NHS RESTART Research Approval Process

The following approval process applies the general principles and GCU policies for Safe Return to Campus (SRTC) / Off-Campus working, adapted to enable resumption of research activity in NHS premises. The overarching process has been approved by the GCU Health, Safety & Wellbeing Committee (HSWC) and local approval for individual projects to resume within NHS premises will be managed within SHLS, applying the following process. (Note, this process does not apply to other research activity off-campus, outside of NHS premises, where full SRTC approvals through the HSWC will be required)

1. The local NHS R&D Department will contact the GCU Principal Investigator (PI) when the site is ready to consider resumption of research activity. This requires completion of a NHS RESTART Risk Assessment form, supplied by the R&D Dept., with a supporting statement from the GCU Sponsor confirming that the study has our approval to resume. In order to provide a Sponsor Statement, GCU must have oversight and approval of planned research activity.

2. The GCU PI is responsible for completion of the following GCU SRTC forms, all of which are available on the GCU SRTC website at https://www.connected.gcu.ac.uk/sites/SafeReturntoCampus

3. All GCU SRTC and NHS RESTART forms should be sent to Associate Dean Research (Prof Kay Currie) for review.  Feedback will be provided by ADR if more detail is deemed necessary.

  • A Health Questionnaire for the member of staff returning to NHS premises. Guidance for completion of the Health Questionnaire and one-to-one discussion with the line manager are on the GCU Share-point site
  • A project specific Infectious Disease Risk Assessment (IDRA) – this can be adapted from a generic Departmental IDRA that the Head of Department may already have approval for.
  • A project specific Standard Operating Procedure (SOP); again this can be adapted from a Departmental SOP.
  • A HSWC Cover Sheet, which should provide brief details, in lay language, of the type of activity that will be undertaken.

These forms should specify the type of contact with research participants and the mitigating actions to reduce risk of transmission of coronavirus.

The GCU PI should also complete the NHS RESTART form, specifying actions to mitigate transmission; what type of PPE will be used and supplied by whom; any infection prevention training that will be undertaken (provided by whom) to reduce risk of transmission.

4. Once the ADR has determined that the documentation has sufficient detail for consideration, she will pass all the forms to Vice-Dean (Prof Anita Simmers) for SHLS approval.

5. Vice-Dean will consider the request (acting on behalf of the SHLS) and review the documents provided.  She will ether request further information, if appropriate, or provide approval.  Such approval will be in the form of an email to the GCU PI, and ADR, copied to HSWC, Dean, and Head of Department for information.

6. ADR will forward confirmation of GCU sponsor approval and NHS RESTART form to the relevant NHS R&D Office.

7. The NHS R&D Office will arrange review of the RESTART form and confirm whether it agrees to the study resuming.

8. The GCU PI is also responsible for arranging SHLS and NHS Research Ethics Approval for revised arrangements, including any required changes to the Participant Information Sheet and Consent Form, prior to resuming the study. Guidance on Ethics requirements for COVID related amendments can be found on the SHLS Research web page at https://www.gcu.ac.uk/hls/research/ethics/ethicalapplicationformsandusefullinks/