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As part of the work to underpin the development of a replacement for the Research Governance Framework (RGF) when the HRA becomes a Non Departmental Public Body, a report has been produced which highlights findings from a preliminary exploration of the perceived risks and barriers to organisations conducting research.
A representative sample of participants with broad experience of R&D governance, including participants from 10 NHS organisations in England, were consulted with in the development of this report. A case study illustrating many of the themes identified by the participants was used to support the study. These conversations continued a process of engagement with the R&D community and served as a scoping exercise to expose perceptions of risk which deter organisations from being more research active.
The report was issued for comment from 26 May 2014 until 4 July 2014. A summary of the key themes and recommendations from the report are detailed at the end of this page.
Next steps
The HRA reviewed the comments received with a summary of the responses available here. The HRA is considering the findings from this exercise in its drafting of a replacement to the RGF. The new UK Policy Framework for Health and Social Care Research was reviewed at the HRA Board meeting on 21 January 2015 with a comment period following.
Themes
a) Research Governance
Participants discussed the principles of research governance in terms of the RGF itself, rather than the document being an expression of principles. It was suggested that compliance with the RGF can be driven by “fear of inspection”. Whilst compliance with the RGF is reported as being perceived as the primary interest, rather than application of its underlying principles, this in itself presents difficulties for R&D staff in that the RGF does not lend itself to common understanding. Terminology used in the RGF can mean different things in different Trusts.
Understanding the relationship between RGF and Good Clinical Practice (GCP) was reported as problematic, particularly in relation to the governance of research which is not a clinical trial.
b) Financial constraint
Most participants reported cost (real or perceived) as a significant risk associated with new research projects. Excess Treatment Costs (ETCs) borne by host sites are seen in particular as a significant risk. Whilst ETCs are the biggest single issue, there are other costs to Trusts in supporting research that can make Trusts cautious in undertaking new research. The case study featured quite prominently the difficulties brought about by “financial paranoia” in sub-contracting between the sponsor and a Trust in Special Measures, and the protracted arguments and modifications to a contract caused delays in start-up and recruitment.
c) Quality Research Culture
Participants commented on the need for R&D staff not only to apply themselves to matters of management and governance, but to play a lead role in the facilitation and promotion of research in the NHS more generally. Financial constraints have, to some extent, contributed to significant variability to the resourcing of R&D in trusts for this essential role. There is also variability in the levels of expertise in departments with significant movement of staff. This can have an impact on departments’ willingness to take on new projects, and on the level of support which can be offered. This, in conjunction with failure to establish an agreed modus operandi prior to study outset, can ultimately affect R&D approval times as borne out by the case study.
Recommendations
1) Clarify the Purpose of the Research Governance Framework
Using standardised terminology to ensure relevance across stakeholders, the role of the RGF in setting out unambiguous principles should be articulated clearly. This should leave no scope for interpretation as a set of standards for local application to research. The RGF’s scope, including its limitations, should be clear.
2) Define Principles for Interface Management Between Stakeholders
The central role of collaboration within a research project should be described. Learning derived from the case study, and participant interviews, suggests clear, upfront agreement of principles and procedures for each project to be essential to the effective conduct and success of a study as well as mitigating some risks.
3) Make the Quality Research Culture Explicit and Relevant to all Stakeholders
Principles of good practice should be explicit, not implied, and should clearly apply to all parties. Systems should enable the identification of failures or breaches and place responsibility with the relevant party. Effective calculation of costs and financial management are critical, as financial probity and value for money can be construed as indicators of quality.
4) Focus on Learning and Sharing Good Practice
Current arrangements for learning are, on the whole, based on informal networks. A greater emphasis is required on identification and implementation of lessons learnt from experience, including incorporating this into training and personal development. Consideration should be given to mechanisms for future updates of the replacement of the RGF, learning from experience.