In light of the COVID 19 outbreak, the Alberta REB’s 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, care should be taken to stay home to prevent transmission of any 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). The REBs will work to expedite these requests to minimize research disruption.
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.
Please see Health Canada’s website for up-to-date information:
HREBA notes that much of the research in Alberta takes place in the community settings. In addition to the above guidance: Research taking place in a community clinic or private setting should consider different scenarios should staff become ill and research activities must continue for the safety of the participants. It is advised these centres collaborate with neighbouring researchers and develop a continuance plan to ensure safe research practices. We will provide updates as available, if you need additional information please email firstname.lastname@example.org or call 780-999-6792.
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic: Click here
Health Canada Guidance on Management of Clinical Trials during the COVID-19 Pandemic: Click here