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 or
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 of
adverse events, both serious and non-serious, occurring in the context
of research are expected in light of the known toxicities and side
effects of the research procedures or are expected due to the natural
history 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.