Ethics reforms at the University of Minnesota are improving the safety and oversight of clinical research, a legislative audit report has found, but bureaucratic hurdles are slowing efforts to rein in researchers’ financial conflicts.
While calling the university’s reforms “ambitious,” the report released Thursday by the Office of the Legislative Auditor found much work left to be done. Questions about how vulnerable patients should be recruited for clinical studies and when their families should be consulted remain at issue.
“We’re encouraged by the steps that they have taken and the policies that they’re looking at developing,” said Elizabeth Stawicki, director of legal research for the legislative auditor’s office. “On the other hand, these are just steps.”
The legislative auditor’s involvement stemmed from the 2004 suicide of Dan Markingson, who was participating in a schizophrenia drug trial to which his family didn’t believe he had the wherewithal to consent. Public reports first emerged in 2008, questioning the role of university psychiatrist Stephen Olson in treating Markingson while also recruiting him into a study for which he received industry funding.
University reforms now prevent that scenario from being repeated. The reforms include a prohibition of recruiting psychiatric patients while they are hospitalized under 72-hour emergency holds.
Olson is suspended from clinical research. His co-investigator in the Markingson study — Dr. S. Charles Schulz — stepped down as Psychiatry Department chairman this year. Both doctors also received reprimands from the Minnesota Board of Medical Practice earlier this month for publicizing confidential patient information in attempts to defend their practices.
One university reform would prohibit researchers from receiving consulting fees from private companies while conducting clinical trials that those companies are sponsoring. The audit report said progress on that proposal has been slowed by the university’s faculty governance structure and a temporary freeze on policy changes while an effort to unionize the faculty plays out. The initial legislative audit report on the Markingson case last year was one of several to scrutinize research conduct by university psychiatrists.
One of the most inflammatory reports was by a consultant, Jan Dugas, whom the university hired last year. Among other things, Dugas found evidence of researchers recruiting minors without first contacting their parents and of unqualified staff members conducting MRI scans of research subjects.
Stawicki said her office checked on those two allegations but found no evidence to corroborate them.
On Thursday, Dugas addressed the Senate Higher Education and Workforce Development Committee after the legislative audit report was presented. She defended her earlier findings — noting that she received an e-mail after her findings were released from a study participant who had been coerced into research — and asked legislators to hold the university accountable for its research conduct.
“Children, parents and patients are depending on your leadership,” she told them.
The legislative audit report concluded with a request for a “culture shift [that] puts a priority on the needs and interests not only of patients but also their families.”
The report commended the U’s new psychiatry chairwoman, Dr. Sophia Vinogradov, for meeting with Markingson’s family even before officially taking charge of the department.