RESTART-COVID & US
Research type
Research Study
Full title
Restarting clinical research after suspension due to COVID-19: RESTART-COVID & US
IRAS ID
288766
Contact name
Susan Pavitt
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 7 months, 27 days
Research summary
Since the emergence of the COVID-19 pandemic in early 2020 many clinical trials have suspended their activities. Only nationally prioritised COVID-19 studies (Urgent Public Health: UPH) were able to continue or commence). The NIHR have developed a framework to ‘RESTART’ paused NIHR research that was underway prior to the COVID-19 outbreak AND support the commencement of ‘new’ NIHR research: https://www.nihr.ac.uk/documents/restart-framework/24886. Research studies need careful planning for re-opening and commencing, this should be done with the public safety and confidence at its core. It has become apparent that study participant re-engagement and engagement has been low. It is suggested participants do not have the confidence and knowledge on the safety aspects to engage research studies. There is a significant risk of research studies not being able to start and restart, some of our largest trials have average running costs of £40-50K per month and recruitment delays will mean costs add up and studies are at risk of failing, thus creating a research gap in many vital research areas. To support research it is essential to investigate the barriers to engaging and re-engaging with research.
This is a qualitative piece of research led by experienced qualitative researchers using online focus group and interviews. Research studies within different speciality areas will be contacted by a researcher to invite their trial participants to take part in RESTART. The RESTART researchers will convene one online focus group in each of the NIHR portfolio areas (or one-to-one interviews for those who are not willing or able to participate in the online focus group) to understand if there are any barriers to engaging or reengaging with research. The focus groups/interviews will be convened online via a secure Zoom meeting. The recordings with be transcribed verbatim and analysed by one lead researcher supported by the Qualitative Research Leads.
REC name
London - London Bridge Research Ethics Committee
REC reference
20/PR/0633
Date of REC Opinion
9 Nov 2020
REC opinion
Favourable Opinion