A University of Minnesota report shows some caregivers at Fairview Heath Services don’t always trust University researchers.
The internal report released May 5 found no non-compliance issues with psychiatric researchers, but reinforced an external report released in February that highlighted a “culture of fear” and intimidation within the University’s Psychiatry Department’s research.
“Fairview caregivers do not trust some [University] researchers to protect human research subjects,” the report said. “For some, the level of distrust is profound.”
Though the report found no cases of research subjects being coerced or improperly recruited into a study, some Fairview employees said consent policies were inadequate, or that their opinions whether a patient could consent weren’t always valued.
The review, conducted by the school’s Institutional Review Board Chair, J. Michael Oakes, included 44 in-person interviews over the course of four months.
The results of the review were similar to some of an external report released in February, which was managed by the Association for the Accreditation of Human Research Protection Programs.
Both reports noted that the University, Fairview and the Department of Psychiatry haven’t been interested in addressing concerns that have been raised regarding the culture surrounding psychiatric research.
“Leaders in both the Department of Psychiatry and the Fairview hospital system do not seem to appreciate the level of distrust or the reasons (whatever they are) for it,” the report said. “[University] and Fairview leadership appear to be exacerbating the tension by not understanding and/or addressing the issues and hand.”
In an emailed statement, Fairview spokesperson Jennifer Amundson said the most recent report was initiated by Fairview after complaints were raised about the behavior services’ work environment.
“A lack of mistrust in the workplace is unacceptable,” she said in the statement. “We are taking action based on the findings that were just released. Our plans will include specific actions to establish an environment of inclusion, shared values, trust, transparency and integrity for psychiatric clinical care and research.”
Discussions about the school’s research practices continued after another external report — completed by the state’s Legislative Auditor in March — revealed ethical concerns and conflicts of interest in the 2004 suicide of Dan Markingson, who was enrolled in a psychiatric drug study at the school when he died.
After the legislative audit was released, enrollment in all psychiatric drug studies was halted until an independent review board approves them.
A draft plan for incorporating dozens of proposed changes to the University’s human research subjects protection methods is expected to be available May 18.