Informed Consent

Author: Cerys Griffith, Becky Maxwell / Editor: Liz Herrievan / Reviewer: Helena Sweeney / Codes: MHP5, SLO7, SLO8 / Published: 09/01/2015 / Reviewed: 23/07/2024

The legal aspects of Emergency Medicine can be difficult and often a trainee spends little time reading about these, unless a specific situation arises at work. These scenarios can be complex, usually occurring at times of the day when the department is busy or there is a lack of senior staff around. A sound knowledge of the basic legal principles can make these situations less daunting when they do happen.

All opinions, unless otherwise stated or referenced, are my own.

“Perform your medical duties calmly…concealing most things from your patient while you are attending to him…revealing nothing of the patient’s future or present condition.” Hippocrates.

What is consent?

A patient with an injured hand is next to be seen, he comes in to see you and he holds out his hand. Is his consent implied or informed? The answer depends entirely on what you have said to him and on what he has understood, demonstrated by what he is able to communicate back to you.

If a patient does not consent to a physical intervention, examination, or indeed any form of physical contact, then in law the doctor might be accused of committing assault and battery against the person. However, most legal disputes relating to consent arise when the patient claims that they have suffered an outcome that they did not consent to. Claiming ‘battery’ in these cases is discouraged, and most cases are therefore argued on clinical negligence grounds. The claimant might argue that the ‘duty of care’ owed by the doctor during the consent process failed, and that the failure of adequate consent led to harm. Legal commentators suggest that our professional standards, set out by the General Medical Council (GMC), demand more accountability and impose more stringent rules than the law is able to efficiently achieve.

How ‘informed’ is appropriate?

There are three essential elements to fulfil in order for consent to be valid: The patient must be informed; must have the capacity to take that specific decision; and must be free from undue influence, in order to make a decision voluntarily.

Professional guidance from the GMC states that:

“The amount of information about risk that you should share with patients will depend on the individual patient and what they want or need to know.”

In Law, traditionally a doctor’s practice was judged using the Bolam Test – judgements were based on if they had acted in line with a body of medical opinion. The case brought by Bolam was that his doctor failed in his duty to inform him of the risks of electroconvulsive therapy, during which he had suffered acetabular fractures. In this well-known case, the ruling deemed that medical practice had been acceptable.

Some years later in the 1980s, Mrs Sidaway claimed that if she had been informed about the risks of paralysis she would not have consented to cord decompression surgery. The judges in the House of Lords rejected her claim that the consent process by her surgeon had been negligent, but they introduced new perspective on what was acceptable medical practice in other jurisdictions. They recognised the doctrine of informed consent that was existing practice in the USA and gave weight to the right of a patient’s ‘self-determination’.

There followed a progressive change in attitude of the law courts, consistent with the departure from the paternalistic doctor-patient relationship to a more patient-centred approach.

In 2015 a new ruling in Montgomery vs. Lanarkshire Health Board superseded the previous legal position with regard to consent. Nadine Montgomery claimed for medical negligence after giving birth to a son with cerebral palsy caused by shoulder dystocia at birth. She had significant risk factors for shoulder dystocia and had expressed concerns about vaginal delivery of a larger foetus, but had not asked about specific risks. Her responsible obstetrician felt that a caesarean section would not be in Mrs Montgomery’s best interests, and she wasn’t warned specifically of the risks of shoulder dystocia, nor offered a caesarean as an alternative. The Supreme Court acknowledged that had Mrs Montgomery been informed of the risks of shoulder dystocia, she would have opted to have a caesarean section.

The ruling from this case was that the doctor must inform a patient of any material risks associated with interventions or 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 the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.’’

‘’The doctor is therefore 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 any reasonable alternative or variant treatments.’’

What does this mean in practice? New GMC guidance on Decision Making and Consent which came into effect in November 2020 acknowledges that whilst every interaction with a patient involves a level of consent, this does not always need to be a formal and time-consuming process. Many non-invasive or minimally-invasive procedures can reasonably rely on non-verbal or verbal consent from the patient – however the purpose and expected outcome of these interventions should still always be discussed with the patient, particularly in the case of intimate examinations. It should also be clearly communicated to the patient that they may withdraw their consent at any time and the clinician should be alert to any signs of distress or discomfort from the patient.

1. Diagnosis and prognosis
2. Uncertainties about the diagnosis or prognosis, including options for further investigation
3. Options for treating or managing the condition, including the option to take no action
4. The nature of each option, what would be involved, and the desired outcome
5. The potential benefits, risks of harm, uncertainties about and likelihood of success for each option, including the option to take no action. By ‘harm’ we mean any potential negative outcome, including a side effect or complication.’

The GMC also recognises that in certain situations it may be difficult or impossible to obtain informed consent, such as in emergency life-saving procedures where the patient is incapacitated or unconscious. They advise that in these scenarios the patient should be informed of what has been done, why, and given the opportunity to be involved with ongoing treatment plans as soon as they recover to the point of having capacity.

As always, all adult patients must be presumed to have capacity to make decisions around their care unless there is evidence to the contrary. It is beyond the remit of this blog to discuss the Mental Capacity Act in detail but decisions around treatment in cases of a patient not having capacity should always be done in the best interests of the patient, involving them as much as possible.

Who can obtain consent?

GMC guidance advises that elements of taking consent may sometimes be delegated by the responsible clinician to another member of the team, for example a junior colleague. However consideration needs to be given to the nature and complexity of the intervention, the level of uncertainty about the outcome and whether the patient has already developed a trusting relationship with the responsible clinician or the person sharing the information. The person being delegated to must be suitably trained and have the skills to have the dialogue with the patient to share the information, have sufficient knowledge of the intervention, benefits and potential harms and alternative options, as well as having recourse to seek further information, support or advice from the responsible clinician.

GMC guidance is also clear that if consent has been obtained or part of the information-sharing and decision making has been done by another clinician, the responsible clinician should review this with the patient prior to the intervention to ensure the patient has further opportunity to ask questions, express concerns and review their consent.

Writing it down

In most cases it is acceptable to write down the details of your conversation with your patient in the ED patient record, including the main risks that have been discussed and the intended outcome. There is a role for the use of “consent forms” for such procedures but well written contemporaneous notes are similarly valid, and certainly in more complex cases regarding suspected or confirmed lack of capacity, a simple tick and signed box would not always be adequate evidence of valid consent. The amount of information we discuss and subsequently write down will vary according to the risk of the proposed treatment. It is appropriate that procedures with an established risk, yet commonly performed, for example a Bier’s Block, or procedural sedation, will involve a longer discussion than is required for a simple wound closure. Most EDs use patient information leaflets that aid patient understanding and help to deliver a reproducible standard of care.

Summary

If consent is to be valid, the patient must be appropriately informed, and the patient must have capacity to make their decision, voluntarily.

References

1. Hippocrates, Decorum. Jones W editor. Hippocrates with an English Translation.
2. General Medical Council (GMC) Consent guidance: Patients and doctors making decisions together, 2008.
3. MDU – Montgomery and informed consent, 2024.
4. Judgment in Montgomery v Lanarkshire Health Board [2015] UKSC 11.
5. Legal Case Summary – Bolam v Friern Hospital Management Committee [1957] WLR 582.
6. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudley Hospital [1985] AC 871.
7. GMC. Professional Standards: Decision Making and Consent, 2020.