COVID-19 Guidance for Researchers: Human Ethics
This page contains information about research operations during the University of Calgary's COVID-19 response.
Last updated: September 15, 2020
Human Ethics Guidance from CFREB and CHREB during COVID-19
The CFREB and CHREB advise investigators to modify their research protocols where possible to minimize personal contacts, including lab visits or trips into clinics and hospitals. Where in-person participant interactions can be reduced or replaced with telephone or online communication, this should be done. Considerations include the nature of the protocol, the type of participants engaged in the research, and any additional risk that may arise by switching from in-person to virtual communication. Revised participant consents or consent addendums may be required (e.g., to update with COVID-19 risk mitigation measures, to update with revised privacy considerations if online methods to be).
While TCPS 2 typically requires review and approval of modifications prior to implementation, an exception can be made where the change is necessary to mitigate an immediate risk to participant(s) (e.g., moving in person data collection to be online platform, temporarily suspending portions of the research study, etc.) or to inform participants about research-related risks (Article 6.15) (e.g., in-person study visits, public transit to study site, close contact with researchers, etc.). Such changes may be implemented but must be reported to the REB at the earliest opportunity (within 5 business days as a guide). For industry-sponsored clinical trials, researchers should also be working with the study sponsors to consult where possible to implement any changes.
A reminder that where the research involves physical assessments and use of equipment (e.g., metabolic carts, facemasks, mouthpieces, noseclips, straps, turbines, valves, tubing, cannula, treadmills, etc.) disinfection according to manufacturer’s standards where applicable is paramount and use of single use accessories is advisable. In the absence of manufacturers standards, and/or other shared equipment (e.g., shoes, insoles) disinfection between participants is required. Personal Protective Equipment worn by research staff should be commensurate with the risk associated with the level of interaction (e.g., face masks only, procedural face masks, masks and shields, masks, shields, gowns/aprons).
Where research staff have symptoms that are not related to a pre-existing illness or health condition (i.e., cough, fever, shortness of breath, runny nose or sore throat) AHS protocols for self-isolation must be followed: https://www.alberta.ca/isolation.aspx
Q: When do I report revisions to my research protocol that were made to eliminate immediate hazards to human participants or to inform participants about research-related risks?
A: The changes should be reported to the REB as soon as possible, preferably within 5 business days. We will request written justification for a delay of more than 5 business days.
Q: When can I make changes to my protocol without prior notice to or approval from the REB?
A: Should you determine that changes in your procedures are required, you can implement them immediately, without prior notice to or approval from the REB when they are necessary to eliminate increased risk due to the COVID-19 pandemic to the human participants (TCPS2 Article 6.15).
Q: How do I report revisions to my research protocol that were made to eliminate immediate hazards to human participants or to inform participants about research-related risks
A: If you are proposing to add a new study component due to COVID-19, implement study-wide changes, or modifying study documentation to address COVID-19 research-related risks, a modification should be submitted.
A protocol deviation is defined any action (or inaction) that does not correspond to the approved protocol. With the COVID-19 pandemic, a protocol deviation may include changes made to eliminate an immediate hazard to participants or others (e.g., a missed study visit/procedure). Protocol deviations are typically implemented first and then reported to the REB afterwards. While such "immediate hazards" may have been relevant early in the pandemic, at this time changes to protocols should be identifiable in advance of implementation, should be study-wide and will likely be in place for the next few months. For these reasons, such changes should now be submitted as Modification requests. If your changes meet these criteria, a Modification should be submitted indicating as appropriate that these changes will be implemented for the duration of the pandemic and physical distancing measures only and the protocol will revert back to its original state once these measures are over. If modifications are described this way, requests to revert back to the originally approved protocol will not be necessary.
For clinical trials, please find further information below:
Q: My research is taking place on the University of Calgary campus. What do I need to think about? How should I proceed?
A: For clinical research taking place in the AHS environment and/or accessing AHS resources, the researcher should refer to AHS Research Guidance. Contact firstname.lastname@example.org with questions.
- follow the guidance available in the Resources for Return to Campus located on the main UCalgary COVID-19 Response page, and
- complete (or ensure you are included in an existing) Workspace Safety Plan.
Q: Will human ethics applications be reviewed and approved by the Research Ethics Board (REB)?
A: The Research Ethics and Compliance team, along with the Conjoint Health Research Ethics Board (CHREB) and Conjoint Faculties Research Ethics Board (CFREB) remain operational. Therapeutic, COVID-19--related studies are being prioritized.
Q: How do I request an expedited review of a new REB application or a modification to an existing application during the COVID-19 pandemic?
A: Please note that the Boards are experiencing a high volume of requests relating to COVID-19. Requests for a priority review of new applications or modifications to expand study objectives during the COVID-19 pandemic must be made in writing to the Chair of your designated Board.
Applications will be prioritized for review where the study has the potential to contribute to the prevention, diagnosis, treatment or care of COVID-19.
Other studies (e.g., observational, survey or qualitative research examining the impact of the pandemic on various populations) will be prioritized based on the availability of REB resources.
Please submit your request for priority with a short description of your study to the appropriate Board: