Audit of U's human research reveals profound ignorance, chaotic mess

A new report says MRIs were conducted by untrained, unlicensed research staff.

A new report says MRIs were conducted by untrained, unlicensed research staff.

Within the past year, the University of Minnesota’s Department of Psychiatry has been dragged through the mud. Rightfully so, according to a series of investigations that gradually unraveled a state of dysfunction that should have been obvious to the U a decade ago.

The case that sparked intense scrutiny of the U’s human research program was that of Dan Markingson, a 26-year-old schizophrenic man who was recruited into a 2003 drug study as an alternative to court-ordered hospital commitment. He killed himself five months into taking the experimental drugs. Since then, his mother, Mary Weiss, has been trying to blow the lid off the U’s coercive recruiting practices of vulnerable, mentally ill people.

It wasn’t until 11 months ago, when the state legislative auditor conducted an independent investigation and published a scathing report, that the U finally acknowledged wrongdoing.

Later, it came out that another mentally ill patient, Robert Huber, had been recruited into a 2007 drug study. He claims that he was not mentally competent to sign the consent forms. Though the experimental drugs gave him stabbing abdominal pains, he was told to keep taking them.

In July, the U’s director for the Center for Adolescent Substance Abuse Research was caught forging a federal patient privacy document. Dr. Ken Winters retired shortly after. 

Forced to reckon with these investigations and the dogged criticism of two bioethicists, Carl Elliott and Leigh Turner, the U of M has been slowly rolling out a number of fixes. These included having the Clinical and Translational Science Institute take over management of drug trials conducted by the department, and hiring private research compliance consultant Jan Dugas to assess its general environment.

The goal is to save the U's research reputation and lift its human research practices "beyond reproach," according to President Eric Kaler.

But Dugas' latest audit is not kind. 

She found that the Department of Psychiatry's faculty and staff were unaware of the most basic professional requirements for a clinical research institution. Physical and psychological harm to study participants, the most important data collected in a study, was routinely unrecorded. Researchers did not understand how to get informed consent. 

"The standard practices in the Department of Psychiatry demonstrate a profound lack of knowledge about how to conduct clinical research and an intentional lack of adherence to requirements," Dugas concluded. "Given the feedback received during these activities, there is concern that practices – similar to those observed within the Department of Psychiatry – are systemic across the University."

Throughout Dugas' interviews of 54 faculty, staff, students, and volunteers, she encountered a couple bullies and a number of totally unqualified people tasked with essential research and medical care responsibilities. 

One faculty member, upset with being interviewed, walked up to Dugas' face shaking a finger and said, "If [Clinical and Translational Science Institute] thinks they are going to come in and dictate anything done in my department or my staff, they will have a war on their hands.”

A study coordinator, hired in September, confessed that her manager had asked her to keep quiet about her employment and her role in ongoing research. That same faculty member had recruited two inexperienced volunteers to work on studies, though neither had completed required training. 

Another faculty member described approaching children in the hospital, without parental permission, to ask if they would be interested in participating in human research. If the kid agreed, she would then contact the family. If the parent wasn't available in person, she would call or email. As long as the parent responded "yes," she would enroll the child in her study, regardless of whether the parents had gotten a chance to even look at a consent form. This person told Dugas that she did not want training because "It would complicate my good research."

One person said the U's required training left her confused about the process of getting informed consent. Nevertheless, she still actively recruits patients for human research. 

A department receptionist, with no medical training, routinely conducts psychotherapy sessions and calls herself a "therapist." 

Non-medical, non-licensed researchers were told to give both adult and teenage study participants MRIs, even though the U requires MRI technicians to have graduated from a school of radiology. 

Research staff met study subjects at coffee shops and fast food restaurants in order to collect urine samples, which they then stored in their purses. 

Dugas recommended that the U hire a professional to take leadership of the department, someone from outside with research, industry, and safety compliance experience. She also suggested that each ongoing study be audited for potential mistakes. "It will be important to communicate to faculty members that conducting research is not a faculty right, but a privilege, and that requirements are established to protect all those involved," she wrote.

The U's response so far to this report has been brisk. 

"The report echoes the serious concerns of earlier reports about research practices and the culture within the Department of Psychiatry," according to a university statement. "We take the claims very seriously and are investigating to be sure the [Clinical and Translational Science Institute] plan will address all of these concerns."  

The U says it is in the process of hiring a new chief for the Department of Psychiatry.