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 continue to be reviewed 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 government guidance, staff and students were in March asked to pause or postpone ongoing or planned non-essential University research involving face-to-face interactions with human participants (unless arrangements could be made for the research to be conducted remotely or online).

Research should still be conducted remotely wherever possible. The University is working towards a measured, phased, and safe resumption of research that cannot be conducted remotely, including research involving face-to-face interaction with other people. Further information about the University’s plans for returning to on-site working is available on the Return to on-site working webpage. This includes guidance for returning postgraduate students.

Research staff and students should also consult: 

  • the University's updates and guidance from their department (in particular from departments which are resuming on-site working)
  • the Safety Office’s guidance on the restarting of UK and international fieldwork, and specific requirements for appropriate risk assessment (in particular the management of risk specifically related to the COVID-19 situation)

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

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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Research should still be conducted remotely wherever possible. The University is working towards a measured, phased, and safe resumption of research that cannot be conducted remotely, including research involving face-to-face interaction with other people. Further information about the University’s plans for returning to on-site working is available on the Return to on-site working webpage. This includes guidance for returning postgraduate students.

Research staff and students should also consult: 

  • the University's updates and guidance from their department (in particular from departments which are resuming on-site working)
  • the Safety Office’s guidance on the restarting of UK and international fieldwork, and specific requirements for appropriate risk assessment (in particular the management of risk specifically related to the COVID-19 situation)

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. 

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

Research on hold

Where research continues to be paused for a number of months, there is no need to notify the research ethics committee. You should, however, inform any participants who enquire about participation that the research has been suspended.

Please also note the following requirement for research reviewed and approved by OxTREC, for studies where it was necessary to arrange additional territory-specific insurance. If it has been necessary to suspend such research, please notify the University’s Risk and Insurance team (via research.insurance@admin.ox.ac.uk). This will enable them to liaise with the insurer to facilitate, where possible, an extension or temporary suspension of the bespoke insurance.

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

Where possible, any research involving face-to-face interaction with others should now take place remotely. Refer to the guidance for researchers working remotely with participant data. The University’s preferred service for videoconferencing is Microsoft Teams  (see guidance on the use of Zoom). JISC Online Surveys, Microsoft Forms (Nexus 365 version) and Qualtrics are the University’s approved platforms for 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 ethics 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. Please note that review of certain applications, such as those related to genuinely urgent COVID-19 research, will be prioritised. 

Once reviewed and approved, ethics 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, ethics 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 are doing their best to conduct ethics reviews within the usual timeframes, some may be delayed, given that members of the team and the ethics committees are working from home and some have caring duties. 

 

We continue to expedite the review process of genuinely urgent COVID-19-related 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.  

Links to a number of funders’ COVID-19 ethics resources and guidance are available from the UKRI website

 

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.

Please note that the University recommends use of JISC Online Surveys, Microsoft Forms (Nexus 365 version) or Qualtrics, which are compliant with UK data protection laws – see the IT help website for more information. Oxford University staff and students can get a free JISC Online Surveys account by emailing help@it.ox.ac.uk

JISC surveys are automatically set up not to track IP addresses (this needs to be turned off in Qualtrics by the researchers), which guarantees better anonymity to participants.

 

Consider whether you need to make any changes to your recruitment strategy, how you approach potential participants or to your process for obtaining informed consent. How will you record the participants’ consent? Guidance and templates are available on our Informed consent page.

The procedures for obtaining the participants’ informed consent should be proportionate to the nature of participation and the risks involved. For example, audio-recorded verbal consent may be suitable if the project is deemed to be low risk. It is also important that consent should be documented in an auditable record and stored securely

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. Microsoft Teams is the University’s preferred platform for recording interactions with research participants. 

University guidance on platforms for conducting research remotely:

 

In line with government guidance, research should be conducted remotely or online wherever possible. The University is working towards a measured, phased, and safe resumption of research that cannot be conducted remotely, including research involving face-to-face interaction with other people. Further information about the University’s plans for returning to onsite working is available on the Return to on-site working webpage. Research staff and students should also consult the University's updates and follow guidance from their department. 

For advice on travelling for University business, including additional COVID-19 risk assessment requirements, see the Safety Office’s guidance

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. 

 

Risks to health, welfare and safety of the research participants, researchers and other people involved in research involving fieldwork must be addressed before the research is carried out. 

If it is impossible to conduct the research online or remotely (for example, the research requires face-to-face interaction with, or observation of, other people), a risk assessment will need to be conducted (including for research involving fieldwork within the UK). A risk assessment proforma should be available from your department or faculty. If not, please use the form available from the Safety Office's Overseas travel and fieldwork webpage or refer to the Safety Office's guidance or Risk assessment webpage for further guidance. Any risk assessment will need to specify how risks related to COVID-19 will be managed. A risk assessment will also be needed if local researchers are going to conduct research on behalf of University of Oxford researchers.

It is important also to consider these risks in terms of the following:

  • type of participant (for example child, adult, those considered vulnerable to COVID-19, elderly)
  • location of research (for example country, University-owned space, schools, public spaces)
  • type of contact required with participants (for example whether social distancing is possible or if close contact is required, such as for fitting equipment for brain imaging procedures, or being in a confined space with inadequate ventilation)

Applications for ethics review of research involving in-person contact with human participants must be accompanied by an authorised risk assessment (see the Safety Office's guidance) and endorsement from the head of the relevant department or faculty.

The ethics application should also include details of how any risks to the researchers, research participants or other people involved in the research will be addressed. 

The extent of any in-person contact and the measures taken by the research team to reduce the risk of transmission of COVID-19 must be explained to participants in advance in order to inform decisions about participating. 

Research in the UK must comply with government guidance

Researchers need to be aware that UK and overseas rules and guidance will be subject to change. Any in-person research approved by a University ethics committee may need to be amended or paused to comply with amended guidance. If this is the case, please follow the process outlined in question 2.

 

It is essential that any on-site research work is considered by each department in relation to its overall assessment of risk. The guidance below currently applies only to departments within the Medical Sciences Division and where the research cannot be conducted remotely. 

When considering resuming a paused study, commencing a study that was approved during the pandemic or starting a new study, researchers will be required to complete the following before approaching the Medical Sciences IDREC:

  1. Where University space is required, that the head of administration and finance (HAF) of the department has confirmed that the study may resume activity, with full consideration having been given to Safety, Estates, HR and IT support, and that the (re)opening of said study is consistent with the current return to on-site working status, including that the building is open.
  2. Refer to your departmental return to on-site working (RTOSW) risk assessments relating to specific buildings or research procedures, and to the COVID-19 specific risk assessments supplementary to the approved procedures for MRI, EEG, MEG and brain stimulation.
  3. Complete any training as stipulated in departmental SOPs revised for use during the COVID-19 pandemic and RTOSW risk assessments.
  4. A risk assessment form must be completed for every study, detailing how COVID-19-related risks will be managed for faxe-to-face research. This form must be signed by the head of department. The head of department may also ask the head of administration and finance to sign the form.
  5. In a situation where there is any doubt in relation to points 1 and 2, the relevant head of administration and finance should contact the divisional registrar.
  6. Download the supplementary information sheet for study participants, and amend to suit the research. If preferred, you may revise your existing study-specific participant information sheet to include COVID-19 related safety measures (bear in mind, however, that guidance changes would result in further participant information sheet changes). If this will be the only change to the study, an amendment form will not be required.
  7. Consider whether any additional amendments to the study procedures or documentation are required. If so, update all documents using the tracked changes function of Word, and complete an amendment form detailing what has changed.
  8. You should then submit the following to the Medical Sciences IDREC:
  • completed signed risk assessment form
  • copy of the supplementary information sheet, adjusted for the study
  • amendment form (if applicable)
  • revised CUREC form (if applicable)
  • revised study documents (if applicable)

 

Once these steps have been taken, CUREC will confirm continuing ethics approval on the understanding that any required methodological or document amendments have been identified by the researcher and submitted as an amendment for approval.

You will then need to obtain confirmation from the facility that you may (re)commence research activity. 

During the research it is advisable that both researchers and participants complete a symptom assessment form before every session. For research in the Oxford University Hospitals, please use 'COVID-19 screening form A: OUH staff member'. For all other research, download this form:

A summary of how this process should operate in departments within the Medical Sciences Division is available:

My research study has been approved by OxTREC but has either been paused or has not yet started due to COVID-19. I now wish to resume or start my study. What should I do?

In the first instance, you should contact your local unit or department for guidance and advice. If your local unit or department is satisfied that it is safe for the study to resume or start, you should then notify the OxTREC secretariat (oxtrec@admin.ox.ac.uk) of your intention to resume or start, including: 

  • setting out the current COVID-19 situation in the territory in which the study will be conducted
  • confirming that resuming or starting is in line with local government or ministry of health guidance 
  • explaining any risk mitigation steps that you will be taking (for example use of PPE, social distancing, hand hygiene, enhanced cleaning, training of staff)
  • providing confirmation that your local unit or department and the local ethics committee are satisfied that it is safe for the study to resume or start

If you have revised any of your study documents as a result of the COVID-19 situation, these should also be submitted to OxTREC (with changes showing as tracked) along with the notification of intention to resume or start the study.

Please also note that, if a bespoke territory-specific insurance policy was in place for the study, you should notify the University’s Risk and Insurance team (research.insurance@admin.ox.ac.uk) of your intention to resume or start.

I wish to submit a new study involving face-to-face research to OxTREC for ethical review. What should I do?

You should submit your study to OxTREC for review in exactly the same way as usual (see the OxTREC application process page for details).

However, please ensure that, as part of your application, you include details of the current COVID-19 situation in the territory in which the study will be conducted, as well as setting out any risk mitigation steps that you will be taking (for example use of PPE, social distancing, hand hygiene, enhanced cleaning, training of staff).

You should also ensure that the participant-facing documents for the study clearly address any risks arising from COVID-19 and clearly set out the measures that the research team will take to mitigate those risks.

If you have any additional questions or require any further guidance/ advice, please contact the OxTREC secretariat (oxtrec@admin.ox.ac.uk). 
 

 

A signature or email endorsement is needed from the PI, the student (if student research) and the head of department or nominee. In lieu of signatures, an email endorsement can be provided.  

  • The PI (and student, where applicable) should copy and paste the text from the ‘Declarations and signatures of researchers’ section of the CUREC 1, 2 or 3 form, or section E1 of the CUREC 1A form into an email
  • The head of department (or deputy) should copy and paste the text from the ‘Acceptance by head of department/faculty or designated nominee’ section of the CUREC 1, 2 or 3 form, or section E2 of the CUREC 1A form

For all emails, insert an electronic signature if possible, and email this from a University address to the mailbox for the relevant ethics committee. Please include the name of the PI and the title of the research project in the email header to help us identify which application the email endorsement relates to.
 

 

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