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FDA - Coast IRB To Halt Drug Studies Due To Violations

Posted by Chrissie Cole
Wednesday, April 15, 2009 11:19 AM EST
Category: Major Medical
Tags: Coast IRB, Clinical Trials, Medical Devices, FDA, Pharmaceutical Industry, Drug Safety



Coast IRB, LLC is voluntarily halting some aspects of its clinical trial oversight operations due to serious concerns about the company’s ability to protect human subjects that participate in clinical trials, according to the Food and Drug Administration (FDA).

Based on company records, these actions involve 300 active human research studies conducted by some 3,000 clinical investigators.

Under federal law, clinical research that involves human subjects and FDA-regulated products, such as medical devices and drugs, must have the review and approval of an institutional review board, or IRB.

An IRB is made up of a panel of scientists, doctors and non-scientists that review the clinical research to protect the rights and welfare of participants as subjects of research.

If the IRB finds the risks to participants is too great, it will not approve the research or it will specify changes that must be made before the research can begin.

The actions follow an undercover operation launched by the U.S. Government Accountability Office (GAO) last year. GAO investigators set up a fake study of a fake medical procedure and submitted it to three IRB companies for review.

Coast was the only one of the three to approve the trial for a make-believe surgical gel that would have involved human subjects. The findings became public in early March and was detailed in a hearing before the House Energy and Commerce Committee on March 26.

Following the sting, the FDA determined Coast IRB had committed several violations of the laws and regulations intended to protect the rights and welfare of human research subjects in clinical trials. The company also failed to perform the proper review needed to approve a study.

The agency sent a formal warning letter to Coastal highlighting the violations of IRB guidelines on Tuesday. In the letter, the FDA described it as the largest shutdown of IRBs in the agency’s history.

Coast released a statement stating, “Coast IRB is cooperating fully with the Food and Drug Administration to implement corrective actions to bring the company into compliance with FDA regulations designed to protect human research subjects.” Read the statement in its entirety here.

In a statement released Tuesday, Rep. Bart Stupak (D., Mich.) said, “Today’s announcement by the FDA and Coast shows how congressional investigations can result in meaningful changes in corporate behavior.” Rep. Joe Barton (R., Texas) added, “The news that the crackdowns have begun is especially good news.” #

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