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Research Adverse Events

The IRB requires reporting of unexpected adverse events that may represent an unanticipated problem involving risks to subjects or others (UPIRSO). Such events are to be reported using the Problem Report Form within IRIS. Upon review the Institutional Review Board (IRB) may require changes to informed consent forms and/or protocols or other actions such as increased monitoring. The IRB makes the final determination as to whether an internal adverse event constitutes an unanticipated problem and whether changes to the consent and/or protocol are required. For external events, the sponsor should indicate if they have deemed the event to be a UPIRSO, and if so the IRB is to be informed.  If the sponsor rules that an external event is NOT a UPIRSO, if the PI disagrees with the assessment of the sponsor the PI can elect to submit a problem report form and explain this difference in opinion.

All investigators and study personnel must be familiar with the policy for reporting unanticipated problems, inclusive of unexpected adverse events that may be unanticipated problems, to the IRB. Such events must be reported using the Problem Report Form within IRIS within 5 working days (7 calendar days) of becoming aware of the event.

The following table summarizes the reporting requirements of adverse events that may constitute an unanticipated problems involving risk:

Event Type Internal or External Expected or Unexpected Related or Not Related to Study Time Frame
Serious Internal Unexpected Related or possibly related 7 calendar days, Continuation, Closure
Serious External Unexpected Related or possibly related to the research and specifically deemed by the sponsor to be an unanticipated problem* 7 calendar days, Continuation, Closure

Investigators can provide sponsors with a copy of the HSPO’s policy for reporting unanticipated problems and/or a copy of the letter from the Director of the HSPP that states that only those external events that have been deemed by the sponsor to be unanticipated problems involving risk to subjects or others will be reviewed by the IRB.