Until further notice, the NIHR Clinical Research Network is pausing the site set up of any new or ongoing studies at NHS and social care sites that are not nationally prioritised COVID-19 studies.
This guidance relates to Research Ethics Committee (REC) and NHS arrangements. This is a rapidly evolving situation and guidance will be updated in response to feedback.
Please visit the following link for guidance issued by the Department of Health and Social Care regarding the impact of COVID-19 on research funded or supported by the National Institute of Health Research.
The COVID-19 pandemic will lead to significant demands being made of clinical services and inevitably this will impact on clinical research in the Trust. The scale of the demands on clinical services in uncertain but there is likely to be significant disruption of research activities. The situation is also dynamic and advice from the Government and other national agencies can change rapidly. Our clinical research portfolio is large and includes the full spectrum of research activity, from Phase 1 studies to health services research and from international CTIMPs to small PhD projects. To manage this portfolio, we’ll need the support of all investigators and research delivery teams and a collaborative approach which is clear, flexible and pragmatic. It is also important to have a consistent approach across the research platforms, research delivery teams and pharmacy. Our aims during the pandemic should be to ensure the safety of patients and staff, to prioritise our research studies and target our resources accordingly, to maintain high standards of research governance and, where needed, enable research staff to support clinical services.
Guidance for sponsors, sites and researchers
The HRA has produced new guidance for sponsors, sites and researchers about the COVID-19 pandemic.
The guidance covers the set up of new studies, amendments to existing studies and changes being made by sponsors at this time.
The guidance can be found at www.hra.nhs.uk/coronavirus and will be updated regularly. The site also contains links for sponsors, sites and researchers who need to get in touch with additional questions.
Advice for Management of Clinical trials in relation to Coronavirus has been published on the MHRA Inspectorate blog. MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.