HJBR May/Jun 2019

research breakdown 28 MAY / JUN 2019 I  Healthcare Journal of BATON ROUGE   consent and the quality of care,”according to their reply, obtained by ProPublica Illinois, though the authors’names were redacted for privacy. “Have you turned this over to your malpractice carrier? If not, we would request that you do so at this time so that we can see what course of action to take fromhere.” A longer follow-up letter to the univer- sity’s claims office was entirely redacted except for the last sentence: “I hope that we can settle this amicably and in the interest of all parties.” UIC said no claim was ever filed. A Failure of Oversight UIC is a federal research powerhouse with one of the largest medical schools in the country. Over the past five years, the univer- sity has received a total of more than $950 million in federal research funding, placing it among the top 60 research universities during that period. The institution had faced trouble for lax research oversight before. In 1999, fed- eral regulators temporarily shut down all research involving humans after finding deficiencies in the scientific and ethical review process. The university’s role in supervising Pavu- luri’s research suggests similar shortcom- ings. Not only was there insufficient ini- tial review by the IRB, NIMH found, but the panel then fast-tracked approval without any justification for doing so. And then, just four months after the study began, the IRB also approved lowering the minimumage of participants in the study to 10 — even thoughNIMHhad specifically pro- hibited that — and did so without requesting Pavuluri’s rationale for the change. The IRB approved an amendment allowing partici- pants to have previously taken other med- ications as long as lithium was not among them. NIMH said it was never informed of these IRB-approved changes. “The changes were significant, because they increased risk to study subjects,” according to the November letter in which NIMH demanded repayment from the university. Five subjects younger than 10 enrolled in the study; Pavuluri said only a few that young were enrolled, and they got in “by mistake.” The IRB also failed to catch omissions in the consent forms, including informing sub- jects and their parents that lithium is not FDA-approved for children under 12 and there are alternative courses of treatment for bipolar disorder. Lithium is not FDA-approved for that age group because there have not been enough studies of its use. The drug continues to be tested in clinical trials; some psychiatrists say it is one of the best available treatments. As Pavuluri’s study progressed, there were other oversight failures. NIH policy recommends that individuals on a study’s data and safety monitoring board, which is tasked with observing a trial’s progress and the safety of its participants, “are in no way associated with the trial.” But the board for Pavuluri’s study included Pavuluri and a co- investigator, while a report by the monitor- ing board, submitted partway through the study, was prepared by a member of Pavu- luri’s research staff, records show. UIC officials said Pavuluri’s co-investiga- tor was originally an independent member before joining the research team and that there were other independent members on the panel. Nicholas Steneck, an emeritus profes- sor of history at the University of Michi- gan who was a consultant to the U.S. Office of Research Integrity, said it is difficult to understand how such a large research insti- tution could have such a “poorly function- ing IRB.” He called the UIC board’s failures “IRB 101 mistakes.” Nicholas Steneck, an emeritus professor of history at the University of Michigan who was a consultant to the U.S. Office of Research Integrity, said it is difficult to understand how such a large research institution could have such a “poorly functioning IRB.” He called the UIC board’s failures “IRB 101 mistakes.” Oversight failure