Human Research Determination: FAQs
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.
Quorum accepts Human Subject Research Determination requests via the OnQ Client Portal, email to our Initial Study Support department, fax, or mail.
Initial Study Support
1601 Fifth Ave., Ste. 1000
Seattle, WA 98101
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.
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.