Purpose
This audit reviews whether consent documentation is clear, proportionate and clinically useful for investigations, procedures, treatments, examinations and care decisions. It focuses on whether the decision was documented, the person was involved, relevant benefits, material risks and reasonable alternatives were discussed, questions were addressed, capacity was considered, interpreters or communication support were used where required, consent form completion was appropriate where required, and agreed actions were recorded clearly.
Inclusion criteria
- Adults aged 16 years or older unless locally adapted.
- Patients undergoing or being offered an investigation, treatment, procedure, examination or care decision where consent should be documented.
- Patients where written, verbal or non-verbal consent was documented or should reasonably have been documented under local policy.
- Patients where shared decision-making documentation was clinically relevant.
- Patients where risks, benefits, alternatives or the option of no treatment should reasonably have been discussed and documented.
- Patients where capacity, communication support, interpreter use, family involvement or legal authority was relevant to consent documentation.
- Patients managed in selected wards, units, departments or pathways.
- Electronic, paper or hybrid records depending on local setup.
Exclusion criteria
- Patients under 16 years old unless locally adapted.
- Paediatric consent pathways unless locally adapted.
- Maternity-specific consent pathways unless locally adapted.
- Emergency life-saving treatment where consent documentation was not possible at the time and local emergency treatment standards apply.
- Patients lacking capacity where the relevant process is better audited under a capacity documentation audit unless locally included.
- Cases where consent documentation is held only in a restricted system that the audit team is not authorised to access.
- Duplicate records or duplicate consent episodes.
- Records outside the selected audit period.
- Records unavailable for review.
- Cases where local governance approval is required but has not been obtained.
- Direct patient identifiers entered into the tool.
Decision and discussion
5 criteria · local target 90%
C1The specific decision, treatment, investigation, procedure or examination was documented.
C2The indication or reason for the intervention was documented.
C3The patient's involvement in the decision was documented.
C4The person's preferences, priorities or concerns were documented where relevant.
C12Questions, concerns or discussion points were documented where relevant.
Risks, benefits and alternatives
7 criteria · local target 90%
C5Benefits of the proposed option were documented where relevant.
C6Material risks were documented in a way that was relevant to the individual patient.
C7Common or serious risks were documented where relevant.
C8Individualised risks were documented where relevant.
C9Reasonable alternative options were documented where relevant.
C10The option of no treatment, no procedure or deferral was documented where relevant.
C11Likely consequences of accepting, declining or delaying the intervention were documented where relevant.
Communication and capacity
6 criteria · local target 90%
C13Written or patient information was provided or signposted where relevant.
C14Interpreter use, accessible information or communication support was documented where required.
C15Capacity was considered.
C16Mental capacity assessment was documented where required.
C22Legal proxy, LPA, deputy, parental responsibility or other legal authority was considered where relevant.
C23Safeguarding, coercion, undue influence or pressure was considered where relevant.
Consent form and authorisation
6 criteria · local target 90%
C17Consent form was completed where required by local policy.
C18Correct consent form was used where a form was required.
C19Consent form was signed, authorised or completed according to local policy.
C20Consent was reviewed or confirmed on the day of procedure where required by local policy.
C24Chaperone offer or presence was documented where relevant to examination or procedure.
C25Sedation, anaesthesia, transfusion, contrast, photography, recording or tissue-use consent was documented where relevant.
Decision, plan and escalation
7 criteria · local target 90%
C21Refusal, declined treatment or withdrawal of consent was documented where applicable.
C26Agreed decision and action plan were documented.
C27Review, follow-up or safety-netting plan was documented where relevant.
C28Consent information was communicated at handover, transfer or discharge where relevant.
C29Reason for delayed, missing or incomplete consent documentation was recorded where applicable.
C30Documentation was clear enough for another clinician to understand the consent discussion, decision and agreed actions.
C31Any consent-related safety, capacity, safeguarding or governance concern was escalated or actioned where identified.
Clinical safety note
This tool supports local audit, quality improvement and governance review. It does not replace clinical judgement, local consent policy, professional guidance, the Mental Capacity Act, safeguarding procedures, specialist advice, legal advice, emergency treatment pathways or incident reporting processes. Any concern about invalid consent, capacity, coercion, safeguarding, serious communication failure, wrong procedure, material undisclosed risk, or patient harm must be escalated according to local policy. Do not enter patient names, NHS numbers, hospital numbers, full dates of birth, addresses or other direct identifiers.