About This Page
This is a clinician-written, evidence-based summary aligned to the 2026 MLA Content Map. It is intended for medical students and junior doctors preparing for the UKMLA. Always cross-reference with NICE guidance, local protocols, and clinical judgement.
The Bottom Line
- Duty of candour: statutory (CQC Regulation 20) and professional (GMC) obligation to be open and honest when a patient safety incident causes harm
- Statutory duty (organisations): triggered by a "notifiable safety incident" causing moderate or severe harm, or death. Must: notify the patient/family, provide a truthful account, offer an apology, and investigate
- Professional duty (individual practitioners): GMC requires honesty with patients whenever something goes wrong, regardless of harm severity
- An apology is NOT an admission of liability — Compensation Act 2006 protects expressions of regret
- Report incidents: NHS trusts use incident reporting systems (e.g. Datix). Learn from errors through root cause analysis and systems improvement
Overview
The duty of candour is the obligation to be open and honest with patients when something goes wrong with their care. It has two components: the statutory duty (CQC Regulation 20, introduced following the Francis Report into the Mid Staffordshire NHS Foundation Trust inquiry, 2013) and the professional duty (GMC's ethical guidance). The statutory duty applies to healthcare organisations and is triggered when a notifiable safety incident results in moderate harm, severe harm, or death. The professional duty applies to individual healthcare professionals and requires honesty whenever any error occurs, regardless of severity. A culture of openness is essential for patient safety — it enables learning from mistakes and prevents recurrence.
Epidemiology
Medical errors contribute to approximately 10% of hospital admissions involving an adverse event. In the NHS, over 2 million patient safety incidents are reported annually through the NRLS/LFPSE (Learn from Patient Safety Events). The most common types are medication errors, falls, pressure ulcers, diagnostic errors, and communication failures. It is estimated that 150 patients die from avoidable harm per week in the NHS. The Francis Report (2013) exposed systematic cover-up of poor care at Mid Staffordshire, leading to the statutory duty of candour.
Key Concepts
Symptoms
Notifiable safety incident (statutory trigger): unintended or unexpected incident that could or did result in moderate harm, severe harm, prolonged psychological harm, or death
Being Open: the NHS framework for communicating with patients and families after an incident — includes apology, explanation, investigation, and support
Apology: an expression of sorrow or regret. The Compensation Act 2006 provides that an apology does NOT constitute an admission of negligence or liability
Root Cause Analysis (RCA): systematic investigation to identify underlying causes of an incident, focusing on systems and processes rather than individual blame
Just Culture: an approach that distinguishes between human error (support), at-risk behaviour (coach), and reckless behaviour (discipline)
Signs
Key distinction: the duty is to be HONEST, not to be RIGHT. If you don't know what went wrong, say so — and commit to investigating
The duty applies even if the error did not cause harm — GMC requires openness about near-misses too
Processes
First-line
Incident reportingReport all patient safety incidents through local incident reporting system (e.g. Datix). National reporting via LFPSE (Learn from Patient Safety Events service — replaced NRLS in 2023)
Immediate actionsEnsure patient safety, provide immediate treatment, inform senior colleagues, document the incident factually
Second-line
Duty of candour notificationWritten notification to the patient/family within 10 working days: what happened, what investigation is being done, what has been learned, apology
InvestigationLocal investigation (RCA/After Action Review) for moderate harm. Patient Safety Incident Investigation (PSII) for serious incidents (replaces Serious Incident framework from 2022)
Specialist
Coroner referralIf the incident resulted in death and falls within coronial criteria
GMC/NMC referralIf individual recklessness or fitness to practise concerns identified
NHS Resolution (NHSR)Manages clinical negligence claims. Early Notification scheme for maternity incidents
1
When something goes wrong
- Put the patient first — assess and treat any harm caused
- Be honest: tell the patient (or family) what happened, as soon as reasonably possible
- Apologise sincerely — an apology is NOT an admission of liability
- Explain what investigation will take place and keep the patient informed of progress
- Offer practical support and ongoing communication
- Report the incident through the local reporting system
2
Organisational responsibilities
- Statutory duty of candour (CQC Reg 20): notify patient/family in writing within 10 working days of becoming aware of a notifiable incident
- Investigate: use PSIRF (Patient Safety Incident Response Framework, 2022) methodology — proportionate response based on severity
- Learn and improve: share findings, implement changes, monitor outcomes
- Support staff involved — "second victim" phenomenon is well recognised
3
Individual professional duties
- Be honest with patients, colleagues, and your organisation
- Report errors even if they did not cause harm (near-misses)
- Do NOT cover up, alter records, or mislead patients
- Participate in investigations and audits
- Seek support if you are involved in an incident — wellbeing matters
Complications
- Cover-up: Attempting to conceal an error is far more damaging than the error itself — professionally, legally, and ethically
- Litigation: Failure to be open increases likelihood of legal claims and higher damages
- GMC investigation: Dishonesty about an error is more likely to lead to erasure than the error itself
- Systemic failure: Without reporting and learning, errors recur (as demonstrated by Mid Staffordshire)
- Second victim: Healthcare professionals involved in errors suffer psychological harm — must be supported
UKMLA Exam Tips
- 1An apology is NOT an admission of liability — the Compensation Act 2006 protects you. Always apologise when something goes wrong
- 2Statutory duty of candour is triggered by MODERATE or higher harm. Professional duty applies to ALL errors (GMC)
- 3Written notification within 10 working days for notifiable safety incidents
- 4Covering up an error is MORE damaging than the error itself — honesty is always the right answer in exam scenarios
- 5Francis Report → Mid Staffordshire → statutory duty of candour. Know this chain of events
- 6Just Culture: human error = support, at-risk behaviour = coach, reckless behaviour = discipline
practicetest your knowledge on medical error and duty of candourApply what you've learnt with UKMLA-style questions from the iatroX Q-Bank — ethics & law and beyond.
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