Protocol Violations: Don’t let this happen to you!
Recently published findings from investigations by federal regulators [Human Res Rept, Oct. 2015, 30(10), 8-9]:
- The U.S. Food & Drug Administration found that a California investigator failed to ensure that the trial was conducted according to the investigational plan. Specifically, subjects were enrolled that did not fit inclusion/exclusion criteria.
- The Office of Human Research Protections investigated a major medical center in New York and found that the informed consent documents contained inadequate information. Specifically, the consent did not describe possible risks.
If you need clarification about avoiding Protocol Violations or how to prospectively obtain a protocol exception from the IRB, call Anu Diekmann at x86215.