Exemption Determinations. With respect to Research submitted for an Exemption Determination, a Reviewing IRB/Reviewing IRB Institution will perform the Exemption Determination (including, as applicable, any Limited IRB Review) in accordance with the requirements of the Federal Policy.
Exemption Determinations. Although not within the scope of the Federal Policy or other federal laws, regulations or policies governing IRB reliance, for Participating Institutions that so wish, this Agreement also permits and serves as documentation of reliance on a Reviewing IRB or on a Reviewing IRB Institution for a determination whether Research is exempt from some or all of the requirements of the Federal Policy (“Exemption Determination”). In the case of Exemption Determinations, including those for which Limited IRB Review (defined in Exhibit A) is required, and with respect to Research that is subject to an Exemption Determination, all of the terms of this Agreement shall apply except for Sections 2.5, 5.4.1, 5.7, 5.9, 5.10, 5.11 5.13, 5.14, 5.15, 6.4, 6.6, 6.8, 6.9, 6.12, 6.13, 6.14, 6.16, and 6.17. Ceded Review of Research and Exemption Determinations shall each constitute a “Covered Activity” for purposes of this Agreement, and one or both may collectively be referred to herein as “Covered Activities.”
Exemption Determinations. The reliance on a Reviewing IRB or on a Reviewing IRB Institution for a Ddeterminations that whether Research is exempt from IRB review pursuant to some or all of the requirements of the Federal Policy. (N.B., Research means human subjects research; see full definition below.)
