Some 12 years after the 2008 version, the General Medical Council (GMC) has just published new guidance on decision making and consent, which will come into effect on 9 November 2020.
On two occasions, the new GMC guidance uses a phrase not found in the previous version: consent as a “meaningful dialogue” between doctor and patient.
The ethicist in me nods in agreement: adieu to the one-way, hurried, mini-lecture by the doctor to the patient.
The barrister in me contemplates suitable wording for my next “lack of consent” case:
“Although a brief discussion did take place on 10 November 2020, the doctor failed adequately or at all to engage in a meaningful dialogue with the Claimant in relation to the operation, in breach of Principle 2 of the GMC’s Guidance on Consent (2020).”
What constitutes “meaningful dialogue” is the subject of much of the new GMC document.
Thus, paragraph 17 states: “You should try to find out what matters to patients about their health—their wishes and fears, what activities are important to their quality of life, both personally and professionally—so you can support them to assess the likely impact of the potential outcomes for each option.”
The next paragraph adds “You must seek to explore your patient’s needs, value and priorities that influence their decision making, their concerns and preferences about the options and their expectations about what treatment or care could achieve.”
Early in the guidance, the authors note in an apparent attempt to reassure their medical readership: “Obtaining a patient’s consent needn’t always be a formal, time-consuming process’”(para 6). Quite right, as some interventions are trivial—for example, the routine auscultation of the chest—but for any significant procedure or intervention it is difficult to see how obtaining consent could be anything but formal and time-consuming. In my lectures to doctors, the lack of time is often mentioned as a barrier to obtaining high quality consent and it is likely to remain so in light of the new guidance.
In the section on discussing benefits and harms, paragraph 21 states that doctors must give patients “clear, accurate and up-to-date information, based on the best available evidence, about the potential benefits and risks of harm of each option, including the option to take no action.” The phrase “based on the best available evidence” is a new addition.
At paragraph 22, the guidance acknowledges that “it wouldn’t be reasonable to share every possible risk of harm, potential complication or side effect” although at paragraph 24(c) it recommends disclosing any risk of serious harm, however unlikely it is to occur. I have concerns about this. Some tiny risks can be material to a particular patient, but others are so negligible that it would be plain silly to mention them. As far as I know, there is no legal authority for the proposition that doctors should disclose a risk that is negligible and immaterial, even if serious harm could result if it eventuates.
On the topic of patients wanting to record a discussion with the doctor, paragraph 27(c) advises doctors to “accommodate a patient’s wishes if they would like to record the discussion.” That recording is then owned by the patient and does not have to be stored with their records (paragraph 53). However, if a doctor makes a visual or audio recording, this forms part of the medical record and should be treated in the same way as other records (paragraph 52).
A notable tightening of language relates to checking the understanding of patients, which in practice can be challenging. The new guidance, at paragraph 30, states “you must check whether patients have understood the information they have been given.” The old rule used the milder “you should check…”
The new guidance issues a caveat about the use of consent forms, reflecting some judicial comments in past cases: “filling in a consent form isn’t a substitute for a meaningful dialogue tailored to the individual patients’ needs.” A consent form may suggest that some sort of interaction took place, but it is a far cry from evidencing the “meaningful dialogue” envisioned by the GMC guidance.
Finally, I must mention the first ever reference in the guidance to seeking advice from a clinical ethics committee in the event of disagreement about the best interests of a patient lacking capacity (paragraph 92(c)). Let us hope more hospitals will set up such committees.
The new guidance merits careful reading by doctors. It will now be the key document by which the quality of their consent is measured.
Daniel Sokol is a medical ethicist and barrister at 12 King’s Bench Walk, London. He is the author of “Tough Choices: Stories from the Front Line of Medical Ethics” Book Guild, 2018). Twitter: @danielsokol9
Competing interests: None declared.