Saturday, July 15, 2017

At the University of Minnesota, a new strategy for keeping research oversight proceedings secret

Since the blistering investigations of 2015, the University of Minnesota has been outsourcing a portion of its human subjects protection program to a company called Quorum Review IRB -- a commercial, for-profit Institutional Review Board based in Seattle. For a time it required that psychiatric studies undergo review by Quorum, rather that the U's own IRB. Then it began giving all U researchers conducting industry-funded studies the option of going through Quorum rather than the U.

I have mixed feelings about this development. I'm generally very skeptical of for-profit IRBs, mainly because of their built-in financial conflicts of interest. For-profit IRBs review studies in exchange for a fee from the research sponsors, which gives the IRB an obvious incentive to go easy on the studies. If they are too tough, it's easy for a research sponsor to take its business to another company. On the other hand, I am also very skeptical of the U's IRB, which has not exactly distinguished itself over the years.

One big problem with for-profit IRBs is secrecy. As private businesses, they are under no obligation to reveal anything about their decisions to anyone other than their clients. Not that the U itself is a model of transparency, but at least the U is (in theory) legally obligated to comply with state open records laws.

What about Quorum? Is the public ever going to be able to see any of its proceedings? If not, how will we ever know if there has been any trouble in the research studies it has reviewed? It is possible that U researchers are conducting industry-sponsored, privately reviewed studies at the U with no obligation to reveal anything about them to the people of Minnesota.

When I asked these questions at the last meeting of the U's Research Compliance Advisory Committee, I was assured by Frances Lawrenz, the Associate VP for Research, that Quorum's reviews would be available to the public. So on May 11, 2017 I decided to test that assurance. I filed Data Practice Act requests for three studies reviewed by Quorum, all of them from the Department of Psychiatry.

Other than the electronic acknowledgement of my requests that day, I have heard nothing since then. I have emailed Susan McKinney, the U's Certified Records Manager, three times, and I have been unable even to get a reply, much less an update.

None of this is surprising.  Of course, it would not have been surprising even if I had been asking for records from the U's own IRB; the U is notoriously noncompliant with open records requests. But if the U keeps outsourcing research oversight, secrecy will be a continuing issue. (And given the U's record, maybe that's the point.)


  1. Let me guess, studying the new psychiatric miracle-pill-turn-class-action-lawsuit like bifeprunox or seroquel. Insert chemical A into neural pathway B. Smashing success!

  2. Wow. Just wow! I don't often comment here, - although I at least scan EVERY F&LiBE... But I just gotta say, *KEEP* *UP* *THE* *GOOD* *WORK* !!!!....