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.