Research In Canada: FAQs
Yes. Quorum Review IRB maintains an ethics review board (referred to as the “North American” Board) and serves as a both a duly convened research ethics board (REB) as well as a central institutional review board (IRB). The North American Board complies with Canadian and U.S. requirements and meets every Wednesday to review U.S. and Canadian studies. Quorum accepts both privately and publicly funded research. Quorum is subject to the same provincial restrictions that apply to other central REBs in Canada. Therefore, Quorum does not provide review in Alberta, Newfoundland and Labrador, and Saskatchewan. In Quebec, Quorum reviews only studies involving adult participants.
The Tri-Council Policy Statement (TCPS 2) is a Canadian Government policy statement that sets ethics standards for conducting research on human subjects. The agencies that make up Tri-Council are as follows: (1) Canadian Institutes of Health Research (CIHR), (2) Natural Sciences and Engineering Research Council of Canada (NSERC), and (3) Social Sciences and Humanities Research Council of Canada (SSHRC). These agencies will consider funding organizations that certify that they will comply with the TCPS 2 for the research study involving human subjects. Many organizations apply the TCPS 2 standards to all studies even if only specific studies are being funded by one of the three agencies. In addition, many organizations voluntarily apply the TCPS 2 to all studies as a matter of policy even if no public funding is being received for any study.
Yes. Quorum will review Canadian research in accordance with applicable regulations and guidelines, including the Tri-Council Policy Statement (TCPS 2).
Since many organizations in Canada have voluntarily elected to adopt TCPS 2, even if they are not required to do so, there is a likelihood that we will encounter a site that will require Quorum to comply with the TCPS 2. As a matter of policy we therefore apply the TCPS 2 to all studies unless the organization provides and explanation regarding why it should not apply.
In accordance with Article 11.11 of the Tri-Council Policy Statement (TCPS 2), Quorum’s REB is required to review the clinical trial budget for Canadian studies in order to “ensure that conflicts of interest are identified and minimized, or otherwise managed.”
Although compliance with provincial and local law requirements are ultimately the responsibility of the principal investigator, Quorum has developed consent forms that are in compliance with provincial and local law requirements where Quorum provides review.
PIPEDA refers to the federal Personal Information Protection and Electronic Documents Act (S.C. 2000, Ch. 5) (Federal Act). The Act applies to all organizations that collect, use or disclose personal information in the course of commercial activities. The term “commercial activity” means any particular transaction, act or conduct or any regular course of conduct that is of a commercial character. Clinical research under contract to a private organization is a “commercial activity”. As of January 1, 2004, the Act applies to all personal information collected, used or disclosed in the course of all commercial activity. Note: If a province passes a law that is substantially similar to the Federal Act, the organizations or activities covered by the provincial law will be exempted from the federal law for collection, use, or disclosure within the province.
Yes. Quorum’s template consent form is PIPEDA compliant, but it is the ultimate responsibility of the of the principal investigator to comply with the federal, provincial, and local law requirements.
The North American Board meets every Wednesday to review U.S. and Canadian studies.
Yes. Quorum Review IRB has an office in Canada; however, our staff is available at the main office in Seattle to support Canadian sites and research. Please send all submissions to the main Seattle office.
Yes. Quorum can provide French Canadian translations and offers translation services in over 100 languages and dialects for all study related documents. By coordinating translation through Quorum staff, you can help ensure that additional translations are not needed for your study documents for submission to the Board. Please contact your Study Manager if you would like more information regarding these services.
For sites with personnel and/or study subjects who speak French, Quorum can provide French translations of the study Consent Form(s) and any other participant materials (such as diaries, recruitment materials, etc.). Quorum also has a phone support system in place with a dedicated mailbox for study personnel and participants who speak French.
What kinds of approval documents will I receive for studies involving sites in both the U.S. and Canada?
Because of the different regulatory requirements in the US and Canada, Quorum issues separate protocol approval documents for the U.S. and Canadian arms of a study.
All Board correspondence will be posted to the OnQ Portal for U.S. and Canadian studies. Sponsors that are approved to conduct research in both the U.S. and Canada will see two separate links to their approval documents when logging into the OnQ Portal. One link will route you to the U.S. arm and another link will route you to the Canadian arm. To easily identify the Canadian arm vs. the U.S. arm, Quorum has assigned an identical Quorum Review tracking number (QR#) with an addition suffix for the Canadian arm. The U.S. arm will contain our standard 5 digit number (e.g. QR# 23333) and the Canadian arm will be assigned the same number with an additional suffix (e.g. QR# 23333CDN).
In addition to Quorum’s standard submission requirements, Canadian sites must provide a copy of the Principal Investigator’s Medical License. A copy of the sites Clinical Trial Budget should also be provided, if applicable.