As if the Coast IRB sting couldn’t get more crazy, the company itself has decided to close up shop on the more than 300 clinical trials it was reviewing, according to an AP story, and transfer them to another company.
But the best part of all is that who helped uncover all of Coast IRB’s negligence and mistakes was Trooper, to be CEO or maybe even IRB head at Med-Device Systems (the fictitious company created by the House Energy and Commerce Committee), a three-legged dog. Trooper, who has since gone on to his great Doggie Reward in the Sky, was the name of a Capitol Hill staffer’s pup.
With other name’s on Med-Device’s application for “Adhesiablog” like “Phake Medical Devices, April Phuls, Timothy Witless and Alan Ruse” (thanks to the Wall Street Journal for this info) it is shocking that this phony scheme went on as long as it did.
So, if a three-legged dog can run an IRB, what does that say about research review organizations generally? The answer is: we don’t know. No one is policing them.
We need a referendum on the state of our human subject review system–both institutionally and for those reviews done externally by contract organizations. For all the fun that we have poked at Coast IRB, it’s time for each of us consider the tough question: should these external organizations exist as currently overseen? Are they ready for the proliferation of them as stem cell protocols and other kinds of human subjects research are about to blossom under the Obama administration? Who is going to ensure that scandals like the Coast IRB debacle will not occur again?
Unless greater vigilance of all these organizations is put in place now, many more protocols will fall through the cracks. We can only wish, perhaps that Trooper’s ghost will be visited upon them.
Summer Johnson, PhD