The following guidance should be used in conjunction with the process chart for non-commercial studies that have excess treatment costs (ETCs) diagram - and provides additional/supporting information around the steps outlined within the process chart.
The steps outlined below correspond with the numbering provided within the chart.
The researcher must prepare and submit their funding application to the Funder. Researchers are usually required to complete the Schedule of Events Cost Attribution Template (SoECAT) as part of research funding applications for non-commercial studies. The SoECAT is a spreadsheet-based application whose purpose is to capture the different activities associated with clinical research and attribute them accordingly as ‘research activities’, ‘support activities’, or ‘treatment activities’ in line with the national guidance document “Attributing the costs of health and social care research and development” (AcoRD). Read the full SoECAT guidance for more information.
The researcher should send their completed SoECAT to their LCRN AcoRD Specialist to be validated. Should researchers require support to complete the SoECAT, they should contact their LCRN Study Support Service as early as possible to request attribution support with 20 working days prior to the submission of a funding application the absolute minimum time required to ensure sign off by the submission date. A maximum of 10 additional working days (prior to funding submission) from confirmation of AcoRD Specialist reviewer is suggested to provide leeway for any amendments or escalations to be resolved. The AcoRD Specialist in the Lead LCRN (meaning the LCRN that takes overall responsibility for the study within the NIHR CRN) must approve the final completed SoECAT prior to submission of the funding application for the application to be valid.
Once a SoECAT is validated by the AcoRD specialist the completed SoECAT and application form is submitted to the Research Funder.
Steps 3 and 4b
If the research funding application indicates that the study will exceed the high cost threshold, the Research Funder will notify NHS England’s High Cost Review team (see step 4a)
If the research funding application is successful and:
- the ETCs for the study exceed the high cost threshold, the Research Funder notifies the High Cost Review Team to commence a clinical alignment review (see step 6c)
- is not subject to any further amendments and the ETCs are less than the high cost threshold, the researcher, once they have been notified by the funder that their application for funding has been successful, will notify the AcoRD specialist for submission to triage (see step 6b)
- is awarded subject to changes, the researchers will revise and resubmit the application to the Research Funder. This may require the SoECAT to also be revised, revalidated by the AcoRD Specialist and resubmitted to the funder.
At application stage and prior to a funding decision being made (final application stage for applications that have a two or more stage process), the research Funders notify the High Cost Team about any studies that may exceed the high cost threshold if funded. The High Cost Team provisionally decide on a commissioner and make preparations for a High Cost Review by identifying a suitable panel should the research application be successful.
Once the funder has made the decision to fund the research funding, the Research Funder notifies NHS England and DHSC about any studies with ETCs above the high cost threshold (i.e. where ETCs are higher than the thresholds). In addition, and in parallel, the AcoRD specialist will also identify any high cost studies thus ensuring that all studies requiring a review are identified as soon as possible.
The research funder indicates research funding approval. The High Cost Team will confirm the responsible commissioner for funding ETCs and begin the high cost review process.
Steps 4b and 5b
If the funding application is awarded subject to changes, the researcher must make those changes and resubmit along with a revised SoECAT as necessary.
The Funder will then review the revised funding application and decide whether to reject it or award it.
If the Funder has decided to approve the funding application, they must notify the High Cost Team if the application is above the high cost threshold.
If a researcher receives confirmation that research funding is awarded, the research team must inform the Lead LCRN’s AcoRD Specialist for the study as denoted on the front of the agreed SoECAT form. If funding has been awarded dependant on changes to the study design, the team must inform the AcoRD Specialist so that any subsequent changes to the attribution of study activities are reflected, if appropriate, in an amended and re-validated SoECAT.
Steps 6b and 7b
Where the study will incur ETCs, this contact will trigger the process followed by AcoRD Specialists to submit the study to the CRN CC triage team to determine:
a) if the study is eligible for automatic ETC funding
b) the responsible commissioner for ETCs
c) whether the study is categorised as having “high cost” ETCs. If it is a high cost study, it will be sent to the high cost team
The AcoRD Specialist will inform the research team of the outcome and next steps.
Following the triage decision, the ETCs, for studies where the responsible commissioners are Clinical Commissioning Groups (CCGs), the ETC per patient value calculated by the SoECAT is accepted as the overall per patient ETC value for the study.
For studies where the responsible commissioner is NHS England (for example Specialised Commissioning), an additional cost assurance process takes place to agree the ETC per patient value. This involves the completion of an additional template by the research team in conjunction with its lead service provider supported by the NHS England finance team if required. The purpose of this additional assurance step is to establish what additional payments for ETCs are required taking into account the contractual arrangements for the service concerned. Once this assurance process is complete, the ETC per patient value and additional per patient payment for the study is confirmed.
For all studies with ETCs that exceed the high cost threshold an assessment of clinical alignment and therefore value to the NHS will be conducted prior to agreement to fund ETCs.
For high cost ETC studies where the ETCs are mainly related to a specialised service directly commissioned by NHS England, NHS England will undertake a clinically led assurance process to ensure the study is of high value to patients and the NHS prior to agreeing ETC funding. This will run in parallel to the finance assurance process to agree ETCs. The assessment of clinical alignment will be undertaken on a case by cases basis by;
- The relevant Regional Medical Director or nominated clinical expert and,
- The Clinical Co-Chair of the relevant clinical or commissioning programme
For studies where the ETCs mainly relate to CCG commissioned services an assessment of clinical alignment will be undertaken on a case by case basis by:
- The relevant NHS England National Clinical Director or nominated clinical expert,
- The Innovation, Research and Life Sciences Director or Deputy Director for Research from NHS England and,
- Relevant clinical expert designated by DHSC.
In both cases, the possible outcomes of the assessment are:
- Clinical alignment agreed and therefore ETC funding is supported.
- Clinical alignment is in question. There will be discussion and negotiation with the lead investigator/sponsor and funder to attempt to agree any changes to the protocol/methodology that will enable alignment to be agreed:
- Agreement to changes to ensure clinical alignment and ETCs funding is agreed.
- Following discussion and negotiation agreement to amend the study to bring into clinical alignment is not possible. ETCs will not be funded.
NHS England will notify the triaging officer, who will then record the decision.