Thursday, December 1, 2016

Kiwi Christmas

What's going on with research protection at the U?

First came the announcement that Brian Herman was stepping down as Vice-President for Research.. This seemed odd, and not just because Vice-Presidents don't usually step down abruptly in mid-semester. It's odd also because Herman has been the administrator in charge of reforming human subjects protection at the U -- an effort to which the administration has devoted millions of dollars as well as a concerted public relations campaign.

Now comes the announcement that the U is giving its researchers the option of having their industry-funded trials overseen by a for-profit IRB rather than going through the the University of Minnesota IRB. (The announcement says, "Effective January 1, 2017, investigators will have the opportunity to submit IRB applications for protocols initiated and funded by business and industry to Quorum Review IRB.) What do we make of that?

Now, the problems with for-profit IRBs are well-known. There is a financial conflict of interest built into the business model. A sponsor pays the IRB; the IRB decides if its study is ethical. Of course, it is possible that Quorum IRB will do a creditable job despite that conflict of interest. The U's own IRB has not exactly distinguished itself over the years. Yet it does seem unusual that the U is making this move after spending so much money on an IRB upgrade.

I am guessing we will hear more soon. Watch this space.