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...

REO - 13 March 2020

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/index.html

https://www.alberta.ca/coronavirus-info-for-albertans.aspx

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