WASHINGTON, March 27 -- Institutional review boards (IRBs) may not provide the clinical trial safety net they were designed to be.
That's what Government Accountability Office (GAO) investigators found when they conducted an operation in which a fake study protocol was approved by an independent for-profit IRB.
In a related sting, GAO investigators created a fictitious IRB that managed to pass approval by a Department of Health and Human Services office.
"The IRB system is vulnerable to unethical manipulation," Gregory Kutz, of the GAO's forensic audit and special investigations unit, told the House Energy and Commerce subcommittee.
In recent years, oversight of clinical trials has increasingly shifted from academic institutions to independent, for-profit companies, raising concerns that the system could be manipulated, Kutz said.
The subcommittee began investigating the review boards in 2007 after it was revealed that an independent IRB allowed a study of an antibiotic to continue after it had received reports of fraud, according to Bart Stupak (D-Mich.), who chairs the subcommittee.
So the legislators asked the GAO to investigate. The GAO fabricated a study of a fake surgical adhesive gel called Adhesiabloc meant to aid healing after invasive abdominal surgery in women. The protocol called for using 1,000 mL of the product for each procedure.
Investigators submitted the protocol to three for-profit review boards. Two rejected it, calling the study "awful," a "piece of junk," and the "riskiest thing I've ever seen," according to Kutz.
The third IRB, Coast Independent Review Board, was taken in by the ruse, and it approved the study by unanimous vote, saying the "gel is probably very safe."
Stupak said "the evidence suggests that Coast was more concerned with its financial bottom-line than protecting the lives of patients."
Daniel Dueber, CEO of Coast, accused the government of breaking several state and federal laws in the course of its investigation, including laws against mail fraud, wire fraud, and false credentialing.
"The GAO perpetrated an extensive fraud against my company," he said.
The agency performed the investigation "without satisfying any of the legal safeguards that the Department of Justice and the federal courts have in place. It acted without probable cause that a crime had been committed," Dueber said.
He asked "whether this committee and the GAO are above the law."
However, after the hearing, Dueber issued a statement promising a series of reforms at Coast. He said the current IRM chair would be replaced and the company would begin performing background checks on every applicant, among other changes.
In another part of the GAO operation, investigators created a fictitious IRB called Maryland Hause and named the made-up CEO after a dead dog.
The IRB was approved by the Department of Health and Human Service's Office for Human Research Protections and even received inquiries about the review of protocols from real-world researchers.
"GAO's findings raise serious questions not only about the specific IRB involved in this investigation, but with the entire system for approving experimental testing on human beings," Stupak said.