Phased re-start of non-COVID-19 research

15 June 2020

In line with NIHR guidance, we are beginning the process of phased re-opening of some non-COVID-19 research studies, while maintaining our contribution to local and nationally prioritised urgent public health studies for COVID-19.

As COVID-19 related admissions continue to fall across our hospital trusts, local research studies will be prioritised as detailed below.  However, as and when this situation changes, this process may need to be further adjusted or paused.  Delivery of front-line care and COVID-19 research remains our priority, and all research delivery teams working within CUH will be allocated studies on this basis.

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Prioritisation of Studies

Level 1

Existing COVID-19 related research – nationally prioritised COVID-19 Urgent Public Health Research studies and CUH COVID-19 related research trials.

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Level 2

Existing clinical trials and studies that are currently suspended, which offer potential therapeutic benefit to patients via improved diagnosis and/or a treatment/intervention improving or extending life. 

Longitudinal follow-up studies of previous interventions; online staff research studies and studies where ALL participant study visits can be integrated with routine clinical management or conducted remotely without imposing major, immediate demand on research workforce and facilities.

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Level 3

All other existing and new clinical research studies.

We anticipate that Level 3 studies will not be able to re-open until the national lockdown has been fully eased. When this occurs, we will provide further information and advice to this effect.

Urgent applications may be considered on a case by case basis.

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Application for re-start

All studies must have Capacity and Capability (C&C) formally re-confirmed by R&D prior to recommencement. R&D sign off is in addition to other approvals required (for example, from the CRF or CCTU).

Principal investigators and study teams wanting to have their studies assessed for re-start need to complete the risk assessment form here. 

R&D will assess the information provided in the risk assessment form to establish which studies are eligible for Level 1 or 2 prioritisation, and can therefore re-start/start all research activities. The availability of necessary supporting services (Pharmacy, Radiology, Labs, CRF, etc) and research staff will also contribute to the assessment.

NIHR centrally will monitor restart across England to identify and help to resolve any cross-cutting issues that may arise. To this end, a cross-Centre ‘NIHR Restart Implementation Group’ has been established, which will be chaired by Dr William van’t Hoff, CEO of the NIHR Clinical Research Network and Senior Responsible Officer for the NIHR Restart Programme. 

Read more on the NIHR website.