Research reforms draw scrutiny

Earlier this month, the state Legislative Auditor announced a planned third review of psychiatric research at the University.

Vice President for Research Brian Herman presents an update and review of human subjects research standards at the University of Minnesota to the Senates Higher Education Committee in the Minnesota Senate Building on March 10.

Maddy Fox

Vice President for Research Brian Herman presents an update and review of human subjects research standards at the University of Minnesota to the Senate’s Higher Education Committee in the Minnesota Senate Building on March 10.

by Kevin Beckman

A year after University of Minnesota leaders vowed to improve human subject research practices, the school continues to draw scrutiny from state lawmakers and officials. 
The same week the University released another external report that found flaws with research practices at the school, Minnesota Legislative Auditor James Nobles announced he will launch a review of the school’s psychiatric research practices — which will be his office’s third investigation of the Department of Psychiatry’s research since last year. 
At recent Senate and House committee meetings, lawmakers and whistleblowers continued to express skepticism about changes to University research procedures. 
“We all know that we have trust to regain,” said University Medical School Dean Brooks Jackson at the House meeting last week. “We are not there yet, but we are working hard.”
Concerns about research ethics at the University surfaced after the 2004 suicide of psychiatric research participant of Dan Markingson. Two reports last year, including one by the Legislative Auditor, revealed a litany of flaws with University research procedures, conflicts of interest and other ethical concerns that prompted dozens of pledged changes by school administrators. 
New legislative audit
Nobles announced earlier this month that he plans to investigate whether the Psychiatry Department has fixed the major problems in recruiting and safety oversight that he identified in an audit released last year.
“We have had a number of studies that have pointed to problems at the University and pointed to problems in the way the University responded to the Markingson case,” Nobles said at Tuesday’s House higher education committee hearing. “And so we feel compelled to go back yet again and see the current practice and whether it’s been changed.”
The new audit will examine potential concerns such as the recruitment of vulnerable people into psychiatric drug studies, “pervasive” conflicts of interest, inadequate communication with the families of drug study participants and insufficient documentation of “adverse effects” on participants, said Elizabeth Stawicki, director of legal research at the Office of the Legislative Auditor. 
The office is still in the planning phase of the review, she said. 
OLA will conduct interviews with University psychiatry faculty and staff and review department documents to determine whether administrators have made progress to address issues in the department, Stawicki said. 
She said the audit should be presented to legislators by the end of this year’s legislative session, which wraps up in May.
External review findings
Earlier this year, an external firm, Compass Point Research and Trading, reviewed 100 active research studies in the department of psychiatry that were deemed the highest risk to study participants.
The report was submitted to the University earlier this month and released to the public last week after administrators reviewed several drafts of the report to “correct grammatical and factual errors.”
The report found multiple instances of researchers lacking valid consent from research study participants, along with problems with documentation errors and inadequate communication between researchers and the University’s Institutional Review Board, which reviews research projects that involve human subjects to ensure participants are protected.
However, the report noted that the issues in some areas in the University’s Department of Psychiatry are less frequent than in clinical research studies at other institutions.
Still, consent issues and IRB communication failures were found to be more frequent at the University compared to other institutions.
“The good news is that the report indicates that we do not have a systematic University-wide issue with the conduct of clinical research,” said University Vice President for Research Brian Herman at Tuesday’s meeting. 
The report suggested improving documentation practices and communication between the school’s IRB and researchers. 
Continued scrutiny about research ethics
While University administrators updated legislators on planned and implemented reforms to research at recent House and Senate higher education committee meetings, lawmakers and critics expressed concern that other problems with the school’s research culture haven’t been addressed. 
Testifying before the House higher education committee Tuesday, whistleblowers said they doubted the University will take appropriate action, despite claims of progress being made in research practices.
“They’re not going to tell you that for years they lied to the public about research misconduct at the ‘U,’ ” said University bioethics professor Carl Elliott. “They’re not going to tell you about the climate of fear.”
Some legislators said they were worried about a lack of accountability at the University. 
“We talk about a culture of ethics, and we can’t have a department above ethical reproach if we don’t have ethical people in there,” said Sen. Eric Pratt, R-Prior Lake. 
At the meeting, Herman said that some researchers who have been criticized for their research ethics have retired or been barred from conducting clinical research. The former head of the Department of Psychiatry, Dr. Charles Schulz, also resigned last year amid the controversy. 
University President Eric Kaler told the committees that leaders are making progress to fix the department’s problems.
“It does require a culture change,” he said at Tuesday’s House meeting. “We are here to be accountable for this change.”
Kaler also said additional staff changes in the department likely need to occur to establish an ethical culture. 
“This has gone on for a long time,” said Regent Michael Hsu. “What I’m trying to understand is what we really need to do to please the critics. If the [implementation] plan is not satisfactory to stakeholders, I’d like to know what we need to do to fix it.”
But despite assurances by University leaders and officials, some lawmakers said they are skeptical about the school’s promises, especially after testimony by longtime critics. 
“I want to believe you and everything that you’ve said,” said Rep. Cindy Pugh, R-Chanhassen. “But I can’t unhear what I heard previously.”
Youssef Rddad contributed to this report.