Federal regulations do not specificallyaddress adverse event reporting, however they require prompt reportingto the IRB of any unanticipated problems involving risks to subjects orothers.
Some of the adverse events experienced by subjects enrolledin research studies will meet the criteria for unanticipated problemsinvolving risks to subjects or others and so must be reported promptlyto 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, mostindividual adverse events do not represent unanticipated problemssubject to the reporting requirements outlined in the federalregulations 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.