New guidance for GPs on obtaining valid informed consent

Anastasia Tsirtsakis

17/09/2020 4:58:40 PM

The resource is designed help doctors empower patients to make the right decisions for their health.

Doctor talking to patient
Informed consent is central to empowering patients to make the right decisions for their health.

The Australian Commission on Safety and Quality in Health Care (ACSQHC) has released a new fact sheet for GPs and other healthcare providers outlining the general legal principles and practice of obtaining informed consent from patients, including: 

  • how to obtain valid informed consent
  • principles for assessing legal capacity
  • information on legal obligations.
 ACSQHC Chief Medical Officer Dr Robert Herkes says informed consent is central to empowering patients to make the right decisions for their health.
‘One of the issues in Australia is trying to improve health literacy, the public having a proper conversation about any proposed therapy or treatment that includes the risks and benefits, and allows the patient or the patient’s family to make an informed decision,’ he told newsGP.
‘It’s really taking the patient on that shared decision-making journey so you can be sure the decision a patient makes is right for them.’
Dr Sara Bird, Executive Manager of Professional Services at MDA National, told newsGP the ACSQHC fact sheet is a very useful summary for GPs.
‘It is essential that GPs are conscious of the need for informed consent – this is a legal, professional and ethical obligation,’ she said.
‘It’s important to note that a patient needs to give consent before any examination, investigation, procedure or treatment, though this may be implied; for example, a patient holding out their arm for a blood pressure measurement.’
Dr Bird has firsthand experience working on medical negligence claims that have arisen out of an allegation of failure to obtain informed consent.
‘Most often those allegations arise out of procedural work, such as skin cancer excisions,’ she said. ‘In these claims, there may be an allegation that “the doctor didn’t warn me of the risks of scarring”, or “the doctor should have told me that I could have been referred to a plastic surgeon”.
‘However, the most common source of claims for GPs is an allegation of failure to diagnose.’
For there to be valid informed consent, the fact sheet outlines that the person consenting must: 
  • have the legal capacity to consent
  • give their consent voluntarily
  • give their consent to the specific treatment, procedure or other intervention being discussed
  • have enough information about their condition, treatment options, the benefits and risks
relevant to them, and alternative options for them to make an informed decision to consent – this includes the opportunity to ask questions and discuss concerns.
‘The term “informed” specifically refers to the need to provide sufficient information about their condition, treatment options, benefits and risks to enable the patient to decide whether or not to undergo the proposed intervention,’ Dr Bird explained.
‘Clearly, if it is somebody who says English isn’t their first language and you’re not sure about their understanding, the use of an interpreter is part of the process that you need to ensure informed consent.’
Dr Bird notes, however, that there may be barriers in obtaining informed consent, such as limited time and the complexity of the decisions being made.
‘There may also be challenges in assessing the capacity of a patient to provide consent; for example, with minors, whether consent is needed [as in the case of] emergency, and if the patient in unable to give consent, who is the substitute decision-maker?’ she said.
A common scenario, Dr Bird said, is when a GP has had a discussion with the patient, but there is no documentation to back it up.
‘Should it be in the form of a consent form or can it be the GP writing in the medical records, for example, “discussed benefits and risks, patient happy to proceed”?
‘Sometimes people think there must be a consent form, but the law doesn’t require that. The documentation becomes an issue when an allegation is made by a patient, but there’s no documentation to support the doctor’s version of the events.
’ she said.
‘However, if you’re doing a procedure there should be a notation that there has been an informed consent discussion.
‘Likewise with medications, there should be a discussion of the benefits and risks; for example, “this is why I’m recommending this medication, these are the benefits, these are some side effects and risks associated with this medication” and you would go through whatever you as the GP think is relevant.’
Documenting a negative response, where a patient refuses to proceed with a treatment or procedure, is equally important.
‘Normally when we’re talking about informed consent, we’re talking about a discussion which occurs where the doctor makes recommendations and the patient agrees to proceed with the recommended treatment. For example, “I recommend that this lesion should be excised because I’m worried it’s a melanoma”,’ Dr Bird said.
‘When you think about consent, it’s all about the patient having autonomy and making a decision as to whether they want to proceed or not.
‘In situations where the patient refuses recommended treatment, and they’ve got capacity, the law says that they can refuse treatment, even when the refusal might ultimately result in their death.
‘It is vital in those situations that that patient’s refusal is documented in the medical records. Using that example of the melanoma, there is a discussion where the doctor says, “I’m really concerned about this lesion, it could be cancerous, could be very serious and it could even cause your death”. If the patient says no, then documenting that patient’s refusal is absolutely critical.’
Dr Herkes says it comes down to ‘appropriate professional behaviour’.
‘You just have to do it,’ he said.
‘In the end, it’s around championing to the patient that they have the right to say no and it’s their life and their body that you’re talking about. So they have to have a good enough understanding of what’s going on to make an informed decision.’
The RACGP’s Standards for general practices (5th edition) include further information on informed patient consent.   
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Dr Julian Hadden Fidge   18/09/2020 11:47:19 AM

This is disappointing, and the "fact" sheet is not very good. I'll see if I can explain what informed consent it a bit better:

Informed Consent is a dynamic process of information transfer from the clinician to the patient that begins when a doctor decides to offer a procedure. Informed Consent is NOT a decision or a signature or a form. It is continual, evolving and dynamic process that does not ever end. The patient is entitled to, and the clinician should expect, questions and concerns to arise before, during and after the procedure. Most of these are so common we don't even notice them, like questions about a BP result and what it means and why it is important, which all relate to why we measured it in the first place.
The information transfer is unlimited. There are some basics we need to provide, like common, less severe adverse reactions or outcomes, and uncommon, severe adverse outcomes, before a therapy commences. But questions can come after a therapy, too.