The emergence of the COVID-19 pandemic led the NHS to suspend many routine clinical services and the NIHR to prepare to support the Government’s research response. As we are entering a new phase of the pandemic, where the number of new cases of COVID-19 is declining, this is a right time 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. NIHR have a significant portfolio of nationally prioritised urgent public health studies which are actively recruiting participants.
The Framework aims to continue to support COVID-19 NIHR research as part of the Government response to tackle the pandemic. The other purpose is to provide a structure to guide the restarting of a full range of NIHR research, across all sectors of health, social care and public health, while maintaining local decision-making and flexibility. The project also focuses on close collaboration with key stakeholders, regulators, HRA, MHRA, patients and the public, and the healthcare and care organisations to support the pace and coordination of the restarting process.
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. It 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.
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.
The first version of the Framework will require iteration in the upcoming weeks and months as the NIHR learns from early experiences of restart.
Please see the below links for more information about the Framework.