Costing clinical research - AcoRD AcoRD is the Department of Health 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 pay indirect costs. What is different about AcoRD? The Department of Health (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 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 in England, the guidelines have been adopted by the health departments of Scotland, Wales and Northern Ireland. 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 Clinical Research Network early to help with study design, cost attribution and availability of resources. Applicants should be working towards completion of a Schedule of Events available from the Health Research Authority (HRA) as part of HRA Approval. Funders should ask for a completed application form and a schedule of events 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 excess treatment costs 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. What help will there be for researchers? The NIHR Clinical Research Network (NIHR CRN) and the Health Research Authority are producing a template - the Schedule of Events - which all researchers in England and Wales will be able to use to work out which category a cost is in, and produce total figures for each category. The NIHR CRN and Research Design Service will be able to help researchers complete the template and suggest improvements to study design. Applicants should be encouraged tp cpontact both during the development of their proposals. 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 monitoring the impact of AcoRD as the schedule of events is released and more applications are awarded under AcoRD. Contact Dr Andy Clempson, senior research policy manager to find out more or to tell us how AcoRD is working for you.