Excess Treatment Costs for Studies Involving non-NHS Organisations

From time to time research studies take place that involve organisations outside the NHS, such as Local Authorities, Councils, or other bodies providing social care services.

Under the UK-wide agreed ACoRD guidelines, costs for non-commercial research projects are categorised as “research”, “support” or “treatment” costs.

Research funders are normally expected to meet the direct research costs.

Support costs, which are additional patient care costs associated with the research, are normally reimbursed to NHS bodies from NHS sources. In Scotland, Health Boards receive these as part of their annual research allocations from the Chief Scientist Office (CSO); it should be noted that this does not extend to non-NHS bodies.

Treatment costs are handled on the basis that they would continue to be incurred if the patient care service in question were to continue to be provided after the study has stopped. Many experimental interventions are therefore considered as treatment costs. In cases where the cost of this exceeds the currently agreed budget for a standard intervention, they are called Excess Treatment Costs, or “ETCs”.

The agreed principle across the UK (AcoRD) is that any organisation incurring treatment costs should meet those costs from their own budgets. This helps ensure clarity about what costs are involved, as well as preparing organisations to meet those costs should the research prove that the intervention in question is effective. Where those costs are significantly more than currently budgeted interventions, the CSO has put in place a mechanism to help research active Health Boards to partially meet those costs. This is funded from NHS sources, and requires an application to the CSO. Similar processes operate in other parts of the UK.

There is currently no formal agreement or process in place for funds to be made available to non-NHS Scottish organisations to provide assistance in meeting excess treatment costs on research projects.

Researchers who wish to carry out projects that may involve ETCs incurred within Scottish non-NHS bodies are advised to take the following steps:

1. Consider the size of the non-NHS ETCs. The Schedule of Events Cost Attribution Template (SoECAT) provides a structured process for assessing ETCs, and is required by most UK funders
2. Take steps to mitigate wherever possible
3. Consider other sources from which they can be met. Non-NHS bodies may be able to support from internal funds

We encourage every research team to consider these costs, and their implications, in advance. For further information, please contact NHS Research Scotland Health and Social Care Coordinator Irina McLean, irina.mclean@nrs.org.uk.