HJBR May/Jun 2019

research breakdown 30 MAY / JUN 2019 I  Healthcare Journal of BATON ROUGE   July 2015 letter that the violations of proto- col “collectively represent serious deviations that violate accepted ethical guidelines and professional standards in clinical practice.” He said that Pavuluri’s behavior “repeat- edly put subjects at risk and damaged the credibility of the research data.” He cited her “reckless disregard”in decid- ing who to enroll in the study, the lack of pregnancy and laboratory testing, and “fal- sification and fabrication of research data in an attempt to obfuscate evidence of non- compliance with the research protocols.” He ordered a review of her clinical prac- tice, barred her indefinitely from conduct- ing research and directed her to retract sev- eral scientific journal articles based on the three studies. Three of Pavuluri’s journal articles were retracted after she told the editors that UIC had concluded she had “intentionally and knowingly”made false statements about the participants’ medication histories and that the falsehoods “seriously compromised” the results and conclusions. The retractions were covered in about a half-dozen posts on the RetractionWatch website, whichmoni- tors scientific misconduct. UIC officials said the review of Pavuluri’s clinical practice did not uncover any prob- lems and there was no reason to report her to the state’s medical licensing board. But UIC informed federal authorities it had reason to think additional children had been harmed in her studies. Reports from parents and other evidence led the inves- tigative panel to conclude that “claims by [Pavuluri] that no subjects were harmed in her studies were false,”according to an email from OHRP to UIC. That conclusion was based on issues raised by parents who contacted UIC in the months after the university informed them of the problems with Pavuluri’s research, according to a response to an open-records request. The Fallout It’s difficult to know how unusual the fed- eral government’s demand for reimburse- ment is; NIH said it does not track such actions. The agency would not provide a comparable example. An NIH spokeswoman said the agency does not discuss its decisions about spe- cific grants but that it “takes seriously non- compliance with the terms and condition of award.” UIC refunded the controversial grant with money froma fund that is supposed to sup- port such areas as research, administration, student scholarships and building opera- tions. Campus officials said they knew of no other time when UIC had to reimburse grant funds for failing to comply with guidelines on research integrity or the use of human subjects. Officials acknowledged the $3 million payout will impact other spending, but said they do not yet know what they won’t fund as a result. UIC’s operating budget is more than $2.3 billion this fiscal year. The financial hit comes at a troubling time for the institution, which has seen state fund- ing decline about 10 percent this year follow- ing a nearly two-year budget stalemate that left universities across the state scrambling tomake ends meet. The University of Illinois system recently requested $585 million in state funding for capital projects that would address “only the most urgent priorities.” Pavuluri, meanwhile, is ending her UIC career. She was called into ameeting in Feb- ruary withAnand Kumar, head of UIC’s psy- chiatry department, and Todd Van Neck, an associate dean in the College of Medicine. They wanted to discuss NIMH’s ruling and its demand that the money be returned, emails show. That evening, Pavuluri sent an email thanking them for giving her “options for the next step.”Most of the email is redacted, but it concludes: “I will cherish, co-operate and be grateful as the loyal UIC employee as I seek the opportunity to keep serving.” Kumar responded several days later. He said he shared her questions with the lead- ership team and came to the conclusion “No matter how angelic I was with my research subjects, or how hard I worked day and night, things crashed.” Reflecting