Research and analysis

Findings of the call for evidence on the statutory duty of candour

Published 26 November 2024

Applies to England

Introduction

This report presents the findings of the call for evidence on the statutory duty of candour for health and social care providers in England, launched in April 2024 by the Department of Health and Social Care (DHSC).

The call for evidence forms part of a review of the duty, announced in the then government’s response to the Hillsborough disaster report on 6 December 2023, to consider its operation, including compliance and enforcement.

The statutory (organisational) duty of candour is a crucial, underpinning aspect of an open and transparent culture which supports staff to be candid when things go wrong during the provision of care and treatment. When such errors occur, patients and service users and their families or caregivers expect to be informed honestly about:

• what happened
• what can be done to deal with any harm caused
• what will be done to prevent a recurrence to someone else

We are publishing this report on the findings of the call for evidence ahead of a final response to the review of the duty of candour. This is due to 3 developments since the call for evidence was published.  

Firstly, the final report of the Infected Blood Inquiry (May 2024) included wider recommendations to improve patient safety, including for the duty of candour to cover individuals in leadership positions in NHS organisations, and making them accountable for responding to concerns about patient safety. Publishing the results of the call for evidence on the statutory duty of candour is also a step towards fulfilling the recommendation from the Infected Blood Inquiry to publish the review as soon as practicable.

Secondly, in the King’s Speech in July 2024, the government committed to bring forward legislation to establish a Hillsborough Law ahead of the next anniversary of the Hillsborough disaster. This would establish a duty of candour on all public servants and officials, with criminal sanctions for the most serious breaches.

Thirdly, the government committed to the regulation of NHS managers and is today launching a public consultation to gather views from managers, regulators, patients, the public, healthcare staff and employing organisations on options and considerations for the regulation of NHS managers. The consultation includes questions on a professional duty of candour for NHS managers and on the existing statutory (organisational) duty of candour in respect of managers.

The government will carefully consider both the responses to the manager regulation consultation (the findings will be published as soon as possible following closure of the consultation), and the call for evidence on the statutory duty of candour, as it continues to develop policy on candour in healthcare.

Summary of main findings

In April 2024, DHSC launched a call for evidence to consider the operation of the statutory duty of candour (‘the duty’) for health and social care providers in England.

We received 261 responses from members of the public, including:

• patients
• service users
• families and caregivers
• healthcare professionals
• healthcare providers
• healthcare regulators
• healthcare organisations

The survey consisted of 10 closed and 12 open-ended questions and covered:

• respondents’ understanding of the purpose, criteria and thresholds of the duty
• compliance, monitoring and enforcement of the duty
• challenges to application of the duty and suggested improvements

We found that:

• 2 in 5 respondents (40%) thought the purpose of the statutory duty of candour is clear and well understood. Some commented that the duty has become a tick-box exercise, with staff and providers going through the motions to fulfil the duty, and not demonstrating compassion, for example through the use of standard templates and wording in letters to patients and/or service users which appear impersonal
• over half of respondents (54%) did not think staff working for health and social care providers know of and understand the duty’s requirements. Respondents felt that application of the duty is inconsistent and open to (mis)interpretation. This may be due to confusion between organisational and professional duty of candour, variations in staff interpretation of criteria for triggering a notifiable safety incident, and some groups having less knowledge of the duty, such as non-clinical, new or agency staff
• less than 1 in 4 respondents said that the duty is correctly complied with when a notifiable safety incident occurs (23%). Some felt staff are reticent about complying with the duty for fear that it admits fault and liability and leaves them open to blame. Others reported instances where staff were empathetic and aimed to follow the process, but senior management did not support them, and they feared not being protected if considered a ‘whistleblower’. Some respondents also believed there to be a culture of covering up incidents, falsification of records and dismissal of complaints
• respondents were divided in their assessment of provider engagement with 94% of patients or service users disagreeing that providers engage meaningfully and compassionately with those affected after a notifiable safety incident, compared to 27% of health or care professionals
• some patients and service users do not understand their rights. Specifically, their rights to access documents and receive an apology or response from a healthcare provider, and what they can do if they feel their case meets the criteria, but communication has been inadequate, or processes not followed
• generally, respondents who were patients, service users, family members or caregivers were more critical of the duty and its application, compared to health and/or care professionals and organisations
• overall, 3 themes are prominent throughout the survey and have been identified across questions, these are:
  • culture (of the health and care system)
  • inconsistency (in understanding and applying the duty)
  • training (the lack of it, the need for further training)

Background

The statutory duty of candour (organisational) places a direct obligation upon NHS trusts and all other health and social care providers registered with the Care Quality Commission (CQC) to be open and honest with patients, service users and their families, when a notifiable safety incident occurs.

A notifiable safety incident is defined as one that:

• was unintended or unexpected
• occurred during the provision of an activity that CQC regulates
• in the reasonable opinion of a healthcare professional, has or might result in death or severe or moderate harm (including psychological) to the person receiving care

Regulation 20 provides further information on the harm thresholds for health service bodies, and for all other services CQC regulates.

Once a provider knows that a notifiable safety incident has occurred, they must:

• notify the relevant person of the incident in person to say sorry, explain what is known, and any further enquiries to be made
• offer the person reasonable practical and emotional support
• provide the person with written notes of the initial discussion and of the notification, details of further enquiries, their results and an apology. The organisation is also required to keep copies of all correspondence relating to the incident

This statutory duty is enforced by the CQC. If a provider is found to be non-compliant, the CQC can impose conditions on them, issue warning notices and fines, remove their registration, and bring criminal prosecutions without needing to first serve a warning notice.

It is important to note that this is distinct from the professional duty of candour, which places an obligation on health and care professionals - as individuals - to be open and honest with patients and service users when things go wrong. This is regulated by professional regulators such as the General Medical Council (GMC), Nursing and Midwifery Council (NMC) and the General Dental Council (GDC).

Methods 

Data collection 

This call for evidence comprised of:

• a digital (‘core’) survey on GOV.UK, open from 16 April to 29 May 2024
• a digital and print easy read version of the survey, open from 22 May to 28 June 2024

It was open to members of the public, including patients, service users, families and caregivers, as well as healthcare professionals, providers, regulators and organisations.

The core survey contained 10 closed-ended and 12 open-ended questions, to find out:

• the extent to which the purpose of the duty is understood
• the extent to which the criteria and thresholds set out in the duty are understood
• whether and how the duty is complied with, monitored, and enforced
• any challenges limiting the proper application of the duty
• suggested improvements

The easy read version contained a shorter list of questions. Responses from the easy read survey have been combined with those of the core survey, to be analysed and presented together, as a single set of results. 

The table below sets out the questions asked in the ‘core’ call for evidence survey, and how these map across to the questions asked in the easy read version.

The first 10 questions listed on the table were closed-ended questions, where respondents were asked to select one of ‘agree’, ‘neither agree nor disagree’, ‘disagree’ or ‘I don’t know’ as their answer. They were then asked to provide views, evidence or experience to explain each answer.

Table 1: call for evidence survey questions

Core survey	Easy read survey
Do you agree or disagree that the purpose of the statutory duty of candour is clear and well understood?	Do you think that it is clear and easy to understand why we need a duty of candour?
Do you agree or disagree that staff in health and/or social care providers know of, and understand, the statutory duty of candour requirements?	Do you think that staff in health and social care know about and understand the duty of candour?
Do you agree or disagree that the statutory duty of candour is correctly complied with when a notifiable safety incident occurs?	Do you think that staff follow the duty of candour rules if an incident happens?
Do you agree or disagree that providers demonstrate meaningful and compassionate engagement with those affected when a notifiable safety incident occurs?	Do you think that staff are honest and open with people when an incident is reported?
Do you agree or disagree that the 3 criteria for triggering a notifiable safety incident are appropriate?	Do you think that these are the right 3 things for it to count as an incident?
Do you agree or disagree that the statutory duty of candour harm thresholds for trusts and all other services that CQC regulates are clear and/or well understood?	Not asked
Linked to the previous question, do you agree or disagree that the statutory duty of candour harm criteria that the incident must have been unintended or unexpected is clear and/or well understood?	Not asked
Do you agree or disagree that notifiable safety incidents are correctly categorised and recorded by health and/or social care providers, therefore triggering the statutory duty of candour?	Not asked
Do you agree or disagree that health and/or care providers have adequate systems and senior level accountability for monitoring application of the statutory duty of candour and supporting organisational learning?	Not asked
Do you agree or disagree that regulation and enforcement of the statutory duty of candour by CQC has been adequate?	Do you think that CQC makes sure services are following the duty of candour properly?
What challenges, if any, do you believe limit the proper application of the statutory duty of candour in health and/or social care providers?	What things make it hard for health and social care services to follow the rules for the duty of candour?  Please tell us here:
Provide any further feedback that you feel could help shape our recommendations for better meeting the policy objectives of the duty of candour.	Is there anything else we could do to help make the duty of candour better?  Tell us here:

Data analysis            

For the closed questions, we analysed the overall proportion of respondents agreeing or disagreeing with each statement. We then looked at variation between individuals, professionals and organisations. The sample size was too small to reliably analyse the results by other characteristics, such as ethnicity. Survey data tables are available and set out the overall proportion of respondents agreeing or disagreeing to each question, and a breakdown by respondent type. Percentages are calculated based on the total number of responses for each question, therefore non-responses to individual questions are excluded from the total for that question.

For the open-ended questions, we undertook inductive content analysis. This enabled us to identify emerging themes and patterns as we read through the responses. Once the core themes were identified and defined, a second analyst then re-read the responses to ensure all were captured under the relevant headings.

We quote a selection of anonymised comments left by respondents. These comments have been selected manually to best represent and give further insight into the themes that emerged during analysis. Where comments have been shortened, the omitted text is represented by an ellipsis in brackets (…). Care was taken to ensure this did not misrepresent what the individual was telling us or their tone of voice. Where we added content to a quote, this is to provide the reader with important information to understand the quote and this is indicated by square brackets [ ]. Spelling errors have not been corrected but are indicated as ‘(sic)’ within the quote. No other changes have been made.

Caveats 

It is important to note the following limitations when interpreting the results of this call for evidence:

• the findings are only representative of those who responded and cannot be generalised to the population at large. For context, in 2023 to 2024 there were an estimated 600 million patient contacts with GP, community, hospital, NHS111 and ambulance services, and in 2023 there were over 1.3 million full-time equivalent (FTE) staff directly employed by NHS England. Regarding social care, in 2022 to 2023, 629,050 clients had long-term care at year end (31 March 2023) arranged or provided by their local authority. During 2023 and 2024, 1.275 million FTE staff were working in social care across independent providers, Local Authorities, the NHS and direct payment recipients
• while the professional duty of candour was outside the scope of this call for evidence, our analysis suggests that many respondents did not know this is distinct from the statutory organisational duty of candour. This may have influenced some of the results
• the Infected Blood Inquiry Report, which highlighted a lack of transparency and candour as a core theme, was published on 20 May 2024. Some respondents provided feedback that they were not aware of this call for evidence until this report was issued, and that they had insufficient time to then meaningfully engage with it before it closed on 28 May 2024
• Any suggestions included in this report are reflective of what respondents told us and are not necessarily endorsed by DHSC, NHS England (NHSE), or the government

Results

We received 261 responses to this call for evidence: 249 to the core survey, and 12 to the easy read survey. We present the results for each question as the statistics describing the closed questions alongside the content analysis of open-ended responses. The last two questions were open-ended only questions.

We report the main themes occurring to each open-ended response in the following chapter. However, it is worth noting that we have analysed multiple other themes and we briefly report on those for each question, too.

Overall, 3 themes are prominent throughout the survey and have been identified across questions, these are:

• culture (of the health and care system)
• inconsistency (in understanding and applying the duty)
• training (the lack of it, the need for further training)

All statistics referred to in this report are also available in the accompanying data tables.

Respondent demographics

The survey (including responses to the easy read version) captures responses from:

• individuals sharing their personal views (34)
• patients and service users (48)
• family members and caregivers (31)
• health and/or care professionals (94)
• organisations (54)

Most respondents were aged 55 to 64 (30%), followed by those aged 45 to 54 (29%) and those aged 35 to 44 (21%). Other age groups were less represented.

The majority of respondents were female (66%). Minoritised ethnic groups are under-represented in this call for evidence. Asian/Asian British, Black/black British and mixed or multiple ethnic groups are represented by less than 5% of respondents each, 80% of respondents state their ethnicity as White.

Overall, we heard fewer examples relating to social care compared to NHS healthcare.

Responses to ‘Do you agree or disagree that the purpose of the statutory duty of candour is clear and well understood?’

Overall, 40% of respondents felt that the purpose of the statutory duty of candour is clear and well understood. While 45% of those who responded as health or care professionals agreed with this statement, it was only 34% of those responding as patients and service users who agreed.

Figure 1: responses to the question ‘Do you agree or disagree that the purpose of the statutory duty of candour is clear and well understood?’, by respondent group

Note: due to rounding, figures may not add up to 100%.

Respondent	agree	disagree	neither agree nor disagree	don’t know	Total
Organisation	45%	33%	22%	0%	100%
Family member	35%	45%	16%	3%	100%
Individual	35%	41%	24%	0%	100%
Health or care professional	45%	36%	18%	1%	100%
Patient or service user	34%	51%	15%	1%	100%

While some respondents said that the overarching purpose and principal of the duty is clear, many respondents felt that there is an inconsistent understanding of duty across provider types, locations and roles.

For example, some respondents felt that health and care professionals understand the duty better than members of the public for whom it may be relevant as patients or family members.

Some respondents found health and care professionals’ understanding of the duty varied. Some indicated that this varied depending on the place of work (primary or secondary care facility) or role (for example, whether in a leadership position) or even specialty.

From an individual:

Very variable. High level staff and patient safety teams generally have a good understanding of the purpose. Other levels of staff - not so much.

Most respondents who are health or care professionals felt that although the regulation is clear and comprehensible, the interpretation of the duty in practice is difficult and levels of understanding vary across staff groups. Other respondents expressed that the legislation and what is required of professionals are open to interpretation.

Individuals, patients and family members responded that they have experienced inconsistent implementation of the duty. Some respondents felt the duty was purposefully not applied correctly in their case, others attributed the inconsistency to a lack of understanding of the duty or barriers such as fear of retribution.

Respondents also mentioned uncertainty created through the interaction with other duties and safety frameworks, some mentioned a lack of training and support, some felt the duty was not widely known. While some felt supporting guidance was helpful, others found guidance confusing.

Responses to ‘Do you agree or disagree that staff in health and/or social care providers know of, and understand, the statutory duty of candour requirements?’

Over half of the respondents who work as health or social care professionals (53%) did not think health and social care providers know and understand the duty’s requirements, only 1 in 5 (25%) thought providers know and understand the requirements. More than 7 in 10 respondents who are patients or service users (71%) did not think that providers know and understand the duty’s requirements.

Figure 2: responses to the question ‘Do you agree or disagree that staff in health and/or social care providers know of, and understand, the statutory duty of candour requirements?’, by respondent group

Note: due to rounding, figures may not add up to 100%.

Respondent	agree	disagree	neither agree nor disagree	don’t know	Total
Organisation	21%	31%	42%	6%	100%
Family member	17%	60%	10%	13%	100%
Individual	21%	62%	12%	6%	100%
Health or care professional	25%	53%	21%	1%	100%
Patient or service user	17%	71%	6%	6%	100%

Respondents from all roles (health and care professionals, individuals, patients and family members, and those responding on behalf of an organisation) felt that the details of the duty were not consistently well understood. This included the duty’s threshold, proper recording of incidents, timings of responses, and roles and responsibilities.

On behalf of an organisation:

Lack of clarity regarding thresholds and some misunderstanding regarding establishing harm as a result of an incident vs poor outcomes or other pre-existing conditions. Similar terminology used in professional duty of candour can give rise to confusion as to when duty of candour applies.

Some respondents did not doubt professionals’ knowledge or understanding of the duty’s requirements but saw a culture of blame and denial at the heart of their poor experiences. Some respondents felt that professionals were actively covering incidents up to protect their or their organisation’s reputation.

A family member:

Our experience suggests that they either do not know or understand the statutory duty or simply demonstrate a blatant disregard for the same. There would seem to be a pervasive culture of attempting to avoid recognising, acknowledging and apologising for neglect and negligence in an attempt to avoid adverse publicity and reports and litigation.

Those respondents who are professionals or applying on behalf of an organisation mentioned that training is inadequate and/or lacking. According to respondents, this might mean staff are aware of the requirements in theory but unsure about how to apply them in practice, leading to inconsistent application of the duty.

Respondents also expressed a sense that staff may be reticent about candour for fear of admitting liability, others suggested staff may be confused about professional, statutory, and contractual requirements for candour. Some staff explicitly said they, or colleagues, were unaware of the duty, while other respondents spoke positively about awareness and understanding of the duty among staff.

Responses to ‘ Do you agree or disagree that the statutory duty of candour is correctly complied with when a notifiable safety incident occurs?’

About a third of respondents who answered on behalf of an organisation (31%) and about 2 in 5 respondents who responded as health and care professionals (39%) said that the duty is correctly complied with when a notifiable safety incident occurs. However, none of the respondents who are family members and only 4% of patients or service users, believed that this is the case.

Figure 3: responses to the question ‘Do you agree or disagree that the statutory duty of candour is correctly complied with when a notifiable safety incident occurs?’, by respondent group

Note: due to rounding, figures may not add up to 100%.

Respondent	agree	disagree	neither agree nor disagree	don’t know	Total
Organisation	31%	35%	31%	4%	100%
Family member	0%	81%	16%	3%	100%
Individual	16%	50%	25%	9%	100%
Health or care professional	39%	26%	30%	5%	100%
Patient or service user	4%	90%	2%	4%	100%

Many of those who responded as patients, individuals or family members told us about poor experiences regarding the application of the duty. In some instances, respondents alleged staff or the wider system to ignore them or to cover up instances (for example, through falsifying notes).

Some respondents believe that the duty is mostly correctly complied with but acknowledge that this might be done inconsistently. Those respondents sometimes felt that the duty was complied with as a tick-box exercise.

Respondents who are health or care professionals, generally felt more confident about the correct compliance with the duty. However, they reported that in some cases the workplace culture (for example, bullying) or a lack of knowledge of the correct procedures (for example, delivering a verbal but not written apology) inhibit compliance. Some expressed that while intending to comply they may not be able to act in a timely way due to workload or communication barriers. Some mentioned uncertainty regarding the correct identification of a notifiable incident using the 3 criteria set out in the legislation. 

A health or care professional:

The duty of candour is followed in the event of a notifiable patient safety incident that has led to moderate harm, or above. The challenge for clinicians is in the definitions and a consistent understanding of when the duty applies.

Related to this, respondents mentioned that the duty of candour framework does not align with other available guidance, such as learn from patient safety events, for example in terms of harm definitions.

Inadequate communication with patients and families was also mentioned by respondents, some also reported difficulties when accessing document. Respondents also made references to staff avoiding the application of the duty for fear of consequences, others because of a lack of awareness and understanding.

Responses to ‘ Do you agree or disagree that providers demonstrate meaningful and compassionate engagement with those affected when a notifiable safety incident occurs?’

Half of all respondents (50%) did not find that providers demonstrate the appropriate engagement with those affected after a notifiable safety incident. However, this varied by the role of the respondents, with 94% of patients or service users disagreeing that providers engage meaningfully and compassionately compared to 27% of health or care professionals.

Figure 4: responses to the question ‘Do you agree or disagree that providers demonstrate meaningful and compassionate engagement with those affected when a notifiable safety incident occurs?’, by respondent group

Respondent	agree	disagree	neither agree nor disagree	don’t know	Total
Organisation	33%	30%	30%	7%	100%
Family member	3%	81%	13%	3%	100%
Individual	15%	55%	24%	6%	100%
Health or care professional	38%	27%	34%	1%	100%
Patient or service user	4%	94%	0%	2%	100%

A common theme among respondents was that there were good and bad examples of meaningful and compassionate engagement, some respondents attribute this to organisational culture and others to individuals.

Many of those who responded as patients, those affected by the duty, family members, or carers reported poor experiences regarding providers’ engagement with them after a notifiable safety incident. Respondents expressed that they were not engaged with in a way that they expected, sometimes without a clear indication of whether the duty applies. Respondents also felt that basic information was withheld from them and at times they felt belittled.

A family member:

I have experienced no meaningful engagement and no compassion whatsoever. Eight months on, I am still lacking basic information about the sequence of events that occurred on the night my father died and I still do not know who was looking after him or supposed to be looking after him.

When attributing poor experiences to organisational culture, respondents often expressed that providers seemed to care more about protecting their reputation or avoiding legislation, than engaging compassionately with patients or family members.

A family member:

(…)   Leaders appear to immediately clamp down on any disclosures- incorrectly pressuring staff that such would be an ‘admission’ of liability. Providers will universally deny incidents - instead of offering disclosure, they will deny until they have seen if the notifiable person has any evidence themselves. (…)

Sometimes, respondents felt that process was followed, however, compassion was lacking. Respondents called it a tick-box exercise or checklist.

Respondents also mentioned that they felt staff may be unclear about their roles in fulfilling the duty. Another theme was that respondents felt staff did not want to admit liability which in turn discouraged them from being compassionate and engaging meaningfully with patients and families.

Responses to ‘ Do you agree or disagree that the 3 criteria for triggering a notifiable safety incident are appropriate?’

Overall, 2 in 5 respondents (40%) agreed that the 3 criteria are appropriate for triggering a notifiable safety incident. However, this varied between respondents who answered as health or care professionals, of which about half (51%) found the criteria appropriate, and patients or service users, of which about a fifth (22%) found the criteria appropriate.

Figure 5: responses to the question ‘Do you agree or disagree that the 3 criteria for triggering a notifiable safety incident are appropriate?’, by respondent group

Note: due to rounding, figures may not add up to 100%.

Respondent	agree	disagree	neither agree nor disagree	don’t know	Total
Organisation	47%	26%	21%	6%	100%
Family member	28%	31%	34%	7%	100%
Individual	38%	38%	22%	3%	100%
Health or care professional	51%	26%	18%	4%	100%
Patient or service user	22%	43%	17%	17%	100%

Few respondents said outright that the criteria were appropriate. Some said that they find the criteria appropriate, however, they needed to be better understood (for example through more robust definitions) and adhered to (for example, more consistently applied).

An individual:

This needs to be reviewed and if necessary the criteria revisited and rewritten to enforce accountability, transparency and openness.

Respondents indicated that criterion 1 (the incident was unintended or unexpected) was unclear. Respondents felt that the outcome, the care or the treatment could all be unintended or unexpected and it was not clear which, or all, were in scope. Respondents also felt that unintended or unexpected can be interpreted differently by different health professionals (for example, a known but unlikely complication may or may not count as unexpected).

Respondents felt that criterion 3 (the incident has or might result in death, or severe or moderate harm to the person receiving care, in the opinion of a healthcare professional) is ambiguous and open to subjective interpretation. Those responding as health or care professionals explained that in some cases it is hard to know whether harm or death is directly caused by an incident. They also said that opinions on the meaning of ‘moderate harm’ can vary. Some explained that because health professionals may not oversee a patient’s full treatment journey, they may not have all the information and therefore may not be able to judge the incident correctly.

Some respondents argued for a lower threshold, which would mean that not all 3 criteria must be met to establish a notifiable safety incident. Some proposed to expand the 3 criteria. Respondents suggested that an expansion could include intended actions, cover-ups, near misses, misdiagnosis or lost records. Respondents also suggested that the definition of a health professional could be extended to include for example social workers.

Respondents also mentioned that they generally find it difficult to apply the 3 criteria effectively, saying it is easier to follow them in secondary or acute care compared to primary and social care. Some patients felt that the duty was not needed in their case and that it brought back traumatic memories, while others felt they were harmed, and the duty was not acted on. Related to this theme, some patients felt their perception differed from the healthcare professionals’ and that they deserved an apology and/or application of the duty. Some respondents criticised that certain services were excluded from the duty (for example learning disability care providers).

Responses to ‘Do you agree or disagree that the statutory duty of candour harm thresholds for trusts and all other services that CQC regulates are clear and/or well understood?’

This question was not asked in the easy-read survey.

Less than 1 in 3 of those who responded on behalf of an organisation (28%) and 1 in 4 of the respondents who are health and social care workers (25%) agreed that the harm thresholds for trusts and services, which are regulated by CQC, are clear and well understood. Those responding as patients or service users or family members see this even more critically with only 1 in 10 (10% of patients and/or service users and 11% of family members) agreeing with this statement.

Figure 6: responses to the question ‘Do you agree or disagree that the statutory duty of candour harm thresholds for trusts and all other services that CQC regulates are clear and/or well understood?’, by respondent group

Note: due to rounding, figures may not add up to 100%.

Respondent	agree	disagree	neither agree nor disagree	don’t know	Total
Organisation	28%	42%	23%	7%	100%
Family member	11%	68%	14%	7%	100%
Individual	20%	53%	23%	3%	100%
Health or care professional	25%	53%	20%	2%	100%
Patient or service user	10%	73%	13%	5%	100%

Respondents commonly mentioned inconsistent application of the duty and its thresholds. The inconsistency is perceived to stem from subjective interpretation of the duty’s thresholds as well as confusion about thresholds that are defined differently in other guidance such as learn from patient safety events.

A health or care professional:

‘In the reasonable opinion of a healthcare professional, already has, or might, result in death, or severe or moderate harm to the person receiving care’, can be interpreted differently by different people and this definition does not align with the harm definitions set under LFPSE [learn from patient safety events].

Respondents felt that the level of understanding of harm thresholds varies among health and care staff. Those who responded as health or care professionals expressed that further education and training on the subject would help.

Some respondents felt that it can be hard to distinguish between a lack of understanding and a lack of compliance. Some indicated they believe that the duty is understood but ignored or intentionally not complied with.

Other topics raised by respondents included:

• the duty being a barrier to adequate patient communication as the process is long and complicated
• the duty being understood differently in different health and care sectors and organisations
• a lack of trust, with patients not trusting the process and staff not trusting managers to support them
• a lack of transparency and openness

Responses to ‘Linked to the previous question, do you agree or disagree that the statutory duty of candour harm criteria that the incident must have been unintended or unexpected is clear and/or well understood?’

This question was not asked in the easy-read survey.

Respondents answered this question similarly to the question which asks generally about the understanding of the harm thresholds. Only 1 in 4 of respondents who answer on behalf of an organisation (25%) and 1 in 3 of those responding as health and care professionals (30%) agree that the duty’s harm criterion about the incident being unintended or unexpected is clear or well understood. About 1 in 10 (11%) of patients or service users and 1 in 5 (22%) of family members agree with this statement.

Figure 7: responses to the question ‘Linked to the previous question, do you agree or disagree that the statutory duty of candour harm criteria that the incident must have been unintended or unexpected is clear and/or well understood?’, by respondent group

Note: due to rounding, figures may not add up to 100%.

Respondent	agree	disagree	neither agree nor disagree	don’t know	Total
Organisation	25%	45%	25%	5%	100%
Family member	22%	44%	26%	7%	100%
Individual	20%	53%	20%	7%	100%
Health or care professional	30%	45%	23%	2%	100%
Patient or service user	11%	71%	11%	8%	100%

A few respondents felt that the criterion regarding incidents being unintended or unexpected was clear. However, a more prevalent impression among respondents was that this criterion was ambiguous. Those who responded as health or care professionals reiterated that this criterion could lead to confusion and said that further training, clearer definitions, examples, or case studies would help to understand which incidents are in scope.

On behalf of an organisation:

This can be confusing and challenging to understand, especially the ‘unexpected’ element.  As a provider of adult social care many individuals in our services may be living with multiple health conditions which may add complexity to this decision.

Respondents mentioned that culture is a barrier to applying this criterion consistently as providers seem to prioritise their reputation over the duty. Respondents also expressed concerns around the roles of staff being unclear in fulfilling the duty.

Responses to ‘Do you agree or disagree that notifiable safety incidents are correctly categorised and recorded by health and/or social care providers, therefore triggering the statutory duty of candour?’

This question was not asked in the easy-read survey.

Overall, about 1 in 5 respondents (21%) thought that health and care providers are correctly categorizing and recording notifiable safety incidents which trigger the duty. However, perceptions of this varied by role. About 1 in 3 of the respondents who answer on behalf of an organisation (30%) and those responding as health and care professionals (31%) agreed that this is correctly done. Less than 1 in 10 of those responding as family members (7%) and even less of those responding as patients or service users (3%) agreed with this.

Figure 8: responses to the question ‘Do you agree or disagree that notifiable safety incidents are correctly categorised and recorded by health and/or social care providers, therefore triggering the statutory duty of candour?’, by respondent group

Note: due to rounding, figures may not add up to 100%.

Respondent	agree	disagree	neither agree nor disagree	don’t know	Total
Organisation	30%	19%	33%	19%	100%
Family member	7%	75%	11%	7%	100%
Individual	16%	39%	32%	13%	100%
Health or care professional	31%	40%	24%	4%	100%
Patient or service user	3%	74%	5%	18%	100%

Respondents commonly expressed that they believe some incidents are not recorded or that they are recorded inaccurately. Respondents attribute this to either an uncertainty in identifying an incident as a notifiable safety incident, or an unwillingness to accept that a notifiable safety incident has occurred.

On behalf of an organisation:

This varies. Some staff are more familiar with the reasoning than others. Very often they are not correctly categorised and have to be amended with DoC [Duty of Candour] Lead and Patient Safety team advice and support.

Related to this, respondents felt that incidents are not categorised consistently across health and social care providers and that different definitions and interpretations are common. Therefore, patients, professionals, and family members may experience incidents very differently. Some respondents felt that staff or the wider organisation were covering up or denying incidents, for example through falsifying notes.

Further, respondents mentioned that timing is an issue with delays to the process being caused by wrong identifications of incidents, staff and paperwork. Related, respondents mentioned that they experienced inadequate communication and with patients or families. Some respondents mentioned the duty has not been triggered because of incorrect identification of events, confusion around the process or conflicting guidelines in other frameworks. Respondents also told us that the identified incidents should be used to improve the system and enable learning.

Responses to ‘Do you agree or disagree that health and/or care providers have adequate systems and senior level accountability for monitoring application of the statutory duty of candour and supporting organisational learning?’

This question was not asked in the easy-read survey.

Overall, 1 in 4 respondents (25%) said that providers have adequate systems and senior level accountability for monitoring the duty’s application and supporting organisational learning. A slightly larger proportion of those responding as health or care professionals (38%) or on behalf of an organisation (30%) responded positively about adequate systems and senior level accountability.

Figure 9: responses to the question ‘Do you agree or disagree that health and/or care providers have adequate systems and senior level accountability for monitoring application of the statutory duty of candour and supporting organisational learning?’ by respondent group

Note: due to rounding, figures may not add up to 100%.

Respondent	agree	disagree	neither agree nor disagree	don’t know	Total
Organisation	30%	26%	30%	15%	100%
Family member	0%	71%	18%	11%	100%
Individual	22%	47%	22%	9%	100%
Health or care professional	38%	40%	20%	2%	100%
Patient or service user	10%	78%	0%	13%	100%

Many respondents felt that systems in place for monitoring and learning were inadequate or not supportive. Respondents referred to paperwork, a lack of digital systems, and the time needed to process incidents in an environment where resource is already stretched. Some highlighted that processes are dependent on different internal reporting and monitoring systems, some of which seem better suited than others. Respondents also explained that administrative staff who are involved in fulfilling the duty, are as stretched as the clinical teams they support. Those who responded as health or care professionals mentioned that opportunities for learning, or sharing lessons across organisations, are rare.

A health or care professional:

Varies between services - systems are in place but not implemented across the board. Some still operate on own without linking into monitoring equipment available. There is little organisational learning or sharing of incidents. Managers operate within a bubble and do not look to each other, or other services to benefit from learning opportunities available from other services. (…)

Respondents also expressed that they felt a lack of accountability at senior levels. Family members and patients felt that senior leaders were not available to be held accountable. Health and care professionals said they felt a lack of support from senior leaders and the wider system, while also referring to a culture of fear.

On behalf of an organisation:

The overall view was that staff members want to do the right thing, but they lack adequate support to do so. The statutory duty of candour has been transformed into a challenging and sometimes confusing process that providers find difficult to adhere to and execute, rather than being an intuitive, compassionate response simply because it is the right thing to do.

Additionally, respondents referred to the need for additional training for staff and the need for improvement oversight to ensure processes are correctly followed.

Responses to ‘Do you agree or disagree that regulation and enforcement of the statutory duty of candour by CQC has been adequate?’

The majority of respondents (52%) did not think that CQC has adequately regulated and enforced the duty. Only 2% of patients or service users and 3% of family members felt regulation and enforcement of the duty was adequate. 1 in 6 respondents who answered on behalf of an organisation (16%) thought the regulation and enforcement of the duty was adequate.

Figure 10: responses to the question ‘Do you agree or disagree that regulation and enforcement of the statutory duty of candour by CQC has been adequate?’, by respondent group

Note: due to rounding, figures may not add up to 100%.

Respondent	agree	disagree	neither agree nor disagree	don’t know	Total
Organisation	16%	31%	31%	22%	100%
Family member	3%	84%	6%	6%	100%
Individual	13%	66%	9%	13%	100%
Health or care professional	23%	33%	29%	15%	100%
Patient or service user	14%	52%	20%	14%	100%

Respondents felt that they had little to no evidence of CQC enforcement of the duty or any sanctions imposed on providers following non-compliance with the duty. This sentiment was shared by family members, patients, professionals, and those who responded on behalf of organisations. Some caveat that this may be due to a lack of information being shared about enforcement or sanctions. Respondents complain about a lack of transparency from trusts and CQC when it comes to the duty.

A health or care professional:

I am not aware of any enforcement except some articles online which suggest enforcement (although many are contradictory and not sure how accurate).

Those who responded as patients and family members complained about CQC being unresponsive to any communication, including details of incidents.

Respondents felt that regulation and enforcement were inadequate. Some respondents criticised the way inspections are conducted, for example through pre-announced inspections. Respondents felt that the duty was inconsistently enforced across locations and incidents, for example a perceived strict enforcement in one case and a perceived light touch enforcement in another case.

Respondents expressed that the quality of interaction with patients and families was important, at times more important than strict compliance with the steps of the duty. Some respondents felt they could not comment on this question.

Responses to ‘What challenges, if any, do you believe limit the proper application of the statutory duty of candour in health and/or social care providers?’

Respondents most commonly referred to the wider culture as a challenge to the proper application of the duty. They noted that the culture among providers should move away from being focused on blame and instead focus on safety, openness, and transparency.

A family member:

Our experience has been that there is a culture of dishonesty, a fear of being blamed and brought to justice - whatever format that might take - and a fear of negative reports and publicity which is takin* [sic] precedence over patient safety in our local trust. (…)

Those responding as health or care professionals expressed a fear of blame and speak of pressure they feel when involved in an incident, as well as concerns about litigation or repercussions. Those who responded as patients, or family members and carers acknowledged the challenges that health or care professionals may feel when confronted with a notifiable safety incident, such as feelings of guilt, fear of consequences, and lack of support.

A health or care professional:

Some staff feeling like they are declaring their own guilt by completing a DoC [Duty of Candour] - despite being informed that is not the case, this creates reluctance to complete or the constant passing around to others, meaning they breach their deadline for completion.

To overcome this barrier, respondents who are health or care professionals said that leadership needs to demonstrate accountability and reward openness, as well as dedicate resource to the appropriate management of incidents.

Respondents also argued that staff needed more training regarding the duty and the incidents to which it applies. Clearer language and illustrative examples are requested to improve understanding and address the inconsistency in application. Some mention that guidance for the duty should be harmonised with other frameworks such as learn from patient safety events, and patient safety incident response framework.

Time and resources are also frequently mentioned as key barriers to proper application of the duty. As previously mentioned, respondents do not feel that staff always have a clear understanding of the duty, this is compounded by the lack of time and resource to engage with incidents and follow necessary procedures. Wider staffing and funding pressures are cited with regards to little time and resource to dedicate to the application of the duty.

A health or care professional:

Resourses [sic] - it can be a whole industry in itself trying to monitor and ensure compliance with statutory duty of candour.

Other topics mentioned by respondents included: some forms of harm occurring outside the scope of CQC regulated activities being excluded from the duty, patients mistrusting the process and falsely understanding following the process as protectionism or falsification, and patients not understanding the language and definitions, leading to confusion.

Responses to ‘Provide any further feedback that you feel could help shape our recommendations for better meeting the policy objectives of the duty of candour.’

Respondents’ suggestions mainly address the challenges identified in the earlier question and focus on improving the existing policy to make the language simpler and clearer, including tangible examples, to shift the culture away from avoiding blame and towards openness and transparency, to increase education offers, for example through ringfenced training, and to increase accountability and introduce stricter consequences for non-compliance.

Some examples of respondents’ suggestions:

• a review and consolidation of duties, safety frameworks and harm definitions in this area, including the professional duty of candour, the Patient Safety Incident Response Framework, and the Learn from Patient Safety Events (LFPSE) service. The aim would be to reduce confusion, maximise harmonisation, and address conflicts in guidance
• standard training to improve staff understanding of when the duty applies and ensure consistency across health and/or care providers and organisations
• accountability and criminalisation at an individual level – ensuring senior managers who fail to comply with duty are held to account and therefore deterred from not being compliant. Where management responsibility is shared, greater clarity is needed over who is accountable
• increase resources to enable more organisational learning from incidents and improve digital systems