The University of Illinois at Chicago (UIC) permanently suspended all research activities for a child psychiatrist years ago following an inquiry into her work, Retraction Watch has learned.
In 2015, a UIC spokesperson told us the university had suspended Mani Pavuluri’s clinical research in 2013, after a child in one of her studies had been hospitalized for exhibiting an increase in irritability and aggression. This prompted the university to launch a misconduct probe, and send letters to approximately 350 families of children participating in the research, notifying them of what happened. Now, a spokesperson has informed us that after the institution concluded its probe, it suspended her research “indefinitely.”
Pavuluri’s work focuses on “brain circuitry function,” according to her website, along with how medication affects the brain in people with bipolar disorder, ADHD, and other mood disorders. She has completed two clinical trials involving children with bipolar disorder, and has received more than $7 million in funding from the National Institutes of Health over the course of her career.
In 2016, we filed a public records request for a report about the probe into Pavuluri’s work; that request was denied, but we did obtain a copy of a 2014 letter sent to hundreds of families after three psychiatric studies of children were halted — minus one redacted line. (We requested a review of that decision, and now know what the line says.)
A 2015 retraction of one of Pavuluri’s papers cites the results of the UIC’s investigation, noting allegations of research misconduct against Dr. Pavuluri were supported by a preponderance of evidence.
If research affected by misconduct was supported by funding from the U.S. National Institutes of Health, institutions must notify the U.S. Office of Research Integrity, which conducts its own review. Yesterday, a spokesperson for the UIC told Retraction Watch:
An investigation by the [U.S. Department of Health and Human Services] Office of Research Integrity remains open…Dr. Pavuluri has not resumed any clinical research studies since they were suspended in 2013. After the internal enquiry was completed, the University suspended all of her research activities indefinitely.
In a previous statement from 2015, a spokesperson told us:The university informed the U.S. Department of Health and Human Services of the investigation in 2013 and submitted its findings in October 2015.
We contacted Pavuluri, but haven’t heard back.
The 2014 letter said three studies contained a myriad of problems that may have put participants at greater risk than was disclosed by consent forms. The problems ranged from enrolling ineligible patients, not informing families of the risks associated with the studies, and skipping tests designed to minimize the risks associated with lithium.
In the section about the “consequence of the discovery of these findings,” one line was redacted. The university’s primary argument for redacting that letter was:
…new or additional disciplinary measures could be implemented as the result of a federal review of the University’ s findings.
…The [Institutional Review Board] suspended Dr. Pavuluri’s research studies and is not allowing the study results to be published in the medical literature or presented at professional meetings.
A UIC spokesperson told us in 2016 Pavuluri was not conducting clinical research, making the decision to redact the line somewhat perplexing. But now we know the findings won’t be disseminated.
The university has also denied our request for the report of the investigation of allegations regarding Pavuluri’s work, noting it “does not contain any final outcomes, only recommendations for administrative actions.” Furthermore, the university claimed the report was exempt under the Illinois Medical Studies Act (MSA), which protects medical studies and reports on a “health care practitioner’s professional competence.”
Source : retractionwatch.com