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Study Coordinator Charged in Scheme to Falsify Clinical Trial Data Details Written by Justice Department
Miami, Florida - A federal grand jury in Miami, Florida, returned an indictment Tuesday charging a Florida woman with conspiring to falsify clinical trial data regarding an asthma medication.
According to court documents, Jessica Palacio, 34, of Miami, worked as a study coordinator at a clinical trial firm in Miami called Unlimited Medical Research. Unlimited Medical Research was one of many companies hired to conduct a clinical trial designed to investigate the safety and efficacy of an asthma medication in children. The indictment alleges that Palacio participated in a scheme to falsify medical records to make it appear as though pediatric subjects made scheduled visits to Unlimited Medical Research, received physical exams from a clinical investigator, and took study drugs as required, when in fact these things had not occurred. The indictment
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The Department of Justice announced Tuesday that a Miami grand jury returned an indictment against Jessica Palacio, a study coordinator at Unlimited Medical Research, a firm that provides clinical trial services for medication.
According to the DOJ press release, “[t]he indictment alleges that Palacio participated in a scheme to falsify medical records to make it appear as though pediatric subjects made scheduled visits to Unlimited Medical Research, received physical exams from a clinical investigator, and took study drugs as required, when in fact these things had not occurred.” The indictment also alleges that Palacio lied to an investigator with the Food and Drug Administration when asked about her conduct.
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A National Science Foundation (NSF) Office of Inspector General (OIG) audit of five Established Program to Stimulate Competitive Research (EPSCoR) awards to the University of Kansas Center for Research (KUCR) questioned $1,550,054 in direct and indirect costs. The largest amount, $625,532, stemmed from what auditors called “inappropriately retained indirect costs.” KUCR’s charges to NSF “exceeded costs paid to its subrecipients,” auditors said in the Jan. 7 report. Subrecipients, under a 2016 agreement, “billed KUCR for indirect costs on EPSCoR awards at rates that were 8 percentage points lower than their formal negotiated indirect cost rates. KUCR paid subrecipients at the lower rates, but it charged the EPSCoR awards for allowable indirect costs at the full, negotiated indirect cost rates and retained the remainder.” Auditors said NSF was not aware of this arrangement. “KUCR agreed to end the practice,” according to the report, but disagreed that its action