Taking Charge of Your Health

Research improves future health and care for patients. Speeding up the set-up of research helps increase the pace of healthcare innovation for all. Local variations in research costing activities are recognised as a cause of delay during research set-up. NHS England is responsible for all healthcare commissioning in England. The Health Research Authority is the legal and ethical regulator for research, while the National Institute for Health Research funds and supports research delivery. All three organisations have worked together to simplify research arrangements, specifically changing the way excess treatment costs are managed in England. Further work is also ongoing with devolved administrations to explore how best to apply these changes for studies across the UK. Excess treatment costs is the name for the additional costs to the health system
when a patient’s involvement in research means their treatment is more expensive than if they had received the current standard treatment. Excess treatment costs must be
accurately identified during the research funding application to ensure that healthcare providers can be reimbursed by the appropriate funder when patients are recruited to take
part in research. This ensures healthcare providers can continue to provide research opportunities for their patients without needing to worry about how to manage the cost difference. There is a specific Department of Health and Social Care Health Service Guidelines Policy, which outlines responsibilities for meeting patient care costs associated with research and development in the NHS. Determining who pays for different types of costs associated with delivering research is supported by guidance from the Department for the “Attribution
of costs for R&D”, also referred to as AcoRD. The NIHR supports research delivery through its Clinical Research Network, which provides AcoRD Specialists to support researchers,
their teams, and Sponsors such as R&D offices or Clinical Trial Units, during research funding applications and study planning. Utilising this specialist expertise ensures all study activities are identified and appropriately attributed in line with the policy. Ensuring
this is clear and correct during the research funding application stage avoids lengthy delays during set-up by preventing disputes around what type of costs should be paid by the
different parts of the system. To provide clarity, the HRA Schedule of Events has been developed into a cost attribution tool for non-commercially funded research. From 1 October 2018, completion of this tool becomes a standard part of the process for research funding applications. This now applies to all new single or final stage funding calls from NIHR funders and NIHR partners. For these new studies, submission of the tool validated by the local AcoRD expert will be a requirement for HRA Approval submission and will form part of the subsequent Clinical Research Network eligibility checks. Having this standardised tool, which is validated by the local CRN AcoRD Specialist supporting the investigator, their study team and Sponsor, ensures all activities for non-commercial studies can be appropriately attributed in
line with the guidance. The costing methodology embedded into the cost attribution tool automatically generates a cost for the different study activities listed. In conjunction with the attribution
allocation for each of these activities, an excess treatment cost for each study is calculated by the tool. This cost is included in the study-specific record within the NIHR’s
Central Portfolio Management System. Using patient recruitment numbers that are also tracked in the same digital record, the Clinical Research Networks can facilitate payments to reimburse excess treatment costs for all healthcare providers involved in the study. This new nationwide, consistent approach to attribution and costing simplifies the research arrangements
for investigators and ultimately, avoids delays in patient access to research.

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