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ST. PAUL, Minn. (AP) — Minnesota's flagship research institution should do more to protect vulnerable participants in human research trials, an external investigation has found.
The University of Minnesota has recently strengthened its human research program, according to a team of investigators who analyzed the school's procedures at its request. But in a report released Friday, the investigators said they found "many weaknesses in policies and practice" that require attention.
Strategic plans for the university and its medical school don't mention research ethics or the protection of human subjects, according to the report. And the university's medical research review board often lacks members with expertise on the projects it evaluates, it said.
University President Eric Kaler said in an open letter that the school will act on many of the group's recommendations, including adding members to that board and spending more money on training.
The university's medical school and research endeavors are playing a bigger role at the state Capitol this year. Gov. Mark Dayton wants to send the medical school an extra $30 million over the next two years to attract more researchers and improve its national standing. Candidates for five open seats on the university's governing board have said the school needs to do a better job of making money from its research.
The report comes after years of accusations that the school mishandled the case of Dan Markingson, who killed himself in 2004 while participating in an anti-psychotic drug trial through the university. Critics allege he was coerced into the study.
University administrators say several investigations into the Markingson case found no wrongdoing on the school's part. The state's legislative auditor is due to release a report on the case next month.
Investigators conducting the review released Friday — which was funded by the university — focused on the school's more recent research practices. But many of the flaws they described centered on the protection of vulnerable adults like Markingson.
A new policy assumes functionally impaired adults are capable of agreeing to participate in studies unless there's substantial evidence otherwise, the report said, but that may not line up with federal standards and best practices.
The report also expressed concern with the university's psychiatry department. Faculty and staff interviewed by the investigators called some researchers in the department "untrustworthy" and said they created a culture of fear, according to the report. The report didn't identify those researchers.
Investigators said many of the university processes they studied were strong. But the school should have worked harder to protect research subjects and regain lost trust in light of criticism, they wrote.
The six-member team of investigators plans to present its findings to the university's Faculty Senate next week.
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