Earlier this year, the FDA has issued an alert that some fictitious applications were submitted to several Institutional Review Boards. 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, according to Pharmalot.
One of the IRBs tripped up by a fictitious clinical investigator was Essex Institutional Review Board, a for-profit operator. 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.
The protocol and the investigator brochure submitted to Essex by the fictitious sponsor indicated there is a “well-established association” with potential increased risk of serious cardiovascular events for the type of drug to have been studied. “However,” the FDA wrote, “there is no evidence in the IRB meeting minutes for the initial review of this protocol to indicate that the IRB considered this risk in determining whether risks to subjects were minimized. The potential for associated cardiovascular risks was also not included in the IRB-approved informed consent form.”
The FDA also noted that Essex “failed to adequately assess the professional qualifications of the clinical investigator purported to be associated with protocol submitted by the fictitious sponsor.” Essex had responded that the sponsor is responsible for selecting qualified, investigators, but the FDA argues that Essex failed to corroborate that the clinical investigator was qualified. “The IRB could have checked, among other things, that the medical license submitted to the IRB was valid in the state of Virginia where the research study was purported to be conducted,” the agency wrote.
Essex also failed to determine at the time of initial review that studies involving children were in compliance with federal regulations that provide added safeguards for children in clinical trials. In addition, the IRB failed to ensure that “basic elements of informed consent are included in the IRB-approved consent form,” according to the FDA. For instance, the protocol given to Essex IRB by the sponsor listed graft rejection as a common side effect in adults taking the drug to be studied. But the IRB meeting minutes for September 7, 2010, indicate Essex requested the sponsor reformat the informed consent form to move the risk of graft rejection to a different paragraph in the document. The FDA writes Essex failed to ensure graft rejection was included in the final IRB-approved consent form. And so, the risk was not included at all.
This is not the first time that Essex has been warned by the FDA for failing to protect clinical trial patients. The agency issued warning letters in 1998.