Coast IRB, the Colorado-based institutional review board caught out in a sting operation by the US Government Accountability Office (GAO), has ceased all operations after losing the confidence of its client base.
The last straw was the warning letter sent to Coast by the US Food and Drug Administration (FDA) earlier this month. In response to the letter, which cited “serious concerns about the company’s ability to protect human subjects participating in clinical trials”, Coast agreed not to approve any new clinical studies regulated by the FDA, nor to add any new subjects to ongoing agency-regulated studies.
According to the FDA, the restrictions were likely to affect some 300 active human research studies conducted by around 3,000 clinical investigators. Coast subsequently issued a letter to its employees and board members noting that “several key customers have already pulled their studies” from the company.
“Thus, it was determined that Coast IRB, LLC should immediately terminate all existing projects and transfer the studies to another IRB,” it stated.
Coast was pilloried for its lax review procedures at a hearing on IRBs organised by the US House Energy and Commerce Committee’s Oversight & Investigations Subcommittee in March.
The company had approved a trial protocol submitted for a fake and potentially dangerous medical device by a sponsor the GAO invented as part of its investigation into IRBs for the Subcommittee. The probe revealed serious flaws in the national system for ethical review and monitoring of clinical trials.
After receiving the FDA’s warning letter and putting any new clinical trials on hold, Coast informed clients that it was co-operating fully with the FDA and would provide the agency with a corrective action plan on or before 29 April 2009.
The IRB had already tried to limit the damage from the Congressional hearing by launching what it described as “immediate and sweeping” reforms of its management and operating procedures. As it turned out, this was too little too late and clients voted with their feet.
