We have responded to the second stage of the Care Quality Commission’s (CQC) Better regulation, better care consultation, which is focussed on proposals to introduce sector specific assessment frameworks.
The proposals aim to help the CQC improve how it assesses health and care services and makes judgements and help providers to better understand what the CQC looks at in an assessment.
In our response to the consultation, we highlight the importance of research in delivering high-quality care and that it should be seen as a business-as-usual activity, not a ‘nice to have’.
We outline how the research activity should be assessed and that research culture, activity and governance for good patient care should be reflected explicitly and consistently in the frameworks.
There is growing evidence that research active healthcare organisations achieve better outcomes and are associated with lower mortality rates and improved patient and carer experiences.
Building on our previous response, we also reiterated our willingness to support the CQC in defining clear research standards and assessment questions.
We responded to the first stage of the CQC consultation last year, which closed in December 2025. You can read our response on the HRA website.
Read our full response
Read our full response to second stage of the CQC better regulation, better care consultation below.
Question 1: Do you agree that the draft assessment framework(s) will support CQC to make clearer, more transparent judgements about quality?
Strongly agree
Agree
Neither agree nor disagree
Disagree
Strongly disagree
Question 2: Do you agree that the draft assessment framework for your sector will help providers to understand what CQC will look at in an assessment?
Strongly agree
Agree
Neither agree nor disagree
Disagree
Strongly disagree
Question 3: Do you agree that the draft assessment framework(s) will help CQC and providers to identify and address inequalities in care?
Strongly agree
Agree
Neither agree nor disagree
Disagree
Strongly disagree
Question 4:
We will retain our 5 key questions, I statements, and 4 levels of quality ratings. New elements include key lines of enquiry to replace the current quality statements. They have been framed as structured questions that describe what we will look for on our assessments.
Do you have any comments about the new key lines of enquiry (KLOEs)? For example, do they prioritise the aspects that are most important for delivering good quality care in the sector? Do any areas need a separate KLOE? Or can any KLOEs be combined?
(optional)
Please provide details, either overall observations or for specific KLOEs
Although research is explicitly included, there are opportunities within the KLOEs to more strongly reflect the importance of research activity. Whilst the HRA is not necessarily suggesting that there needs to be a separate KLOE for research, we would however encourage that the KLOEs are clear that supporting and delivering research is a key component of good care. There is growing evidence that research active healthcare organisations achieve better outcomes: research activity is associated with lower mortality rates, improved patient and carer experiences and lower staff turnover. This also reflects the ambition set out in the Government’s 10 Year Health Plan for England for research to be embedded throughout the NHS, with the NHS an active and collaborative partner in research and innovation that can improve patient outcomes.
Whilst we acknowledge research may be set up, approached and delivered differently across sectors and the necessity for the key lines of enquiry to allow for and reflect this nuance in each sector, we would encourage consistency across sectors in the importance placed on research activity in the rating characteristics.
Under the NHS England Medium Term Planning Framework, provider boards must discuss research every 6 months and from the 2026-2027 financial year, meet site-specific timeframes for setting up clinical trials. In addition, the NHS Standard Contract already requires every provider of NHS-funded services to help recruit suitable people, whether patients or staff, into approved research studies. From April 2026, NHS providers will be measured against a target to set up clinical trials within 150 days. This could provide the Care Quality Commission (CQC) with an objective way to monitor research activity at provider organisations.
We would therefore recommend that, particularly under well-led and effective, research activity, research enabling behaviours and the structures that are in place to support it are explicitly reflected in the rating characteristics to allow for research to be consistently looked for and assessed across each sector.
Question 5:
Rating characteristics will support us to make judgements about care. They aim to help the public and providers to understand what good care looks like, support our inspectors to make consistent judgements about quality, and recognise the important differences between sectors. They are not a complete checklist as we cannot include every aspect of care.
Do you have any comments about the rating characteristics that describe quality under each key line of enquiry (KLOE) for each rating level?
(optional)
The HRA strongly agreed with the reintroduction of rating characteristics as part of assessment frameworks to provide a clear structure to the assessment approach. With this change in approach, the HRA strongly encouraged continued recognition of ‘clinical research activity in the NHS as a key component of best patient care’. In our previous response, we advocated that this was not only carried forward but strengthened to ensure the importance of incorporating research as a core standard for all health and care providers is clear- in line with the UK Government’s 10 Year Health Plan for England. The HRA would like to see the expectation that research becomes business-as-usual activity, not a ‘nice to have’ reflected in the KLOE.
The HRA welcomes the rating characteristics reference to utilising data and research evidence, staff being empowered to participate in research programmes, and working with external partners in research under ‘outstanding’ and ‘good’. However, we would recommend widening research related rating characteristics within the KLOE to include-
- developing a culture that supports and promotes research,
- developing and maintaining infrastructure and capability to undertake research activities,
- patient involvement and community engagement in the design and conduct of research, and communication and implementation of findings from research.
For ‘outstanding’ and ‘good’ ratings we would also encourage the inclusion of well-run and proportionate research governance as part of effective leadership and assurance.
The need to publish research results in a publicly accessible space, as well as communicating the findings to participants, should be explicit across all sector-specific frameworks. For clinical trials of new medicines, registering the trial, publishing the summary of results, and offering to share results summary with participants is a legal requirement.
Metrics should be developed to measure embedded research activity in hospitals, including research infrastructure, research staffing, support for participation and evidence-based practice. Metrics should go beyond trial recruitment to assess integration of findings, staff training, patient access, and research-informed service redesign.
The HRA were pleased to see the inclusion of actively involving those who are likely to have poor outcomes in research opportunities within the assessment of improvement, innovation and learning. We would like to see this sentiment carried across the rating characteristics for all sectors and to be broadened to include rating characteristics reflecting the need for inclusive research design and practices providing equitable access to research opportunities for patients. Ratings should consider inclusive research culture that supports and ensures diversity of staff who conductus and delivers research and diversity of research participants.
Question 6: Overall, how clear do you find this draft assessment framework(s), for example is the language clear and understandable?
Very clear
Somewhat clear
Neutral
Somewhat unclear
Very unclear
Please give more detail:
The overall framework is clear and concise with a predictable format that is easy to follow. However, there are instances where the language surrounding research is not as explicit as it should be and could lead to uncertainty and inconsistency in how research is assessed. For example, in the references to the use of research evidence, it is not always clear whether this refers to service evaluation, other data or health research. Similarly, when research and clinical trials are listed within the scope section of the KLOE it is not always reflected within the rating characteristics how this should be assessed.
Question 7: We are keen to know whether these 4 assessment frameworks represent the sectors we regulate appropriately, or if they need to be separated in a different way, and if so, how?
Please provide specific details
N/A
Question 8: The content of the assessment frameworks is still in draft; do you have any overall comments that would help us to improve them, for example is anything missing, or is there any overlap?
Please provide specific details
The HRA would reinforce that core expectations of research culture, activity and governance for good patient care should be reflected explicitly and consistency in the KLOEs across all four sectors, even where the scale and nature of research activity differ.
The HRA would like to offer our support in highlighting sector specific considerations relevant to research and are keen to work with CQC to refine the wording within the rating characteristics.
Who we are
The Health Research Authority is part of the health and social care research sector that is focused on improving everyone’s health and wellbeing. Our vision is for high quality health and social care research today, which improves everyone’s health and wellbeing tomorrow.
The HRA was established in 2011 with a core purpose to protect and promote the interests of patients and the public in health and social care research. It is responsible for coordinating and standardising health and social care research regulation, overseeing Research Ethics Committees (RECs), managing approvals for confidential patient information, and making it easy to do safe, ethical, and transparent research that people can trust.
We work in partnership with the devolved administrations in Scotland, Wales and Northern Ireland so that people taking part in research anywhere in the UK have the same experience. Together we work with other public bodies to create a connected regulatory system that is easy for researchers to find out what they need to do and earn approvals that people can trust.
To make it easy to do research that people can trust, the HRA:
- works with people to understand what you want research to look like and acts on this so that you can trust research
- makes sure that people taking part in research in the UK are treated ethically and fairly, by reviewing and approving health and social care research activities that involve people, their tissue or their data before they can start as part of a UK-wide regulatory service
- champions research transparency, so that you can see when research is taking place, or the results of that research if it has finished
- works with other organisations across the UK to reduce the burden, cost and time to set up research, meaning that wherever you are, research studies can be set up smoothly and are always subject to the same scrutiny before they start. This includes running digital services and a UK-wide partnership to help plan, approve, set up, manage and complete research in the UK
- is one of the gatekeepers of patient data, making sure that your information is only used in research in ways that you can trust