Report on Research Compliance 19, no. 1 (January, 2022)
◆ Although a continuing resolution is now in place that funds the federal government through Feb. 18, committees are still working on bills that could contain provisions onerous to universities, the Association of American Universities (AAU) warned. AAU officials noted that some bills being debated have eliminated provisions requiring contractors for the Department of Defense to make “publicly available all diversity, equity, and inclusion training materials, internal policies, and other educational or professional materials ‘for review and identification of Critical Race Theory,’” which AAU and other groups oppose.
AAU also reported that “not included in the final [appropriations] bill are measures related to increased cyber incident reporting requirements; prohibitions on the participation of federally funded researchers in malign foreign talent recruitment programs; and the creation of a new pilot program to vet researchers working on non-classified research.” Still, these provisions could be “considered during conference negotiations on other legislation,” AAU said, such as the U.S. Innovation and Competition Act, National Science Foundation for the Future Act, the Department of Energy’s Science for the Future Act, and the fiscal year 2022 Intelligence Authorization Act. (12/16/21)
◆ The University of Texas at Dallas (UTD) has agreed to pay a little more than 11% of costs questioned by the National Science Foundation (NSF) Office of Inspector General (OIG) in a Dec. 9 audit. Auditors tested $671,000 of $37 million in costs claimed from Sept. 1, 2017, to Aug. 31, 2020, and questioned $249,210 related to 25 awards. “Specifically, the auditors found $91,771 of inadequately supported expenses; $70,604 of expenses not appropriately allocated to NSF awards; $63,753 of expenses for which NSF approval was not obtained before transferring the award research to other organizations; and $23,082 of unallowable expenses [for travel]. The auditors also identified two compliance-related findings for which there were no questioned costs: non-compliance with UTD policies and insufficient controls related to the application of indirect cost rates.” Auditors made a total of 24 recommendations “to ensure UTD strengthens administrative and management controls.” Overall, UTD disputed $220,199 and agreed with $29,011 in questioned costs.
The largest chunk of questioned expenses was $88,160 in “foreign organization subaward costs charged to three NSF awards,” for which auditors said UTD “did not provide adequate financial management system documentation to support.” Two awards totaling $54,660 were made to the Instituto Geofisico Del Peru and $33,500 to Ciencia International. In this category of questioned costs, UTD agreed to repayment of only $551 for travel and meals. The amounts OIG said were inappropriately allocated included $54,690 for “purchases made near grant expiration dates.” UTD disputed all but $5,378, which was mostly for travel expenses. UTD also said the majority of the expenses for awards that were transferred were allowable because the principal investigator joined a “partner organization” and that annual reports detailing the move and the expenditures were approved by an NSF program officer. (12/16/21)
◆ As required by the fiscal year 2021 Consolidated Appropriations Act and following a review, the Animal and Plant Health Inspection Service (APHIS), part of the U.S. Department of Agriculture, has lifted a stay imposed eight years ago on a 2012 final regulation that required “research facilities and dealers, exhibitors, intermediate handlers, and carriers [to] meet certain requirements for contingency planning and training of personnel.” As APHIS explained in the Dec. 3 Federal Register notice, it first proposed lifting the stay in a June 25 notice. The final rule makes minor changes to the 2012 regulation, which the agency stayed a year later, such as changing dates. APHIS first called for contingency plans in a 2008 proposed rule that was a response to the (still) record of 15 hurricanes, including Katrina, that occurred in 2005. At the time, APHIS’ animal care program concluded that “entities responsible for animals covered by the AWA [Animal Welfare Act] could better safeguard the health and welfare of their animals by developing contingency plans for possible emergencies or disasters.”
According to the 2012 regulation, plans will need to be developed and reviewed annually but do not have to be submitted to the agency, which described the “minimum criteria necessary to ensure a successful contingency plan.” Among the criteria are identifying common emergencies and describing “specific tasks required to be carried out in response to the identified emergencies including, but not limited to, specific animal evacuation plans or shelter-in-place plans and provisions for providing backup sources of food and water as well as sanitation, ventilation, bedding, veterinary care, etc.,” as well as listing individuals and their responsibilities. The effective date of the regulation is Jan. 3, 2022, and registered organizations must have plans in place by July 5, 2022. Training for personnel is required within 60 days after the plan is put in place, according to the December final rule. Organizations that have a Public Health Service animal welfare assurance are already required to implement similar disaster plans. (12/9/21)
◆ The federal government is pursuing wire fraud and charges of false statements against six former university researchers, including Charles Lieber, who is on paid leave from Harvard University, where he was chair of the Department of Chemistry and Chemical Biology. The charges against him and others stem from alleged failures to report income, positions or other affiliations with Chinese institutions. Lieber, whose trial began in December, is joined by Simon Ang, who is facing trial in February on charges of wire fraud and making false statements related to awards from NASA and the Department of Defense, according to Science. Ang was formerly an engineering professor with University of Arkansas.
Franklin Tao, also a professor of engineering, has been suspended without pay from the University of Kansas. His trial on wire fraud and making false statements related to Department of Energy and NSF awards is scheduled for April, as is Zhengdong Cheng’s, formerly with Texas A&M University. No trial date has been set for Gang Chen, who is on leave with pay from Massachusetts Institute of Technology, which is paying for his defense. Mingqing Xiao, who is suspended without pay from Southern Illinois University, also doesn’t yet have a trial date. Lieber’s trial “comes amid growing calls from university faculty, Democratic lawmakers, and other groups for U.S. Attorney General Merrick Garland to end the China Initiative or at least curtail its scope,” the article said. It noted that “prosecutors failed to win the first case that went to trial: On 9 September, a federal judge acquitted mechanical engineer Anming Hu, a former tenured professor at the University of Tennessee, Knoxville. Hu was facing charges of failing to disclose information about his links to a Chinese university to NASA, which funded his work.” The university has offered to reinstate Hu. The federal government “dropped its prosecution of seven scientists, six of whom faced charges of violating U.S. immigration law, and its case against one scientist who returned to China before his indictment is unlikely to move forward,” according to the article. (12/9/21)
◆ APHIS has finalized as issued a proposed rule published in 2020 that amends five requirements in three sections of regulations implementing the Animal Welfare Act (AWA). Under the rule, published Nov. 24 and effective Dec. 27, research facilities will not have to update their registration every three years nor will institutional animal care and use committees (IACUCs) be required to “conduct a continuing review of research activities involving animals.” The rule, instead, requires “a complete resubmission and review of such activities at least every 3 years. We will also no longer require that research facilities request an inactive status if they no longer use, handle, or transport AWA covered animals.”
The rule also clarifies “the duration of a registration and conditions for its cancellation and will no longer require that the Institutional Official or Chief Executive Officer sign the annual report.” APHIS made other “miscellaneous changes to improve readability.” The changes are designed “to reduce administrative burden on investigators, IACUC members, attending veterinarians, and other related facility staff, and will not affect the Animal Welfare regulations that ensure humane animal care during research, testing, experiments, or teaching,” according to the rule. (12/2/21)
◆ NIH has issued an extensive request for information (RFI), with a three-month comment period, seeking to update and consider long-term changes to the agency’s Genomic Data Sharing (GDS) Policy, which was issued in 2014. Since that time, NIH has “adjusted implementation” to reflect some changes in practices but said “several key developments affecting the conduct of NIH-supported genomic research warrant reassessment of aspects of the GDS Policy.” Among the categories for which NIH is seeking information include de-identification and data linkage.
The RFI also proposed a series of principles it said were “expectations” for non-federal but NIH-supported depositories of human genomic data to “maintain appropriate standards and protections.” NIH noted that it “is not proposing at this time that sharing of human genomic data in non-NIH-supported repositories or platforms would satisfy the GDS Policy’s expectations.” Further, NIH announced it seeks to harmonize the GDS policy and its Data Management and Sharing Policy, which doesn’t go into effect until January 2023. The agency is also seeking input on the types of research that should be subject to the GDS policy. The deadline for response is Feb. 28, 2022. (12/2/21)
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