The University of Minnesota has halted the recruiting of patients for all its psychiatric drug studies, including 14 underway and three in the pipeline, until problems with oversight and safety monitoring of psychiatric research on campus are addressed.
The decision comes in the wake of a critical external review and legislative audit that raised ethics concerns about the recruitment and treatment of a patient in a schizophrenia drug study who died by suicide a decade ago.
The length of the suspension and its impact on research is unclear.
Recruitment for studies examining drug therapies for autism, depression, substance abuse and schizophrenia has been suspended, regardless of whether researchers had any connection to the trial in which the patient died. Examples include Dr. Kathryn Cullen's study of whether a dietary supplement reduces self-harm behaviors in teens, and the university's arm of a national, industry-funded trial of an experimental drug for obsessive-compulsive disorder.
Cullen said a colleague was about to enroll four families into a study of therapy and medication approaches to adolescent depression, but now he'll probably lose them: "It's hard enough to get our projects done without hindrances like this. It's difficult to recruit families."
Still, she supports the suspension as a step to improving her department's credibility.
Nothing will change for patients already enrolled in trials, but others will have to wait to participate until an independent review board examines oversight of the studies and determines that they minimize the risk of patient harm, said Dr. Brian Herman, the university's vice president for research.
"We just need to make sure … that the danger to the patient has been minimized and the approach by which the patient consented and was asked to participate in a trial was correct," he said.