Report: Research practices involving human subjects are problematic

A report released on Friday found “significant problems” with the University’s human subjects protection program.

Haley Hansen

The University of Minnesota’s efforts to protect human subjects in research doesn’t consistently reflect best practices, a report released to the public Friday from an external review committee found.

The report, which reviewed the University’s clinical research practices, follows over a decade of scrutiny after the 2004 death of University research subject Dan Markingson, who committed suicide while participating in an antipsychotic drug study.

In Dec. 2013, the University’s Faculty Senate passed a resolution calling for an external review of clinical research practices involving human subjects at the University. A month later, University President Eric Kaler charged Vice President for Research Brian Herman to oversee the request.

The University signed a contract with the Association for the Accreditation of Human Research Protection Programs, Inc. last summer to oversee the five-person review team.

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 “evidence of weak and often inadequately expert review of research,” from the processes of the University’s Institutional Review Board, which evaluates research projects that involve human subjects to ensure subjects’ protections and their consent is informed and not coerced.  

In a statement released Friday, Kaler said the University plans to implement the team’s recommendations.

“It is my expectation and intent to review each carefully and take the steps necessary to become exceptional,” the statement read.

The state’s 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 is set to be released mid-March.