CRN: South London Funding Model

Summary of Partnership Group Agreement to Clinical Research Network: South London Funding Model Proposal 1. Introduction The Clinical Research Network: South London (CRN: South London) was formed in April 2014 as a result of a National NIHR reorganisation. This new Network is tasked with meeting seven High Level Objectives (HLOs - see Appendix 1) and providing a contribution to the eligible service support costs related to the delivery of NIHR Portfolio studies. A funding subgroup was convened (see Appendix 2 for Membership details) and a summary of funding model proposals was circulated. Support for the proposals was received from a significant majority of Member Organisations, with concerns raised by the Royal Marsden NHS Foundation Trust and Oxleas Foundation Trust. 5. Funding Group Proposal to CRN: South London Partnership Group The funding allocation for CRN: South London is detailed below: The 2014/15 core allocation = 21,554,885 The 2014/15 RcF allocation = 804,163 It was reiterated that the Clinical Research Networks are delivery only and funded on a predominantly activity based model. The CRN receives funding to provide service support cost contributions to all portfolio studies and to ensure that the DH s seven high level objectives are met. The slide below was used to summarise the Proposed Funding model: CRN: South London Funding Model Host organisation (GSTT) responsible for governance Overall funding determined by network performance Transparent mapping of funding by specialty group Investigators and division negotiate access to embedded staff Trust type A S London CRN Division Specialty groups Specialties feed into Divisions and create a business case for access to flexible staff, and funds for support services Trust type B Mixture of embedded and flexible staff 1

The following proposal consisting of eight recommendation principles- from the Funding Subgroup was circulated prior to the Partnership Group meeting and was discussed in detail: A. Research support will be provided through a combination of core funding to trusts and flexible staff employed through the larger centres but managed by the CRN Divisional Managers. There is a requirement in the Performance Operating Framework for a responsive and flexible workforce to deliver NIHR CRN Portfolio studies. Currently 16% of the CRN allocation funds flexible research delivery staffs who were previously employed either through the topic networks or CLRN strategic funding initiatives these contracts all finish at the end of the current financial model, 30 th September 2014. The remaining allocations are devolved to Trusts and predominantly used to employ embedded research staff. There were a number of points raised regarding flexible staff: Issues related to management across organisations were raised Issues related to employment status and financial risk to the larger organisations raised It was highlighted that short term contracts for research staff resulted in poor recruitment and retention and that the funding model could be a solution to this issue It was agreed that the Host and CRN should constitute a H.R and workforce group to look at these issues and potential risk sharing options It was noted that the Network funded staff were only able to provide the service support elements related to research studies as per AcoRD guidelines (Attributing the costs of health and social care Research & Development https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/140054/dh_1 33883.pdf). There were a number of points raised relating to this statement: Research costs for portfolio studies are often under- funded, particularly for sites that do not have the Chief Investigator within their organisation. - Previously Network funding has been utilised to fill this gap and ensure that the study can go ahead. It was noted that CRN funding has also been utilised to support treatment costs in some instances. This is a problem across many CRN s and it was agreed that the Partnership Board Chair, in conjunction with Network Host Organisation, would write to NIHR on behalf of South London to highlight the issues related to portfolio studies that were not funded appropriately. The CCGs do not currently see research as high priority; accessing treatment and particularly excess treatment costs is delaying research studies being set up For smaller Trusts, Network staff can be the only research infrastructure and provide some support for non portfolio studies Outcome: The majority of Partnership Group representatives agreed to this Funding Action Point Letter from Chair and Host Organisation to NIHR highlighting the issues related to portfolio studies that were currently not adequately funded to provide research costs or treatment costs at all sites. Action Point Host and CRN to set up HR and workforce group to examine issues related to current and future flexible workforce. 2

B. To encourage growth in recruitment, core funding to trusts will reflect recruitment to portfolio studies in the previous 2 years. Funding will be allocated in the ratio of 1:3:14 for large observational, observational and interventional studies. This formula is also used by NIHR to determine funding levels for each CRN. There was significant debate regarding this recommended principle. It was highlighted that complexity had been examined at national level, involving previous cancer and mental health networks in particular. Apart from the introduction of the 1:3:14 formula three years ago, which includes additional weighting for interventional studies, no further progress had been made. It was noted that many of the aspects related to trial complexity were not eligible for service support funding as they related to research or treatment costs. It was agreed that the Partnership Group Chair, in conjunction with the Host Organisation, on behalf of the Group, would write to the NIHR highlighting the issues related to the complexity weighting in the national model and offer support from South London to input into any revisions of the national model with regard to this issue. Smoothing the recruitment data over a two year period to prevent peaks and troughs (as per National and previous CLRN model) was agreed Outcome: The majority of Partnership Group representatives agreed to this funding Action Point Letter from Chair and Host Organisation to NIHR highlighting the issues related to complexity weighting and extend offer for South London to input into any National revisions of the funding model C. To ensure transparency, the CRN will publish and disseminate information about trust core allocations including a breakdown of funding and recruitment by specialty group. It was noted that one of the three NIHR CRN principles in the Performance Operating Framework relates to transparency and that the NIHR openly publishes and reports on performance information via the Open Data Platform. This will include financial information (anonymised) going forward. Outcome Agreement to this funding model principle by all members of the Partnership Group D. Each Research Division will construct a business plan detailing staffing and other resource required to deliver the portfolio over and above that already provided by trust core funding. The published information about core allocation by specialty group will inform these business plans It was noted that there would be one business case per division and these would be submitted to the funding sub group for review and agreement on funding. The business plan will be developed fully over the next 2-3 weeks and will include current and previous 3

performance data and financial information. The Business cases will be written by the Divisional Managers in conjunction with Division and Specialty Leads and Trust R&D staff. Outcome: The majority of Partnership Group representatives agreed to this Funding E. Currently 16% of the CRN allocation funds research delivery staff who were previously employed either through the topic networks or CLRN strategic funding initiatives. As part of the interim funding model this cohort of staff had their contracts extended until 30th Sept 2014. It is proposed that these staff form the basis of the future flexible workforce however this will require a consultation process and an HR group will be established to take this forward. As the CRN contract explicitly states that CRN funding cannot be used to support redundancies, this proposal recommends that the current flexible staff not funded from Trust s devolved allocations are offered the opportunity to become part of the flexible workforce. It was noted that this organisational change would require HR support in each affected organisation. Outcome: The majority of Partnership Group representatives agreed to this Funding Action Point Host and CRN to set up HR and workforce group to examine issues related to current flexible workforce. F. Discussions at CRN strategy forums have indicated preference for a greater proportion of flexible resource to be managed by the network. The funding group also took this view and modelled the impact on trust allocations of 5 and 10% increments in funding of flexible staff over and above the current 16% baseline. The funding group recommended a compromise position in which 21% of the funds available for distribution to Trusts are set aside for funding flexible staff. This resource will be accessed through divisional business cases. Discussion summary There was discussion regarding the interface between Trusts and Division staff, with concerns raised that if this was not managed robustly then research studies could be adversely affected. There were also concerns raised re governance and management of staff, which would be picked up in the HR working group. CRN to provide a paper detailing the Operating Model for flexible staff this will be prepared in conjunction with the cross network HR Group. It was noted that in the first instance the business cases would be fairly limited as most of the funding was already committed to salary costs of staff members in post. It was highlighted that the specialist trusts had been particularly affected by a change in the type of studies coming onto the portfolio - with more complex interventional studies and smaller sample sizes becoming more common in a number of specialties. Trusts supporting many specialties are able to manage these fluctuations across a broader portfolio. Outcome The majority of Partnership Group representatives agreed to this Funding 4

Action Point - CRN to provide a paper detailing the Operating Model for flexible staff G. Analysis of performance data indicate that a number of smaller organisations have recruitment levels that, using the previous funding formula, result in allocations that are too small to drive growth in research. The view of the funding group was that organisations that contribute <2% of the network recruitment should not have directly allocated funds but instead should be provided with a centrally managed resource to support research growth. It is proposed that this will commence in April 2015 after further consultation with the affected trusts. Discussion summary A number of points were discussed: There was a concern raised that this may lead to reduced level of PI engagement at the affected Trusts. However, it was noted that a number of flexible staff may remain within one organisation, but work across a number of specialties. Whilst other flexible staff would work within the same speciality but across organisations It was highlighted that having a critical mass of funding would provide stable infrastructure in the form of research staff. This would allow the roll out of studies to smaller recruiting trusts where support is currently not available It was noted that Trusts receiving less than 50,000 core allocation would be exempt from reporting on the 70 day targets for all studies (portfolio and non portfolio) to the NIHR It was noted that all affected Trusts would be consulted with prior to the introduction of this proposal in the next financial year. Outcome The Partnership Group strongly recommended this approach, but agreed that individual negotiations between the CRN and affected Trusts should take place with implementation negotiated on an individual Trust level H. It was proposed that the above funding model should run for 18 months from October 2014 with a review of progress after 9 months. Discussion summary There was agreement for this proposal with no alternatives put forward Outcome Agreement to this funding model principle by all members of the Partnership Group 5

Appendix 1 CRN High Level objectives Objective Measure CRN 1 Increase the number of participants recruited into NIHR CRN Portfolio studies 2 Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment target and time Number of participants recruited in a reporting year into NIHR CRN Portfolio studies A: Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites B: Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period Target 650,000 LCRN Goal/Target 37,718 3 Increase the number of commercial contract studies delivered through the NIHR CRN 4 Reduce the time taken for NIHR studies to achieve NHS Permission through CSP 5 Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies 6 Increase NHS participation in NIHR CRN Portfolio Studies A: Number of new commercial contract studies entering the NIHR CRN Portfolio B: Number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II IV studies Proportion of studies obtaining NHS Permission at all sites within 40 calendar days (from receipt of a valid complete application by NIHR CRN) A: Proportion of commercial contract studies achieving first participant recruited within 30 calendar days of NHS Permission being issued or First Network Site Initiation Visit, at confirmed Network sites B: Proportion of non-commercial studies achieving first participant recruited within 30 calendar days of NHS Permission being issued A: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies 600 n/a 75% n/a 80% n/a 99% 99% 7 Increase the number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio B: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies C: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies Number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio 70% 70% 25% 25% 13,500 900 6

Appendix 2 Members of the Funding Executive Subgroup Professor Stephen Devereux CRN South London, Clinical Director / Chair Ann Marie Murtagh CRN South London, Chief Operating Officer Elizabeth Bishop The Royal Marsden NHS FT, Chief Operating Officer Professor Tom Craig South London and Maudsley NHS FT, R&D Director Dr Kate Blake Guys and St Thomas NHS FT, Host Accountable Officer Jeremy Brinley Codd Guys and St Thomas NHS FT, Host finance representative Ceri Potts - Guys and St Thomas NHS FT, finance representative Professor Irene Higginson Kings College Hospital NHS FT, Associate Medical Director Dr John Chang Croydon Health Services NHS Trust (non teaching hospital representative) Dr. Stephanie Hazlehurst St Georges Healthcare NHS Trust, Head of Joint Research Office Professor Ray Chaudhuri Division 4 Clinical Leads representing CRN Specialty Groups 7