Troubled IRB closes shop

A company that serves as an independent review board for clinical trials and was caught approving a fake medical device study will close, the Wall Street Journal linkurl:reports.;http://online.wsj.com/article/SB124042341694744375.html The company, Colorado-based linkurl:Coast IRB,;http://www.coastirb.com/ was exposed in a government sting operation last month. Based on the undercover investigation's findings, the US Food and Drug Administration (FDA) sent Coast a formal reprimand on April 14 f

Written byAlla Katsnelson

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A company that serves as an independent review board for clinical trials and was caught approving a fake medical device study will close, the Wall Street Journal linkurl:reports.;http://online.wsj.com/article/SB124042341694744375.html The company, Colorado-based linkurl:Coast IRB,;http://www.coastirb.com/ was exposed in a government sting operation last month. Based on the undercover investigation's findings, the US Food and Drug Administration (FDA) sent Coast a formal reprimand on April 14 for violating rules protecting clinical trial subjects. The FDA's action resulted in Coast freezing some of its key operations and promising to devise a plan to correct its shoddy practices by the end of the month. In a linkurl:letter;http://s.wsj.net/public/resources/documents/WSJ_Letter-Coast-employees-Board-Members_041709.pdf sent to employees and board members last week and posted today (April 22) by the WSJ, the company wrote that as a result of the FDA's letter, "several key customers have already pulled their studies from Coast IRB. Thus, it was determined that Coast IRB, LLC should immediately terminate all existing projects and transfer the studies to another IRB."
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[ 14th April 2009]*linkurl:Trial safety lacking, says GAO;http://www.the-scientist.com/blog/display/55546/
[26th March 2009]*linkurl:Subject death halts clinical trial;http://www.the-scientist.com/blog/display/54825/
[8th July 2008]*linkurl:Paying for patients;http://www.the-scientist.com/article/display/54196/
[February 2008]