CON-SOP-001: Informed Consent Before Significant Care

At a glance

• Confirm the procedure needs written consent (see the list in the clinical policy).
• Explain the diagnosis, the procedure, its benefits, risks, alternatives, and what happens if the patient says no.
• Check the patient understands, by asking them to explain it back in their own words.
• Use an interpreter if the patient does not understand the language used.
• Record consent on CON-FRM-001 with a witness, before the procedure starts.
• Stop and get help straight away if: the patient does not understand, has not been given the information, is pressed to decide, asks to stop, or no interpreter is available when one is needed.

Step 1. Introduce yourself and the purpose of the conversation.

• Give your name and role.
• Say what procedure is planned and why it is needed.
• Ask the patient how they would like the information (full detail, or summary and questions).

Key point: The patient controls how much they hear. Some people want detail, some want the outline first.

Step 2. Give the information.

• Explain the diagnosis and the reason for the procedure in plain language.
• Describe what will happen, who will do it, and how long it takes.
• Explain the benefits and the material risks, with the likelihood where known.
• Explain the alternatives, including no treatment, and what happens if the patient declines.
• Give the leaflet and say where to find more information.

Key point: Use everyday words. Avoid jargon. Give numbers where you have them, and say when you do not know.

Step 3. Check understanding (teach-back).

• Ask the patient to explain in their own words what will happen and what the main risks are.
• If the explanation is incomplete, repeat the missing part and ask again.
• Ask whether they have any questions, and answer them.

Key point: Teach-back is the test that the information was understood, not just given.

Step 4. Confirm the patient has capacity.

• Check the patient can understand, retain, weigh up the information, and communicate a decision.
• If capacity is in doubt, follow the hospital capacity assessment (EC) and involve the senior clinician.
• If the patient lacks capacity, identify the legal representative and follow the legal pathway in section 10.

Key point: Capacity is decision-specific. A patient may have capacity for one decision and not another.

Step 5. Confirm the decision and ask the patient to sign or confirm.

• Ask whether the patient agrees to the procedure, declines, or wants more time.
• If they agree, the patient signs CON-FRM-001 or confirms verbally in the presence of a witness.
• Do not sign on the patient’s behalf.

Key point: The signature is the patient’s own. A witness is needed for verbal consent.

Step 6. Record the consent before the procedure.

• Complete CON-FRM-001: procedure, risks and alternatives explained, interpreter used if any, capacity confirmed, signature or verbal consent with witness, date and time.
• File the form in the medical record and check it is present before the procedure starts (the pre-procedure safety check).

Key point: If it is not recorded, the procedure should not start.

Step 7. Respect a change of mind.

• Tell the patient they can change their decision at any time, before or during the procedure.
• If the patient withdraws consent, stop safely, make the patient safe, and record the withdrawal and the time.
• Inform the clinician responsible for the care plan.

Key point: Consent is not a one-time event. Stopping safely is part of the procedure.