Federal regulations do not specifically address adverse event reporting, however they require prompt reporting to the IRB of any unanticipated problems involving risks to subjects orothers.
Some of the adverse events experienced by subjects enrolled in research studies will meet the criteria for unanticipated problems involving risks to subjects or others and so must be reported promptly to the National Jewish Health IRB (NJH IRB). However, the vast majority ofadverse events, both serious and non-serious, occurring in the contextof research are expected in light of the known toxicities and sideeffects of the research procedures or are expected due to the naturalhistory of subjects' underlying diseases and conditions. Thus, most individual adverse events do not represent unanticipated problems subject to the reporting requirements outlined in the federal regulations at 45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1).
Effective July 1, 2009, investigators need only report adverse events deemed to meet the criteria for unanticipated problems involving risks to subjects or others. Refer to the Unanticipated Problems page for definitions, examples, and reporting criteria.