UBC Behavioural guidance during the COVID-19 Research Restrictions

The University has curtailed on-campus research activity and creative scholarship on its Vancouver and the Okanagan campuses. In addition, no research that involves in-person contact in any location can occur until the University restrictions are lifted. Research activities that are off-campus AND involve no in-person contact may proceed once BREB approval has been given.

Exceptions to the above will be considered for research related to COVID-19 OR if stopping or delaying the research would pose a risk to participants. Exemption information can be found on the VPRI website for campus based and in-person field research, but also see the section below about applying for an exemption.

Please visit this webpage regularly for updates.

BREB Operations During COVID-19

Behavioural research ethics applications can be submitted as normal to the Behavioural Research Ethics Boards (Point Grey and Okanagan) through RISe. Staff are available for consultations and can be reached by emailing them at the addresses shown on our contact pages | Vancouver Campus and Okanagan Campus

UBC REBs are reviewing a high volume of new research related to COVID-19. In addition, many researchers are adding COVID-related questions to their approved research. UBC’s Behavioural Research Ethics Boards recognize the importance of collecting data during this pandemic. At the same time, concerns have been raised about the proliferation of COVID-related research projects, the additional burden this may place on some participant populations, and the potential increased risks caused by these projects. This is especially true in the case of people who have pre-existing physical and mental health vulnerabilities.

With this in mind, the BREB is temporarily altering its submission requirements and procedures. Please review the remainder of this page carefully before submitting your ethics application or amendment and follow the steps that relate to your research.
 

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Can previously approved research proceed?

Research that has received ethics approval before the COVID restrictions were implemented can proceed as long as it does not involve in-person contact AND research staff are able to work remotely AND use of on-campus facilities is not required. If you need to alter your methods to replace in-person contact, please review the sections below for additional instructions before you submit your amendment.

Can I access research funds before my ethics application has been approved?

If you are delayed in getting ethics approval due to the COVID-19 restrictions and need access to grant funding, a request for early release of funds before ethics approval will be considered. 

How do I submit an amendment that includes COVID-related research questions?
  1. Consider
    • how the additional questions support your original research goals
    • what additional risks will be incurred by participants
    • what supports are in place to mitigate the added risks for participants
  2. Modify as needed all supporting documents (see Research Documentation Requirements for details)
  3. Complete the COVID Form​.
  4. Open an amendment in RISe.  Name your amendment "COVID-19 Research." Modify your ethics application with the revised information and attach the COVID Form to Box 9.7.

Research involving COVID-related topics cannot proceed until all provisos have been addressed and a certificate of approval has been issued.

Can I change my participation methods in response to the COVID restrictions without prior BREB approval?

If a change in participation interaction is necessary to eliminate an immediate risk to participants and comply with COVID-19 restrictions AND you will not have time to submit an amendment before interacting with participants (see TCPS 2 Article 6.15), you may implement the changes without prior REB approval. This applies only to changes made to move approved methods to an online environment, e.g. in-person interview changed to phone or online platform interview. In these circumstances only, you will be granted a grace period of up to 10 business days to submit the amendment. You may not delay submitting an amendment if you are changing the content or focus of your research.

If you submit an amendment to remove (temporarily) all in-person contact:

  1. Open an amendment and briefly explain the change and list the new/modified supporting documents (consent form, letter of invitation, etc.) in the PAA Coversheet.
    Name your amendment “COVID-19 related protocol changes.”
  2. Review the ethics application and add details where needed, including changes to recruitment (Box 5.4), procedures (Box 5.4), consent (Box 6.6), data storage and confidentiality (page 8).
  3. At the bottom of each box, include a sub-heading and describe the changes. (Do not overwrite existing approved content.)
    E.g. Box 5.6. “COVID-19 amendment | In-person interviews will be replaced with online interviews using Zoom (UBC account). Audio only will be recorded and transcribed by the PI.” See BREB Zoom Guidance
  4. Ensure that the supporting documents (letters of introduction consent forms, etc.) are revised to reflect the change in participant interaction and uploaded to page 9.
What are the BREB requirements for *NEW* research related to COVID-19?

If your new behavioural research proposal involves the study of COVID-19 or its effects, please make this clear by including “COVID-19 Research” in the nickname (Box 1.8). These applications will receive priority consideration.

  • If your COVID-19-related study requires in-person contact, it will be subject to a full (above minimal risk) review. An ad-hoc committee will be convened to ensure timely review.
  • If your COVID-19-related study can be conducted entirely online, an expedited review and approval will be completed, after which research can proceed.

In either case, the COVID Form will need to be completed and attached to Box 9.7 before the study will be reviewed.

What does the BREB need if I am applying for an exemption to the restriction on in-person research?

If you intend to apply for an exemption in order to conduct in-person research, you will also – at minimum –need to amend your supporting documentation before ethics approval can be granted. The ethics application amendment can be submitted in parallel with the exemption approval process and should consider:

  • Are the risks of conducting in person research during the COVID pandemic reflected in your ethics application?
  • What safety measures will be put in place to protect participants during the COVID-restriction period?
  • How will you inform invitees of the exemption status of your research?

Ensure your intention to seek an exemption is clearly stated in your PAA or initial ethics application. Conditional approval will be granted until the signed Exemption Form for on campus research or evidence of Departmental, Dean and VPRI approval for field research (community based or in- person data collection) is uploaded to the ethics application (in Box 9.7).

See the VPRI Website for more information.

Tips for completing the VPRI Exemption Form for on-campus research

You may want to include the following in the section “Compliance certificate on file”:

If ethics approval was received prior to COVID restrictions

  • Human | Detail “Amendment will be submitted with approved exemption form”

If you will apply for the exemption after conditional approval from the BREB is received

  • Other | Detail: “conditional approval received; pending this approval”
What research documentation is required for COVID-related research?

The following applies both to new studies and amendments to previously approved ethics applications. In order to mitigate risks associated with the inclusion of COVID-related topics, please follow this guidance.

Recruitment materials (including ads, posters, letters of invitation, information sheets)

  • Clearly state that the research involves discussion/consideration of topics related to the COVID-19 pandemic. If questions about the pandemic are not optional, make this clear in recruitment materials so invitees can opt out.

Consent forms/scripts

  • Clearly disclose that the researcher will be asking COVID-related questions and provide the research justification in lay terms for including the topic.
  • Provide examples of COVID-related questions you will be asking. 
  • Indicate whether COVID-related questions can be skipped. If answering the COVID-related questions is a condition of eligibility, (i.e. if not answering would disqualify a participant), make this clear so invitees don't waste their time.
  • If COVID-related questions are being added to a study in progress, all participants still active in the study will need to be reconsented. This could be done either through a supplementary script or email explaining the nature of the additions and options available to them (i.e. withdraw from further participation without penalty, skip the COVID-related questions, proceed to answer all questions). Attach the consent renewal materials to Box 9.2.

Questionnaires/surveys

  • Provide a warning at the point where COVID-related questions begin, e.g. “The next 5 questions are asking about your experience with the COVID-19 pandemic. You can skip these questions if you prefer not to answer them. “
  • Ensure that the survey tool allows participants to skip questions, either by providing a “prefer not to answer” response or by allowing users to bypass the question set. E.g. “I would like to skip this section.” The BREB prefers that both options are provided, since some people may not even want to read the questions or may change their mind partway through.

Interview Script

  • During the interview introductions, explain how you will handle the COVID-19 related questions and what options are available to participants.
  • If answering questions about COVID are essential to participating in the research, we recommend that you seek verbal confirmation from the participant at the beginning of the interview to ensure that they understand, but also remind them that they can decide at any point to discontinue the interview. E.g. “I am asking for your agreement to answer questions about the COVID-19 pandemic during this interview. But even if you say “yes” now, you can still change your mind later.”
  • If the questions are optional, explain how participants can signal to you that they do not want to answer COVID-related questions.

Focus-group Script

Because individual participants will have less control over a focus group discussion than in a one-on-one interview scenario, special care should be taken. Before the discussion begins:

  • Remind participants that COVID-19 will be discussed.
  • Include a warning that participants may find the topic upsetting and they should feel free to leave at any time. 
  • Advise participants that information disclosed in the session should not be shared outside the group, but remind participants that the researcher cannot guarantee confidentiality.

List of Support Services & Resources

  • Attach a list of resources to your application and ensure the services are continuing to function during the pandemic restrictions.
  • Provide the list of resources to participants at the outset of their engagement.  
Can I apply for or amend my Course-Based Research Project ethics application? 

Course-based research projects that are ongoing and are exclusively using online methods can continue.

Course-based research projects that involve in-person contact will need to be amended before the projects can begin. Please update the ethics application sections where appropriate, and attach the modified supporting templates/documents (consent forms and introductory emails), to reflect that no in-person methods will be used.

Registries of COVID-19-related Research in BC

In order to have an accurate listing of COVID-19 related research in BC, UBC has joined with other research institutions and agencies in compiling these studies in a publicly available registry. The collaborators include BC Academic Health Sciences Network (including Clinical Trials BC and Research Ethics BC), the Ministry of Health, Michael Smith Foundation for Health Research, and the BC Centre for Disease Control. In support of this initiative, the BREB will be providing information about your study for publication in the inventory, including: Principal Investigator, study title and description.

For more information please go to: https://bcahsn.ca/covid-19-response/inventory/

A separate registry of COVID-related studies is also being compiled by UBC and is meant to assist researchers in connecting with other researchers working in similar areas. To see the Registry, please go to https://COVID19.research.ubc.ca/research-projects for details.  

If you have any objections to your research information being listed, please let us know during the ethics application review process. The BREB encourages researchers to review both registries for potential collaborations.

Using ZOOM for data collection in research

UBC faculty and staff have access to Zoom via UBC IT. For best practices on using Zoom in research, please go to the new BREB Zoom guidance.