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Operational Information for UHL & UoL researchers - COVID-19

This page provides a place for UHL and UoL researchers to find the latest information on local processes on the set-up, approval and conduct of research in order to comply with national guidance in light of the COVID-19 outbreak.

Introduction

We are aware that the current situation is fast paced and everyone is struggling to keep up to date with guidance and requests, which are arriving at an increasing rate. We know that for many researchers your research work is on top of your clinical work, which also currently poses significant challenges.

We’ve created this webpage to pull together guidance and actions you need to take into one place. We will update it regularly and ensure that where things change they are published here and emails are sent out to alert you.

Non-NHS Research at the University of Leicester

The University issued updated guidance on the 24th of March 2020 (see email to Staff 15:22) to take into account the government's updated instructions to citizens and business. In effect University Ethics approved research is scaling back as the University has closed for all but essential research. Please refer to the latest guidance via:

Sponsored (NHS) Research at University Hospitals of Leicester and University of Leicester

The majority of clinical research sponsored by the Leicester Joint Research Office, or hosted in Leicester, is being paused until the COVID-19 pandemic has passed. At the same time, a number of new pandemic related studies are being opened with the highest priority being given to those from DHSC and via the CMOs office.

The HRA and the MHRA have issued guidance on how researchers should manage the necessary changes to their existing projects in light of COVID-19. We have created an internal process to minimise the admin burden on you and your teams, please see below.

There is also a new internal process for obtaining authorisation to proceed with NHS-related COVID-19 research during this period, please see below.

Both UHL (Research &Innovation) and UoL (Research Governance Office) staff are working from home, but are operating as normally as possible. We anticipate that there will be a significant spike in workload due to researchers submitting amendments to vary their research activity. Please bear with us. If you have a particularly urgent issue, please ensure that you flag this in the email header.

What do I need to do – Existing Research?

Researchers need to review research risks in light of COVID-19:

1.Read the guidance:

2. Complete the Risk Assessment Form and Site File Note

.We have provided a template with headings and things to think about. Not all sections will be relevant to all projects – please amend as appropriate

3. Submit the Risk Assessment and Site File Note to your Sponsor

If you think your amendment meets the criteria of an Urgent Safety Measure please inform us immediately and ensure that you make this clear in the email subject line so that we can prioritise your amendment approval

4. Await Sponsor approval for your amendment – please do not implement your changes prior to Sponsor approval.=

5. File all completed documentation

What do I need to do – New Research?

Prof. Nigel Brunskill has established a small group of colleagues who will assess short study proposals from local colleagues and then advise on whether they should be taken forward.

Several principles will apply to these assessments.

  1. Due to workforce capacity restrictions, priority will be given to delivery of national studies.
  2. Although processes for local study work up will be streamlined, robust research governance will still be required.
  3. Most COVID-19 research applications, that require access to the UK health and care system, regardless of funder should be submitted to the NIHR Urgent Public Health Research application portal. Please consult the FAQs on the NIHR webpages to determine whether or not you should make an application. This can be done in parallel to funding applications. See below for full details
  4. That potential investigators will comply with guidance from the Health Research Authority and the NIHR

If you intend to develop a new project, please forward the following prior to starting significant work:

  1. A very short, 1 paragraph or protocol
  2. Evidence of endorsement from beyond Leicester and including any of the NHS organisation(s) that you wish to work with
  3. A description of the resources needed to support
  4. How will the activity be funded – whether this is an existing grant being repurposed or if a funding application is pending.

These should be sent to your Sponsor:

UHL are not issuing Capacity & Capability for non-COVID research, like most other NHS trusts. This will most likely impact upon non-COVID research/grants currently in work up and may affect funder timelines and expectations.

 

What do I need to do – Restarting Research?

As and when restrictions are lifted at participating NHS Organisations, it may be possible to restart your research.

The decision to restart studies will be made on a case-by-case basis as each clinical service or area may have different needs and capacities.

Each Trust is responsible for making their own decision about research activity at their own site. You will therefore need to be aware of all relevant correspondence being issued by your participating NHS organisation(s).

Before making a request to restart your study, please consider the following:

1. The safety of your participants and the staff involved – Does re-opening your study expose participants and staff to avoidable risk?

    • Can data collection be adapted (e.g. virtual appointments, paper-based questionnaires, or web-based tools) removing the need to attend in person?
    • If not, are there ways to minimise the risk of infection (e.g. PPE use, social distance/minimal contact, decontamination procedures)?
    • Are there any local site policies that will affect your ability to conduct your study?
    • Can study visits and assessments be incorporated into normal clinical services as/when they are restored?
    • Can you reduce the length and/or number of visits that need to be made to the hospital? How many participants does your study require, how many times and for how long?
    • Are your participants happy and able to come to the hospital? Some may feel concerned about the risk, what can you do to make they feel safe and reassured about the study?

2. The burden on the NHS – Do the research sites have capacity to deliver your study?

    • If this is a NIHR portfolio study is your LCRN in agreement with restarting?
    • Can study delivery be aligned with restarting of routine NHS services in the relevant clinical service, or would it conflict in any way?
    • Is staffing currently available to re-start the study? This may be a particular issue if staff have been re-deployed to other priority studies

3. Other considerations:

    • Do you need to make an amendment to the end of study date?
    • Do you need to add in any additional items to include COVID-19 elements?
    • Do you have evidence of sufficient funding? You will be required to provide your RM Code (or equivalent).
    • Have you contacted your funder to arrange an extension to the grant award?
    • If applicable, do you have any contracts or agreements with funders or third parties that require any changes?
    • Is your study still viable? Some studies that have been paused may no longer be viable, for scientific, clinical, financial or practical reasons and it would be unethical and inefficient to re-start studies that are no longer viable.
    • How you will manage the study in the event of a ‘re-pause’?

THE PROCESS FOR RESTARTING YOUR RESEARCH IS AS FOLLOWS:

Please be aware that this process may be subject to change in response to further government advice and the progress of COVID-19. Please ensure you regularly check here for the latest available information.

1. Submit the request

Please send following to Sponsor at rgosponsor@le.ac.uk:

The process for applying for Substantial and Non-Substantial Amendments has recently changed.

2. Confirmation of Study Viability

Once we are satisfied the issues have been addressed, we will confirm study viability via email.

3. Contact your sites

You can then contact each of your participating NHS organisations to request confirmation of capacity and capability for restart at their site. Each site will have their own process, but you will need to provide detail and reassurance about the changes you will be making. You must provide your email of “Confirmation of Study Viability” issued at Step 2 above.

You may also need to contact the University of Leicester for confirmation that any relevant University staff can return to work and/or that any relevant University premises can be accessed. Please see the Resource Hub for further details on how to do this. It is our intention that the Research Governance process will run alongside that of the Lockdown Exit Group; please be patient while we develop a seamless framework.

4. Green Light to Restart

We will issue Sponsor Green Light to restart the research following receipt of:

  • Confirmation of Capacity and Capability (or equivalent) from each of your participating sites
  • Confirmation for relevant University staff to return to work and/or for access to University of Leicester premises (if applicable)
  • Any outstanding amendment approvals (if applicable)

Please be aware that as a Sponsor we are following national guidance and will need to establish where your research falls within the national prioritisation efforts. Therefore, we cannot guarantee that we will be able to provide Sponsor green light to restart for all studies and each request will be considered on a case-by-case basis. We thank you in advance for your patience, help and understanding.

Useful Documents

Site File Note

Risk Assessment

Useful Links

National Guidance from the UK Government

https://www.gov.uk/coronavirus

The latest from the World Health Organisation

https://www.who.int/emergencies/diseases/novel-coronavirus-2019

The latest from the National Institute for Health and Social Care Research

https://www.nihr.ac.uk/covid-19/

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