U of Illinois at Chicago overlooked serious issues with clinical trial, documents show

University of Illinois at Chicago has publicly denied its failure to oversee a troubled clinical trial involving adolescents, but newly obtained documents show the university did acknowledge some shortfalls to federal investigators, according to an investigative report from ProPublica Illinois.

Five things to know:

1. Mani Pavuluri, MD, a former child psychiatrist at UIC, launched the study in 2009 to assess the use of lithium to treat adolescents with bipolar disorder. The clinical trial was shut down in 2013 after federal officials discovered Dr. Pavuluri violated numerous research rules, such as enrolling children who were too young for the trial or failing to alert parents of the study's risks. Her actions required UIC to pay a $3.1 million fine to the federal government, according to ProPublica Illinois.

 2. While UIC downplayed its failure to identify and respond to issues with the clinical trial, documents obtained by ProPublica Illinois show the organization acknowledged shortcomings with its Institutional Review Board to federal officials. The IRB is a committee responsible for protecting clinical trial participants at UIC.

3. In the documents, UIC said its IRB improperly fast-tracked Dr. Pavuluri's trial, failed to catch major omissions from parental consent forms, and allowed 89 ineligible children to enroll in the study, according to the report.

4. A UIC spokesperson told ProPublica Illinois the university did not discipline any employees for the IRB issues. Researchers are "responsible for the ethical and professional conduct" of their studies and "internal safeguards did not fail," UIC said.

5. The university also noted it took appropriate actions after discovering issues with Dr. Pavuluri's study. UIC notified federal agencies, suspended the study and ordered Dr. Pavuluri to retract journal articles. She retired in June 2018, according to a separate ProPublica Illinois report.

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