NHS Lothian Research Prioritisation Strategy during COVID second wave

NHS Lothian Research Prioritisation Strategy during COVID second wave

Dear colleagues

The past 8 months have been enormously challenging for all clinical researchers. We are enormously grateful for the patience and immense efforts of research teams supporting COVID research, and pausing and then re-starting much non-COVID research.

With your help recruitment to COVID research across Lothian now exceeds 3000! This includes the key UK-wide studies such as the Recovery trial, and trials and studies led by Edinburgh researchers.

As the second wave continues, COVID research is even more challenging because we are now also participating in vital vaccine trials, studies investigating the long terms effects of COVID, and surveillance studies in addition to the studies of acutely unwell patients. The UK and Scottish governments have a clearly stated prioritisation policy for this research, which we need to follow.

We do not intend to pause non-COVID research unless we have no alternative. This means our governance and research teams are under immense pressure.

We have agreed a strategy to help us manage research through the winter and second wave, which is available here. This has been agreed after much consideration and consultation.

Key points of relevance to researchers are:

  • COVID research will take priority in terms of use of ACCORD, research teams, pharmacy, and other support services – see updated NIHR prioritisation levels at the end of this email
  • Non-COVID research should continue, but recruitment may require to be slowed or stopped in some areas if resource is insufficient or needs to be diverted to support COVID research
  • Non-COVID research that has not yet restarted should not re-start before January 5th 2021 unless the ACCORD risk assessment shows it will not use resources required for COVID research (eg research staff, pharmacy). The situation will be reviewed in January.
  • ACCORD will still support new grant proposals and the sponsor review/set-up of eligibly funded projects.
  • ACCORD will not accept new applications for R&D approval for new non COVID research before January 5th 2021, when the situation will be reviewed – see attached NHSL research prioritisation strategy p7 for details of how to seek exemption from this condition
  • Amendments relating to hosted non-COVID research that have not re-started since March 2020 will not be reviewed before January 5th 2021, when the situation will be reviewed.
  • The ACCORD team will continue to progress amendments to studies that have already re-started but there is a significant backlog of work, and delays should be expected
  • A request for exemption from these principles will be available, but will require a strong justification.
  • Applications for R&D approval for non-commercial studies that do not have an eligible source of funding are the lowest priority for review and are unlikely to be processed for many months. The CSO list of eligible funders can be seen by following this link- http://www.nhsresearchscotland.org.uk/uploads/tinymce/NRS%20Funding%20Guidance%20-%20Annex%202%20-%20Eligible%20Funders%2029%20June.pdf

 

The updated NIHR prioritisation levels are:

 

  • Level 1A (Top Priority) - COVID-19 UPH vaccine and prophylactic studies (as prioritised by the Vaccines Task Force and agreed by Jonathan Van-Tam, deputy CMO) and platform therapeutics trials (currently RECOVERY/RECOVERY +; PRINCIPLE; REMAP CAP).

 

  • Level 1B - Other COVID-19 UPH 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 COVID-19 studies not in Level 1A or 1B).

 

Thank you for your ongoing commitment to support research during these difficult times.

 

Tim Walsh

Tim Walsh BSc(Hons) MBChB(Hons) FRCP FRCA FFICM MRes MD

Chair of Critical Care, University of Edinburgh

Head of Department, Anaesthesia, Criical Care & Pain Medicine, University of Edinburgh

PA Dawn Campbell: (dawn.campbell@ed.ac.uk)

 

Director of Research & Innovation, NHS Lothian & SE Scotland East Region

Director, Acute Care Edinburgh, Usher Institute, University of Edinburgh