University of Minnesota proposes new safety, ethics oversight of research

The University of Minnesota is poised to "radically redistribute" the power to investigate scientific misconduct and oversee safety in studies that use human subjects.

The proposed shake-up comes 11 years to the month after a Twin Cities man died by suicide while participating in a U study of antipsychotic drugs — a case that became an ethics touchstone for the Department of Psychiatry — and two months after the department chairman stepped down.

An expert panel appointed by President Eric Kaler recommended Monday that the U overhaul its Institutional Review Board (IRB) process, which oversees the safety of research using human subjects. The U would raise the stature of review-board service by paying faculty who participate, but also hold them accountable for attendance and the quality of research reviews.

The U also would create a new panel specifically to evaluate studies that recruit vulnerable patients whose capacity to consent to research might be limited or fluctuating.

The recommendations weren't specific to the case involving Dan Markingson's suicide, but they reflect concerns that arose after the 2004 death of the young man, whose family believed he lacked the wherewithal to consent to research and pleaded with U psychiatrists to withdraw him from their study.

"You could call it Markingson's legacy in terms of taking the death seriously — regardless of causality — and saying we are going to do everything humanly possible to try and prevent similar … concerns from happening again," said Dr. Steven Miles, a U bioethicist who served on the panel.

The panel also recommended more frequent monitoring of studies after they commence and stripping the IRB of the responsibility to investigate research misconduct — because it presents a conflict for IRB members to scrutinize studies they approved in the first place.

The recommendations were issued Monday for public review. University officials now must decide whether the state can afford them. Hiring additional staff members, paying IRB members and increasing ethics training would cost some $2 million. The panel also recommended spending $5 million on an electronic IRB system for filing and reviewing research proposals.

That money could come by earmarking more grant money toward oversight — sacrificing some of the breadth of research in favor of enhanced safety, said Dr. Brooks Jackson, dean of the university's Medical School, and a panel member.

Markingson's death led to news coverage and criticism from bioethicists that in turn prompted an investigation of the case by the state legislative auditor as well as an external review that found shortcomings in the university's research oversight.

Kaler appointed the expert panel in March to address deficiencies raised in the external report.

In his review, Legislative Auditor James Nobles expressed concern that Markingson was recruited, while hospitalized for psychosis, by a psychiatrist who was also his doctor and an adviser to a judge on whether Markingson should be civilly committed.

State law has since prohibited a researcher from having that kind of potentially conflicting relationship. However, two U.S. Food and Drug Administration reviews of the study in which Markingson was enrolled have found no violations of federal research requirements.

Prof. Leigh Turner, a bioethicist who is a leading critic of the Psychiatry Department, said Monday that the new recommendations reflect "introspection" that should have happened a decade ago, when Markingson died. Suggestions such as improving IRB attendance didn't impress him.

"It's unobjectionable," he said. "It's also obvious."

Other panel recommendations include eliminating peer review — allowing a professor to review the study of a colleague or supervisor in the same department — and seeking input from patients, clinical staff and the community over research projects.

The heightened scrutiny could have far-reaching implications, including scaring corporations, which fund a substantial portion of clinical research, Miles said.

"Private corporations tend to seek the path of least resistance," he said.

The recommendations extend beyond the Psychiatry Department, which saw its chairman step down last month and its research recruiting suspended.

Miles noted that many circumstances beyond mental illness can make potential research subjects vulnerable, including dementia, homelessness and incarceration. Under one panel recommendation, vulnerable patients would be able to appoint substitute decisionmakers to evaluate their continued participation in research if they lost the competency during a study to make that choice on their own.

Other recommendations are specific to the Psychiatry Department, including leadership and ethics training for two psychiatrists who were linked in the external review to a "culture of fear" among hospital staff members over raising questions about research.

Management of psychiatric studies also would be transferred to the Clinical and Translational Science Institute, which was created in 2011 to convert bench research at the U into medical treatments.

The Markingson case also raised critical questions about research funding, because the trial in which he participated was financed by a drug company, AstraZeneca, that had other financial ties to the lead researchers.

If researchers receive grant money from companies, the panel recommended that they now forfeit other personal compensation from that company, such as speaking fees, until the study is complete.

Jeremy Olson • 612-673-7744