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Costing clinical studies taking place within the NHS

Research conducted using NHS patients or facilities is subject to the guidelines for attributing the costs of health and social care research and development (AcoRD guidance), published by the Department of Health.

Prior to completing an application to Diabetes UK for a clinical study taking place within the NHS, you must contact all relevant parties to ensure all costs are correctly attributed, and studies are designed to make effective use of research support staff.

Relevant parties to contact prior to applying:

  • The Research and Development (R&D) office in the NHS Trust(s) where the study will be held.
  • The Finance Office in the institution where the Principal applicant is based.
  • In England, the lead National Institute for Health Research (NIHR) Clinical Research Network (CRN) responsible for providing infrastructure for the study, the Chief Scientist Office (CSO) in Scotland, the National Institute for Social Care and Health Research (NISCHR) in Wales, or the Health and Social Care (HSC) R&D office in Northern Ireland.

You should also refer directly to theAcoRD guidancewhich explains in detail how the costs of clinical studies should be attributed. Annex A of theAcoRD guidancefully details the subset of costs that may be requested from Diabetes UK, and those which we would expect to be funded by the Department of Health through the National Institute for Health Research or local NHS Trusts but you can find a brief overview of the costing types below for guidance.

Annex B of theAcoRD guidancealso includes a set of Frequently Asked Questions and costing examples.

Research Costs

This is the cost of the research itself. These costs end when the research ends and they relate to activities that are being undertaken to directly answer the research questions.

Diabetes UK would expect any research costs identified as ‘Part B’ in theAcoRD guidance(e.g. local study trial co-ordination or data collection) for work that is carried out by existing staff employed by the NHS, NIHR Clinical Research Network (NIHR CRN) or other clinical organisations to be paid by the Department of Health through local networks or the appropriate NHS trust. As a member of the AMRC, Diabetes UK will not meet these costs.

Diabetes UK will pay the full direct costs of the research however, along with other charitable medical research funders, we expect universities and the NIHR (or its equivalents) to provide the infrastructure enabling the research to be carried out.

Some examples of research costs that Diabetes UK will not pay, and which need to be discussed with and attributed to either the university or the NIHR (or its equivalents), include:

  • Sponsorship fees and insurance.
  • Regulatory preparation and compliance work.
  • The salary (or part of the salary) of tenured active clinical investigators.

Please also refer to ourgeneral guidelinesfor a full list of allowed and disallowed costs.

NHS Treatment Costs

These are the patient care costs, which would continue to be incurred if the patient care service in question continued to be provided after the research study had stopped.

NHS Treatment Costs include the costs of:

  • Supplying and administering the medicine/device/therapy being studied.
  • Supplying and administering any active comparators - including medicines, devices or therapies, but not placebo or sham treatments.
  • Training of clinicians to deliver the treatment.
  • Investigations and tests which would continue to be incurred if the patient care service in question continued to be provided after the R&D study has stopped.
  • Patient follow-up where this is required as part of the clinical management of a patient. If the primary purpose of the follow up is to inform the long-term evaluation of an experimental treatment, the activity should be attributed as a Research Cost. If the primary purpose of the follow-up is to monitor patient safety rather than efficacy, the activity should be attributed as an NHS Support cost.

NHS Treatment Costs and Excess Treatment Costs are attributed to the NHS and must be discussed with the NHS Trust R&D Department involved in the study when making an application.

NHS Support Costs

These are the additional patient care costs associated with the research, which would end once the research study had stopped, even if the patient care involved continued to be provided.

NHS Support Costs include:

  • The processing of the patient record to identify NHS patients who may be suitable to approach to ask if they wish to participate in a research project.
  • Obtaining informed consent from patients where the study is a health research study, taking place within the NHS.
  • Additional investigations, assessments and tests where the results are required by the patient’s care team to ensure patient safety and where arrangements are in place to feed the results back to the clinician.

NHS Support Costs are met from the R&D budget of the Health Departments of the UK. Prior to applying to Diabetes UK you must discuss the provision of NHS support for your study with the lead NIHR CRN in England, the CSO in Scotland, the NISCHR in Wales, or the HSC R&D office in Northern Ireland.

You can find more information about accessing support from theNIHR Clinical Research Networks.

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