In June 2005, a year after Dan Markingson committed suicide in a research study at the University of Minnesota, the state office of the Ombudsman for Mental Health and Developmental Disabilities issued a detailed set of recommendations addressing problems with the way university psychiatrists had handled Markingson’s treatment.

University officials ignored the ombudsman’s recommendations. For years afterward, they simply pretended that the ombudsman’s report did not exist.

Eleven years later, Minnesota legislators want the ombudsman’s office involved again. And this time, they want to give the ombudsman some real power.

In committee, Rep. Connie Bernardy, DFL-New Brighton, introduced an amendment to the higher education omnibus bill to have the ombudsman’s office monitor participation of people in psychiatric research studies at the university. This was a recommendation made by a scathing Office of the Legislative Auditor report on the Markingson case in March 2015. The amendment has had bipartisan support, has passed the House floor and is now in conference committee.

An external monitor for psychiatric research would be a positive step forward. But the U’s administration is opposing the bill.

I have been a nurse at the University of Minnesota Medical Center (formerly Fairview-University Medical Center) for 23 years. For the past 16 years, I have been a member of the university’s Institutional Review Board, which is supposed to protect the rights and welfare of research subjects.

I was working at Fairview in 2003 when Markingson was pressured into enrolling in a study of antipsychotic medications. Markingson had been hospitalized under an involuntary hold. As part of the commitment process, he had been given a “stay” of commitment. This meant that he was required to follow the orders of his treating psychiatrist or face confinement in the state psychiatric hospital in Anoka.

I objected to Markingson’s recruitment and participation in the drug study. I did not believe that a subject could give truly informed consent under these circumstances. But I was ignored. His mother strenuously objected. Her concerns were ignored as well.

Markingson committed suicide on May 8, 2004.

For the past year, U officials have insisted that they are fixing the problems in the Department of Psychiatry, mainly by adding more layers of bureaucratic oversight. But they have ignored the main problem, which is that members of the department are simply not following the rules. On the rare occasions when they are caught breaking the rules, they are not punished.

Last summer, it was reported publicly that the Institutional Review Board learned that Ken Winters, a faculty member in the Department of Psychiatry, had forged a federal document intended for use in a research study. The federal document protects the confidentiality of participants in the research, such as adolescents using illegal drugs. The university allowed Winters to retire without any sanctions.

In February, the results of yet another review of psychiatric research were released. The problems were very familiar. Researchers were not getting proper informed consent. They were recruiting subjects into studies inappropriately. They were altering study documents to prepare for audits.

It was clear that members of the Department of Psychiatry were still not following the rules, but once again, university officials simply dismissed the findings.

I saw all of these problems in 2003. I am still seeing them now. Until there is external oversight, the problems will continue.

The bill that the Legislature is considering would authorize the Office of the Ombudsman for Mental Health and Developmental Disabilities to provide the external monitoring so desperately needed. The ombudsman’s office would have the power to oversee researchers and hold them accountable.

I strongly support this legislation. Unlike the steps taken by the university so far, this legislation would genuinely protect research subjects in the Department of Psychiatry. And if researchers are really following the rules, as the university claims, then university officials have nothing to fear.

 

Niki Gjere lives in New Brighton. The opinions expressed in this article are not intended to represent those of her employer or the University of Minnesota’s Institutional Review Board.