MINNEAPOLIS (KMSP) - A new report about human research study participants at the University of Minnesota shows there are still problems nearly a year after school officials promised to improve the program.
In March of 2015, a state audit prompted by a Fox 9 Investigation, found serious ethical concerns surrounding the case of Dan Markingson who died while enrolled in a psychiatric drug study at the school. The University followed up by setting aside $8 million to adopt research reforms. The consultant's report is part of that effort and will be released Thursday.
The report offers a scathing critique that says "practices in the department [of psychiatry] demonstrate a profound lack of knowledge about how to conduct clinical research."
According to the report, there's an "intentional lack of adherence to follow requirements" set by the University and state and federal regulators. Key findings of the report include:
-One faculty member admits to recruiting children for studies without first getting parental consent to approach them.
-Support staff are conducting psychotherapy sessions, taking MRI images and even offering treatments for study participants without having the appropriate training or licensing.
-Record keeping is sloppy, documents are back dated. Side effects and other harms related to studies are not always reported.
-Grant money for faculty members running studies, is often deposited into their personal bank accounts.
It adds up to a blistering review of the psych department after the University President, Eric Kaler vowed to make research practices "above reproach."
"We've got a lot of eyes on this. But it does take time to make the kinds of change we need to make," Kaler told Fox 9 on Wednesday.
Kaler said the report looked at a time period last summer, when planned improvements in the psych department were just starting to happen.
"There are some things there that we believe are not true, I'm sure they're honest mistakes but we wanted to clarify the record before we released the report," Kaler added.
The report was submitted to University officials at the end of December. According to Kaler, only one member of the Board of Regents has actually seen it so far.
"We've created a management response to the report and we'll release the report at the audit committee tomorrow," Kaler said.
The report also calls for a comprehensive audit of every study being conducted by the Department of Psychiatry and reads there's concern that what was observed in the psych department could be "systemic across the University."