Informed consent and patient information leaflets
The law relating to consent is of central importance to patients, clinicians and those who act for them because it protects the ethical principle of autonomy, the right of individuals to have the final say about what is or is not done to their bodies. The courts take a dim view of treatment that is provided without a patient’s consent, and the clinician who ignores a patient’s wishes risks, in the very worst circumstances – where consent is not just uninformed but entirely vitiated as unreal – a finding of battery (1).
By far the commoner situation, however, is the practitioner who, whilst acting in good faith, fails to provide his patient with sufficient disclosure about the risks and complications of a proposed procedure. In short hand, lawyers often refer to these cases as ‘informed consent’ cases, and here the correct cause of action is not battery but rather a claim in negligence for breach of duty (2).
The leading case on informed consent is Sidaway v Bethlem Royal Hospital Governors (3). Here, the House of Lords held that the clinician’s duty to inform a patient of the risks of a procedure is part of the more general duty to exercise reasonable care and skill and that the issue of precisely what risks should be disclosed to patients is a question that is governed, in large part, by the Bolam test, i.e. what a responsible body of medical opinion would conclude are the risks that should be disclosed to a patient about any given procedure.
There has been much academic debate since Sidaway about whether the standard of disclosure is entirely a matter to be determined by the medical profession or whether, since Pearce v United Bristol Healthcare NHS Trust (4), clinicians must be guided by the following dicta of Lord Woolf MR:
“If there is significant risk which would affect the judgement of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt.”
Here is not the place to attempt to review, much less resolve, such academic debate (5) but it is worth pointing out that Sidaway remains the only House of Lords decision to consider the duty and standard of disclosure of risk as the central issue; as such, it remains binding authority notwithstanding any subsequent glossing or re-interpretation by lower courts.
Whatever the nature of the duty of disclosure it is clear that clinicians, NHS Trusts and private treatment providers take their obligations in this area extremely seriously. It has long been the case that standard consent forms have been used to give healthcare professionals the opportunity to set out the ‘serious or frequently occurring risks’ of procedures, but a more modern development is the Patient Information and Consent Leaflet. A whole industry has emerged in the last decade or so in researching, producing, publishing and constantly updating such leaflets. Whilst in the past NHS Trusts and private providers might themselves have shouldered the not inconsiderable burden of producing these leaflets in-house, increasingly the task is farmed out to private companies.
In the UK, there is one company in particular that provides information leaflets to a significant minority of NHS Trusts under a licensing agreement that gives the Trusts access to an electronic library of treatment-specific leaflets that are then available for staff to download and distribute directly to patients.
A brief trawl of several NHS Trust and private provider websites confirms that information leaflets have been produced to cover almost every procedure and intervention from abdominal hysterectomy to x-rays. Typically, these leaflets are divided into sections that usually explain:
There is no doubt that such leaflets are an important part of the contemporary consenting process. However, they are no more than that: a single part. The responsibility of ensuring that a patient is adequately apprised of all those risks that they must be in order to give an informed consent still rests with the treating clinician.
The provision of a leaflet which comprehensively deals with all of the above points (perhaps more) will not absolve a clinician of his or her duty to provide information as part of the more general duty of care. Such leaflets can provide good evidence of what risks/complications have been discussed but they will rarely be the determinative ‘silver bullet’. Patients can deny that they have been provided with a copy of the leaflet or that they have not read or understood the information contained in it (6).
Ultimately, having seen and heard all of the evidence, it remains the task of the trial Judge to determine whether the patient has been told all that he or she should have been told. This is an exercise that involves assessing:
None of this should come as a surprise, yet for those who regularly have to defend allegations of lack of informed consent there are still cases when excessive reliance is placed on the provision of an information leaflet. Without more this is unlikely to be good enough. As always they have, the best practitioners will continue to view consent not as a single event (whether that be the signing of the consent form or the handing over of a leaflet) but as a clearly documented, well-evidence collaborative process in which clinician and patient guide each other along the narrow pathway between information paucity and information overload.