CSO Health Research Strategy

CHAPTER 1 - EFFICIENT Rand D SUPPORT FOR RESEARCH

1.1 It is critical to the success of our national ambitions that research in Scotland is supported by efficient structures in the NHS - both for Rand 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. In 2013 the median time across Scotland to approve non-commercial studies was 13 working days and 22 for commercial studies. 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 has been expressed from industry, as evidenced by the strategic collaborations with some of the world's 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

1.2 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.

1.3 The success of NRS relies substantially on the close working relationship between the NHS Board Rand D staff and CSO. This is a defining characteristic of NRS and it works well.

1.4 However the burden of managing NRS activity within the NHS falls disproportionately on the 4 nodal Rand D Directors, and the successful delivery of NRS and CSO policy through them is key to success. At present CSO allocates an additional allowance to their Boards in recognition of the additional time commitment to national business, but has not defined formally their NRS nodal responsibilities.

1.5 Further, having key national Rand 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 CSO's expectations on their replacement.

1.6 CSO will therefore define the job description of a nodal Rand D Director and become formally involved in the recruitment of new appointments to these key posts.

Question 1: Should CSO and the Health Boards set any eligibility criteria for nodal Rand D Directors? Should appointment of a nodal Rand D Director be for a specific term, and if so what term would be appropriate?

1.7 CSO currently spends in excess of £2m annually on Rand D Office staff across Scotland. This is a significant investment of public funds although compared to other countries in the UK is not excessive. CSO allocates funds for this function based on the level of research the Health Board is undertaking, but currently allows complete flexibility in deploying those funds.

Question 2: CSO proposes to approve the functions of staff in Rand D Offices; should CSO seek to standardise local Rand D functions across Scotland, or is it preferable to allow local flexibility?

1.8 NRS has operated well through the current system of generic issues being considered and determined once on behalf of Scotland. However if we are to support efficiently the increased commercial activity being attracted to Scotland, and use management information more effectively to drive improvements, further evolution is required. At present co-ordination and assessment of management information is fragmented and sometimes hinders strategic consideration of issues at the NRS Strategic Board.

1.9 We therefore propose the creation of an NRS General Manager (NRS-GM) with a small support team collectively working as the NRS General Manager Services (NRS-GMS). They will undertake the high level co-ordination of NRS activities and specific NRS operational functions previously undertaken directly by the NHS or CSO, including budgetary aspects.

1.10 Being able to act independent of all Health Boards - and being seen to do so -

is critical to the success of the NRS-GMS. Equally, becoming an integral part of the wider NRS initiative is key; it is not our intention to create a new management layer between CSO and the Health Boards. CSO has considered a number of options and concluded that contracting with Scottish Health Innovations Ltd (SHIL) to undertake this function is the appropriate way forward. SHIL - jointly owned by Scottish Ministers, NHS Tayside and the National Waiting Times Centre Board and funded by CSO - is already part of the research and innovation landscape and engages well with the Health Boards in a quasi-independent manner.

1.11 The new NRS-GMS will assume responsibility for conducting the NRS annual activity based funding and annual reporting exercises currently managed through CSO. The NRS-GMS will also assume responsibility for the oversight and financial management of the CSO Service Support Costs and Infrastructure budgets. This will not replace the current responsibilities of the NRS nodes to manage these funds efficiently, but will provide a better oversight of their deployment than has been possible to date. The NRS-GMS will also work with the distributed NRS national functions, particularly the NRS Permissions Co-ordinating Centre and the NRS Industry Manager, to co-ordinate activity and provide regular reports and advice to the NRS Strategy Board. The NRS-GMS will also become the NRS Strategy Board secretariat with the NRS-GM a new member of that Board.

1.12 The contract for the NRS-GMS will be awarded for an initial period of 3 years.

Question 3: Are there other NRS functions that might usefully be transferred from the Health Boards or CSO to the new NRS-GMS? Are there functions not currently being undertaken that the NRS-GMS might carry out?

Management of NRS Investments

1.13 At the core of an efficient NHS Rand D management system is close collaboration with both 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 in key areas, most of the investments made 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 the research.

1.14 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 made to support their work. As a consequence some studies are still being declined in the belief that the required support will not be available, losing the opportunity for more patients to participate in research. Feedback from our Networks and Specialty Groups also indicate a belief that resources are not always available to support studies. It is therefore critical that the Health Boards regularly assess with their NHS and academic researchers how well the deployment of the funds meet their needs in terms of providing the necessary support for all eligible studies.

1.15 Promoting these CSO investments within the research community, and publicising CSO's condition of grant that the first call on the use of our deployed funds is supporting eligible research, is an activity that may not have been afforded sufficient priority in the past. CSO will therefore require that all Boards take adequate steps promote the availability of resources to support research. Further, to ensure resources are deployed where the need exists, we will require joint planning of NRS Infrastructure investments with 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, should make the link between the research activity and the infrastructure played to support it more transparent.

Question 4: To what extent should the joint planning of the deployment of infrastructure resources be formalised? Should there be a formal record of such discussions?

1.16 Infrastructure support aside, one of the main barriers to undertaking more research is the lack of clinician time. Although CSO allocates £12.7m per annum to Boards through its 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 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 as such. CSO intends freeing up this resource so that it is fully deployed in transparently supporting research activity. NRS Researcher Support will be fully allocated for researcher time and associated activities by April 2016. CSO will approve the Board methodology to ensure it meets our expectations.

Question 5: Taken together, will these steps to both free up and promote the availability of NRS resources address current concerns over lack of time and support? If not, are there other steps CSO should take?

Management of NRS Networks and Specialty Groups

1.17 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 need for closer engagement between these groups and the research community, and in the case of Specialty Groups greater support for their activities within the NRS Infrastructure.

1.18 Those findings are now being implemented through the following changes:

• The paramount focus of NRS Networks and Specialty Groups will be to recruit to studies on time and to target
• NRS Networks and Specialty Groups will proactively support all eligibly funded research within their clinical areas and no longer "adopt" studies they wish to support
• Three Specialty Group areas with high levels of activity - Cardiovascular, Musculoskeletal and Reproductive Health and Childbirth - will have new delivery managers appointed
• All other Specialty Groups will have NRS nodal delivery managers to oversee recruitment and support the Specialty Group lead
• The Network lead role will be extended to support oversight of study delivery and lead strategic development as NRS Champions
• NRS Champions will also be appointed for the three Speciality Group areas with high levels of activity
• All Network and Specialty Group lead appointments will be by open competition and regularly reviewed

1.19 Taken together these changes, alongside the new joint planning proposal mentioned should ensure that all eligible studies in Scotland have managerial oversight of recruitment and an escalation procedure to resolve problems.

Question 6: Are there any further changes that should be made to improve the efficient delivery of patients to studies through the NRS Networks and Specialty Groups?

The Research Ethics Service, NHS Rand D and University Systems

1.20 A distinct feature of the Scottish research landscape is the close working relationship between the NHS Research Scotland Ethics Service and the wider Health Board Rand D functions. When England decided to separate out the ethics service into a distinct organisation, CSO chose to integrate the ethics and Rand D functions more closely within the Health Boards. This closer working, along with the appointment of ethics Scientific Officers, has removed many of the artificial barriers between these two functions and streamlined the process of obtaining the necessary approvals for study commencement. We therefore welcome the Health Research Authority's review of these services in England with a view to closer integration.

1.21 In pursuit of greater efficiency in study start-up, the Health Research Authority proposes introducing a single assessment that will integrate elements of ethics and Rand D approvals. Scotland already has commendable approval times for both ethics and NHS Rand D and as such, while it is critical to maintain a common system across the UK, we will await the details of how the HRA single assessment delivery model will operate before deciding whether it would be sensible to adopt it in Scotland. Experience of the UK ethics systems suggest that a unified system can be delivered through different structures and operational models working to the same principles. It will therefore be important to await further details of the HRA's proposals before committing Scotland to significant organisational change.

1.22 Meanwhile, it is imperative that Scotland continues to lead the agenda on streamlining the approvals process and reducing bureaucracy. It is widely recognised that the role of both ethics and NHS Rand D is to facilitate good research, yet much activity is focused on gatekeeping rather than assisting researchers to undertake their research. CSO believes that with a more proactive approach to early support for researchers many of the issues that arise at the formal approvals process might be avoided. There are already examples of good practice in both ethics and NHS Rand D but there is a need to formalise this approach across both services.

1.23 CSO recognises that much of the current way of working has been driven by the Research Governance Framework, which focuses on responsibilities rather than outcomes. At a strategic level, CSO, the Health Research Authority and the other devolved administrations are therefore undertaking a review of the current Research Governance Framework to create a new document that gives greater emphasis to supporting research rather than policing it. Further, we will initiate discussions within and outwith Scotland on how the paperwork and significant volume of guidance and Standard Operating Procedures associated with ethics and NHS Rand D functions can be reduced - both have increased significantly over the years. We will also seek to combine the Scottish Research Ethics Service and NRS Rand D Offices into a single integrated service for researchers while retaining the independence of the REC decision making function.

1.24 To signal our intention that both ethics and NHS Rand D should place a greater emphasis on supporting research rather than focusing on approving it, we propose these functions should be renamed as NRS Integrated Support Services. Such changes will make Scotland well placed to participate in the emerging Health Research Authority plans for a single assessment.

1.25 CSO has responsibility for NHS systems, but considering them in isolation from those in their related universities will not be sensible. Scotland has a commendably close relationship between its NHS and academic institutions, at a strategic as well as operational level, and as a consequence many of the issues that arise in other parts of the UK from universities operating independently do not arise. Joint offices are common and are to be commended, and routine co-sponsorship of research is a good example of the two organisations working closely together for the researcher's benefit.

1.26 We believe there is a responsibility on universities to support NRS policies for streamlined and efficient systems and implement them without modification. Health Science Scotland - comprising the lead universities, their NHS Boards and CSO - provides a suitable forum for strategic discussion and resolution of issues should they arise.

Question 7: To what extent do delays continue to occur as a consequence of differing NHS and university requirements? To what extent is closer integration of NRS and university functions possible and desirable?