Earlier this year, the FDA has issued an alert that some fictitious applications were submitted to several Institutional Review Boards. And the agency noted that the name and address of the clinical investigator listed on a required FDA form are the same as that used in a sting operation conducted by the US Government Accountability Office two years ago (back story). Well, one of the IRBs tripped up by a fictitious clinical investigator was Essex Institutional Review Board, a for-profit operator. And last March, FDA inspectors visited its Lebanon, New Jersey, facilities and found that not only Essex reviewed and approved the fictitious clinical investigator to conduct a clinical trial protocol, but the IRB failed to protect the participants, according to a July 26 warning letter (read here).
