Review: U of M not doing enough to keep research subjects safe

An independent review finds the University of Minnesota's research policies are "weak" and not doing enough to protect the people who take part in its studies.

An independent review finds the University of Minnesota's research policies are "weak" and not doing enough to protect the people who take part in its studies. The controversial case of Dan Markingson helped trigger the need for a team outside the University to examine the human research program.

Mike Howard has stood with his close friend, Mary Weiss during her decade-long battle with the University of Minnesota. "I gave her the report to read. As she got into it her eyes swelled up and it was difficult for her," Howard recalled.

Weiss' only child, Dan Markingson committed suicide while enrolled in a Department of Psychiatry drug study. Just before Mother's day 2004, he grabbed a box cutter and violently slashed his chest and neck while on a study drug. In the last couple years, Weiss has suffered two strokes and is not able to do an interview.

"This report indicates exactly the same concerns that happened ten years ago with her son and they have not been corrected," said Howard.

The Faculty Senate at the school voted for the independent review just weeks after a report by the Fox 9 Investigators (Nov. 2013) raised troubling questions about Markingson and the drug trial.

"I think they did a great job and they obviously looked at every aspect of what the concerns were," Howard said of the independent review.

The national panel of experts said there are "significant problems with core functions of the human research protections program." And added that "given the history of concern and scrutiny of its programs, the University leadership should have taken more informed and affirmative steps to identify and address deficiencies, particularly within the Department of Psychiatry."

"The report really helps provide the University a healthy roadmap in terms of raising our program to one that is beyond reproach," said Dr. Brian Herman, vice president for research at the U of M.

The school says it began work on some improvements such as increased staffing, training and monitoring of study subjects.

But the report makes a total of 63 recommendations.

"A lot of us worried it was going to be a white wash, said Carol Elliott, a bioethics professor at the school and big critic of the school's polices regarding human research. "It seems like a small step and we got a long way to go."

In mid-March, the MN Legislative Auditor is expected to release his report of the University's human research practices.

Complete report: http://www.research.umn.edu/news/external-review.html#.VPIHpJ3nYdU

Original Fox 9 Investigators report: http://www.myfoxtwincities.com/story/23994239/investigators-side-effects-of-drug-study


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