The U of M's plan to make human research safer is pretty good, review finds


After some scathing reviews that found serious issues with the way the University of Minnesota's Department of Psychiatry handled human research trials, the U completely rewrote its standards and practices for the program.

And that new plan is apparently a pretty good one, as long as the university follows through, according to a new report from the Office of the Legislative Auditor.

The University of Minnesota suspended enrollment in human trials last March, after those earlier reviews found serious problems with how the psychiatry department handled the case of Dan Markingson, who had been diagnosed with schizophrenia. He took his own life in 2004 while taking part in a drug trial.

Last summer the U outlined and approved a full revamp of how it conducts human trials, which the auditor's office did a review of.

Because things are still being implemented (the audit called the reform efforts "fluid"), the review from the legislative auditor's office can't offer a "definitive judgment" on whether the plan will be effective.

But, based on the goals and current progress that's been made, the audit says things are in good shape.

They called the reforms "ambitious and far-reaching," and noted that some changes have already been made (while other, bigger ones have to go through the U's governance system before they can be adopted).

"If the University accomplishes and sustains all of the proposed changes, we think it will significantly strengthen protections for human research subjects," the auditor's report says.

The full review is 31 pages, and you can read it here.

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