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 the Coronavirus (COVID-19): Advice for students, staff and visitors page.

 

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.

Although the guidance the HRA/MHRA have provided is helpful, we do expect a small number of queries. Where we receive these we will answer your query directly, as well as put them in the Frequently Asked Questions (FAQ) section below. Please do check here before contacting us as it may save you waiting

 

What do I  need to do – Existing Research?

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

  1. Read the guidance:
    1. Health Research Authority (HRA)
    2. MHRA guidance (CTIMPS and Medical Device Studies under MHRA regulations)
  2. Complete the Risk Assessment Form
    1. 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

    It is acceptable to use the same Risk Assessment Form for multiple studies a Chief Investigator is running if the risks posed and actions taken are the same (e.g. multiple questionnaire studies). Please submit this with separate file notes for each study.

  3. Complete the Site File Note
    1. We have constructed the template so that you can use this as your amendment request form and file note – to reduce the amount of paperwork you need to complete. You are welcome to continue to add to this one document until you re-open recruitment.
  4. Submit the Risk Assessment and Site File Note to your Sponsor
    1. RGOSponsor@leicester.ac.uk
    2. UHLSponsor@uhl-tr.nhs.uk
    3. 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

  5. Await Sponsor approval for your amendment– please do not implement your changes prior to Sponsor approval.
    1. Please ensure that any amendment you submit does not contain a mixture of non-notifiable/notifiable elements (e.g. general amendments should not be bundled with changes relating to COVID-19).
    2. We will assess your application and provide approval. Should your application not meet the criteria for a non-notifiable amendment, we will liaise with you regarding appropriate actions
  6. File all completed documentation

Researchers must continually review risks in light of COVID-19 and changing guidance

  1. Review the risks to your research, participants and staff continually in light of emerging guidance and policy – document these on the Risk Assessment Form and Site File Note
  2. Where further changes to the delivery of the project are required - including lifting restrictions on recruitment/data collection a further amendments request should be submitted to your Sponsor using the same forms.

 

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. It is likely that any studies approved locally will need to be supported and endorsed by a national or international society or learned body.
  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 protocol
  2. Evidence of endorsement from beyond Leicester
  3. Evidence of HRA/CRN engagement
  4. A description of the resources needed to support
  5. How will the activity be funded

These should be sent to your Sponsor:

  1. RGOSponsor@leicester.ac.uk (cc Cat.Taylor@leicester.ac.uk)
  2. UHLSponsor@uhl-tr.nhs.uk (cc Carolyn.Maloney@uhl-tr.nhs.uk)

Do not proceed with any significant work on your project without authorisation

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/

 

Frequently Asked Question Section

Can I take patient data home with me to conduct phone follow-ups?

If you are going to be working from home, there is no issue with you conducting telephone follow-ups if this is in your existing protocol. You just need to ensure that you are compliant with the Data Protection Act, in that personal identifiable data is stored securely and only accessible by those delegated the task. This should be done via University or Hospital (depending on where you said you were storing the data in your IRAS form) managed laptops and VPN. Paper copies of records should be avoided as they present compliance issues.

If telephone follow-ups are not part of your current protocol, please ensure that you include this in your non-notifiable amendment – see Section 3 of the HRA Guidance

Can I take a Trial Master File (TMF) or Investigator Site File (ISF) home?

It is UHL and UoL policy that these files should not be taken home, in whole or in part.

Can I introduce remote consent to my study?

There are several options for remote consent procedures, here are a few of them:

  1. Postal Consent – the consent form is posted to participants along with the invitation letter and PIS. Assuming that the study is of low risk and does not cover sensitive topics etc, the participant simply fills in the consent form and returns to the study team where you can either countersign it and return to them or, acknowledge, or countersign when you receive it but don’t return a fully signed copy.
  2. Telephone consent – the consent form is adapted so that there are two complimentary versions – (1) the normal consent form and (2) a telephone consent script which is used at the office end and becomes more of a statement of fact (i.e., “I confirm that the participant has read and understood the PIS……”, “I confirm that the participant has had the opportunity to ask questions…”, “I confirm that the participants understands that their participant is voluntary and that they can withdraw at any time. I have explained the procedure for withdrawal to them…” etc, so that the statements are read from the perspective of the research team member having the conversation over the phone and confirms that each statement has been discussed, understood and agreed with by the person on the end of the phone). This is then signed and dated and a copy is sent to the participant for their records. They don’t need to do anything with their copy, that’s just for reference.
  3. Combination of 1 and 2 however you see fit and as appropriate to the level of risk associated with the study etc.
  4. Implied consent can be used if you are collecting questionnaire data – i.e., if they fill in and return completed consent forms then consent is implied. But if you are asking to extract data from medical records and GP records this might not be suitable.
  5. Email consent works in a similar way but is sometimes a bit more difficult to sort out logistically. There is a joint statement re: electronic consent from the HRA and MHRA at this link here: https://www.hra.nhs.uk/planning-and-improving-research/best-practice/informing-participants-and-seeking-consent/

Essentially, there are lots of ways of doing it and as long as the process is both robust, transparent and proportionate to the study, it is relatively easy to implement.

Please ensure that you submit any changes to consent due to COVID-19  as part of our non-notifiable amendment.

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