Researcher Guidance for Public Health ETC
Managing Excess Treatment Costs for Research into Public Health Interventions Commissioned by Non-NHS Organisations in England
This guidance is for researchers who are undertaking research in public health in England and who are seeking funding for Excess Treatment Costs (ETCs). The term ‘ETC’ refers to the cost of the intervention being researched. It is the difference between the cost of the existing standard care/intervention offered to people eligible to be recruited to the research study and the cost of care/intervention(s) offered as part of the research study where those costs are higher.
Research in public health is funded through the National Institute for Health Research (NIHR) and its partners. These research funders only fund costs that are attributed as research costs (see AcoRD guidance), and do not fund ETCs.
Public health research is undertaken in services that are outside the remit of the NHS that, for the most part, are not commissioned by Clinical Commissioning Groups and are not included in NHS specialised commissioning. An exception to this may be interventions delivered in non-NHS settings that are jointly commissioned by a CCG and a Local Authority (LA). For non-NHS public health research, the responsible organisation is usually the LA but could include other non-NHS organisations that have been commissioned to deliver services that are the responsibility of the LA. The Association of Directors of Public Health has published a position statement on the funding of ETCs by LAs.
The Department of Health and Social Care (DHSC) has stated as a matter of principle that the organisation responsible for commissioning the intervention being researched should be expected to pay the ETC.
If it has not been possible to secure funding for the ETCs from the commissioning organisation, DHSC will consider requests for ETC support for PHE approved studies. PHE will look for evidence that the researchers have worked closely with the commissioning organisation in developing their research funding application in advance of its submission to the research funder. Researchers are advised to have these discussions early in the process of developing the funding application. Funding from DHSC is not guaranteed, the criteria and process are set out further below.
NHSEI works closely with PHE and DHSC to provide and commission a range of public health services such as national immunisation services and screening services. For ETCs for research into the Section 7a services the NHSEI process must be followed.
The Role of the NIHR Local Clinical Research Network (LCRN)
Support with the submission of the full funding application
The research lead will need to make contact with the LCRN when the research funder has invited them to submit a full funding application. A lead LCRN based in the study lead’s geographical area will provide support for multicentre studies.
The LCRN will support the research sponsor with the completion of the Schedule of Events Cost Attribution Tool (SoECAT). The SoECAT captures details of the activities undertaken in the research study to allow cost attribution. It must be signed off by the AcoRD specialist and submitted alongside all applications for new single stage calls and invitations to submit a final application that are issued after 1st October 2018.
Support when funding has been awarded
When research funding has been awarded the LCRN can help with inclusion of the research onto the NIHR portfolio and arrange for provision of ongoing support in line with DHSC eligibility criteria.
For public health research studies, the LCRN will utilise the ETC Triage process to confirm the commissioning organisation(s) that would be responsible for the payment of the ETCs identified in the SoECAT.
The process for applying for ETC support for public health research studies
When the research funder has confirmed the award and the commissioning decision has been received following ETC Triage, the research lead will need to complete the PHE ETC funding application form if they wish to apply for DHSC funding for the ETCs. The grant award letter, protocol, SoECAT and blank ETC funding application form will be attached to the commissioning decision email copied to PHE. Once completed, the research lead will need to submit the PHE ETC funding application form directly to PHE for review.
The study team must demonstrate that they have discussed the following with the commissioning organisation(s) (evidenced in the funding application form):
- The feasibility, sustainability and affordability of delivering the intervention being researched
- The assets required e.g. the organisational infrastructure and facilities
- The fit of the research intervention with current services delivered by the organisation and any duplication of provision
- Whether the research addresses a priority in the area
- The impact level of the research. The demonstrable contribution that it will make
- The capacity and capability of the organisation to enable completion of the research
- The provision of ETCs
PHE will also determine if the:
- Research is in line with national government priorities
- A commissioning organisation has agreed to pay a contribution to the ETC
PHE will inform the research lead of PHE’s decision. If the study is approved the application will be forwarded by PHE to DHSC and the research lead can access DHSC funding, which may be partial or full, to pay the ETCs.
If the study is not approved by PHE, then the research lead cannot access funding for ETCs from DHSC and will need to independently identify an alternative source of ETC funding.