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FDA Warns Trial Investigator for IRB, Consent Form, Protocol Violations


The FDA handed a cardiac surgeon at Washington, D.C.-based Washington Hospital Center a warning letter for not having institutional review board (IRB) approval when recruiting some patients into a clinical trial.

During an Aug. 24 to Sept. 15, 2011, inspection, investigators found five subjects recruited into an investigational drug study had signed consent forms indicating the trial was IRB-approved. But according to the Sept. 28 letter posted recently online, IRB approval had expired in early May of that year. Patients were still being recruited through July, the letter adds.

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