Published: 21 May 2020
We are entering a new phase of the pandemic, where the number of new cases of COVID-19 is declining and we have a significant portfolio of nationally prioritised urgent public health studies which are actively recruiting participants. The time is right to work towards the restoration of a diverse and active portfolio of research funded and/or supported by the NIHR - including both non-COVID-19 research and important COVID-19 research which does not meet our urgency criteria.
To help initiate this process,the NIHR has developed a ‘Framework for restart’ which is a guidance document to support local decision-making. The Framework includes:
- The strategic objectives and guiding principles of NIHR restart work.
- The preconditions for restarting paused studies or starting new studies at site level
- Details on how support from the NIHR’s Clinical Research Network and Clinical Research Facilities will be prioritised in localities if that is necessary.
- The overall roles and responsibilities of organisations at local and national level in restarting any paused NIHR activities.
- The establishment of an Implementation Group and an Advisory Group to ensure a coordinated and collaborative approach to recommencement of a diverse portfolio of research.
- A template Restart Assessment Checklist.
There are a number of important points to note about the Framework and our restart work generally, as outlined below:
- The Framework applies to England, but has been developed in consultation with representatives of the devolved administrations, who may themselves publish analogous guidance in due course.
- The Framework is intended to support local decision-making. We fully recognise that decisions as to which studies open, when and where need to be made by sponsors, funders, investigators and site R&D directors.
- This is version one of the Framework, it will need iteration in the coming weeks and months as we learn from early experiences of restart.
- Work to restart studies must be complementary to ongoing work on urgent public health COVID-19 studies, which continue to be afforded the highest priority given their vital importance to the overall national and international response to COVID-19.
NIHR centrally will monitor restart across England so that we can identify and help to resolve any cross-cutting issues that may arise. To this end, we have established a cross-Centre ‘NIHR Restart Implementation Group’, which will be chaired by Dr William van’t Hoff, CEO of the NIHR Clinical Research Network and Senior Responsible Officer for the NIHR Restart Programme.
This will be aided by an ‘NIHR Restart Advisory Group’, which will comprise representatives of stakeholder organisations, patients and the public, and the devolved administrations. It will be co-chaired by Sheuli Porkess, Executive Director, Research, Medical and Innovation at the Association of the British Pharmaceutical Industry (ABPI) and Aisling Burnand MBE, Chief Executive of the Association of Medical Research Charities (AMRC).
The aims, working practices and memberships of these two groups may evolve as we learn from experience how best to support local decision-making.
Complementary work will be undertaken by the joint Government and industry Clinical Research Working Group to identify lessons from our ways of working across the research community since the beginning of the pandemic which could be sustained to further enhance performance of the UK’s research ecosystem. This work will feed into the UK Clinical Research Collaboration and the Life Sciences Council.
For further information:
- If you have questions about the pausing or restart of a clinical study: email@example.com
- If you are a patient or member of the public and have been recruited into a research study, please contact your study team or visit our Be Part of Research website.
- If you are from a company wanting to be connected to the NIHR's expert researchers: firstname.lastname@example.org
- If you have questions about career development award funding including fellowships: email@example.com
- If you have questions about programme funding: either firstname.lastname@example.org (i4i, PRP, PGfAR, PDG, RfPB and RIGHT) or email@example.com (EME, HS&DR, HTA, PHR, ESP, CTU support funding, HSPR and global health units and groups)
- If you are part of NIHR's broader research infrastructure or a school or unit: firstname.lastname@example.org