The federal government needs to boost its oversight of the institutional review boards that approve scientific studies and protect clinical trial participants, especially since more for-profit companies are taking running these reviews, a report from a government watchdog warns.
Also known as ethics committees, institutional review boards occupy a crucial, but behind- the-scenes role in ensuring clinical studies are conducted properly. Federal regulations require certain research conducted on humans to first win approval from such a board. The committees therefore have the authority to approve a study, require modifications, or reject proposed research if the risk to participants is too great.
The U.S. Food and Drug Administration and the Office for Human Research Protection at the U.S. Department of Health and Human Services oversee about 2,300 of these boards. However, the U.S. Government Accountability Office found the agencies have not assessed the extent to which the boards effectively protect human subjects, because they have not determined the best approaches for doing so.
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