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Trial safety lacking, says GAO

The system for protecting the safety of people who participate in clinical trials is in shambles and needs a major overhaul, according to the conclusions of a two-year undercover US government investigation. The undercover investigation, which caught a commercial institutional review board approving a fake study made up by investigators at the Government Accountability Office (GAO), is "absolutely" a positive step, said Adil Shamoo, a professor of biochemistry and molecular biology at the Univ

Alla Katsnelson
The system for protecting the safety of people who participate in clinical trials is in shambles and needs a major overhaul, according to the conclusions of a two-year undercover US government investigation.
The undercover investigation, which caught a commercial institutional review board approving a fake study made up by investigators at the Government Accountability Office (GAO), is "absolutely" a positive step, said Adil Shamoo, a professor of biochemistry and molecular biology at the University of Maryland School of Medicine. "The current system is broken and it will require reform," Shamoo, who has worked extensively on research subject protection issues, told The Scientist. He noted that there are about 10,000 IRBs operating in the US. "So if there is 10% bad IRBs, you're talking about a million human subjects put at risk." At a Congressional hearing today, legislators lambasted a commercial institutional review board, linkurl:Coast IRB,;http://www.coastirb.com/ for giving a green...
The ScientistThe ScientistEditor's note (March 26, 2009): This story has been updated from a previous version to correct the spelling of the IRB invented by the GAO, Maryland Hause.



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