HJBR May/Jun 2019

Healthcare Journal of BATON ROUGE I  MAY / JUN 2019 29 “In this case, it is the institution that failed,” he said after reviewing the case for ProPublica Illinois. “It could be a case of an overstressed system simply losing a sense of what they were responsible for and where they needed to draw lines.” In fact, UIC’s research oversight problems were not limited to Pavuluri’s studies. In 2014, prompted at least in part by the problems with Pavuluri’s research, the NIH and the OHRP conducted an on-site evalu- ation of UIC’s system for protecting human research subjects. Federal officials deter- mined that, in approving other research projects, university IRBs “sometimes lacked sufficient information tomake the determi- nations required for approval of research,” according to a December 2014 letter from OHRP to UIC. The letter cited a study — not a Pavuluri project — that the IRB approved before it had enough information and other studies for which research approval was expedited when it shouldn’t have been. UIC officials said in a statement that they have tightened oversight. IRBs, they said, now complete more detailed reviews of protocols before approving changes, and they conduct more randomaudits of clinical trials to determine if researchers are follow- ing protocols. Still, in the case of Pavuluri’s studies, the officials put the blame on her. “The principal investigator is responsible for the ethical and professional conduct of sponsored research projects in compliance with applicable laws and regulations, includ- ing for timely and accurately informing the IRB of all changes in scope,” UIC officials said in their emailed responses to questions. But Amneh Kiswani, who served as an assistant director in the campus’ Office of Research Services, said the university bears at least some of the responsibility. When Pavuluri sought an amendment to expand the age of participants, for example, the IRB should have made sure that NIMH had already approved of that change, Kiswani said. “There are supposed to be controls and policies and procedures in place so these types of occurrences don’t happen,” said Kiswani, who left UIC in 2014. “In this par- ticular situation, both are responsible: the institution for failing to follow the rules for changes in scope and the investigator for not knowing her responsibility as a princi- pal investigator.” Carl Elliott, a professor of bioethics at the University of Minnesota, agreed that the NIMH’s determination of wrongdoing “sounds at least as critical of the IRB as it does” of Pavuluri. And he noted that the problems began even before her research got underway. “It baffles me how an IRB could give its ethics approval without reading the proto- col,”said Elliott, who also reviewed the case at ProPublica Illinois’ request. “If it doesn’t have the protocol, they can’t really know what it is they are approving. It doesn’t make any sense at all.” Pavuluri said she is shouldering more than her share of the blame when the uni- versity was also at fault. “It was in their interest to kind of maybe see this as one person’s mistake [rather] than the responsibility of the IRB as well,” she said. Stinging Criticism Pavuluri, in an interview, said she expanded the criteria for who could be included in the study because it was diffi- cult to find enough subjects within the nar- row age range. She said it also was difficult to find children with bipolar disorder who weren’t already taking other medication. She said she also believed a wider pool of subjects would strengthen her findings. “I thought it would be a better scientific outcome if I have power in the study in the higher numbers,” she said. While her transgressions remained unknown to the general public, she appeared to address them in a chapter of the book, “Women inAcademic Psychiatry,”which fea- tures 16 leading women psychiatrists dis- cussing their careers. She described her large laboratory as a “three-ring circus”where she oversaw a flurry of grant submissions and a staff of faculty and students. Asked to name her obstacles, she wrote: “I could not attend to some IRB amend- ments that were due or problem-solve the nuances in the large laboratory. No matter how angelic I was with my research sub- jects, or how hard I worked day and night, things crashed. Here, I learnedmymain les- son, which is the need to have a tight grip on research supervision. No work is done till the paperwork is done.” A university panel tasked with investi- gating the integrity of Pavuluri’s research was less forgiving. UIC refused to provide the panel’s report to ProPublica Illinois or even say who took part in the review. University officials declined to answer questions about girls not being given preg- nancy tests and other shortcomings with laboratory tests, citing the pending federal investigation. Pavuluri said some of the younger children did not get pregnancy tests because she didn’t think they were sexually active. But after reviewing the panel’s report, UIC chancellor Michael Amiridis wrote in a