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"The study, “Affective Neuroscience of Pediatric Bipolar Disorder,” began in 2009 and aimed to use imaging to examine how the brains of adolescents with bipolar disorder functioned before and after taking lithium. The scans were compared with brain images of healthy, unmedicated children.
The study was almost complete, and the money spent, when it was shut down in 2013, when one of the young subjects became ill after she withdrew from other medication to begin receiving lithium for the study.
According to the protocol NIMH had approved, subjects should not have been able to participate if they had previously used psychotropic medication. The IRB did not approve medication withdrawal, records show.
The child’s hospitalization was reported to the IRB and then to federal officials, who requested more information. UIC conducted the initial audit and then an investigation, keeping federal officials informed of the findings over the next two years.
NIMH officials eventually determined both Pavuluri and the IRB had failed in numerous ways and demanded the $3.1 million be refunded. The study, NIMH officials concluded, had been compromised and the results had no scientific merit. The university had previously returned about $800,000 for two of Pavuluri’s other federally funded projects that also shut down prematurely when similar problems were discovered.
The newly obtained documents describe disorganization in Pavuluri’s work, with poor record keeping that included missing dates and identification numbers for the research subjects, among other problems. That made it difficult for UIC officials who later reviewed the research to understand who took part in the trial and the details of their participation.
Still, the records contain details that explain why 89 of the 103 children who participated should have been ineligible, including because they had histories of substance abuse, seizures or suicidal tendencies."
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