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UoM board agrees to suspend enrollment in human psychiatric drug studies

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The Board of Regents at the University of Minnesota has backed President Eric Kaler's decision to suspend enrollment in psychiatric trials after a report criticized the U's handling of a patient who took his own life.

State auditor Jim Nobles identified "serious ethical issues and conflicts of interest" in his report into the 2004 suicide of Dan Markingson, who was enrolled in a human subject research trial testing anti-psychotic drugs.

Nobles findings followed a similarly critical report from the U's own Faculty Senate.

In a statement released Friday, Board of Regents chair Richard Beeson backed steps taken by Kaler in the wake of the criticism, saying that "recent independent reports have made it clear that we must improve our current practices."

The board on Friday approved the following actions:

  • Suspending enrollment in all 17 current Department of Psychiatry interventional drug studies that are either active or waiting approval, until they are reviewed by an external and independent Institutional Review Board.
  • Develop a plan of action by May 15 to review and implement recommendations from the Faculty Senate.
  • Examine other clinical studies that target vulnerable populations.
  • Appoint a community oversight board of external experts in human subjects research and research ethics to ensure best practice.

Markingson, a 27-year-old who suffered from schizophrenia, took his own life in May 2004 while participating in a university clinical drug study funded by pharmaceuticals giant AstraZeneca.

Nobles concluded in his report that it is not possible to know whether Markingson’s suicide could be connected to his participation in the trial. But concerns were raised over how he was recruited into the trial, and the report was heavily critical of the U’s response to the case, and its unwillingness to acknowledge the ethical issues and conflicts it raised.

Efforts to address the problems are being welcomed by Leigh Turner, of the Center for Bioethics, but he argues the U isn't going far enough.

He told the Pioneer Press that concerns about aggressive recruitment of vulnerable research subjects and retaliation against whistleblowers will continue if psychiatry chair Charles Schulz and research Stephen Olson, who were both involved in the Markingson case, remain at the U.

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