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.