Legislative Auditor review says U of M psychiatry department ‘inadequate’ in reporting adverse events

A new Legislative Auditor’s review [PDF] of the University of Minnesota’s psychiatry department did not find additional cases of patients who died while participating in industry-sponsored research, other than the 2004 case of Dan Markingson, who committed suicide.

But the new report indicates that “the reporting of adverse events by some study researchers has been inadequate.”

In March, a Legislative Auditor’s initial report on the case was scathing in its criticism of the university’s handling of the case of Markingson, a mentally ill young man from St. Paul who committed suicide in 2004 while enrolled in a U of M industry-sponsored clinical trial.

In that report, legislative auditor James Nobles wrote:

“The Markingson case raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge. They have repeatedly claimed that clinical research at the University meets the highest ethical standards and dismissed the need for further consideration for the Markingson case by making misleading statements about past reviews. This insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation.”

The University’s Board of Regents last week approved a plan designed to strengthen research protections.

Board Chairman Richard Beeson said of the new plan: “It charts the right course for the future of medical research at this University, and we will oversee its full implementation.”

The new Legislative Auditor’s report, issued this morning, had two goals:

  • Determine whether anyone — other than Markingson — died while participating in a University of Minnesota Department of Psychiatry industry-sponsored study
  • Assess whether researchers conducting psychiatric studies at the University have adequately reported adverse events to the University’s Institutional Review Board

The reviewers found one other death reported in relation to industry-sponsored studies, but said it was clearly not related to the research.

But the review says that University researchers often provided the Institutional Review Board “with little documentation about the nature of adverse events or whether those events related to the study.”

The reviewers also offered some options for better reporting of adverse events.

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