Nearly a year after school officials promised to implement improvements, a new external report released Thursday revealed further problems with the University of Minnesota’s human research program.
The report, issued by an independent consultant, detailed several issues with the University’s Department of Psychiatry’s clinical research program. The University has said not all of the allegations are true.
According to the report —which was based on conversations with several people involved in the human research study program — some staff members expressed concerns about sloppy record keeping, outdated information about open research studies and inadequate training for research staff.
The report details faculty comments alleging some researchers altered documents about their practices before outside investigators could view them.
“We go behind the scenes and fix things up,” one faculty member said in the report. “What people don’t know won’t hurt them.”
Vice President for Research Brian Herman said that many of the report’s allegations are unfounded or “absolutely not true.”
The report also alleges that researchers have deposited federal grant money into their personal bank accounts and that one faculty member approached children for studies without first getting parental consent. Sometimes the faculty member acquired parent permission through email or phone, the report said. In a cover letter released with the report, the University said that these claims are not true.
“… There are some elements in the report that we have been unable to verify without additional context or details,” the University said in a statement.
Some University faculty members expressed concern that the report was submitted to University officials in January but wasn’t available for several weeks, despite multiple requests for the report through an open records request.
Carl Elliott, a University bioethics professor, said he submitted a Minnesota Data Practices Act request for the report early in January but didn’t receive a response.
“Getting information from the University is incredibly difficult,” Elliott said. “They delay. They stonewall you. They redact it. It’s almost impossible.”
In an email obtained by the Minnesota Daily, Associate Vice President of Internal Audit Gail Klatt told a faculty member that the external report wasn’t released because “a significant amount of fact checking” needed to be done.
The report comes after more than a decade of scrutiny and criticism of the University’s human subject research program following the 2004 suicide of 26-year-old University research subject Dan Markingson.
In response to criticisms following Markingson’s death, the University’s Faculty Senate passed a resolution in December 2013 calling for an external review of clinical research practices involving human subjects at the University.
The February 2015 report, which was overseen by the Association for the Accreditation of Human Research Protection Programs, Inc., examined protection practices for human subjects from 2011 to 2014.
The review found “significant problems” with the University’s Human Research Protection Program’s core functions.
Those problems included concerns that the University’s Institutional Review Board — which evaluates research projects that involve human subjects to ensure protection for participants — wasn’t sufficiently reviewing research, leaving participants at risk.
A review of the circumstances surrounding Markingson’s suicide was released in March 2015 by the Minnesota Office of the Legislative Auditor. The report found serious ethical issues and several conflicts of interest, which University leaders have been “consistently unwilling to discuss or even acknowledge.”
University officials repeatedly claimed that clinical research met the highest ethical standards.
The report called these claims “insular and inaccurate.”
Following the two reports, the University proposed several changes to the way it protects human subjects last June, including hiring more staff for the IRB, increasing the number of the board’s review panels and paying review board members.
That same month, the state legislative auditor’s office released another report that highlighted multiple failures of clinical researchers to report adverse medical events to the IRB, such as patient hospitalization and disruption of normal life activities.
Bioethics professor Leigh Turner said the new report raises serious questions about the behavior of University researchers and whether patients and research subjects in the psychiatric department are being adequately protected.
“We’re reading about what appear to be systemic problems in the department of psychiatry, systemic problems in how psychiatric clinical research is conducted here,” Turner said. “Why don’t we have more people coming forward and condemning what’s going on?”
Youssef Rddad contributed to this report.
