An outside review of psychiatric research at the University of Minnesota has found continued ethics lapses, including underqualified staff working with research subjects and a psychiatrist who cut corners on obtaining patient consent.
The assessment, presented Thursday to the Board of Regents audit committee, suggests that the U still has not resolved lingering ethics questions that emerged after the 2004 suicide of a young man who participated in a study of psychiatric drugs.
"The standard research practices in the Department of Psychiatry demonstrate a profound lack of knowledge about how to conduct clinical research and an intentional lack of adherence to requirements set forth by the U [Institutional Review Board] and state and federal regulatory agencies," the report concluded.
The reviewer, Jan Dugas, specifically raised concerns about a receptionist who conducted psychotherapy, two unqualified volunteers involved in research, and a psychiatrist who enrolled children in clinical trials with only verbal or over-the-phone permission from parents — and obtained written consent later.
University leaders challenged the most alarming allegations, saying they reflected hearsay that the author reported without verification and that subsequent internal investigations found them untrue.
Dr. Brooks Jackson, dean of the medical school, said that inappropriate consent for a child in a psychiatric study is "alarming," but that the allegation "just was not true." The receptionist mentioned in the report actually is trained in psychotherapy, he added.
Regardless of which claims are true, Jackson said the report is proof that heavy investment over the past year on revamping the ethics and oversight of psychiatric research was warranted. The U temporarily suspended psychiatric studies to make sure they adequately protected vulnerable patients, and increased the number of monitors who will conduct random safety audits, among other steps.
Still, at least one regent expressed shock at the list of issues raised in Dugas' assessment.
"I'm a little bit concerned as to whether or not we're going to be able to fix all of these problems," said Regent Michael Hsu.
The university ordered the assessment to identify problems in the department before turning supervision and support of psychiatric studies over to its Clinical and Translational Science Institute (CTSI), which was created to help researchers convert basic science discoveries into medical treatments.
"I have assured [the psychiatric faculty] we are there to support them, protect them, help them protect the patients," Jackson said. "Too many times, we have not supported the faculty enough with the right mentorship and oversight."
Jackson's rebuttal to the more egregious criticisms struck some observers as odd, considering that Dugas — a consultant with prior experience coordinating and monitoring clinical trials — was hand-picked by the university.
Dugas also reported instances of psychiatric researchers belatedly fixing or completing documents so research protocols would comply with ethics rules and pass reviews by the university's Institutional Review Board.
Jackson told the regents' committee that the U is addressing any lapses in record keeping or other problems.
The assessment is the latest in a series of steps to improve the conduct of psychiatric research following the 2004 suicide of Dan Markingson, whose family believed he was coerced into a U schizophrenia drug trial. News stories in recent years brought fresh reviews of the case.
Last March, Legislative Auditor James Nobles raised similar concerns about Markingson. The psychiatry department's longtime chairman, Dr. Charles Schulz, resigned a month later.
Dugas wrote that she encountered hostility from some psychiatrists and department staff when she conducted her interviews last fall — with one claiming university leaders "will have a war on their hands" if they transfer management of their research to CTSI. Many lamented the heavy oversight after "one error in judgment that happened 10 years ago" — a reference to Markingson.
Claims such as psychiatric staff operating beyond their capabilities echo problems that surfaced in Markingson's care, though. A social worker overseeing the CAFE drug study in which Markingson was enrolled agreed in 2012 to a "corrective action" by her licensing board because she, among other things, conducted clinical assessments that were beyond her scope of practice.
Morale among psychiatric faculty was low when Dugas conducted her interviews, Jackson said. Their studies had just been scrutinized, some study coordinators had left, and researcher Ken Winters had been ushered into retirement after admitting to forging federal confidentiality documents for a study.
That could explain why Dugas found some faculty members nervous or hostile.
Jackson said he believes the department has turned a corner, though, and will embrace the CTSI oversight to help them conduct research and keep patients safe.
An announcement of a new chairman for the department will help as well, he added. "New leadership is needed."