Report on Research Compliance Volume 20, Number 1. In This Month’s E-News: January 2023

Health Care Compliance Association (HCCA)
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Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 1. January 02, 2023

Alice C. Chang, formerly an associate professor of basic medical sciences in the College of Veterinary Medicine at Purdue University, “falsified and/or fabricated data from the same mouse models or cell lines by reusing the data, with or without manipulation, to represent unrelated experiments from different mouse models or cell lines with different treatments,” the HHS Office of Research Integrity (ORI) announced Dec. 13. The data was used in 384 “figure panels” in two awards funded by the National Cancer Institute (NCI) and 14 applications NCI did not fund from 2014 to 2018. The falsified figures were also included in two published papers. ORI said Chang “neither admits nor denies ORI’s findings with respect” to the papers but did not mention whether she agreed with the other findings.

However, Chang agreed with ORI’s sanctions for the research misconduct, which call for her to exclude herself for 10 years from participating in federally funded programs, beginning Dec. 7. She also will “exclude herself voluntarily from serving in any advisory or consultant capacity to [the Public Health Service] PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee.” Chang will also request that the two papers be “corrected,” although it is not clear what type of corrections would be appropriate. ORI also has the authority to request retractions. The papers appeared in Cancer Research in 2015 and Oncogene in 2017. (12/15/22)

Despite objections from the University of Kansas Center for Research (KUCR), the National Science Foundation (NSF) has disallowed all costs flagged by its Office of Inspector General (OIG) and is requiring repayment of $1,550,054. NSF “conducted detailed reviews of applicable Federal and NSF requirements, proposal and award information maintained by NSF, and documentation provided by KUCR,” NSF said in a Dec. 8 resolution report. The audit, issued Jan. 7, 2021, was one of five Established Program to Stimulate Competitive Research (EPSCoR) awards expended from Oct. 1, 2015, through Sept. 30, 2018. At the time of the audit, KUCR disputed $874,000 in direct and indirect costs that auditors said were unallowable or unsupported.

Of the total, $625,532 was for indirect costs claimed by subrecipients. Auditors said subrecipients “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.” The $569,477 was for “unsupported subaward expenses to two EPSCoR awards” to cover “salary, fringe, material, supplies, and travel costs claimed by Haskell Indian Nations University.” Auditors concluded, and NSF agreed, that KUCR was “unable to provide documentation in support of actual costs.” Since the audit, NSF said KUCR had taken a number of corrective actions “to strengthen administrative and management controls and processes related to unallowable expenditures and use of materials and supplies under participant support costs,” which it said were “responsive to the compliance and internal control recommendation in the audit report.” (12/15/22)

In its first resolution of an audit conducted this year, the National Science Foundation (NSF) agreed with its Office of Inspector General (OIG) to disallow approximately $30,000 in costs claimed by the University of Idaho (UI). However, it permitted more than $5,000 for publication-related expenses OIG had questioned. The audit covered $42.7 million for 50 awards from their “inception date through” Sept. 2, 2021; it only proceeded through an “initial phase” because auditors “did not identify any extraordinary circumstances that justified the need for a second audit phase,” according to the May 6 audit. In a resolution report dated Nov. 18, NSF said UI agreed with its decision to disallow $24,855 in unallocable expenses and $5,446 in improper cash drawdowns. These amounts included $9,552 for software related to a cybersecurity training program for which UI later received state reimbursement, and $9,100 for a car purchase from a rental company that should have been accounted for as a capital asset, not an indirect cost.

UI had argued the publication costs were permissible. Auditors said UI charged one award $5,015 for the entire cost of publishing a paper, although NSF “was only one of the three funding sources identified in the publication.” According to the auditors, “UI did not document or provide a reasonable justification as to why it allocated 100 percent of the cost to this NSF award, [thus] we were unable to determine the percentage allocable to this award.” UI told the auditors the mention of three funding sources was done “in recognition of the science developed as a foundation to support the research performed for [redacted]” and that they were “concerned about the precedent that could be set” by this finding. In concurring with UI, NSF said it “does not agree that publication acknowledgements necessarily represent the relative benefits received for the purpose of allocating publication expenses. NSF determined that UI’s rationale for allocating publication expenses was reasonable.” UI had also disputed an OIG finding that employed incorrect indirect cost rates; in this instance, NSF agreed with auditors but not for the reason they offered. According to the resolution, the rates UI used were “provisional,” and it should have subsequently revised them to reflect final rates. (12/8/22)

According to reporting by The Stanford Daily, the student newspaper of Stanford University, at least four publications dating as far back as 1999 for which university president Marc Tessier-Lavigne was an author are under investigation for alleged image manipulation, a type of research misconduct. The Daily reported that on Dec. 2, Stanford’s Board of Trustees announced it was investigating Tessier-Lavigne following revelations published Nov. 29 that the European Molecular Biology Organization was reviewing a paper. The Daily also contacted misconduct experts who confirmed potential problems in a total of eight papers, which spurred additional investigations by Cell and Science. A Stanford investigative committee member stepped down, following The Daily’s disclosure that he had invested $18 million in a biotech firm Tessier-Lavigne founded.

On Dec. 5, Tessier-Lavigne posted a “letter to faculty regarding scientific papers,” in which he said he is “dedicated to the rigorous pursuit of the truth. The integrity of my work is of paramount importance to me, and I take any concerns that are expressed very seriously.” Some of the concerns are not new and were previously addressed, he said, adding that he has “been in communication with the editors of both journals to determine the appropriate next steps.” Tessier-Lavigne also noted that “in addition to these senior-authorship papers, questions have been raised about other papers on which I am a co-author. The studies that have been flagged were led by various collaborators who were the senior authors on the papers, and the specific images that are being queried are from collaborators’ laboratories.” Tessier-Lavigne said he has “never submitted a paper without firmly believing that the data were correct and accurately presented. I also want to be clear that I take responsibility for any concerns that arise with respect to any work with which I have been involved. I trust that a thorough examination will fully address the concerns that have been raised and will affirm my commitment to the highest standards of scientific integrity.” (12/8/22)

ORI has taken the rare step of debarring a former researcher for three years, among the harshest sanctions available for research misconduct. Douglas D. Taylor, former professor and vice chair for research in the Department of Obstetrics and Gynecology at the University of Louisville School of Medicine, “used falsely labeled images to falsely report data in figures, and in one finding, intentionally, knowingly, or recklessly plagiarized, reused, and falsely labeled an image to falsely report data in a figure,” ORI said in a Nov. 22 post on its website. Taylor’s false images, figures and finding were found in a funded Public Health Service (PHS) award, 12 unfunded PHS applications and two PHS-supported papers, ORI said. Taylor’s research was funded by the National Cancer Institute (NCI).

In some instances, Taylor used data from ovarian cancer research and relabeled it to represent pancreatic cancer studies. For three years, beginning Oct. 17, Taylor was prohibited from participating in federally funded programs and serving as a PHS advisor. HHS will request retraction of the papers published in 2008 and 2009. Retraction Watch reported that Taylor left the university in 2013 and that he had NCI funding of $153,215 from 2009 to 2011. Instead of imposing debarment, ORI typically reaches voluntary settlement agreements with investigators who are routinely required to have their research supervised for several years. (12/1/22)

Auditors for the NSF OIG are recommending NSF seek repayment of $29,951 for unallowable costs claimed by the University of Mississippi (UM). Auditors tested $660,000 of the more than $10.3 million of costs claimed to NSF from June 1, 2018, to May 31, 2021. However, UM disputed $13,750 of questioned costs. Auditors found “$69,775 of inadequately supported expenses, $34,688 of inappropriately allocated expenses, and $25,488 in unallowable expenses,” according to the audit. Among the costs auditors flagged were those for recruiting services, genotyping, publications, lodging and batteries.

UM disagreed with $5,000 in recruitment cost, saying the amount was actually a misnamed stipend and $8,750 for items including batteries and lodging. In response to a finding related to late closeouts, UM noted these occurred “due to remote work during COVID-19” and were not otherwise “a normal occurrence within the university.” As with other recent reports, auditors also said UM did not apply appropriate indirect cost rates, using rates for six awards from 2015 to 2017 that were current at the time of proposal but that were actually lower than when the awards were made. Auditors said UM proposed the awards “without documenting that it verified its use of the proposed indirect cost rates would not result in indirect costs being overcharged to the NSF award.” They also made 16 recommendations related to changes UM should make to “strengthen its award management environment.” (12/1/22)

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