Retraction Watch

Tracking retractions as a window into the scientific process

Child psych studies halted for “unanticipated event,” sparking misconduct investigation

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mpavuluri

Mani Pavuluri

We’ve just learned what sparked a University of Illinois at Chicago investigation that recently concluded a child psychiatrist had committed misconduct: An “unanticipated event during a study,” which halted three studies and resulted in a letter sent out to 350 research subjects.

Earlier this week, we reported that an investigation at the University of Illinois at Chicago found “a preponderance of evidence” that child psychiatrist Mani Pavuluri had committed misconduct. The university told the U.S. Department of Health and Human Services about the investigation in 2013. The findings of the investigation led the university to request the retractions of three papers, one of which has been pulled so far, for not properly disclosing how much medication children had received outside the study.

Today, we found out what prompted the university to launch that investigation, courtesy of a statement from a spokesperson:

The University of Illinois at Chicago conducted an investigation into allegations of research misconduct against Dr. Mani Pavuluri, a tenured professor employed in the College of Medicine’s department of psychiatry.

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 to be in non-compliance with federal and university research policies.

All necessary federal agencies were informed of the investigation. 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 errors.  The IRB suspended all research protocols involving the investigator.

In compliance with federal and university policies, an inquiry and, subsequently, a formal investigation of the allegations of research misconduct were undertaken.  Based on the results of the investigation, appropriate university sanctions were imposed.

The university informed the U.S. Department of Health and Human Services of the investigation in 2013 and submitted its findings in October 2015.

The university is committed to adhering to the highest standards for research integrity and to comply with all federal, state and university regulations.

Pavuluri told us earlier this week that, in regards to her retracted paper, there was “a bit of an [Institutional Review Board] infraction.”

Last year, the Office for Human Research Protections (OHRP) conducted an on-site evaluation of the “system for protecting human research subjects” at UIC, according to a letter that they sent to the university. The OHRP sent us a link to the letter in response to a query about their investigation into Pavuluri; she is the only researcher cc’d on the letter who is not directly connected to a position that oversees research, and when we asked the UIC spokesperson about the letter, we received the above statement.

The OHRP found that there were shortcomings in the information provided to the institutional review boards:

We have determined that the institutional review boards (IRBs) sometimes lacked sufficient information to make the determinations required for approval of research under HHS regulations at 45 CFR 46.111.  For example, IRB #1 had the following “Modifications Required” at initial review on May 22, 2014 for study 2014-0439::  “Explain the treatment for DSA; include the explanation of the substudy in the initial review application; explain the inclusion/exclusion criteria for the substudy; include how many subjects are expected to participate.”

Earlier this week, Pavuluri told us that she still had her position at the University, and was seeing patients.

We’re trying to get more information about the nature of the “unanticipated event,” the studies that were halted, and the sanctions imposed as a result of the investigation.

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Written by Shannon Palus

November 6th, 2015 at 2:47 pm

Comments
  • Paul Thompson November 6, 2015 at 2:57 pm

    If these are ongoing studies, and they have interventions that are “more than minimal risk” (which I would assume is the case with medication), then the question is 1) what did the DSMB (Data and Safety Monitoring Board) know about the situation, since these are certainly protocol violations and 2) were protocol violations filed about these cases? If the answers are 1) nothing and 2) no, then the situation is certainly one in which adequate oversight was not maintained.

  • Conrad Seitz MD November 6, 2015 at 5:12 pm

    I’m shocked, shocked that my alma mater (the biggest medical school in the US at that time) would have such problems.
    Are these problems with investigational medications for childhood psychosis? Or technical violations of consent requirements? What exactly is “a bit of an infraction”? Inquiring minds want to know.

  • J Bollen, MD November 9, 2015 at 10:42 am

    It only takes about five seconds to find her current research projects here http://www.psych.uic.edu/human/154-about-us/directory/faculty/477-mani-pavuluri-md-phd

    She appears by the way to be very highly qualified- ” Pavuluri is MD PhD, Distinguished Fellow of the American Academy of Child and Adolescent Psychiatry, Professor at the University of Illinois at Chicago (UIC), Berger-Colbeth Chair in Child Psychiatry, and the Founding Director of the Pediatric Mood Disorders Program and the Pediatric Brain Research And InterventioN (BRAIN) Center” with numerous published and in-press articles.

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