HJLR Mar/Apr 2019

research breakdown 32 MAR / APR 2019 I  Healthcare Journal of Little Rock   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 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. 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