Define UPIRHSOs, Adverse Events, and
Clarifying the Difference Between UPIRHSOs and
Reporting Requirements to USF IRB
Examples of Reportable UPIRHSOs
Federal regulations (45 CFR 46, and 21 CFR 56) require that
institutions establish written procedures for ensuring prompt
reporting to the IRB, appropriate institutional officials, and the
federal department or agency head of any unanticipated
problems involving risks to subjects or others (UPIRHSOs).
The FDA has separate regulations that require the prompt
reporting of adverse events (or effects) from the investigators
to the sponsor and from the sponsor to the FDA as well as to
other clinical investigators using the same test article.