What is informed consent?

Shared Decision Making
  • A patient needs to understand:
    • Risks
    • Benefits
    • Alternatives
  • A health practitioner needs to ensure that the patient shares their understanding of:
    • What is involved
    • What is achievable
    • The material risks
    • The possible complications.

Who should obtain consent from the patient?
  • The practitioner performing the procedure is legally responsible for ensuring that valid consent has been obtained
  • Consent should not be taken by someone who is not familiar with the procedure, does not understand the risks involved, alternative treatments and who is unable to answer the patient’s questions.
What constitutes a valid consent?
  • The patient must be legally competent
  • It must be given voluntarily
  • It encompasses the procedure/s to be performed.
For consent to be given voluntarily it must be given without duress. It is not effective if given under the influence of drugs, alcohol, family and cultural attitudes or time constraints.

An adult patient may refuse medical treatment even if it may result in death or disablement provided they are competent to do so.

Do I have a duty to explain the proposed procedure to the patient?
You have a duty to explain the proposed procedure to the patient.

In general terms you are required to explain the following:
  • Diagnosis or findings that warrant the procedure
  • Nature, consequences and risks of the proposed procedure
  • Likely consequences of not proceeding with the proposed procedure
  • Any alternative courses of action that might reasonably be considered in the circumstances of the particular case.
Complaints and claims often focus on the issue of failing to warn patients of the risks involved in a proposed procedure. In failing to warn the patient of a “material risk” the patient would only be successful in an action against the health practitioner if she/he could show that the alleged failure to disclose a material risk actually caused damage. In essence, the patient must be able to show the link between them not being told of the risks and the damage caused by the practitioner.

What does the term “material risk” mean?
A health practitioner has a duty to warn patients of a material risk involved with proposed treatment, which are risks which:
  • a reasonable person in the patient’s position would likely think significant, or
  • the practitioner knows, or should know, the particular patient is likely to think significant.In practical terms to ensure that you are confident that you have covered all material risks, assess each individual patient, listen to their concerns about the proposed surgery and apply good clinical judgment.  One way of eliciting what is material to a patient would be to ask what they are worried about, or what would they want to avoid. 
Remember when discussing with the patient
  • Informed consent is an extension of good communication techniques and helps establish practitioner/patient rapport
  • Patients have a right to information and make decisions affecting their health
  • It is essential to take your time. In an ideal situation neither the practitioner nor the patient should feel rushed
  • Allow the patient time to digest the information you have provided them
  • Encourage questions as this provides you with a better understanding of the patient’s comprehension of the information and it promotes dialogue
  • Don’t assume what the patient knows or understands.
Is it necessary to discuss the risks with simple procedures?
Where the danger of risks is commonly appreciated to be remote, such as with the administration of antibiotics, disclosure need not be extensive and will depend on what is material in the circumstances and to the individual patient.

What should be included in the consent discussion?
The patient needs to be advised of:
  • Possible or likely nature of the illness
  • Proposed approach to investigation and treatment, including:
  • What the proposed approach entails
  • Expected benefits
  • Common side effects and material risks
  • Whether the procedure is conventional or experimental
  • Who will undertake the intervention
  • Other options for diagnosis and treatment
  • Degree of uncertainty of the diagnosis and any therapeutic outcome
  • Likely outcome of not having the procedure or treatment, or of not having any procedure or treatment at all
  • Any significant long term physical, emotional, mental, social, sexual, or other outcomes which may be associated with the proposed intervention, and
  • Time and cost involved including any out of pocket expenses.
The use of a form will not guard against litigation, but it is useful because it marks that the procedure has at some point been discussed.

The use of brochures or other documents, explaining treatments, options, benefits and risks, prepared by yourself or professional colleges/associations can be a useful part of the process of informed consent.  However, they should not replace a discussion about these issues with the patient. 

RACGP Standards-Informed patient decisions

Documentation
  • In writing
    • the process you have undertaken to ensure that the patient has been informed
    • that you have taken all steps to inform the patient about the procedure
    • that you believe the patient has understood the information which has been given to them
  • Include a copy of any handouts, instructions or checklists you have used
  • Place the signed informed consent form in the patient’s health records.
 Educational material
  • Studies show that patients remember approximately 30 per cent of verbal information
  • Educational pamphlets, written handouts and pre-operative and post-operative instructions help the patient make an informed decision and remember what he/she consented to, and give guidance on what to do if complications occur
  • A pamphlet will only be useful if it is written in the patient’s first language and they are literate.
What if the patient refuses to undertake the recommended procedure or treatment?
If the patient refuses your recommendations it is even more critical to ensure that the patient has made an informed decision. Include in your informed consent discussion the possible adverse outcomes of refusing or delaying treatment. This conversation should be documented in the patient file and if appropriate, the patient should sign a document confirming their informed refusal, setting out the information given to them and awareness of risks involved.

What is the lifespan of a valid consent?
Consent will remain valid until it is withdrawn by the patient or until the patient’s circumstances change in a significant way.
Sometimes there can be a significant delay between the consent process and the treatment received. A patient may also face a repeat of a procedure or treatment undertaken previously.
Whether it is necessary to repeat the consent process will depend on the patient’s circumstances.
For example:
  • Can the patient still recall the comprehensive process of informed consent and the information provided?
  • Has there been a change in the patient’s condition that would affect the treatment?
  • Are there now alternative treatments to the recommended treatment?
  • Have new risks or side effects associated with the recommended procedure been identified?
Where a significant period of time has lapsed since the original consent was obtained a new consent form should be obtained or the patient should be asked to confirm their previous consent.

We would suggest that, as a general guide, consent to treatment should be re-visited after 6 – 12 months, depending on the nature of the procedure, potential for change in a patient’s circumstances and whether a significant delay was contemplated. You should also check the guidelines for a hospital consent form as they may specify when consent to treatment should be revisited. In our experience, this can vary, from 3 to 12 months.

Substitute decision-makers
If a patient is unable to make their own decision about treatment, i.e. if they are unconscious or otherwise lack decision-making capacity, it may be a substitute decision-maker can provide consent.

Who can be a substitute decision-maker, and what they can and cannot do, varies throughout Australia.  For more information on the requirements in particular States and Territories, see: Further information on these requirements is available from MIGA claims solicitors. 

Is consent required in emergency situations?
In an emergency, where the patient or their substitute decision-maker is unable to give consent and the treatment is required immediately to save the patient’s life or to prevent serious injury to the health of the patient, the practitioner can administer necessary treatment unless there is a clear direction from the patient that such treatment is not to be provided in any circumstances.

Be aware that a patient may carry an advance care directive, or other document, setting out their wishes for how they are to be cared for in certain circumstances.  If valid, these must be followed. 

For more information about advance care directives, see QUT End of Life Law in Australia – Advance Directives

Insurance policies are issued by Medical Insurance Australia Pty Ltd.  MIGA has not taken into account your personal objectives or situation.  Before you make any decisions about our policies, please review the relevant Product Disclosure Statement (which can be found here) and consider your own needs.