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NIHR - Guidance for a 'second wave’ of COVID-19 activity

 

Contents

Purpose

This document provides guidance for the prioritisation of NIHR infrastructure resources (including NIHR Clinical Research Network resources) during a ‘second wave’ of high COVID-19 activity. The guidance applies to England, but has been developed in consultation with representatives of the devolved administrations, who may themselves publish analogous guidance in due course.

Key points to note

The deployment of staff funded through an NIHR Infrastructure award or funded by the NIHR Clinical Research Network (CRN) to front line duties should only occur in exceptional circumstances. The deployment of clinical academic staff should be undertaken within the guidelines issued by a working group convened by the UK Clinical Academic Training Forum and the Conference of Postgraduate Medical Deans of the UK.

NIHR research activities and restart decisions should continue to be locally led and the study prioritisation levels in the Restart Framework remain unchanged.

Wherever possible we continue to encourage restart of the non-COVID-19 NIHR CRN Portfolio paused by sponsors and sites due to the pandemic. This includes opening new commercial and non-commercial studies
It should be noted that, while NIHR CRN has a goal of 80% of studies that were paused being restarted by 31 March 2021, this is an ambition and not a target.

Background

  • The emergence of the COVID-19 pandemic in March 2020 led the NHS to suspend many routine services and the NIHR to prepare to support the Government’s research response. Subsequently, the decisions taken in March 2020 by research sponsors, funders and investigators and study sites to pause some non-COVID-19 research and by the NIHR CRN to pause set up of new sites or studies other than for Urgent Public Health (UPH) COVID-19 studies had a major impact on non-COVID-19 research activity.
  • As caseload fell in May, and NHS routine services began to recover, the Restart Framework was issued and NHS providers engaged in the process of restarting non-COVID-19 research which had previously been paused. The framework provided guidance on prioritisation of NIHR infrastructure resources in order to maintain a priority for UPH studies while also recognising the importance of non-COVID-19 research. (The guidance applies to NIHR research studies at all stages of the research pathway, from study set up to close down, in both the non-commercial and commercial portfolio).
  • Numbers of COVID-19 positive cases have increased across many regions in the last few months and especially since late August. Local control measures are an increasingly regular occurrence. More far-reaching national measures are held in reserve to meet severe and critical increases in NHS caseload. This is a dynamic situation.
  • Whilst there is no formal definition of ‘second wave’, the increase in COVID-19 activity mandates preparation for its impact on the NHS and research.
  • The NIHR UPH group continues to meet weekly and review COVID-19 commercial and non-commercial studies submitted for UPH status and provide recommendations to DHSC on research that needs to take place during the emergency phases of the pandemic when infection rates are high. This now also extends to COVID-19 vaccine studies including but not limited to those funded through the Vaccine Task Force. To support the rapid set up of these important studies, MHRA and HRA continue to offer a fast track process to review new studies and amendments to existing ones and issue approval within days.
  • All NIHR research activity is currently taking place in the context of the recovery and reconfiguration of NHS clinical services. This is taking time and decisions on restarting research are being led at local level, recognising sites are best placed to understand the way in which local NHS services are recovering and know the capacity and capability of local research teams.
  • General winter pressures and particularly increased incidence of flu and respiratory illnesses will increase workload and impose a further burden on NHS services and the associated research that NIHR supports.
  • In response to the changing profile of NHS services, patient pathways and national pandemic study protocol amendments are adding resilience to existing non-UPH studies so they can successfully continue to recruit. Proactive incorporation of 'lessons learned' into the design of new studies will help to ensure that they are less impacted by potential future outbreaks.

 

Guidance

  1. In these circumstances it is expected that the response should be locally led and the following guidance will be issued to organisations for managing the use of NIHR infrastructure resources:
  2. An outbreak at regional or local level may require increased resources to be assigned to theUPH portfolio with consequences for the non-UPH study portfolio and restart programme of work.
    1. The deployment of staff funded through an NIHR Infrastructure award or funded by the NIHR CRN to front line duties should only occur in exceptional circumstances (see point 4 below) so that UPH studies (including vaccines studies) and wider non-COVID-19 portfolio research activity can be maintained.
    2. The deployment of clinical academic staff (both medical and non-medical) should be undertaken within the guidelines issued by a working group convened by the UK Clinical Academic Training Forum and the Conference of Postgraduate Medical Deans of the UK. These relate to people in both medical and non-medical roles.
    3. In the context of this national pandemic, UPH studies remain the highest priority for research support. COVID-19 vaccine studies, prioritised by the Vaccine Task Force and by the NIHR UPH Panel, are also part of this highest priority group.
    4. NIHR CRN weekly returns on COVID-19/UPH staff deployment should continue so that demand and capacity can be actively monitored nationally.
    5. Pausing studies should be a last resort only after all efforts have been made to maintain recruitment rates alongside other research and clinical activity. Reducing recruitment rates would be an option to consider before studies are re-paused. Pausing or stopping a study altogether should only occur if there are no other options.
    6. The principles set out in the Restart Framework should be invoked and where necessary re-assessments should be undertaken.
    7. Study prioritisation levels in the Restart Framework remain unchanged (see above).
    8. Communications with sponsors must be timely and specific.
    9. Study data on Local Portfolio Management Systems should be updated as requested by the NIHR CRN Coordinating Centre so changes are reflected in local and national reports.
  3. Whilst the government response to increased COVID-19 combines general measures and local restrictions, and the NHS has good capacity for COVID-19 patients, it is not considered necessary for NIHR to systematically pause non-COVID-19 studies.
  4. However, in the event of a major rise in cases and patients, the NHS may pivot to primarily focusing on managing the COVID-19 caseload. In these circumstances, guidance may need to be updated.