The Covid-19 pandemic has had implications for research and researchers at Barts Health and Queen Mary.
On this page we publish information to support our researchers, covering:
- Reopening clinical studies (March 2021)
- Get involved in Covid-19 research
- New Covid-19 studies: The JRMO Covid-19 Review Committee
- Covid-19 data requests and project proposals: Barts Life Sciences' COVID-19 Data GroupCovid-19 vaccine research
- Celebrating 10,000 participants in Covid-19 research at Barts Health, 1 February 2021 [PDF 270KB]
- QMERC Covid-19 guidance
- Travel policy for fieldwork
- Guidance on remote monitoring of Barts Health clinical research
- Barts Health Knowledge and Library Services' Covid-19 Evidence updates, Clinical Decision Tool and related resources
- Queen Mary Doctoral College FAQ
Where clinical research studies were formally suspended at Barts Health and Queen Mary in 2020 and have yet to reopen, there are various factors to consider before that can happen. To help with that process the JRMO produced the following:
- Statement on the principles around reopening research studies [PDF 177KB]
- JRMO study restart assessment checklist [DOC 69KB]
The HRA has also published guidance on re-starting or making changes to existing studies that the JRMO will take into account.
All other studies, which had to be paused during the latest phase of the pandemic, can restart from 22 February 2021. However, Principal Investigators (PIs) should still consider if their study is urgent enough to warrant restart and if it is safe to restart. No formal restart process is required, but three principles will apply:
- The impact of the research on routine clinical workload - especially where there is significant strain;
- The need for experienced research staff who could make a life-saving contribution to patient care; and
- The implications for the safety of study participants.
In conjunction with these principles, PIs are reminded of their obligation to evaluate and minimise any risks of Covid-19 amongst both research staff and study participants. This should include consideration of travel to and from clinical sites, the need for infection prevention and control during including any necessary risk assessment for the research activities (in some cases poorly understood by researchers), aligning with clinical service priorities, and maintaining social distancing as per government guidelines.
The JRMO will prioritise study restart using the Prioritisation list for non-Covid research Sponsorship (February 2021) [DOC 15KB]
Please contact firstname.lastname@example.org to discuss where your study falls in the priority listing if that is unclear.
Barts Health is now running 'healthy volunteer' Covid-19 vaccine trials at its bespoke centre based at Bethnal Green Library, in the heart of East London. If you would like to take part in a vaccine study, send an email with your full name, and contact telephone number to email@example.com. You will be contacted by a member of the research team, who will explain more about the study.
NIHR ARC East Midlands has produced a useful document Public perceptions towards vaccine trial research within ethnic minority and vulnerable communities [PDF 343KB] which should be of assistance in tackling some commonly-held misconceptions that can act as a barrier to research inclusion.
The Barts Health website also has information, aimed primarily at patients, setting out how to get involved in the Trust's Covid-19 research. This is a very useful resource for research staff who need help with drafting information for patients or volunteers. The page covers such items as 'why do research into Covid-19', 'taking part in research, information about the Trust's PPIE Advisory Group, along with details of the Trust's major ongoing Covid-19 research projects. The JRMO's can help further with this.
In addition, the NIHR has launched a central website where anyone can sign up to take part in a variety of expedited clinical trials relating to the development of a vaccine.
As of 8 April 2021 all research, including that related to Covid-19, needs to follow the standard review and set-up pathway as set out on the Performing Research Section of this website.
All audits and service evaluations revert to being reviewed by the Barts Health Clinical Effectiveness Unit (CEU) and QMERC projects will no longer require dual review by both QMERC and the Covid-19 Review Committee. Any questions about this should be directed to the JRMO: firstname.lastname@example.org
From March 2020 to April 2021 the JRMO Covid-19 Review Committee met 52 times and reviewed a total of 456 projects, including 226 JRMO overseen research projects, 121 Clinical Effectiveness Unit (CEU) audit/service evaluations, and 109 studies.
If you need to do fieldwork for research continuation now, then you can do so provided you comply with the following. You must ensure you complete the risk assessment, and give specific consideration to local Covid-19 related policies of your institution, any institutions you will be working with and the governments of any countries outside the UK if the research is to be carried out overseas. Contact your line manager or supervisor for further information.
Risk assessments need to be signed off by your Head of School or Institute, and you must be aware that insurance cover will only remain valid if you can demonstrate to your Head of School or Institute that travel is necessary at this time and you can practice social distancing throughout the trip. Risk assessment templates for fieldwork are available on the HSD website.
The JRMO has published Guidance for site study teams and sponsors for remote monitoring and source data verification within Barts Health NHS Trust during the Covid-19 pandemic. This and additional JRMO guidance can be found on the Guidance documents page.