The AAMC has responded to the federal Food and Drug Administration's April draft document, "Guidance for Clinical Investigators, Sponsors, and Investigational Review Boards on Adverse Event Reporting-Improving Human Subject Protection."  The document intends to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse event reports to institutional review boards. The AAMC expressed support for the document, in which the FDA acknowledged and moved to address a significant problem in human subject protection: the inundation of IRBs with large volumes of individual adverse event reports that for various reasons can hamper IRBs' ability to protect human subject rights and welfare. The association is also gratified that the recommendations in the draft guidance are consistent with the suggestions previously provided by the AAMC and others at a 2005 FDA hearing. In the letter, the AAMC also commended the FDA for providing specific guidelines on what constitutes a reportable unanticipated problem, and made several additional comments to further improve the guidance. To view the letter, please visit http://www.aamc.org/advocacy/library/research/corres/2007/060707.pdf.