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 period examined—and that a psychiatrist was present at only four of 26 meetings when new protocols were considered; 85 psychiatry protocols were submitted for review during that time. The second report was an in-depth review of the violent suicide of Dan Markingson, a 27-year-old who signed on to a drug trial while involuntarily committed to a University of Minnesota hospital. His treating psychiatrist was also one of the trial’s leaders and receiving funding from the drug company. The state report concluded that “the case involves serious ethical issues and numerous conflicts of interest.” Concerns about Markingson’s death were first raised publicly 7 years ago, in a three-part series by the local Pioneer Press.
University of Minnesota bioethicist Carl Elliott was shocked by the news stories. Since then, he has been a thorn in the side of his institution, calling for an independent investigation into Markingson’s death, as well as information on the number of people who have died or been injured in psychiatric drug trials at the university. Over time, he garnered support from colleagues, students, and even a former governor. The ground shifted in late 2013, when the Faculty Senate called for an inquiry to examine current practices in clinical trial protections. In May 2014, Elliott was profiled in a lengthy story in Science.
Reached this morning while on vacation in Maine, Elliott said he was pleased by the report’s proposals, in particular a ban on researchers accepting consulting fees from companies for whom they’re also currently running trials. But he remains troubled that so many years elapsed before the university took major action, and he wishes the report itself had examined why. “It should not have taken 11 years and the involvement of a former governor and hundreds of people writing the university … and yet it did,” he said. Why change took so long to come “is a really important piece,” Elliott says. “And how do we prevent this from happening the next time?”
“While the changes we are making to our human subjects research protections do indeed have roots in the Markingson case 11 years ago, it would be incorrect to state that it took us 11 years to investigate or to make any changes related to this issue,” says Brian Lucas, a spokesperson for the University of Minnesota. He notes that several bodies, such as the U.S. Food and Drug Administration, have conducted inquiries into the case. “Our practices and protections have evolved over the last 11 years, as have national standards. Unfortunately, in some areas we did not evolve as quickly as we should have.”
In a press release, university president Eric Kaler, said that “Minnesotans want us to get this right, but they also want us to continue the research that they and their family members depend on.”