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COVID-19 - important updates for researchers

Please check back regularly for the latest information.

Page last updated: October 2020.

This page outlines the processes and requirements for managing the pausing and restarting of clinical research at UCL and UCLH. This page contains the following core information:

  • Research taking place at UCLHinformation for Principal Investigators and sponsors on UCLH studies.
  • Restarting research studies at UCLH: the requirements and processes for studies which were suspended at UCLH following the relaxation of Covid-19 lockdown measures
  • Studies not yet active at UCLH: guidance on the introduction of new studies to UCLH
  • UCL and UCLH sponsored studies: information for Chief Investigators with studies sponsored by UCL or UCLH. Including the suspension and management of studies during the introduction of Covid-19 measures
  • Restarting studies as a sponsor (UCL and UCLH): the requirements and processes for studies which were suspended at UCLH following the relaxation of Covid-19 lockdown measures
  • Furlough and those in receipt of NIHR funding: latest updates for those in receipt of NIHR funding
  • Further information about restarting research: Government and regulatory advise on restarting research, NHS and academic activity
  • Remote studying: Links to remote courses relevant to researchers at UCL and UCLH
  • Remote monitoring at UCLH: Guidance and policies relating to visitors, including research monitors at UCLH
  • HRA advice on student research

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COVID-19 procedures are in place for researchers at UCLH and UCL

Researchers wishing to initiate new Covid-19 studies with UCL or UCLH as the sponsor or lead, should refer to the relevant sections below.

Guidance in the event of a change to clinical service delivery due to Covid-19

The JRO has published guidance informing Principal Investigators of their responsibilities should there be a change to clinical service delivery at UCLH as a result of:

  • the lockdown
  • the proposed tiered approach to exit lockdown
  • other national or local (UCLH specific) Covid-19 policies and guidance.

This guidance outlines the expected response from PIs where UCLH is required to fully or partially halt routine clinical activity. This guidance is subject to change (as the position at UCLH and/or nationally alter). PIs should review this web page weekly for updates.

Research studies taking place at UCLH

All research activity at UCLH (hosted at UCLH) was suspended in March 2020 unless the study fell into the priority/permitted categories outlined in the UCLH Research Directorate Covid-19 recommendations.

We are now in the process of restarting some studies where we can do so safely.

Set up of Covid-19 therapeutic trials

Researchers wishing to set up Covid-19 treatment trials should contact the JRO on uclh.randd@nhs.net – in the first instance marking the email as a new Covid-19 therapeutic research study.

These proposed trials will be considered first by the JRO’s Covid-19 technical group chaired by Prof Rob Heyderman, which will forward recommendations to the UCLH Covid-19 Research Strategy group, chaired by Prof Bryan Williams, for final discussion and agreement.

All non-therapeutic Covid-19 studies should bse sent to uclh.randd@nhs.net marking the email as a new Covid-19 non-therapeutic study. These studies will be considered by the JRO.

Restarting research studies at UCLH

Pandemic measures remain, and therefore any re-activation of research that was paused during the pandemic requires detailed planning and consideration.

In October 2020, the UK government introduced a new three tier approach to Covid-19 infection rates. The JRO have issued guidance on how these tier’s may impact re-starting research at UCLH. This guidance can be accessed here.

Each UCLH Clinical Division has assigned a research lead to support with determining which studies can open within their divisions. The lead has the list of studies for their division and a link person within the JRO. The lead, JRO and service support departments work with the PI to determine and approve the re-start of studies at UCLH.

Researchers wishing to re-start a study which was suspended by Covid-19, should email the JRO on uclh.rannd@nhs.net or make contact with their divisional research lead.

Read our guidance to be followed to obtain approval to re-start research at UCLH.

Studies not yet active at UCLH

The Joint Research Office, Clinical Research Facility and Cancer Clinical Trials Unit will continue to review studies which were in the process of being set-up at the time lockdown measures were issued. However, a  Decisions to Deliver (to begin at UCLH) will not be issued until approval has been sought under the process for Restarting research studies at UCLH.  

In October 2020, the UK government introduced a new three tier approach to Covid-19 infection rates. The JRO have issued guidance on how these tier’s may impact re-starting research at UCLH. This guidance can be accessed here.

Researchers who wish to submit a new study (was not open at UCLH or was not in the pipeline to reopen at UCLH at the time pandemic measures were enforced), should discuss their request with the JRO (uclh.randd@nhs.net). Currently such applications are not being processed unless the study falls into the three categories as outlined in the UCLH R&D statement (issued 3rd April 2020).

UCL and UCLH sponsored studies

Chief Investigators of UCL and UCLH sponsored studies, were asked to terminate all new participant recruitment, in March 2020, following Covid-19 measures being applied. Full details The guidance issued can be found in this guidance.

We are now in the process of restarting some studies where we can do so safely. The sections below outline the requirements for restarting these studies.

Restarting studies as a sponsor (UCL and UCLH)

Pandemic measures remain, and therefore any re-activation of research will require detailed planning and consideration. Therefore, any Chief Investigator of a UCL or UCLH sponsored research study (clinical research study) should ensure a thorough risk and mitigation strategy is in place prior to restarting activity.

In October 2020, the UK government introduced a new three tier approach to Covid-19 infection rates. In response the JRO have issued guidance for CI’s for UCL and UCLH sponsored studies. This guidance can be accessed here.

Written agreement from the sponsor will be required before the restart of all activity.
The “sponsor” at UCL and UCLH are represented by the following groups (only):

•    UCLH/UCL Joint Research Office (JRO)
•    Cancer Clinical Trials Unit at UCL (CTC)
•    Comprehensive Clinical Trials Unit at UCL (CCTU)
•    PRIMENT at UCL 
•    MRC Clinical Trials Unit at UCL

Read our guidance and principles which should be followed to obtain the approval to re-start research sponsored by UCL or UCLH.

Furlough and those in receipt of NIHR funding

The JRO is following the government's published guidelines on furloughing.

Further information about restarting Research

https://www.nihr.ac.uk/news/supporting-the-restart-of-paused-nihr-research-activities/24890

https://www.therqa.com/resources/resource-bank/covid-19-toolkit/

https://www.nihr.ac.uk/documents/restart-framework/24886

Remote Studying

Remote PPI can be a challenge but we would encourage researchers to keep their patient involvement going. See more

Monitoring arrangements at UCLH (including other sponsor visits e.g. audits, SIVs, close out visits)

Please refer here for the latest information on remote monitoring arrangements at UCLH.

HRA position on student research

The HRA and devolved administrations are not currently reviewing applications for individual undergraduate and master’s student projects due to Covid-19.

This pause on health and social care research for educational purposes in is place until September 2021. The decision is in line with national priorities for NHS/HSC to support Covid-19 studies and the restart of clinical trials, studies and research and recognises the continuing pressure of the pandemic.

You can find more information on the HRA’s current position on their website.