A decade or so ago, the Government Accounting Office published a series of reports faulting human protections at VA hospitals, raising concerns about HHS oversight of human research, and urging continued vigilance in human research.
After a seeming pendulum swing toward protections bashing (witness the outpouring of condemnation after OHRP sanctioned a team of researchers investigating ways to cut infection rates in intensive care units, or the Tricouncil draft policy's use of the phrase "over-protection"), a recent GAO report may show a revival of concerns about independent review operations.
In it, GAO reports the result of a "sting" operation in which a sham device study was presented to three private IRBs. The IRBs were selected on the basis of having "less burdensome initial paperwork requirements." Two of the IRBs rejected the protocol, describing it as "awful" and "the riskiest thing I've ever seen on this board." But one– identified in a New York Times article as Coast Independent Review Board (whose webpage lists "speed" as the first selling point), unanimously approved the protocol, characterizing it as "probably very safe."
Congress, GAO, and press reports are framing this as evidence of flaws in private IRB review. I'm actually impressed that the glass is 2/3 full. And without suggesting endorsement of the private IRB model, I actually wonder how well academic medical center IRBs-- most of whose members are salaried by an institution with a significant financial and professional stake in seeing research protocols approved-- would have performed. (photo credit: laughing squid, 2008)