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May 13, 2009, Vol 301, No. 18 >

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Capitol Health Call | May 13, 2009

IRB Oversight Questioned

Mike Mitka
JAMA. 2009;301(18):1868. doi:10.1001/jama.2009.604.
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The federal government needs to improve its mandated oversight of institutional review boards (IRBs) that approve research on humans, said members of the House Energy and Commerce Subcommittee on Oversight at a March 26 hearing.

The call for improvement came after the Government Accountability Office (GAO) provided testimony on its undercover investigations into the IRB system. The GAO created a bogus IRB and successfully registered it with the Department of Health and Human Services (DHHS). The GAO said it also succeeded in getting approval from an actual IRB to test a fictitious medical device on human participants even though the apparatus matched several examples of “significant risk” devices from Food and Drug Administration guidance.

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