Obtaining informed consent is a fundamental process in healthcare where a clinician and a patient agree on future treatment. Despite its importance, this process has become increasingly complex over the past decade, posing challenges for professionals and patients. This article provides an overview of the legal framework. It outlines the responsibilities of healthcare professionals in ensuring well-informed consent to avoid liability.
The legal framework for obtaining informed consent in England is based on two key Supreme Court decisions: Montgomery v Lanarkshire Health Board (2015) and McCulloch v Forth Valley Health Board (2023).
The Montgomery case is crucial for practitioners and their insurers due to its significant legal test:
“When obtaining informed consent, a doctor must take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative treatments”.
This test has two components: ensuring the patient is informed of material risks in the recommended treatment and informing them of reasonable alternative treatments. Montgomery clarified that a doctor cannot evade liability solely by demonstrating that their view as to what constitutes a material risk aligns with a responsible body of medical opinion, as was the case under the ‘Bolam Test’ that is used to determine the standard of care. Instead, the determination of ‘reasonableness’ is based on the patient's individual circumstances, a matter for the Court rather than the medical professional to decide.
The McCulloch case (2023) focused on the second aspect of the Montgomery test: the obligation to inform patients about reasonable alternative treatments. Mrs McCulloch’s legal team argued that, like the duty to disclose material risks, the duty to inform about ‘reasonable alternative treatments’ should not be bound by the Bolam test but should be determined based on the individual patient’s circumstances, goals and values.
However, the Supreme Court agreed with the hospital's legal representatives, supported by the General Medical Council (GMC) and British Medical Association (BMA), that determining the ‘reasonableness of alternative’ treatments should remain a matter of professional judgment, assessed through the Bolam test. Consequently, a healthcare provider will not be considered negligent for not disclosing a treatment option if their professional judgment that it is not a reasonable alternative is supported by a responsible body of medical opinion.
Many lawyers viewed the McCulloch ruling as a departure from the patient-centric approach championed in Montgomery, seeing it as a return to paternalistic medicine. However, the general legal consensus is that, rather than marking a substantive departure from Montgomery, the McCulloch judgment simply clarified that a ‘reasonable alternative’ is one that is clinically significant and consistent with professional judgment. A balanced assessment suggests that McCulloch underscores the interactive and collaborative nature of obtaining informed consent, requiring dialogue between healthcare professionals and patients. In this light, the impact of these key cases can be summarised as follows:
Montgomery: Mandates professionals to customise advice regarding material risks associated with those identified options for the patient.
McCulloch: Requires professionals to present options/alternatives recognised as reasonable by peers rather than an exhaustive list of every possible treatment.
The McCulloch judgment has raised significant questions about the practitioner’s duty to inform patients about alternative treatments.
The courts will likely test these questions and limits in the coming months and years.
Nadine Montgomery’s case undeniably influenced both professionals and patients. While some patients still prefer professionals to dictate treatment decisions, many are now empowered by the law and online resources to be more informed and autonomous in their choices. Thanks to legal frameworks, extensive guidance and training from regulators and professional bodies, clinicians are better equipped to engage with patients, fostering shared decision-making. To achieve this healthcare professionals should:
Given the litigious climate, focusing on steps to protect healthcare providers against allegations of a failure to obtain informed consent may seem defensive. However, allegations stemming from resource constraints, poor record keeping, factual disputes, and communication deficits are thriving in our claims culture. Recent judicial decisions offer reassurance to practitioners that patients who litigate after adverse outcomes but cannot prove lack of informed consent will not receive compensation.
Therefore, it is important to provide evidence of the consent process, highlighting its interactive and collaborative nature. All conversations between the practitioner and the patient should be recorded in the clinic notes and included in follow-up clinic letters. This should include the risks and benefits of operative and non-operative treatments, leaflets provided and directions to websites. This approach not only aids the patient's memory of the information discussed but is also invaluable for defence lawyers in consent claims, particularly when it includes the advice given and the rationale behind it. Ideally, the consent process should not be conducted on the day of the procedure although clinicians should always check with their patient whether anything has changed since the consent discussion. Providers should offer dedicated consent clinics to allow sufficient time for a thorough discussion.
Obtaining informed consent is a complex but essential process in healthcare. The legal framework, shaped by the Montgomery and McCulloch cases, provides a structure for practitioners to follow. Achieving shared decision-making requires effective communication, understanding patient perspectives and providing tailored information. By thoroughly documenting the consent process, healthcare professionals can protect themselves against allegations while ensuring patients are well-informed and autonomous in their treatment choices.
