UIC doctor’s research misconduct ‘ an isolated event’
In response to the May 1 editorial and recent Sun- Times/ ProPublica story, we want to clarify and correct some of the key facts related to what we have done since we first identified the issue related to Dr. Mani Pavuluri’s clinical research.
Following an unanticipated event during a study, a review and audit of the investigator’s research was initiated by the UIC Institutional Review Board ( IRB). Based on audit findings, the UIC IRB found the investigator, Dr. Pavuluri, to be in non- compliance with federal and university research policies.
UIC self- reported the onset of its investigation to all necessary federal agencies, and as a result, three research studies were immediately stopped. A letter was subsequently sent to approximately 350 study subjects, or their parents/ guardians, informing them of the research non- compliance. The UIC IRB also suspended all research protocols involving this investigator.
Bipolar disorder is, unfortunately, a chronic condition where behavioral symptoms such as mood, sleep and, emotional control fluctuate substantially. Lithium is one of the most widely used and safe treatments for bipolar disorder in adults and represents the standard of care in pediatric psychiatry to treat bipolar disorder in children and adolescents between the ages of 12 and 17. It is not uncommon, however, for clinicians to use lithium for mood stabilization on even younger patients diagnosed with bipolar disorder as an “off- label” use of the medication. Additionally, there is no evidence that therapeutic doses of lithium, for a five- week period, have any long- term deleterious consequences either to the brain or behavior in children and adolescents.
In compliance with federal and university policies, an inquiry and, subsequently, a formal investigation of the allegations of research misconduct were undertaken by UIC. UIC submitted its findings of the internal research misconduct investigation in October 2015. Based on the results of the initial audit, UIC put a hold on Dr. Pavuluri’s research, and at the conclusion of the internal investigation, UIC suspended all of Dr. Pavuluri’s research activities indefinitely. Dr. Pavuluri has not resumed any clinical research studies since 2013.
A detailed external audit was conducted by three Department of Health and Human Services agencies in July 2014, which determined that the human subjects’ research at UIC did not have any systemic issues of lax research oversight and was performed upholding the highest standards in ethical and responsible research conduct. Hence, the case of Dr. Pavuluri’s research misconduct is believed to be an isolated event. The case that is the subject of media reports remains an open investigation with the DHHS Office of Research Integrity.
In December 2017, UIC repaid $ 3.1 million to the National Institutes of Health for one of Dr. Pavuluri’s research grants. UIC had also returned unexpended funds from three of her grants — including this one — in 2013. This is the only time in its history that UIC has had to reimburse grant funds due to human subject noncompliance.
The non- compliance related only to Dr. Pavuluri’s research work. A review of her clinical practice demonstrated high- quality patient care with appropriate clinical documentation.
UIC’s research office provides continuing education and training to our research community, in addition to routine re- evaluations of each research protocol and random audits of clinical trials. In fact, Dr. Pavuluri participated in a number of training sessions before and during her research work. We take these matters very seriously and we are committed to adhering to the highest standards for research integrity — particularly regarding research issues involving minors — and to comply with all federal, state and university regulations.