Informed consent for surgery: a guide for surgeons
General information for surgeons, not legal advice. The law differs between states and countries: follow your hospital's policy, and ask your medical defence organisation when unsure.
Informed consent is the patient's voluntary decision to have an operation, made after their surgeon has explained what it involves, the expected benefits, the material risks and the alternatives, including not operating. The patient must have capacity to decide, must not be pressured, and the consent covers the operation that was discussed.
Consent is a conversation; the form is the record of it. A signed form shows what was discussed and that the patient agreed. On its own, a signature does not prove that consent was informed, and a standard form or information sheet does not replace a discussion fitted to the patient in front of you.
Three questions decide whether consent is valid: does the patient have capacity to make this decision, are they deciding freely, and have they been given the information they need?
Consent problems are common in claims. In Avant's review of 5,640 claims finalised between July 2016 and June 2018, about 1 in 10 involved consent. Of those, 86% were about a procedure, and the most common problem was that patients felt they had not been told enough, especially about the risks.
The law in Australia
Australian surgeons must warn patients of material risks. The High Court set the test in Rogers v Whitaker (1992): a risk is material if a reasonable person in the patient's position, if warned of it, would be likely to attach significance to it, or if the doctor is, or should reasonably be, aware that this particular patient would.
The test looks at the patient, not only at what other surgeons would disclose. In Rogers v Whitaker the risk of losing sight in the good eye (sympathetic ophthalmia) was about 1 in 14,000. The patient had asked many questions about possible complications and was anxious about her good eye, so the court held the risk was material for her.
| Source | What it requires |
|---|---|
| Rogers v Whitaker (1992) 175 CLR 479 | Warn of material risks, judged by a reasonable person in the patient's position and by what this patient would want to know |
| Civil Liability Act 2003 (Qld), s 21 (an example of the test in legislation) | Give the information a reasonable person in the patient's position would need to make a reasonably informed decision, and the information the doctor knows or ought to know the patient wants |
| Chappel v Hart (1998); Wallace v Kam (2013) | In a claim, the patient must also show that a warning would have changed their decision, for the risk that actually happened |
| Medical Board of Australia, Good medical practice (2020), s 4.5 | Explain in a way the patient can understand; obtain consent before treatment, except in an emergency; tell patients about fees in time for them to decide (informed financial consent) |
| National Safety and Quality Health Service Standards, Partnering with Consumers (Actions 2.04, 2.05) | Hospitals' consent processes must comply with legislation and best practice; hospitals must identify a patient's capacity to decide, and a substitute decision-maker when they lack it |
| Australian Charter of Healthcare Rights (2nd ed., 2019) | Patients have a right to clear information about the possible benefits and risks of treatments, so they can give informed consent |
What to explain before surgery
Cover these in words the patient understands, and leave time for questions:
- The diagnosis and why you advise surgery, including anything still uncertain.
- What the patient wants: their goals, concerns and expectations, so you can say honestly what the operation is likely to achieve.
- The operation: what is done, the side and site, the anaesthetic, and any additional (+) or possible (+/−) procedures that may be needed during it.
- The expected benefits, and how likely they are.
- The material risks: the common ones, the serious ones even if rare, and any that matter to this patient (their job, sport, or an instrument they play).
- What would happen if a complication occurred, and any plans the patient may need to make, such as more time off work or help at home.
- The alternatives, including other treatment and not operating, with their benefits and risks.
- Recovery: time in hospital, rehabilitation, time off work and driving.
- Who will operate, and whether trainees will take part.
- Costs, including out-of-pocket costs for private patients, and that the anaesthetist and any surgical assistant may charge separately.
- The patient's choices: they can ask more, take time, bring a support person, seek a second opinion, and change their mind before the operation.
Numbers help when you have them: "about 1 in 100" is clearer than "uncommon". A procedure-specific consent form lists the benefits and risks of each operation, each with a plain-language explanation, so nothing important is left out.
Check understanding. Ask the patient to explain the operation and its main risks back in their own words, and explain again in a different way if needed. Diagrams, written information and decision aids help, but they do not replace the conversation.
What makes a risk material depends on how likely and how serious it is; on the operation (how complex, whether its effects are permanent, whether it is elective or urgent); on how much the patient wants to know (their questions and their own reading); and on the patient (their work, interests, health, anxiety and understanding). The more complex, invasive or elective the operation, the more detail the discussion needs.
Who, when and what to record
Who. Ideally the surgeon who will operate. If a trainee takes consent, they should know the operation and its risks well enough to answer the patient's questions. A colleague who does not know the operation well enough should decline the task. The treating surgeon remains responsible for the consent.
When. Before the day of surgery where you can, so the patient has time to think and to talk with family; the discussion can take more than one visit. On the day, confirm that the patient still agrees. Consent covers the operation that was discussed: a plan in stages needs consent for each stage, and if the plan, the patient's condition or the risks change, discuss it again. Consent lasts until the patient withdraws it or circumstances change; if a long time passes before surgery, review it, and check how long your hospital accepts a signed form.
In writing. The law generally accepts consent that is spoken, but hospitals require written consent for operations, and some treatments need it by law. The form should name the procedure with its side and site, list the benefits and risks discussed, and be signed and dated by the patient (or their substitute decision-maker) and the doctor.
In your notes. Record what was discussed: the main risks and alternatives, the patient's questions and particular concerns, any written information or diagrams given (keep a copy of the version you gave), the interpreter's name or number if one was used, and the patient's decision. Keep the signed form in the medical record.
Capacity, young people, emergencies and interpreters
Capacity. Adults are presumed to have capacity. Capacity relates to the decision at hand and can change: the patient must be able to understand the information, retain it, weigh it and communicate a decision. Reassess it when there is doubt, and support the patient to decide as far as they can.
Substitute decision-makers. When an adult lacks capacity, consent comes from their substitute decision-maker, and an advance health directive must be taken into account. Each state and territory sets out who that is. Usually it is a guardian or attorney first, then a spouse or partner, an unpaid carer, or a close relative or friend. The titles differ: "person responsible" (NSW), "medical treatment decision maker" (Victoria), "statutory health attorney" (Queensland). Some treatments need a tribunal's approval whoever consents. When unsure, ask your state's guardianship tribunal or public guardian.
Young people. Parents or guardians usually consent for children. A young person who fully understands the proposed treatment may be able to consent for themselves, as the High Court accepted in Marion's case (1992). Some states set an age in legislation, such as 16 in South Australia.
Emergencies. When a patient cannot consent, treatment needed urgently to save their life or prevent serious harm can generally be given without consent. A refusal you know of, such as a valid advance health directive, must still be respected. Record why the treatment could not wait.
Interpreters. Use a professional interpreter rather than family members, and never a child. In private practice, approved medical specialists can use TIS National's Free Interpreting Service for Medicare-rebateable services to Medicare-eligible patients. Record the interpreter's name or number.
Refusal, withdrawal and other consents
Refusal and withdrawal. A patient with capacity may decline an operation, or withdraw consent at any time before it. Check that they understand what declining means for them, offer a second opinion, and record the information you gave, the risks of not proceeding and their decision.
Pressure. Make sure the decision is the patient's own. Family, carers or the treating team can put pressure on a patient, sometimes without meaning to.
Beyond the operation. Ask separately, and record the answer, for anything else that will happen: blood products, clinical photographs or video, students or observers in theatre, and any examination under anaesthesia that is not part of the operation. The patient can agree to the operation and decline these.
Consent signed on screen or by email
Signing on a tablet, or on the patient's own phone, changes how the form is signed, not what consent requires: the conversation still comes first.
- Check that your hospital accepts consents signed electronically or sent by email.
- Send it soon after the consultation, while the discussion is fresh, and make sure the patient knows how to reach you with questions before they sign.
- Make sure the right person signs. Surgery Consent Companion sends a secure link that opens only with the patient's date of birth, and encrypts the signed PDF it emails to you and the patient.
- Let the patient decline parts. Additional consents, such as blood products or clinical photography, can be declined without declining the operation.
- Confirm on the day of surgery, as you would with a paper form.
In the United States
The principles are the same; the rules come from state law and, for hospitals, from Medicare's conditions of participation.
- The standard of disclosure depends on the state. About half the states ask what a reasonable patient would want to know (the approach of Canterbury v Spence, 1972); most others ask what a reasonable physician would disclose.
- A signed form before surgery. Hospitals in Medicare must have a properly executed informed consent form in the medical record before surgery, except in emergencies (42 CFR 482.51(b)(2)).
- What the form must contain, at a minimum (CMS guidance): the hospital's name; the procedure; the practitioner responsible; a statement that the procedure, its anticipated benefits, material risks and alternatives were explained; the signature of the patient or their legal representative; and the date and time it was signed.
- What the discussion should cover (CMS guidance, revised 2024): the surgery and the anesthesia, why it is advised, the material risks and benefits, the alternatives, the likely result of declining, who will operate and give the anesthetic, and whether residents or others will perform important tasks.
- Examinations for teaching. Since April 2024 CMS expects the consent process and form to say whether breast, pelvic, prostate or rectal examinations will be performed for training, especially when the patient will be under anesthesia, and to ask the patient's permission.
- Professional ethics. The AMA's Code of Medical Ethics (Opinion 2.1.1) asks physicians to assess the patient's ability to understand, explain the diagnosis, the purpose of the intervention and the risks and benefits of all options including no treatment, and to document the discussion and decision.
- Language. Hospitals receiving federal funds must offer qualified interpreters free of charge (Section 1557 of the Affordable Care Act).
Make a procedure-specific consent form
Choose from 350+ procedures, and the benefits and risks are listed, each with a plain-language explanation you can edit. The patient signs on paper, on screen or by email. There is a free plan for registered medical practitioners.
Sign up free See a sample surgical consent formThis page is general information about informed consent for surgery, not legal advice. Laws and hospital policies differ between places and change over time; check the rules where you practise, and ask your medical defence organisation about a particular case. Last reviewed November 2026.
References
Australia
- Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479
- Civil Liability Act 2003 (Qld), s 21
- Chappel v Hart [1998] HCA 55; Wallace v Kam [2013] HCA 19
- Medical Board of Australia, Good medical practice: a code of conduct for doctors in Australia (October 2020), ss 1.4, 4.5, 4.6, 4.9
- Australian Commission on Safety and Quality in Health Care, NSQHS Standards: Partnering with Consumers Standard, Actions 2.04 and 2.05
- Australian Charter of Healthcare Rights, 2nd edition
- Royal Australasian College of Surgeons, Informed consent position paper (2019)
- Secretary, Department of Health and Community Services v JWB and SMB (Marion's case) [1992] HCA 15; (1992) 175 CLR 218
- Consent to Medical Treatment and Palliative Care Act 1995 (SA)
- Guardianship Act 1987 (NSW); Medical Treatment Planning and Decisions Act 2016 (Vic); Powers of Attorney Act 1998 (Qld)
- TIS National, Free Interpreting Service: private medical practitioners
Medical defence organisations
- Avant, Consent: the essentials
- Avant, Consent claims insights (claims finalised July 2016 to June 2018)
- MDA National, Concise advice: consent for treatment
- MDA National, Informed consent
- MIPS, Informed consent in healthcare: legal essentials
United States
- Studdert DM, Mello MM, et al. Geographic variation in informed consent law: two standards for disclosure of treatment risks. J Empirical Legal Studies 2007;4(1):103-124
- 42 CFR 482.51 (surgical services)
- CMS State Operations Manual, Appendix A (Hospitals): interpretive guidance for 42 CFR 482.13(b)(2), 482.24(c) and 482.51(b), including the minimum contents of a properly executed consent form
- CMS State Operations Manual, Appendix A, Transmittal 220 (April 2024), with memo QSO-24-10-Hospitals (1 April 2024)
- AMA Code of Medical Ethics, Opinion 2.1.1 Informed consent
- HHS Office for Civil Rights, Section 1557 language access letter (5 December 2024)