Save for a limited number of exceptions, all patients must give their permission or consent before undergoing a treatment or test. Of particular concern recently, is whether consent is informed consent. But just how informed do patients need to be?
For consent to be valid, it must be voluntary and informed and the person consenting must have the capacity to make the decision. The NHS presently defines informed consent as “the person must be given all of the information in terms of what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment doesn’t go ahead”.
But do doctors actually provide and explain all of the information that the particular patient may consider important? And who decides what alternative treatments are reasonable?
Do the alternatives include the most expensive options, just the ones available on the NHS, the cheapest, the quickest?
Should you be told of every possible risk, just the worst three, or the ones which are the hardest to fix?
Do you consider the doctor must know best?
What does the law say about informed consent?
The law says it should be decided largely by the patient, but that hasn’t always been the case. In fact, prior to a landmark case decided in 2015, it was the doctor who decided what information was important for that patient to know.
The standard of what a patient must be told about their treatment/options/side effects had been largely unchallenged since 1957 in a case referred to as Bolam. This was confirmed in the case of Sidaway in 1987, which fundamentally decided that if a doctor could prove that a reasonable body of doctors at that time would have provided that information to a patient, then if something goes wrong for that patient as a result of a risk/consequences they were not informed of then the doctor won’t be held to account and that patient won’t receive any redress.
The British Medical Journal has recently published an article on this 2015 landmark case and how the decision has been applied. This case, known as Montgomery concerned a baby born in 1999 with serious disabilities as a result of complications during a vaginal delivery. Mrs Montgomery’s obstetrician had not disclosed the increased risk of this particular complication in vaginal delivery, despite Montgomery asking if the baby’s size was a potential problem. The Supreme Court of the UK accepted her argument that, if she had known of the increased risk, she would have requested a caesarean section and potentially avoided the baby’s injuries.
The appeal decision decided that:
“The doctor is under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of reasonable alternatives or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or if the doctor is or should reasonably be aware that their patient would be likely to attach significance to it.” Therefore a patient should be told the information they consider important, not just what the doctor thinks they should be told. This is true even if the doctor considers that providing this information may lead to a decision by the patient that the doctor disagrees with. In the final judgement of this case, Lady Hale held “A patient is entitled to take into account her own values…..The medical profession must respect her choice, unless she lacks capacity…she is at least entitled to information enabling her to take part in the decision”. [paragraph 115 of the judgement].
What does it mean for doctors?
Some may think that this provides too high a standard for doctors to adhere to, and advising patients of every risk and every alternative would cause distress and lead to poor decisions, whilst taking up valuable and scarce NHS time. However the Montgomery case appears to have been applied quite sensibly so far. Doctors have not been held to ransom at the whim of every patient’s demands. The patient must prove that a reasonable person and the patient themselves would have attached significance to the particular piece of information that the doctor did not provide them with.
This does not mean doctors are liable for every omission of disclosure if treatment does not work out. It means doctors have to tailor the information they provide to that particular patient, consider what is important to that patient and perhaps if they do not know, then ask questions.
In the case of Mrs A v East Kent Hospitals University NHS Foundation Trust (April 2015), the claimant’s baby, who was conceived using intracytoplasmic sperm injection, had a chromosomal abnormality. The claimant alleged that the trust was negligent in failing to advise of this possibility. The court applied the Montgomery test and decided that the risk was not material, because neither a reasonable patient nor the patient herself would have attached significance to it.
The GMC(General Medical Counsel) guidance, prior to 2015, which doctors should have already highlighted the importance of communication between doctors and their patients. It says the doctor’s role is to ensure that relevant information is presented to enable the patient to use it meaningfully. The NHS appears to be playing catch up. Their website page on informed consent does not mention this development, but they do say “If an adult has the capacity to make a voluntary and informed decision to consent to or refuse a particular treatment, their decision must be respected. This is still the case even if refusing treatment would result in their death, or the death of their unborn child”.
What does it all mean?
The full implications of the Montgomery case continue to be tested. Whilst it doesn’t change the process of how consent is given, it does put the legal ball in the court of the patient. It recognises that collaboration is needed between doctors and patients and that patients should be respected as decision makers too. Equally a patient should realise they will get a lot more out of this shared decision making if they are open with their doctor about their own particular circumstances, priorities, fears, work and family commitments and what is important to them. The decision in Montgomery is fact sensitive. The doctor must know or should be aware what is important to that patient before they are held accountable for an omission of information.