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FDA censures lax IRB

A company that serves as an independent review board for clinical trials and was the center of a recent Congressional "sting operation" was linkurl:reprimanded;http://www.fda.gov/bbs/topics/news/2009/NEW01996.html today (April 14) by the US Food and Drug Association (FDA) for violating rules protecting research subjects. The company has agreed to freeze some of its key operations. Specifically, under pressure from the FDA, the company, Coast IRB, voluntarily agreed not to approve any new stu

Alla Katsnelson
A company that serves as an independent review board for clinical trials and was the center of a recent Congressional "sting operation" was linkurl:reprimanded;http://www.fda.gov/bbs/topics/news/2009/NEW01996.html today (April 14) by the US Food and Drug Association (FDA) for violating rules protecting research subjects. The company has agreed to freeze some of its key operations. Specifically, under pressure from the FDA, the company, Coast IRB, voluntarily agreed not to approve any new studies or take on any new patients in studies already on its books. The company will continue to provide ethics oversight to patients already enrolled in studies now underway. The Congressional investigation, which was made public about three weeks ago, caught Coast IRB approving a fake medical device trial that other ethics review boards deemed unsafe for patients. In linkurl:today's letter;http://www.fda.gov/cder/warn/2009/Coast_IRB_letter.pdf to Coast IRB, the FDA stated that, based on the investigation, the company had broken several federal laws and regulations,...

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