FWA; Oversight of All Research Sample Clauses

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.
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  • Public Posting of Approved Users’ Research Use Statement The PI agrees that information about themselves and the approved research use will be posted publicly on the dbGaP website. The information includes the PI’s name and Requester, project name, Research Use Statement, and a Non-Technical Summary of the Research Use Statement. In addition, and if applicable, this information may include the Cloud Computing Use Statement and name of the CSP or PCS. Citations of publications resulting from the use of controlled-access datasets obtained through this DAR may also be posted on the dbGaP website.

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