Scrutiny continues for research practices by U of M Department of Psychiatry

Research practices at the University of Minnesota’s Department of Psychiatry have been criticized for more than a decade following the highly publicized 2004 suicide of Dan Markinson, a participant enrolled in a psychiatric drug study at the Fairview University Medical Center.  

The House Higher Education Policy and Finance Committee heard from university administrators Tuesday about progress being made in research practices, but the legislative auditor and several university whistleblowers urged lawmakers to remain vigilant.

Legislative Auditor Jim Nobles said that while past audits found no evidence that Markinson’s suicide was connected in any way to his participation in the study, they did find “serious ethical issues” and significant conflicts of interest in the case and that the university’s response had hurt its credibility and reputation.

Psychiatric nurse specialist and former university Institutional Review Board member Niki Gjere pointed to a more recent case of researcher Ken Winters forging a certificate of confidentiality while conducting research on adolescent substance abuse. Although Winters was forced into retirement last year, Gjere said university administrators “blamed the IRB for picking on him” during the board’s review of his research.

She said that despite “a lot of activity” by university administrators, the core issue, a “lack of integrity,” is not being fixed.

“Patients and subjects are at grave risk of serious harm,” she said. 

Another former IRB member, Dr. Carl Elliott, a professor at the university’s Center for Bioethics, said that while he sat on the board, there was strong institutional pressure to approve research protocols and they were rarely rejected as unethical. He cautioned lawmakers against believing the testimony of administrators, who he thinks “still don’t believe they’ve done anything wrong.”

“They’re not going to tell you that for years they lied to the public about research misconduct at the U,” he said. “They’re not going to tell you about the climate of fear.”

University President Eric Kaler testified that progress is being made, but it is nowhere near finished.

“It does require a culture change,” he said. “We are here to be accountable for this change.”

Kaler, who took office in 2011, admitted that he had not taken issues with the Psychiatry Department seriously enough early in his administration.

“I have been rightly criticized for not listening more,” he said. “This will be a Department of Psychiatry you can be proud of.”

The university has requested outside reviews and developed an implementation plan to improve human research protections, including transferring management of clinical trials to the university’s Clinical and Translational Science Institute.