Before you complete your application
Before completing an application to us for a clinical study, you must consult with all relevant parties to identify how the costs of the study will be resourced and how governance will be handled.
Relevant parties will usually include:
- The finance office in the institution where the principal investigator is based.
- The Research and Development (R&D) office in the NHS Trust(s) where the study will be led.
- 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.
The Department of Health has published guidance, known as AcoRD guidance, for attributing the costs of clinical studies. This guidance clarifies the distinction between Research Costs, NHS Support Costs and NHS Treatment Costs. The guidance also provides a set of examples and Frequently Asked Questions. You should refer to these documents and to our guidance below when costing your clinical study.
The costs of a clinical study fall into three categories
These are the costs of the research itself. They include the costs of data collection and analysis and other activities that are undertaken specifically to answer the research questions.
In general, we are prepared to pay the full direct costs of the clinical research, including salaries of staff employed to carry out the research and consumable costs associated with the research.
However, as with other medical research charities, we expect universities and the NIHR (or its equivalents) to provide the infrastructure enabling the research to be carried out, and in general we will not pay indirect costs of research or directly allocated costs (e.g. fractional salaries of staff who already have academic PAs in their contracts). We will also not take on the role of a sponsor in a clinical study.
Examples of research costs that we will not expect to 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.
- R&D support for processing research approvals.
- PAs for tenured active clinical investigators.
- Posts for support services (for example pharmacy or radiology).
- Local study co-ordination and management costs outside the lead centre (the centre where the principal investigator is based).
- Data collection where the activity is undertaken by existing staff employed by the NHS, NIHR Clinical Research Network or other organisations funded by the NHS to provide patient care services.
NHS Support Costs
These are the additional patient care costs associated with the research which would end once the research has stopped, even if the treatment, device or diagnostic test being studied continues to be provided.
NHS Support Costs include the costs of identifying patients who may be suitable to approach for participation in the study, obtaining informed consent, extra patient tests, extra nursing attention or extra in-patient days required to monitor the patient’s condition to ensure their safety during the study.
NHS Support Costs are met from the R&D budget of the Health Departments of the 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.
Find out more information about accessing support from the NIHR Clinical Research Networks.
NHS Treatment Costs
These are the patient care costs that would continue to be incurred if the treatment, device or diagnostic test continued to be provided after the end of the study.
Excess Treatment Costs are the difference between the costs of the treatment being studied and that of the standard treatment.
NHS Treatment Costs include the costs of:
- Supplying and administering the medicine/device/therapy being studied.
- Supplying and administering any active comparators (but not placebos or sham treatments).
- Training of staff to deliver the treatment.
NHS Treatment Costs and Excess Treatment Costs are the responsibility of the NHS and must be discussed with the NHS Trust R&D Department involved in the study when making an application.