Legislative Auditor James Nobles is launching a fresh review of ethics concerns in psychiatric research at the University of Minnesota — and lobbing criticism at the university's Board of Regents.
Auditor plans second review of U of M psychiatry ethics problems
Kaler notes staff changes since scathing 2015 report; auditor scolds regents.
March 16, 2016 at 2:31AM
Testifying on Tuesday before the House Higher Education Policy and Finance Committee, Nobles said this review seeks to determine whether the U has fixed lapses in recruiting and safety oversight of psychiatric research that he identified in a scathing audit last year.
Nobles commended lawmakers, who grilled U officials for two hours about the controversy, for holding the U accountable for its psychiatric research, then asked why the regents hadn't done so.
"You elected the regents to do what you did today," he said, "and they have not done."
University leaders at the hearing acknowledged a history of problems in the Psychiatry Department but reviewed a litany of changes over the past year, including the replacement of the department chairman, a suspension of psychiatric studies until they were deemed safe, a transfer of oversight authority for psychiatric studies, and new rules for the recruitment of unstable psychiatric patients.
U President Eric Kaler told the committee that the department already has made three major staff changes, but he added: "More than three people are probably going to have to go.
"My regret … is that I did not start on this sooner," Kaler added, acknowledging that problems were raised by media reports and university whistleblowers years ago.
Concerns emerged after the 2004 suicide of Dan Markingson, who was enrolled in a U schizophrenia drug study at the time of his death. Markingson's family alleged that he was coerced into the study by a psychiatrist, Dr. Stephen Olson, who was treating him while also receiving funding from drugmaker AstraZeneca to conduct the study. Media reports raised concerns about the case in 2008.
Olson remains on faculty, but university leaders said he is not allowed to conduct clinical research until he completes additional training. Kaler noted that the U has replaced Dr. S. Charles Schulz, the former chairman who also was involved in the Markingson study. An announcement on his permanent replacement is expected soon. Another researcher was forced to step down after he admitted forging a federal research document to expedite a study.
The university's Faculty Senate will vote next month on a policy that prohibits researchers in all departments from receiving financial perks from private companies such as drug manufacturers while conducting research for them.
Whistleblowers also testified at the hearing and expressed skepticism about the university's reforms.
Bioethics Prof. Carl Elliott noted that his concerns about the Psychiatry Department's overall research and treatment of Markingson had been rebuffed for years. So he said he has trouble believing the same university officials are now taking action.
They say their "eyes have been opened, 'We've been converted,' " he told lawmakers. "Well, don't believe it."
Jeremy Olson • 612-673-7744
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