Unanticipated Problems & Adverse Event Procedures

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Upon receipt of an unanticipated problems/adverse event form, the protocol file will be accessed and these materials will be reviewed by the IRB chair and one other member of the IRB. Depending on the seriousness of the situation a subcommittee of the IRB may be convened to review the matter and develop recommendations. In keeping with the OSU IRB Federalwide Assurance(FWA), incidents of serious non-compliance will be reported to institutional officials. For federally funded research, federal officials and the sponsoring agency must be notified. The IRB Manager will coordinate these contacts.