Recently published findings from investigations by federal regulators [Human Res Rept, Jan. 2016, 31(1), 9-10]:
- The U.S. Food & Drug Administration (FDA) found that a California investigator persistently failed to ensure that a number of his research subjects fulfilled enrollment inclusion criterion. FDA’s Warning Letter suggests that the physician attempted to change subject enrollment data months after actual enrollment.
- The Office of Human Research Protections investigated a major medical center in New York and found that researchers changed the informed consent before getting IRB approval. Investigators suspended enrollment for two affected studies until revisions were approved by the IRB.
If you need clarification about avoiding Protocol Violations or how to prospectively obtain a protocol exception from the IRB, call Anu Diekmann at x86215.