Research Compliance Report, Volume 19, Number 1. In this month’s email newsletter: January 2022 | Healthcare Compliance Association (HCCA)

Research Compliance Report 19, no. 1 (January 2022)

?? Although an ongoing resolution is now in place that funds the federal government until February 18, committees are still working on bills that could contain provisions onerous for universities., warned the Association of American Universities (AAU). AUA officials noted that some bills currently under discussion removed provisions requiring MoD contractors to make “publicly available all training materials on diversity, equity and education. ‘inclusion, internal policies and other educational or professional documents’ for the review and identification of the critical breed. Theory ‘”, which the AAU and other groups oppose.

The AUA also reported that “not included in the [appropriations] bill are measures related to increasing cyber incident reporting requirements; a ban on the participation of federally-funded researchers in malicious foreign talent recruitment programs; and the creation of a new pilot program to monitor researchers working on unclassified research. Nonetheless, these provisions could be “considered during conference negotiations on other laws,” the AAU said, such as the U.S. Innovation and Competition Act, the National Science Foundation for the Future Act, the Science for the Future Act of the Department of Energy and the fiscal year. Intelligence Authorization Act 2022. (12/16/21)

?? The University of Texas at Dallas (UTD) agreed to pay just over 11% of the costs questioned by the Office of the Inspector General (OIG) of the National Science Foundation (NSF) during an audit of the December 9.. Auditors tested $ 671,000 of the $ 37 million in fees claimed from September 1, 2017 to August 31, 2020, and questioned $ 249,210 related to 25 awards. “More specifically, the auditors found $ 91,771 in insufficiently justified expenses; $ 70,604 in expenses not appropriately allocated to NSF scholarships; $ 63,753 of expenses for which NSF approval was not obtained prior to the transfer of scholarship research to other organizations; and $ 23,082 of ineligible expenses [for travel]. The auditors also identified two compliance-related findings for which no costs were called into question: non-compliance with UTD policies and insufficient controls linked to the application of indirect cost rates. The auditors made a total of 24 recommendations “to ensure that UTD strengthens administrative and management controls”. Overall, UTD disputed $ 220,199 and accepted $ 29,011 in disputed fees.

The largest amount of disputed expenditure was $ 88,160 in “costs of sub-grants from foreign organizations charged to three NSF grants,” for which auditors said UTD “failed to provide adequate documentation. on the supporting financial management system ”. Two prizes totaling $ 54,660 were awarded to Instituto Geofisico Del Peru and $ 33,500 to Ciencia International. In this category of disputed expenses, UTD agreed to reimburse only $ 551 for travel and meals. Amounts that the OIG said were inappropriately allocated included $ 54,690 for “purchases made near grant expiration dates.” UTD disputed everything except $ 5,378, which primarily related to travel expenses. UTD also said the majority of expenses for transferred scholarships were eligible because the principal investigator joined a “partner organization” and the annual reports detailing the move and expenses were approved by an NSF program manager. (12/16/21)

?? As required by the Consolidated Appropriations Act for fiscal 2021 and following a review, the Animal and Plant Health Inspection Service (APHIS), part of the United States Department of Agriculture, lifted a suspension imposed eight years ago on a 2012 final rule that required “research facilities and dealers, exhibitors, intermediate handlers and carriers [to] meet certain contingency planning and staff training requirements. As APHIS explained in December 3 Federal Register notice, he first proposed to lift the suspension in a June 25 notice. The final rule makes minor changes to the 2012 regulations, which the agency stuck with a year later, such as the change of dates. APHIS first called for contingency plans in a 2008 settlement proposal that was a response to the (still) record 15 hurricanes, including Katrina, that hit in 2005. At the time, the care program to animals of APHIS had concluded that “the entities responsible for animals covered by the AWA [Animal Welfare Act] could better protect the health and welfare of their animals by making contingency plans for possible emergencies or disasters.

According to the 2012 regulation, plans will have to be drawn up and revised every year, but do not have to be submitted to the agency, which described the “minimum criteria necessary to ensure a successful emergency plan”. Criteria include identifying common emergencies and describing “specific tasks to be performed in response to identified emergencies, including, but not limited to, specific animal evacuation plans or shelter plans. place and arrangements to provide emergency sources of food and water as well as sanitation, ventilation, bedding, veterinary care, etc. », As well as a list of the people and their responsibilities. The effective date of the regulation is January 3, 2022, and registered organizations must have plans in place by July 5, 2022. Staff training is required within 60 days of the plan being put in place, depending on the plan. the final rule of December. Organizations that have animal welfare insurance from the Public Health Service are already required to implement similar disaster plans. (12/09/21)

?? The federal government is pursuing wire frauds and misrepresentation charges against six former university researchers, including Charles Lieber, who is on paid leave from Harvard University, where he was chair of the chemistry and chemical biology department.. The charges against him and others stem from alleged breaches of income reporting, positions or other affiliations with Chinese institutions. Lieber, whose trial began in December, is joined by Simon Ang, who is due to stand trial in February on wire fraud and misrepresentation related to NASA and Defense Department awards, according to Science. Ang was previously an engineering professor at the University of Arkansas.

Franklin Tao, also an engineering professor, was suspended without pay from the University of Kansas. His trial for Department of Energy and NSF wire fraud and price misrepresentation is scheduled for April, as is that of Zhengdong Cheng, formerly of Texas A&M University. No trial date has been set for Gang Chen, who is on paid leave from the Massachusetts Institute of Technology, who is paying for his defense. Mingqing Xiao, who is suspended without pay from the University of Southern Illinois, does not yet have a trial date. Lieber’s lawsuit “comes amid growing calls from university professors, Democratic lawmakers and other groups to US Attorney General Merrick Garland to end the China Initiative or at least reduce its scope,” according to the ‘article. He noted that “prosecutors failed to win the first case that went to trial: On September 9, a federal judge acquitted mechanical engineer Anming Hu, a former full professor at the University of Tennessee, Knoxville. . Hu was accused of failing to disclose information about his ties to a Chinese university to NASA, which funded his work. The university offered to reinstate Hu. The federal government “has dropped its lawsuits against seven scientists, six of whom have been charged with violating US immigration law, and his case against a scientist who returned to China before his indictment is unlikely to succeed. the front “, according to the article. (12/09/21)

?? APHIS has finalized as published a proposed rule released in 2020 that amends five requirements in three sections of regulations implementing the Animal Welfare Act (AWA). Under the rule, published on November 24 and entered into force on December 27, research facilities will not have to update their registration every three years and Institutional Animal Care and Use Committees (IACUC ) will not be required to “carry out an ongoing review of research activities involving animals.” . “The rule, on the contrary, requires” a resubmission and full review of these activities at least every 3 years. We will also no longer require research centers to request inactive status if they are not using, manipulating or no longer transport animals covered by the AWA. “

The rule also clarifies “the duration of a registration and the conditions of its cancellation and will no longer require that the head of the establishment or the director general sign the annual report”. APHIS made other “miscellaneous changes to improve readability”. The changes are designed “to reduce the administrative burden on investigators, IACUC members, attending veterinarians and other facility staff, and will not affect animal welfare regulations that ensure humane care of animals during research, testing, experiments or teaching, ”according to the rule. (12/02/21)

?? The NIH issued a broad Request for Information (RFI), with a three-month comment period, seeking to update and consider long-term changes to the Genomic Data Sharing (GDS) policy of the NIH. agency, which was released in 2014.. Since then, the NIH has “adjusted implementation” to reflect some changes in practice, but said “several key developments affecting the conduct of NIH-supported genomic research warrant a reassessment of aspects of SWM policy.” . Some of the categories that the NIH seeks information for include anonymization and data linkage.

The RFI also proposed a set of principles which it said were “expectations” for non-federal custodians but supported by NIHs of human genomic data to “maintain appropriate standards and protections”. The NIH noted that it “is not currently proposing that sharing human genomic data in repositories or platforms not supported by the NIH would meet the expectations of the SCM policy.” In addition, the NIH has announced that it is seeking to harmonize the SWM policy and its data management and sharing policy, which will not come into effect until January 2023. The agency is also seeking comments on the types of research that should be subject to SWM policy. The deadline for responses is February 28, 2022. (12/02/21)

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