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Feedback from the NIHR restart advisory group meeting 22nd June 2020

Date: 29 June 2020

• A comprehensive 12-month outline communications plan has been developed to address all stakeholders including the public – to be updated monthly.
• Viability assessment is still a problem. In some centres it has been suggested that people get going with a study they believe is viable, going back to funder if necessary when evidence of recruitment etc means an extension funding is needed. However, Restart says to get approval from funder before restarting and therefore there is a confusion.
• Concern that some funders are assessing all their studies centrally, with doubtful capacity to do this is a timely way, therefore delaying restart. WvH to follow up on pragmatic approach.
• Some organisations have reported that the main delaying factors  is radiology due to clinical backlog (mainly CT scans). Pharmacy an issue in some Trusts as is delivery staff capacity.
• CTUs concerned about the Effort needed to restart studies only to pause again if a second spike. It is likely that pausing of studies in future can be more nuanced and targeted as further outbreaks likely to be localised.
• Some sponsors unable to support eConsent and require wet signatures leading to additional risk if participants are attending clinic (or staff visiting them) just for signature.
• Wales has developed a mutual support system between Trusts and Health Boards.

We raised 

• Retention of R&D staff to deliver the pipeline of UPH and vaccine Studies along with restarts and new studies against a background of reduced workforce covering 7/7 and very significant reduction in income. We also asked for a CMO letter to go to CEOs and FDs stressing the need to retain R&D capacity and sooner rather than later to avoid unintended consequences.
• Concern for clinical academics and other researchers whose research forms part of a qualification, especially those due to finish this year.  Information on NIHR awards is available on the NIHR site site re NIHR awards and we are checking for guidance for people funded by other sources.
• As numbers testing positive decline the speed of recruitment to UPH studies is falling.  Prioritisation within the UPH cohort, or some sort of geographic prioritisation, to help those studies reach statistical significance in a timely way.
• Still some confusion over who pays for PPE and Covid testing where sponsors require it and we expect guidance soon.

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