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CSO Statement on research Restart Framework

CSO Statement on research Restart Framework

27th May 2020

Research, development and innovation are an integral and vital part of our NHS. We are entering a new phase of the current pandemic, where the number of new cases of COVID-19 is declining and the time is right to work towards the restoration of a diverse portfolio of Health and Social Care Research here in Scotland.

The National Institute for Health Research have published a framework for restarting research activities paused due to the COVID-19 pandemic.

The document outlines guiding principles for a coordinated restoration of the research portfolio. Scotland and the other devolved administrations have been fully involved in its development and are supportive of the guiding principles and prioritisation criteria.

The Restart Framework recognises three prioritisation levels:

  • Level 1: Essential studies providing evidence for pandemic management, i.e. nationally prioritised COVID-19 Urgent Public Health (UPH) Research studies
  • Level 2: Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life-preserving or life-extending treatment not otherwise available to the patient
  • Level 3: All other studies (including new COVID-19 studies not in Level 1)

It should be noted that these classifications reflect the current situation (the lack of an effective treatment or vaccine for COVID-19, the risk of further critical waves). They will be kept under review.

The Restart Framework also sets out three preconditions for restarting/starting research. In brief these are:

  • Study Viability: Only research that is still viable should restart/start. Some studies that have been paused or have not yet started may no longer be viable, for scientific, clinical, financial or practical reasons. It would be unethical and a waste of money to restart/start studies that are no longer viable
  • Safety: Research should only restart/start when safe to do so. Safety of research participants and personnel is of paramount importance
  • Capacity and site readiness: The pace of restart and the commencement of new studies should be commensurate with capacity and readiness in local health and care services and the NHS Research Scotland supporting infrastructure

The restart of a currently paused study and the start-up of new studies will be dependent on the above preconditions being met. It is the responsibility of the sponsor, funder, Chief Investigator, the study site(s) legal entity, and, where applicable, the Principal Investigator at each site to assess that these are met before restarting/starting.

On May 21st the Scottish Government published the Coronavirus (COVID-19): framework for decision making – Scotland’s route map through and out of the crisis.

This route map takes an evidence-led and transparent approach to easing restrictions and sets out a phased approach towards the future. We wish to stress that the Restart Framework does not in any way supersede the SG guidance around non-essential on-campus University lab work contained within the Coronavirus (COVID-19): framework for decision making document. Non-essential, on-campus University lab work should not restart until SG has issued further specific guidance to do so subject to physical distancing as part of the staged implementation of the route map.

The Chief Scientist Office will monitor restart across Scotland and is setting up a COVID-19 Restart Operational Group to share best practice and support development of operational processes and guidance to support the resumption of non-COVID research activity across NHS Research Scotland.

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