FDA: IRB Corrects Consent Issues But Other Problems Remain

Although an institutional review board (IRB) has rectified FDA concerns regarding a lack of required information in consent forms, the board needs to specify how it plans to ensure staff assesses studies and risks, an FDA warning letter says. Florida Atlantic University’s IRB addressed the informed consent issue by terminating five studies cited by the FDA that did not include in their informed consent forms such basic required elements as an indication that certain procedures were experimental, a description of all reasonably foreseeable risks or a disclosure of appropriate alternative treatment, according to the letter.
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