HJBR May/Jun 2019

research breakdown 24 MAY / JUN 2019 I  Healthcare Journal of BATON ROUGE   • Included children who had previously used psychotropic medication though, under the protocol, that should have made them ineligible; • Managed the medical care of some of the children involved in her study though she was told to keep her clinical and research roles separate; • Failed to give some girls pregnancy tests before they began taking lithium even though consent forms said they would be tested. The drug can lead to an increased risk of birth defects. Pavuluri isn’t solely at fault, accord- ing to NIMH. The agency determined that the university’s institutional review board, known as an IRB, a faculty panel responsi- ble for reviewing research involving human subjects, conducted an “insufficient” initial assessment of Pavuluri’s research plans. The board didn’t even have a copy of her research protocol at its initial review. Officials documented other oversight shortcomings as well. “These are clearly egregious problems that occurred,” said Michael Carome, a for- mer senior official at the U.S. Department of Health and Human Services’ Office for Human Research Protections, or OHRP, who reviewed the case for ProPublica Illinois. Carome said NIMH’s decision to demand UIC repay the grant funds “is very, very uncommon.” “I don’t recall inmy 12-13 years there that this occurred,”added Carome, now director of the health research group at Public Citi- zen, a nonprofit consumer-advocacy orga- nization. “I don’t think I would have forgot- ten an event like that.” UIC officials declined to be interviewed. But in response to written questions, they said that “internal safeguards did not fail” and that they suspended Pavuluri’s research and took other corrective steps when they realized she was not complying with pro- tocols. They said the university “is commit- ted to adhering to the highest standards for research integrity.” They said that Pavuluri’s violations were isolated to her research work, and that a review of her psychiatry practice, where she treated children with mental health issues, concluded she provided “high qual- ity patient care.” University officials halted Pavuluri’s lith- ium research in 2013 and also shut down two other federally funded projects she ran, returning nearly $800,000 that hadn’t yet been spent on those two studies. Yet they named her a university scholar later that year, an honor given to about half a dozen faculty each year who excel in research and teaching and show “great promise for future achievements.” The award included $30,000. They allowed her to keep her prestigious position as a faculty chair and paid her a base salary of nearly $200,000 a year, plus bonuses. And over the past five years, they allowed her to treat and oversee the care of more than 1,200 children and teens. The accolades didn’t stop even after UIC’s chancellor, having reviewed an inter- nal research-integrity investigation into her grants, concluded in 2015 that her conduct reflected a “pattern of placing research pri- orities above patient welfare.” As recently as January, just weeks after the university sent off themultimillion-dol- lar check, its psychiatry department boasted on its website that a survey had named Pavuluri a “top doctor.” Pavuluri, 55, recently filed paperwork to retire in June. The decision came after a meeting with her supervisors to discuss the NIMH decision, records show, and after ProPublica Illinois began asking UIC about the matter. In a telephone interview, Pavuluri called her mistakes oversights and said her deci- sions were made in the best interests of her patients. She said she received minimal guidance and training from the university throughout the research process, though she received $7.5million inNational Institutes of Health grants during her time at UIC. “I thought I was doing the right thing and not harming any child,” she said. “I treated them like an angel, all of them. I was care- ful and tried to do my best with each indi- vidual child. I thought that I could manage that pretty reasonably and that is something “University officials halted Pavuluri’s lithium research in 2013 and also shut down two other federally fund- ed projects she ran, returning nearly $800,000 that hadn’t yet been spent on those two studies.” Research suspended