Wednesday, April 15, 2009

Human Experimental Oversight A SHAM

April 14, 2009 From WSJ Blog

An institutional review board that approved a fake clinical trial brought to it by a government sting operation won’t have the chance to approve any real FDA-regulated studies any time soon.
Coast IRB was snagged by an undercover investigation in which congressional staff and the Government Accountability Office created a fake medical study of a fake product to see whether for-profit review boards adequately supervise medical trials. IRBs must sign off on clinical trials before they can go ahead; a major charge they have is to look out for the well-being of trial subjects.

Coast “approved our bogus research protocol for human subjects testing after only minor edits to our submission materials, even though we were a bogus company with falsified credentials and an unproven medical device,” the GAO wrote in a report. (GAO didn’t name Coast directly in the report, but did so in congressional testimony.)

The FDA said today that Coast has agreed, until further notice, to stop reviewing new FDA-regulated studies and will direct researchers involved with ongoing FDA-regulated studies it previously approved to halt enrollment of new subjects. Some 300 studies involving some 3,000 researchers may be affected, the agency said. The agency added that the already-approved trials would be allowed to continue and said in a Q&A that its action was “precautionary.”
In a warning letter to the company, the FDA said Coast’s violations included failing to determine whether risks to subjects would be minimized and to show its ability to determine whether the research was acceptable under legal and professional standards.

Update: In a written statement, Coast CEO Daniel Dueber said the company is cooperating with the FDA and is making “sweeping” changes “designed to exceed the level of protection required by existing law.” Changes in the works include putting a new board in place, establishing new standard operating procedures and doing frequent internal audits.

“We are revamping every aspect of the company,” Dueber said. “Within the next 30 days this company will be completely different, operated by different people, relying on different standard operating procedures, even having a different name.”
See Coast news releases on the matter.

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