Sponsored Research Covid-19 Guidance
Studies that are undertaken involving some aspect of NHS collaboration and have been subject to HRA/NHS REC approval) that have the University of Sussex as the formal research ‘Sponsor’
The University is conscious of the complexity of its portfolio of clinical research activity and is also mindful that as the COVID-19 outbreak evolves there will be unprecedented calls on the NHS and its resources. It is therefore vital that decisions on ongoing and planned research should be made in close consultation with sites and research funders.
- Amendments
-
The HRA has published guidance on the types of amendments that can be submitted to the Sponsor that will not require a submission to the HRA - https://www.hra.nhs.uk/covid-19-research/covid-19-guidance-sponsors-sites-and-researchers/#allamendments
Please also note that, as of June 2020, the HRA introduced a new Amendment Tool that replaced the previous processes. https://www.myresearchproject.org.uk/help/hlpamendmentsresearch.aspx
When completed, the Amendment Tool spreadsheet should be submitted to the Sponsor in the usual manner (researchsponsorship@sussex.ac.uk)
- Sponsorship applications for new studies and restarting those 'paused'
-
For new studies relating to COVID-19, the University will continue to follow the guidance of the Health Research Authority (HRA), and it supports expediting standard University research governance authorisations where possible.
The Sponsorship Sub-Committee (SSC), that oversees the University’s Sponsor responsibilities is, in principle, open to a ‘proportionate and pragmatic’ recommencement of research. For full information on this please read the letter to Chief Investigators sent on 12 June 2020. Cases for restart will be considered at scheduled meetings of the SSC.
New applications and requests for restart should be accompanied by a completed copy of the University's Restart Framework form.
Following the recent publication of the NIHR’s Restart Framework, the SSC has agreed that this be used as the basis for paused studies to make the case for recommencement to the Sponsor.