Legislative Auditor James Nobles and his staff investigated the case of a 26-year old man who suffered from schizophrenia. In 2004, Dan Markingson committed suicide while enrolled in a University drug research study from the Department of Psychiatry. He died after he tried to decapitate himself.
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The report says it's almost impossible to connect Markingson's death directly to his involvement in the study but the school was unwilling to acknowledge problems within its program.
"They have repeatedly claimed that clinical research at the University meets the highest ethical standards and dismissed the need for further consideration of the Markingson case by making misleading statements about past reviews," the report continues. "This insular and inaccurate response has seriously harmed the University of Minnesota's credibility and reputation."
Nobles noted researchers ignored the pleas of his mother to remove Markingson from the study because she feared he was in danger of killing himself. Contrary to the University's ongoing claims that the case was thoroughly investigated, the Legislative Auditor's office found that wasn't the case.
Mike Howard is a close friend of Weiss' and represented her at Thursday's hearing. Weiss is recovering from a series of strokes.
"Nothing is going to change for Dan" said Howard. "I hope Mr. Noble's report will save other people."
Lawmakers asked for the probe after seeing a series of stories by the Fox 9 Investigators which raised serious questions about the school's human research program.
U 'commits' to improving research practice
In a news release Thursday, University of Minnesota President Eric Kaler outlined steps that the University will take to improve its human subjects research practices "so they meet the highest standards of ethics and science." This is a response to the two external reviews.
"Before all else, I want to express our deepest sympathy to Dan Markingson's mother, Mary Weiss, and apologize to her for his death while he was under our care. The loss of Dan Markingson's life was a terrible tragedy," Kaler said in the release.
"Our doctors, nurses, researchers and leaders at the University of Minnesota are dedicated to finding cures and treatments for diseases that affect Minnesotans, including mental illness, which takes an incredible human toll," he said. "While we strive to be the very best, it is clear that we can do better. Today we reaffirm our commitment to protect patients, and we are taking immediate action to improve Minnesota's research university."
The Board of Regents will review the Legislative Auditor and the external panel reports at its next public meeting on March 27.
The steps include:
-Suspending enrollment in all Department of Psychiatry interventional drug studies – those both active and awaiting approval – until they are reviewed by an independent Institutional Review Board
-Developing a plan of action by May 15 – in fewer than 60 days from today – to review and implement recommendations from an external review panel report on the U's human subjects research practices, which was issued earlier this month
-Examining other clinical studies that target vulnerable populations, using an independent Institutional Review Board and the U's post-approval monitoring process; the studies will be reviewed to ensure researchers are meeting best practices
-Appointing a Community Oversight Board of external experts in human subjects research and research ethics to ensure we are using best practices.