March 31, 2009Institutional Review Board Approves Testing Of Fake ProductThis falls under the category of "One of the weirdest stories I've ever seen": Investigators for HHS created a bogus product and an obviously bogus clinical trials protocol for the same and submitted it to three institutional review boards and one of the boards actually approved the trial. IRBs, as they are known, are roughly the same thing as human subjects committees at medical centers and they are supposed to evaluate protocols for trials of drugs and devices that will be used on patients in clinical trials shops. The trial called for a full liter of a fictitious liquid to be poured into a woman's stomach after surgery (which I've never heard of before) and while two IRBs rejected the protocol, one--namely, Coast IRB, LLC., of Colorado Springs--approved the protocol, calling it "probably very safe," according to the AP. The HHS investigators also created a fake IRB and was contacted by at least one research coordinator looking for quick turnaround of a protocol approval. All of this shows how easily the IRB process can be manipulated. Posted by Philip Dawdy at March 31, 2009 12:01 AM
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It's worth looking at the hearing on this scandal: Coast IRB, the private for-profit review board that approved the fake product, openly marketed itself as the fast, easy road to approval. It offered $1,300 discount coupons and promised it could help you "Coast through your next study!" Posted by: Johanna at April 1, 2009 02:27 PMPost a comment
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