Information for researchers
EMAIL CONTACT: Covid19research@addenbrookes.nhs.uk
Phased re-start of non-COVID-19 research
Update 15th June 2020
In line with NIHR guidance, we are beginning the process of phased re-opening of some non-COVID-19 research studies, while maintaining our contribution to local and nationally prioritised urgent public health studies for COVID-19.
As COVID-19 related admissions continue to fall across our hospital trusts, local research studies will be prioritised as detailed below. However, as and when this situation changes, this process may need to be further adjusted or paused. Delivery of front-line care and COVID-19 research remains our priority, and all research delivery teams working within CUH will be allocated studies on this basis.
Prioritisation of Studies
Existing COVID-19 related research – nationally prioritised COVID-19 Urgent Public Health Research studies and CUH COVID-19 related research trials.
Existing clinical trials and studies that are currently suspended, which offer potential therapeutic benefit to patients via improved diagnosis and/or a treatment/intervention improving or extending life.
Longitudinal follow-up studies of previous interventions; online staff research studies and studies where ALL participant study visits can be integrated with routine clinical management or conducted remotely without imposing major, immediate demand on research workforce and facilities.
All other existing and new clinical research studies.
We anticipate that Level 3 studies will not be able to re-open until the national lockdown has been fully eased. When this occurs, we will provide further information and advice to this effect.
Urgent applications may be considered on a case by case basis.
Application for re-start
All studies must have Capacity and Capability (C&C) formally re-confirmed by R&D prior to recommencement. R&D sign off is in addition to other approvals required (for example, from the CRF or CCTU).
Principal investigators and study teams wanting to have their studies assessed for re-start need to complete the risk assessment form here.
R&D will assess the information provided in the risk assessment form to establish which studies are eligible for Level 1 or 2 prioritisation, and can therefore re-start/start all research activities. The availability of necessary supporting services (Pharmacy, Radiology, Labs, CRF, etc) and research staff will also contribute to the assessment.
NIHR centrally will monitor restart across England to identify and help to resolve any cross-cutting issues that may arise. To this end, a cross-Centre ‘NIHR Restart Implementation Group’ has been established, 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.
Read more on the NIHR website.
National guidance for prioritising funding and support for COVID-19 research across the UK
Published by NIHR 26 March 2020:
Working with partners across the health and care system, NIHR is leading, enabling and delivering world-class COVID-19 research, a key element of the Government’s overall response to the pandemic. Given the extraordinary pressures currently being faced by the health and care system, we must also ensure that we are making best use of the limited resources and capacity available to support research.
We will do this by establishing and implementing a single, national process that will allow the Chief Medical Officer (CMO) / Deputy Chief Medical Officer (DCMO) for England to draw on expert advice to prioritise the COVID-19 studies which hold the most potential for tackling the challenges we face.
This process will cover all funded studies, irrespective of whether they are funded by the public sector, industry or charities and also, in partnership with UKRI, studies that require funding. It aims to prevent duplication of effort and to ensure that the capacity of the health and care system to support research is not exceeded.
Details of the process and the new single point of entry for prioritising COVID-19 studies can be found here.
With regard to HRA approvals, researchers should make an application through the national prioritisation process first and will be signposted for expedited regulatory approvals so that approval review can progress in parallel to the system of assessment leading to a view from CMO/DCMO on prioritisation.
All NHS Trusts, health and care providers and universities will need to prioritise support for studies which have been nationally prioritised. A live list of these studies is being collated. Organisations may support COVID-19 research activity only when this does not impact on the system’s ability to recruit participants and/or provide the resources (including staff, samples and data) needed to support nationally prioritised research. Organisations will be expected to pause any local studies that impede their ability to contribute to national research efforts.
- Government support for research related to COVID-19: Find out how to get your study nationally supported or funded as high priority COVID-19 Urgent Public Health Research.
- COVID-19 and Clinical Research Oversight Group CUH: This has been established under the governance of the NIHR Cambridge BRC and will review nationally prioritised studies to consider which can be supported locally with the available resources.
- NIHR response to COVID-19 pandemic: All NIHR updates on one page.
- Covid-19 response from the NIHR Cambridge BRC: Information for researchers, academics and clinicians on clinical research taking place on the Cambridge Biomedical Campus during the COVID-19 outbreak.
- Brain Injury MIC COVID-19 Challenge: Researchers are being invited to submit expressions of interest for new study ideas and potential solutions to address the issues and impacts of the COVID-19 pandemic and who need funding/support.
Information for Research Teams
If you are a researcher in or around Cambridge who is looking for healthy volunteers for COVID-19 research or would like to involve our PPI panel in your research, please get in touch with the CUH R&D PPI and Communications team at firstname.lastname@example.org.
In order to feature in this list, the study needs to be registered through CUH R&D and be recruiting patients from in and around Cambridge. Cambridge based researchers are welcome to involve the CUH PPI panel at any stage of their research project or proposal.