F08 - Navigating Ethical and Institutional Considerations for Data and Biospecimen Sharing in the Era of Single (sIRB)

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For nearly a decade, institutions and IRBs have been grappling with regulatory and policy requirements for sIRB review and increased expectations for data and biospecimen sharing. However, little guidance exists to help HRPPs/IRBs navigate the potential intersection of these regulatory and policy requirements and consider who is responsible for addressing data and specimen sharing requirements in the era of sIRB review. This interactive session will discuss the role of reviewing IRBs and relying institutions in addressing requirements for data and specimen sharing, and topics will include: funding requirements for data and specimen sharing, potential roles of the reviewing IRB and relying organization in managing these requirements, possible conflicts that may arise when institutional expectations differ from the determinations of the reviewing IRB, and recommendations for how these conflicts might be addressed.