Dr Udvitha Nandasoma
A recent Supreme Court judgment introduced the concept of 'informed consent' to the law of negligence. Dr Udvitha Nandasoma reviews the ethical and legal challenges in the complex area of consent, which is central to the provision of medical treatment.
What is consent?
Usually, we think of consent in the context of surgery or major medical interventions, but consent underpins even 'routine' interactions.
A patient may give their consent expressly (verbally or in writing), or their consent may be implied, as is often the case in routine examinations or procedures - for example, when a patient holds out an arm to have their blood pressure measured or gets on to the examination couch.
Disputes about the adequacy of consent often arise in clinical negligence claims some time - even years - after the event. While written consent is rarely required by law, it is for this reason that the MDU recommends that consent is confirmed in writing for all procedures where there is more than a minimal degree of risk.
Challenges to obtaining consent
The central challenge for doctors on a day-to-day basis is how to ensure that arrangements for signed consent are in place and can be implemented in a busy clinical environment.
There is no simple answer to this but, while clichéd, it is the case that consent is a process rather than simply a signature on a form. Each point in the pathway of clinical care is an opportunity to enhance the quality of consent by providing information and discussing the nature and risks of the procedure. The burden does not have to fall to a single consultation.
Information for patients - an evolving legal picture
For many years, the law considered that the adequacy of information provided to a patient would be assessed by reference to a responsible body of medical opinion - the 'Bolam' principle. The case of Sidaway made clear that the view of the responsible body of medical opinion must nonetheless be a reasonable one.
In practice, many doctors would think carefully as to what a prudent patient (and the patient in front of them) might wish to know, and would understand that a rare but recognised complication might have particular significance to an individual patient. For example, the risk of nephrotoxicity of a given drug to a patient with pre-existing renal impairment.
In addition to considering how a court might view the adequacy of the consent process, a doctor must also consider the stringent GMC requirements as to what information must be shared with a patient (see GMC guidelines below).
The guidance emphasises the information which must be shared with patients when seeking consent. Maximising opportunities to share information in a controlled way, using written information, procedure leaflets and online resources where appropriate, could make this a much easier task.
Informed consent - recent legal judgment
For the last few years, it seemed that the regulatory standards expected of a doctor in seeking consent exceeded what was considered in law to be valid consent.
However, the recent Supreme Court decision in Montgomery v Lanarkshire Health Board [2015 UKSC 11] made clear a doctor is under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in proposed treatment, and of reasonable alternatives.
The court ruled that a risk is 'material' if a reasonable person in the patient's position would be likely to attach significance to it, or if the doctor is or should reasonably be aware that their particular patient would be likely to attach significance to it. The concept of consent is now judged from the patient's, rather than the doctor's, perspective.
The court made three further points:
- The assessment of whether risk is material is no longer an issue of a percentage possibility of it arising. The significance of a risk to a particular patient reflects, for example, the nature of the risk, the effect it would have on the life of the patient if it were to happen, the importance to the patient of the benefits of the treatment, and alternative treatments and the risks associated with them.
- The doctor's role is to talk to the patient to ensure the patient understands the seriousness of the condition, the anticipated benefits of the proposed treatment and the risks it carries, and any reasonable alternatives. Information provided to the patient must be comprehensive, but not so technical that the patient could not reasonably be expected to understand it, and would therefore not be properly informed.
- There is a therapeutic exception to providing comprehensive information when the information would be seriously detrimental to the patient's health, or when treatment is required in circumstances of necessity. This is a limited exception and should not be abused, the court warned.
Making detailed records of what information you give to, and discuss with, the patient is likely to be even more important in view of the judgment.
The social and legal developments which we have mentioned…point towards…an approach to the law which, instead of treating patients as placing themselves in the hands of their doctors (and then being prone to sue their doctors in the event of a disappointing outcome), treats them so far as possible as individuals who are capable of understanding that medical treatment is uncertain of success and may involve risks, accepting responsibility for the taking of risks affecting their own lives, and living with the consequences of their choices.
Judgment in Montgomery v Lanarkshire Health Board  UKSC 11, paragraph 81