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COVID-19 guidance for research ethics

Given the unprecedented nature of the situation arising as a result of the COVID-19 pandemic, the University requires all research including face-to-face participant interaction to make changes to how those interactions are conducted.

This guidance relates to research projects involving face-to-face participant interaction granted ethical clearance by the General University Ethics Panel (GUEP) or the NHS, Invasive of Clinical Research (NICR) Panel.

Researchers must consider how their research could be adapted to conduct participant interactions remotely. If this is not possible then research must be put on hold.

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 there the change does not constitute a substantial[1] 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.

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.

[1] 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.

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.

New applications for ethics clearance

Researchers may continue to submit applications for ethical approval and reviews will continue to be conducted. However, as will be made clear on your outcome letter you are not permitted to begin data collection that requires any face-to-face interactions with participants until further notice. The following options are possible/appropriate

    • Obtain ethical clearance for a project involving face-to-face interactions with participants in person
      1. Immediately amend these interactions to be conducted remotely as outlined above.
      2. If it is not possible to conduct your participant interactions remotely then you must wait until you are advised by the University that face-to-face interactions can recommence before you begin any data collection in person.
    • If you are a student with time constraints around conducting your research and cannot conduct remote participant interactions, it is advised that you change your research to involve secondary data analysis only (i.e. data which has already been collected) so that no primary data collection is required.

New studies relating to COVID-19

An expedited review process will be considered for any new research studies relating to COVID-19, where there are proven public health grounds to commence. In order for such a study to gain approval to proceed with face-to-face participant interactions and for the ethical review to be expedited the Principal Investigator must provide the following information:

    • What are the public health grounds for the study to be conducted?
    • What is the rationale for the study to be conducted at this time? Why can it not be conducted at a later time?
    • Evidence of a risk assessment, considering the potential risk to the researcher themselves, signed off by the Division or Faculty.

Researchers should send the answers to these questions to GUEP (guep@stir.ac.uk) or NICR (nicr@stir.ac.uk) for consideration. Please make it clear in the email subject line that this is a new study relating to COVID-19.

Contact us

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

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