The law and practice around consent for medical procedures has been a changing landscape for the last few years. The landmark Montgomery Supreme Court decision came in 2015, and there have been many high-profile cases since, including the Diamond v Royal Devon Court of Appeal decision in 2019. As a result, ensuring that patients have given effective informed consent can feel like one of the biggest challenges for surgeons.
While high-profile court decisions set binding legal precedents, they are not usually written in a way to make the practical implications for surgeons clear. Incision has been working hard to support its members over this time, including providing several in-depth guidance notes written by DWF Law LLP, to provide practical guidance on how to obtain proper informed consent. You can find that earlier guidance in the following links:
Part 2 – Taking the medical and social history
Part 3 – Consultations and Information Leaflets
Part 4 – Particular challenges in obtaining consent
The GMC have now updated their own guidance on consent, which was last published in 2008. The new guidance comes into force on 9 November 2020, and all surgeons need to comply with it. This should be good news for surgeons. While the GMC’s new advice essentially reflects the legal principles set out in Montgomery, it is nevertheless helpful to have formal guidance from a reliable source written in an accessible way. This in itself should help reinforce what the standard of care is for surgeons in relation to the consent process, and following this guidance should make it easier for surgeons to be able to demonstrate good medical practice in relation to consent.
For surgeons, there is probably no safe alternative to reading the whole thing at least once, and the entire document (44 pages) can be found here.
But in very brief summary, the guidance addresses such key issues as:
- Taking a proportionate approach – there will be judgement calls to make about whether too much information will overwhelm a patient, while at the same time making sure that the patient understands all the risks that are “material” to them as an individual.
- Dialogue leading to a decision – which includes the information you give to patients, finding out what matters to a patient, discussing benefits and harm, answering questions, supporting decision making, the scope of decisions, support from other members of your healthcare team and what to do if you disagree with a patient’s choice of option.
- Recording decisions – with reference to medical records, recordings (visual and audio) and consent forms.
- Reviewing Decisions.
- Circumstances that affect the decision-making process –time and resource restraints, emergencies, patient not wanting to be involved, capacity and limitations by law.
The GMC website also provides a short video (only 1 minute 44 seconds) at https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consent. It is helpful to watch because is summarises the seven principles of decision making and consent:-
Principle One: All patients have the right to be involved in decisions about their treatment and care and be supported to make informed decisions if they are able.
Principle Two: Decision making is an ongoing process focused on meaningful dialogue – the exchange of relevant information specific to the individual patient.
Principle Three: All patients have the right to be listened to, and to be given the information they need to make a decision and the time and support they need to understand it.
Principle Four: Doctors must try to find out what matters to patients so they can share relevant information about the benefits and harms of proposed options and reasonable alternatives, including the option to take no action.
Principle Five: Doctors must start from the presumption that all adult patients have capacity to make decisions about their treatment and care. A patient can only be judged to lack capacity to make a specific decision at a specific time, and only after assessment in line with legal requirements.
Principle Six: The choice of treatment or care for patients who lack capacity must be of overall benefit to them, and decisions should be made in consultation with those who are close to them or advocating for them.
Principle Seven: Patients whose right to consent is affected by law should be supported to be involved in the decision-making process, and to exercise choice if possible
We hope that this update helps Incision members to stay up to date on all the relevant guidance relating to this crucial aspect of their clinical role. Unfortunately, allegations of a failure to obtain proper informed consent can give rise to a legitimate claim for compensation, even if there was no negligence whatsoever in the procedure itself. Therefore, if a patient complains that they weren’t properly warned of the risks of a procedure, Incision members should protect their interests by contacting the Incision medico-legal team for guidance and for help with any precautionary notifications to insurers – at medicolegal@incisionindemnity.com
Incision Indemnity
November 2020