What does a researcher need to report?
Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] require the IRB to ensure that investigators promptly report “any unanticipated problems involving risk to subjects or others” (UPIRTSO). The IRB defines UPIRTSO as any problem or event which in the opinion of the local investigator was unanticipated, reflects new or increased risk to the subjects and was possibly related to the research procedures. The IRB makes the determination of whether the unanticipated problem meets the criteria as a UPIRTSO.
