A small NHS Engagement team in the National Institute for Heath Research (NIHR) Clincal Research Network have a remit to build opportunities to influence integration of research into patient care. Building these opportunities means considered work on a number of levels: from national high level strategic work - to the needs of frontline research and non-research staff in the NHS.

The NHS Engagement workstream forged work with the Care Quality Commission (CQC) and brought together a project partnership to agree how to include clinical research in CQC Monitoring and Inspection of NHS Trusts.

The partnership included:

• National Institute for Health Research (NIHR)
• Care Quality Commission (CQC)
• UK Research and Development Leaders (UKRD)
• NHS R&D Forum
• Health Research Authority (HRA)
• Patient Research Ambassadors (PRAs)
• Medicines and Healthcare products Regulatory Authority (MHRA)
• Association of UK University Hospitals

Patient Research Ambassadors have had a key catalysing role in this partnership work.

In September 2018 the CQC signed off the incorporation of clinical research in its Well Led Framework (NHS Trusts). This is the first time a major NHS regulator has formally recognised clinical research activity in the NHS as a key component of best patient care.

The new research questions can be found in section W8 in the CQC Trust Wide Well Led Framework:

Clinical research is no longer just a 'nice to do' exercise in the NHS - it is now a key part of improving patient care

Research is written into the NHS Constitution and this is now backed up through the CQC inspection process.

The focus is on how well an NHS Trust as a whole supports research activity. This involves strategic and divisional leadership, and patient opportunity and access around research:

The Three Levels:

• Research equity – how does the organisation support the research programme across the breadth of its services?
• Research facilitation – how does the organisation proactively support the delivery of research from board level to the clinical setting(s)?
• Research awareness – how does the organisation make research opportunity known to patients, the public and healthcare professionals?

The 3 Levels were first summarised by one of the Patient Research Ambassadors involved in the project and this structure has been used since.

Dr William van’t Hoff, Clinical Director for NHS Engagement at the NIHR, Clinical Research Network says:

“We are delighted to see the inclusion of the research questions into the CQC inspection framework for the well-led category. It is hoped this key development will support trusts who have a strong portfolio of research to widen their commitment to research opportunities into more specialties areas."

“For those trusts with less research taking place, it is hoped that the introduction of these questions will help them recognise more that access to research opportunities really does drive high quality patient care and is highly rated by participating staff and patients alike.”

The research questions in the CQC Well Led Framework are backed up by 'A Brief Guide to Research in the NHS' which has been published internally by the CQC for use by CQC Inspectors. The guide is in two parts:

• Part 1: Background including related policy, evidence, and operational context of research in the NHS
• Part 2: Details on what ‘good’ looks like within the three levels (described above).

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There is also now a research access question included in the CQC Annual In-Patient Experience Survey:

"During this hospital stay, did anyone discuss with you whether you would like to take part in a research study?"

This is now live and offered to about 80,000 patients in 150 Trusts during the Autumn. The CQC publish their survey report online in the Spring of 2019. The question is currently for in-patients. It does not cover specialist Trusts at this time.

The online survey report will show the overall response to the patient experience question for each non specialist NHS Trust. It will therefore be possible for LCRNs to start conversations with their partner Trusts about how they have fared with respect to offering research to eligible patients.

The data that will be available has potential use in a number of areas that can help build an understanding of the extent to which patients are given access to research in (non specialist) NHS Trusts.

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How can the NIHR Clinical Research Network be helpful following these outputs?

The requirements of the CQC are a matter between it and healthcare provider organisations it regulates, but the Clinical Research Network's role can be supportive and facilitative in respect of research in NHS Trusts in a number of ways and at a number of levels. It supports an estimated 80% of all clinical research studies carried out in the NHS.

The Clinical Research Network is made up of 15 Local Clinical Research Networks that cover the length and breadth of England. These local networks coordinate and support the delivery of research across the NHS in England

The Clinical Research Network works closely with NHS Trust R&D teams to be able to achieve this.

You can find out more about how research is supported in the following:

Other resources:

There is an increasing body of evidence which shows that NHS Trusts with a good level of research activity also have better patient outcomes than those Trusts with lower or no research activity. Click for example:

Many resources and examples of practice to support Trusts with well led inspection readiness can be found in the NHS R&D FORUM resources exchange.

Keyword search for CQC or explore all of the categories for examples of good practice.