UMN president agrees to outside review of clinical research practices
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University of Minnesota President Eric Kaler says he will form an outside panel to review how the U treats human subjects in clinical trials.
His announcement followed a faculty resolution today requesting a review of the U's practices. (See Item No. 10 on the second-to-last page above.)
The panel is a response to the 2004 death of patient Dan Markingson, who killed himself while enrolled in a clinical drug study at the U.
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Faculty leader Naomi Scheman says lingering questions over his death have put the U's reputation under a cloud.
"It's not going away because -- despite the university's insistence that it has been adequately investigated -- very credible, serious, thoughtful, fair-minded people do not find those investigations genuinely to be credible."
Kaler says he welcomes the review, saying it would put to rest any doubts over how the U handles people in clinical research.
"Let's look at what we're doing now, currently. I have a great deal of confidence in what we're doing, and I think an external validation of that -- which is what I expect it to be -- will close the chapters."
Kaler said he will form the panel early next year.
Carl Elliott, who has been one of the main scholars raising questions -- and who has called for an outside investigation into Markingson's death -- says he's trying to stay optimistic:
"It all depends on who picks the panel, what they're allowed to look at, and what kind of access and power they have to get at records, to get at court documents, to get at finances, to interview people who have been involved in clinical care as patients and research subjects that were in the department of psychiatry. All that stuff is going to be important .. for whoever sets up this panel to make sure they're given the tools and expertise to do their job."
This morning, a friend of the Markingson family, Mike Howard, delivered a petition with almost 3,500 signatures to Gov. Mark Dayton's office asking for "an external panel of experts to investigate ethical wrongdoing in psychiatric research at the University of Minnesota, including the circumstances surrounding Dan’s death."
He later Kaler's announcement of the panel "a tremendous first step."
He added:
"The records will speak for themselves. ... It does restore some faith that there is some honesty and integrity at the University. Because for a long time, it has been held in a closet. And today is the first day it came out."