Applications may be made for research costs associated with NHS studies. Costs included in these applications comprise:
- research costs
- NHS treatment costs
- NHS support costs.
Research costs of a study
MRC will only fund costs which fall under this heading. These are funded at the appropriate FEC rate, usually 80%. The research award does not include NHS support or treatment costs, although MRC will take NHS support and treatment costs into account when considering the value for money of the research.
Where a research study takes place in, or involves the NHS, Department of Health guidance on the responsibilities for meeting patient care costs associated with research and development in the NHS applies.
NHS support costs
These are the additional patient care costs associated with the research, which would end once the research and development activity in question has stopped, even if the patient care service involved continues to be provided. These might cover items such as extra patient tests, extra in-patient days and extra nursing attention.
Researchers should contact their local NHS research and development department initially. If they are unable to help directly or if there is no local NHS research and development department, contact the local Comprehensive Local Research Network (CLRN) senior manager.
NHS treatment costs
These are the patient care costs that would continue to be incurred if the patient care service in question continued to be provided after the research and development activity has stopped. In determining NHS treatment costs the applicant must assume that the patient care service being assessed will continue even though there may be no plans for it to do so.
Where patient care is being provided which differs from the normal, standard treatment for that condition (either an experimental treatment or a service in a different location from where it would normally be given), the difference between the total treatment costs and the costs of the usual standard care, if any, constitutes excess treatment cost or saving, but is nonetheless part of the treatment cost, not an NHS support or research cost. These costs should be determined in conjunction with your NHS trust partners and their commissioners.
3.5.1 Excess treatment costs of studies involving human participants
Researchers applying for research grants involving human participants will need to complete a schedule of events cost attribution template (SoECAT).
The SoECAT will need to be completed to be eligible for the National Institute for Health Research (NIHR) portfolio and the support it provides.
Who needs to complete a SoECAT?
A SoECAT must be completed if any of the following apply:
- the proposed study is intended for the NIHR CRN portfolio, the route through which support and excess treatment costs are provided in England; this may include studies that will take place in a social care or public health setting
- the research requires HRA and HCRW Approval in England or Wales, or studies requiring NHS or HSC Management Permission in Northern Ireland or Scotland
- the research will use NHS resources.
A SoECAT must be completed even if you do not think your clinical research will involve excess treatment costs (ETCs).
A SoECAT is not required if an outline stage proposal is being submitted (if a full proposal is invited, a SoECAT must be completed and submitted with the full application).
When applying for a programme grant that includes a clinical study, but where the clinical study is not yet fully defined a SoECAT will need to be completed at the application stage and updated prior to requesting approval from HRA.
Completing a SoECAT form
When applying for MRC funding, the following steps need to be completed:
- Complete a new form called a ‘Schedule of Events Cost Attribution Template (SoECAT)’, which can be downloaded from the excess treatment costs page on the NIHR website.
- Once completed, this form needs to be reviewed and signed off by a Local Clinical Research Network (LCRN) AcoRD specialist. A list of LCRN specialists can be found on the excess treatment costs page on the NIHR website. Early engagement with the LCRN AcoRD specialist in the application process is recommended.
- Append the ‘study information’ and ‘summary’ pages of the signed off SoECAT form with your completed grant application. Please note that Je-S does not allow the upload of MS Excel files, therefore please convert the completed template to a PDF and upload it to the application as a ‘Letter of Support’. Please detail the file’s description as ‘Schedule of Events Cost Attribution Tool’. MRC reserves the right to request a copy of the original signed MS Excel form.
- If the application is supported the LCRN AcoRD specialist must be informed. Please note, where ETCs are over a ‘high threshold’ of £1 million per study or £20,000 per patient further assessment by an NHS specialist commissioner will be required before any funding award can be made.
For further information, please see:
- responsibility for meeting patient care costs
- Attributing the costs of health and social care research (AcoRD)
- EL(97)77: Meeting patient care costs associated with research and development in the NHS detailed guidance
- information on excess treatment costs on the NIHR website the latest information and updates on the new ETC arrangements, including the SoECAT form and guidance notes.
Additional advice and guidance can be obtained from your local trust’s research and development office or from the Department of Health and Social Care Research and Development finance team.
For research based in Scotland, advice can be sought from the chief scientist’s office. For advice on NHS funding and policy, research ethics, IP, information and communication, telephone: 0131 244 2246.
For research based in Wales, refer to NHS research and development in Wales.
For research based in Northern Ireland, refer to NHS research and development in Northern Ireland.