Background

The emergence of the COVID pandemic in early 2020 has led to the suspension of many research projects. Projects which are currently under Sponsorship and require access to laboratories, NHS facilities and/or face to face contact were paused due to lockdown and pressures in the national health system. As we work to support the opening of our laboratories, and NHS sites resume their routine work there is an opportunity to restart paused projects, start delayed ones and consider what new studies can be approved.

This guide is designed to support researchers (staff or students) who are:

restarting projects currently under Sponsorship which have been paused due to the pandemic
starting projects already under Sponsorship which were not able to be started due to the pandemic
applying for Sponsorship of new projects which will start during the pandemic

Process

The Vice-Chancellor’s Office, through the Research Governance Coordinators with the HoDs and Deans will support the (re)starting of research as soon as it is appropriate to do so. The Sponsor is required to approve any restart of projects currently under their Sponsorship.

It is proposed that this process is considered separately from laboratory restart for those projects that do not require access to campus. For those that do, confirmation that laboratory/facility readiness exercise has been completed will be required.

The (Re)Start process is a temporary measure due to the pandemic. It does not replace the Sponsorship process and needs to be seen as an additional step to ensure the safety of our researchers, the people they interact with and the integrity of the research being carried out. For more information on the Sponsorship process please see this webpage.

Researchers restarting a project

All Researchers (staff or students) wanting to restart a paused study or a study with a delayed start date should:

Complete the Health Screening Test to obtain access to campus
Work with their supervisors/Line Manager and Laboratory Managers to revise their Health and Safety Risk Assessments and identify amendments if appropriate in light of the COVID pandemic. The University adopted template should be completed taking into consideration guidance from the Physiological Society and HM Government. Obtain, from their HoD and Dean, confirmation that the risk assessment is approved, that the project is safe to restart in the current pandemic and that the member of staff has been cleared through the health screening. For studies where access to campus is needed to carry out laboratory work and/or access facilities confirm that the laboratory/facility has been cleared for opening. For projects that involve access to NHS sites or facilities please contact the relevant R&D office first and include any relevant communication about re-opening of their facilities.
Complete the Study Restart and Readiness Forms
Send the following completed documents to the Faculty Research Governance Facilitators:

a. Restart Risk Assessment

b. Readiness form– include any relevant communication from the appropriate NHS Trust R&D office indicating that they are considering re-opening studies

c. Study restart form

d. Amendment form obtained from IRAS (where applicable)

Researchers applying for Sponsorship for the first time

In addition to completing the standard Sponsorship process, all Researchers (staff or students) wanting to apply for Sponsorship for a new project must:

Complete the Health Screening Test to obtain access to campus
Work with their supervisors/Line Manager and Laboratory Managers to revise their Health and Safety Risk Assessments and identify amendments if appropriate in light of the COVID pandemic. The University adopted template should be completed taking into consideration guidance from the Physiological Society and HM Government. Obtain, from their HoD and Dean, confirmation that the risk assessment is approved, that the project is safe to be carried out in the current pandemic and that the member of staff has been cleared through the health screening. For studies where access to campus is needed to carry out laboratory work and/or access facilities confirm that the laboratory/facility has been cleared for opening. For projects that involve access to NHS sites or facilities obtain confirmation from the relevant R&D office that they would be happy to consider capacity and capability once Sponsor has confirmed Sponsorship.
Complete the Readiness Form
Send the following completed documents to the Faculty Research Governance Facilitators:

a. Risk Assessment to take into account public health measures in place due to the pandemic. Please see this website for a template which you can adopt.

b. Readiness form– include letter/communication from the relevant NHS Trust R&D office if applicable

Deans and HoDs Roles

Depending on which Faculty you are in your Dean or HoD will need to confirm:

that the study is still viable (for paused/delayed start projects)
that the safety of staff and participants has been considered
that theres access to campus is been managed in a COVID safe manner (acccess to NHS staff, patients or premisses needs to be confirmed by the relevant NHS Trust R&D office)
that this project has been prioritised to (re)start.

Faculty Research Governance Coordinators

The Faculty Research Governance Facilitators will:

Check that all paperwork is present, completed and signed off by appropriate members of staff
Forward all paperwork to the Vice-Chancellor’s Office nhs-sponsorship@bath.ac.uk

Vice-Chancellor’s Office

The Vice-Chancellor’s Office will:

confirm the paperwork against internal records
appoint a member of the Sponsorship Risk Assessment Panel to consider the paperwork
collect a recommendation from the Sponsorship Risk Assessment Panel
give feedback to researcher upon recommendation from the Sponsorship Risk Assessment Panel
liaise with the Sponsor to generate letters where applicable

Sponsorship Risk Assessment Panel

The Sponsorship Risk Assessment Panel will:

Consider all paperwork and restart request
Issue recommendation to (re)start and where applicable confirm that amendment is ready for submission via IRAS
Give feedback to researcher, via VCO, to address any issues should this Panel be unable to approve the request/amendment

The Sponsor is the signatory of the (re)start letters upon receiving a favourable recommendation from the Sponsorship Risk Assessment Panel.