FWA; Oversight of All ResearchAssurance and Oversight Sample Clauses

FWA; Oversight of All ResearchAssurance and Oversight. Unless it is an Independent IRB Organization, the iInstitution must (i) maintain an OHRP-approved Federalwide Assurance (“FWA”),assurance of compliance with the Federal Policy (defined in Exhibit A) with at least one federal department or agency (“Assurance”), regardless of whether it engages in federally funded human subjects research that is subject to the Federal Policy for the Protection of Human Subjects (“Federal Policy”)even if it does not engage in federally funded research; and. In addition, the iInstitution, by policy or otherwise, must (ii) require IRB review and provide institutional oversight of its non-exempt human subjects research regardless of funding source or the scope of its FWA. In the case of human subjects research that would be exempt from IRB review under Federal Policy, the institution must still provide institutional oversight of such research. Such policy need not require, and this Agreement does not require, reporting unanticipated problems, serious or continuing noncompliance, or suspension/termination of such research to OHRP or other agencies when such reporting is not required by the institution’s FWA or policies or otherwise by regulation. However, nothing in the institution’s policies may preclude, and this Agreement shall not preclude, the institution from reporting such events to OHRP or other agencies in such circumstances. For clarity, this Agreement does not require the Institution to extend its Assurance(s) to research that is not federally funded. The Institution may elect to do so (where permitted by the relevant federal department or agency) or may maintain internal policies or other requirements for IRB review and institutional oversight of such research. The institution must inform all Participating Institutions involved in Research (defined below) of the applicability of its FWA to the Research prior to such institution’s participation in any determination of the acceptability of a Ceded Review for the Research pursuant to Section 3 hereof. For clarity, it is not a requirement for participation as a Relying Institution in this Agreement for an institution to have an IRB.
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Related to FWA; Oversight of All ResearchAssurance and Oversight

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