In a statement issued Tuesday, Coast Independent Review Board (Coast IRB; Colorado Springs, Colorado) said it has discovered what appeared to be a fraudulent clinical trial submitted to it for evaluation. Coast IRB said it has since learned that the fraudulent trial was apparently commenced as part of a congressional "sting" operation.

Apparently at the behest of the U.S. House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce agents submitted false credentials and clinical trial data to Coast IRB and possibly other IRBs to induce them to perform reviews. According to Coast, evidence of the progress of the trials could then form the basis for arguments critical of FDA and in favor of greater regulatory oversight.

Coast said that unless pursuant to a court order or under the auspices of the Department of Justice, the sting could be illegal, violating wire fraud, mail fraud, and state laws against fraud and false credentialing.

Coast IRB CEO Daniel Dueber told Medical Device Daily he had been asked by subcommittee staff to submit to an informal interview prior to giving testimony before the committee on March 19. Following notice from Coast IRB that the fraud had been detected, committee staff informed Coast that the hearing would be postponed until March 26, and that the chairman of Coast IRB and possibly another Coast official would now have to appear for a "transcribed interview" with committee staff.

Dueber said the subcommittee had requested about a week's worth of documentation related to a specific study Coast IRB had reviewed and approved. The committee wanted Coast to submit all of its documentation and communication related to study protocol submitted by a Device Med Systems (Clifton, Virginia) for a device called Adhesiabloc.

Dueber said he was curious to find out why the subcommittee had picked this specific study to investigate out of all the studies that Coast has approved since it was founded in 2002 so on March 5 he began to do some investigating of his own.

As it turns out, the three sponsors who had submitted the study for review claimed that the device had FDA 510(k) clearance. However, through his research Dueber said he discovered, and confirmed with the FDA, that the device did not have 510(k) clearance. Then, Coast IRB began looking into the applicants who had submitted the study for review and found that none of the three MDs were registered as doctors in Virginia or Maryland and that the "doctor" who had submitted a copy of his medical license had in fact submitted a fraudulent license. The address and phone numbers for the company were not legit either, he said.

"That night we realized we'd been had; this was a fraud," Dueber said.

Coast IRB and Dueber ordered the immediate termination of the trial, referred evidence to federal and state authorities for investigation and prosecution, and instituted measures to prevent a recurrence, he said. On Tuesday the company issued a statement alerting the public that it had discovered what appeared to be a fraudulent clinical trial submitted for evaluation.

Dueber told MDD that on Wednesday an individual from the subcommittee staff contacted Coast and was upset that the company had issued a statement notifying the public about this fraudulent study because the subcommittee had intended to use the information to make its case at the March 19 hearing.

"Essentially, he did not deny the fact that the subcommittee was behind this sting," Dueber said. "He was upset that I found this out and made it public."

Dueber believes the subcommittee was going after the FDA, attempting to make an example out of IRBs to make a case for stronger regulatory oversight.

A representative from the subcommittee declined to comment on the record about the investigation but told MDD that there would be a hearing on the matter later this month.

"We are doing our level best to ensure protection for subjects of clinical trials under our review, an objective we share with the [FDA]," Dueber said. "We are legally and morally obliged to report any unlawful conduct we find occurring in a clinical trial and, so, fulfilled that responsibility in this case."

Dueber said that when Coast IRB originally reviewed the study protocol there was nothing remarkable about it, it was a low-risk trial, and the board had no reason to doubt the validity of the study or the credentials of the people who submitted it for evaluation.

"It is very, very hard to believe or even fathom why somebody would submit a fraudulent clinical trial," he said.

Dueber said IRBs are not required to check on the credentials of the applicants submitting trials for review, however that after having this experience Coast has changed its policy in hopes of preventing something like this from happening again.

"I feel like there is a thousand-pound gorilla trying to jump on top of me and beat me up," he said.

The FDA defines Institutional Review Boards (IRBs) as a group that has been formally designated to review and monitor biomedical research involving human subjects. According to agency regulations, an IRB has the authority to approve, require modifications prior to approval, or disapprove research. The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of human research subjects.

IRBs are governed by Title 45 Code of Federal Regulations Part 46. IRBs are regulated by the Office for Human Research Protections within the Department of Health and Human Services. In order to approve research the IRB is required to determine the following: that risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits; selection of subjects is equitable; informed consent will be sought from each prospective subject and the consent will be documented; when appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects; and, when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Dueber said that if the subcommittee wanted to address the regulatory oversight, he believes it would have been more productive to get a symposium together of industry players and FDA to discuss it in an open forum.

"Instead, they took an underhanded sting approach," Dueber said, adding that the way the subcommittee chose to address the issue has only caused undue stress and workload for his organization.

"We've spent two weeks on this," he said. "Our job is to protect human test subjects, not kowtow to an angry congress."

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