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Responses to review show U still downplaying problems in human research protection

You’ve got to hand it to the propaganda ministry in the University of Minnesota’s Morrill Hall. Only hours after an external review panel delivered its scathing 92-page condemnation of the university’s failure to protect research subjects, President Eric Kaler said, “I am particularly gratified — but not surprised — that the panel found no legal or compliance violations.” Never mind that the panel discovered flaws so serious that they raised “profound questions” about the ability of the university to conduct reliable research reviews. Never mind a “culture of fear” and “intimidation” in the Department of Psychiatry so severe that staff members are afraid to speak up on behalf of patients. We are supposed to be thrilled that the report uncovered no felonies.

Of course, this is a review Kaler never wanted. For years, the university has fought back against accusations of research misconduct and neglect in the 2004 death of Dan Markingson, a mentally ill young man under a civil commitment order who tried to decapitate himself after being enrolled in an industry-funded drug study against the wishes of his mother. It took a public letter from more than 170 international experts and a resolution by the Faculty Senate in 2013 to force Kaler to commission a review.

Not a look back

Even then, Kaler resolved that past misconduct would be off-limits. “It’s not a review of the Markingson case,” he told the Minnesota Daily. “It’s a review of what we are doing now and what we’re going to do moving forward.”

But the message of the external review was clear: Every failure and abuse that led to the death of Dan Markingson remains a serious risk to research subjects today.  The review team found “little evidence that the University’s Institutional Review Board (IRB) engaged in a meaningful process of evaluating research risk” (p. 78). It found that researchers have failed to address issues of vulnerability to coercion or undue influence, even for patients under involuntary commitment orders, such as Dan Markingson (p. 66-67). The team discovered “inadequate and inconsistent attention to the process of consent,” especially in mentally ill patients (p. 4). In fact, they found that the IRB did not even have the scientific expertise necessary to review research studies adequately (p. 26). To repeat:  At Minnesota’s flagship university, the program charged with making sure that human subjects are not killed or injured in medical experiments does not have the necessary scientific expertise to carry out the task.

Found ‘sense of doubt’

Kaler’s reaction to this alarming news has simply reinforced the review team’s most predictable finding: University leaders have convinced many of us on campus that they simply don’t care about keeping research subjects safe: 

“Most striking was the commonly conveyed sense of doubt in leadership’s commitment to human subjects protection,” the review team wrote. “There is a widespread and seemingly well‐founded perception that the University has reacted to the death of Dan Markingson, and to the ongoing criticism in its aftermath, by assuming a defensive posture.”

elliott portrait
Carl Elliott

A vivid illustration of that posture came last summer in a meeting between Kaler, former Gov. Arne Carlson and Board of Regents Chair Richard Beeson. According to Carlson (and recounted in a letter that Carlson, I and two others wrote to the Legislature last month), Beeson’s response to the six-year controversy over Markingson’s suicide was simply: “It has not risen to the level of our concern.”

Apparently, it has not risen to the level of Kaler’s concern either. On Friday, Kaler claimed that the external reviewers “looked at a narrow slice of our research enterprise: human subjects research related to people with diminished decision making capacity. This represents a small fraction of our clinical research enterprise.” A reading of the review’s final report shows this to be patently untrue. The external review looked at the university’s human subjects protection program, which is responsible for protecting subjects in all medical research studies at the university. In other words, it is not just subjects with psychiatric or neurological impairments who are in danger. It is all subjects who volunteer.

You can’t fix a problem until you admit it exists. Anyone who examined the circumstances surrounding Dan Markingson’s suicide could see that there were serious problems with research protection at this university. The news reports of a very similar case in the Department of Psychiatry last spring only heightened the growing sense of alarm. Yet for years, the university has stonewalled open records requests, dismissed its critics and hidden behind a public-relations smoke screen. So far, that strategy shows no sign of abating.

Carl Elliott, MD, Ph.D., is a professor at the Center for Bioethics, University of Minnesota. He has long sought an independent investigation of the Markingson case and related research ethics issues.

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Comments (2)

  1. Submitted by Bill Gleason on 03/05/2015 - 10:11 am.

    Thank you, Professor Elliott

    Dr. Elliott is a courageous man.

    He has been harassed and ridiculed by the University of Minnesota administration for years over his persistent dedication to patient safety and ethical behavior at the U of M medical school.

    Some ethicists at the University have chosen to ignore this situation. It is easier – and safer – to write books of concern about, say, Abu Ghraib, than to campaign about what is going on in your own back yard.

    There is a longstanding culture of denial in this and other ethical problems at the University of Minnesota. To point out and request correction of them is viewed by many as disloyal. Ultimately, if we are to be the great university we all wish, this culture has to change.

    I am particularly disturbed by the re-election to the Board of Regents yesterday of two significant contributors to this problem. One is a doctor and the other is the Board chair who seems to be more concerned about brand management than about integrity and ethical behavior.

    Will things change? I hope so, but I have my doubts unless the person at the top “gets it.”

    William B. Gleason
    U of M grad and retired med school faculty

    One sad Gopher

    +++

    As long-time readers will know, numerous posts about the Markingson scandal have appeared on my blog, The Periodic Table, over the years.

    To wit: http://bit.ly/18lMLBB

    One of the major problems at the university is that the administration, by and large, ignores the concerns of faculty. And of course the Board of Regents gets its information from the administration. A recipe for the disasters that have occurred.

  2. Submitted by Paul Udstrand on 03/05/2015 - 12:59 pm.

    set it and forget it…

    I think part of the problem is that the IRB and human subjects reviews all take place BEFORE the study is initiated. You have to get approval for the study design, but once you have that approval you’re good to go, and the only real backstop is typically a medical director or some other administrator that’s not usually not keen on interference.

    Once the study is underway, which is usually when problems develop, you can’t get IRB involved.

    One thing that always kind of struck me as odd is the fact that typically the researching doc takes over as the primary doc when a patient is enrolled, if they weren’t to begin with. I’ve always thought a common sense safety valve would be for some other doc to be the primary, while a different doc ran the study. That way if the primary didn’t like what they were seeing they could pull their patient or make treatment changes. A doc might be reluctant to bud into what some other docs doing with a patient, but docs are less bashful about speaking up when someone messes with their own patients.

    What I’m suggesting would be more complex, and you’d have to work out protocol kinks, but I think it would ad a safety to the system?

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