Funding clinical research Costing clinical research - AcoRD AcoRD is the Department of Health and Social Care guidance for attributing the costs of health and social care research. The NHS defines three types of clinical research costs: Research costs – the costs of the R&D itself. These end when the research ends. They relate to activities that are being undertaken to answer the research questions. NHS treatment costs – the patient care costs, which would continue to be incurred if the patient care service in question continued to be provided after the R&D study had stopped. NHS support costs – the additional patient care costs associated with the research, which would end once the R&D study had stopped, even if the patient care involved continued to be provided. Research costs can be direct and indirect, and charities do not have to pay indirect costs. What is different about AcoRD? The Department of Health and Social Care (England) agrees there are four types of ‘Part B’ research costs linked to research infrastructure that AMRC funders do not have to pay: Local study trial co-ordination and management. Data collection needed to answer the questions that the research study is addressing (including collecting data for and completing the report). Regulatory preparation and compliance including obtaining ethical approval and complying with the Medicine for Human Use (Clinical Trials) Regulations 2004. The time taken by chief and principal investigators (CI and PI) to explain the study to professional colleagues, and to understand, the research elements of a study. Under AcoRD, AMRC charities that fund in open competition do not have to pay these costs. The work will be done by the NIHR Clinical Research Networks (NIHR CRN) or will be covered by the infrastructure support funding going to NHS trusts and universities. Is this just England? Although AcoRD was first agreed with the Department of Health and Social Care in England, the guidelines have been adopted by the health departments of Scotland, Wales and Northern Ireland. Excess treatment costs Clinical research projects often involve giving patients new treatments or changing the way that care is delivered. Sometimes treatment costs for patients who are enrolled in research are less, but often there is an excess treatment cost (ETC). For non-commercial research studies, these costs are the responsibility of the NHS and are funded through normal arrangements for commissioning patient care. In the past, researchers and funders have found it difficult to get commissioners to agree to pay these costs, although some primary care trusts have developed a transparent process for decision making. NHS England has been working with funders, the Health Research Authority, the NIHR and Clinical Commissioning Groups to simplify the process for getting ETCs paid. They have published an action plan aiming to better support research. Following a public consultation on new ways of managing ETCs, NHS England has published their response and will implement changes during 2018/19. Read more about this in our blog. What do AMRC charities have to do? If you fund research in the NHS, you should ask for research applications to be costed using AcoRD. Applicants should be encouraged to contact their local NIHR CRN (LCRN) early to help with study design, cost attribution and availability of resources. As of 1st October 2018, applicants will need to complete a Schedule of Events Cost Attribution Template (SoECAT) in order to be eligible for the NIHR portfolio and the support this provides. This applies to: New calls for single stage applications issued after 1 October 2018 Invitations to submit the second and final stage of an application where the invitation is issued after 1 October 2018 (the call for the first stage application may have been issued prior to 1 October). The SoECAT form is designed to capture the different costs associated with clinical research and attribute them accordingly. We explain more about this in our blog but funders should ask for a completed application form and a SoECAT to aid peer review. At the research review committee, peer reviewers should carry out a value for money assessment, comparing the cost of research to the costs identified to support and treatment. Studies that have very high ETCs or support costs are unlikely to be adopted by NHS trusts or commissioners, and so may not represent good value for money. When your panel agrees to award a grant, they may wish to add other conditions of award, or say that the application costs are not accurately attributed, and thus the study is not feasible. At that point funders can ask researchers to resubmit with revised costs. Further information is available in our Q&A document to help you understand more about the changes. What help will there be for researchers? The NIHR CRN and Research Design Service can help researchers design and work up their research funding applications. A guide to help researchers, study teams and sponsors to complete the SoECAT during grant application and study planning will be made available and dedicated support can be accessed through AcoRD Specialists via the CRN. How will we know what affect AcoRD is having? AMRC is involved in the Department of Health and Social Care's non-commercial costing attribution group. We are also working closely with NHS England to monitor the impact of AcoRD and the SoECAT.