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Research Reset third letter issued and process launched
Date: 25 May 2022
Research Reset is the approach being implemented to recover the UK’s capacity to deliver clinical research. The DHSC and NHSE&I objective is to give as many studies as possible the chance of completing and yielding results, generating the evidence needed to improve care and sustain our health and care system. At its heart, Reset is a review by sponsors and their chief investigators of studies which do not appear to be progressing in the current context.
The next phase of Reset started on 10 May 2022 with the issuing of a third letter from DHSC and NHSE&I to funders and sponsors, and the opening of the database where sponsors can view whether their studies are flagged for action and indicate their intentions. More information is provided on the Reset microsite and in the Technical Instructions for Stakeholders posted there as well as the more detailed guidance for staff.
The NIHR CRN has developed an online tool allowing a live view of NIHR CRN Portfolio studies that have been identified for action to support stakeholders with their reviews and categorisation. Access to the tool has been provided by the NIHR CRN to existing established points of contact for organisations, via key account information. For those organisations where the NIHR CRN does not hold contact information, these have been drawn from the Integrated Research Application System (IRAS).
DHSC and NHSE&I are asking sponsors to liaise with participating sites, funders, CROs and CTUs (if applicable) and Chief Investigators to inform the assessment of whether the study can meet the recruitment targets and timelines indicated. If it is felt a study is not deliverable, sponsors must seek to address this through a viable deliverability plan. Sponsors will be able to select, amend and submit intentions for studies in the Reset Study Assessment Tool. The NIHR CRN will be taking a data snapshot at the end of May to inform DHSC of engagement with the process. It is important to note that all studies are in scope for the Reset review and that decision making at this stage lies with sponsors alone.