Human Subjects Protections Under Fire at the University of Minnesota

A damning report on how the University of Minnesota (UM) protects volunteers in its clinical trials concludes that researchers inadequately reviewed research studies across the university and need more training to better protect the most vulnerable subjects. It also found that a “climate of fear” existed in the Department of Psychiatry, where concerns about clinical trials first surfaced.

The 97-page report, released 27 February, was prepared by a group of six experts appointed by the Association for the Accreditation of Human Research Protection Programs. It comes after years of complaints by some UM faculty members, led by bioethicist Carl Elliott. They charged that the school and its doctors failed to protect 27-year-old Dan Markingson, who died by suicide while enrolled in a psychiatric drug trial in 2004. They also expressed grave concerns about how Markingson’s death was investigated. (More on that case is here and here.)

Recently, Elliott’s crusade began having an impact. In December 2013, the UM Faculty Senate called for an independent review of current practices in clinical trials. The administration agreed to open its records...