Chapter 1 - Efficient R&D Support for Research
It is critical to the success of our national ambition that research in Scotland is supported by efficient structures in the NHS - both for R&D governance purposes and for ethical approval. Since the publication of the last strategy NHS Research Scotland ( NRS), a partnership between Scottish Health Boards and CSO, has continued to deliver efficient and prompt approval for study start-up. Further, the last few years have seen even greater efficiencies with the introduction of a single costing for all studies - commercial and non-commercial - now in place. As a consequence of this business-like approach, significant interest and support have been expressed from industry. This is evidenced by the strategic collaborations with some of the worlds largest clinical trials contract research organisations and pharmaceutical companies. In the area of research ethics, our REC approval times remain among the fastest in the UK. It is our ambition to build on this success and deliver even greater efficiencies.
Management of NHS Research Scotland Activity
Central to the NRS ethos is working on a pan-Scotland basis. NRS operates in four regional nodes, with oversight and strategic direction achieved through the NRS Strategy Board that meets monthly to progress issues of relevance to the overall operation of NHS research in Scotland. The success of NRS relies substantially on the close working relationship between the Health Board R&D staff and CSO. This is a defining characteristic of NRS and it works well.
However the burden of managing NRS activity within the NHS falls disproportionately on the four nodal R&D Directors, and the successful delivery of NRS and CSO policy through them is critical. Having national R&D Directors of the appropriate standing and commitment is vital to its future success. It is therefore important to clarify both the key responsibilities of these national posts and the expectations on their successors.
"Excellence in clinical research requires having the right design, the right process and the right data to build evidence that can answer the right questions. NHS Research Scotland ( NRS) is developing the right research environment for our members to achieve this excellence in Scotland. ABPI companies welcome the leadership from the CSO in building a collaborative approach with industry to make this happen, and we welcome the significant improvements in approval times for commercial trials."
Dr Virginia Acha - ABPI Executive Director of Research, Medical and Innovation
CSO currently spends approximately £2m annually on R&D Office staff across Scotland. This is a significant investment of public funds. CSO allocates funds for this function based on the level of research each Health Board is undertaking, but currently allows complete flexibility in deploying those funds. Given the need for the R&D function to fit with different Health Board structures and scales of activity, central definition of all NRS posts would be counterproductive. Nonetheless there is a strong case for key functions to be delivered in the same way across different Health Boards, strengthening the Scotland wide nature of the services. The move to nodal staff taking on national functions for R&D permission makes the consistency of the delivery of those functions to national standards all the more important.
1. CSO will define the job description of a nodal NRS R&D Director and become formally involved in the recruitment of new appointments to these posts.
2. CSO will define the functions of key NRS posts, particularly where they provide a nodal or national function. CSO will also more closely define the NRS services to be delivered locally and the associated delivery targets, but will not normally determine the grading or detailed functions of posts delivering those services.
NRS has operated well through the current system of generic issues being determined once on behalf of Scotland. However if we are to efficiently support the increased commercial activity being attracted to Scotland, and use management information more effectively to drive improvements, further evolution is required.
From October 2014 CSO has therefore funded the NRS Central Management Team ( NRS CMT) to provide greater co-ordination and oversight of national NRS functions. In a rationalisation of national functions to deliver efficiencies and declutter the Scottish research landscape, the NRS Industry Manager post, and another post to support partnerships of medical universities and their Health Boards in the field of clinical and translational medicine, have been relocated to the NRS CMT.
The successful delivery of these functions through the CMT is critical to the success of NRS.
3. CSO will undertake a formal review of the NRS Central Management Team in April 2016 in order to ensure it is optimally delivering on its functions.
Management of NRS Investments
At the core of an efficient NHS R&D management system is close collaboration with NHS and academic researchers. While the strategic investments referred to in Chapter 3 are designed to meet national need and bridge some of the gaps between NHS and academic investment, most of the funds deployed through NRS are designed to ensure either that NHS researchers have the time to undertake research for the benefit of our patients, or the necessary NHS staff ( e.g. nurses) are available to support that research.
Even though these investments have been ongoing for a number of years, not all researchers are aware of the significant investments in staff and researcher time to support their work. Feedback from our Networks and Specialty Groups also indicate a concern that resources will not always be available to support studies. As a consequence there is a risk that studies may be declined in the belief that the required support will not be available. It is therefore critical that the Health Boards regularly assess with their NHS and academic researchers how well the deployment of the funds meets their needs in terms of providing the necessary NHS support for all eligible studies.
"As a researcher leading a number of multicentre studies, I can see how the infrastructure investments made through NHS Research Scotland have transformed the environment in which research is conducted. By allowing a significant degree of flexibility in the deployment of its resources, CSO has facilitated investment targeted on areas of local expertise while maintaining an effective national infrastructure for the co-ordinated delivery of studies."
Professor David Newby - British Heart Foundation John Wheatley Professor of Cardiology
Promoting these investments within the research community, and publicising CSO's condition of grant that the first call on the use of those funds is supporting eligible research, is an activity that may not have been afforded sufficient priority in the past. CSO also needs to ensure resources are deployed where the need exists.
4. CSO will require that all Health Boards take adequate steps to promote the availability of resources to support research.
5. CSO will require formal consultation and joint planning of NRS Infrastructure investments with partner universities and NRS Network and Specialty Group leads as a condition of funding.
These steps, alongside the intention to make infrastructure funding fully activity based from 2016, will make the link between the research activity and the infrastructure allocated to support it more transparent.
One of the main barriers to undertaking more research is the availability of clinician time. Although CSO allocates £12.7m per annum to Health Boards through the NRS Researcher Support budget to meet the time of staff conducting research, how this funding is used to "buy out" researcher time is not usually understood by researchers. Although in recent years a number of Health Boards have taken steps to allocate this funding to clinical departments in line with research activity, in others it remains embedded in the wider NHS allocations and is not identifiable as a research resource, or managed by R&D Offices as such. CSO intends freeing up this resource so that it is fully deployed transparently supporting research activity.
6. By the end of 2015 CSO will require the submission of proposals from Health Boards on how the NRS Researcher Support funds will be pro-actively managed and allocated for researcher time and associated activities by their NRS R&D Directors, from April 2016. Access to the NRS funding schemes will be conditional on CSO agreement to the Health Board proposals.
Management of NRS Networks and Specialty Groups
During 2013 CSO consulted on changes to the NRS Topic Networks and Specialty Groups to improve their impact on clinical research in Scotland. The consultation identified a wish on the part of the community to retain the current Network and Specialty Group structures but recognised a need for closer engagement between these groups and the underpinning NRS Infrastructure. Changes were made to deliver closer working in 2014-15.
Strategic oversight at a Scotland level is also required to ensure that the planned improvements in performance are delivered. To that end a new post has been appointed within the NRS Central Management Team to supply CSO and the NRS Boards with regular reports on progress. Additionally, CSO will hold regular meetings with Network Leads throughout the year at which performance against national objectives will be discussed. Taken together these changes, alongside the new joint planning proposal, should ensure that all eligible studies in Scotland have operational oversight of delivery and an escalation procedure to resolve problems.
7. To ensure that the Networks and Specialty Groups remain the most efficient way of supporting our research activity, CSO will review the success of these revised arrangements in the second half of 2016.
"The Scottish Diabetes Research Network ( SDRN) works to improve the quality and increase the quantity of Diabetes research in Scotland. The funding provided by CSO since 2006 has allowed the network to achieve this aim. CSO has supported the network in its development of innovative initiatives such as the Diabetes Research Register. The SDRN has benefited from the NHS Research Scotland infrastructure when engaging with potential commercial partners. This has led to notable successes including: the First Global Patient in a Sanofi study; First Global Patient for the IMPERIUM Study, lead UK recruiters for NOX, DEVOTE and LIXILAN-O studies and top recruiters for CARMELINA. Finally, the SDRN- Primary Care Initiative won the Diabetes UK award for service improvement in primary care for 2015."
Professor Rory McCrimmon - Scottish Diabetes Research Network
The Research Ethics Service and NHS R&D Systems
A distinct feature of the Scottish research landscape is the close working between the NHS Research Scotland Ethics Service and the Health Board R&D Offices. This relationship, along with the appointment of ethics Scientific Officers, has removed some of the artificial barriers between these two functions and streamlined the process of obtaining the necessary approvals for study commencement. However it is imperative that Scotland continues to lead the agenda on streamlining the approvals process and reducing bureaucracy; and there is scope for further improvement.
A high percentage of ethics submissions across the UK receive a provisional opinion, requiring the submission of additional information and further ethics consideration before a full opinion is forthcoming. Many of these resubmissions could be avoided by the provision of advice to researchers prior to their submission of documents. Similarly in R&D permission early contact with, and support for, researchers can significantly reduce delay later on in the process. However much activity is focused currently on gatekeeping rather than assisting researchers, driven by the Research Governance Framework which focuses on responsibilities rather than outcomes. CSO believes that through the provision of early advice supported by a revised Research Governance Framework that recognises the importance of facilitating good research, greater efficiencies will be forthcoming in the handling of applications.
8. CSO will seek to combine the Scottish Research Ethics Service and NRS R&D Offices into a single integrated service for researchers while retaining the independence of the REC decision making function.
9. CSO will arrange for shared access to study data for ethics and R&D staff through the Health Research Authority HARP database, streamlining access to electronic documents for R&D staff throughout Scotland.
10. CSO will refocus the early contact of ethics and NHS R&D staff with researchers on facilitating study approvals, with named R&D contacts being given to support the researcher in obtaining those approvals.
11. CSO will work with the HRA to revise the Research Governance Framework and implement an efficient ethics and R&D permission system across the UK that both builds on the efficiencies already delivered through NRS and operates seamlessly for sponsors and researchers across the UK.
NRS Relationships and Academic Institutions
Scotland has a close relationship between its Health Boards and academic institutions, at a strategic as well as operational level. Joint offices are common and are to be commended. Routine co-sponsorship of research is a good example of the two organisations working closely together for the researcher's benefit.
However the prominence given to local collaborative working and systems in some websites gives the impression that R&D permission is a local function operating to local arrangements, rather than to a nationally determined set of documents and standards. As a consequence researchers are not always aware of the services they should be receiving or how NRS systems operate with other Health Boards, or NHS Trusts in England, to streamline multicentre studies. Further, some of the NRS strategic investments are not always identified as such, with the associated expectations of CSO not always understood by those seeking access to those resources.
12. It is proposed that the NRS website will be the portal through which researchers access relevant information on NRS resources and services, with local sites being linked through that portal. This will greatly improve understanding of the national NRS systems, infrastructure and service standards that NHS R&D Offices deliver through NRS funding.