The focus of the law on consent changed last year as a result of a landmark legal decision.
The change to consent law is consistent with the advice that we have been giving regarding gaining consent with a patient focussed approach, in keeping with the latest research and medical standards. It is worth understanding the laws relating to consent so that you can be confident that your consent procedures are following the law. Really this is just the law catching up with what professional standards have been requiring for a long-time.
Why has there been a change?
The change in the law has occurred as a result of a landmark decision in Montgomery v Lanarkshire’s Health Board, in the UK Supreme Court March 2015.
“Nadine Montgomery was a woman with diabetes who gave birth by vaginal delivery. Her baby, Sam, was born with serious disabilities after shoulder dystocia during delivery. The doctor, Dina McLellan, did not tell Montgomery of the 9-10% risk of shoulder dystocia. McLellan said that she did not routinely discuss the risk of shoulder dystocia with women with diabetes for fear that, if told, such women would opt for a caesarean section. The court held that McLellan should have informed Montgomery of the risk and discussed with her the option of a caesarean section.”
The conclusion is that a patient has their own right to make their own decision based on sufficient information.
History of Consent
Consent law was formerly shaped on two significant cases – Bolam and Sidaway.
The Bolam test was used in cases of negligence. In Bolam vs Friern Barnet Management Committee 1957 a patient suffered severe injuries as a result of receiving Electro Convulsant Therapy without muscle relaxants. The judge ruled that the doctor had not been negligent and noted that “A doctor is not guilty of negligence if he has acted in accordance with a practise accepted as proper by a responsible body of medical men skilled in that particular art.” The doctor can still be found to be negligent if common practise is thought to be unreasonable by the court.
So, in summary the Bolam test asked whether a doctor’s conduct would be supported by a reasonable body of medical opinion. If enough peers would have behaved similarly there was considered no case to answer.
Sidaway vs Bethlem Royal Hospital Governors 19852 – a case where a patient was left with paralysis after an operation to relieve a trapped nerve. In the court of appeal, the patient claimed negligence as she had not been informed of the risk of this outcome. The judge rejected the appellants claim as a respectable body of medical opinion agreed that it was not necessary to warn a patient of every risk. The case did however establish in English common law that a doctor has a duty to provide to their patients sufficient information for them to reach a balanced judgement. Patients must be informed how necessary a procedure is, any alternatives, and any common or serious consequences of it. (There remains some debate of what constitutes “common” or “serious”.)
If a patient is not properly informed and suffers harm as a result of the procedure, the doctor will be liable for negligence.
Initially there was a focus on whether the practitioners consent procedures were consistent with the behaviour of peers. Later there was an increased requirement to provide sufficient information to make a decision.
What is the change?
Consent law has been changed so it is patient focussed now. This is another push away from the historic paternalistic model of the practitioner-patient relationship.
The law now requires a practitioner to take “reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment and of any reasonable, alternative or variant treatments”
Material risk = a risk to which a reasonable person in the patient’s position would be likely to attach a significance or a risk that a doctor knows – or reasonably should know – would probably be deemed of significance by this particular patient.
Particular patient = a material risk to one patient may not be to another.
Patients are not solely reliant on the information that practitioners give them. In this day and generation they have access to many sources of information through the internet, patient support groups etc. Patients are to be treated as adults capable of understanding medical treatment is uncertain of success and may involve risks, accepting responsibility for taking of risks and living with the consequences of those choices.
The reference to the particular patient is very important. Family history, patient history, values and preferences will all influence the information that should be given to patients. For example, patient’s decisions about treatment may be affected by family history of stroke or nerve damage, fear of pain, home responsibilities, financial pressures etc. etc.
Information must be given to patients in clear, understandable terms. Doctors must disclose information rather than wait for the patient to ask. The patient has the right to advise that they do not wish to be advised of the risks of any procedure.
When obtaining informed consent, doctors/practitioners will no longer be judged by reference to their peers’ practice. The courts will now decide whether a doctor met the expectations of any “reasonable person in the patient’s position”.
This is an extract from GMC guidance:
“The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. The patient weighs up the potential benefits, risks and burdens of the various options as well as any non-clinical issues that are relevant to them. The patient decides whether to accept any of the options and, if so, which one.”
Evidence of Consent
The three basic caveats of consent remain:
- With capacity i.e. ability to understand, weigh and retain the information.
“consent is a process – it results from open dialogue, not from getting a signature on a form” Medical Protection
The key components are that it is the patient’s decision, the patient has been given all the information they need and the patient is able to understand and apply that information.
A signature on a form does provide some evidence that consent was obtained but there is no proof that the consent was valid. The key issue is whether the patient was given all the information they needed to make an informed decision.
The key facts of discussions with patients should be documented in the medical record. The notes should include the proposed treatment and the risks, benefits and alternatives explained to the patient. If the patient raises any fears or concerns these should also be noted. Your records are your evidence should any problems arise in the future. Develop your own consistent, robust procedures for informing patients and recording your evidence.
Statistics on probability of a risk are not justification for a failure to inform. The significance of a risk is associated with the nature of the risk, the effect it would have on the life of a patient, the importance to the patient of the benefits of the treatment, the alternatives available and their associated risks. Patients are not to be bombarded with technical information but informed with facts as appropriate to the particular patient.
Patients need to be informed how likely it is that treatment will work, the side effects or risks of treatment and given comparable details about alternative treatments. There still needs to be more information in many of these areas, but that is not an excuse to avoid explaining to patients all that we do know.
In order for practitioners to be able to comply with the laws on consent there is an essential requirement for practitioners to be informed of benefits, risks and alternatives – information that needs to be sought out and applied. In osteopathy the common complaint is that we don’t know the risks of treatment. This is a myth. There has been some good quality research (Carnes et al (2009), Vogel et al (2013)) identifying risks and benefits of treatment and if this information is not being passed on to patients practitioners are at risk of negligence.
At Mint we are hoping to gather information on treatments and alternatives and their risks for practitioners over the next few weeks/months.
Sokol, D.K. Update on the UK law on Consent. British Medical Journal, 2015 BMJ 2015;350:h1481 doi: 10.1136/bmj.h1481
Carnes, D., Mars, T., Mullinger, B. and Underwood, M. (2009) “Adverse events in manual therapy: a systematic review”, available at: www.ncor.org.uk [accessed 29 December 2014]
Vogel, S., Mars, T., Keeping, S., Barton, T., Marlin, N., Froud, R., Eldridge, S., Underwood, M. and Pincus, T. (2013) “Clinical Risk Osteopathy and Management Scientific Report: The CROaM Study”, available at: www.osteopathy.org.uk/uploads/croam_full_report_0313.pdf