COVID-19 Information for UoA and/or NHSG Sponsored studies

We are continuing to follow the UoA, NHSG and Government advice with regard to COVID-19.

UPDATE 07/07/2020: If your study meets the criteria outlined below (Update 28/05/2020) then you are able to apply for an exemption to the Sponsor Exemption Committee by completing the Sponsor Exemption form and emailing it to researchgovernance@abdn.ac.uk.   

UPDATE 28/05/2020: Following the publication today of the CSOs Statement on the Restart Framework, we will now start to review requests for restarting/ starting face to face recruitment in the following scenarios:

  • Essential critical care activities where the research takes place at the same time as the clinical care activity/ or provides an essential treatment not otherwise available. Any follow up visits would need to be conducted as part of the clinical care visits or remotely.
  • When non-essential clinical services resume and patients are attending for face to face or remote (Near-me or telephone) clinic appointments. Studies which can recruit/ consent at the clinic visit with all follow up research activity being done as part of clinical care visits or remotely (with appropriate amendment to allow for remote clinical contact).

Further details about restarting face to face research and how to apply for exemptions can be found here

UPDATE 26/03/2020: All face to face visits for studies should now have been stopped. We have asked that all CI's complete a risk assessment for their studies and return this to Research Governance. On receipt of your risk assessment Research Governance will review and advise on any amendments that may be required for your study to allow for remote visits or, if required, to change the protocol to enable follow up visits to continue. If you have a study that is 'active' or 'in folow up' and you have not received a risk assessment please contact researchgovernance@abdn.ac.uk.    

UPDATE 16/03/2020: From Monday 16th March 2020 UoA and NHSG single sponsored and co-sponsored studies are required to suspend all new recruitment involving NHS patients across the UK. Patients who have already signed informed consent should continue to screen and register for the trial where the local principal investigator considers it safe and in the patient’s best interests to do so.  Please consider that face-to-face follow-up visits may also be suspended in the near future.

Please consider the impact that this may have on your research participants and studies and prepare to put contingencies in place.

There may be a requirement for certain studies to either halt (temporary pause) or put in temporary measures to allow the study to continue e.g. completion of questionnaires over the phone, halting recruitment of new participants, cancelling face to face study visits in favour of phone/ virtual visits (where possible), withdrawing participants who are are unable to complete or any other changes to protocol. 

In the first instance please acquaint yourself with the guidance below and contact Research Governance (researchgovernance@abdn.ac.uk) where amendments may be required to your studies.

All studies (excluding CTIMPs)– follow guidance from the HRA:

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/

CTIMPs – follow guidance from the MHRA:

https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/

 

Guidance is likely to be amended regularly, so please refer to the above pages for updates, or look at the relevant twitter feeds:

https://twitter.com/HRA_Latest

https://twitter.com/MHRAgovuk

If you have any further queries please feel free to get in touch with Research Governance and we will do our best to answer them.   

Please be aware that Research Governance will be receiving a large volume of queries during this time and there may be a delay in responding.