HJBR May/Jun 2019

Healthcare Journal of BATON ROUGE I  MAY / JUN 2019 27 “The records the university released, however, show that twomonths after its initial report of a problem, the IRB suspended Pavuluri’s research and the university launched an audit of the protocol to determine what had gone wrong.” according to records, and when symptoms worsened, she was hospitalized — her first time for a manic episode. Pavuluri said the drugs weren’t an issue. She said the episode was caused by conflicts at home. Research guidelines require that a serious and unanticipated “adverse event” involv- ing a human subject be reported to the IRB, and Pavuluri did so in January. The univer- sity’s IRB chair at the time, James Fischer, a pharmacy professor, determined the study “likely contributed to the increased sever- ity”of her symptoms. According to records, he reported the incident to the NIMH and OHRP. It was the only adverse event reported during the study. ProPublica Illinois obtained hundreds of documents related to Pavuluri’s studies in response to Freedom of Information Act requests. But university officials withheld or redacted many records, citing federal and state laws regarding patient privacy and the confidentiality of research. Those records include some communi- cations between the university and the fed- eral agencies that likely would providemore detail about the extent of the research fail- ings and how the university responded. The university also withheld Pavuluri’s research protocols. The records the university released, how- ever, show that two months after its initial report of a problem, the IRB suspended Pavuluri’s research and the university launched an audit of the protocol to deter- mine what had gone wrong. In a letter to OHRP, Fischer commended Pavuluri for her “cooperation and forthrightness”in address- ing the issue. But as the IRB dug deeper into Pavulu- ri’s three studies, it found more problems. In subsequent letters, Fischer reported “serious non-compliance” in the study and by the IRB, and he proposed a corrective action plan. ByApril 2013, the university also had suspended Pavuluri’s other two active NIMH-funded studies, for aminimumof six months, while her research privileges were revoked. After reviewing the other two studies, the IRB determined they also were out of com- pliance, according to letters sent in June 2013 from the university to OHRP. Those studies had similar problems. Patients were enrolled despite not meeting eligibil- ity requirements, research procedures began before the dates on the permission forms, and some children were enrolled in multi- ple studies. UIC officials decided to shut down the other two studies and return the unex- pended funds, emails and other documents show. For one, the university returned $356,810 that hadn’t been spent from a $3.2 million grant. For the other, in its early stages, the university returned $431,256, university offi- cials said. In June 2014, the Mallard family and about 350 others — including healthy control subjects — received a letter from the univer- sity saying it had found “problems”with the conduct in Pavuluri’s three studies. It said children may have been put at greater risk than what had been explained in consent and parental permission forms. Cynthia Mallard, dealing with a particu- larly tough time in Luke’s life, filed the letter with other paperwork on his illness. Another family wrote back. “We have been struggling with this letter since we received it and have been deeply disturbed, specifically regarding the parental