COVID-19: CUREC guidance on research involving human participants

The health, welfare and safety of students and staff is the number one priority for the University. We also have a duty to protect members of the public who participate in our research, and research partners and collaborators outside the University. In view of the extraordinary situation caused by the COVID-19 pandemic, all research involving human participants should be reviewed immediately by staff and students, by their supervisors and principal investigators as appropriate and, where necessary, by the relevant head of department.

In order to comply with the latest government guidance, staff and students are now required to pause or postpone ongoing or planned non-essential University research involving face-to-face interactions with human participants (unless arrangements can be made for the research to be conducted remotely or online).

The only exceptions to this should be for:

  • research that is itself related to COVID-19 (where there are public health grounds for the research to commence or continue)
  • clinical research that is vital for patient care or safety

Separate guidance around clinical research is available on the COVID-19 funding and project management guidance page.

Given that this is a rapidly-evolving situation, research staff and students should also consult the University's updates.

FAQs for research reviewed and approved by CUREC

Research reviewed by the Medical Sciences Interdivisional Research Ethics Committee (MS IDREC), the Social Sciences and Humanities Interdivisional Research Ethics Committee (SSH IDREC), the Oxford Tropical Research Ethics Committee (OxTREC) and departmental research ethics committees (DRECs)

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In order to comply with the latest government guidance, research staff and research students are now required to pause or postpone ongoing or planned non-essential University research involving face-to-face interactions with human participants (unless arrangements can be made for the research to be conducted remotely or online).

The only exceptions to this should be for: 

  • research that is itself related to COVID-19 (where there are public health grounds for the research to commence or continue)
  • clinical research that is vital for patient care or safety

Separate guidance around clinical research is available on the COVID-19 funding and project management guidance page.

Putting the research on hold

Where research will simply be paused for a number of months, there is no need to notify the research ethics committee at this point. You should, however, inform participants that the research has been suspended.

For CUREC 1, CUREC 1A or OxTREC minimal risk applications – if you are going to change your research to conduct this online or remotely

For research that was being conducted face-to-face (such as studies involving interviews only), this may be continued by switching to speaking to participants on the phone or via other platforms, such as Zoom video conferencing or Microsoft Teams, rather than face-to-face.  It may also be possible for research to be continued by switching from face-to-face participation to using online survey platforms such as JISC Online Surveys.

If this is possible for your research, you should notify the relevant ethics committee that originally reviewed and approved the study.  Submit any revised documents to the ethics committee via email indicating the changes made.  Completion of an amendment form will not be required.  Please update any information that will be provided to existing participants to explain how the amended remote or online interaction will proceed. It is important that you make clear to existing participants that if they no longer wish to take part owing to this change, or for any other reason, they are free to withdraw at any point. The ethics committee will acknowledge receipt of the changes being made. The requirement for formal approval of such changes is, for now, suspended.

If you are amending your research to use online surveys, please read the CUREC Best practice guidance for internet-based research (BPG06). You should adapt the template information sheet/consent record in the appendix of BPG06 (also available on the Informed consent page) to prepare a survey introduction to provide participants with the information they need to make an informed decision about participating, and consent to this, rather than having separate information sheets and consent forms.

For research that will be conducted remotely (for example by phone or teleconferencing), further guidance and templates are available on the Informed consent page

Extension of study end-date

CUREC 1 or CUREC 1A applications

If an amendment to a previously-approved CUREC 1 or CUREC 1A application is solely to extend the end-date of the ethics approval, researchers should notify the relevant ethics committee that originally reviewed and approved the study via email, indicating the original end date of ethics approval and the proposed new end date. Completion of an amendment form will not be required. The ethics committee will acknowledge receipt of the changes being made. The requirement for formal approval is, for now, suspended.

OxTREC applications 

If an amendment to a previously approved OxTREC application (minimal risk or full committee) is solely to extend the end-date of the ethics approval, researchers should notify OxTREC via email, indicating the original end date of ethics approval and the proposed new end date. OxTREC will acknowledge receipt of the changes being made. The requirement for formal approval is, for now, suspended.

Researchers may also notify OxTREC of the extension of an end-date in the usual way via the annual report, if submission of the annual report is imminent.

Other amendments

Including for all CUREC 2 or CUREC 3 studies

If changes to the research design and methodology related to a CUREC 1 or CUREC 1A application are required, other than the above, or any change to a previously-approved CUREC 2 or CUREC 3 application is required, a project amendment will need to be submitted in the usual way to the relevant committee for review and approval.

OxTREC studies

All other changes to OxTREC studies (both minimal risk and full committee) should be submitted as amendments for review and approval in the usual way.

 

Researchers may continue to submit applications for University ethical review to CUREC (via the MS IDREC, SSH IDREC (and its DRECs), or OxTREC) and reviews will continue to be conducted. Note that for OxTREC, full committee studies will continue to be reviewed on the advertised committee meeting dates and the submission deadlines indicated should therefore be adhered to.

However, researchers will not be permitted to begin primary data collection for non-essential research which requires any face-to-face interactions with participants until further notice. Please note that review of certain applications, such as those related to COVID-19, will be prioritised.  

Once reviewed and approved, ethical approval will be granted for a minimum period of 18 months (and up to five years on request) to allow for delays to research caused by the COVID-19 pandemic. For OxTREC studies, ethical approval will continue to be granted for five years, as per OxTREC’s usual practice.

If your proposed research will involve face-to-face interactions with human participants, you will need to notify the research ethics committee that granted approval during the COVID-19 pandemic before undertaking any recruitment for face-to-face interaction with participants, once face-to-face research is permissible again.

Whilst all committees will do their best to conduct ethics reviews within the usual timeframes, these may be delayed, given that people are working from home and with caring duties. 
 

 

We will do our best to expedite the review process of COVID-19 applications where possible. Please contact the relevant research ethics manager (for applications to the Medical Sciences IDREC, Social Sciences and Humanities IDREC, or OxTREC) or your departmental research ethics administrator (for applications reviewed by DRECs) for advice.  

 

Please note that the University recommends use of JISC Online Surveys, which is known to be fully compliant with UK data protection laws – see the IT help website for more information. Oxford University staff and students can get a free account by emailing help@it.ox.ac.uk
Survey authors in JISC can’t track IP addresses, which guarantees better anonymity to participants.

For research involving online surveys please read the CUREC Best practice guidance for internet-based research (BPG06). You should adapt the template information sheet/consent record in Appendix of BPG06 to prepare a survey introduction to provide participants with the information they need to make an informed decision about participating, and consent to this, rather than having separate information sheets and consent forms.
 

 

Consider whether you need to make any changes to your recruitment strategy: do you need to change how you approach potential participants, for example? 

Do you need to make any changes to your process for obtaining informed consent? How will you record the participants’ consent? Guidance and templates are available on our Informed consent page.

Are there any risks associated with where the participants are located for the interviews? For example, are they in a safe place or could they be overheard? Who could be captured in the background if video is required?

Consider any additional communication challenges. It might be harder to tell if a participant needs a break or is upset when conducting interviews remotely. 

If you will be making audio or video recordings or capturing images, familiarise yourself with the University’s research data management guidance and policies.

 

Students will not be able to undertake fieldwork involving face-to-face interaction with participants that may have been planned for Trinity term. The same may apply to some other types of project, such as those that require access to materials that are only available in hard-copy archives. We recognise that some students may already have started a project that cannot now be completed, and that the scope will need to be dramatically altered. 

If this change affects you, you should consult the course director in your department or faculty to agree an alternative project that can be completed from your desk (such as literature reviews, data analysis, conducting interviews by telephone or via teleconferencing, using online surveys or computer modelling). We understand how disappointing this will be for many students, and would like to reassure you that academic staff are committed to giving you the best experience they can in the current circumstances. 

If you have any questions about the above, please contact your college or department/faculty in the first instance, and we will keep you updated as soon as more information becomes available. 

For further advice about overseas travel and fieldwork, please see the University Safety Office’s guidance

 

Researchers are welcome to contact a member of the Research Ethics and Integrity team for advice. All team members are now working from home but still available via the usual telephone numbers and email addresses. 

 
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