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Faculty Senate passes clinical research resolution

The measure recommends creating an external review panel for University clinical research trials.

The University of Minnesota Faculty Senate voted 67-23 on Thursday afternoon to create an independent, external panel to investigate clinical research on human subjects at the University.

The decision came after renewed calls from scholars and bioethicists to re-examine the 2004 suicide of Dan Markingson, a 26-year-old who participated in a clinical drug trial at the University of Minnesota Medical Center, Fairview ten years ago.

Since Markingson’s suicide, individuals and groups both within and outside the University have raised questions about CAFE, the study he participated in, and the University’s standards for ethical research.

In October, an international group of bioethicists wrote to President Eric Kaler and the Faculty Senate asking for an independent investigation of the issues arising from the CAFE study.

The resolution passed Thursday expresses the sentiment of the faculty senate as a body, but isn’t binding, said Eva von Dassow, vice chair of the Faculty Senate. She said further steps will be taken by Kaler.

Kaler, who chairs the Faculty Senate, told reporters after the meeting that he’s moving forward with the recommendation.

University officials will begin scouting nationwide early next year for experts to conduct the investigation, Kaler said. He said there is currently no timeline for when the investigation would be completed.

An external review would provide “a way for the public to have the utmost confidence in the integrity of research conducted at the University of Minnesota,” the Faculty Senate resolution said.

Kaler said he thinks the investigation will show the University’s current research policies are “in very good shape.”

The proposed investigation wouldn’t necessarily consider past research like the CAFE study, but instead would examine “current policies, practices, and oversight of clinical research on human subjects at the University, in particular clinical research involving adult participants with diminished functional abilities.”

The vote came after three amendments to the original proposal, including one that requires the results of the inquiry be reported back to the Faculty Senate for discussion.

The other two amendments added more details about Markingson to the resolution and struck the word “investigative” from the definition of the panel.

More than a dozen representatives spoke at the meeting Thursday. Some debated the extent to which the Markingson case should be investigated by an external panel. Others voiced concerns that the case and resulting controversy was casting a shadow on all research at the University.

Stephen Olson, the CAFE study’s lead psychiatrist, told reporters after the meeting that he welcomes any investigation into the Markingson case.

“I’ve got nothing to hide,” he said. “We didn’t do anything wrong.”

Mike Howard, a representative for Mary Weiss, Markingson’s mother, said the action taken by the Faculty Senate Thursday was “a huge vindication.”

“After all these years, it instantly kind of turns some really sour tastes about the University,” he said.

Several prominent scholars don’t believe past inquiries into the case were credible, said philosophy professor Naomi Scheman, who signed the October letter to the Faculty Consultative Committee. She said the University community “has to care how we look in their eyes.”

“We do have a good reputation and we’ve worked hard to earn that reputation,” Scheman said, “but it’s crumbling before our eyes.

“We can’t sacrifice that reputation for the integrity of the research that goes on here.”


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