15. Research Delivery

15.1.1. Deliver the NIHR RDN Study Support Service in accordance with the national Standard Operating Procedures to enable customers to experience a ‘One RDN’ service. 

15.1.2. The RDN is transforming some aspects of the Study Support Service and associated processes. This will enable the services to support compliance with portfolio inclusion Terms and Conditions and contribute to system wide developments, as specified in the Full Government Response to the O’Shaughnessy Review. RRDN teams should adapt the delivery of the Study Support Service, and associated processes, as per the RDN Transformation - High Level Plan outputs and timelines. 

15.1.3. It is the NIHR RDN’s role to monitor and oversee the national portfolio of health and care research across England on behalf of the Department of Health and Social Care (DHSC). In order to undertake this activity, it is the Sponsors responsibility to provide NIHR RDN with up-to-date study data, as set out in the DHSC policy Terms and Conditions for NIHR RDN support (T&Cs). The NIHR RDN has a role to support Sponsors (or their delegates) to meet their responsibilities as per the T&Cs (e.g. provision of training, raising awareness at an organisational level) but not to undertake the Sponsor responsibilities.

15.1.4. It is the role of the NIHR RDN to monitor Sponsor adherence to the T&Cs and enact the implementation of non-adherence on behalf of DHSC (RDN POF Support Page).

15.1.5. The RRDN will engage with local partners and NIHR infrastructure to expand clinical and applied research to underserved regions and communities with major health needs. Local data and knowledge will need to be shared across partners and NIHR infrastructure in order to achieve this. The RRDN must endeavour to optimise delivery of, and performance in, all appropriate research settings. 

15.1.6. Support researchers and sponsors to identify research resource requirements at a study level by properly identifying and attributing activities as Research Costs, NHS Support Costs and NHS Treatment Costs (including Excess Treatment Costs) as defined in and in accordance with AcoRD and utilising the mandated national tools (i.e. Schedule of Events Cost Attribution Tool (SoECAT) or the interactive Costing Tool (iCT)) and associated national processes (i.e. National Contract Value Review).

15.1.7. Enable and support delivery of all NHS Support activities and other permitted activities (as defined by AcoRD) for all NIHR RDN Portfolio studies open within the RRDN region. 

15.1.8. If the RRDN Host Organisation or any Delivery organisation (having discussed with the RRDN Director) determines it cannot provide the required resource (as set out in the AcoRD policy) for any ‘high priority’ RDN Portfolio study (as defined in the RDN Eligibility Criteria) on grounds other than non-feasibility, then they must advise the RDN Board in advance of communication of this decision to the investigator via supportmystudy@nihr.ac.uk. Please mark your message ‘Unable to support high priority study FAO RDN Board’. Any such refusal of a high-priority study also must be reported to the RDN Board, upon request.

15.1.9. Put in place arrangements to support the rapid set up and delivery of urgent public health research, which may be in a pandemic or related situation. This will include:

a) an RRDN Urgent Public Health Research Plan which can be immediately activated in the event the DHSC requests expedited urgent public health research. This should be provided to the RDNCC on request.

b) Identify one of the RRDN’s Directors as the person responsible for maintenance of the local Urgent Public Health Plan, this activity can be delegated as appropriate however the person responsible should be at a senior level.

15.1.10. Increase access to research for people living in care homes, including delivery of dementia research, by developing and supporting a network of research-ready care homes and liaising with the NIHR School for Social Care Research and other NIHR Partners involved in the NIHR ENRICH initiative (available at: https://enrich.nihr.ac.uk/) as well as other stakeholders involved in care home research delivery.

15.1.11. Provide active support for Government priority projects, including:

• Network-wide implementation of processes to ensure compliance with RDN Support Terms and Conditions (springboard 1)

• Development and launch of Network-wide Site ID service for England (springboard 2)

• Development and launch of a Key Account management service for commercial and non-commercial sponsors with significant UK portfolios

• Continued support for the implementation of the National Contract Value Review and associated processes to streamline costing and contracting for all commercial contract research taking place in the NHS

• Implementation of the Be Part of Research Development plan, including achieving 1m registered participants by March 2025

• Input into the development of the Research Delivery Data and Intelligence (RDDI) 'system of systems' ensuring RDN needs are effectively communicated, captured and met by the programme team and support testing and implementation of the systems developed

• Lead and support the development and implementation of Service Delivery Tools required specifically for RDN to effectively deliver its services utilising the RDDI 'system of systems' (RDN SDT)

• Support, and lead on specific elements of, the NIHR-wide strategy to increase commercial research in primary care

• Support the successful implementation of the Vaccines Innovation Pathway and delivery of government strategic partnerships with Moderna and BioNTech

• Implement a new approach to the oversight of use of allocations to delivery partners (including NHS support cost allocations) to increase the flexibility with which NHS support costs funded by DHSC can be used for the delivery of research in the NHS while still operating in line with guidance on appropriate cost attribution.

15.1.12. Provide active support for the RDN Primary Care Strategy / NIHR RDN Primary Care Programme.

15.2.2. It is advised that the Leadership team continues with current specialty grouping arrangements to support operational management purposes and ensure local operations efficiency until the RDN operational model has been agreed.

15.2.2. The RRDN Team must deliver all support activities throughout the research delivery pathway in line with the AcoRD guidance. In particular, in line with NHS England activities to simplify research arrangements, RRDNs are required to provide support for researchers to use the national standard tools referenced in the AcoRD guidance, which are mandatory for the presentation, negotiation and agreement of study costing and / or attribution as defined in the NHS contract. For example, the NIHR Interactive Costing Tool (iCT) for commercial contract studies which enables a National Contract Value Review or the Schedule of Events Cost Attribution Tool for non-commercial studies which enables the payment of Excess Treatment Costs as set out in the Research Delivery RDN POF Support Pages.

15.2.3. Additional supporting information is available in the RDN POF Support Pages.