Canadian Research for Sponsors and CRO's
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Review of Research Conducted in Canada
Quorum Review IRB maintains an ethics review board (referred to as the "North American" Board) and serves as 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 is AAHRPP-accredited and accepts both privately and publically funded research in Canada.
Provincial Restrictions
Quorum is subject to the same provincial restrictions that apply to other independent REBs. Quorum therefore does not provide review in the provinces of Alberta and Saskatchewan. In addition, Quorum reviews only studies involving adult participants in the province of Quebec.Important Note regarding Newfoundland: Although Quorum may currently provide review in Newfoundland, if and when the 2006 legislation prohibiting certain types of REBs from providing review is proclaimed in force (the legislation is enacted), Quorum will no longer be able to provide review for any new research studies conducted in that province. As the law is currently written, such a proclamation will not affect any studies under Quorum's oversight prior to the date of enactment.
Submission Requirements
Researchers from the U.S. and Canada generally use the same Quorum forms. For the initial submission of a protocol, please use the forms found on the Sponsor > Initial submission page and be sure to check the appropriate box on the Central Study Questionnaire (CSQ) that designates whether the study will be conducted solely in Canada or in both the U.S. and Canada. If your protocol is approved in the U.S. and you want to expand it into Canada, please submit the "Expansion into Canada Central Study Questionnaire" instead of the standard "Central Study Questionnaire." For site submissions researchers also use the same initial site submission Quorum forms, which are found on the Site > Initial Submission page. Canadian guidelines require that Quorum collect additional paperwork from Canadian investigators, such as a copy of the site’s clinical trial budget. For more information see our FAQ on Canada.Submission Deadlines
The submission deadline for research activities in Canada (including protocols and protocol amendments) is 5:00 p.m. Pacific Time on Wednesday, one week prior to the meeting. Some site submissions might qualify for expedited review. Quorum will deliver services and turnaround times according to the same timelines in both countries.As Indicated
F-014 - Canadian Extension Central Study Questionnaire
This form should be submitted to Quorum if you plan to expand an approved US study to include sites in Canada.
Guidance
G-043 - Handbook for Quorum Review IRB (Requires an OnQ Portal Account)
The Handbook provides a guide for using Quorum Review IRB as an ethics review board. It contains policies, procedures, and guidelines to be used in preparing materials for Board review, as well as information on managing ongoing research activities, continuing and periodic review, and closing.
Q. Does Quorum review research in Canada? >>
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 publically funded research. Quorum is subject to the same provincial restrictions that apply to other central REBs in Canada. Quorum does not provide review in Saskatchewan and Alberta. In Quebec, Quorum reviews only studies involving adult participants.
Important Note regarding Newfoundland: Although Quorum may currently provide review in Newfoundland, if and when the 2006 legislation prohibiting certain types of REBs from providing review is proclaimed in force (the legislation is enacted), Quorum will no longer be able to provide review for any new research studies conducted in that province. As the law is currently written, such a proclamation will not affect any studies under Quorum's oversight prior to the date of enactment.
Important Note regarding Newfoundland: Although Quorum may currently provide review in Newfoundland, if and when the 2006 legislation prohibiting certain types of REBs from providing review is proclaimed in force (the legislation is enacted), Quorum will no longer be able to provide review for any new research studies conducted in that province. As the law is currently written, such a proclamation will not affect any studies under Quorum's oversight prior to the date of enactment.
Q. What is TCPS? >>
The Tri-Council Policy Statement (TCPS) is a Canadian Government policy statement that sets ethics standards for conducting research on human subjects. The agencies that make up TCPS 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 for the research study involving human subjects. Many organizations apply the TCPS 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 to all studies as a matter of policy even if no public funding is being received for any study.
Q. Is Quorum TCPS compliant? >>
Yes. Quorum will review Canadian research in accordance with applicable regulations and guidelines, including the Tri-Council Policy Statement (TCPS).
Q. Why do I have to be TCPS compliant when my study is not publically funded? >>
Since many organizations in Canada have voluntarily elected to adopt TCPS, 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. As a matter of policy we therefore apply the TCPS to all studies unless the organization provides and explanation regarding why it should not apply.
Q. Why do I have to submit a Clinical Trial Budget? >>
In accordance with article 7.3 of the Tri-Council Policy Statement (TCPS), Quorum’s REB is required to review the clinical trial budget for Canadian studies in order to “assure that ethical duties concerning conflict of interest are respected” and in order to “determine whether there are any unnecessary or unjustified costs which may raise questions regarding inappropriate incentives or issues about the existence of a conflict of interest.”
Q. Do Quorum’s consent forms comply with Canadian provincial requirements? >>
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.
Q. What is PIPEDA? >>
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.
Q. Do Quorum’s consent forms comply with PIPEDA? >>
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.
Q. What days does the Board meet to review research in Canada? >>
The North American Board meets every Wednesday to review U.S. and Canadian studies.
Q. Does Quorum have a physical office in Canada? >>
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.
Q. Can Quorum provide French Canadian translations? >>
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.
Q. In what ways do you support French Canadian speakers? >>
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.
Q. 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.
Q. Will all my Board correspondence post to the OnQ Portal? >>
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).
Q. What additional submission elements are required for Canadian sites? >>
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.