Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Adverse Event Reporting-Improving Human Subject Protection; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Adverse Event Reporting--Improving Human Subject Protection." This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to institutional review boards (IRBs). FDA developed this guidance in response to concerns raised by the IRB community that increasingly large volumes of individual, unanalyzed adverse event reports are inhibiting, rather than enhancing, the ability of IRBs to adequately protect human subjects. The guidance provides recommendations to IRBs, sponsors, and investigators on improving the usefulness of the adverse event information submitted to IRBs. Elsewhere in this issue of the Federal Register, FDA is issuing the final rule entitled "Institutional Review Boards; Registration Requirements."