Chapter 31

Special Considerations for Canadian Research

The WCG Canadian Panel is located in Vancouver, Canada. Its membership is compliant with the requirements outlined in the Division 5 regulations of Health Canada. The Panel is able to review research for Canadian sites that do not need to use their own local Research Ethics Board (REB). For more information about the Canadian Panel, please call Client Care at 855-818-2289.

Submitting the No Objection Letter from Health Canada: The sponsor must submit clinical trials of drugs and devices to Health Canada before the study can begin. If there are no objections or issues, Health Canada will issue a No Objection Letter (NOL), typically within 30 days. Review by Health Canada and the Research Ethics Board may occur in parallel so the NOL may not have been issued prior to Board review. If the sponsor has received the NOL prior to submitting to the REB, they should include it as part of the submission. If the sponsor has not received the NOL prior to submitting to the REB, they should submit it as soon as they receive it.

While the Tri-Council Policy Statement (TCPS) does not generally apply to the research reviewed by WCG IRB, the Board will apply it to all Canadian Research. TCPS has additional consent requirements for consent, storage of biospecimens, and research that involves genetic analyses. 

If the protocol requires collecting biospecimens, the Board requires information on where and for how long the samples are stored. The Board prefers to know the exact location of where the samples will be stored, but at a minimum the Board will need to know the country they will be stored. 

For more information about the TCPS requirements please see: https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2022.html.

1.  Information about biological samples and genetic research. To avoid conditional approvals or deferrals, the Board asks for the necessary information on the required Canadian Supplement HRP-213. For more information please see TCPS Chapter 12 and 13.

2.  A statement that if a subject withdraws consent, the subject can also request withdrawal of their data or human biological materials; and any circumstances that do not allow withdrawal of data or human biological materials once collected.

3.  Confidentiality of personal information is protected under the Personal Information Protection and Electronic Documents Act (PIPEDA). While there is a lot of overlap between PIPEDA and HIPAA, there are some key differences. Specifically PIPEDA is broader than HIPAA and applies to Personal Information used in a commercial context.

4.  A statement that, by consenting, subjects have not waived any rights to legal recourse in the event of research-related harm.

5.  Information concerning the possibility of commercialization of research findings.

6.  To avoid therapeutic misconception, TCPS indicates that the preferred term is participant as opposed to patient; the Board will change patient to participant when appropriate.

7.  Units of measure should be in both Metric and Imperial units; for example, 10 mL (2 teaspoons).

Other considerations for Canadian research:

  • Research Ethics Training: Prior to approval, Principal Investigators and those study team members who interact with participants (and their personal information) complete the online tutorial TCPS 2: CORE-2022 (Course on Research Ethics), https://www.tcps2core.ca/welcome
  • Province of Québec: In respect of Article 21 of the Québec Civil Code, WCG IRB Canada will not review research involving minors and incapacitated adults from the province of Québec.
  • Review of studies involving adults lacking capacity to consent in British Columbia — WCG is not a designated Research Ethics Board (REB) under the British Columbia Representation Act, and as such the Board cannot review research studies involving adults lacking capacity to consent unless the individual has entered into a representational agreement that allows the legally authorized representative to enroll the individual or continue the individual’s participation in medical research.
  • Review in Various Provinces:  WCG is not able to review research is several provinces without local review. For a complete list of the Provinces that WCG can and cannot review in please contact Client Relations.