Consent

This special issue on consent is a timely opportunity to reflect on where current thinking and practice on consent is in the wake of the Montgomery case. The articles from eminent people in this field will be of great interest I am sure. I am particularly pleased to see the contribution from James Badenoch QC who was so influential in the Montgomery case and is a long-term friend of AvMA and a patron of the charity. I am sure James would be the first to acknowledge the pivotal role that two of our longstanding lawyer friends from Scotland – Lauren Sutherland and Fred Tyler – also had. It is a reminder of how fortunate we are to have such a formidable movement of lawyers who contribute to wider justice and patients’ rights considerations as well as access to justice for their clients.

From a patient’s perspective Montgomery certainly seems a move in the right direction as regards fully informed consent. Perhaps, we will eventually see an end to the perfunctory ‘consenting’ of patients to a situation where patients are genuinely empowered to make fully informed decisions in partnership with their treating health professionals. Rather than seek to duplicate what esteemed contributors to this issue of Clinical Risk may have to say, I would simply like to flag up some related issues around the subject of consent. One that is very topical is the issue of consent and how that relates to the statutory Duty of Candour in England.

The statutory Duty of Candour was introduced in November 2014. It is a legal duty (on organisations registered with the Care Quality Commission) to provide information, explanations and apologies to people who appear to have been caused significant harm, or who could suffer significant harm, as a result of the care or treatment they did (or did not) receive. A constant area of discussion has been whether a known risk or complication occurring, the possibility of which had formed part of the consent process, constitutes a ‘notifiable safety incident’ under the regulations. Some argue simply that if the patient gave consent in the knowledge of the risk of the complication arising, then it does not. However, whilst this may at first seem logical, I am glad to say that the CQC have confirmed that this is an incorrect interpretation. However, it is also incorrect to say that every complication which would meet the definition of significant harm does constitute a ‘notifiable safety incident’ under the Duty of Candour. Imagine the enormous bureaucracy that would arise if every such complication (including for example an unplanned return to theatre) required the full Duty of Candour process to be followed, including both face to face and written explanations and apologies. Imagine the bemused reaction of patients who were the subject of such a process just because an unavoidable complication, the risk of which they were aware of, had arisen and staff acted appropriately to address it.

The key to answering whether a known risk or complication arising does in fact invoke the full Duty of Candour requirements is whether or not there had been, in the words of the regulations, an ‘unexpected’ or ‘unintended’ incident in the course of treatment which appears to have or could result in significant harm. Such incidents include omissions as well as acts. Say for example, a patient is not given medication they should have been which would have been likely to have prevented the complication arising. Or say normal hygienic practices were not followed which appears to have resulted in a patient getting an infection. The outcomes may well be known risks or complications, but the ‘incident’ was both ‘unexpected’ and ‘unintended’. Surely it is only right that a patient should be told the full truth in such circumstances and that the health provider is under a legal obligation to make sure this happens. (Whilst it is not mandated by the Duty of Candour, it is of course good standard practice that even if the incident strictly speaking does not meet the statutory definition of a notifiable safety incident, that a conversation takes place with the patient about it).

Another interesting debate could be had over consent if there were circumstances pertaining at a hospital, which increased risk for patients, but which the patient was not made aware of at the time of giving consent. Let’s say that there was significant under-staffing; or that there was increased infection risk at the hospital; or that the success rates of surgeons at that hospital were significantly lower than the norm. If a complication arises when the risk of that complication has been significantly increased by the circumstances pertaining at that time, should it be said that the patient had given proper consent? Your answers on a post card (or an email!) please. One thing is for sure. The subject of what constitutes informed consent will continue to generate discussion and debate for years to come. That cannot be a bad thing.