Ensuring that informed consent is properly obtained is a legal, ethical and professional requirement on the part of all treating health professionals and supports person-centred care in Australia. 

Informed consent is a person’s decision, given voluntarily, to agree to a healthcare treatment, procedure or other intervention. 

The decision must be made with knowledge and understanding of the benefits and risks involved, including material risks. 

Material risks are risks where a ‘reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it or if the healthcare provider is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it’—Rogers v Whitaker (1992) 175 CLR 479. 

Failure to adequately warn a person of these risks is a breach of the healthcare provider’s duty of care. 

It is necessary to obtain informed consent from adults with capacity as they have a right to decide what happens to their own bodies. 

This means that they have the right to consent to treatment, refuse to consent to treatment for any reason or withdraw their consent, even if refusal or withdrawal of treatment is likely to lead to serious injury or death. 

These principles are reflected in the law that governs consent to medical treatment.

As a general rule, no operation, procedure or treatment may be undertaken without prior consent from the patient or, if the patient lacks capacity, from the patient’s substituted decision-maker. 

The only exceptions are:

• in an emergency when the patient lacks capacity and the patient’s express wishes are unknown.
• where the law otherwise allows or requires treatment to be given without consent.

Informed consent can only be obtained:

• following the provision of accurate and relevant information about the healthcare intervention and alternative options available
• with adequate knowledge and understanding of the benefits and material risks of the proposed intervention relevant to the person who would be having the treatment, procedure or other intervention.

The following four core criteria must be met irrespective of whether the consent is in writing or oral.

• The patient giving consent must have capacity. The patient must have the capacity to give consent. A person has decision-making capacity if they can understand the facts and choices involved, weigh up the consequences and communicate their decision. Capacity or lack of capacity should not be assumed on the basis of a patient’s diagnosis or condition. For example, a patient with an intellectual disability may have capacity to make decisions about their own health treatment if information is provided to them in an appropriate manner or with appropriate assistance.
• The consent must be freely given.
• The consent must be sufficiently specific to the procedure or treatment proposed. The consent must be specific and is valid only for the condition being treated and the specified treatment or procedure about which the patient has been informed and agreed to.
• The consent must be informed.

The mere mechanical signing of a consent form is, of itself, of limited value and is not necessarily evidence of a valid consent.

The need to obtain informed consent may be required at different stages over the course of a treatment pathway, including prior to giving treatment or undertaking a medical examination.

In a recent podcast (see below), members of the Physiotherapy Council of NSW discussed various examples related to informed consent as well as suggestions for improving clinical practice.

Section 4.2 of the National Boards’ shared Code of conduct states that in relation to informed consent, ‘Good practice includes that you:

• provide information to patients in a way they can understand before asking for their consent
• give the patient enough time to ask questions and make informed decisions
• act according to the patient’s capacity for decision-making and consent, including when caring for children and young people, based on their maturity and capacity to understand, and the nature of the proposed care. You should consider the need for the consent of a parent, carer, guardian or other substitute decision-maker
• get informed consent from the patient or where the patient does not have the capacity, from their parent, carer, guardian or other substitute decision-maker before carrying out any examination or investigation, providing treatment (this may not be possible in an emergency), or involving patients in teaching or research. When obtaining informed consent you should include information on material risks and expected outcomes and take into account any advance care directive (or similar)
• get financial consent by discussing fees in a manner appropriate to the professional relationship and addressing the costs of all required services and get general agreement about the level of treatment to be provided, preferably before the service is provided
• inform your patients of the benefits, as well as associated costs or risks, when referring them for further investigation or treatment, which they may wish to clarify before proceeding, and
• document consent appropriately, including considering the need for written consent for procedures which are of higher risk or may result in serious injury or death.’

Informed consent should be documented in writing by way of a signed consent form or notes in the healthcare record for all healthcare interventions other than the most minor interventions.

Looking for more information on informed consent? 

The Physiotherapy Council of NSW podcast 

The Physiotherapy Board of Australia

The National Health and Medical Research Council

The Australian Charter of Healthcare Rights

The National Safety and Quality Health Service Standards

NSW Health Consent to Medical and Healthcare Treatment Manual

New South Wales consent to treatment legislation
Children and Young Persons (Care and Protection) Act 1998 Guardianship Act 1987
Guardianship Regulation 2016
Minors (Property and Contracts) Act 1970