International FAQs

Under what regulatory authorities does Quorum operate?

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Quorum provides review services in accordance with the ICH Guidelines for Good Clinical Practice. For research to be conducted in the U.S., Quorum applies the requirements for institutional review boards found in the U.S. Food and Drug Administration regulations (21 CFR Part 56) and the U.S. Department of Health and Human Services regulations (21 CFR Parts 50 & 56). For research to be conducted within Canada, Quorum Review applies the requirements for research ethics boards found in the Canadian Food and Drug regulations (Part C, Division 5). Quorum conducts its review in accordance with the ethical principles outlined in the Belmont Report.

Does Quorum review research that will be conducted at Canadian sites

(53 People have viewed this FAQ)

Yes. Quorum’s North American Board is an institutional review board/research ethics board that meets on Wednesdays and is authorized to review research involving Canadian sites. Some Canadian sites may qualify for a daily review of sites; other site and protocol reviews will be scheduled for the North American meeting. Read more about our North American review.

What is TCPS 2?

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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.

Does Quorum have a physical office in Canada?

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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.

Does Quorum review research in Canada?

(29 People have viewed this FAQ)

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.

What kinds of approval documents will I receive for studies involving sites in both the U.S. and Canada?

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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.

Why do I have to be TCPS 2 compliant when my study is not publicly funded?

(25 People have viewed this FAQ)

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.

Will all my Board correspondence post to the OnQ Portal?

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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).

What days does the Board meet to review research in Canada?

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The North American Board meets every Wednesday to review U.S. and Canadian studies.

What submission documents are required by Quorum?

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Quorum requires the following documents:

  • "Site Information Questionnaire: Primary Research Facility" form
  • Principal investigator’s Curriculum Vitae including clinical research experience with human subjects and education (if applicable,the principal investigator needs to submit a CV to Quorum only once)
  • Canada sites only: Hard copy of principal investigator’s Medical License
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