CSP071: Principles for provision of a support service, including local set-up activities, for studies in wider health and social care settings

This document describes the offer from the CRN Study Support Service for Study-Set-up Activities for studies in wider health and social care settings. The service is intended to facilitate set-up in a nationally consistent manner whilst recognising the different governance structures and processes. 

Following changes to the Department of Health and Social Care¹ policy in January 2018, the equivalent of NHS support² is now available for eligible¹ research taking place in wider health and social care settings e.g. research carried out in social care, care homes, hospices, or public health settings. 

Research in these settings is largely within the scope of the UK Policy Framework for Health and Social Care. Some studies will meet the criteria for review by an NHS Research Ethics Committee (REC) or the Social Care REC, while for others review by a university ethics committee is permissible under the policy arrangements described in Governance Arrangements for Research Ethics Committees. HRA Assessment, the standard process within the NHS in England for assessing the legal and governance compliance aspects of a research study, does not currently extend to studies taking place in  wider health and social care settings. As a result, each organisation must provide a management decision that considers the deliverability of the study as well as an assessment of any legal and governance implications of participating in the research. 

Aside from the absence of a standard national governance review for research taking place in wider health and social care settings, there is also variability in the application and approval processes for setting up research at sites providing health and social care. This variability arises from a number of factors, including the diversity of potential sites, the potential lack of experience in doing research, as well as diverse governance structures covering these different settings.  In addition, the capacity and maturity of R&D support functions within these settings are variable or may be non-existent. Whereas the review of legal and compliance issues rests with Sponsors and host sites, until such a time as HRA processes extend to a wider range of settings, there is value in the CRN clearly documenting the support offered via the Study Support Service  to facilitate on organisation’s assessment of the ‘’deliverability’ aspects of NIHR CRN Portfolio research studies at these locations. 

The HRA issued a statement in October 2022 in response to questions around indemnity arrangements for NHS staff delivering research outside of traditional NHS settings. "Research is a core NHS activity. NHS staff (including honorary contract holders) undertaking research as part of their job role are covered by NHS Resolution indemnity schemes if working for a member of those schemes... [t]hese schemes provide cover for NHS staff conducting research, whether that activity is taking place within NHS premises, patients’ homes, care homes, hospices or other spaces in which NHS researchers undertake NHS research." More information can be found on the HRA website.

¹ Eligibility Criteria for NIHR Clinical Research Network Support

² ●  the NIHR CRN Study Support Service- a standard national framework for supporting the planning, set-up and delivery of high quality clinical research in England (Reference 1)

●  NHS Support as defined by AcoRD (Reference 2)

●  AcoRD Part B Research activities, where relevant, as defined by AcoRD (Reference 3) 

Service outline for local set-up activities:

A. For eligible studies, LCRNs should provide support through existing elements of the Study Support Service, tailored to meet the specific needs of the study; this includes the provision of support for local set-up activities at sites providing health and social care. 

B. The model for providing the service should be flexible, taking account of capacity already in the region. To ensure consistency of service, LCRNs should explore centralised approaches where appropriate and work to develop their understanding of what capacity and management structures and processes for research exist within the sites providing health and social care in their region. 

C. Support explicitly excludes any activities relating to the assessment of governance and legal compliance. Responsibility for ensuring compliance with requirements in this area rests with the Sponsor and the host site. 

D. Sponsors wishing to conduct research at sites providing health and social care should be encouraged to link with the LCRN in the first instance to facilitate a coordinated approach to local sites.

E. Where appropriate, LCRNs should provide support for site set-up taking account of the capacity and experience that may already exist within the system for making decisions to participate in research. Due to factors such as the absence of a standardised governance process and the varied research settings across the sector, additional time may be required to support the set up of sites.  

F. LCRNs should provide a service that supports sites to assess, arrange and confirm their capacity and capability to participate in an NIHR Portfolio study as part of local set-up activities. Consideration needs to be given to the variability of capacity and capability of specific sectors. 

G. LCRNs should draw on the available expertise in their region when supporting local set-up activities and sites to arrange and confirm their capacity and capability to participate in an NIHR Portfolio study. This includes the local specialty leadership, the NIHR Applied Research Collaboration (ARC)  and where appropriate the ENRICH leads. Please see CSP092 (NIHR ENRICH Delivery in Local Clinical Research Networks) for further information. 

H. LCRNs may support research delivery sites providing health and social care by providing advice and directing sites to useful tools and resources that may support the site in its decision to participate in research. 

I. Relevant outputs from the Study Support Service should be shared with sites providing health and social care to facilitate set-up.

J. The final decision to participate in a research study rests with the host site, similar to models currently used to support Primary Care. 

K. In the absence of a standardised application process for setting up research across wider settings providing health and social care, participating sites / applicants may be directed to existing resources for NHS sites that provide an indication of areas they may wish to consider when agreeing to participate in research (e.g. proportionate templates such as the UK Wide Organisation Information Document) bearing in mind that these resources are developed for NHS / HSC organisations so parties would need to consider what is appropriate for their needs. 

L. The appropriate LCRN Partner Contract or agreement (for example a Service Level Agreement or appropriate template). 

M. In the absence of a nationally defined application pack and single approval process for set-up, there will be no requirement to formally collect start-up data points for set-up activities at sites providing health and social care. During this period, work will be undertaken to understand the workflow and make proposals regarding what data is helpful to support visibility of the process. Consideration will be given to the different types of study and the differing level of associated risk with the aim of developing a simplistic consistent data collection.

ACoRD: Attributing the Costs of health and social care Research & Development 

ARC: Applied Research Collaborations

CRN: Clinical Research Network 

DHSC: Department of Health and Social Care

ENRICH: Enabling Research in Care Homes 

HRA: Health Research Authority 

HSC: Health and Social Care

LCRN: Local Clinical Research Network 

NIHR: National Institute for Health and Care Research 

R&D: Research & Delivery 

REC: Research Ethics Committee

Version number: 2.0 

Effective from date: April 2023 

Catherine Birch

Research Delivery Lead

Email: catherine.birch@nihr.ac.uk