Informed consent: the frontline reality v the law

In this article, Bevan Brittan Trainee Solicitor Angus Kirkwood draws on his past experience working as a physiotherapist whilst discussing the topic of informed consent in medical practice.

Informed consent is a key issue in medical practice. In this article, I draw on the knowledge I have acquired working as a Trainee Solicitor in the Clinical Negligence Team at Bevan Brittan to briefly consider the law around informed consent. I then reflect on my previous experience working as a physiotherapist for 7 years to explore the challenges in clinical practice. I conclude by providing some practical advice designed to assist practitioners with meeting their legal duties.

What is the law on informed consent?

The rules around informed consent are constituted within case law. The leading case which established the duty as described below is Montgomery v Lanarkshire Health Board [2015] UKSC 11. The legal position continues to be developed and refined by case law since 2015.

Duty:

Every practitioner has a duty to take reasonable care to ensure that the patient is aware of:

1. Any material risks; and
2. Any reasonable alternative treatment options.

Scope of this duty:

It is not possible to verify a patient’s knowledge at the time informed consent is provided. For this reason, the law is not concerned with the patient’s knowledge, but rather, with whether the practitioner met an objective standard when providing the patient information. This standard can be broken down into three main components:

1. The practitioner must identify all risks and alternative treatment options that a reasonably competent practitioner would.
2. Of the risks identified, the practitioner must disclose those that are ‘material’ to the particular patient. Of the alternative treatment options identified, the practitioner must disclose those that are reasonable.
3. The practitioner must take reasonable care when disclosing information with the aim being to increase the patient’s understanding.

What is a ‘material risk’?

This is a risk that a reasonable person in the patient’s position would likely attach significance to and one that the practitioner ought to be aware that a particular patient would likely attach significance to.

What is a ‘reasonable alternative treatment option’?

These are treatments that any reasonably competent practitioner would be able to identify as being appropriate for the particular patient. These treatments must be accepted practice at the relevant time.

The challenges of obtaining informed consent in clinical practice

In healthcare there is a drive to optimise efficiency so as to cater for ever-increasing demands with limited resources. As a physiotherapist, I often treated up to 70 patients per week with a time allocation of around 30 minutes per patient. Under such time constraints, it was not practical to document everything that was discussed with each patient. Therefore, it was necessary to be selective, which carried the risk of omission.

As a physiotherapist, I found that patients sometimes had fixed ideas about their problem and what treatments they needed. This would detract from any discussion about reasonable alternative treatment options and would sometimes give rise to a conflict, whereby I had to reconcile what I thought was best for the patient with what the patient thought was best for them.

During my time in practice, it struck me that the threshold at which consent becomes informed is not immediately apparent. I was conscious not to rush the consenting process while also wanting to be efficient and conserve as much time for treatment as possible so as to meet patient expectations and cater for their needs. Moreover, I did not want to cultivate a preoccupation with risk which could lead to maladaptive behaviours and dissuade patients from treatment. 

Minimising exposure to claims with tips for clinical practice

As a Trainee Solicitor, I have reviewed contemporaneous medical records, clinician comments and associated factual evidence, which has given me the opportunity to observe the significance of informed consent and how the issue manifests in claims. I have reflected on the insights derived from this to identify the following tips:

1. Time allocation:
   Do not rush the process, even if the patient or your busy caseload demands it. Err on the side of caution and provide more rather than less information. However, always tailor this to the individual and focus on the ‘material risks’ and ‘reasonable alternative treatment options’.

2. Documentation:
   As a general rule, the more documentation relating to the consent the better when it comes to defending a claim. Consider including wording to the effect that the patient understood or was satisfied with what was discussed.

3. Standard forms:
   Ensure that the contents are discussed with the patient and that this discussion is documented. Again, focus on the ‘material risks’ and ‘reasonable alternative treatment options’. Do not allow this to become a tick-box exercise – a signature alone will often not suffice.  

4. Materiality of risks:
   In order to determine what is material to the patient consider what risks the patient would regard to be significant in the context of their health, lifestyle and expectations for treatment. As a general rule, the greater the risk both in terms of probability and severity of outcome, the more likely it will be material.

5. Reasonable alternative treatment options:
   Even when a particular treatment option is strongly preferred, always take the time to discuss the reasonable alternatives. A reasonable alternative treatment option need only be appropriate to the patient and accepted practice at the time, it need not be the best treatment option.

6. Reasonable care:
   What is reasonable will depend on how material the risk is, or how suitable the alternative treatment option is. The more material the risk or the more suitable the treatment option, the more emphasis should be placed on it (i.e. discuss on multiple occasions / provide information in multiple formats).

7. Individualised:
   What constitutes reasonable care will vary between patients as each patient has different needs. For that reason, the consenting process must be individualised.

8. Delegating the consenting process:
   The duty to obtain informed consent will fall on the practitioner providing the treatment. Therefore, try to avoid delegating this responsibility where possible. If delegation is necessary, then check the documentation and check this with the patient. If in doubt, repeat the process and document it.

Further resources

• The Getting It Right First Time (GRIFT) and NHS Resolution best practice guide for
  clinicians and managers
• GMC guidance on decision making and consent

This article was co-written and prominently contributed by Angus Kirkwood, Trainee Solicitor.