An update regarding the COVID-19 pandemic relating to research projects involving face-to-face participant interaction granted ethical approval from College Research Ethics Committee (CREC) or University Research Ethics Committee (UREC).
Last updated: 24 March 2020
The University is guided by the fundamental principle that research involving humans and/or animals, and/or the environment should involve no more than minimal risk of harm to physical or psychological wellbeing. Therefore, in light of the current COVID-19 pandemic the University Research Ethics Committee requires all researchers to make changes to ongoing research involving participant interactions and how these are conducted. All face-to-face research interactions, eg participant interviews must be ceased with immediate effect.
Researchers must consider if they can adapt their research to conduct participant interactions remotely. If this isn’t possible the research must be paused. Either change must be made by Friday 27 March 2020.
UREC has temporarily suspended the requirement for approval of amendments that relate only to changes to participant interactions from face-to-face to remote, unless there is a substantial change to the protocol* as a result of the change. Please note that such changes would normally require an amendment to protocol to be submitted for ethical review and will do so again when this situation has passed.
Students – please discuss whether it would be appropriate to change to remote interaction with your supervisor as soon as possible. Once the appropriate way forward has been agreed, please follow the guidance below to adapt your research.
*A substantial change to protocol might be a change that would alter the level of risk to the participant or researcher or others involved in the research eg if you are working with vulnerable participants, to do so remotely might remove the safeguard of the researcher being able to detect distress face-to-face and mitigate risk by referring to an appropriately trained person.
Guidance for those who need to pause their research
You must inform your participants that the research has been paused. It will be key that in whatever communication you send to participants that you describe how any actively enrolled participants will be managed, particularly concerning any safety monitoring/follow-up etc. where applicable.
Unless the changes made to pause the study result in a substantial change to protocol*, the pausing of a research study and issue of an update to participants will not need to be considered as an amendment. However, please note that once you can recommence your research you will need to notify UREC or CREC if there will be a change in the end date of your research project as specified in your original ethics application. If your research period as specified in your application has ended by the time you recommence your research, an extension in the form of an amendment will need to be submitted to UREC or CREC as appropriate.
Guidance for those who will conduct their research remotely
A. I have not yet begun data collection but have University or College Research Ethics approval to do so. I will amend my recruitment plan to recruit and interact remotely.
Unless the changes made to the way in which you interact with participants results in a substantial change to protocol*, you will not need to submit an amendment to protocol request. Simply update your recruitment documents to outline how you will remotely interact and then proceed.
B. I have already begun data collection and will now change to remote participant interaction.
Unless the changes made to the way in which you interact with participants results in a substantial change to protocol*, you will not need to submit an amendment to protocol request. Simply update your recruitment documents to outline how you will remotely interact with participants and use this version moving forward. Any already active participants must be informed of the change to remote interaction and be provided with the updated participant information sheet. It is important that you make clear to participants that if they no longer wish to participate owing to this change, or for any other reason, that they are free to withdraw at any point.
New applications for Research Ethics Review (to UREC/CREC)
Researchers may continue to submit applications 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 which requires any face-to-face interactions with participants in person until further notice. The following options are possible/appropriate:
- Obtain ethical approval for a project involving face-to-face interactions with participants in person
- If you wish to commence data collection immediately you must amend these interactions to be conducted remotely as outlined above
- If it is not possible to conduct your participant interactions remotely then you must then wait until you are advised by the UREC 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 recommended 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
Research involving research fieldtrips
You should not conduct any research fieldwork until further notice. All colleague and student travel outside the UK for University-related reasons including research is suspended until further notice. Colleagues and students are also expected to avoid University-related UK travel where possible and to work or study from home.
Risk Assessments and Insurance
Researchers should adapt their Risk Assessments as these can be dynamic risk assessments which undergo continuous review to identify hazards; any measures regarding remote participant interaction should be updated on a Risk Assessment and advice from Safety Health and Wellbeing Team (SHW Team) sought if necessary ([email protected]). Updates to Risk Assessments relating to changes from face-to-face participant interaction to remote participant interaction do not need to be submitted to UREC/CREC as an amendment unless the update introduces a potential substantial change to protocol*.
Procurement can be contacted for any questions regarding Insurance via [email protected].
All researchers should consult the University’s Coronavirus Response page regularly for further updates.
Doctoral researchers should discuss the above with their Director of Studies, all other students should discuss with their Supervisor.
All researchers are also advised to consult the University’s Code of Practice Governing the Ethical Conduct of Research (PDF).
Researchers and their Supervisors must consider research ethics, academic quality, data protection and other legal matters: a change of mode of data collection may give rise to ethical and legal issues as well as compromising quality and standards. Therefore, these must be carefully considered. See guidance from Seriss.EU (PDF) for an indication of some issues that may arise using social media.
Health Research Authority (HRA) have published their own guidance, researchers working under the HRA approvals must check this page regularly for updates and are responsible for following the requirements.
Researchers working under the Medicines and Healthcare products Regulatory Agency (MHRA) should refer to the MHRA website which has published information, including ‘Managing clinical trials during Coronavirus (COVID-19)’.
Queries: contact UREC via email at [email protected].