Research Study Payments

How are GP Practices paid for delivering Research Studies?

Non - Commercial Research studies comprise a number of component activities, which, for the purpose of agreeing funding arrangements, are attributed to one of three broad cost categories :

• Research Costs - the costs of the research itself that end when the research ends. They relate to activities that are being undertaken to answer the research questions.

Funds are paid to sites via the Study Sponsor.

• NHS Treatment Costs - the patient care costs, which would continue to be incurred if the patient care service in question continued to be provided after the R&D study had stopped.

Funds are paid to sites via their Normal Local Commissioning Process.

NHS Support Costs - the additional patient care costs associated with the research, which would end once the Research Study in question had stopped, even if the patient care involved continued to be provided.

Funds are paid to sites via the sites Local CRN (us!)

Examples

  • Participant Screening / Eligibility Tests (Bloods, ECGs etc after the patients have been approached to ask if they wish to participate in the study, but before they are accepted onto the study.

  • Interventions / Assessments / Tests which are intended to answer the research question

  • Patient Follow-Up where the Follow-Up is not a part of Individual Patient Clinical Management

  • Data Storage archiving of Clinical Research Records

Examples

  • Supplying and Administering the Medicine / Device / Therapy being studied

  • Supplying and Administering any Active Comparators - Excluding Placebos

  • Investigations / Tests which would Continue to be Incurred if the Patient Care service in Question continued to be Provided after the Research Study Stopped

  • Patient Follow-Up where this is Required as part of the Clinical Management of a Patient.

Examples

  • Processing of patient record to identify NHS patients who may be suitable to approach to ask of they wish to participate in the research study (Database Searches)

  • Screening of Database Search Lists to check eligibility before patients are approached.

  • Obtaining informed Consent from patients where the study is a health research study.

Commercial Contract Research studies are more straightforward. The NHS is required to recover, from industry, all costs over and above the standard NHS Treatment Cost. The attribution of costs is, therefore, not an issue for commercial contract research.

Further information on how Research Costs are attributed please view the Department of Healths - Attributing the Cost of Health and Social Care Research and Development


How is the Funding to be paid to GP Practices, per Research Study, Calculated?

The NIHR uses the National Schedule of Events Cost Attribution Tool (SoECAT) to ensure that site-level research costs are appropriately attributed according to AcoRD Principles at the time of application for research funding and hence to ensure that site level Research Costs are met via that funding.

NOTE: monetary values contained in the SoECAT are agreed as part of the Sponsor / CI application and approvals process and so are NON-NEGOTIABLE. Practices will be paid a set amount for each activity for each study as outlined on study information section of the website.

For Further information on the SoECAT process click here.


What is the Process for GP Practices to be paid NHS Support Costs by the CRN East Midlands?

As noted above NHS Support Costs also known as Service Support Costs are paid to GP Practices by Local CRNs.

To ensure that GP Practices are reimbursed accurately and efficiently for Research Study Activity categorised as being attributed to NHS Support Costs the CRN East Midlands Primary Care Research Delivery Team are implementing a new process.

The process continues to rely on GP Practices to inform the CRN East Midlands Primary Care Research Delivery Team of the work they have completed at their sites in regards to Research Activity Service Support Costs. The new process enables a more automated, simpler, and quicker system for payments to be calculated and paid. Sites will also be able to access all of their payment information online via a simple to use dashboard, providing transparent and helpful access to such information.

Sites are asked to complete a short online form to document all Service Support Cost activity completed at site for each study.

Click below for full guidance on completing this process and to submit a claim.