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: May 27, 2020
Human Ethics Guidance from CFREB and CHREB during COVID-19
In light of the COVID-19 outbreak, the CFREB and CHREB advise investigators to consider if their research protocols could be modified or delayed, to limit personal contacts, laboratory visits or trips into clinics and hospitals. Specifically, in some research settings in-person participant interactions could be reduced and/or replaced with telephone or online communication. Considerations include the nature of your 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 privacy considerations with use of different communication channels).
Where research staff are feeling unwell – particularly those who interact with research participants – it is recommended to stay home to prevent transmission of illness. If COVID-19 is known or suspected, AHS protocols should be followed:https://www.albertahealthservices.ca/topics/Page16944.aspx.
While TCPS 2 typically requires review and approval of modifications prior to implementation, an exception can be made where the change is necessary to eliminate an immediate risk to participant(s) (Article 6.15). 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, thorough cleaning between participants is advised.
Q: When do I report revisions to my research protocol that were made to eliminate immediate hazards to human participants?
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
A: If you are proposing to add a new study component due to COVID-19 or implementing study-wide changes, a modification should be submitted.
If changes were made to eliminate immediate hazards to participants or others please submit a reportable event in IRISS. See the Reportable Event guidance document for more details.
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. 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.
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. If the situation changes, turn-around times may lengthen, as applications focused on COVID-19 may be 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: