GAO Borrows Sting Tactics from Chief Wiggum to Bust For-Profit IRBs

March 27th, 2009

Posted by: admin

Nature’s The Great Beyond blog has an interesting, if annoying, entry on a recent Congressional investigation into for-profit Institutional Research Boards (IRBs).  For those readers who haven’t done research involving humans, IRBs sign off on research protocols in human subject research.  Universities and other non-profit research organizations have them, but there are also for-profit IRBs.  As the profit motive in such operations can skew toward generating approvals rather than fulfilling the expected research oversight, a Congressional investigation into these companies makes sense to me.

You can read the specifics – statement from witnesses and Representatives, supporting documents – about the hearing via the House Energy and Commerce Committee’s website.  The really short version – the committee had Government Accountability Office (GAO) investigators set up fake companies with fake products seeking IRB approval.  So far, so good.  The tactics, however, suggest an interest in the eventual Congressional grandstanding had way too much influence over the investigation.   From the blog entry:

A three-legged dog named Trooper overseeing experiments on humans? An ethics committee named “Phaké Medical Devices” and based in “Paynesville, South Carolina”?

Another [fake IRB], called E-Z Reviews, was based in “Chetesville, Arizona” and was staffed by April Phuls, Timothy Wittless, and Alan Ruse.

By setting up the companies to look like something out of The Onion’s reject pile, the GAO and the Subcommittee on Oversight and Investigations manage to make a mockery out of for-profit IRBs and the role of Congressional oversight.  Now if there’s cause, I have no problem with the former.  I have little patience for research misconduct and other shenanigans that undercut the practice of research.  To send a well-respected investigative agency – the GAO – out to capture a few instances of incompetence with an eye toward press releases and political vaudeville bothers me a great deal.  It suggests that the Subcommittee is not serious about thoroughly documenting the conflicts inherent within for-profit IRBs and examining whether or not regulations of not-for-profit IRBs (which aren’t perfect) could be of use.  I hope I’m wrong.

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