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Abuse and fraud of the US system to screen medical research into products tested on humans has been reported by government investigators.
The Government Accountability Office (GAO) says that the system “is vulnerable to unethical manipulation, particularly by companies or individuals who intend to abuse the system or to commit fraud.”
It reports that it was able to register a false institutional review board – complete with a dog as its fictional president – with the Health and Human Services Department.
It also reports that it “easily” won approval for a fake product, to be used in medical testing on human subjects, from a private review board.
Coast IRB has hit back by claiming that by falsely representing itself to be a medical device company and forging a medical license, the GAO violated federal and state criminal laws.
Boss Daniel Dueber said: “We were hoodwinked.”
Not so, says Bart Stupak, chairman of the House Energy and Commerce Committee’s oversight and investigations panel: “You took the bait, hook, line and sinker.”
Copyright Press Association 2009