Funding

The costs of the R&D itself that ends when the research ends. They relate to activities that are being undertaken to answer the research questions. Research costs are usually met by grant funders through the award of a research grant in most cases. Invoice the Study Team.

Examples include:

• Screening / assessments to determine eligibility for a study, performed after the patient has been approach about the study and before they are accepted on to the study.

• Study specific central trial co-ordination and management (normally includes study set-up at practice).

• Investigation, assessments and tests to see if an intervention works.

• Investigations or assessments that are not reported back to the patient or GP.

• Patient follow-up, if not part of usual care.

• Associated costs associated with placebos.

The additional patient care costs associated with the research, which would end once the  study in question had stopped, even if the patient care involved continued to be provided. Support costs are met from the R&D budget by the Health Departments of the United Kingdom. Invoice to Clinical Research Network (our Support Officer will send you a template invoice).

Examples include:

• Processing of a patients record to identify if they are suitable to approach for a research study.

• Obtaining informed consent.

• Additional investigations / assessments where results are required by the GP to ensure patient safety.

The difference between the Treatment Costs and the costs of the existing standard treatment is referred to as the Excess Treatment Cost (ETC). ETCs are paid for by service commissioners. The ETC amount will be clearly stated on any of our Research Information Sheets for Practices which will be shared with you when the study researchers are looking for practices to take part along with any other reimbursement. 

ETC payments are made to primary care providers at the end of quarter two, once the minimum payment trigger is reached. If a primary care provider does not reach their minimum payment trigger value during the year, they will be reimbursed at year-end irrespective of whether the ETC payment trigger value has been reached.

The RSI scheme run by the Local Clinical Research Network (CRN) Thames Valley and South Midlands offers funding to help build an infrastructure for research at practices. This funding is from the Department of Health and is allocated to the Clinical Research Network.

• Annual Infrastructure Funding Stream; funding runs with each financial year (April - March) and practices will be invited to apply for the scheme just before the beginning of each financial year.

• Payments linked to level of research activity.

Please find our Research Site Initiative online application form here - the deadline for applications is 31st October 2023 for practices renewing their application, and 31st January 2024 for Introductory/new practices. 

Changes to the Research Site Initiative Scheme

After running its current format for several years, the Research Sites Initiative (RSI) scheme continues to develop in accordance with the changing Primary Care Landscape. With the challenges practices face with staffing and workload, we are doubling the time to target payment for studies that require patients to be recruited opportunistically at the practice, by practice staff. We will assess studies on a case by case basis with the Research Delivery Manager when considering this additional funding, and will add this to our Research Information Sheet for Practices. 

Hub and Spoke Model to deliver Primary Care Research: New Funding Available

Benefits of 'Hub-and-Spoke' working

The hub and spoke model enables practices to work together to reach out to a wider population and give more patients the opportunity to participate in research.

Hub practices act as the site and can offer the full or partial array of research activities as required by the study, whilst the Spoke practices act as Participant Identification Centres (PICs). The Spoke benefits from mentoring and guidance to enable them to build their own infrastructure.  

Available funding from the Clinical Research Network

Funding is available to set up a hub and spoke model and to cover the following activities:

• Time to assess capacity and capability, including feasibility.

• Discuss the research delivery model between hubs and spokes, including staff involved in delegated tasks, and completion of other essential documents.

• Time to put contracts/agreements in place between hub and spokes and discussions with the CRN. 

Hub and spoke funding will be paid directly to the Hub and they will be responsible for having an agreement in place to pay the Spoke/s.

How to identify suitable studies

Studies suitable for the hub and spoke model will be assessed by the CRN Portfolio Manager in collaboration with GP Research Champions and will be highlighted on our Research Information Sheet for Practices (RISPs) and/or promotional emails.

Eligibility

No practice is excluded from this funding, but all practices should already be in receipt of sessional funding or signed up to the Research Site Initiative (RSI) scheme.  Hub and spoke funding is paid in addition to any other research funding and/or support. 

Minimum criteria for 'Hub' practices:

• Must be signed up to the Research Site Initiative Scheme and have an LCRN contract in place

• Identified a research lead (and a GP to support if the lead is not a GP)

• At least one GP to complete Good Clinical Practice (GCP) training (free training available at NIHR Learn - you may have to create an account)

• Demonstrate ability for conducting at least one site based study (as Hub)

• Identify someone in house to act as admin support

• Raise awareness of research at the practice

• Communicate with allocated research facilitator

• Consider signing up up the RCGP Research Surveillance Centre and CPRD

• Consider signing up for the RCGP Research Ready accreditation (reimbursed by CRN)

Minimum criteria for 'Spoke' practices:

• As above but at least one PIC feeding into Hub

Applying for hub and spoke funding

Please discuss your plans to use a hub and spoke model of delivery with a Primary Care Portfolio Manager (contact email below) before completing the application form. We need to check the study is suitable for this model, and ensure practices meet the minimum criteria above. The application form can be found here.

For more information, and to discuss the options available, please email pcresearch-tvsm@nihr.ac.uk