BIMO guidance agenda
This article was originally published in The Gray Sheet
Executive Summary
FDA's Bioresearch Monitoring program is finalizing 2007 draft guidance on investigators' responsibilities in FDA-regulated clinical trials; updating a 1998 draft on institutional review boards' continuing review after clinical investigation approval to add detail on the criteria, process and frequency of continuing review; and reviewing comments and finalizing a 2006 draft guidance on exceptions from informed consent requirements for emergency research, according to a March 25 1progress report on the Critical Path-originated program. BIMO is also working on a new "guide to informed consent" draft guidance that will discuss topics such as review of patient records, children as subjects and patients' participation in multiple studies