FDAnews
www.fdanews.com/articles/122992-irb-8217-s-approval-of-studies-comes-under-fda-fire

IRB’s Approval of Studies Comes Under FDA Fire

December 15, 2009
The Burzynski Research Institute’s institutional review board (IRB) failed to discuss a member’s concerns about the source of an investigational drug for a safety and efficacy study and the need for a patient risk-benefit analysis, an FDA warning letter says. Minutes from a 2008 IRB meeting — more than a year after the concerns were raised — reveal the board was aware that dosing of 15 subjects had begun without approval, according to the Oct. 5 warning letter posted to the FDA’s website recently. But the IRB didn’t report the noncompliance.
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