In light of the ongoing COVID-19 pandemic, the majority of clinical research across St George’s will be temporarily suspended in accordance with the guidance Implications of COVID 19 on clinical research studies. Our priority will be to support COVID-19 related clinical research studies.
If you are currently either setting-up a study or have an existing study which is sponsored by St George’s NHS Trust/University, and involves seeing study participants at St George’s, please refer to this guidance document issued by the Joint Research and Enterprise Services (JRES) which has regard for the current Health Research Authority (HRA) advice.
I want to set-up a COVID-19 study, can I get this approved quickly?
The HRA are fast-tracking all studies concerning COVID-19, and facilitating the set-up of COVID-19 studies is the highest priority for JRES. If you are planning to conduct a study in this disease area, please contact the Head of Research Governance and Delivery, Subhir Bedi in the first instance - firstname.lastname@example.org
I want to amend my study to address elements related to COVID-19, how shall I do this?
We recognise that you may want to amend your protocol to include additional testing for SARS-CoV-2, take new samples, collect additional epidemiological data etc.
Please discuss this with your JRES Research Governance & Facilitation Officer at your earliest convenience to advise you of the best process.
Will I be able to commence/continue with setting up my Clinical Research Study?
Yes, the JRES will continue to work with you and support you through all processes to set up your study, including the ethics submission, contracts and finance processes. However, please note that you will only be able to start your research at St George’s when approved by the Trust, which will be once the current burden on the health service alleviates (unless this is a COVID-19 related study or falls under other exceptions made by the Associate Medical Director (Research) as outlined in the guidance Implications of COVID 19 on clinical research studies).
If you have not already submitted your study documents to the JRES to initiate Sponsorship review, please send them to your nominated Research Governance & Facilitation Officer or the shared inbox (email@example.com). The JRES will be able to review and provide feedback on your research project in order to assess suitability for confirmation of Sponsorship.
Whilst the HRA is still accepting submissions for approval, it is unclear how long they will continue to do this and we are cognisant that applications for COVID-19 trials are taking precedence.
Please be aware that as of the 20th March 2020, the HRA has stopped accepting undergraduate and masters level research projects requiring their ethical and or compliance review.
My study has already been submitted and I am just waiting for approvals, can I still start my research?
No, in line national procedures, the JRES will be pausing the Confirmation of Capacity & Capability approval process until the Trust sanctions this apart from COVID-19 related studies and other exceptions made by the Associate Medical Director (Research) as outlined in the guidance Implications of COVID 19 on clinical research studies.
If you feel your study should be treated as an exception at St George’s during this time, please discuss this with Subhir Bedi, Head of Research Governance & Delivery - firstname.lastname@example.org
What about NIHR performance metrics?
The NIHR have issued reassurance that metrics will be adjusted or suspended to account for the current situation.
Who do I need to inform if patient recruitment and/or the study is suspended?
JRES will keep a record of classification of studies and decisions made the in accordance with the guidance Implications of COVID 19 on clinical research studies.
Please get in touch with your Research Governance & Facilitation Officer to inform us of the particular situation with your study. You do not need to inform the Research Ethics Committee (REC) or the HRA that you have temporarily suspended recruitment, as this is to be expected.
Simply pausing recruitment does not need to be reported as a temporary halt, although researchers should record such decisions for their records. For a formal suspension of all trials activity:
CTIMPs, in the scenarios where MHRA has advised this would be substantial amendment, such amendments will be categorised and assessed according to existing guidance, but the process will be expedited. They should be sent to sites following the instructions above. These should be implemented at sites on the date specified by the sponsor.
non-CTIMPs where a formal halt is required, there should be a non-substantial amendment that does not require HRA/HCRW Approval or R&D agreement. For studies involving the NHS/HSC, these should be marked by the sponsor as category C and not requiring assessment and sent directly to sites following the instructions above. These should be implemented at sites on the date specified by the sponsor.
As the situation progresses, we can work with you to submit an amendment to extend the study to make-up the shortfall in recruitment and delivery if required and JRES can discuss this with the funder at that point to ensure they are agreeable to this.
Can I continue to set-up new sites for an existing study?
No, the JRES will not be able to sign any new contracts for participating sites at this time. The is to support other healthcare organisations manage during this time. The JRES will can continue the set-up process at sites up until this point (including negotiating contracts), but please be aware that sites’ scope to assess capacity and capability to deliver the trial will likely be diminished due to the COVID-19 outbreak.
Can we still continue with Site Initiation Visits (SIVs), Site Feasibility Visits and or monitoring visits from external sponsors for studies that would recruit when we return to normal service?
No, we must limit the number of visitors onsite for non-essential reasons. For that purpose, no external researchers and or sponsors should be permitted onsite in line with the St Georges visitor restriction policy. In addition, where source data verification is required for monitoring, it is not possible to remotely allow access to external sponsors for data protection purposes.
I want to submit an amendment for my study, can I still do this?
We do not know how long the HRA will be accepting amendments and there is likely to be a significant delay in the approvals process. For now, you should follow the normal process and make contact with your Research Governance & Facilitation Officer to review the amendment prior to submission.
How do I make a change to how or when patients are seen to avoid the risk of exposing patients to COVID-19 or to reduce burden on clinical services?
If the changes are thought to reduce the risk to COVID-19 exposure by changing on-site visits to remote visits, then this should be handled as a non-substantial amendment (category C) that does not require HRA approval and can be implemented immediately. Please contact your Research Governance & Facilitation Officer to ensure you follow the correct process before implementation and any such change should not increase the burden on Trust staff or resources.
If such a change could increase the risk to patients (e.g. increased safety concerns due to lack of on-site visits and assessments) then this should be handled as a substantial amendment. Please contact your Research Governance & Facilitation Officer in JRES.
It may be appropriate to record if the change might affect the study data, for example subjective interview responses.
Where can I find further information?
The official guidance from the HRA can be found here:
COVID-19: Guidance for sponsors, sites and researchers (v2.1 20 March 2020)
The situation is changing rapidly, so please check the most recent HRA guidance and get in touch with your JRES Research Governance & Facilitation Officer to determine the most appropriate course of action.
JRES contact details
You can find contact details for the JRES Team here: JRES contact details
No, the government has advised that everyone must stay at home and work from home.
Only priority projects on Covid-19 (as agreed with the Deputy Principal (Research and Enterprise)) will be ongoing now that the University is closed.
During this time only skeleton staff will be present on site for essential maintenance/support.
For those staff on site, performing essential Covid-19 research, they must follow the guidelines for lone and out of hours working and sign in with Security on entry to the university and sign out when they leave.
If you are in the laboratory on your own, you must follow the guidelines for lone and out of hours working and implement the buddy system to ensure someone knows where you are.
It is essential that you read and follow the risk/COSSH assessment guidelines associated with the protocols you are using in the lab and familiarise yourself with the processes/equipment needed to minimise risks. You should also make sure you clearly understand the waste disposal processes and check that they are available.
You need to ensure that you know what to do in the event of an emergency, fire, chemical and biological spills and how to report incidents and accidents.
Further information can be found on the Health Safety and Environment webpages.