Given the current COVID-19 outbreak, Research Ethics Boards (REBs) should ensure they have in place a Standard Operating Procedure for the management of ethical review processes during public health emergencies. Please refer to N2-CAREB SOP 501.003 guides the REB to continuing to perform their function during emergency circumstances, including prioritization of research reviews.
Other considerations for ensuring your REB can review and efficiently approve studies or prioritized amendments include making use of the opportunity for full reciprocity in harmonized reviews. Ad hoc reviewers from other REBs can also be used to ensure you have quorum. If your REB needs support during this time, whether it be implementation of the SOP as noted above, or connecting you with ad hoc reviewers to be able to continue important reviews, please let us know at REBC (firstname.lastname@example.org or email@example.com).
In addition, REBC recommends that all REBs in BC 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 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 privacy considerations with use of different communication channels).
Where research staff are feeling unwell, care should be taken to stay home to prevent transmission of any illness. If COVID-19 is known or suspected, your institutional protocols should be followed.
TCPS 2 typically requires review and approval of modifications to research protocols 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 clinical trials regulated by the Department of Health and Human Services (DHHS) and where REBs are subject to the Code of Federal Regulations, the exception to prior REB approval before implementation of an amendment to study procedures/protocol is “where necessary to eliminate apparent immediate hazards to the human subjects.” 21 CFR 56.108(a)(4).
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 manufacturer’s standards, thorough cleaning between participants is advised.
Please see Health Canada’s website for up-to-date information: https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19.html
- Click here for the downloadable PDF version of this page.
- For further information, please see our Resources for Research Ethics During a Public Health Emergency page.
Thank you to UBC and the University of Calgary for their guidance and expertise.