The adverse event that prompted the University of Illinois at Chicago to shutter three trials by a child psychiatrist occurred when one of the study subjects was hospitalized.
According to a 2013 letter obtained by Retraction Watch through a public records request, the subject was admitted to a 10-day inpatient treatment program after exhibiting an increase in irritability and aggression, which prompted researcher Mani Pavuluri to notify the university’s Institutional Review Board (IRB) in January of that year. As a result, the university halted three studies by Pavuluri, sent out letters to 350 research subjects, and launched a misconduct inquiry.
Here’s how the document describes the event (with some details blacked out):
On {blacked out} the subject was admitted to the [illegible] for a 10-day, inpatient treatment program due to increased irritability and aggression. The [Principal Investigator, Pavuluri] was notified on {blacked out} at which point the subject was withdrawn from the study to ensure that proper care could be completed by physicians at the hospital.
In a letter to the Office for Human Research Protections at the Department of Health and Human Services, James Fischer, the director of the Office for the Protection of Research Subjects at the University of Illinois at Chicago explains that Pavuluri evaluated the patient, who told her current medications were not properly addressing his or her symptoms. So Pavuluri prescribed a “wash-out regimen and rescue medications to ease the transition before completing study procedures.”
However, the subject began to display an increase in irritability, and was eventually hospitalized, Fischer writes:
It was determined that the event represents a Local Serious Unanticipated Adverse Event. The event was determined to have occurred locally since this was a UIC subject, and to be serious, as it required hospitalization to manage. The event was also determined to be unanticipated, as serious irritability and aggression requiring hospitalization is not a listed risk within the consent and protocol. Lastly, the event was determined to be possibly related to the research, as the study procedures likely contributed to the increased severity of the subject’s symptoms.
Fischer concludes:
I believe these actions regarding this adverse event are being appropriately addressed.
After this event, the university looked deeper into Pavuluri’s record, discovering she was “in non-compliance with federal and university research policies.”
A spokesperson for the institution told us Pavuluri is not currently conducting clinical research.
Pavuluri has since logged three retractions, most recently for misrepresenting young patients’ medication histories.
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