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 – Re-Opening Research?

Restrictions may start to be lifted at participating NHS Organisations meaning that it may be possible to re-open some studies.

As each clinical service or area may have different needs and capacities, the decision to re-open studies will be made on a case-by-case basis. Ultimately this decision is the responsibility of your Host NHS organisation(s), in consultation with all the relevant individuals including subsidiary departments such as imaging, pharmacy and pathology.

For multi-centre studies, 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 re-open 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 LCRN in agreement with re-opening?
    • Can study delivery be aligned with re-opening 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?
    • 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 restart studies that are no longer viable.

 

Please start by updating your Risk Assessment Form and Site File Note to detail how you will conduct the study safely and submit to Sponsor at rgosponsor@le.ac.uk for review along with your supporting documentation.

You must contact each of your participating NHS organisations (for example, UHL R&I via riadmin@uhl-tr.nhs.uk) and, where applicable, the NIHR/LCRN to inform them of your intention to re-start your study, providing detail and reassurance about the changes you will be making. You could provide them with a copy of your Risk Assessment.

We must receive evidence from each of your participating NHS organisations (and NIHR/LCRN) that they are happy for your study to re-start prior to us processing your request. Please ensure that you provide this evidence (i.e., email confirmation) with your Risk Assessment, Site File Note and supporting documentation. Failure to provide this will result in your request being denied.

Please be aware that as a Sponsor we are following national guidance and will need to establish where your study falls within the national prioritisation efforts. Therefore, we cannot guarantee that we will be able to provide Sponsor green light to re-start 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.

Any further surges in COVID-19 could affect the research system again and the potential for a ‘re-pause’ must be considered by Sponsors, Chief Investigators, and local sites in the plans to restart individual studies. Therefore, please ensure that you remain vigilant to ongoing challenges and are ready to change and/or stop your study at short notice.

 

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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