University of Illinois at Chicago officials on Tuesday told faculty, staff and students that research misconduct by one of the campus’ star faculty members was an anomaly and there are no systemic oversight problems at the institution.
Still, the university’s president and chancellor also acknowledged Tuesday in emails to ProPublica Illinois that the campus can improve oversight of research, especially when it involves children.
The message to the campus came after a ProPublica Illinois investigation last week revealed how the National Institute of Mental Health recently ordered the university to repay $3.1 million in grant money that it had received to fund one of UIC psychiatrist Mani Pavuluri’s studies on bipolar disorder among children.
NIMH demanded the refund in November after determining there was “serious and continuing noncompliance” by Pavuluri as well as failures by the university’s institutional review board, or IRB, a faculty panel responsible for reviewing research involving human subjects.
Pavuluri’s research remains under investigation by federal officials, according to the university.
“The case of Dr. Pavuluri’s research misconduct is believed to be an isolated event,” Mitra Dutta, the vice chancellor for research, and Anand Kumar, head of the psychiatry department, wrote in a campus-wide email. They said it was the only time in UIC history that grant funds were reimbursed due to human subjects noncompliance.
The university already had returned about $800,000 it had received for two of Pavuluri’s other federally funded studies.
Pavuluri’s study, which began in 2009 and was shut down in 2013, was designed to use imaging to look at how the brains of adolescents with bipolar disorder function during a manic state, and then again after eight weeks of treatment with the powerful drug lithium.
Pavuluri, a tenured psychiatry professor, violated terms of the federal grant by testing lithium on children younger than 13 although she was told not to. She also failed to properly alert parents of the study’s risks, failed to conduct required pregnancy tests on some girls, and falsified data to cover up the misconduct, records show.
In all, 89 of the 103 subjects enrolled in the study — 86 percent — did not meet the eligibility criteria to participate, records show. They were too young, had previously used psychotropic medication, or did not meet other guidelines to participate.
The ProPublica Illinois investigation revealed lax oversight throughout Pavuluri’s clinical trials. Among other issues, Pavuluri sat on a panel that was responsible for monitoring the clinical trial as it proceeded.
NIMH noted several problems with the university’s review of Pavuluri’s research protocol.
The IRB, according to records, conducted an “insufficient initial review” of Pavuluri’s plans, including not having the research protocol at the time of the review, and then approved an expedited review though it did not have adequate documentation.
The IRB also failed “to request or review the rationale for the change in age range” during the review of an amendment that lowered the age of eligible participants to 10 years old, the records show.
Nor did it identify omissions in consent forms provided to research subjects or their parents, including that lithium is not FDA-approved for children under 12. The forms also did not disclose alternative courses of treatment.
On Tuesday, UIC officials outlined steps they took after identifying problems with Pavuluri’s work when a child enrolled in the lithium study was hospitalized in January 2013. The university reported its findings to NIMH and other federal agencies, initiated an audit of Pavuluri’s research, stopped three of her studies, and alerted about 350 study subjects or their parents about the noncompliance, the statement said.
Following an internal investigation in 2015, UIC suspended Pavuluri’s research indefinitely.
University officials have declined to provide a copy of the investigative report to ProPublica Illinois as well as some of their communications with federal agencies, citing state and federal privacy laws and other reasons. They also have refused to say who participated in the audit or in the internal investigation, citing an ongoing federal investigation.
After reviewing the investigative report, however, Chancellor Michael Amiridis wrote in a letter that Pavuluri’s conduct reflected a “pattern of placing research priorities above patient welfare.”
Privacy rules were an obstacle to finding participants in Dr. Mani Pavuluri’s lithium studies, but we got around them.
He ordered a review of her clinical practice, barred her indefinitely from conducting research and directed her to retract several scientific journal articles based on the three studies. Three articles were retracted.
Yet she continued to treat or oversee the care of more than 1,200 patients after 2013, records show.
In Tuesday’s statement, university officials said a review of Pavuluri’s medical practice “demonstrated high quality patient care with appropriate clinical documentation.”
Pavuluri, who joined UIC in 2000, founded the Pediatric Mood Disorders Program for children with bipolar disorder, depression and other disorders, which draws patients from around the country.
She secured about $7.5 million in grant funding from the National Institutes of Health during her years at UIC.
Pavuluri, 55, plans to retire from UIC at the end of June. She made the decision after meeting with her supervisors in February to discuss the NIMH decision and demand for repayment. In an interview with ProPublica Illinois, she said she was shouldering too much of the blame when the university also was 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.
In the statement, university officials said there were no systemic issues of lax research oversight, citing a 2014 audit conducted by the U.S. Department of Health and Human Services. The UIC officials said the audit determined human subjects research “was performed upholding the highest standards in ethical and responsible research conduct.”
But federal agencies did, in fact, find problems beyond those in Pavuluri’s research after conducting an onsite evaluation of UIC’s system for protecting human research subjects in July 2014.
A letter sent by HHS’ Office of Human Research Protections to Dutta later that year said the agencies had determined that, in approving other research projects, university IRBs “sometimes lacked sufficient information to make the determinations required for approval of research.”
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.
In emails to ProPublica Illinois on Tuesday, Amiridis, the Chicago campus chancellor, said officials will continue to review IRB processes, while University of Illinois President Timothy Killeen said he is confident the campus handled the matter appropriately.
“UIC takes these matters seriously and is committed to the highest standards of research integrity now and into the future—particularly regarding research issues involving minors,” Killeen wrote.
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Cite this: Jodi S. Cohen. University Officials Defend Handling of Researcher's Misconduct - Medscape - May 15, 2018.