosure aspect of the decision in of fitness to practise investigations.35 The For this workflow, seen in Figure 1, we
Montgomery and fail to focus on the fact registrant’s age and the number of years assume that the patient has the capacity to
the case was about patient choice.25 Latterly, practising are significantly associated with an consent to treatment. As discussed earlier,
it has become clear that presenting the increased likelihood of investigation due to robust guidelines and tools are available to aid
benefits of each option for treatment is also consent issues. This suggests that older, more judging capacity to consent.18

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 CLINICAL Consent

The workflow is not a foolproof way to gain º ‘Patient-specific risks’ are those which a meaningful choice based on adequate
valid consent for treatment. It is intended may apply to the specific patient in information on the available treatments or
more as an aide-memoire to be used where question. These would include risks due therapies and the risks and benefits of each.
appropriate and as a reminder that consent is to any medical condition from which the The decision in Montgomery brings the law
a process, not a one-time event. patient may suffer, such as diabetes. The in line with existing standards of registration.
The consent process can be broken down practitioner should consider any risks From a practitioner’s point of view, the
into the following components: associated with the specific anatomy consent process has not materially changed.
1. Explain diagnosis – explain the diagnosis of the patient, for example, if a patient As practitioners, we should already explain the
you have come to (or alternative differential was attending for implant placement risks and benefits of all appropriate treatments
diagnoses if there is no single definitive where the maxillary sinus was close to to patients. Given these existing standards, it
diagnosis) the intended implant site. The potential can be strongly argued that the Montgomery
2. Talk to the patient to identify their specific social impact of any failure of treatment case hasn’t changed anything concerning what
needs, fears and requirements should also be considered from both healthcare practitioners should do to gain
3. Explain treatment options – explain every personal and occupational viewpoints valid consent for treatment. Montgomery
reasonable treatment option to the patient, 5. Enter into dialogue with patient – the simply gives additional recognition to the
including the choice of no treatment. If practitioner should ensure that the patient role of patients as decision-makers.38 Lady
there is a clear recommended treatment, has the chance to discuss each treatment Hale summarised in the Montgomery
explain this to the patient. The patient is option and the associated risks and benefits. ruling: ‘she cannot force her doctor to offer
free to choose any option for treatment The patient should be allowed to ask treatment which he or she considers futile or
or decline treatment altogether. You may questions and be given time to reflect on inappropriate. But she is at least entitled to
advise a patient on what you feel is the the treatment options discussed the information which will enable her to take
best option, but the patient should not be 6. Additional information – the patient a proper part in that decision’.3
pressured to accept a choice you consider should be provided with any additional Subsequent cases, both within and outside of
the ‘best’. A patient is entitled to select an information they need to make an informed health care, will continue to clarify the effects
option you believe is not the ‘best’ and is choice on treatment. This information could of Montgomery. Until then, it is clear that,
perfectly entitled to make decisions you be delivered through leaflets, webpages, or a although the legal landscape has changed, the
may feel are inappropriate. Patients are fully-fledged information booklet regarding clinical ramifications are fewer than initially
free to make what you may consider a procedures predicted.
poor decision. Equally, you are not duty- 7. Signed consent form – when the practitioner
bound to carry out any treatment you and patient are satisfied the consent process Ethics declaration
disagree with is complete, an individualised consent The authors declare no conflicts of interest.
4. Explain the benefits and risks of each form should be completed in duplicate.
treatment option – the practitioner should This form should contain information of Author contributions
explain the benefits and material risks the consent process and what has been Shaun Sellars: initial concept, draft and production
of each treatment option to the patient discussed. A similar amount of detail about of workflow, and final revisions. Lauren Sutherland:
alongside each other. Any costs associated the consent process should be entered into development and revision of the text, revision to
with each treatment option should be the patient notes. workflow, and addition and revision of legal context
discussed. Risks have been broken down to the manuscript. All authors contributed to the final
into three categories. A risk is material Conclusion manuscript.
where the incidence is high or if the
incidence is low, but the risk of damage is Montgomery is undoubtedly a landmark case References
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