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Informed consent – A legal and regulatory requirement handout

Duty to obtain informed consent

Valid informed consent is an open two-way dialogue between a healthcare practitioner and a patient. It involves full disclosure of diagnosis, treatment costs, and alternatives, as well as the obligation to inform the patient of any material risks before any treatments and the repercussions associated with refusal to treatment and with each therapeutic choice1,2.

In the last decades, Australian Courts have endorsed a patient-centred standard in determining what risks healthcare practitioners must disclose to patients.

Legal frame of reference of consent to clinical treatment

Failure to obtain a patient’s consent is unlawful and a breach of your code of conduct and it escalates the risk of clinico-legal action (claim, complaint and or investigation) against healthcare professionals.

For consent to be valid, it must be:

  • given voluntarily
  • given with an acknowledgement of the material risks involved in any proposed clinical treatment
  • given to a lawfully competent person or legal guardian in case of children
  • educated; patients must have adequate understanding of the benefits and risks of any therapeutic choice before any treatment is done.

What does ‘material risk’ imply?

Within a therapeutic context, a risk is material if:

  • a ‘reasonable’ person (in the same position as the patient) when notified of the risk is likely to attach significance to it
  • the healthcare practitioner is or should reasonably be aware that the patient in question, if warned of the risk, would be likely to attach significance to it.

Consequently, a known risk should always be communicated to the patient if:

  • an unfavourable outcome is frequent, even if the impairment is minimal
  • an outcome is detrimental, even if its likelihood to occur is very low (rare event).

Key advice for healthcare practitioners

  • Document all informed consent discussions in the patient’s medical record accurately
  • Patients must have the legal capacity to provide both clinical and financial consent. In the case of minors or persons with cognitive impairments, a parent or legal guardian may consent on behalf of them. Refer to State or Territory legislation regarding patients unable to consent.
  • If you have concerns about a patient’s competence to consent, you must assess their ability to understand clinical information, in order to decide if they are able to consent to treatment.
  • Communicate information about clinical procedures using plain, non-technical language and ensure your message is tailored to the patient’s circumstances, values and culture
  • Use open ended questions to patients to foster discussion and to check for understanding of the information given. Never assume that a patient ‘knows’ or ‘understands’ what you are trying to convey. Use professionally qualified interpreters if needed.
  • Informed financial consent entails that a patient understands and consents to4: o the fee for a healthcare service, procedure or treatment, to be performed by a clinical practitioner.
  • costs for any implantable prostheses and/or devices to be used during the provision of clinical services.
  • Medicare rebates and private health insurance benefits where applicable
  • Changes to fees and costs that may arise if the therapeutic approach is altered for clinical reasons.

In Australia, who defines the reasonable standard of care in relation to obtaining informed consent?

  • A court of law decides the reasonable standard of care in regard to obtaining informed consent to clinical treatment.

What is the High Court's definition of 'material risk' inherent in a proposed treatment?

  • A healthcare practitioner is or should reasonably be aware that a particular patient is likely to attach significance to a risk if warned about it.

And

  • A reasonable person, in the patient’s position, is likely to attach significance to the risk if warned about it.

It is legally correct to state that in relation to legal definitions, the High Court has determined:

  • A medical practitioner has a duty to exercise reasonable care and skill in the provision of professional advice and treatment. The standard of reasonable care and skill required is that of the ordinary skilled person exercising and professing to have that special skill.

References

Skiba R, Sikotra N, Wilson A, Clay TD, Gabbay E. Doctors understanding of consent law. Internal Medicine Journal. 2020 May 1.

Lennox A, Wright B. How can we improve informed consent processes? Briefing Document. Melbourne, Australia: BehaviourWorks Australia, Monash University. May. 2019.

RACGP Informed Consent Information Sheet

AMA position Statement - Informed Financial Consent

MIPS relevant resources

Webinars

Practice notes