University of Minnesota to Overhaul Research Protections

More than a decade after a young man committed suicide during a psychiatric clinical trial at the University of Minnesota—and a bioethicist there spent years lobbying for changes to the school’s clinical trials system—the university is announcing major changes to how it oversees trials and protects its most vulnerable research subjects. Last week, the school released a 75-page document describing an effort to restructure its system and calm its critics. Changes include tighter conflict-of-interest rules; a larger institutional review board (IRB) whose members will be compensated; improved training for researchers working with vulnerable populations, such as the severely mentally ill; and a board of external advisers to monitor the university’s efforts.

The report comes after two damning reviews earlier this year: one by a group of experts appointed by the Association for the Accreditation of Human Research Protection Programs and the other by the state’s Office of the Legislative Auditor. The first report examined protections for university clinical trial participants. Among other things, it found that many IRB members did not regularly attend meetings during the first half of 2014—the...