Informed consent: make it meaningful

picture of yes dice

Ensuring patients have given their informed consent to a course of medical treatment is integral to safe medical practice and is embedded in everyday language as a doctor. ‘Have you consented the patient?’ is a question many of us have asked or heard. It is a revealing one – it implies the consent is something done to the patient by the practitioner as opposed to the patient fully understanding and consenting to their treatment.

Unfortunately, the Medical Council continues to receive too many complaints about doctors where it is clear the patient has not given their informed consent to a particular course of treatment or surgery. These types of complaints are avoidable. In this article, we discuss how to avoid this risk of complaint and ways to improve communication with a patient so that their consent is voluntary, active and informed.

Often a complaint involving lack of informed consent is the result of a doctor’s inadequate or hasty explanation of a proposed course of medical treatment and the reasons why, and its risks and benefits (see our article on iron infusions). This can include a doctor assuming consent has been given when the patient has not had enough information to provide informed consent.

What is informed consent?

The Medical Council uses the definition of informed consent contained in the Medical Board of Australia Code of Conduct to assess complaints.

“Informed consent is a person’s voluntary decision about medical care that is made with knowledge and understanding of the benefits and risks involved. Good medical practice involves:
4.5.1 Providing information to patients in a way they can understand before asking for their consent.
4.5.2 Obtaining informed consent from the patient or where the patient does not have the capacity, from their substitute decision-maker and taking into account any advance care directive (or similar) before you undertake any examination, investigation or provide treatment (except in an emergency), or before involving patients in teaching or research.
4.5.3 Ensuring your patients are informed about your fees and charges in a timely manner to enable them to make an informed decision about whether they want to proceed with consultations and treatment.
4.5.4 When referring a patient for investigation, treatment or a procedure, advising the patient that there may be additional costs, which patients may wish to clarify before proceeding.”

Case study:

A 62-year-old patient of Croatian-descent consulted his long-term GP regarding changes he had observed to a lesion on his face. The GP advised his patient (in Croatian) that a referral to a dermatologist would be required, for their assessment of the lesion and a possible biopsy. The GP wrote the referral, included the patient’s existing conditions and medications and queried the need for biopsy.

Shortly after, the patient attended the specialist’s office who undertook an excision biopsy of the affected lesion. The specialist did not detail the specific type of biopsy to be undertaken but did outline why the procedure was required and the provisional diagnosis of actinic keratosis. However, the specialist was not sensitive to English being the patient’s second language and did not confirm the patient had a thorough understanding of the discussion and assessment of alternative options. As a result, the patient formed the view that the specialist would only be required to scratch the surface of the lesion. Upon finding he had stitches following the biopsy the patient was frustrated and upset. In his complaint to Council, the patient advised he has ongoing pain and is embarrassed that his face is “disfigured”.


  • The patient did not have the opportunity to understand the information presented to him as his English was not sufficiently proficient and an interpreter was not used.
  • The doctor did not confirm the patient’s understanding of the procedure and failed to outline what would happen during and after the procedure. This resulted in a mismatch of expectations and an inability of the patient to provide informed consent.
  • The referring GP did not make it clear in the referral letter that the patient was from a culturally and linguistically diverse background.

Factors in assessing informed consent complaints

When complaints from patients are reviewed by the Council and consent appears to be a key issue, the Council’s assessors are interested in whether the patient:

  • Had all the materially relevant information they needed to decide to proceed with a treatment option
  • Understood the risks and benefits presented to them and could weigh up the pros and cons of each option
  • Was competent to make the decision
  • Made the decision freely, without coercion or influence
  • Had the opportunity to withdraw consent at any time.

Fully informing the patient can take time and depend on the complexity of information patients may need additional time to digest the information and ask further questions. Written information regarding the proposed treatment options including all the relevant risks, benefits and costs can be provided for patients to consider in their own time and discussed at a later appointment. 

If you are uncertain or require clarification about your legal obligations involving consent, please seek advice from a colleague and/or your insurer.

Fully informing the patient can take time and depending on the complexity of information patients may need additional time to digest the information and ask further questions.