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
Apr 13, 2009
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,...
primanded;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, including failing to ensure a trial would minimize risks to study subjects. The agency placed an indefinite hold on the company's operations, until it determines that Coast has corrected its problems. Coast previously received a linkurl:warning letter;http://www.fda.gov/cder/warn/2008/08-HFD-45-1101.pdf from the FDA in March 2008 for problems with its study review process. After last month's hearing, the company pledged to reform its practices, and according to its linkurl:web site,;http://www.coastirb.com/ is currently in the midst of a 30-day internal audit scheduled to end on 1 May. Dan Deuber, Coast IRB's president and CEO, did not immediately reply to a phone and email request for comment.
**__Related stories:__***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]

Interested in reading more?

Become a Member of

Receive full access to more than 35 years of archives, as well as TS Digest, digital editions of The Scientist, feature stories, and much more!
Already a member?