Informed consent is a complex and challenging issue for dental practitioners, and so we are all constantly seeking ways of making our consent ‘bulletproof’. Regretfully, a consent form alone does not provide that level of protection, and can, in some circumstances be more harmful than helpful. Dr Annalene Weston, dentolegal consultant at Dental Protection, explores why

What is consent and why do we have it anyway?

The complexity and subtle nuances of consent have evolved over time from their troubled genesis of the Nuremberg Trials. An exploration of the atrocities committed in World War II, the Nuremberg Trials highlighted that there is a profound criminality in medical intervention without permission.

Flowing on from that, it was deemed that there needed to be a granting of permission from the patient to the clinician for any medical act, as earlier identified and crystallised by the law as: “Every human being of adult years and sound mind has the right to determine what is done with his own body.”¹ And each country has taken this concept and built their law upon and around it.

The current Australian definition of consent states: “Informed consent is a person’s voluntary decision about health care that is made with knowledge and understanding of the risks and benefits involved.”²In itself, this does not seem complex, and yet an alarming amount of litigation arises, not from a failing in the treatment provided, but from a failing in the pre-treatment phase – the conversation of consent. It seems then that many of us are getting it wrong more often than we are getting it right.

What does consent look like?

In a medical context, consent is essentially a conversation between a clinician and a patient, in which the clinician provides the patient with sufficient information to increase their understanding of the nature, purpose and type of their treatment as well as the cost implications, including any alternatives (which of course includes the option of no treatment) to a level at which the patient can make a voluntary and informed decision.

Naturally this also includes a rundown of all of the pertinent risks and warnings, and frequently occurring known risks must be disclosed. Perhaps confusingly it is not necessarily the likelihood that a less common risk may occur that indicates it needs to be disclosed, but rather the relevance to that particular patient if the risk occurs; this is known as material risk, or the specific patient test.³ The key issue with standardised consent forms flowing on from this is that they do not necessarily detail ‘what is important to me’ as a patient, nor give me the opportunity to explore that with you, as the clinician.

While the patient will be giving consent for their own treatment most of the time, there are certain patients who need a substitute decision-maker, known as those who do not have capacity. Commonly children, or impaired adults would fall into the category (but not always).

Three factors will need to be at play for consent to be valid:

1. The patient must have capacity
2. The decision must be voluntary
3. The patient must be informed.

How do I obtain consent?

The lead Australian legal case in medical consent, Rogers v Whitaker,⁴taught us that:

A risk is material if in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk – would be likely to attach significance to it, or where a medical practitioner is (or should reasonably be aware) that the particular patient, if warned of the risk, would be likely to attach significance to it.

The onus lies with the practitioner to ensure that they have provided the patient with sufficient information, tailored to their unique situation, and to ensure that all material risks are covered. The only way to understand what is important to that specific patient is to talk to them and gauge that. The law tells us that:

The doctor’s duty is not… fulfilled by bombarding the patient with technical information, which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form.⁵

In this case, a consent form was not enough, as the conversation underpinning this was found to be lacking in the detail that this patient would have attached significance to.

And so it could be reasonable to take a three-step approach to providing the patient with information:

1. Explain what the common risks for the procedure are
2. Set out which of these clinical risks are most relevant (if any) to the particular patient you have in your chair
3. Knowing as much (or little) about the patient as you do – which risks or outcomes might they consider to be more important to them?

Choosing Wisely Australia⁶ is part of a global initiative aimed at improving the conversation of consent between clinicians and their patients, suggesting that prior to treatment, all patients should ask five questions:

1. Do I really need this test, treatment or procedure?
2. What are the risks?
3. Are there simpler, safer options?
4. What if I do nothing?
5. What are the costs?

It can of course be tricky if the patient asks no questions, or shows no interest in the procedure, with some patients even refusing to discuss risk. Again, the onus lies on the clinician to ensure that an adequate conversation of consent takes place. It is our responsibility to ensure this, not the patient’s.

How do I document consent?

I hope by now that the reason standardised consent forms do not satisfactorily verify that a legitimate conversation of consent occurred has become self-evident.

In our exploration of the issues surrounding the deficiencies of standardised consent forms, we should of course not overlook that there are certain circumstances where we are required to have written consent, as set out by the Dental Board of Australia, which advises us to:

Document consent appropriately, including considering the need for written consent for procedures that may result in serious injury or death.⁷

We would all agree that this does not necessarily relate to most of our daily practice, and so the ADA guidelines may ring true for more us, which state:

Consent may be given in writing, orally or by conduct. In most routine dental examinations and treatment, the patient’s consent is obtained verbally. However, were the proposed treatment involves complex or invasive procedures, anaesthesia or sedation, significant expense and/or is of an elective or cosmetic nature, good professional practice warrants the use of a signed written consent form to document the process of consent and confirming the patient’s agreement to the proposed treatment. A signed consent form does not, by itself, provide conclusive proof of a legally valid consent.⁸

Consent forms can be a helpful aide memoir to ensure that we work through the risks and warnings in a consistent manner in our conversation with the patient, and can form a framework for the conversation of consent. However, the documentation of this conversation in our clinical records is the critical component in recording the conversation of consent.

Many Dental Protection resources have been developed to help practitioners predictably document the conversation of consent in their clinical records. It should be remembered that records need to be contemporaneous (written as soon as possible after the treatment, and preferably before seeing the next patient) and also objective rather than subjective, as notes written with a ‘defensive bias’ have proved harmful to a clinician in their defence in the past.⁹

What would good practice look like?

DON’T

• Rely on standardised consent forms.
• Delude yourself that a signature on a consent form will be accepted as demonstrating consent – it won’t.
• Overload the patient with technical information in the misconception this is informed consent – it isn’t.
• Fail to get to know your patients before entering into a therapeutic relationship.
• Stop your patient from asking questions.

DO

• Learn how to best structure your records to reflect your conversation of consent.
• Develop a consistent process to ensure an appropriate conversation of consent.
• Consider the use of personalised consent forms in the circumstances as set out by the ADA, to underframe your conversation of consent and provide a helpful framework for this.
• Consider that the patient needs time to think about it – particularly before embarking on elective, complex or expensive treatments.
  
  You can also listen to our podcast series for further guidance and advice.