Key Takeaways
- Rogers v Whitaker (1992) 175 CLR 479 established the material risk test in Australia: practitioners must disclose any risk a reasonable person in the patient's position would consider significant in deciding whether to proceed. This is a patient-centred test, not a practitioner-centred one.
- AHPRA's Shared Code of Conduct (2022) requires all regulated health professions to obtain informed consent before providing care and to document that consent in the patient's health record. The Code applies to GPs, nurses, pharmacists, physiotherapists, occupational therapists, psychologists, and other allied health practitioners.
- RACGP Criterion C1.3 (Informed patient decisions) requires general practices to have documented processes for obtaining and recording consent. Equivalent requirements carry forward into the RACGP 6th Edition under the Clinical Governance and Patient Participation domains.
- Verbal consent is legally valid for most routine procedures in Australian general practice and allied health settings, but the discussion must be documented in the clinical record immediately. A signed consent form does not replace that note; it supplements it.
- Children under 18 can consent to their own healthcare if assessed as Gillick competent (also described as the mature minor doctrine). There is no fixed national age threshold. The test is whether the child has sufficient understanding and intelligence to fully comprehend the proposed treatment, its risks, and its alternatives.
- AHPRA's 2024 guidance on artificial intelligence requires practitioners to obtain informed consent before inputting patient data into an AI tool or recording a clinical consultation using an AI scribe. That consent must be noted in the health record.
- A clinical note that records only "patient consented" is not adequate documentation under AHPRA or RACGP standards. The absence of a record showing what risks were discussed creates a presumption, in practice, that they were not discussed.
Informed consent documentation failures are one of the most consistent contributing factors in AHPRA notifications and civil litigation involving Australian health practitioners. AHPRA received 13,327 notifications about registered practitioners in 2024/25. Inadequate consent is a recurring element in clinical care notifications across almost every regulated profession.
The law has been settled since 1992. Practitioners must disclose all material risks before a patient can give informed consent. The question that arises at complaint or in civil litigation is rarely whether the risk conversation happened. It is whether any record shows what was said. Practices that treat consent as a verbal formality rather than a documentation obligation are carrying significant medico-legal risk.
This guide covers what consent documentation must contain under Australian law and professional standards, when written consent is required, how the mature minor doctrine applies, and what AHPRA's 2024 AI guidance means for practices using scribes.
The Legal Standard: Rogers v Whitaker and Material Risk
Rogers v Whitaker (1992) 175 CLR 479 is the foundation of Australian consent law. The High Court rejected the Bolam test used in the UK (which judged disclosure standards by what a responsible body of practitioners would do) and replaced it with a patient-centred standard.
A material risk is one that a reasonable person in the patient's position would attach significance to when deciding whether to undergo a procedure. A risk is also material if the practitioner knows, or should know, that this particular patient would find it significant, even if a reasonable person generally might not. That second limb matters. Patients who express specific concerns, ask questions about particular outcomes, or signal that certain risks would affect their decision create a heightened disclosure obligation for those risks, regardless of how remote they may be statistically.
Quantification is part of the obligation. Courts have found that stating a risk exists is insufficient when the probability was not conveyed. "There are risks associated with this procedure" does not satisfy the duty. "There is approximately a one in two hundred risk of nerve damage in your particular case, given your anatomy and the nature of the procedure" does.
The clinical note must show that the conversation was tailored to the patient, not delivered from a generic script.
AHPRA Obligations Across All Regulated Professions
The AHPRA Shared Code of Conduct applies to 14 of the 16 health professions regulated under the Health Practitioner Regulation National Law. Medical practitioners and nurses are covered by their own profession-specific codes, but those codes carry equivalent consent obligations.
Section 4.3 of the Shared Code of Conduct requires practitioners to obtain informed consent before providing care. Good practice under the Code includes obtaining consent for each significant intervention rather than relying on a blanket authority; providing information the patient can understand; giving adequate time to consider options; and documenting the consent process in the health record.
Practitioners who face an AHPRA notification for inadequate consent must demonstrate compliance with these requirements. A clinical record showing what was discussed, what questions the patient asked, and what the patient appeared to understand is the strongest available evidence. A record noting only "patient consented to procedure" is effectively no record at all.
For a broader overview of AHPRA employer obligations, including mandatory notification requirements and registration condition monitoring, see the AHPRA registration compliance guide.
What RACGP Criterion C1.3 Requires
For general practices, the specific accreditation criterion is C1.3: Informed patient decisions in the RACGP 5th Edition Standards. The RACGP 6th Edition (available for assessment from 2026) maintains equivalent requirements under the Clinical Governance and Patient Participation domains.
A compliant clinical record entry for any procedure requiring consent should document all of the following:
- What information was provided: the nature of the procedure, its purpose, and any relevant background the patient needed to make their decision
- The material risks discussed: both probability and severity, tailored to the patient's specific circumstances and any concerns they raised
- Alternatives presented: including the option of not proceeding and what the expected outcome of non-treatment would be
- Questions the patient asked and the answers given by the practitioner
- The patient's apparent understanding: a brief note of whether the patient appeared to comprehend the information, particularly for complex or higher-risk interventions
- The form of consent given: verbal (documented immediately in the record), written, or witnessed written for high-risk or invasive procedures
A signed consent form records that consent was given. The clinical note records what the patient was told before giving it. Both are required for surgical or procedural consent. Neither alone is sufficient.
The ClinicComply consent procedures template is built to the C1.3 standard and includes documentation checklists for both routine and procedural consent scenarios. The RACGP Accreditation Quiz provides a rapid gap assessment across C1.3 and the full range of accreditation criteria.
Consent for Patients Under 18: The Mature Minor Doctrine
Children under 18 can consent to their own medical treatment without parental involvement if they are assessed as competent. This is confirmed by the High Court of Australia in Secretary, Department of Health and Community Services v JWB and SMB (Marion's case) (1992) 175 CLR 218, which adopted the Gillick principle from English law into the Australian common law framework.
The test is whether the child has sufficient understanding and intelligence to fully comprehend the proposed treatment, its risks, and its alternatives. There is no fixed national age at which this presumption applies. Competence is assessed individually, consultation by consultation.
Several practical rules follow:
- The more serious or irreversible the procedure, the higher the level of understanding required before treating a minor as competent to consent
- A competent minor can also refuse treatment their parents want, although courts can override refusal involving serious harm
- A minor assessed as not competent requires parental or guardian consent, or Family Court authorisation for certain categories of special medical procedures
- Document the competence assessment in the same record entry as the consent note, including the child's age, questions asked, apparent understanding, and the complexity of the intervention
State-specific note: New South Wales is the clearest jurisdiction legislatively. Section 49 of the Minors (Property and Contracts) Act 1970 (NSW) provides that consent to medical treatment given by a person aged 14 or over is as effective as adult consent. Below 14, the common law Gillick test applies. Other states and territories rely entirely on the general common law test without a legislated age threshold.
For situations involving child patients where a practitioner suspects abuse, neglect, or a child protection concern, mandatory reporting obligations arise separately from consent. The patient complaint handling and escalation guide covers the AHPRA notification thresholds and the distinction between internal escalation and external reporting obligations.
Telehealth Consultations and AI Scribes
Two developments have added consent obligations that many practices have not yet formalised in their documentation processes.
Telehealth. The consent obligation for the clinical intervention itself is identical via telehealth and in person. The additional obligation is to confirm, before the consultation begins, that the patient is in a private location, that the practitioner's setup is confidential, and that the patient understands and accepts the limitations of remote examination. This should be documented at the start of every telehealth record. The telehealth Medicare billing compliance guide covers the broader MBS requirements for telehealth, including the MyMedicare established clinical relationship rules that now apply to mental health telehealth services.
Artificial intelligence. AHPRA's 2024 guidance on AI in clinical practice requires practitioners to seek informed consent before inputting patient data into an AI tool or recording a consultation using an AI scribe. Consent must be noted in the health record. The practitioner should explain what AI system is being used, how patient information will be processed, and whether data will be stored or shared outside the practice. Practices that deployed AI scribes without a documented consent process are not compliant.
The RACGP 6th Edition also introduces AI governance as a mandatory requirement, covering tool selection, clinical validation, and patient consent. See the AI privacy and compliance guide for healthcare practices for the full OAIC obligations that apply alongside the AHPRA consent requirements.
How ClinicComply Helps
Consent documentation failures accumulate quietly. A practitioner who consistently records only "patient consented" may complete hundreds of entries with this gap before a complaint makes it visible. By that point, the pattern itself becomes evidence of systemic failure.
ClinicComply's compliance module stores your consent policy and supporting checklists against RACGP Criterion C1.3 and the AHPRA Shared Code of Conduct obligations they satisfy. For practices using telehealth or AI scribes, separate consent checklists can be added for those workflows and tracked as distinct policy items with their own review schedules and responsible owners. The policy library keeps procedures version-controlled, attributed to a named reviewer, and linked to the specific standard each document addresses.
Use the compliance calendar tool to schedule your next consent policy review, or browse the full template library for consent forms and documentation checklists mapped to Australian standards.
See the full feature set at cliniccomply.com.au/features or start a free 30-day trial at cliniccomply.com.au/signup.
Frequently Asked Questions
What is "informed consent" under Australian law?
Informed consent in Australia requires practitioners to disclose all material risks of a proposed treatment before obtaining the patient's agreement. A material risk is one a reasonable person in the patient's position would consider significant in deciding whether to proceed, plus any risk the practitioner knows would be significant to this particular patient. The standard was established in Rogers v Whitaker (1992) 175 CLR 479 and applies to all registered health practitioners in Australia.
Does informed consent always need to be in writing?
No. Verbal consent, documented in the clinical record immediately after the discussion, is legally valid for most procedures in Australian general practice and allied health settings. Written consent (a signed form) is generally expected for procedures involving anaesthesia, surgery, tissue collection, significant irreversible risks, research participation, and major investigative interventions. The clinical note documenting the discussion is required regardless of whether a written form is also used.
What must be recorded in the clinical notes to document consent properly?
The clinical record should document: what information was provided about the procedure and its purpose; the specific material risks discussed, with probability where known; the alternatives that were presented, including non-treatment; questions the patient asked and the answers given; the practitioner's assessment of the patient's apparent understanding; and the form of consent obtained. A notation reading "patient consented" without this detail does not satisfy AHPRA or RACGP documentation standards.
Can a child under 18 give informed consent in Australia?
Yes, if the child is assessed as Gillick competent (also called a mature minor) under Australian common law. The test is whether the child has sufficient understanding and intelligence to fully comprehend the proposed treatment, including its risks and alternatives. There is no fixed national age threshold, although New South Wales legislates a presumption of competence for those aged 14 and over under section 49 of the Minors (Property and Contracts) Act 1970 (NSW). The more serious or irreversible the procedure, the higher the level of understanding required before treating the child as competent to consent.
What happens if a parent and a Gillick competent minor disagree about treatment?
If a minor is assessed as Gillick competent, their consent is valid and, for most treatments, the practitioner can proceed without parental agreement. If a competent minor refuses treatment their parents want, the Family Court can be asked to resolve the dispute for significant procedures. If a minor is not competent to consent, parental consent governs, except for special medical procedures such as sterilisation which require court authorisation regardless of parental views.
Does AHPRA require consent before using an AI scribe?
Yes. AHPRA's 2024 guidance on artificial intelligence requires practitioners to seek informed consent before recording a clinical consultation using an AI tool or inputting patient data into an AI system. Consent must be noted in the health record. The practitioner should explain what system is being used, how data is processed, and what patient information will be involved. Practices that deployed AI scribes without implementing this consent process are not currently compliant.
Is a blanket consent form at the start of a treatment relationship sufficient?
No. AHPRA's Shared Code of Conduct requires consent to be obtained for each significant intervention, not as a once-off authority granted at the beginning of care. A new consent process is required when the treatment plan changes materially, when a new procedure with distinct risks is proposed, or when the patient has previously declined and the practitioner is proposing to proceed again after further discussion.
What are the record retention obligations for consent documentation?
Consent documentation is part of the medical record and must be retained for a minimum of 7 years from the date of the last entry for adult patients. For records created when a patient was under 18, the record must be retained until the patient's 25th birthday. These timeframes apply under the Privacy Act 1988 (Cth) and RACGP guidelines. Some states have additional retention requirements, particularly for hospital-based and surgical records.