Informed Consent Best Practices for Surgery

A White Paper for Surgeons, Registrars, Consultants, Medical Officers, and Medical Students

A note on language: This white paper is written in plain, clear English. We have deliberately avoided complex medical and legal jargon wherever possible. Where technical terms are used, they are explained. This is intentional — informed consent is a concept that must be understood clearly by every member of the clinical team, regardless of whether English is your first language or your third.

Important disclaimer: This white paper is for general educational purposes only. It is not jurisdiction-specific legal advice. Laws, regulations, and professional guidelines differ between countries. Always follow the laws of your country, your institution’s policies, and the guidance of your professional regulatory body.

Table of Contents

1. Executive summary
2. Why informed consent is necessary
3. What constitutes informed consent — the five core elements
4. Legal consequences when consent is not properly obtained
5. Best practices: how to obtain informed consent well
6. Common pitfalls and how to avoid them
7. Implementation guidance for departments and training programmes
8. Appendix A: The CONSENT checklist
9. References and further reading

1. Executive summary

Informed consent is one of the most important duties a clinician has. It is both an ethical obligation and a legal requirement. At its heart, informed consent means this: before you do something to a patient’s body, that patient must understand what you are going to do, why you are going to do it, what the risks are, and what their other options are — and they must agree freely.

Understanding informed consent best practices for surgery is essential for both patients and clinicians. It ensures that patients are fully aware of their options, the risks involved, and the expected outcomes of their surgical procedures.

A signature on a form is not enough. A form is just a piece of paper. What matters is the conversation — the process of explaining, listening, answering questions, and confirming that the patient truly understands.

For consent to be legally and ethically valid, five things must be in place:

1. Capacity — The patient is able to understand and make a decision.
2. Disclosure — You have explained everything that matters.
3. Understanding — The patient has actually understood what you explained.
4. Voluntariness — The patient is deciding freely, without pressure.
5. Documentation — The conversation and the decision are properly recorded.

When any one of these five elements is missing, consent may be invalid — and the clinician may face serious legal and professional consequences.

Legally, inadequate consent can result in claims of battery (performing a procedure without proper permission) or negligence (failing to disclose important risks or alternatives). It can also lead to complaints to professional regulatory bodies, disciplinary action, and damage to your reputation and career.

Best practice is to treat consent as a process that happens over time, not a single event just before the procedure. Counsel the patient early, use plain language, check that they have understood, invite questions, allow time for reflection, and document everything carefully.

By embracing informed consent best practices for surgery, clinicians can build trust and improve patient satisfaction, ultimately leading to better health outcomes.

2. Why informed consent is necessary

Implementing informed consent best practices for surgery includes clear communication and documentation, which are critical in avoiding misunderstandings and potential legal issues.

2.1 The patient’s right to decide

The most fundamental reason for informed consent is simple: a patient’s body belongs to them, not to the doctor.

Every person has the right to decide what happens to their own body. This is called autonomy — the right to make your own decisions. In medicine, respecting autonomy means that we do not perform procedures on patients without their knowledge and agreement, even if we believe the procedure is in their best interest.

This principle was established in law over a century ago. In the landmark 1914 American case Schloendorff v. Society of New York Hospital, Justice Benjamin Cardozo wrote:

“Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”

This statement remains one of the most quoted principles in medical law and ethics worldwide. It tells us that the patient — not the doctor — is the final decision-maker about their own care.

2.2 The ethical foundations: where this comes from

The modern framework for informed consent did not develop overnight. It grew out of some of the darkest moments in medical history — moments when patients were subjected to procedures and experiments without their knowledge or agreement.

The Nuremberg Code (1947) was developed after World War II, in response to horrific medical experiments conducted on prisoners without their consent. It established that voluntary consent is “absolutely essential” in medical research.

The Declaration of Helsinki (1964), developed by the World Medical Association, extended these principles to all medical research involving human subjects. It has been revised multiple times and remains a cornerstone of research ethics globally.

The Belmont Report (1978), produced by the United States National Commission for the Protection of Human Subjects, identified three core ethical principles: respect for persons (which includes informed consent), beneficence (doing good), and justice (fairness). These principles now underpin medical ethics education worldwide.

While these documents were originally focused on research, their principles have been adopted into clinical practice. Today, informed consent is required not just in research, but in every clinical procedure where a patient faces meaningful risk or where their body will be altered. (Reference 1, Reference 6)

2.3 Informed consent improves clinical outcomes

Beyond ethics and law, there is a practical reason to take informed consent seriously: it leads to better outcomes for patients and fewer problems for clinicians.

When patients are properly informed:

• They have realistic expectations about what the procedure will achieve and what recovery will look like. This reduces disappointment and complaints.
• They are more likely to follow post-operative instructions because they understand why those instructions matter.
• They are better prepared to recognise and report complications early, because they know what to watch for.
• They feel respected and involved in their own care, which builds trust in the clinical team.

Patients who are well-informed about their surgery through informed consent best practices for surgery often report higher satisfaction and better adherence to post-operative care instructions.

Conversely, when patients feel they were not properly informed, they are more likely to complain, to pursue legal action, and to lose trust in the healthcare system — even if the clinical outcome was technically good.

2.4 The evidence: patients often do not understand — even when they have signed

Research consistently shows that many patients do not fully understand what they have consented to, even after signing a consent form. A systematic review published in the journal Trials examined 14 studies on patient comprehension of informed consent and found that patients’ understanding of the basic components of consent is often limited — particularly regarding risks, alternatives, and the purpose of the procedure.1

This is not because patients are unintelligent. It is because:

• Medical language is complex and unfamiliar.
• Patients are often anxious, which makes it harder to absorb information.
• Consent is frequently rushed, happening just before a procedure when the patient has little time to think.
• Clinicians sometimes assume that explaining something once is enough.

This evidence tells us that the way we explain things matters enormously. Signing a form does not mean the patient understood. It is the clinician’s responsibility to make sure understanding has actually occurred. (Reference 3)

3. What constitutes informed consent — the five core elements

Informed consent best practices for surgery require clinicians to ensure that patients fully understand the information presented to them before making decisions regarding their treatment.

Think of informed consent as a structure with five pillars. If any one pillar is missing or weak, the whole structure is unstable. Let us look at each pillar carefully.

3.1 Capacity

What does “capacity” mean?

Capacity means that the patient is able to understand the information you give them, think about it, and communicate a decision. It is sometimes also called “competence,” though in most clinical and legal contexts, “capacity” is the preferred term.

Capacity is not a fixed quality — it is decision-specific and time-specific. This means:

• A patient may have capacity to consent to a simple procedure but not to a complex one.
• A patient may have capacity in the morning but not in the afternoon (for example, if they become delirious later in the day).
• A patient may have capacity on one day but not on another.

You must assess capacity before every significant consent conversation. Do not assume that because a patient seemed fine yesterday, they have capacity today.

When should you be more careful about assessing capacity?

Be especially careful when the patient:

• Has delirium (acute confusion, often seen in hospitalised patients)
• Has dementia or another cognitive impairment
• Is under the influence of alcohol, drugs, or sedating medications
• Is in severe pain or extreme distress
• Has a severe psychiatric illness that is currently affecting their thinking
• Has a significant language barrier and no interpreter is present
• Has low literacy or low health literacy (difficulty understanding health information)

How do you assess capacity?

A practical way to assess capacity is to check four things:

1. Can the patient understand the information you give them?
2. Can they retain that information long enough to make a decision?
3. Can they weigh up the information — think about the pros and cons?
4. Can they communicate their decision to you?
5. If the answer to all four is yes, the patient likely has capacity. If the answer to any one is no, you need to investigate further and possibly involve a colleague, a psychiatrist, or follow your institution’s policy for patients who lack capacity.

What if the patient does not have capacity?

If a patient lacks capacity, you must follow the laws of your country and your institution’s policies. In most systems, this involves:

Limited understanding of informed consent best practices for surgery can lead to dissatisfied patients and potential legal challenges for clinicians.

• Identifying a substitute decision-maker (often a family member or legal guardian)
• Making decisions in the patient’s best interests
• In emergencies, proceeding with treatment that is immediately necessary to save life or prevent serious harm, and documenting your reasoning carefully

3.2 Disclosure — what you must explain

Disclosure means telling the patient everything they need to know to make a meaningful decision. (Reference 6)

This is the part of consent that most clinicians focus on — and it is important. But disclosure is not just about reading out a list of risks. It is about having a real conversation that gives the patient a genuine understanding of their situation.

The American Medical Association’s Code of Medical Ethics (Opinion 2.1.1) states that informed consent involves communication resulting in patient authorisation for a specific intervention, and that clinicians should disclose the diagnosis, the nature and purpose of the proposed intervention, the burdens, risks, and benefits, and the alternatives — including the option of forgoing treatment.1

What should you disclose? Here is a practical guide:

a) What you are proposing to do


Explain the procedure in plain language. What will happen? Where on the body? How long will it take? Will the patient be awake or asleep? What will they feel during and after?

Example: “We are going to make a small cut behind your ear, remove the bone that is causing the problem, and close the wound with stitches. You will be under general anaesthetic, so you will be asleep and will not feel anything during the operation.”

b) Why you are recommending it


Explain the clinical reason. What problem are you trying to solve? What will happen if the problem is not treated?

Example: “The bone growth in your ear canal is blocking sound and causing repeated infections. If we do not remove it, the infections are likely to continue and your hearing may get worse over time.”

c) The expected benefits

Be honest and realistic. Do not promise outcomes you cannot guarantee. Explain what the procedure is likely to achieve, and also what it may not achieve.

Example: “Most patients experience significant improvement in hearing and fewer infections after this procedure. However, we cannot guarantee a specific level of hearing improvement, and in some cases, a second procedure may be needed.”

d) The risks — both common and serious

This is often the most difficult part of disclosure, but it is one of the most important. You must explain:

• Common risks — things that happen frequently, even if they are not serious (e.g., pain, swelling, bruising, temporary numbness)
• Serious risks — things that are rare but could have a major impact on the patient’s life (e.g., nerve damage, permanent hearing loss, infection requiring further surgery)

The legal standard in most countries is that you must disclose “material risks” — risks that a reasonable patient in this person’s situation would want to know about. This includes both common minor risks and rare but serious risks.

Tailor your risk discussion to the individual patient. A risk that is rare in the general population may be more likely in a patient with specific comorbidities. A risk that seems minor to you may be very significant to this particular patient (for example, a professional musician who is concerned about any risk to their hearing).

e) Reasonable alternatives


You must explain what other options the patient has. This includes:

• Different surgical approaches (if applicable)
• Medical or conservative management (medication, physiotherapy, observation)
• Referral to another specialist (if appropriate)
• Doing nothing — watchful waiting — and what the consequences of that choice would be

Many clinicians forget to discuss the “do nothing” option. But patients have the right to refuse treatment, and they need to understand what will happen if they do. Explaining this is not pessimistic — it is respectful.

To enhance patient engagement, healthcare providers should emphasize informed consent best practices for surgery during every patient interaction.

f) What to expect after the procedure

Explain the recovery process honestly:

• How much pain should the patient expect, and how will it be managed?
• How long will recovery take?
• What activities will they need to avoid, and for how long?
• When should they return for follow-up?
• What signs of complications should they watch for, and what should they do if they notice them?

g) Uncertainty


Be honest about what you do not know. Medicine is not always predictable. If there are aspects of the procedure or the outcome that are uncertain, say so. Patients generally respond well to honesty — it builds trust.

3.3 Understanding — checking that the patient has actually understood

Explaining is not the same as being understood.

This is one of the most important distinctions in the entire consent process. You may have explained everything correctly and thoroughly — but if the patient did not understand, the consent is not truly informed.

Research published in Trials found that patients’ comprehension of informed consent components is often limited, even after the consent process has taken place. A study published in The American Journal of Medicine highlighted that issues of health literacy, language, and the patient’s ability to comprehend what is being presented can lead to significant misunderstanding — and that this is a widespread problem, not an exception. (Reference 3, Reference 9)

So how do you check understanding?

The most widely recommended method is called teach-back. This means asking the patient to explain back to you, in their own words, what they have understood.

This is not a test of the patient’s intelligence. It is a check on whether you have explained things clearly enough. If the patient cannot explain it back, that is a signal that you need to explain it differently — not that the patient has failed.

Examples of teach-back questions:

• “Just to make sure I explained things clearly — can you tell me in your own words what the operation is for?”
• “What are the main risks that you are concerned about?”

Adhering to informed consent best practices for surgery can mitigate risks associated with misunderstandings and ensure patients are well-informed about their choices.

• “What are your options if you decide not to have the operation today?”
• “What should you do if you notice [specific warning sign] after the procedure?”

If the patient cannot answer these questions accurately, go back and explain again. Use simpler language. Use a diagram or a model. Ask if they would like a family member present. Give them written information to take home.

Document that you used teach-back and what the patient’s responses were. This is important for your records.

3.4 Voluntariness — the patient must decide freely

Consent is only valid if it is given freely, without pressure or coercion.

Voluntariness means that the patient is making their own decision, based on their own values and preferences — not because they feel forced, frightened, or manipulated.

What threatens voluntariness?

• Time pressure: Telling a patient they must sign “right now” or the procedure cannot happen — when this is not clinically necessary — is a form of pressure. Patients should be given reasonable time to think, ask questions, and if they wish, discuss the decision with family.
• Hierarchical pressure: In teaching hospitals and busy clinical environments, patients sometimes feel that they cannot say no to a doctor, especially a senior one. Be aware of this dynamic. Make it clear that the patient has the right to refuse, and that refusing will not affect the quality of care they receive.
• Emotional pressure: Patients who are very anxious, in severe pain, or emotionally overwhelmed may agree to things they would not agree to if they were calmer. Where possible, have the consent conversation at a time when the patient is as comfortable and clear-headed as possible.
• Sedation and medication: Obtaining consent from a patient who has already received sedating medication (such as benzodiazepines or opioids) is problematic. Their ability to think clearly and make a free decision may be compromised. Avoid this where possible.
• Financial or social pressure: In some contexts, patients may feel pressured by family members, financial circumstances, or social expectations. Be alert to these dynamics, particularly in cultures where family decision-making is the norm. While involving family is often appropriate and culturally important, the patient’s own wishes must remain central.

A practical note on cultural context:

In many African and other non-Western cultures, medical decisions are made collectively — by the patient together with their family or community. This is a valid and important cultural practice, and it should be respected. However, it is important to ensure that the patient’s own voice is heard and that they are not being overridden by family members. The goal is to support the patient’s decision-making, not to replace it.

3.5 Documentation — recording the conversation

If it is not written down, it did not happen.

This is a principle that every clinician should take seriously. In a legal dispute, the clinical record is often the most important piece of evidence. A well-documented consent process can protect you. A poorly documented one can leave you very vulnerable — even if you did everything correctly.

A clinical reference on informed consent summarises documentation expectations as including the nature of the intervention, the risks and benefits discussed, the reasonable alternatives (and their risks and benefits), and an assessment of the patient’s understanding. (Reference 5)

Regularly revisiting informed consent best practices for surgery is vital for maintaining high standards of care and patient safety.

What should a good consent note include?

• The patient’s diagnosis or working diagnosis
• The name and brief description of the proposed procedure
• The clinical indication — why the procedure is recommended
• The specific risks discussed (not just “risks explained” — list the actual risks)
• The benefits discussed
• The alternatives discussed, including the option of no treatment
• Questions the patient asked, and the answers you gave
• Evidence of understanding (e.g., “Patient was able to explain back the purpose of the procedure and the main risks in their own words”)
• Who was present (family members, interpreter, nursing staff)
• The patient’s decision
• Any specific preferences or concerns the patient expressed
• The date and time of the consent conversation

A signed consent form is not a substitute for a good consent note. The form confirms that a conversation happened. The note tells you — and any future reader — what was actually discussed.

4. Legal consequences when consent is not properly obtained

By integrating informed consent best practices for surgery into daily practice, healthcare professionals can enhance the overall patient experience.

This section explains what can happen legally when the consent process fails. Understanding these consequences is important — not to frighten clinicians, but to help them understand why the consent process matters so much.

4.1 Battery / trespass to the person

Battery (in some countries called “trespass to the person”) is a legal term for touching someone without their permission. In medicine, this means performing a procedure that the patient did not agree to.

You do not need to cause harm for a battery claim to succeed. The mere fact that you did something the patient did not consent to can be enough.

Cornell Law School’s Legal Information Institute explains that courts may hold physicians liable for battery and other torts where they clearly exceed consent — including classic scenarios such as operating on the wrong site, performing a different procedure from the one consented to, or extending a procedure beyond what was agreed. (Reference 8)

Practical examples of when battery claims can arise:

• A patient consents to a procedure on their left ear, but the surgeon operates on the right ear.
• A patient consents to a diagnostic procedure, but the surgeon proceeds to a therapeutic intervention without prior discussion.
• A surgeon extends the scope of an operation significantly beyond what was discussed, even if they believed it was in the patient’s best interest.

The key principle is this: the patient’s consent defines the boundaries of what you are permitted to do. If you go beyond those boundaries — even with good intentions — you may be acting without consent.

4.2 Negligence — failure to disclose material risks or alternatives

Negligence is a different type of legal claim. In a negligence claim related to consent, the patient argues that:

1. You failed to disclose a material risk or a reasonable alternative.
2. If they had known about that risk or alternative, they would have made a different decision.
3. As a result of that different decision, they would have avoided the harm they suffered.

This type of claim is more common than battery claims in most countries, because it does not require the patient to prove that the procedure itself was performed badly — only that they were not properly informed.

The clinical record is central to defending a negligence claim. If your notes show that you discussed the specific risk that the patient is now complaining about, your defence is much stronger. If your notes say only “risks explained” with no detail, it is very difficult to prove what was actually discussed.

4.3 Professional discipline

Even when a legal claim does not proceed, inadequate consent can result in:

• A formal complaint to your professional regulatory body (such as the Health Professions Council of South Africa, the General Medical Council in the UK, or equivalent bodies in other countries)
• Hospital disciplinary processes, which can affect your employment and privileges
• Adverse incident investigations, which can affect your credentialing and career progression
• Reputational damage, which can affect your practice and your relationships with colleagues and patients

4.4 “The Consent Form is not a shield”

This is a phrase used in medico-legal education, and it is worth understanding clearly.

A signed consent form does not automatically protect you from legal or professional consequences. In most real disputes, the question is not “Was there a form?” but rather: “Was the patient meaningfully informed, and can you show it?”

A form helps. But it is rarely sufficient on its own. What protects you is a well-documented, patient-centred consent process — one that shows you took the time to explain, to listen, to answer questions, and to confirm understanding.

5. Best practices: how to obtain informed consent well

Informed consent best practices for surgery should be a foundational element of every surgical procedure, ensuring that patients are active participants in their healthcare decisions.

Implementing informed consent best practices for surgery requires moving beyond the signature to a structured communication process. Leading medical risk-management organisations emphasise that thorough documentation and contemporaneous notes are the defining factors in a successful legal defense. (Reference 14)

This section gives you a practical, step-by-step guide to obtaining informed consent in a way that is both ethically sound and legally defensible.

5.1 Use a staged approach — consent is a process, not an event

One of the most important principles in modern consent practice is that consent should happen over time, not all at once.

Research in the field of clinical research ethics has recommended two-step consent models to reduce pressure and improve understanding. (Reference 9) The same logic applies in clinical practice. A patient who has had time to think, ask questions, and discuss the decision with their family is far more likely to give truly informed consent than a patient who is handed a form in the pre-operative holding area.

A practical staged model for elective procedures:

Step 1 — The initial consultation (clinic or ward round)

• Explain the diagnosis and the proposed procedure.
• Discuss the main risks, benefits, and alternatives at a high level.
• Ask about the patient’s goals, concerns, and values.
• Give the patient written information to take home (a patient information leaflet, if available).
• Encourage them to discuss the decision with family if they wish.
• Tell them they can contact you with questions before the next appointment.

Step 2 — The confirmation consultation (before the procedure)

• Ask if the patient has had a chance to read the information and think about the decision.
• Ask if they have any questions.
• Go through the key risks and alternatives again, more specifically.
• Use teach-back to confirm understanding.
• Document the conversation and the patient’s decision.

Step 3 — Day-of-procedure confirmation

• Briefly confirm that nothing has changed since the last conversation.
• Check that the patient still understands and still agrees.
• Re-confirm the key risks.
• Sign the consent form together.
• This staged approach is not always possible — for example, in emergency situations or when a patient presents acutely. But for elective procedures, it should be the standard.

5.2 Use plain language

Training programs must prioritize informed consent best practices for surgery, preparing future clinicians to effectively communicate with their patients.

Medical language is a barrier to understanding. When you use technical terms without explaining them, patients often nod and pretend to understand — because they feel embarrassed to admit they do not.

Practical tips for plain language:

• Use short sentences.
• Use everyday words instead of medical terms where possible. For example:
  —Say “cut” instead of “incision”
  —Say “remove” instead of “excise”
  —Say “nerve damage” instead of “neuropraxia”
  —Say “bleeding” instead of “haemorrhage”
• If you must use a technical term, explain it immediately.
• Speak slowly and clearly.
• Pause regularly and ask if the patient has questions.
• Avoid using numbers alone to describe risk — combine numbers with words. For example: “There is about a 1 in 100 chance of this happening — that means it is uncommon, but it does happen.”

5.3 Use visual aids

One of the most significant barriers to truly informed consent is the difficulty patients have in visualising what a procedure involves. When a surgeon explains that they will be “removing a bony exostosis from the ear canal” or “decompressing the orbit”. most patients have a very poor mental picture of what that means. They may nod and sign the form — but they have not truly understood. This is where 3D anatomical models can make a real difference.

By showing a patient a 3D model of the relevant anatomy — for example, the temporal bone, the sinus cavity, the orbital region, or the airway — the clinician can:

• Point to the exact location of the problem and the proposed intervention
• Demonstrate the spatial relationships between the target area and surrounding structures (such as nerves, blood vessels, and the brain)
• Explain the risks in a concrete, visual way — for example, showing how close the facial nerve runs to the surgical site
• Illustrate what will be removed or altered, helping the patient understand the physical change to their anatomy
• Set realistic expectations about what the procedure will and will not achieve

This kind of visual explanation is particularly valuable for patients with low health literacy, patients for whom English is a second language, and patients who are anxious or overwhelmed. A model communicates in a way that words alone often cannot. Anatomex3D has a growing range of models that can assist with this. Their Bookface Sinus Model, in particular, was created specifically for ENT consultations to aid patient understanding and enhance informed consent.(Reference 10)

Important: A 3D model is an aid to the consent process — it is not a substitute for it. The clinician must still ensure that all five elements of valid consent are in place: capacity, disclosure, understanding, voluntariness, and documentation. The model supports the “understanding” element by making complex anatomy and procedures more accessible.

5.4 AI dictation and structured summary tools

Clear documentation is one of the defining features of informed consent best practices for surgery. In medico-legal review, the quality of the record often determines whether the consent process can be demonstrated to have been adequate.

Digital dictation and AI-supported summary tools may assist clinicians in documenting consent discussions more thoroughly and efficiently. For example, platforms such as Heidi Health describe functionality that converts consultation conversations into structured clinical notes (Reference 12). Used appropriately, such tools may help ensure that key elements — risks discussed, alternatives offered, patient questions, and confirmation of understanding — are recorded contemporaneously.

Some platforms also support multilingual transcription and document generation, including languages such as Afrikaans and Swahili (Reference 13). In multilingual settings, this may assist clinicians in producing patient-friendly summaries in a language the patient reads comfortably. However, any AI-generated output must be carefully reviewed, corrected, and approved by the clinician before it is stored or shared. Importantly, digital tools do not replace the consent conversation. They support documentation of that conversation. Responsibility for obtaining valid consent remains entirely with the treating clinician.

Disclaimer: Anatomex3D is not affiliated with third-party software providers and does not endorse specific products. Clinicians and institutions remain responsible for ensuring that any documentation tools used comply with local legal, ethical, and data protection requirements.

5.4 Use teach-back (and document it)

Utilizing visual aids can significantly enhance the effectiveness of informed consent best practices for surgery, helping patients better understand complex concepts.

As discussed in Section 3.3, teach-back is the most effective way to confirm that a patient has understood. Make it a routine part of every consent conversation.

Document your teach-back. Write in your notes what questions you asked and how the patient responded. For example: “Patient was able to explain back the purpose of the procedure and correctly identified the main risks discussed, including the risk of facial nerve injury.”

5.5 Discuss alternatives seriously — including “no treatment”

Alternatives are not a checkbox. They are a genuine part of the consent conversation.

When you discuss alternatives, be honest about the trade-offs. Do not present the alternatives in a way that makes them seem obviously inferior — even if you believe the procedure you are recommending is the best option. The patient needs to understand the real pros and cons of each option so that they can make a genuine choice.

The “no treatment” option is particularly important. Patients have the right to refuse treatment, and they need to understand what will happen if they do. Explain the natural history of the condition — what is likely to happen over time if the problem is not treated. This is not about frightening the patient into agreeing to the procedure. It is about giving them the information they need to make a real decision.

5.6 Use professional interpreters

When a patient does not speak your language fluently, use a professional interpreter. Do not rely on family members to interpret, for several reasons:

• Family members may not know the correct medical terms.
• They may (consciously or unconsciously) filter, summarise, or change what you say.
• The patient may feel unable to express concerns or ask questions freely in front of family.
• There are privacy implications — the patient may not want family members to know certain details of their medical situation.

Many hospitals have access to professional interpreters, either in person or by telephone. Use them. If no interpreter is available, document this clearly and consider whether it is appropriate to proceed.

5.7 Avoid obtaining consent when capacity or voluntariness is compromised

When applying informed consent best practices for surgery, clinicians should be mindful of the patient’s emotional state and any factors that might influence their decision-making capacity.

Where possible, do not obtain consent when the patient’s capacity or voluntariness may be compromised. Red flags include:

• The patient has recently received sedating medication (opioids, benzodiazepines)
• The patient is in severe pain or respiratory distress
• The patient is delirious or acutely confused
• The patient is in a state of extreme anxiety or emotional distress
• The patient is hypoxic (low oxygen levels)

If the procedure is urgent and cannot wait, follow your institution’s emergency consent policy and document your reasoning carefully. If the procedure is elective, wait until the patient is in a better state to have the conversation.

5.8 Document like a clinician who expects the note to be read in court

This is a useful mindset when writing consent notes. Ask yourself: “If this note were read by a judge or a professional disciplinary committee in five years’ time, would it show that I did my job properly?”

A good consent note is specific, detailed, and patient-centred. It does not just say “risks explained” — it says which risks were explained. It does not just say “patient agreed” — it says what the patient understood and what questions they asked.

A template for a good consent note:

“Consent discussion held with [patient name] on [date] at [time]. Diagnosis: [diagnosis]. Proposed procedure: [procedure name and brief description]. Indication: [clinical reason]. Risks discussed: [list specific risks]. Benefits discussed: [list benefits]. Alternatives discussed: [list alternatives, including no treatment, and their implications]. Patient asked: [list questions]. Responses given: [summary of answers]. Teach-back: patient was able to explain [what they demonstrated]. Present during discussion: [names of others present, e.g., family member, interpreter, nurse]. Patient’s decision: [agreed to proceed / requested time to consider / declined]. Any specific preferences or concerns: [note any].”

6. Common pitfalls and how to avoid them

Special attention should be given to informed consent best practices for surgery in diverse populations, ensuring that language barriers do not hinder patient understanding.

Even experienced clinicians can fall into habits that undermine the quality of the consent process. Here are the most common pitfalls and how to prevent them.

Pitfall 1: Using generic risk lists with no patient-specific tailoring

The problem: Many consent forms list the same risks for every patient, regardless of their individual circumstances. A patient with diabetes, for example, has a higher risk of wound infection than a healthy young patient — but both receive the same form.

The fix: Tailor your risk discussion to the individual patient. Consider their comorbidities, their anatomy, the complexity of the procedure, and what matters most to them personally.

Pitfall 2: Rushed consent immediately before the procedure

The problem: Obtaining consent in the pre-operative holding area, minutes before the patient goes to theatre, is one of the most common and most problematic practices in surgery. The patient is anxious, possibly already sedated, and has no time to think or ask questions.

The fix: Stage the consent process. Have the main consent conversation well in advance of the procedure. Use the day-of-procedure encounter only to confirm and document, not to initiate.

Pitfall 3: Overpromising outcomes

The problem: Clinicians sometimes, with the best of intentions, present procedures in an overly optimistic light. When outcomes do not match expectations, patients feel misled — and this is a common trigger for complaints and legal action.

The fix: Be honest about uncertainty. Describe the expected benefit and the range of possible outcomes. Use phrases like “most patients experience improvement” rather than “you will be cured.”

Pitfall 4: Not disclosing trainee or registrar involvement

The problem: In teaching hospitals, procedures are often performed by registrars or supervised trainees. Patients are not always told this. In many countries, patients have the right to know who will be performing their procedure.

The fix: Explain clearly who will be performing the procedure and what level of supervision will be in place. Be transparent about the training context. Most patients accept trainee involvement when it is explained honestly.

Pitfall 5: Poor documentation

The problem: Notes that say only “consented for procedure” or “risks explained” provide almost no protection in a legal or disciplinary context.

The fix: Use structured consent templates as a prompt, but always add patient-specific detail. Document the actual conversation, not just the fact that a conversation happened.

7. Implementation guidance for departments and training programmes

Programs aimed at improving informed consent best practices for surgery should involve regular audits and feedback loops to continuously enhance communication strategies.

Improving consent practice is not just an individual responsibility — it is an institutional one. Here is how departments and training programmes can build a culture of excellent consent practice.

7.1 Standardise consent training from the beginning of clinical training

Consent skills should be taught early — from medical student level through internship, community service, and registrar training. This training should include:

• Didactic teaching on the legal and ethical framework
• Observed consent encounters with structured feedback
• Role-play of difficult consent scenarios (language barriers, high-anxiety patients, capacity concerns, complex risk trade-offs)
• Reflection on real cases where consent went wrong

7.2 Use templates thoughtfully

Consent templates and procedure-specific forms are useful because they prompt clinicians to cover all the important elements. However, they must be used as a starting point, not a substitute for individualised discussion. The danger of templates is that they encourage copy-paste documentation that does not reflect the actual conversation.

7.3 Audit consent quality regularly

Departments should periodically review consent documentation — not just to check that forms are signed, but to assess the quality of the consent process. This can be done by reviewing notes against a checklist, or by examining cases where complaints or adverse events occurred and asking whether the consent process was adequate.

7.4 Use simulation for clinicians

Just as Anatomex 3D models are used to train surgeons in procedural skills, simulation can be used to train clinicians in consent skills. Role-play scenarios — where one clinician plays the patient and another plays the doctor — are an effective way to practise difficult consent conversations in a safe environment.

7.5 Provide patient education resources

Give patients written information about their procedure that they can take home and read at their own pace. This information should be written in plain language and, where possible, in the patient’s home language. Encourage patients to bring a family member or trusted person to the consent consultation if they wish.

Appendix A: The CONSENT checklist

This checklist is designed as a quick reference for clinicians. Use it before and during every significant consent conversation.

• C – Capacity – Can this patient understand, weigh up, and communicate a decision today? Are there any factors that might affect their capacity?
• O – Options – Have I explained all reasonable alternatives, including no treatment? Have I been honest about the trade-offs?
• N – Nature – Have I explained what the procedure involves — what will be done, where, by whom, and how?
• S – Serious and common risks – Have I discussed both common minor risks and rare but serious risks, tailored to this patient?
• E – Expectations – Have I explained what recovery will look like — pain, restrictions, timeline, follow-up, possible complications?
• N – Next steps – Have I explained what will happen if complications occur? Does the patient know what to watch for and who to contact?
• T – Teach-back and Time – Have I confirmed understanding using teach-back? Have I given the patient enough time to think and ask questions? Have I documented everything?

References and further reading

Informed consent best practices for surgery are integral to legal and ethical obligations in healthcare, guiding clinicians in their interactions with patients.

Reference 1: Bazzano, L.A. (2021). A Modern History of Informed Consent and the Role of Key Information. The Ochsner Journal, 21(1), 81–85.

Reference 2: Manti, S. & Licari, A. (2018). How to obtain informed consent for research. Breathe (Sheffield), 14(2), 145–152.

Reference 3: Pietrzykowski, T. & Smilowska, K. (2021). The reality of informed consent: empirical studies on patient comprehension — systematic review. Trials, 22(1), 57.

Reference 4: Perrault, E.K. & Keating, D.M. (2024). Enhancing comprehension of online informed consent. Ethics & Behavior.

Reference 5: Nora, L.M. et al. Informed Consent. StatPearls [Internet].

Reference 6: American Medical Association. AMA Code of Medical Ethics, Opinion 2.1.1: Informed Consent.

Reference 7: U.S. Department of Health and Human Services (OHRP). Informed Consent FAQs.

Reference 8: Cornell Law School Legal Information Institute. Informed Consent (Wex Legal Dictionary).

Reference 9: Naarden, A.L. & Cissik, J. (2006). Informed Consent. The American Journal of Medicine, 119(2), 194.e1–194.e4.

Reference 10: Anatomex3D. High-Fidelity 3D Surgical Simulation and Medical Models.

Reference 11: Shaughnessy, A.F. & Slawson, D.C. (2021). Informed Consent — We Can and Should Do Better. JAMA Network Open, 4(3), e213566.

Reference 12: Heidi Health – product overview (“AI care partner…”, includes Scribe)

Reference 13: Heidi Supported Languages (transcription, notes and document generation; includes Afrikaans and Swahili):

Reference 14: SVMIC. Informed Consent: Best Practices. (Medical professional liability insurance and risk management guidance).