HJBR May/Jun 2019

Healthcare Journal of BATON ROUGE I  MAY / JUN 2019 23 In December, the university quietly paid a severe penalty for Pavuluri’s misconduct and its own lax oversight, after the National Institute of Mental Health demanded weeks earlier that the public institution — which has struggled with declining state funding — repay all $3.1 million it had received for Pavuluri’s study. In issuing the rare rebuke, federal officials concluded that Pavuluri’s “serious and con- tinuing noncompliance” with rules to pro- tect human subjects violated the terms of the grant. NIMH said she had “increased risk to the study subjects”andmade any outcomes scientificallymeaningless, according to doc- uments obtained by ProPublica Illinois. Pavuluri’s research is also under investi- gation by two offices in the U.S. Department of Health andHuman Services: the inspector general’s office, which examines waste, fraud and abuse in government prowgrams, according to subpoenas obtained by Pro- Publica Illinois, and the Office of Research Integrity, according to university officials. AProPublica Illinois investigation, which included interviews and the review of hun- dreds of documents, revealedmultiple layers of failure at the university. UIC didn’t prop- erly screen andmonitor Pavuluri’s research. Even after realizing she had broken rules meant to protect her subjects, it continued to promote her to the public and within the university. Pavuluri’s study, which began in 2009 and was shut down in 2013, was designed to use imaging to look at how the brains of adoles- cents with bipolar disorder function during a manic state, and then again after eight weeks of treatment with lithium. The hope was that the results would provide new information to help identify the disease earlier, lead to treatment and potentially even reverse how the disorder affects the brain. But Pavuluri, a professor of psychiatry, strayed from the approved guidelines and abandoned safety precautions written into the study protocol, according to a November letter fromNIMH to UIC inwhich the agency said it had determined there was wrongdo- ing and demanded the repayment. In all, 89 of the 103 subjects enrolled in the study — 86 percent — did not meet the eligi- bility criteria to participate, records show. Among other violations, Pavuluri: • Enrolled children younger than 10 though the study was approved only for boys and girls ages 13 to 16; “Pavuluri’s study, which began in 2009 and was shut down in 2013, was designed to use imaging to look at how the brains of adolescents with bipolar disorder function during a manic state, and then again after eight weeks of treatment with lithium.”