Auditor: University of Minnesota human research reforms on track

A year after issuing a stinging criticism of how University of Minnesota researchers dealt with human test subjects, Minnesota's legislative auditor says the university's policy changes appear to be ambitious and far-reaching.

Last year, Legislative Auditor Jim Nobles declared the University of Minnesota ignored "serious ethical issues" in its handling of Dan Markingson, a psychiatric patient under the care of a university researcher. Markingson killed himself while participating in a corporate-sponsored clinical drug trial at the university.

The U responded to the auditor's criticism by suspending enrollment in new drug trials and putting together a task force that came up with new policies for dealing with human test subjects.

Those reforms appear to be on the right track, Nobles told lawmakers Thursday.

"In general, we think they are ambitious and far reaching. Indeed, they go beyond the Department of Psychiatry," he said. "We believe if the university accomplishes and sustains all of the proposed changes, they will make a significant difference in strengthening research for human research subjects."

Nobles noted the changes are still being implemented. The school is 10 months into an 18-month plan. Nobles said it was too early to give an in-depth assessment.

"The real proof is what happens in a room when there's a patient and a doctor and somebody shows up at Fairview (Hospital) for treatment and there's somebody that wants to recruit them into a study," he said.

Among the changes, the university now prohibits researchers from recruiting patients who are on involuntary 72-hour emergency holds. The university also now prohibits the treating doctor from recruiting study participants and it also strengthens the U's institutional review board, which gives ethical oversight of research and is designed to protect research subjects.

Still, the preliminary review cited ongoing problems. It criticized U researchers for allowing underqualified people to perform tasks beyond their competency. It also said the U has not worked quickly enough to develop a system to inform research participants and their families on how to provide confidential feedback.

University officials said they were pleased with the report, which they said showed the progress that has been made.

"Putting in place the changes we've described will create a much better capability for us to conduct clinical research and especially ensure the safety of human participants that volunteer for that research," said Brian Herman, vice president for research at the university.

The U plans to put $5.5 million toward implementing the proposed changes in the 2017 fiscal year.

Nobles said after interviews with 24 people involved in research at the U, he was pleased with what he believes is a genuine desire to make changes. But he also noted that the U didn't respond to the issues raised in the Markingson case until it was under great pressure to do so.

"I think that's something to contemplate," he said. "Yes, we think we are moving forward in a positive way, but again it would not have happened if there had not been outside oversight and pressure."

Mike Howard, a friend of Dan Markingson's mother, Mary Weiss, and an advocate for reforms and action from the university, echoed Nobles' concerns about how long the reforms have taken to be put in place.

In May, he met with Dr. Sophia Vinogradov, who will take over in August as the head of the U's Department of Psychiatry.

"She asked a lot of what I thought were pertinent questions and she genuinely seemed interested in learning more about what happened and how that can be prevented from ever happening again," Howard said.

Some critics skeptical of the U's capacity to change have lobbied to have the state Ombudsman for Mental Health and Developmental Difficulties monitor the participation of human subjects in psychiatric research.

A measure to allow that, which is opposed by U administration, has passed both the House and Senate. It awaits final action as lawmakers enter the last days of the legislative session.