OHRP Finds Oversight Lapses in 11 Cancer Clinical Trials

An academic medical center failed to prepare and maintain adequate documentation of institutional review board (IRB) activities for 11 cancer clinical trials. In one of the studies, a clinical investigator made changes to the protocol without informing the IRB, the HHS Office for Human Research Protections (OHRP) says. As a result, OHRP sent a combined determination letter earlier this month to the Carle Clinic Association and Carle Foundation Hospital, which serves as the teaching hospital for the University of Illinois College of Medicine at Urbana-Champagne.
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