By Dr Graham Howarth, Medical South Africa Lead, Medical Protection

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Informed consent remains an important issue on the medicolegal landscape. It is a frequent topic of discussion on Medical Protection’s medicolegal advice line, and the consent modules on our Online Learning Hub are extremely popular.

In South Africa not only is there a moral obligation to take consent – respecting a patient’s autonomy – but also a regulatory responsibility and a legal obligation. The HPCSA expects it and a practitioner can be criticised and censured for failings regarding consent Additionally, the National Health Act mandates the requirement to take informed consent and sets out the basic tenets of what requires to be discussed. 

Given there is a statutory requirement one could argue that there is a doctrine of informed consent in South Africa.

From the National Health Act it is clear that when taking consent one is obliged to inform the patient of the diagnostic and therapeutic options generally available to them, so it is not a matter of only discussing the option suggested but also the alternatives – including no therapy or treatment. 

As an example, if you offer a patient a screening test and they decline, you are obliged to inform them of the potential consequences thereof – do not give them the opportunity to later try and hold you liable for any consequences claiming that if they had appreciated these they would’ve had the screening test.

When it comes to discussing the potential benefits, risks and consequences the question is often asked regarding the level of disclosure.

Three levels of disclosure are generally discussed. These are what a reasonable doctor would consider appropriate – now more of historical value; what the individual patient consenting would consider appropriate - clearly a subjective standard; and finally what a reasonable patient would consider appropriate, which is a more objective standard. 

Prudent advice, when it comes to disclosure of risks, is to disclose risks that a reasonable patient in the patient’s circumstances would want to have disclosed. 

For example, even a low but real risk of some hearing loss should be disclosed to a concert pianist as opposed to necessary disclosure to a bricklayer; clearly hearing loss is of material interest to a concert pianist and probably less so to a bricklayer.

With respect to costs, giving a quote may prove problematic as unforeseen factors may increase the costs. A cost estimate is less restrictive and allows for contingencies. If you are a surgeon and suggesting a surgical procedure you may not be able to accurately advise on additional costs such as hospital stay or the costs related to anaesthetic, but you need to be satisfied that the patient is aware of the fact that additional costs will likely be incurred. Likewise, you may have an idea what a third-party funder, such as a medical aid, may contribute but the detail falls to the patient.

While the taking of consent is important, the documentation and retention thereof is equally important. A patient may deny that consent was taken, or that certain aspects were discussed.  Even if they were discussed such denial is not necessarily dishonest as the patient may well forget the nuances of a conversation. Another lamentation is that a patient will deny that they understood the content of the consent process. To overcome this, a helpful tip is to note that during the conversation you were of the impression that the patient understood the issues. Asking some questions may also be help.

When you don’t take consent

So what are the potential consequences of either not taking informed consent or the consent process being lacking? 

Firstly, if a patient complains to the HPCSA, you could be criticised and censured. In the total absence of any consent there is a small risk of criminal prosecution. 

What about litigation? While it is not uncommon for consent issues to play a role in a claim where allegations are made that there was either not consent or the consent process was flawed, it would be unusual for the consent process in isolation to be the deciding factor – for Medical Protection to settle a claim there is inevitably a degree of negligence that leads to settlement.

What about cases where a patient sues in negligence but there is no clinical negligence so the patient sues for what they claim was a material complication that occurred but was not mentioned during the consent process?  Here the claimant has a few hurdles to overcome – firstly that the complication was indeed material, secondly that it was not discussed and thirdly that the patient would likely have not had the surgery were they aware of the risk of the complication. We have had a claim of this nature that we had to take on appeal to be successful.

To sum up, taking consent is a moral, regulatory and legal obligation.  Documenting and retaining evidence of the consent process can be most useful.  Often the first a practitioner knows of pending litigation is a request for records. Doubtless claimant attorneys, particularly those working on contingency fee arrangements, scrutinise such records for references to consent and one can only wonder how often well documented consent may have brought an early close to pending litigation.

Continued learning

It is important for all healthcare professionals to keep up to date with guidelines around consent to help in improving patient care. Understanding the challenges that can arise in this area can also protect healthcare professionals from a complaint or claim relating to consent.

Medical Protection’s Online Learning Hub hosts a wide range of interactive courses, webinars and videos to help doctors reduce their risk, and has some excellent modules on consent.

I would encourage all members to make use of it - it is a benefit of membership, counts towards CPD requirements and the resources can be accessed any time.

To find out more about the Online Learning Hub, log in or activate your account visit: www.medicalprotection.org/professionaldevelopment