On 21st May, 2020, NIHR published its Framework for Restart https://www.nihr.ac.uk/documents/restart-framework/24886
This guidance is to support not only local decision-making for non-COVID-19 studies which have been paused, but also COVID-19 research which does not meet the urgency criteria. The Framework will be updated in the coming weeks and months as we learn from early experiences of restart.
The guidance from NIHR is in line with Trust plans in relation to the Restart, Reset and Recovery of research https://newcastlejro.com/wp-content/uploads/2020/05/RD_restart_final.pdf
For hosted studies, Initial assessment is conducted by the PI and Team Lead. A reduced capacity form is to be completed and assessed by R&D which can be found on the NJRO website https://newcastlejro.com/wp-content/uploads/2020/06/Study-Restart-Capability-Form-V1.1-2020.06.09.docx
In cases where further medical expertise is required review will be supported by the R&D Clinical Director.
R&D will review NuTH sponsored restart risk assessments but consideration must be given that sites participating in the trial may need to have a staggered restart, depending on local policy and preparedness.
During this time, the MHRA and HRA will continue to provide an approvals service for all studies, prioritised in accordance with the national situation, ensuring site set-up can restart promptly in due course. The advice is frequently updated so it is advised to regularly check their websites for the most up to date information. The Trust, through the NJRO, will continue to support new commercial feasibility requests and non-commercial attribution support for non-commercial studies. Please be mindful that there may be delays during this period as we continue to implement new ways of working in the Team.