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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]. (Please reference Appendix O). 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 Customer Relations department with any questions regarding exempt determinations.

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