Colorado Springs, CO (March 11, 2009) – On Friday, March 6, 2009, Coast IRB notified Criminal Fraud unit of the U.S. Department of Justice, the FBI, the FDA, and the Commonwealth of Virginia Department of Health Professions of a fraudulent clinical test. Coast Independent Review Board discovered that a protocol submitted for review of a medical device called Adhesiabloc by Device Med Systems of Clifton, Virginia, was fraudulent in violation of federal and state law. Upon receipt of proof of the fraud, Coast IRB and its CEO, Daniel Dueber, ordered immediate termination of the clinical trial, referred evidence to federal and state authorities for investigation and prosecution, and instituted measures to prevent a recurrence.
Coast IRB has urged authorities to investigate and prosecute the perpetrators whose actual identities remain unknown. Several felony fraud violations and potential RICO may have been committed. “We are informing the media in the hopes of alerting those who might otherwise become study subjects that this appears to be a fraudulent trial,” said Coast IRB CEO Daniel Dueber. “We are also doing so because we want other institutional review boards to learn of our experience and avoid review of this trial pending the result of federal and state investigations”.
Coast IRB discovered the evidence in a routine audit of the trial. Coast IRB discovered that credentials for the principal investigator were forged and that neither the principal investigator nor the medical director was licensed in Virginia. The Department of Health Professions from whence the forged license was allegedly issued reported no record of granting license to the person involved, no record of the license number listed on the forged credentials, and no issuance of licenses in the history of the Commonwealth in the format presented by the study sponsor. Coast IRB further discovered through on-site visit the address for the clinical trial organization where testing was presumably taking place, was in fact a strip mall. A 510(k) FDA number given for the medical device did not exist in FDA’s records.
Coast IRB is one of the largest independently owned IRB’s. Its mission is to protect the rights and welfare of subjects in clinical trials by providing ethical and thorough review. It is located in Colorado Springs, Colorado.
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