Researcher sues U.S. government following debarment, misconduct finding

A former researcher at the University of Utah has filed for a temporary restraining order against the U.S. government agency that last week barred her from receiving federal funds. 

Ivana Frech – formerly Ivana De Domenico – “engaged in research misconduct by intentionally, knowingly, or recklessly falsifying and/or fabricating” images in three different papers whose work was funded by grants from the National Institutes of Health, according to the Office of Research Integrity (ORI). ORI barred Frech from receiving federal funding for three years starting on August 21, making no mention of whether she agreed to the sanctions.

But on August 29, Jackson Nichols, an attorney representing Frech, filed for a temporary restraining order against the Department of Health and Human Services. The complaint in the case is under seal, and the summons refer only to a “suit to enjoin further action by U.S. government agency” under the Administrative Procedure Act. 

Neither Nichols nor Frech immediately responded to Retraction Watch’s request for comment about the goals of the lawsuit, but the filing is consistent with others aimed at blocking such debarments.

The case dates back to at least 2012, when Frech and colleagues retracted two papers from Cell Metabolism. As we reported at the time, Jerry Kaplan, the senior author of those papers, said “the data were lost when an employee, who was dismissed, discarded lab notebooks without permission.” That employee – who was not a co-author of the paper – was a technician, Kaplan said. “This occurred prior to the identification of errors in the manuscripts and was reported at that time to the University authorities.”

Asked about the apparent discrepancy between those comments and the ORI placing blame on Frech, Kaplan tells Retraction Watch: “I now think the ORI report was accurate.”

More papers were corrected that year, and Frech and Kaplan left the university in 2013. That year, the Salt Lake Tribune reported that the university had investigated the case and issued a scathing report in which it said it “could not determine by a preponderance of the evidence that these items were the work of Dr. DeDomenico.” 

But it said that there was misconduct “based on reckless disregard of accepted practice, a finding heavily influenced by the number of departures from established norms over an extended period.” Utah, as required by the assurance agreement governing its acceptance of federal funds, notified the ORI of its findings.

In 2014, the group retracted another paper from Cell Metabolism. And the ORI said it would request the retraction of a fourth paper, this one published in 2008 in Developmental Cell.

Grants with Frech’s name on them totaled in the millions of dollars while she was at Utah, although she was not principal investigator on all of them. She appears to have served as lab manager for Frank Zhan at the University of Iowa for at least four years. Zhan told a medicine department blog in 2018: “She emphasizes the importance of academic integrity and best lab practices, creating a positive lab culture.”

Update, 8/31/23, 1900 UTC: An HHS spokesperson tells us that Frech missed a deadline to request a hearing in front of a judge about the sanctions:

Under the Public Health Service Policies on Research Misconduct, at 42 C.F.R. Part 93, ORI may make findings of research misconduct and propose administrative actions and notifies a respondent in a charge letter. If debarment is proposed, the charge letter serves as a notice of proposed debarment and is cosigned by the HHS debarring official. The respondent then has 30 days to contest the findings and proposed administrative actions by requesting a hearing in front of an Administrative Law Judge (ALJ) with the HHS Departmental Appeals Board, or the findings become final. ORI may settle a research misconduct proceeding at any time with a voluntary agreement when it is in the best interests of the Federal government and the public health or welfare. In this case, ORI issued a charge letter, and the respondent did not request a hearing with an ALJ within the 30-day period prescribed by regulation, so the research misconduct findings and proposed administrative actions became the final HHS actions.

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