IRB Exemption Determination: FAQs
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 (TCPS 2), Article 2 (Canadian Research). An applicant may therefore apply to Quorum Review for an exemption determination.
If you would simply like more information regarding how to make an exempt determination please refer to the Quorum handbook.
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.
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.