Putting IRBs under the microscope

I am a member of the University of Wisconsin Health Sciences Institutional Review Board. Reviewing a new protocol application can be a very lengthy process, depending on how well the application and protocol are written, but I would say in general I spend several hours on each new protocol review. Other board members also review the same protocol and application, even if only one of us is presenting the information. It is a lot of work, but clearly is in the study participants' best interests, so we view it as an honor to be on the IRB.

So, I was shocked when I came across a story in the New York Times and the Wall Street Journal about a sham product, including a fraudulent company and principal investigator, which made its way through a private IRB. Congress apparently arranged for this sting operation, given concerns that private IRBs may be too concerned about alienating the companies that use them to sufficiently and independently enough review the applications. The company in question feels that this sting was done to publicly embarrass them, and they contend that they did follow all the rules when they approved the study, but when they went back to validate the company's address at the credentials of the principal investigator, they found that neither really existed.

It seems like private IRBs may be getting the most scrutiny from lawmakers right now, but potentially all IRBs could be subject to this kind of investigation. Frankly, I think it is right and fair to carefully monitor IRBs, and I welcome it. At the end of the day, if the IRB members aren't doing their "due diligence," we aren't protecting patients. And that is the whole point, is it not?