Health and Care Research Wales Support and Delivery service: Guidance regarding pandemic preparedness and response to COVID-19 outbreak (pdf) 18/03/20
Health Research Authority: Covid-19 Guidance for Sponsors, Sites and Researchers
Medicines and Healthcare products Regulatory Agency: Advice for Management of Clinical trials in relation to Coronavirus
Department of Health and Social Care: Guidance on the impact of COVID-19 on research funded or supported by NIHR
Working with partners across UK, Health and Care Research Wales 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.
A single, UK process has been implemented that will allow the Chief Medical Officer (CMO) / Deputy Chief Medical Officer (DCMO) for England to draw on expert advice from across the UK to prioritise the COVID-19 studies which hold the most potential for tackling the challenges we face.
This process will cover 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.
Those with research ideas seeking project funding should also initially go through the portal. Projects assessed as offering work of real value will be triaged to the NIHR/MRC administered COVID-19 UK-wide research funding stream and asked to complete an appropriate application form
UK Research and Innovation (UKRI) is offering funding to support excellent proposals of up to 12-18 months duration for projects addressing and mitigating the health, social, economic, cultural and environmental impacts of the COVID-19 outbreak. More details about the opportunity, including the criteria and the application form can be found on the UKRI website.
With regard to HRA and Health and Care Research Wales 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 organisations and universities in Wales will need to prioritise support for studies which have been nationally prioritised. See the live list of these studies
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.
Until further notice, Health and Care Research Wales through its services is pausing the site set up of any new or ongoing studies at NHS and social care sites that are non COVID-19 studies. This will enable our research workforce to focus on delivering COVID-19 studies or enabling redeployment to frontline care where necessary. These studies are enabling the clinical and epidemiological evidence to be gathered to inform national policy and will enable new treatments, diagnostics and vaccines to be developed and tested. The complete focus of the NHS R&D Services will be on delivering these highest priority COVID-19 studies.
During this time, the MHRA and HRA will continue to provide an approvals service for all studies, prioritised in accordance with the national situation, ensuring site set-up can restart promptly in due course.
Working with partners across the health and care system, Health and Care Research Wales enables and delivers world-class research that transforms people's lives, promotes economic growth and advances science. This is why the Health and Care Research Wales community must prioritise nationally-sponsored COVID-19 research activity, a key element of the Government’s overall response. We urge all parts of the research system to help progress these studies at pace.
Many of our community who drive or deliver Health and Care Research Wales research also provide direct care to patients and the public. Given the scale of the national and global challenge of COVID-19, clinical and academic health and care professionals currently funded by Health and Care Research Wales who are working on topics other than COVID-19 should prioritise frontline care, where requested to do so by their employing organisations. Similarly, research staff with other relevant skills, such as pharmacists and laboratory technicians, should also prioritise support to frontline care. In addition, researchers should consult with their employers to make facilities which currently support research studies available for frontline care.
This will mean that many research studies funded by Health and Care Research Wales, or supported by Health and Care Research Wales (via the NHS R&D services and parts of the wider Health and Care Research Wales infrastructure) may need to be paused, to free up Health and Care Research Wales funded staff to help bolster the frontline response to COVID-19. In addition, we recognise that Health and Care Research Wales award holding organisations may need to pause research studies for locally determined public health reasons.
However, clinical trials or other research studies which are funded or supported by Health and Care Research Wales should continue if discontinuing them will have significant detrimental effects on the ongoing care of individual participants involved in those studies. These are clinical decisions which will need to be made on a case-by-case basis by local decision makers on the basis of local risk and capacity assessments.
All organisations holding Health and Care Research Wales awards that are paused will, in the short term, continue to receive payments from Welsh Government’s R&D Division in line with existing Health and Care Research Wales contractual payment schedules. This will be reviewed and if necessary payment schedules will be updated through the usual contractual process. Where necessary, contract deliverables will be rescheduled allowing staff to concentrate on frontline care and COVID-19 research.
Any individuals or organisations funded by and/or supported by a particular Health and Care Research Wales funding stream who have further questions should contact the R&D Division in the first instance. Your usual contacts will apply, but if in any doubt, please get in touch via the contact points outlined below.
Health and Care Research Wales is working closely with NIHR, CSO Scotland and HSC R&D Division Northern Ireland to ensure there is alignment in our communication and respective positions.
Our colleagues in NIHR have produced a Q&A and the principles within the responses will also apply to the research community in Wales.
We will update this advice in the event of further developments.
Finally, may I thank you for the efforts you are already making to support COVID-19 research and your response to the needs of the health and care system during these extraordinary times.
Professor Kieran Walshe, Director of Health and Care Research Wales