The University of Minnesota’s human subject research program has significant shortfalls that may put participants at risk, a report released Friday found.
The report, in which an external committee reviewed how the University protects human subjects with diminished functional abilities, follows over a decade of scrutiny after University research subject Dan Markingson committed suicide in 2004 while participating in an antipsychotic drug study. School leaders plan to implement several of the report’s 63 recommendations.
Prompted by ongoing criticism of the University’s response to the Markingson case, 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. A month later, President Eric Kaler charged Vice President for Research Brian Herman with overseeing the request.
The University signed a contract with the Association for the Accreditation of Human Research Protection Programs Inc. in the summer to oversee the five-person review team, which examined protection practices for human subjects from 2011 to 2014.
Members of the external review committee will present the report’s findings to the Faculty Senate on Friday.
Though the report recognized strengths in the University’s Human Research Protection Program, the team found “significant problems” with the program’s core functions.
Among other concerns, the team found that the University’s Institutional Review Board wasn’t adequately reviewing research, potentially leaving participants at risk. The IRB evaluates research projects that involve human subjects to ensure participants are protected and that their consent is informed and not coerced.
The external review team also wrote that University leadership should have worked to identify and address deficiencies, particularly pertaining to the Department of Psychiatry, given the history of scrutiny toward its programs.
In interviews, some of the psychiatry department’s faculty and staff told the team stories of intimidation by researchers and said they feared retaliation if they were to report problems.
The review team also criticized the University’s ethics education and wrote that there’s room for the school to improve ethics training.
In a statement released Friday, Kaler said he charged Herman and Dean of the Medical School and Vice President for Health Sciences Brooks Jackson with leading a team that will use the review to work with faculty to help outline necessary changes within the human subject protection program.
“It is my expectation and intent to review each carefully and take the steps necessary to become exceptional,” Kaler wrote in the statement.
Among other changes, the University plans to add members to the IRB and create a Research Compliance Advisory Committee.
University bioethics professor Carl Elliot, a longtime critic of the school’s research practices regarding human subjects, said he was unhappy with the University’s response to the report.
“The response of the administration doesn’t give me a lot of sense that they’re taking it seriously,” he said.
The state legislative auditor’s office is also conducting its own review of the University’s clinical trial practices. That review will examine the Markingson case, and it’s set to be released mid-March.