IRB Exemption Determination


Home › Additional Services › IRB Exemption Determination


Research activities that involve human subjects may be exempt from IRB review under certain conditions pursuant to 45 CFR 46.101(b) [federally funded projects] and 21 CFR 56.104(d) [FDA regulated studies]. An applicant may therefore apply to Quorum Review IRB for an exemption determination. Prior to Quorum Review IRB's review of an exemption determination request, the following documentation should be submitted:

  • Quorum Review IRB Request for Exemption Determination Form
  • A copy of the final protocol or research proposal
  • Institutional Jurisdiction Waiver Form, if applicable

Please contact Quorum Review IRB's Initial Study Support department with any questions regarding exempt determinations.

Required

F-020 - Exemption Determination Request
If an applicant would like Quorum Review to make a determination regarding whether research is exempt from review, this form should be submitted. The protocol must also accompany the 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 an Exemption Determination Request? >>
Some research activities that involve human subjects may be exempt from IRB review under certain conditions pursuant to 45 CFR 46.101(b) (federally funded projects), 21 CFR 56.104(d) (FDA regulated studies), and the Tri-Council Policy Statement, Article 1.1c-d, 2.3 (Canadian Research). An applicant may therefore apply to Quorum Review for an exemption determination.
Q.    How can I determine if I am exempt from review? >>
If you would simply like more information regarding how to make an exempt determination please refer to the Quorum handbook.
Q.    How do I submit an Exemption Determination Request to Quorum? >>
Quorum accepts Exemption Determination Request via the OnQ Client Portal, email to our Initial Study Support department, fax, or mail.

Quorum Review
Initial Study Support Department
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 an Exemption Determination Request? >>
For an exemption determination, the Quorum Review Request for Exemption Determination 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 an Exemption Determination Request? >>
Our Initial Study Support department should be contacted with any questions regarding exemption determination requests. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.