Information for researchers
EMAIL CONTACT: Covid19research@addenbrookes.nhs.uk
Page last reviewed: 26 January 2021.
DHSC statement on prioritising research studies and deploying NIHR CRN-funded staff
The Department of Health & Social Care (DHSC) has provided guidance relating to the prioritisation of research studies and deployment of NIHR CRN-funded staff in the current situation. Please find their statement below.
We recognise that at the current time those working in many NHS sites are under huge pressure as the number of COVID-19 cases and admissions to hospitals continue to rise and frontline clinical staff are unable to work due to sickness.
While we have a small number of proven treatments and vaccines for COVID-19, more are needed to reduce transmission, reduce the number of patients that require hospitalisation and to improve outcomes for those that do.
It is therefore critical that at this challenging time we continue to recruit participants to our urgent public health (UPH) studies. The current levels of prioritisation for research studies, set out within the Restart Framework, still apply as follows:
- Level 1a (Top Priority) – COVID-19 UPH vaccine and prophylactic studies (as prioritised by the Vaccines Task Force and agreed by Jonathan Van-Tam, deputy CMO) and platform therapeutics trials (currently RECOVERY/RECOVERY +; PRINCIPLE; REMAP CAP)
- Level 1b – Other COVID-19 UPH studies
- Level 2 – Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life preserving or life-extending treatment not otherwise available to the patient
- Level 3 – All other studies (including COVID-19 studies not in Level 1a or 1b)
NIHR guidance for a second wave of covid 19 activity still applies and, as outlined, states that the deployment of staff funded through an NIHR Infrastructure award or funded by the NIHR Clinical Research Network (CRN) to front-line duties should only occur in exceptional circumstances.
The deployment of clinical academic staff should be undertaken within the guidelines issued by a working group convened by the UK Clinical Academic Training Forum and the Conference of Postgraduate Medical Deans of the UK.
Where NHS Trusts consider they need to redeploy staff to support the frontline this should only be done to support clinical activity during the emergency phase of the pandemic and we would expect them to return to their R&D roles as soon as possible, once the pressures on the system reduce.
As indicated by the Restart Framework, at the current time, we need to continue prioritise our support for the most urgent COVID-19 research as part of the response to tackle the pandemic.
At the same time we need to ensure we continue to try and maintain support to deliver non-COVID studies currently open on the portfolio, particularly those within Level 2. A system-wide Recovery, Resilience and Growth programme has been established which brings together the key partners across the clinical research ecosystem to ensure the UK is well-positioned to take a coordinated national approach to achieving the recovery of the UK’s clinical research delivery and restore a full, diverse and active research portfolio as soon as practicable.
Supporting research at Cambridge University Hospitals
Published on 14 October 2020
As the COVID-19 situation develops, research staff at Cambridge University Hospitals (CUH) continue our support of COVID-19 research studies, including Urgent Public Health Studies (UPH), while maintaining safe recruitment to existing open studies and, where possible, safely restarting research studies that were paused during the initial stages of the pandemic.
To date, we have supported, and continue to support, more than 30 COVID-related research studies, including RECOVERY and the Cambridge-led TACTIC trials, as well as recruiting patient and staff participants to the NIHR COVID-19 BioResource project and participating in vaccine studies. At the same time, we have re-opened recruitment to more than 300 paused studies and continue to work toward re-opening the remaining studies on our portfolio.
Following NIHR guidance, R&D is closely monitoring the pandemic situation, and will continue to release guidance to research teams as local and national infection levels fluctuate. We will support the provision of safe patient care within CUH while maintaining recruitment to currently open clinical trials and studies where possible.
Subject to the approval of the COVID-19 Research Oversight board, we will also continue to accept and support new local and nationally prioritised COVID studies; new non-COVID research studies should be submitted to R&D. All CRN funded staff have been directed to work on UPH-listed studies as their priority.
Questions regarding research restart, COVD-risk assessment, staffing, finance and new COVID- or non-COVID research should direct their enquiries to firstname.lastname@example.org in the first instance. Enquiries regarding CRN funded staff contact Christian.email@example.com or Tel: 01223 596458
NIHR guidance for ‘second wave’ COVID-19 activity
Published by NIHR on 13 October 2020
In continuation of its response to COVID-19, the NIHR has issued Guidance for the prioritisation of NIHR infrastructure resources during a ‘second wave’ of high COVID-19 activity, the aim of the guidance being to protect both COVID-19 and non-COVID-19 research.
The guidance states that research staff funded by NIHR should not be deployed to front line duties except in exceptional circumstances. We have set out the background and guidance, with key points to note below:
- The deployment of staff funded through an NIHR Infrastructure award or funded by the NIHR Clinical Research Network (CRN) to front line duties should only occur in exceptional circumstances. The deployment of clinical academic staff should be undertaken within the guidelines issued by a working group convened by the UK Clinical Academic Training Forum and the Conference of Postgraduate Medical Deans of the UK.
- NIHR research activities and restart decisions should continue to be locally led and the study prioritisation levels in the Restart Framework remain unchanged.
- Wherever possible we continue to encourage restart of the non-COVID-19 NIHR CRN Portfolio paused by sponsors and sites due to the pandemic. This includes opening new commercial and non-commercial studies.
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 Cambridge University Hospitals (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 NIHR Cambridge Clinical Research Facility (CRF) or Cambridge Clinical Trials Unit).
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 Patient and Public Inovlvement (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.