FDA: IRB Allowed Researchers to Vote on Their Own Studies

The IRB of Provena St. Joseph Medical Center allowed clinical investigators to vote on their own studies on at least three occasions, the FDA says in a warning letter to the board chairman, Se Choi. On two other occasions, the IRB’s meeting minutes indicate that several board members voted on research studies by email, which “is not permitted because this method, in these instances, does not constitute a convened meeting,” the warning letter, which was posted earlier this month to the FDA website, says.
Clinical Trials Advisor