Human Subject Research Determination


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Human Subject Research Determination

An applicant may apply to Quorum Review IRB for a determination of whether a proposed activity is human subjects research in accordance with applicable U.S. federal regulations and/or the Canadian Tri-Council Policy Statement: 21 CFR 50.3(c) and (g); 21 CFR 56.102(c) and (e); 45 CFR 46.102(d) and (f); TCPS 2, Article 2.

Prior to Quorum Review IRB's review of a Human Subjects Determination Request, the following documentation should be submitted:

  • Quorum Review IRB Human Subjects Determination Request Form
  • A copy of the final protocol or research proposal (and any supporting material, if applicable)
  • Institutional Jurisdiction Waiver Form, if applicable

Please note that as a matter of policy, Regulatory will not make a determination that an activity is not research involving human subjects for FDA-regulated studies. If the sponsor intends to submit the research data to the FDA in support of a research or marketing permit, the FDA regulations apply and such a determination is not applicable.

Please contact Quorum Review IRB's Initial Study Support department with any questions regarding Human Subject Determinations.

Required

F-118 - Human Subjects Research and Exemption Determination Request
If an applicant would like Quorum Review to make a determination regarding whether research is human subject research or whether research is exempt from review, this form should be submitted. The protocol must also accompany the Human Subjects Research and Exemption Determination Request Form.

As Indicated

F-016 - Institutional Jurisdiction Waiver Form
Formal document by which an institution waives local IRB jurisdiction of a particular study to Quorum Review IRB.

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.    What is a Human Subject Research Determination request? >>
An applicant may apply to Quorum Review IRB for a determination of whether a proposed activity is human subjects research in accordance with applicable U.S. federal regulations and/or the Canadian Tri-Council Policy Statement(TCPS 2): 21 CFR 50.3(c) and (g); 21 CFR 56.102(c) and (e); 45 CFR 46.102(d) and (f); TCPS 2 Article 2.1.
Q.    How do I submit a Human Subjects Research Determination request to Quorum? >>
Quorum accepts Human Subject Research Determination requests via the OnQ Client Portal, email to our Initial Study Support department, fax, or mail.

Quorum Review
Initial Study Support
1601 Fifth Ave., Ste. 1000
Seattle, WA 98101
Fax: 206-448-4193
InitialStudySupport@quorumreview.com
Q.    Which form should I complete if I want to submit a Human Subject Research Determination request? >>
For a Human Subject Research Determination, the Quorum Review Human Subject Research Determination Request Form should be completed. Additionally, a copy of the final protocol or research proposal is required.
Q.    Who should I contact if I have questions about completing a Human Subject Research Determination request? >>
Our Initial Study Support department should be contacted with any questions regarding Human Subject Research Determination requests. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.