Home » FDA: IRB Corrects Consent Issues But Other Problems Remain
FDA: IRB Corrects Consent Issues But Other Problems Remain
February 2, 2010
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. Clinical Trials Advisor