COVID-19 guidance for research ethics

As lockdown continues to be eased, it will become possible to resume some research activities that were suspended due to lockdown.

It is important to recognise that a significant degree of uncertainty remains and that as well as moving forward through lockdown phases, there may be regression to previous stages either regionally or across the country.

Where it is possible to conduct research remotely, this should continue at least as long as there are restrictions in place. GUEP and NICR have temporarily suspended the requirement for approval of amendments that relate only to changes to participant interactions from face-to-face to remote, this applies only in cases where the change does not constitute a substantial change to the project as a result. Such changes, from face-to-face to remote, would normally require a Panel amendment to be approved and will again once this situation has passed. A substantial change to a research project might be a change that alters the potential risk of harm to participants. E.g. if your research discusses traumatic issues it may be difficult to detect distress in the participants via a remote method and the ability to refer the participants to an appropriately trained person.

Students – if you are unsure if it will be appropriate to change to remote interaction please discuss this with your supervisor as soon as possible. Once the appropriate way forward has been agreed, please follow the guidance below to adapt your research.

Research involving overseas collaborators

Overseas collaborators may continue with their research only with their own institution’s explicit consent. In all cases, staff of the University of Stirling must ensure no pressure is put on collaborators to continue research at this time.

Guidance for those that need to pause their research

If your research is being placed on hold you must, where possible, inform your participants. Especially with actively enrolled participants regarding how they will be managed, safety monitoring and follow ups.

Unless the changes made to put the study on hold constitutes a substantial change to the research project then halting the research and the issuing of an update to participants will not need to be considered as an amendment.

Guidance for those who will conduct their research remotely

I have ethical clearance but have not yet begun data collection. I will amend my recruitment plan to recruit and interact remotely.

Unless the changes to the way you interact with participants constitutes a substantial change to the project, you will not need to submit an amendment request. Simply update your recruitment documents to detail how you will remotely interact and then proceed.

I have started data collection and will now change to remote participant interaction.

Unless the changes to the way you interact with participants constitutes a substantial change to the project, you will not need to submit an amendment request. Update your recruitment documents to detail how you will interact and use this version going forward. Any already active participants must be informed of the change and be provided with a copy of the updated participant information sheet. It is important that you make it clear to participants that if they no longer wish to participate owing to this change, or for any other reason, they are free to withdraw.

I have ethical clearance but have not yet begun data collection. I plan to commence my research activity now that lockdown is easing.

All studies must follow the University’s restarting research framework. Researchers wishing to recommence face-to-face research must inform the relevant ethics panel and include detailed consideration of the ethical implications of restarting in-person research.

New applications for ethics clearance

Researchers may continue to submit applications for ethical approval and reviews will continue to be conducted. All studies must follow the University’s restarting research framework.

New studies relating to COVID-19

An expedited review process will be considered for externally funded research studies relating to COVID-19. Expedited review can be sought in the following way:

  • Complete the full ethics review form, ensuring that all questions are answered and all supporting documents are attached to the application (i.e. participant information sheets, consent forms and recruitment materials).
  • Email the completed form to the relevant research ethics panel (GUEP guep@stir.ac.uk or NICR nicr@stir.ac.uk) and provide justification as to why your project requires urgent ethical review. Justifications should include the public health grounds for the study to be conducted and the rationale for conducting the study at this time.
  • The subject header of your email must include: COVID-19 Expedited Review
  • Your request will be reviewed by a member of the research ethics team and a decision in relation to whether the project is eligible for urgent review will be confirmed via email within 24 working hours.
  • If approved your application will be reviewed by experienced members of the ethics Panels within 72 working hours and a decision issued.
  • If your request for expedited review is denied your application will be allocated to the next Panel meeting for consideration.

 

Contact us

Please contact Rachel Beaton, University of Stirling Research Integrity and Governance Manager.