New guidance from the GMC: what constitutes meaningful dialogue?
BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m3933 (Published 12 October 2020) Cite this as: BMJ 2020;371:m3933
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Dear Editor
Informed Consent is an “ agreement or permission to do something from someone who has been given full information about the possible effects or results” (1)
With regard to vaccination this is achieved by the physician disclosing information on risks and benefits etc to the individual patient (relevant to that patient’s personal situation), and engaging in full dialogue.
What is or isn’t discussed publicly on the subject has no bearing on whether or not informed consent to vaccination (and other procedures) is obtained correctly as it is required to be patient specific with responsibility for a failure to properly obtain informed consent resting on the individual suggesting the specific treatment to the party.
(1) https://dictionary.cambridge.org/dictionary/english/informed-consent
Competing interests: No competing interests
Dear Editor
As I understand it the British government's legal position over vaccination presently hinges on informed consent [1]. The citizen or patient makes a decision on what should be a full disclosure of the benefits and risks [2], and while the patient may theoretically be able to sue if something goes wrong the risk in the first place lies with the patient rather than state or the manufacturer.
But surely the government will put itself in an invidious positon and undermine its own legal defence if it seeks to limit public discussion about products and promotes a public hue and cry over citizens accepting them [3,4,5].
I am not for a second suggesting that anyone ought to be able to promote false information about products only that they must be allowed to discuss them publicly in a normal, civilised way like anything else [6]. Otherwise the legal condition for informed consent will not exist, and the government may nullify its position, particularly if relevant information was prevented from coming to public light by its actions.
[1] John Stone, 'Re: We can change practice—can we also change culture?', 13 August 2020, https://www.bmj.com/content/364/bmj.l108/rr-9
[2] Daniel Sokol, 'New guidance from the GMC: what constitutes meaningful dialogue?',
BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m3933 (Published 12 October 2020)
[3] ‘ Social media giants agree package of measures with UK Government to tackle vaccine disinformation’ GOV.UK, 8 November 2020, https://www.gov.uk/government/news/social-media-giants-agree-package-of-...
[4] Danyel Hussain, ‘GCHQ spies launch cyber counter-attack against anti-vaccine propaganda being spread by Russia’ , Daily Mail 9 November 2020, https://www.dailymail.co.uk/news/article-8927865/GCHQ-spies-launch-cyber...
[5] Jon (sic) Stone, 'Coronavirus vaccine: Labour calls for emergency censorship laws for anti-vax content', Independent 15 November 2020, https://www.independent.co.uk/news/uk/politics/coronavirus-vaccine-covid...
[6] John Stone, 'Re: New guidance from the GMC: what constitutes meaningful dialogue? (Coercive atmosphere over vaccination)', 13 November 2020, https://www.bmj.com/content/371/bmj.m3933/rr-12
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor
Dear Editorw
Might I yet again request the Mr Sokol, Barrister, Ethicist, to respond to my rapid response?
Surely my questions are not impossible to answer.
Even more urgent is the latest response from Mr John Stone. He shows how the staff at the level of school education are commanding the parents to carry out bureaucratic diktat, blithely ignoring the safety of the child.
Even more amazing: Mr Stone, a layman highlighting the dangers. The school doctors should have picked up the point.s.
Mr Sokol might agree that the point raised by Mr Stone is one that should have been considered by the lawyers of the Dept of Education and the Dept of Health?
Competing interests: No competing interests
Dear Editor
I express concern about the coercive atmosphere being generated over vaccination in this Covid episode which surely infringes the legal right to informed consent of the citizen, having previously remarked here on the repeated comments of the Prime Minister (who is not a medical authority) [1,2].
I have, for example, been forwarded a standard letter to parents who have not signed the consent by ‘School Immunisation Team - Hertfordshire (Vaccination U.K.)’ which has prevented the team from vaccinating a child with nasal flu spray. The letter takes no account of the parental right to refuse. It reads:
“Vaccination UK are coming back to the school for a second visit. Please complete the consent form attached to the school office so we can make sure you child is not missed again...”
This ignores all reasons a parent might have for refusing (for instance issues of health which Vaccination UK are not aware of). At the top we read “Make sure you protect you child against Flu and protect against Pandemics”, but this is problematic since the benefits are by no means straightforward. At the the EMC site we read [3].
“Vaccine recipients should be informed that Fluenz Tetra is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination. Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in Fluenz clinical studies. In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.”
Yet this important information is not (perhaps no longer?) in the Patient Information Leaflet [4] even if this is provided: possibly even immunocompromised children at the school might be exposed.
There are a host of complex ethical issues here and it is not clear that the approach of Vaccination UK meets these, while the lack of courtesy is truly disturbing. It is also surely completely out of line with the Montgomery ruling and the new GMC guidelines [5,6]. Moreover, the PIL withholds important information which would seem to invalidate the possibility of informed consent anyway.
[1] John Stone, ‘ Re: New guidance from the GMC: what constitutes meaningful dialogue? Vaccines are a matter of individual autonomy too’, 20 October 2020, https://www.bmj.com/content/371/bmj.m3933/rr-0
[2] John Stone, ‘Regarding the Use of the Term “Anti-Vaxxer”’, 27 August 2020, https://www.bmj.com/content/370/bmj.m3099/rr-5
[3] https://www.medicines.org.uk/emc/medicine/29112
[4] https://www.medicines.org.uk/emc/files/pil.3296.pdf
[5] Noel Thomas, ‘ Re: New guidance from the GMC: what constitutes meaningful dialogue?’ , 4 November 2020, https://www.bmj.com/content/371/bmj.m3933/rr-9
[6] Daniel Sokol, ‘ New guidance from the GMC: what constitutes meaningful dialogue?, BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m3933 (Published 12 October 2020)
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor
Dear Editor
Two of the UK’s best known cases on the subject of Informed Consent were both found in favour of the claimant in circumstances where the attending physician disregarded and failed to disclose/discuss what were viewed to be “small” risks but with disastrous consequences for the patient.
From Chester vs Afshar [2004]
“Mr Afshar was however subject to a further, important, duty: to warn Miss Chester of a small (1%-2%) but unavoidable risk that the proposed operation, however expertly performed, might lead to a seriously adverse result, known in medical parlance as cauda equina syndrome”. (1)
From The Royal College of Physicians And Surgeons of Glasgow on Montgomery vs Lanarkshire Health Board [2015]
“The consultant stated that the risk of shoulder dystocia occurring in a woman with diabetes was 10% but that the risk of a serious consequence from said shoulder dystocia was 0.2% for a brachial plexus injury and less than 0.1% for hypoxic injury. As the risk of serious consequence was felt to be so small, it was not discussed.”(2)
Montgomery does not support the disregarding of ‘risk’ if deemed, in the opinion of the medical professional, to be small, negligible, minimal etc. A ‘risk’ has to be disclosed to the patient (apart from the permitted exceptions stated in the Judgement) irrespective of rate, severity or likelihood if they fall within what has been defined as a material risk.
The test of “materiality” as defined in Montgomery 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 likely attach significance to it”.
There appears to be plenty of evidence from the Courts and professional bodies alike that risks, even when thought to be small, have to be disclosed to the patient in order to secure informed consent.
The Royal College of Surgeons of England advise their membership to discuss with patients………..
“The risks inherent in the procedure, however small the possibility of their occurrence, side effects and complications.” (3)
A June 2020 paper by Davies et al on the British Orthopaedic Association site “Consent for surgery during Covid-19 pandemic” also states that risks however small should be disclosed to the patient.
“The best practice for consent mandates that the risks inherent in a procedure, however small, should be discussed with the patient and the details of the consent discussion should be recorded” (4)
Against that backdrop it would be misleading to the medical profession to suggest any legitimacy in withholding information re risks on the basis that they are viewed as miniscule, small, remote or minimal etc.
If knowledge of a ‘risk’ exists then Montgomery surely demands that it be disclosed to the patient irrespective of anything else with particular regard to whether or not it is something the patient would attach significance to.
The General Osteopathic Council capture the point perfectly on their website…………
“Statistics on probability of a risk are not justification for a failure to inform” (5)
(1) https://publications.parliament.uk/pa/ld200304/ldjudgmt/jd041014/cheste-...
(2) https://rcpsg.ac.uk/college/this-is-what-we-stand-for/policy/consent/the...
(3) https://www.rcseng.ac.uk/standards-and-research/gsp/domain-3/3-5-1-consent/
(4) https://www.boa.ac.uk/policy-engagement/journal-of-trauma-orthopaedics/j...
(5) https://cpd.osteopathy.org.uk/learn-from-others/thought-pieces/the-law-o...
Competing interests: No competing interests
Dear Editor,
I am grateful to Daniel Sokol for his response.
Daniel Sokol’s original article spoke of “a risk that is negligible and immaterial, even if serious harm could result if it eventuates.” I enquired how one can assess whether such a risk can also cause serious harm.
Sokol’s explanation uses examples where he describes the risk of death or serious harm as minuscule. Minuscule has a significantly different meaning to negligible, and to immaterial, and for that reason I find Sokol’s explanation unconvincing.
Most of my response was concerned with risks that are not minuscule, and certainly not negligible or immaterial, but are “everyday areas of clinical practice.”
It is in such everyday areas of clinical practice that the words of the UK Supreme Court, explaining the nature of the materiality of a risk, are so important in guiding us, when talking with, and listening to, patients and parents: “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.” (1)
The reality of the risks inherent in vaccination are often mentioned, here, in the BMJ online, as they are on the hard copies of Patient Information Leaflets, intended to be read carefully before vaccination.
As the Green Book is more than six years out of date (2), it is important that the new GMC guidance on decision making and consent can begin to fill that hiatus. Do these exchanges support such optimism?
1 https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf Paragraph 87
2 https://www.gov.uk/government/collections/immunisation-against-infectiou...
Competing interests: No competing interests
Dear Editor
In relation to Dr Thomas’ question, “Will Sokol please explain how one can assess that a risk is negligible and immaterial, if it can also cause serious harm?” (21 October 2020), I think, the factors to be taken in to account in such situations are succinctly stated from para.89 to 92 in Montgomery v Lanarkshire Health Board [2015] UKSC 11 below [1].
“89…..First, it follows from this approach that the assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient.”
“90. Secondly, the doctor's advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision……The doctor's duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form.”
“91. Thirdly, it is important that the therapeutic exception should not be abused. It is a limited exception to the general principle that the patient should make the decision whether to undergo a proposed course of treatment: it is not intended to subvert that principle by enabling the doctor to prevent the patient from making an informed choice where she is liable to make a choice which the doctor considers to be contrary to her best interests.”
“92. here are, of course, arguments which can be advanced against this approach: for example, that some patients would rather trust their doctors than be informed of all the ways in which their treatment might go wrong; that it is impossible to discuss the risks associated with a medical procedure within the time typically available for a healthcare consultation;…….”
References
[1] https://www.bailii.org/uk/cases/UKSC/2015/11.html
Competing interests: No competing interests
Dear Editor
Might Barrister/ Ethicist Mr Sokol forgive me for taking issue with his stance?
He leaves the reader waiting. Waiting for the judgement of a higher court? A jury?
If it is MY CHILD, who might be at 1 in a 1000 risk of Kawasaki, to me it is a material risk.
I practised medicine on the principle:
What is best for my child, for my wife, is good enough for me. And I would offer it for my patient.
Please note: OFFER. The child’s parent/legal guardian would be welcome to reject my offer.
Would Dr Thomas and Mr Sokol quarrel with my stance? They are welcome to topple me!
Competing interests: Patient
Dear Editor,
I am grateful to Dr Thomas for his comment on my article.
Dr Thomas asked: “Will Sokol please explain how one can assess that a risk is negligible and immaterial, if it can also cause serious harm?”.
The assessment of whether a risk is material is fact-sensitive and the seriousness of the potential harm will be one factor. However, I do not believe that a risk that may cause serious harm should *always* be disclosed. One example might be the minuscule risk of death (e.g., from anaphylactic reaction) every time a local anaesthetic is used. Commonly prescribed drugs, such as antibiotics, also carry minuscule risks of severe complications but these risks are not routinely discussed by doctors at the time of prescription.
The courts have also placed limits on the duty to disclose very small risks, even if the harm if the risk eventuates is serious. Thus, in Mrs A v East Kent Hospitals University NHS Foundation Trust [2015] EWHC 1038 (QB), the issue was whether the NHS Trust had a duty to inform the mother that her baby might be suffering from a chromosomal abnormality. The Court found that the risk was 1 in 1000, which the judge described as “background level”. He found that a reasonable patient in Mrs A’s position would have attached no significance to such a small risk. The judge said his view would have been different had the risks been “somewhere between 1-3 per cent or anywhere approaching that level”.
However, it is important to note that the Court in Montgomery v Lanarkshire Health Board [2015] UKSC 11 made clear that the “assessment of whether a risk is material cannot be reduced to percentages”.
Similarly, in my view, the assessment of whether a risk is material cannot be reduced solely to the seriousness of the harm.
Best wishes,
Daniel Sokol
Competing interests: I am the author of this article.
Re: New guidance from the GMC: what constitutes meaningful dialogue?
Dear Editor
I am perplexed at Wendy Stephen’s response [1]? I think we can all appreciate that a dialogue might be made less meaningful if a patient was subject to undue pressure to accept an intervention irrespective of the moment at which consent is obtained [2]. For myself I have been in benign hospital situations and situations where the staff terrified me out of my wits. What happens in the present situation over Covid vaccines which have been developed and trialled in only a few months and where the government is anxious to curtail discussion over safety and even attribute malice to people who attempt to discuss it [3,4]? What happens when this is against a background where the government’s own trustworthiness (notably over contracts) is in question [5]? Would the basis for informed consent then exist?
[1] Wendy E Stephen, ‘ Re: New guidance from the GMC: what constitutes meaningful dialogue?’, 18 November 2020, https://www.bmj.com/content/371/bmj.m3933/rr-16
[2] Helen Haskell, ‘ Cumberlege review exposes stubborn and dangerous flaws in healthcare’, BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3099 (Published 06 August 2020)
[3] John Stone, 'Re: New guidance from the GMC: what constitutes meaningful dialogue? (Coercive atmosphere over vaccination)', 13 November 2020, https://www.bmj.com/content/371/bmj.m3933/rr-12
[4] John Stone, ‘Informed Consent and the Government’s Legal Position’, 16 November 2020, https://www.bmj.com/content/371/bmj.m3933/rr-14
[5] Kamran Abbasi, ‘ Covid-19: politicisation, “corruption,” and suppression of science’, BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4425 (Published 13 November 2020)
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor