Candour about harm
Where death or serious harm has been or may have been caused to a patient by an act or omission of the organisation or its staff, the patient (or any lawfully entitled personal representative or other authorised person) should be informed of the incident, given full disclosure of the surrounding circumstances and be offered an appropriate level of support, whether or not the patient or representative has asked for this information.
- Regulation 20(3) requires the provider to provide the patient or their representative with a truthful account of all facts known about the incident at the time of the notification, provide reasonable support, and offer an apology. Regulation 20(5) requires the provider to provide a written notification including the results of any further enquiries into the incident (SI 2014/2936, Regulation 20).
- The Patient Safety Incident Response Framework (PSIRF), mandatory for all NHS-funded providers from autumn 2023, includes requirements for open and transparent communication with patients and families following patient safety incidents. PSIRF emphasises engagement with those affected throughout the investigation process (PSIRF, NHS England).
- DHSC's call for evidence on the duty of candour (November 2024) found that while the statutory obligation exists, compliance varies. Some respondents reported that organisations notify patients of incidents but do not always provide the ongoing explanation and support that Regulation 20 requires (DHSC Duty of Candour Call for Evidence, November 2024).
How was this evidence gathered?
Response
Accepted
Response
AcceptedThe government published "Hard Truths: the Journey to Putting Patients First" (Cm 8777) on 19 November 2013, responding to all 290 recommendations of the Francis Report. This followed an initial response "Patients First and Foremost" in March 2013. Key reforms included a new Chief Inspector of Hospitals, strengthened Care Quality Commission inspection regime, a statutory duty of candour, and the fit and proper person test for NHS directors. Volume 2 (Cm 8754) contains the government's detailed responses to each of the 290 recommendations. See: https://assets.publishing.service.gov.uk/media/5a7cd486ed915d63cc65d167/34658_Cm_8777_Vol_1_accessible.pdf
Published Evidence
Published assessments of progress from inspectorates, select committees, official progress reports, and other sources. Source type badge indicates whether each assessment is independent or government self-reported.
DHSC published findings of call for evidence on statutory duty of candour. 261 responses received. Key finding: 52% of respondents said CQC had not adequately enforced the duty. Many reported it had become a "tick-box exercise". Only 40% thought the purpose was clear and well understood. Final government response still pending.
Research published 2023 marking ten years since the Francis Report found mixed results. Structural and legislative changes largely delivered (duty of candour, FPPR, CQC overhaul, revalidation, Freedom to Speak Up Guardians). However, cultural change not fully embedded; understaffing, fear of speaking up, and poor complaint handling persist in parts of the NHS.
Government published "Culture Change in the NHS" (Cm 9009) reporting progress on all 290 recommendations. Key achievements: 19 hospitals placed in special measures; those trusts recruited 109 additional doctors and 1,805 additional nurses; 129 board-level changes made; excess avoidable deaths fell by 450 in less than a year.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 20: statutory duty of candour came into force for NHS trusts November 2014, extended to all CQC-registered providers April 2015. Requires providers to notify patients/families of notifiable safety incidents and apologise.
Government published "Hard Truths: The Journey to Putting Patients First" (Cm 8777) in two volumes. Vol 1 set out new actions; Vol 2 provided detailed response to each of the 290 recommendations. Approximately 204 of 290 recommendations were fully accepted.