Wednesday, March 6, 2013

Does President Kaler really believe that research regulations at the U are "excessively burdensome"?

On Monday afternoon, President Eric Kaler held an hour-long "conversation" with faculty members in the Academic Health Center.  For most of the hour Kaler fielded softball questions from the moderator and said nothing especially controversial. He did not address the case of Dan Markingson or any other ethical misconduct in the Department of Psychiatry. But I was alarmed to hear his enthusiastic remarks about ramping up university collaborations with private industry, especially in light of recent research scandals. I was especially taken aback by Kaler's rather dismissive comments about conflict-of-interest regulations. So I had a look at his recent "State of the University" address and read this passage:

"Our new vice president for research Brian Herman has begun a strategic planning process for his office, and he wants to promote collaboration between researchers in all disciplines and to increase public-private partnerships. Of course, I strongly support that..."

"Now, you know I’ve been on a quest to “free” our organization from unnecessary administrative burden—those that we impose on ourselves because we have a low tolerance for risk, or because we’re afraid a misdeed of two decades ago will reappear again."

"I expect and insist we will always meet our legal and regulatory obligations. At the same time, however, we must continue to recalibrate our risk tolerance. That means we must look at our own internal policies and ask the question—do they meet—or do they exceed—our legal or regulatory requirements?"

"If they are excessively burdensome, going beyond what the feds or other entities require us to do, we should change them…or at least make a conscious decision not to!"

Now I'm not entirely sure what Kaler means with phrases such as "unnecessary administrative burden" or "low tolerance for risk" or "excessively burdensome" regulatory requirements.  Nor am I sure what he means by a "misdeed of two decades ago."  He could be referring to either of the two university psychiatrists that the FDA investigated and barred from conducting research, one of whom was sentenced to federal prison, or the crippling sanctions imposed on the university by the NIH after the Najarian scandal.  But the current problems at the university are not the result of any excessive regulatory burden. They are the result of industry-funded university investigators ignoring research regulations, repeatedly failing to meet their ethical obligations, and fearing no sanctions whatsoever.  University officials have repeatedly defended this misconduct or looked the other way. To suggest that the university needs to "recalibrate its risk tolerance" is an insult to the research subjects who are being asked to bear those risks.


  1. Kaler seems to be the ultimate "bubble-boy," he lives within his own little world, doesn't breathe the air the rest of do, he's free to ignore the conflict-of-interest's issues that have plagued the University for years, he never has to acknowledge the unethical and repulsive behavior by certain members of the department of psychiatry, yep...he's free to run around with "Goldy" at all the sporting events and pretend all is well Kaler-Land. Someone needs to pull him aside and whisper in his your damn job.

  2. Heaven forbid the University risk exceeding its legal or regulatory requirements.

  3. I would say that "recalibrating risk tolerance" and eliminating excessively burdensome requirements could increase protections for participants in truly risky studies.

    Millum and Menikoff explain this well:

    "IRBs always have constraints on their time and resources, and any time they spend reviewing one protocol takes away time from reviewing others. Institutional review boards should prioritize their time to focus on protocols that are more likely to generate ethical issues but need a way to determine whether a study will raise ethical issues without actually reviewing the full protocol. The regulatory measures we have detailed identify categories of research that are unlikely to be ethically problematic. Using them therefore frees up resources for reviewing riskier research."

    [Joseph Millum and Jerry Menikoff, "Streamlining Ethical Review," Annals of Internal Medicine 153, no. 10 (November 15, 2010): 655-657]

    To the extent that the UMN IRB has been nitpicking relatively safe studies it has been distracted from review of more dangerous studies. I hope that's what Kaler is trying to say.

  4. I doubt it. And citing Menikoff is unlikely to convince skeptics like me, given the failures of OHRP to police risky studies.

  5. Mr. Schrag@.... Curiously, whenever the topic comes up surrounding the IRB at the University of Minnesota and how well they do or don't do their job...the one constant missing factor is the numerical number of protocols that they declined in a any given year. I doubt any. I can only reference data from the CAFE' study, but the IRB was paid $1500. for approving the study back in 2001 or so. In my mind, that makes them a for-profit IRB, and if the IRB memebers are truly volunteer...which I seriously doubt...that's a lot of money generated every month, every year at the U. That's all that matters. For what it's going to cost the UMN in fees from the outside consulting firm to determine how top heavy the administration is...the U could have hired five independent investigators to look into the Markingson if they weren't afraid of the results.

  6. @mike howard -- The IRB is paid (in this case, $1500, which is lower than my private central IRB) to REVIEW a study. They are not paid to approve it. They have the authority to approve, require changes in, and disapprove studies. Some IRBs never disapprove studies, but instead table them or issue "conditional approvals" (sometimes repeatedly) until the research meets the IRB's standards.


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