Report on Research Compliance Volume 18, Number 3. In This Month's E-News: March 2021

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Report on Research Compliance 18, no. 3 (March 2021)

A former post-doctoral fellow at the McGovern Medical School, part of the University of Texas (UT) Health Science Center, admitted to committing research misconduct by “knowingly and intentionally falsifying, fabricating, and plagiarizing data and text” in six papers and eight manuscripts, according to the HHS Office of Research Integrity (ORI). In its Feb. 4 Federal Register notice, ORI said Yibin Lin “falsely created fictitious author names and affiliations without listing himself as an author to disguise himself from being the offender, and submitted them for publication in bioRxiv and medRxiv, open access preprint repositories, by falsely assembling random paragraphs of text, tables, and figures from previous publications and manuscripts to improve his citation metrics.”

Lin agreed to the most severe administrative sanction available in cases of misconduct, namely a 10-year, governmentwide exclusion (also called a debarment when imposed rather than agreed to) that prohibits him from participation in government programs beginning Jan. 7. As noted by Retraction Watch, none of the published articles—since retracted—bear Lin’s name as an author. It also reported that John Inglis, a co-founder of the pre-print servers where the papers appeared, said their staff was responsible for “uncovering the deception.” Inglis called Lin’s actions “the most egregious example of deception we have seen in bioRxiv’s 7 years and 107,000 manuscripts,” adding he was “really pleased that UT acted so promptly and thoroughly to investigate and deal with the perpetrator.” Lin’s is the first misconduct finding ORI has released in 2021, following a year in which it made 10 such findings. (2/11/21)

Lin Yang, a former University of Florida (UF) researcher, has been indicted on six counts of wire fraud and four counts of making false statements, the Department of Justice (DOJ) announced Feb. 3. A grand jury returned the indictment on Dec. 15 related to an award of $1.75 million for which Yang was the principal investigator from 2014 to 2019. Yang would not have been eligible had he disclosed “support he received from the Chinese government and a company that he founded in China to profit from that research,” DOJ said. Yang’s grant was to “develop and disseminate an imaging informatics tool for muscles known as ‘MuscleMiner,’” the government said.

“During that same period, in 2016, Yang established a business in China known as ‘Deep Informatics.’ The indictment further alleges that Yang promoted his business in China by relating that its products were the result of years of research supported by millions of dollars of U.S. government funding,” DOJ said. “Simultaneously, Yang applied for and was accepted into the People’s Republic of China’s Thousand Talents Program (TTP) in connection with Northwestern Polytechnical University, located in Xi’an, China. The TTP was a talent plan established by the Chinese government to encourage the transfer of original ideas, technology, and intellectual property from foreign institutions, such as American universities.” Yang has been in China since traveling there in August 2019, DOJ said. If convicted, Yang faces a sentence with maximum prison terms ranging from five to 20 years and fines of up to $250,000 per charge. (2/11/21)

Li Chen, a former researcher at a hospital in Akron, Ohio, was sentenced Feb. 1 to 30 months in prison after pleading guilty this summer to “conspiring to steal scientific trade secrets and conspiring to commit wire fraud concerning the research, identification and treatment of a range of pediatric medical conditions.” According to the Department of Justice (DOJ), “Chen admitted in her guilty plea in July 2020 to stealing scientific trade secrets related to exosomes and exosome isolation from Nationwide Children’s Hospital’s [NCH] Research Institute for her own personal financial gain.” She and Yu Zhou, her husband and “co-conspirator,” both worked at the institute but in different labs for 10 years ending in 2018 and 2017, respectively. Chen and Zhou “founded a Chinese company to monetize the technique Zhou developed, using intellectual property that belonged to NCH,” and received more than $800,000, according to a DOJ presentation on foreign influences in research.

According to Chen’s plea announcement, she “agreed to forfeit approximately $1.4 million, 500,000 shares of common stock of Avalon GloboCare Corp. and 400 shares of common stock of GenExosome Technologies Inc.” Chen and Zhou were arrested in July 2019 in California. Zhou, who pleaded guilty in December, has not yet been sentenced. In announcing Zhou’s plea agreement in December, DOJ said the two “conspired to steal and then monetize one of the trade secrets by creating and selling exosome ‘isolation kits.’” They also were accused of receiving “benefits from the Chinese government, including the State Administration of Foreign Expert Affairs and the National Natural Science Foundation of China.” (2/4/21)

An audit of two Established Program to Stimulate Competitive Research (EPSCoR) awards made to the University of Wyoming (UW) by the National Science Foundation (NSF) Office of Inspector General questioned a total of $256,351 in direct and indirect costs. These consisted of $90,000 in an unsupported cost transfer, $7,908 in unsupported and unallowable promotional expenses, $15,207 in unallowable activity expenses, $24,773 in unallowable indirect cost charges, $864 for unallowable meal expenses, and $117,599 in unsupported subrecipient expenses. UW agreed to repayment of all but $11,057. This amount was attributable to direct expenses for UW’s Summer Research Apprentice Program (SRAP) that auditors said were for “unallowable entertainment expenses.” Auditors said the costs, which included “museum and zoo admission, yoga and gym access, and theater and movie tickets,” were “entertainment, rather than necessary to accomplish the objectives of UW’s EPSCoR awards.” They added that UW “did not disclose these activities, or their programmatic purpose, in its NSF proposals or request prior written approval from NSF to pay for them through the EPSCoR awards. Additionally, UW’s documentation supporting the costs did not identify who attended the activities to confirm it was SRAP participants.”

However, UW officials said the costs were “necessary expenses” to support SRAP, which they said consisted of a two-month “residential program for high school students that provides hands-on experience in science, mathematics, statistics, and/or engineering research in support of NSF’s broader impacts requirement for this award. The program also provides educational and research activities outside of the lab to keep students engaged and safe. The expenses in question were primarily for activities that may be considered entertainment for a research project, but these activities are vital to the success of this residential program that includes minors living on a college campus.” NSF will resolve the audit findings with UW. (2/4/21)

Stating that “racial funding disparity” by NIH “remains the most insidious barrier to success of Black faculty,” 16 women representing an informal network are urging NIH Director Francis Collins to publicly acknowledge that “racism persists in the US academic research enterprise and that it must be expelled” and to announce a plan to “immediately achieve racial funding equity.” Writing in a commentary in Cell that was posted online Jan. 26, the authors suggested NIH implement “diversity score-driving criteria, prioritize diverse teams for funding, and diversify review panels” and offer training to empower “NIH leadership, staff, and grant reviewers and recipients to recognize and stop racism.” Individual scientists and institutions also must be engaged, they wrote. “While immediate and radical action by NIH is desperately needed, the collective actions by scientists and other entities have a vital role to play as well. We, the individuals and institutions that comprise our profession, are each ultimately responsible for the racism that permeates it,” according to the commentary. (1/28/21)

ORI intends to launch an “online file transfer and collaboration cloud-based system” in the spring but will also accept documents sent electronically through other means until that time. In a recent announcement posted online, officials acknowledged that ORI is “experiencing delays in receiving and processing physical deliveries to the office,” and said that electronic submission may be a more timely option. (1/28/21)

A recent audit by the NSF Office of Inspector General of $137.2 million in costs claimed by the University of Florida (UF) from Oct. 1, 2016, to Sept. 31, 2019, questioned $640,723 of $3.2 million in transactions tested. “Specifically, the auditors found $412,363 of unapproved subaward expenses; $113,816 of unallowable expenses; $112,827 of inappropriately allocated expenses; and $1,717 of expenditures that did not comply with NSF award terms and conditions,” according to the Jan. 15 audit.

Auditors also found two compliance-related issues, including “incorrect application of proposed indirect cost rates.” In a response to draft findings, UF disagreed with subaward expenses auditors flagged, saying they were incurred by three principal investigators with NSF’s knowledge and approval. UF also did not agree to pay $47,226 in “questioned participant support, travel, and publication expenses,” nor $83,227 of what auditors called inappropriately allocated expenses. UF disputed that it used lower indirect cost rates than it should have, saying this “is allowable as voluntary uncommitted cost-sharing.” It will be up to NSF to resolve the findings. (1/28/21)

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