COVID-19 Updates for Researchers
A significant update to the AHS COVID-19 Guidance for Researchers document was released March 27, 2020. Please review this document here: https://extranet.ahsnet.ca/teams/AHSRA/SitePages/Home.aspx
The Cross Cancer Institute FAQ for Clinical Trial Sponsors is found here. This is relevant for information regarding remote study monitoring.
Health Canada released a notice to clinical trial sponsors found here. This contains guidance that pertains to clinical trial sites as well as monitoring activities.
Human Participant Research Guidance during COVID-19 Outbreak
In light of the COVID 19 outbreak, the Research Ethics Boards (REBs) administered by the University advise investigators to:
· consider if their research studies can be modified or delayed and
· limit personal contacts, laboratory visits or trips into clinics and hospitals.
Specifically, in some research settings it may be possible to reduce in-person participant interactions or replace them 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 consent forms 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 the REBs typically review and approve modifications prior to implementation, an exception can be made where the change is necessary to eliminate an immediate risk to participant(s) (TCPS2 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.
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 manufacturer’s standards, thorough cleaning between participants is advised.
Note too that research plans involving travel and/or large public gatherings should be re-assessed in light of the University travel advisory issued on March 7, 2020 and the decision yesterday
by Alberta Health Services March 12, 2020 to cancel international events and events involving more than 250 people.
https://www.ualberta.ca/services/health-centre/coronavirus-info/updates/03/update-4.html
https://www.alberta.ca/coronavirus-info-for-albertans.aspx#p22780s5
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