Post June 16, 2014: News Media Reports and Commentary Following the Announcement of the Legislative Auditor’s Investigation

Advocates for an independent investigation of alleged psychiatric research misconduct at the university provided numerous recommendations concerning how the Legislative Auditor’s review should proceed.

Former Minnesota Governor Arne Carlson emphasized the importance of examining not only clinical trial records and conflicts-of-interests but also oversight mechanisms, including governance oversight that is supposed to be provided by the university’s Board of Regents. “Are its members independent of management?” he asked. “How do they manage dissent involving management, faculty and/or the public? Why did they not intercede, particularly knowing the ills of the past involving criminal misconduct and continuing with public records of ongoing concerns relative to the care of enrollees?”

Carl Elliott identified different set of concerns that the Legislative Auditor needed to take into account. “It will not be enough to examine records,” he wrote. “Records can be destroyed, manipulated and hidden. A credible review will need to involve extensive interviews with research subjects and their families, whose experiences are often at odds with what is recorded in their medical files. Elliott added an additional cautionary note, stating, “For reasons that are unclear, many former subjects and their families who have contacted me seem unable to speak about their experiences publicly, or even privately. Some appear to be afraid of punishment, retaliation or legal sanctions of some sort. I do not know if these families would be willing to speak to the Legislative Auditor, but unless they do, I cannot see any real clarity coming out of this review. So it will be necessary for these subjects and their families to be given some assurances of protection.”

Jeff Baillon, “Legislative auditor to review drug trial practices at U of M,” KMSP-Fox 9, June 16, 2014.

Alex Friedrich, “Auditor: I’ll review decade of U drug trials,” MPR News, June 17, 2014.

Jeremy Olson, “Auditor to review U’s drug trial suicide,” Minneapolis StarTribune, June 18, 2014.

Arne H. Carlson, “A necessary audit of University of Minnesota drug research,” Minneapolis StarTribune, June 20, 2014.

Minnesota Daily Editorial Board, “U’s reviews are not enough,” June 25, 2014.

Carl Elliott, “What the legislative auditor must do,” Fear and Loathing in Bioethics, June 26, 2014.

Ed Silverman, “A University’s Clinical Research Practices Will be Examined,” WSJ Pharmalot, June 30, 2014.

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