In early March, Coast IRB, a company based in Colorado Springs, Colorado that offers independent review board services for clinical trials, issued an unusual pair of press releases. The first claimed that the company had uncovered an inappropriate clinical trial and immediately alerted the authorities. A few days later, Coast reported that the inappropriate trial was actually part of a sting operation run by the US Government Accountability Office (GAO). Some journalists, including this writer, commented in news stories and blogs on what appeared to be an amusing but ultimately harmless chain of events: the GAO probed IRBs, and Coast apparently passed the test.

But, according to government investigators, Coast had in fact granted an expedited approval to the fake clinical trial, revoking it five months later only after being contacted by congressional investigators.

“Coast IRB, a for-profit company, approved a fictitious study led by a fictitious doctor and submitted by a fictitious company,” stated US House Oversight and Investigations Subcommittee chairman Bart Stupak at a 26 March hearing on the matter. Worse, the GAO's sham study had been rejected up front by two other IRBs, who had slammed the protocol as being too risky.

It was not Coast's first run-in with the authorities. Precisely a year earlier, the US Food and Drug Administration (FDA) had temporarily suspended the company's ability to perform expedited trial reviews, after ruling that Coast had improperly approved a trial's recruitment poster.

Company representatives remained on the offensive, at least initially. In his opening statement, Coast chief executive officer Daniel Dueber asserted that “the Government Accountability Office, at the behest of this Committee, perpetrated an extensive fraud against my company, Coast IRB. It did so without probable cause that Coast had committed any crime. Indeed, no one at Coast has committed any crime.” Dueber went on to claim that the GAO's sting operation had violated state and federal law to “prove a political point.”

After a thorough grilling by the committee, however, Dueber abruptly changed tacks. In a contrite statement issued shortly after the hearing, he announced a barrage of policy changes at Coast IRB and conceded that “we were duped. Had we started from a premise of skepticism rather than trust, we would not have been.”

And in a major development two weeks later, the FDA announced on 14 April that Coast IRB had agreed to voluntarily freeze ongoing reviews of clinical trials at the request of the agency—a move the FDA said could affect more than 300 trials.