O&G · Perioperative care — medico-legal
Consent and provision of information
Also known as Informed consent · Consent · Material risk disclosure · Capacity assessment · Mature minor · Gillick competence · Advance care directive · Substitute decision-maker
Exam-exhaustive FRANZCOG reference on informed consent and provision of information: the three legal elements (capacity, voluntariness, adequate information), the reasonable patient standard from Rogers v Whitaker and Montgomery v Lanarkshire, the threshold for disclosing material risks, RANZCOG C-Gen 2 requirements, consent for adolescents, mature minors, the patient who lacks capacity, advance care directives, and the special situations (Jehovah's Witness, innovative procedures, off-label use, obstetric emergencies).
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Red flags
- Treating a patient who withdraws consent at the door of theatre — stop, clarify, document
- Operating on a patient who lacks capacity without a documented legal framework — battery, not surgery
- Failing to disclose a material risk that a reasonable patient would want to know — the consent is invalid, even if signed
- Using a next-of-kin for consent when the patient has capacity — the patient owns the decision
- Failure to revisit consent at a significant time lapse — a 2019 consent is not a 2026 consent
- Pressuring a patient to consent on the day of surgery — coercion invalidates voluntariness
It is 17:30 on the gynaecology ward. Mrs Patil, a 42-year-old booked for laparoscopic hysterectomy tomorrow morning, has just handed back her consent form with a question you have not heard before: "Doctor, if you find something unexpected inside, what happens to my decision?" She is not testing you — she is doing exactly what the reasonable patient standard asks a person to do. Your answer determines whether tomorrow is consent or coercion. This topic is the language for that conversation, and the legal scaffolding that makes it work.[1][3]
Overview and definition
Informed consent is the legal and ethical foundation of every clinical encounter. In Australia and New Zealand it is governed by common law, by statutes, by guidelines from the Medical Board of Australia and the Medical Council of New Zealand, and by specialty statements from RANZCOG (C-Gen 2 Consent and provision of information, C-Gen 5 Care of women with decision-making capacity concerns, C-Gen 22 Statement on mature minor consent).[3][5][13][14]
The legal definition is a negative: a procedure performed without consent is the tort of battery. The clinical definition is a process: a conversation that gives the patient the information they need to make a decision that reflects their own values and goals. The two definitions are not the same — the legal one is the floor, the clinical one is the practice.[1][2][3]
References16ShowHide
- [1]High Court of Australia Rogers v Whitaker (1992) 175 CLR 479 High Court of Australia, 1992.Source
- [2]Supreme Court of the United Kingdom Montgomery v Lanarkshire Health Board [2015] UKSC 11 UK Supreme Court, 2015.Source
- [3]Royal Australian and New Zealand College of Obstetricians and Gynaecologists Consent and provision of information (C-Gen 2) RANZCOG, 2024.Source
- [4]Health and Disability Commissioner (Code of Health and Disability Services Consumers' Rights) Regulations Code of Health and Disability Services Consumers' Rights New Zealand Government, 2009.Source
- [5]Medical Board of Australia Good medical practice: a code of conduct for doctors in Australia Medical Board of Australia / AHPRA, 2020.Source
- [6]General Medical Council (UK) Decision making and consent (guidance for doctors) GMC, 2020.Source
- [7]Dathatri S, Gruberg L, Anand J, et al. Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods Ann Thorac Surg, 2014.PMID 24629303
- [8]Wilkinson DJ, Truog RD The luck of the draw: physician-related variability in end-of-life decision-making in intensive care Intensive Care Med, 2013.PMID 23435951
- [9]Teshome M, Wolde Z, Gedefaw A Surgical informed consent in obstetric and gynecologic surgeries: experience from a comprehensive teaching hospital in Southern Ethiopia BMC Med Ethics, 2018.PMID 29793471
- [10]Wada K, Charland LC, Bellingham G Can women in labor give informed consent to epidural analgesia? Bioethics, 2019.PMID 30358905
- [11]Stacey D, Légaré F, Lewis K, et al. Decision aids for people facing health treatment or screening decisions Cochrane Database Syst Rev, 2017.PMID 28402085
- [12]Australian Health Practitioner Regulation Agency (AHPRA) Annual report notifications and tribunal decisions AHPRA, 2024.Source
- [13]Royal Australian and New Zealand College of Obstetricians and Gynaecologists Care of women with decision-making capacity concerns (C-Gen 5) RANZCOG, 2022.Source
- [14]Royal Australian and New Zealand College of Obstetricians and Gynaecologists Statement on mature minor consent (C-Gen 22) RANZCOG, 2021.Source
- [15]Wainstein M, Menzies AR, Brennan FP, et al. The Legal Doctrine of Informed Consent and Renal Dialysis — Do Patients Really Consent? J Law Med, 2018.PMID 29978680
- [16]National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research NHMRC, 2023.Source