Board approves psychiatric drug trial suspension

Regents and administrators vowed to improve human research ethics in the wake of two critical reports.

Christopher Aadland

The University of Minnesota Board of Regents unanimously approved plans Friday to make the school’s human subjects research program “beyond reproach” after two external reports highlighted areas of concern where the University should improve their protection practices.

Last week, President Eric Kaler announced the suspension of enrollment in psychiatric drug trials after the release of a report by the state’s legislative auditor called the University’s responses to ethical concerns in its human research “insular” and “defensive,” while finding numerous conflicts of interests and ethical concerns surrounding the 2004 suicide of Dan Markingson, who was enrolled in an antipsychotic drug study at the school when he died.

“I must reiterate our deepest sympathy to Dan Markingson’s mother, Mrs. Weiss, and apologize to her for his death while under our care,” Kaler said Friday. “I deeply regret that we have not always lived up to Minnesotans’ expectations.”

The suspension of psychiatric drug trials will continue until an independent review board recommends lifting the suspension.

Clinical studies that target vulnerable populations will also be sampled to ensure the subjects are being properly protected.

The regents also agreed to create a community oversight board to guide the University’s approach to human subject research.

A task force, composed of mainly faculty and external experts, will make implementation recommendations to Kaler and the board by May 15.

“Obviously, like everyone else, we would have loved to have avoided the issue that gave rise,” Regent Darrin Rosha said Friday. “But, in this circumstance we have an opportunity to make great strides.”

Still, some longtime critics of the University and its research conduct weren’t satisfied with Friday’s meeting.

Leigh Turner, an associate bioethics professor and longtime critic of the University’s handling of the Markingson case said he was frustrated after the board meeting.

“I didn’t hear a lot of frank, honest discussion of the very serious nature of the research misconduct that seems to have occurred,” he said. “The reality is a very serious institutional failure has taken place here.”

But Mike Howard, a family friend of Markingson’s mother, Mary Weiss, said the release of the two reports and the subsequent actions by the University are validation of the concerns she first raised more than a decade ago.

“It’s a little bit late but obviously it’s a start and that’s what she cares about, is to not have let her son die in vain,” Howard said.