The law regarding informed consent has evolved over the past 40 years. In the Supreme Court decision, Montgomery v Lanarkshire Health Board*, the right to self-determination was recognised and patients now have to be provided with sufficient information, which is relevant to them, in order to enable them to make informed decisions about which treatment to decline or pursue.
The test of what a reasonable clinician may disclose to a patient in order to assist them in reaching a decision is no longer an automatic defence; a clinician is tasked with understanding the needs and wishes of their patient in order to determine what they, the patient, would deem “material”.
Whilst the law on informed consent can be seen as complicated, the following tips can help clinical professionals in avoiding potential pitfalls:
- Make time: explore what would be relevant to the individual patient in front of you to determine what information they may deem “material”. “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.” *
- Evidence: It is essential to document that such a discussion has taken place; you must not only engage in dialogue with your patient, but also evidence such discussions.
- Avoid the percentage focus: A 0.5% risk of harm or side-effect will be material if the facts relevant to an individual patient make it so.
- Be sure you are understood: Make sure that the patient understands the risks involved and the alternative treatment options available. Ask them to repeat what they have heard to demonstrate understanding and give written information for them to review in their own time. Document the discussion in your notes and include a copy or the reference of the literature given.
- Do not withhold information: An informed patient is more likely to be able to make the right decision for their circumstances – withholding anything must be thoroughly justified and clear in your notes. If a patient does not wish to receive information, then this should also be clearly documented.
The duty to obtain informed consent goes hand in hand with my previous blog. By demonstrating accountability, honesty and transparency about risk we can create a culture of candour and improve patient safety and self-determination for patients in respect of which treatment they undergo.
*Montgomery v Lanarkshire Health Board [2015] 2 WLR 768
I am Caroline White, Risk Control Director for International Healthcare at CNA Hardy, and I have over 25 years’ experience in the Healthcare sector. Follow CNA Hardy’s blog series on LinkedIn.
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