Managing research finance in the NHS

Version 2. July 2026

Introduction

The health research and innovation ecosystem is a national asset that improves the quality of care for patients, while improving NHS performance and productivity and delivering economic growth.

The 10 Year Health Plan and Life Sciences Sector Plan include commitments to accelerate the pace and scale of research in the NHS to drive reform, improve outcomes and deliver growth. The government has committed to reducing clinical trial set up times to under 150 days and to doubling commercial interventional trial participants by 2026 and again by 2029, as well as increasing activity in out of hospital settings.

The Medium Term Planning Framework requires NHS boards to have regular research reporting processes in place. Our framework for NHS boards on monitoring research activity supports them with this and to understand research activity across their footprints.

Research finance is multifaceted and complex and needs to be well-managed to deliver research in the NHS effectively. Accounting and financial standards apply to all NHS finance, however, there are specific aspects to how research finance is managed, reported and governed. This document sets these out and is for:

  • all NHS organisations undertaking research, particularly providers
  • those with senior responsibility in providers and integrated care boards (ICBs) for finance or operationalising research, including at board level
  • finance directors and managers, including those with research finance in their portfolio
  • research and innovation directors, leaders and managers
  • research-active staff
  • heads of services engaged in research

Partner organisations may also find it useful, such as local authorities, social care services, the voluntary, community, faith and social enterprise sector, and other providers of healthcare services including financial auditors.

See the National Institute for Health and Care (NIHR) and Health Research Authority websites for a glossary of research terms.

Requirements

This document specifically sets out requirements for managing research finances for all NHS organisations participating in research. Organisations need to deliver these priorities:

1. meet the requirements of the Medium Term Planning Framework:

  • the site-specific timeframes of the government’s 150-day clinical trial set up metric. This will be reported via the NHS Oversight Framework. The government will also monitor site-level performance in meeting this target
  • report activity and income to boards on a 6-monthly basis, in line with the framework for NHS boards on monitoring research activity

2. meet financial rules, conduct good financial practice and have clear reporting and governance processes to support research, using mandated costing and contracting tools:

  • track activity and assign and recover costs in a timely manner, using the right methods for the type of research being conducted. This includes accurate and timely invoicing. See sections 1.2, 1.3 and 3
  • forecast research financial activity to plan and invest in capacity. See section 1.4
  • meet financial rules (including international financial reporting standard 15) and the requirements of external audit and assurance reviews. See section 1.5
  • manage financial risks including bad debt and pipeline issues. See section 1.5
  • ensure appropriate payments are made for public and patient involvement in research participation and decision making. See section 2.2
  • use National Contract Value Review (NCVR) for costing commercial contract research (requirement for trusts, recommendation for primary care) and the standardised single contracting approach. See section 3.1
  • use Unmodified Schedule of Events Cost Attribution Tool (SoECAT) for costing non-commercial research. See section 3.2

3. build capability and capacity to accelerate the pace and scale of research. Organisations in receipt of capacity funding through commercial and non-commercial research must use it for research capability and capacity building. Organisations need to:

  • have the right mix of skills and expertise across a research finance function (clinical, finance, research). See section 1.1
  • clearly and transparently account for this income to avoid auditing issues (in line with priority 2)
  • support different models of expanding research activity across their wider organisational boundaries. See section 2.3
  • provide sufficient and protected staff time and resource for research

This document provides information on how to meet the above requirements. It explains core components, and the need-to-know information to reach optimal management of research finance as a high performing organisation. It also provides helpful case studies to describe how others have made progress in key areas listed above.

Guidance was initially published in 2024, and it has been updated to give clarity on requirements for research finance in NHS organisations.


Definition of research and categorisation

The UK policy framework for health and social care research uses the following definition of research:

“… the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods. This excludes audits of practice and service evaluation.”

Research is distinct from activities such as data gathering, service evaluation, clinical audit and innovation pilots, and ranges from small observational studies to large multinational trials. It may involve single or multiple sites or research locations and be national or international.

From a finance perspective, research can be funded and run under commercial or non-commercial contracts. Whether the contract and funding are for a commercial or non-commercial contract study will impact on processes for managing finance, so staff must understand their differences and implications. Attributing the costs of health and social care research (AcoRD) provides a detailed definition of commercial and non-commercial contract studies.


1. Research finance structures, processes and transparency

1.1 Research finance structures and ways of working

      The organisation’s finance function must ensure the research finance capabilities (referred to as the research function) in this document can be delivered. The research function could sit within a Research and Development (R&D) department or equivalent, a mainstream finance team or across both. NHS R&D departments and their functions may be outsourced or shared between organisations (particularly for smaller providers). Primary and community care R&D and research finance functions may be hosted by an integrated care board (ICB) or another provider, in a hub and spoke or collaborative model.

      Effective management of research finance requires:

      • an understanding of the operational environment and settings in which research is delivered
      • financial, research – and often clinical – knowledge and expertise
      • oversight, governance and transparency

      The scope and tasks of the research finance function are broad:

      • financial planning and strategy: developing financial plans and forecasts, managing budgets and ensuring financial sustainability
      • allocating resources: deciding how money is spent to support staff and patient care, using funds appropriately
      • processing transactions: timely and accurate handling of daily financial tasks like payroll, accounts payable, invoicing, associated queries and procurement of goods and services
      • supporting decisions: providing financial analysis and information to guide strategic decisions and support innovation
      • reporting and compliance: reporting requirements for funding bodies and ensuring compliance with national policy – for example, the Medium Term Planning Framework, the NHS Oversight Framework and the 150 day metric
      • providing value for money: delivering cost-effective research studies and ensuring optimal outcomes for the NHS
      • improving health inequalities: tackling health inequalities by directing resources where they are needed most

      Additionally, the research finance function should develop a strategy for growing and maintaining research capacity and capability, championed by the board.

      If the NHS organisation’s finance and R&D teams are not in the same department, they should work together to provide a defined research finance function. The mechanisms and split of their responsibilities may vary but the function should deliver the above tasks.

      1.2 Tracking activity and assigning costs

        Accurate systems are required to manage and track income and expenditure across different income streams, whether through multiple cost centres or other means.

        NHS organisations must have robust and transparent research income distribution policies and processes. These have 2 purposes: transparency and oversight, and tracking and assigning costs to enable timely and accurate cost recovery. Disparities or queries should be raised with funders in a timely manner through the study sponsor and agreed process.

        Different financial processes apply for different funders. These are outlined in the relevant sections, but some important principles should be applied to commercial and non-commercial research alike:

        • the basis for good practice is tracking and assigning costs. The budget that pays for the activity should be reimbursed for it. For example,the department or organisation that incurs the direct cost for an MRI undertaken as part of a research study should be reimbursed for it. The processes for tracking and assigning overheads and indirect costs should also be clear, with departments involved in research delivery receiving timely, agreed and transparent reimbursement for them
        • research income should not be reassigned or redistributed to different budgets, unless they have paid for the activity (direct costs), capacity or overheads (indirect costs) or a contribution is being made to infrastructure or equipment whose use will include research activity. Processes should transparently account for what has been delivered and how funding income has been used
        • providers must ensure local definitions align with NCVR and NIHR guidelines and that funding is used for its intended purpose. Definitions of funding for research capacity are provided in NCVR and NIHR guidelines; these should be followed locally to ensure this funding is used for its intended purpose. Many providers and research functions are using a range of solutions to track activity and assign costs, and some have developed their own sophisticated trackers. Solutions that allow tracking, assigning and invoicing for costs are a basic requirement and should be implemented if not in place

        Case study: importance of dedicated research finance teams in managing complexities of R&D finance

        NHS Cambridgeshire and Peterborough ICB hosted an NIHR-funded 5-year study with academic partners. The research was additionally supported by a £100,000 contribution from a charity, paid in full at the start of the study – a normal practice for a charitable contribution to a research project.

        The payment schedule for the ICB to disburse funds to the research partners specified by NIHR drew down on this charitable sum over the first 3 years (combined with their own payments from DHSC). The ICB’s research office worked with finance colleagues to recognise the requirement for some of the charity monies to be deferred beyond the year in which the cash was received in line with the contractual obligations imposed by hosting the grant.

        Some hosted research awards involve a range of academic, NHS and other partners, creating complex payment schedules. On occasion, partners may invoice 6 to 12 months behind schedule or even later, despite the best efforts of the NHS host organisation. It is important to understand the obligations that give rise to income recognition; this can differ from the payment schedules. Again, having financial staff and systems that understand and help manage dedicated research funding is vital for operational delivery.

        1.3 Invoicing processes

        The timeliness and accuracy of invoicing is crucial for the effective management of research finance. Effective cost recovery is part of good in-year financial management. Factors that can slow the invoicing process down and place a significant administrative burden on the research finance function include: difficulties in tracking and assigning costs; the volume and complexity of commercial trial invoicing; and queries on activity and costs. The following checklist offers practical solutions.

        For research finance, a cross-sector approach is required between funders or sponsors and contract research organisations for commercial research and providers.

        Checklist for timely and accurate invoicing

        The following must be considered in invoicing processes:

        • pragmatic invoicing approach within contracts – some contracts allow for headline costs within a certain amount, meaning separate invoicing for detailed individual activities is not necessary
        • tracking activity and assigning costs – a sophisticated approach can enable timeliness and accuracy of invoicing. This can be supported by trackers, specialist software or local portfolio management systems

        Providers should also consider:

        • automated templates for invoice creation –automation can be enabled by specialist software or internally developed solutions. Consider compatibility and interoperability between systems before developing or implementing a solution
        • efficient query resolution processes –an agreed process should be established between all contract partners. Clear communication is key to good working relationships and successful partnerships. Agreeing processes at the contracting stage for raising, escalating and resolving queries is essential to good financial management of research across partner organisations

        1.4 Research finance forecasting, transparency and governance

          Forecasting research financial activity

          In the NHS, forecasts are routinely made to the end of the current financial year (and milestones within the year) and the medium to long term (2 to 5 years) as part of the annual planning cycle.

          A full picture of all research-related costs, income and expected expenditure will be needed for an accurate forecast. Unlike standard NHS budgets, which are set at the start of a financial year, income from research awards and commercial contract research will fluctuate throughout the year. It is important to identify income that may be received in one financial year but spent in a subsequent year, as this can affect bottom line figures, particularly where all costs fall within a single cost centre or budget.

          Research-related forecasts are generally set late in the previous financial year. While some costs will not be known – for example, level of recruitment to studies – assumptions can be made based on the previous year’s performance, with forecasts then adjusted as more information becomes known.

          Processes that capture participant-level information and at a study level will enable more accurate monthly, quarterly and annual forecasts based on real-time participant activity. This will help teams understand how much income could be received for their activity.

          Forecasting enables a ‘forecast to invest’ model. This is where providers can develop a budget and investment case aligned with forecast capacity and indirect costs, increasing the certainty of recruiting suitable study participants, recruiting and retaining skilled staff and delivering the study in a timely and effective manner.

          Case study: Leeds research finance model to support timely invoicing and recruitment-based forecasting

          Leeds Teaching Hospitals NHS Trust has developed a research finance model – a centralised research finance tracking system – to support its research delivery teams to manage financial activity at individual participant recruitment and study level. This has streamlined processes across teams, introduced consistent data standards and enabled real-time visibility of research income.

          Previously, management of research finance was inconsistent across delivery teams. Each area was responsible for its own invoicing and income tracking, leading to variations in practice and limited assurance over the completeness of invoicing. Without a centralised system there was also no reliable method for forecasting research income, hindering effective financial planning and strategic decision-making.

          The model is built around a series of finance trackers that capture comprehensive information about each study, including recruitment performance, participant-level activity, detailed breakdowns of research activity and associated costs and invoicing by participant, support service and organisation. This structured approach enables more accurate and timely invoicing, improved forecasting of income and greater transparency in how costs and income are attributed across studies and collaborating organisations.

          The finance trackers are designed to manage both simple and highly complex trials, supporting cross-organisational collaboration and assurance that income follows place-based research activity. Each tracker summarises data by participant visit and invoicing to date. By capturing participant-level data at the study level delivery teams can calculate the income that could be generated if participant visits are completed and produce monthly, quarterly and annual forecasts based on real-time recruitment and activity data.

          The summary data from each tracker can be consolidated into a central report, offering a comprehensive overview of recruitment performance, income received to date, and projected income based on actual recruitment figures. This central view of both activity and financial performance facilitates collaboration between organisations, strengthens financial assurance and supports research accountants to maintain robust oversight of all income-generating studies, while also enabling the central research and innovation management team to identify potential financial risks at an early stage. In addition, the data generated through the model provides valuable insights into current and future research capacity requirements, helping teams to plan resources effectively and support sustainable growth in research activity.

          Visibility and audit of research finance

          The R&D department should base decisions on an accurate understanding of research income and expenditure – to ensure the income the NHS organisation receives is directed efficiently and transparently. Research activity is managed in a controlled way to support the requirements of funders and to comply with the organisation’s policy on research. The visibility and transparency of research finance must also satisfy internal governance and external audit requirements to demonstrate robust financial management.

          NHS organisations need to comply with standing financial instructions, standing orders, reservation and delegation of powers and, by implication, accounting standards including IFRS 15 (see section 1.5).

          Health and social care research is governed by a range of laws, policies and international, national and professional standards. The Health Research Authority (HRA) is responsible for ensuring research-related regulation is co-ordinated and standardised across the UK, to make it easier to do research that people can trust. All NHS and adult social care organisations must have regard to HRA’s guidance on the management and conduct of research, including financial management (within the unmodified contract model clinical trial agreements).

          There are 3 main methods for scrutinising research finances:

          • internal auditing and reporting: clear governance structures and processes to enable the reporting of research finance routinely at board level, alongside site-level performance metrics. The Medium Term Planning Framework requires research activity to be reported to provider boards on a 6-monthly basis. This may be through dedicated finance committees or R&D governance groups. Any reporting structure should have clear lines of escalation and accountability. Providers with significant research activity may wish to consider periodic internal audit to ensure their governance, reporting and financial processes are of a high standard
          • external audit: organisations involved in research delivery may have their accounts audited by external financial auditors, which may or may not include research monies. This will be done by an independent auditor. Accounting standards apply equally to research monies as to all other NHS finance and those involved in auditing research finance should understand the implications of these standards for their work
          • assurance reviews: organisations that host research awards or are in receipt of funds from grant-making bodies such as NIHR need to be aware of the research funder’s requirements as the funder may request a review at any time during or after the award or funding

          Clear and mutually understood definitions and transparent tracking and assigning of costs will support audit and review of research finance. As assurance reviews and internal and external audits may require substantial preparation and information gathering, having named individuals and robust documentation processes will aid the audit process. Management of information storage will, where applicable, also need to adhere to the organisation’s records retention and disposal schedule.

          1.5 Financial considerations

            International financial reporting standard 15: revenue recognition

            The NHS often undertakes research in partnership with other organisations, for example, through a collaboration with other provider sites on the same study. When this involves the transfer of monies – for example, from an NHS organisation to third parties – this is either described in written agreements or established practice. Being able to manage annual income, expenditure and projected income in-year is important because this allows researchers and R&D departments to use any income and invest any projected surplus within the financial year to comply with international financial reporting standard (IFRS) 15.

            IFRS 15 provides a single, principle-based 5 step model to be applied to all contracts with customers:

            1. identify the contract(s) with a customer
            2. identify the performance obligations in the contract
            3. determine the transaction price
            4. allocate the transaction price to the performance obligations in the contract
            5. recognise revenue when (or as) the entity satisfies a performance obligation

            IFRS 15 should not be used as a mechanism to recognise income on a cost accounting basis. The income can be recognised as and when the performance obligations – for example, agreed research activities – have been completed. At that point, the NHS organisation will select an appropriate measure of progress to determine how much revenue should be recognised as part of IFRS 15.

            Value Added Tax

            The NHS divisional VAT registration is a concessionary arrangement from HMRC that treats NHS organisations within England (NHS trusts, NHS foundation trusts, ICBs and other NHS bodies) as a single VAT registration. This allows supplies of goods and services between these bodies to be outside the scope of VAT, meaning no VAT is added to such transactions.  

            Businesses going into administration

            Sponsors (usually of commercial research) going into administration during or immediately after delivery of research activity is a serious risk for bad debt. Refer to government guidance when this happens; it can be challenging to recover costs, especially if the company is not based in the UK. Providers should carry out due diligence and credit checks to minimise the risk of experiencing bad debt with a company.

            Seeking research finance support

            Individuals who are not familiar with local research processes and are seeking research finance support for their study should consider the following:

            • whether your organisation has an R&D department or function that supports a research finance function. See the UK R&D contacts directory
            • if your organisation’s R&D department does not support a research finance function, check if the finance department does
            • engage with your organisation’s R&D department and finance teams as early as possible to obtain advice on delivery support and research-related finance
            • for commercial contract research studies, the NIHR Industry Hub provides information, advice and costing support
            • for non-commercial research studies, the NIHR Research Support Service gives researchers, especially those in receipt of NIHR funding (pre-application through to post-application), access to support, advice and expertise in the development and delivery of their research project

            2. Capacity, inclusion and expansion

            21. Using research finance to build and maintain research capacity

            Both commercial and non-commercial categories of research include provisions to secure a proportion of income to grow and maintain capacity to deliver research, for example, staff time and resources. Growing capacity may require a business case and skills and expertise to develop a funding application. See NHS England’s guidance on developing and approving business cases and the Health Innovation Network’s information on writing NHS business cases.

            The organisation should reinvest any indirect research income received (defined as anything that is not a direct unit cost of research delivery), above that required to deliver the research. This will help to increase research capacity and efficiency to deliver the national metrics, including those in the NHS Oversight Framework. Investments across the organisation, including outside the R&D department, can achieve this for example by funding clinical time to release staff for research. Within NIHR funding, there is a specific allocation for Research Capability Funding (RCF), see section 3.2 for more information.

            The NIHR Research Delivery Network (RDN) provides infrastructure support for portfolio studies, for the initiation and delivery of high-quality research that benefits patients and the NHS, including relevant research in public health and social care – find out more.

            The NIHR RDN will provide funding to study sites they can use for relevant service support costs across the study delivery pathway. Financial oversight is needed to ensure this funding is used to support activities in line with DHSC’s guidance on the attribution of costs to support the research. Dedicated support to ensure study sites are recovering all appropriate costs to sustainably fund and grow research delivery staff and facilities is available from the RDN.

            NIHR RDN funding (for portfolio studies) will enable the NHS organisation to:

            • increase opportunities for participants to take part in research
            • ensure studies are carried out efficiently
            • improve the environment for commercial contract research

            Case study: driving practice growth and staff engagement by investing in research

            Darlington Primary Care Network implemented a strategic workforce approach to foster research engagement among nurses, midwives and allied health professionals. These colleagues were invited to participate in research projects through a competitive process, supported by pump priming funding (£21,000) from the local clinical research network (LCRN), which is now part of the NIHR RDN.

            One practice nurse, initially supported through a fixed-term position, received assistance from the LCRN to conduct multiple commercial trials in the primary care setting. The income generated from these trials (£40,000 to £50,000 per annum) was reinvested in the practice, with the nurse’s position made permanent. This then continued to generate additional funding, which was reinvested in the practice to benefit patients.

            These commercial research opportunities not only increased clinical knowledge but also yielded significant financial gains for the practice, enabling staff advancement and growth. This created a sustainable cycle, one that reinforced the business case while fostering an environment that encouraged staff participation in ongoing research initiatives.

            Research pipeline

            Establishing a mixed portfolio of research is encouraged. Growing the portfolio of research can mean significant fluctuations in income between years initially, which should be planned for to establish a more stable research income across years and support the resources needed to deliver research.

            2.2 Managing payments for public and patient involvement and engagement

            Research finance functions should use NIHR’s guidance on payment for public involvement in health and care research to support the development of clear and timely payment policies; and payment guidance for researchers to support the costing and planning of payment for public contributors.

            It is good practice for organisations to have a policy for managing payments to public contributors, particularly where these amount to more than the reimbursement of expenses. This will help ensure clear mechanisms are in place for tracking and managing activity and payments, and there is transparency over eligibility and rates of pay for public contributors.

            Considerations when drafting a public and patient involvement and engagement payment policy include:

            • mechanisms to pay expenses upfront or in cash or vouchers to enable involvement of individuals or groups
            • tax and national insurance implications for public contributors (covered in the NIHR guidance) where payments over and above reimbursement of expenses are made. Public contributors will need to be aware of these. Payment in vouchers is considered the same as cash payments
            • payment through groups or third parties, for example, voluntary, community, faith and social enterprise sector organisations
            • research finance planning should also build in resource to address reasonable adjustments

            2.3 Expanding research activity across the provider landscape

            Growing research participation within primary and community care is a commitment in the 10 Year Health Plan. Sound financial management is essential to delivering this commitment. Capitalising on existing local infrastructure and exploring different models of collaboration and delivery with groups or networks of providers has been effective in expanding research activity across different settings. ICBs can play a convening role, and through the new operating model there are further opportunities to improve, for example, via integrated health organisations. The key is collaboration between different providers,enablingthe research finance function to work across provider boundaries with clear finance mechanisms agreed.


            3. Guidance on different types of research funding

            3.1 Commercial research

            Commercial contract research is the category funded solely by industry and where NHS organisations are contracted to carry out the research, as explained in the AcoRD guidance.

            The NHS does not subsidise the delivery of commercial contract research so the funding arrangements must ensure the NHS recovers all costs over and above the standard NHS treatment cost, including indirect and capacity building costs. There is a standardised process in place through the NCVR for costing commercial contract research that funders and providers should adhere to.  

            Commercial contract research is generally costed at a granular level (for example, per patient, activity or hour). See section 1.2 for general principles for tracking activity and assigning costs. A delay in triggering the payment milestones in the study finance schedule can delay the payment of the invoice or stop it altogether, which can result in ‘bad debt’.

            National directive on commercial contract research studies

            The NHS Standard Contract mandates adherence to the national directive on commercial contract research studies, which states that providers must:

            • adhere to Health Research Authority policy, guidance and the single contracting process (use of appropriate unmodified model agreements)
            • use the standard costing methodology to set prices for commercial contract research undertaken by NHS organisations; this is in NIHR’s interactive Costing Tool (NIHR iCT)
            • use the NCVR process in line with national rollout

            National contract value review

            NCVR is a standardised, national approach to costing for commercial contract research; it is mandatory for all commercial trials in acute, specialist and mental health trusts. The NCVR ensures all NHS costs (direct and indirect) are covered. The 10 Year Health Plan commits to aligning the NCVR with the NHS Payment System guidance and making it business as usual in out of hospital settings.

            The NCVR process significantly reduces the time it takes to set-up commercial studies in the NHS as the activity and cost negotiation is done once rather than at each study site (the average is 10 sites per study).

            The NCVR creates transparency and standardises processes by providing the site-level costs as a financial appendix for direct insertion into localised contracts. Its core principle is that a single site (the lead site) costs a study and the other sites involved accept that cost without further negotiation as part of the single contracting process. Local negotiation of contract value is not permitted. A site-specific multiplier, indirect costs and a capacity building element are added to give a site-specific cost. There are nationally set expectations on how long it should take to cost a study. The current expectation is that it will take no longer than 20 calendar days to carry out the lead site review and the escalation process is replaced with a quality assurance step including a second reviewer.

            General practices are strongly encouraged to participate in the NCVR through a voluntary scheme that enables practice staff to set up studies quicker and generate additional income for the practice. General practices that do not sign up are advised to identify an authorised member of staff with expertise on cost negotiation to review and agree costs and payments on their behalf.

            The NCVR uses NIHR’s iCT to:

            • determine resource requirements for study delivery at a national level
            • calculate site-specific prices to ensure commercial trials are costed correctly and the NHS fully recovers the costs
            • include a site-specific multiplier that considers the local market forces factor (MFF) and overheads

            A capacity building rate is added to both direct staff time and investigation costs within the NCVR to maintain, strengthen and grow sustainable research infrastructure, as well as build capacity, retain skills and strengthen eligibility to deliver future research.

            The inclusion of the MFF tariff in the cost of the study provides an adjustment value to accommodate the unavoidable cost differences of providing healthcare across the country and is NHS organisation specific. The MFF also adjusts for specific considerations when commercial studies are undertaken in general practice, for example, out-of-hours working.

            Once completed, the budget in the iCT and unscheduled event template will automatically form the financial appendix of the appropriate trial agreement.

            Capacity building funding from commercial research

            The capacity building element of commercial contract research income supports a sustainable research infrastructure in the NHS. Organisations are required to use capacity funding for research capability and capacity building, and to ensure there is board-level visibility of research income and how it is used. This income should be clearly and transparently accounted for to avoid issues when auditing.

            Reinvesting a proportion of the capacity building element can be achieved in several ways including: incentivising principal or chief investigators, research teams, ancillary staff in pharmacy, radiology and administrative support staff to ensure timely approvals and increase research activity.

            Case study: percentage allocation model to incentivise research

            The Newcastle upon Tyne Hospitals NHS Foundation Trust has developed a percentage allocation model for income from indirect costs that incentivises research.

            NHS organisation A (without private finance initiative (PFI)):

            • 40% of indirect income is allocated to the organisation to recognise support functions and estate
            • 30% is allocated to the organisation-wide business case development fund (non- research specific)
            • 10% is retained by research management for strategic investment
            • 10% is allocated to the chief investigator for specialty investment
            • 10% is allocated to the chief investigator department to invest in facilitating research

            NHS organisation B (with PFI):

            • 30% of indirect income is allocated to the organisation to recognise support functions
            • 20% is allocated to the organisation’s PFI budget
            • 10% is allocated to the organisation-wide business case development fund (non- research specific)
            • 20% is retained by research management for strategic investment
            • 10% is allocated to the chief investigator for specialty investment
            • 10% is allocated to the chief investigator department to invest in facilitation of research

            In both instances, the R&D department or finance team should report annually to the finance committee on the income received and how it was distributed.

            Case study: expanding the commercial portfolio and generating income in a general practice setting

            Breckland Alliance Primary Care Network comprises 3 general practices serving a total patient list of about 45,000. Before this alliance was formed, the 3 practices conducted research separately.

            In 2019, the alliance only had one new commercial study and one ongoing from 2018. There was one part-time research nurse who worked from home. That year, the Breckland Alliance Board and partners made several strategic and operational changes:

            • research is a primary objective of the alliance and part of the role of all staff
            • if applicable, the research team can call on any other member of the alliance staff to help with research
            • research information is displayed in all 3 general practices
            • each practice’s website hosts research information

            With these changes and the help of the alliance operation manager and the income generated from commercial research, Breckland Alliance quickly expanded its commercial portfolio and set up a dedicated research unit.

            Growth continues and the Breckland Alliance is now recognised as an NIHR Primary Care Commercial Research Delivery Centre, reflecting its strengthened infrastructure, increased capacity with the recruitment of new staff across the healthcare professions and expanded influence within the research system across the region.

            For example, the team is currently running 7 commercial studies, closed 2 recently and expects to close 2 more soon, and the alliance already has 3 commercial studies scheduled to start, ensuring continued growth and financial sustainability. Across its commercial portfolio, the alliance is consistently in the top 3 highest-recruiting primary care sites in the UK (over 200 patients since January 2024) and in several studies has outperformed much larger secondary care trusts.

            3.2 Non-commercial research

            Non-commercial research award funding generally has a contractual arrangement between the funder and a lead organisation or contractor. As set out in the DHSC policy statement,  the following need to be used: SoECAT, the unmodifiable existing model Non-Commercial Agreement, and the Organisation Information Document. Lead sites are responsible for completing the SoECAT; other sites must accept this without further modification. The lead organisation is responsible for putting in place collaboration agreements with other research collaborators, including other study sites. This means all organisations collaborating on a particular research project have a written description of how they receive funding.

            Some funders stipulate which organisations can receive funding. NIHR provides a good practice research funding guide. Other funders may require different financial and project reporting arrangements.

            Organisations in receipt of NIHR funding may be invited to participate in a funding review to examine whether their governance, financial and risk management systems are effective. Selected organisations need to complete a funding review assurance questionnaire and this is assessed by the Department of Health and Social Care.

            Non-commercial research funding sources

            Non-commercial research undertaken in the NHS and other health and care settings is often aligned with national priorities and funded through national calls and awards provided by government funders such as NIHR and UK Research and Innovation (UKRI); UKRI includes the Medical Research Council and Economic and Social Research Council. Research charities, such as members of the Association of Medical Research Charities, are also funders of health research in the NHS.

            Commercial organisations can collaborate with NHS organisations or non-NHS research funders to support non-commercial research. A ‘commercial collaborative’ is defined as studies funded, wholly or in part, by the life sciences industry and sponsored by a combination of life sciences industry and non-commercial organisations.

            Some studies (for example, student projects or those with minimal impact on an organisation) may have no funding attached and individual organisations should determine whether they wish to participate on this basis.

            There are standard application forms for each of the main funding bodies (such as NIHR, UKRI) for non-commercial research. Teams supporting researchers need to interpret a funding body’s guidance on funding applications, so they can plan and schedule the body’s financial reporting requirements once funding is awarded. These requirements often span financial years.

            For some funders, researchers may be informed that their application has been “recommended for funding”. This does not guarantee funding; a study will only progress to contracting once satisfactory responses have been received to the funder’s queries and the application, including any updates to the project costings (for example, research, study support and Excess Treatment Costs), amended to reflect any agreed changes. Any subsequent changes to project costings should be agreed between the team and R&D department or finance team involved in the funding application.

            Costing non-commercial research activity

            The lead organisation (typically the site where the chief investigator is located) will need to work with its collaborators to get accurate and appropriate costings for the entirety of the research project. It is essential to have a process to determine costings (including cost identification, attribution and pricing of a research proposal) and cost management, and costing templates and pricing policy.

            Site-level costs may be reviewed and amended following protocol development to reflect the actual delivery model for the trial. Any project extensions will need funder approval and potentially re-costing and reapplication for funding, including support costs and Excess Treatment Costs (ETCs).

            The individual leading the research project costing needs to understand the differences between collaborators’ costing approaches. Researchers and finance professionals should refer to the funder’s guidance when applying for a research award.

            The AcoRD policy puts the different activities in non-commercial research studies into 3 broad cost categories:

            1. research costs: the costs of the R&D itself, which end when the research ends. They relate to the activities that aim to answer the research questions
            2. ETCs:for NHS ETCs, patients participating in a research study may receive healthcare that differs from what is standard in the NHS, for example, activity requires more clinician time or is delivered in a different location. The associated NHS treatment costs may exceed or undercut those of the standard treatment. If greater, the difference is referred to as the NHS ETCs, set out in DHSC’s guidance. For non-NHS ETCs, see researcher guidance for non-NHS public health and social care intervention shortfall costs
            3. NHS study support costs: the additional patient care costs associated with the research, which end once the study ends even if the patient care involved continues to be provided. These activities are primarily concerned with ensuring the safety of the participant within the context of the study

            As part of the cost attribution process, the primary purpose of each activity needs to be assessed, regardless of who will be delivering it. For example, blood samples taken for safety reasons during a study are deemed to be NHS support costs as their primary purpose is patient safety.

            For studies in the NIHR RDN portfolio, access to study support costs and ETCs is the same regardless of the setting of the research activity. Sites should claim research costs from the study sponsor with arrangements for invoicing agreed during study set-up.

            SoECAT

            All studies requesting NIHR portfolio status have to complete the SoECAT for all new funding submissions, following NIHR study set-up guidance. Completion of a SoECAT is also required to claim ETCs. Its primary purpose is to ensure site-level costs in the funding application follow AcoRD principles. The SoECAT, as part of the research funding submission, introduces greater consistency and streamlining across the funding, planning, and site set-up stages of a project.

            The NIHR has a network of AcoRD specialists and the NIHR Regional Research Delivery Networks can help identify relevant specialists. They provide specialist advice, signpost researchers to resources, help resolve attribution queries, authorise the SoECAT and facilitate the triage process to help identify the clinical commissioners for any additional clinical activity the study protocol requires. SoECAT is non-negotiable once agreed by the lead site and funder.

            Contracting and financial schedule

            The finance schedule will usually form part of the main contract for the award between the lead organisation and the study funder. This needs to reflect the anticipated spend on the project to minimise any large in-year variance in spend versus income.

            Onward payments to collaborators will usually be detailed in a collaboration agreement between the parties. Payments to NHS sites or participant identification centres will be via the appropriate UK template agreement, for example, model non-commercial agreement and non-commercial organisation information document. No UK template agreements exist for non-NHS sites, but the NHS templates are appropriate for wider use.

            Research capability funding

            Research-active NHS organisations may also be eligible for NIHR income-related research capability funding (RCF). NIHR RCF is allocated to research-active NHS organisations or NHS providers to enable them to maintain research capacity and capability. The principles of RCF funding are subject to change. Read more about the aims of RCF.

            All NIHR programmes where the funding agreement is held by an NHS organisation in England are eligible for RCF. However, if the funding agreement is held by a higher education institution, it will not attract RCF, even if an NHS organisation is working with them (as overhead costs are charged through the grant instead). See the list of eligible programmes.

            Example: using RCF to support research and development capacity

            ICBs can use RCF to support a stable research and development (R&D) function (whether an individual or team) that is protected from other fluctuations in ICB income. This enables longer term development and retention of staff with specialist R&D knowledge and skills, and the development of relationships, partnerships and activity across an ICS to build wider research capacity. This in turn enables expert deployment of RCF to support research across the ICS, increased research activity and bigger returns on investment for delivering research statutory responsibilities.

            It is a condition of RCF funding that recipient organisations provide an annual report on how the funding has been used.

            Organisations in receipt of RCF funding allocations should have an RCF policy. This might cover a local RCF allocation process including award criteria, an escalation process and project award versus actual spend. Refer to NIHR’s frequently asked questions on RCF when developing your policy.

            Case study: ICB using RCF to support primary care research capacity

            NHS Nottingham and Nottinghamshire Integrated Care Board Research Strategy Group, chaired by a GP lead, strategically allocates and monitors the ICB’s NIHR RCF following NIHR guidance.

            The RCF funds 2 primary care research champions (a GP and a practice manager). Both are from research active general practices and were appointed following a competitive process. Their role is to engage with primary care, primary care networks and wider stakeholders, including in partnership with the East Midlands Research Delivery Network, to promote, advise, support and provide mentorship to integrate research into everyday primary care practice. They focus on supporting research where patient need is greatest.

            They have opened new NIHR research opportunities to patients and the workforce, and demonstrated the importance of having trusted research leaders who enthusiastically champion research, act as role models, mentor and provide practical support for their primary care colleagues.

            One outcome of their work has been 15 more general practices joining the RDN Research Sites Initiative (RSI) scheme in 2023/24 (to 56 of 130 practices across the ICS), with a third of the new practices being in some of the most disadvantaged communities in the ICS. Also, 9 more practices joined the Clinical Practice Research Datalink in 2023.

            The RSI is being replaced by NIHR’s wider care settings funding call. Practices are invited to apply for the scheme on an annual basis and payments are linked to the level of research activity. This funding is additional to the study specific patient-related costs a practice receives as reimbursement for service support activities.

            NHS Norfolk and Waveney Integrated Care Board receives RCF based on the NIHR award income received. This income is used to support capacity and capability building by funding the research development team, who work with academic colleagues to develop and cost NIHR award funding applications; and project development awards and early career fellowships with academic partners that meet the priorities of the ICS. This entails buying the time of a research associate to write the NIHR award application and supporting community engagement to strengthen applications. In return for funding, the award submission must be made through the ICB to generate further RCF for reinvestment in future research awards development and to prepare evidence briefings for commissioners.

            Case study: models of clinical trial delivery in primary care in the South West

            The consortium model

            This is a collective of independently functioning, research-active GP sites collaborating under a shared management while retaining local autonomy. Each site delivers trials end-to-end, supported by common standards and peer learning. This model fosters ownership, efficiency and innovation, and relies on strong trust and shared values across sites.

            There is no single point of failure in this model and it is flexible and adaptable – sites can work together or individually. One disadvantage is that it takes time to mature as new sites need to develop all administrative and clinical functions to be fully operational. Also, sponsors must monitor all the sites separately, which could create barriers.

            Every site has its own identical contract for each trial negotiated by the consortium manager. Invoicing and cost recovery is managed by sites separately but this can be co-ordinated centrally by the consortium manager. Each site retains all remuneration but contributes to the manager’s salary.

            The ‘hublet’ framework

            This is an extension to the consortium model and is applicable to primary care network (PCN) level research endeavours. Each main site functions as a mini-hub (‘hublet’) within its own PCN, forming formalised spoke relationships with neighbouring PCN practices. These partnerships go beyond traditional participant identification centre arrangements, with defined financial agreements and shared governance. Existing PCN data-sharing frameworks make rapid expansion straightforward. The potential here is considerable. The consortium encompasses 7 PCNs and can reach more than 300,000 patients.

            The hublet holds the trial contract and enters a locally agreed financial arrangement with its spoke sites which is based on the trial tasks and activities performed by the hublet versus spoke, for example, between 10% and 65% of trial remuneration will go to the spoke sites.

            The hub-and-spoke model 

            A central hub GP practice holds governance, contracts, trial documentation and medication accountability. Collaborating practices act as spoke sites and these have a research doctor and a nurse.

            This model offers simplicity, standardisation and scalability for regions new to research. However, it is an inherently top-heavy model as one principal investigator (PI) is responsible for many sites and patients. Spokes have little autonomy and pay a significant amount to the hub for core functions, which can lead to disengagement. The model is also prone to single points of failure, especially around the PI. If, for example, the PI resigns or their oversight is insufficient, the entire organisation can be vulnerable to regulatory scrutiny and closure.

            The hub site holds the contracts for all trials and charges spoke sites for the services and tasks it performs which can include investigational product accountability, administrative functions, and data entry. A typical charge to the spoke sites would be 25% of the total trial remuneration.


            Publication reference: PRN02274 (updated PRN00984)