Research in limbo after suspension

Christopher Aadland

University of Minnesota researchers are voicing concerns over the psychiatric departmentâÄôs long-term future amid discussions between school and state officials on the institutionâÄôs research practices. Last month, University President Eric Kaler halted enrollment in 17 University psychiatric drug trials âÄî which include studies of schizophrenia, depression in adolescents and autism âÄî after two external reports found flaws and ethical concerns in the schoolâÄôs human research programs. With the suspension, some researchers are worried that future drug studies will be hard to complete, and they wonâÄôt be able to finish their in-progress work. Though researchers are allowed to continue to work with patients who were enrolled prior to the suspension, they arenâÄôt allowed to recruit or enroll additional participants until an external institutional review board asses all current and pending psychiatric drug studies. âÄúItâÄôs not clear to me when weâÄôll be able to start again. I donâÄôt have confidence it will be soon,âÄù said Dr. Kathryn Cullen, an assistant professor in the Department of Psychiatry. CullenâÄôs two studies that are examining adolescent depression and self-harm were halted, and she said the delay could cause some faculty members to miss vital research deadlines âÄî potentially impacting their federal funding. She said one of her colleagues scheduled nine families to participate in another study to treat adolescent depression but was was forced to turn them away because of the suspension. Funds for research studies are âÄútrickling away,âÄù Cullen said, because staff members are still getting paid even as the suspension continues. This could cause funding to run out before studies are completed, even if enrollment is reinstated, she said. Potential study participants may also be more hesitant to enroll once sanctions are lifted, said Jeffrey Wozniak, an associate professor in the Department of Psychiatry. His study on prenatal alcohol exposure was impacted by the suspension. âÄúItâÄôs safe to say that anyone involved in clinical research at the University is very concerned about how this will impact our perception,âÄù he said. Wozniak said the group who will be most affected by the enrollment delay are patients who are struggling with mental health issues. âÄúWeâÄôre already in a situation where there isnâÄôt enough research being done to help people with mental illness,âÄù he said. And as the Medical School attempts to boost its ranking by bringing in top-notch faculty members, Cullen said the suspension could make prospective hires reconsider the University. âÄúHow can I do my research at this institution? Are there going to be barriers at this institution for my research?âÄù she said in reference to what she believes potential hires would consider. One of the external reports released earlier this year, managed by the Association for the Accreditation of Human Research Protection Programs, noted a culture of fear and retaliation within the psychiatry department. Kaler previously told the Minnesota Daily that the allegation was concerning and the school will be âÄútaking action very soon to help understand and repair that situation.âÄù A team made up of mostly faculty members and outside experts will also make recommendations by May 15 on how the UniversityâÄôs human subjects protection program should change. Wozniak said though his research has been delayed, he understands why the University halted his departmentâÄôs drug studies. âÄúGiven the circumstances, itâÄôs important to take a pause and make sure we have some accountability from the outside because the perception is that we need to make some changes,âÄù he said.