IRB Research in the News: Researcher late reporting deaths

An NCI researcher was several months late reporting “unanticipated problems” in an IRB-approved lymphoma study, as described in this article.  Two subjects died of aspergillus infections and several other adverse events were not promptly submitted to the sponsor or the IRB.   NIH Director Francis Collins called the reporting problems troubling and unacceptable.  The PI has been suspended from clinical research until he undergoes additional training.  Consult LLUH IRB’s policy for more information on unanticipated problem reporting.  Call Anu Diekmann at x86215 if you have any questions.