The Health Research Authority's fast-track research review process is available for participants in studies affected by the war in Ukraine.
The authority’s proven expedited review process can be used for urgent public health reasons or if studies have been disrupted by world events. It was well-used during the COVID-19 pandemic when new studies were set up at short notice, or existing studies were amended to learn more about how to prevent, diagnose and treat coronavirus. More than 700 studies were fast-tracked in the first 12 months of the pandemic, the most urgent reviewed in only 24 hours.
Dr Janet Messer is Director of the HRA’s Approvals Service:
Dr Janet Messer
‘We’ve all seen the awful situation in Ukraine and the terrible impact it is having on people. The war is also impacting health and social care research. The UK might need to pick up health research that would have been delivered in Ukraine or Russia. There could also be patients on clinical trials being delivered in Ukraine who are arriving in the UK and need to continue their treatment.
‘We already have methods in place to handle any urgent amendments that need to be made to research studies. We’re already talking to some sponsors, and encourage all study teams who are affected to contact us for advice. We want to act quickly as a regulator to ensure that crucial research can continue safely and quickly by providing fast-tracked ethics review.’
The decision to offer fast-track review of a study or an amendment takes account of the potential loss of valuable study data, the potential impact of any delay on public health and the importance of the research for informing, shaping or defining health policy and service provision.
Sponsors whose studies are impacted by the situation in Ukraine and Russia should contact the HRA as soon as possible by emailing email@example.com with the subject ‘fast track’.
The European Commission, the European Medicines Agency and the Heads of Medicines Agencies have also issued initial advice for sponsors on how to manage the conduct of clinical trials in this situation.