Re-starting non-COVID-related clinical research

Approach across NHS Research Scotland

As a consequence of the COVID-19 pandemic, many non-COVID clinical research projects across Scotland have been suspended or had recruitment halted in order to help protect patient safety and support resilience in the NHS.

Since March 2020, resource and capacity has been directed to the NHS frontline and to deliver urgent public health COVID-19 research. This research remains a priority, but as the number of patients affected by COVID-19 begins to decline, work begins to restore the diverse portfolio of health and social care studies that Scotland offered before the pandemic.

During this period of restart, NRS will follow the UK principles and prioritisation guidance issued by NIHR, as set out in a statement from the Chief Scientist Office (CSO). The Scottish restart process will be implemented in accordance with the Scottish Government route map out of the crisis.

• NIHR Restart Framework
• CSO Restart Framework
• Scotland's route map through and out of crisis
• CSO Statement on guidance to protect research during a second wave of COVID-19 activity

The Chief Scientist Office (CSO) has convened two groups of NRS stakeholders to address restart issues and agree a common and consistent way forward:

• The Restart Advisory Group sets overall polices, priorities, and strategic targets for Scotland
  • Restart Advisory Group - Minutes - 30 June 2020
  • Restart Advisory Group - Minutes - 13 July 2020
  • Restart Advisory Group - Minutes - 5 August 2020
  • Restart Advisory Group - Minutes - 9 September 2020
  • Restart Advisory Group - Minutes - 12 November 2020
• The Operational Restart Group agrees common implementation and coordination at site level

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Where does Re-Start Start for Researchers?

Individual Health boards share the responsibility of reviewing studies for restart, alongside Sponsor, Funder and Chief Investigator to ensure that the study viability, safety and approval of new and ongoing studies are met.

Sponsor assessment

Studies sponsored by a Scottish Health board will be assessed for restart through a Sponsor Risk Assessment checklist issued to the CI. This may involve recommendations for the coordinating study team to retrain staff (repeat Site Initiation Visits), amend the protocol (to accommodate home visits, telemedicine, eConsent, and participant permission for remote monitoring), revision of study timelines and associated funding. Once approved this will allow the CI to contact sites for assessment of re-opening.

Academic sponsors from elsewhere in the UK, and Commercial sponsors, are encouraged to issue sites with study level assessments for study reopening.

Site assessment

Risk Assessment checklists will also be issued to Principal Investigators (PI) from their local Health board for completion in order to evaluate issues applicable to their site, such as resource availability, amendments to local Standard Operating Procedures, alignment with Health board services.

Health boards are currently contacting all PIs to issue them with the relevant risk assessment and guidance on how to complete, in the meantime you can also contact the Health board directly for this information or download the relevant guidance and risk assessments below.  

Although each Health board will base its consideration on the CSO restart framework statement, the process for implementation may vary from board to board. Appropriate Health board guidance should therefore be followed for completion of the local Risk Assessment.

If you have any further queries on how to restart or discuss new studies then please contact your local Health board who will be able to deal with your enquiry as quickly as possible.