Human Research Determination: FAQs
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.
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
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.
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.
