Op-Ed: Improving Protection of Trial Participants

January 15, 2008

These are difficult times for the FDA. At the close of 2007, a major controversy swirled around one of the agency’s core oversight functions: the protection of human subjects of clinical research. In September, the DHHS Office of Inspector General (OIG) released a report that was sharply critical of the FDA’s Bioresearch Monitoring (BiMo) program. (Genetic Engineering News)