FDA Cites Clinical Investigator for Informed Consent Failures

A clinical investigator did not get informed consent, enrolled an ineligible patient in a clinical trial, let institutional review board approval lapse and let another clinical investigator work on trials without registering with the FDA, the agency says. George Brewer of the University of Michigan Medical School was cited for his conduct in three studies of the same investigational drug, according to the warning letter the FDA posted on its website last week. The name of the drug was redacted from the letter.
Washington Drug Letter