Common use of FWA; Oversight of All Research Clause in Contracts

FWA; Oversight of All Research. Unless it is an IRB Organization, the institution must maintain an OHRP-approved Federalwide Assurance (“FWA”), 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”). In addition, the institution, by policy or otherwise, must require IRB review and provide institutional oversight of its 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. 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.