Friday, March 27, 2009

Red Handed: An Independent Review of IRBs


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)

3 comments:

Anonymous said...

I noticed the IRB involved in the story in not accredited (otherwise, it will be promoted on their website, as it is the case of other for profit IRBs). Although I am not sure accreditation would solve all the problems/concerns it may help on conducting a more proper work.

Jonathan Kimmelman said...

Thanks for your comment. Perhaps accreditation might have made a difference (I was able to find news reports on the web that Coast sought accreditation-- but could not find any reports that they actually received it!)

Based on the GAO, registration systems with the federal government do not provide much if any of a check. The report included a second "sting" operation, in which GAO created and registered a "bogus IRB," with Office for Human Research Protections (OHRP). According to the GAO report, OHRP "currently has three employees who review all registrations and applications... [and] the department does not review IRB registrations or assurance applications to assess whether the information submitted is factual."

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