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YOU would hope that a fake company, proposing to test a risky medical procedure, would be turned down flat. But that鈥檚 not what happened in an elaborate operation set up to probe the US system for protecting volunteers in clinical research.

Trials of new drugs or medical devices can only begin if approved by an Institutional Review Board (IRB). Often these are attached to the hospitals or universities where the research will take place. But the task is increasingly being performed for profit by commercial IRBs, prompting fears that some may be rubber-stamping risky trials without proper scrutiny.

鈥淔ears that some boards may rubber-stamp risky trials without proper scrutiny may be justified鈥�

Now it appears these fears may be justified. At a on 26 March, the Government Accountability Office revealed the results of an investigation commissioned by the US House of Representatives Committee on Energy and Commerce. To test the responses of commercial IRBs, the GAO created a proposal from a fictitious company called that wanted to test the ability of a gel, poured into the abdomen, to reduce the growth of scar tissue after surgery. The for the trial matched multiple examples described as posing 鈥渟ignificant risk鈥� by the Food and Drug Administration.

The GAO submitted the fake proposal to three commercial IRBs, two of which rejected it. But of Colorado Springs by a unanimous vote, describing it as 鈥減robably very safe鈥�. The Committee on Energy and Commerce also found that Coast approved all 356 proposals it received in the past five years, and earned $9.3 million for its services in 2008 alone.

Committee chairman Henry Waxman has to 鈥減ush for reforms that will protect the health and safety of the American people鈥�.