Science Fiction and Device Trials

A sting operation conducted by the U.S. Government Accounting Office (GAO) documented lax screening by an institutional review board (IRB), which may now result in stricter regulation of medical groups that monitor clinical trials. The GAO successfully registered a fictitious company and a fake medical device, which one independent IRB approved for testing on humans; two other IRBs rejected the bogus protocol. What does this imply about the state of medical device safety in the U.S.?

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