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Brighton & Sussex Medical School

COVID-19 updates for applicants and researchers

BSMS > Research > Support and governance > Governance and ethics > COVID-19 updates for researchers

COVID-19 updates for researchers

COVID-19 updates for applicants and researchers.

COVID-19 updates for RGEC applicants

The BSMS Research Governance and Ethics Committee (RGEC) operates a schedule of monthly virtual Committee and Sub-Panel meetings at which it undertakes ethics review of BSMS staff and student proposals for non-clinical research. During the easing and cessation of lock-down measures in the UK, applicants should:

  • Continue to book new projects and substantial project amendments in for review at a scheduled RGEC meeting (rgec@bsms.ac.uk) and, in parallel, submit their application via Sussex Direct before the respective submission deadline. 
  • Be aware that COVID-19 related new studies, as well as amendments to add a COVID-19 component to an existing project, are eligible for fast-tracked ethics review. The PI should discuss the proposal with the RGEC management team before online submission. Contact the Research Integrity, Ethics, and Governance Administrator, Caroline Brooks, to arrange an initial discussion for your project.

Email Caroline Brooks >

  • Arrange an informal virtual discussion with the RGEC management team for any complex re-submissions, or new applications posing significant logistical concerns which they think would best be talked through.
  • Consider attending an online ethics drop-in and advice session, offered each Tuesday morning between 10am-12pm. Staff or students may have questions relating to the COVID-19 guidance and procedures, or simply want some guidance on submitting a new ethics application to the Research Governance and Ethics Committee (RGEC). If so, they can book a time to attend a virtual ethics ‘drop-in’ online with the RGEC management team on Tuesday mornings (between 10.00 – 12.00) by contacting Caroline Brooks on c.e.brooks@bsms.ac.uk
  • Consult the University of Sussex guidance on the use of video conference platforms in research conducted remotely. The document offers clear guidelines on video conferencing platforms that are compliant with data protection legislation to conduct online research interviews and focus groups.

Guidance on using video conferencing in research >

Face-to-face human participant research on campus

The University of Sussex has updated its guidance to allow face-to-face research with human participants undertaken by postgraduate taught or postgraduate research students or staff to be conducted on campus, provided that research activity:

  • Is considered suitable by the School;
  • Considers continued requirements for effective social distancing; 
  • Complies with the relevant government and University Covid-19 guidelines.

However, research conducted on campus by undergraduate students which would normally be conducted in-person should continue to be undertaken remotely. 

Please see the University’s Health & Safety COVID-19 resources > 

For in-person research conducted on campus, the Research Ethics and Governance Committee will require supporting evidence of compliance with COVID-19 measures outlined in the University’s Guidance for Researchers on Face to Face work with Human Participants and Guidance for Close Contact Work issued on the Health & Safety web pages >

Where researchers wish to adapt previously approved studies to in-person data collection, or to resume paused studies, the submission of a project amendment to RGEC will be required which includes protocols and supporting documents required in line with the University’s guidance. 

New Postgraduate Taught student projects involving face-to-face research on campus will be categorised as ‘high risk’ and require review via the Research Governance and Ethics Committee rather than a School Research Ethics Officer (SREO).   

Key points to note from the updated Guidance for Researchers on Face to Face work with Human Participants to be included in the ethics application are:  

  • Risk Assessment and Standard Operating Procedure detailing how specific guidelines on close contact work and all in-person activities will be adhered to for the research activity.
  • Researchers to: 
    • Have recently obtained a negative COVID-19 lateral flow device test.
    • Provide participants with detailed instruction on how to access the research area. 
    • Collect and store participant Track & Trace details.
  • Participants to: 
    • Be advised to download the NHS track and trace app whilst on campus.
    • Complete a Covid-19 health screening questionnaire. 
    • Provide contact details for Track & Trace. 
    • Have recently obtained a negative COVID-19 lateral flow device test.
    • Be instructed to complete a University ‘symptoms reporting form’ if they develop symptoms within 48 hrs of being on-site. 

The latest version of the guidance covers COVID-19 testing for participants and includes a link to book a test at the University’s Asymptomatic Testing Centre (ATC). The guidance also contains:  

  • Standard wording on Track & Trace for use in participant information sheets.
  • Track & Trace record sheet. 
  • Risk Assessment template.
  • COVID-19 screening document. 
  • Template letter to research participants about testing and booking a test at the ATC.

BSMS Doctoral students undertaking face-to-face data collection

BSMS Doctoral students will need to comply with guidance published by the University of Brighton in its 'Statement on face-to-face data collection for research'. 

A mandatory health & safety Risk Assessment is required to be submitted with the supporting study documents uploaded in Sussex Direct as a part of the application to the BSMS Research Governance and Ethics Committee (RGEC) for ethics approval for a new study, or for an Amendment to recommence fieldwork involving face-to-face data collection conducted in the UK or overseas. 

Currently, the Risk Assessment is designed to assure the ethics committee of measures to mitigate COVID-19 risks while the students are engaged in data collection in the field, and is also required where students are resident in the countries in which they plan to undertake fieldwork. 

The Risk Assessment requires sign-off by a supervisor or Head of School or nominee. 

A Word-based version of the form which students can use instead of accessing AssessNet to submit their risk assessment is available below.

Download Word version of the form here >

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Travel

Staff should consult the University of Sussex’s guidance on ‘Travel on University business and off-site working,’ available here >

This section contains key information relating to the restrictions for field work for staff and postgraduate taught students.

BSMS doctoral-level students should adhere to the University of Brighton’s ‘Research-related travel’ guidance, available here >

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Sponsored research

Studies that are undertaken involving some aspect of NHS collaboration and have been subject to HRA/NHS REC approval and have the University of Sussex as the formal research ‘Sponsor’.

  • The University is conscious of the complexity of its portfolio of clinical research activity and is also mindful that as the COVID-19 outbreak evolves there will be unprecedented calls on the NHS and its resources. It is therefore vital that decisions on on-going research should be made in close consultation with sites and research funders.
  • For new studies relating to COVID-19, the University will continue to follow the guidance of the Health Research Authority (HRA), notably how such work, if supported through standard University authorisations, it can be expedited from a research governance perspective.
  • The Sponsorship Sub-Committee (SSC), that oversees the University’s Sponsor responsibilities is, in principle, open to a ‘proportionate and pragmatic’ recommencement of research.  For full information on this please read the letter to Chief Investigators sent on 12 June 2020. Cases for restart will be considered at scheduled meetings of the SSC. New applications and requests for restart should be accompanied by a completed copy of the University's Restart Framework form.
  • Following the recent publication of the NIHR’s Restart Framework[1], the SSC has agreed that this be used as the basis for paused studies to make the case for recommencement to the Sponsor.

[1] nihr.ac.uk/documents/restart-framework

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