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Thursday 15 December 2016

Navigating the rules on patient consent

By Linda Millband

New rules on patient consent mean doctors have to be more upfront with patients about risks. Here’s what managers need to know.

Signing Form

"Informed consent" must be given before a medical professional can perform any treatment or procedure on a patient. For consent to be valid, it must be both voluntary and informed – the patient’s decision cannot be influenced by anyone else and they must have full details of the risks of treatment and any possible alternatives. A doctor must also determine whether the patient has the capacity to make this decision by themselves.

The process wasn’t always like this. Previously, under the Bolam test, which relied on doctor’s “duty of care” towards the patient, there could only be a finding of negligence if there was no respectable body of medical opinion which supported the doctor’s actions.

In the case of Chester v Afshar, the courts prioritised the need for a doctor to inform the patient of risks arising from surgical procedure, superseding the process of only having to show that their conduct would have caused the patient harm. Mrs Chester’s disc protrusion surgery carried a 1-2% risk that the procedure could worsen her condition. The court ruled that, since she had not been informed of this in advance, the doctor had breached the duty to obtain valid consent for the procedure.

Material risks

The Supreme Court’s 2015 ruling on Montgomery vs Lanarkshire Health Board made further changes necessary. Doctors must now ensure that patients are aware of any “material risks” involved in a proposed treatment, and of reasonable alternatives. Material risks occur when a “reasonable person” in the patient’s position would find the risks to be important in their decision – in this case, the risk of injury to either the mother or baby of a vaginal delivery birth. 

Nadine Montgomery experienced complications during delivery which meant her son was born with cerebral palsy. Ms Montgomery believed her doctor, Dr McLellan, had not disclosed the risks of shoulder dystocia, a form of obstructed labour, or discussed the possibility of an elective caesarean. If he had, Ms Montgomery said she would have elected to have a caesarean which would have reduced the chance of her baby being born with cerebral palsy. 

As a result of the ruling, doctors, and other healthcare professionals, are now under a clear duty to take reasonable care to ensure that patients are aware of all material risks.

Royal College guidance

The Royal College of Surgeons (RCS) has published new guidance on consent following the court’s ruling. The key principles are as follows: 
  • The aim of the consent discussion is to give the patient the information they need to decide what treatment or procedure (if any) they want.
  • The discussion has to be tailored to the individual patient, and requires time to get to know them well enough to understand their views and values.
  • All reasonable treatment options, along with their implications, should be explained.
  • Material risks for each option should be discussed with the patient. A risk is “material” if a patient could reasonably be expected to find the risk significant in their particular case. 
  • Consent should be written, recorded on the form and signed.
  • A record of the discussion should be included in the patient’s case notes. This is important even if the patient chooses not to undergo treatment.

From a legal perspective, it is vital that healthcare professionals understand how to conduct such discussions. Not having written proof of consent weakens the doctor-patient relationship and leaves professionals and managers open to legal challenges and litigation.

Compliance 

Patient consent must be underpinned by three key factors. First, a clinician must decide that the patient has the capacity to make a decision about their care. This means complying with the Mental Capacity Act 2005 (England or Wales), the Adults with Incapacity Act 2000 (Scotland), or the Mental Capacity Bill 2015 (Northern Ireland). Second, consent must be given voluntarily, without influence from anyone else. Third, the patient must be made aware of all key information to inform their decision. 

Managers should ensure these guidelines are followed to significantly reduce the chance of any legal repercussions from treatment given to a patient.

Linda Millband is national practice lead for clinical negligence at Thompsons Solicitors. Legal Eye does not offer legal advice on individual cases. MiP members in need of personal advice should immediately contact their MiP rep or national officer.
       

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