Although injuries are not per se a reportable event (unless they also meet the definition of a unanticipated problem), the SMART IRB Agreement specifically calls out research-related injuries as needing to be reported to the Reviewing IRB because many institutions view injuries as inherently significant enough that the IRB should know about them and make the judgment call about whether they constitute unanticipated problems, rather than leaving sole judgment of whether an injury needs to be reported to the study investigator.
Why does the SMART IRB Agreement require Relying Institutions to report research-related injuries if the events do not also represent unanticipated problems?
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