The Government’s increased scrutiny on potential foreign influence on U.S. based research remains in full force. While the federal government continues to prosecute individual scientists alleged to have received – and not disclosed – foreign support from China and other countries, the U.S. Department of Justice has equally targeted institutions who, as grant recipients, have allegedly failed to adequately disclose receipt of foreign funding. On September 1, 2021 the DOJ announced a $1.1 million settlement with Van Andel Research Institute (“VARI”), an independent research institute in Grand Rapids, Michigan, to settle allegations that VARI violated the False Claim Act (“FCA”) by failing to disclose a foreign component of a National Institutes of Health (“NIH”) award, and by failing to disclose research support for two VARI researchers, who served as principal investigators on NIH awards.
In addition to the settlement, NIH imposed Specific Award Conditions on all of VARI’s NIH Grants, requiring personal executive level certification to the accuracy of all NIH submissions. VARI is further required to withdraw certain expanded grant authorities, and to remove all of their NIH grants from the Streamlined Non-competing Award Process.
VARI’s Previous Settlement
In December 2019, VARI, a recipient of grant funding from NIH, paid $5.5 million to resolve allegations that it violated the FCA by submitting grant applications and progress reports to NIH which failed to disclose other support, including Chinese government grants that funded two VARI researchers. Specifically, the settlement resolved allegations that VARI had made certain factual representations to NIH with deliberate ignorance or reckless disregard for the truth regarding the Chinese grants.
VARI’s Second Settlement
Shortly after VARI paid the 2019 settlement, U.S. Customs and Border Protection stopped a former VARI researcher who also held an appointment as a professor at the Harbin Institute of Technology in China at Detroit Metro Airport with undeclared biological research samples in his luggage. This led to a second settlement agreement between VARI and DOJ resolving new concerns.
While the recent settlement stems from allegations that the professor brought the biological research samples from China to VARI’s faculty, the Settlement also addressed VARI members’ potential participation in one of China’s highly-scrutinized foreign talent programs. In the Statement of Covered Conduct, the Government contends that a different VARI faculty member accepted an invitation from a Chinese university to join an application to China’s “111 Program;” a program, similar to the Thousand Talents Program (“TTP”), that is funded by the Chinese government to recruit foreign scientists to work at “innovation centers” established through Chinese universities. The Statement alleged that VARI “knew or should have known” about the Professor’s affiliation with the 111 Program based on the Professor’s statement, informing VARI that he had agreed to contribute to—but declined to participate in—a “111 collaborative research project.” The government’s theory in this case was that the Professor’s application to join the 111 Program, which also involved an agreement to engage in cooperative research with Nanjing Agricultural University, constituted “Other Support” that should have been disclosed in the Institute’s submissions to NIH.
The DOJ’s focus on ensuring institutions fully disclose “Other Support” has been the focus of numerous government and institutional probes and has triggered a new wave of compliance at many research institutions which are eager to comply with the federal government’s evolving disclosure expectations. NIH requires all grant recipients to obtain prior approval from the agency if a significant scientific element or segment of an NIH-funded project will be performed outside of the U.S.[1] NIH also requires grant recipients to disclose “Other Support,” which is defined broadly as “all resources made available to researchers in support of and/or related to all of their research endeavors, regardless of whether or not such resources have monetary value.”[2] Other Support includes high-value materials that are not freely available (e.g., biologics) and selection to foreign talent recruitment programs, such as the TTP and 111 collaborative research program. Violations of these requirements can lead to investigation and ultimate settlement.
What This Means For Institutions
This Settlement underscores that the so-called China Initiative and the Department of Justice’s campaign to address perceived threats of foreign influence in U.S.-based research remain in full effect for researchers and institutions. Universities and researchers should continue to take steps to implement robust disclosure requirements and conduct periodic audits of faculty members outside activities to ensure the institution, in its annual disclosures, does not run afoul of its obligation to diligently monitor its employees and accurately report its sources of support to NIH and other funding agencies. Proactive reviews of institutional policies, paying particular attention to the definition of conflict of interest, as well as prompt and thorough investigation of any purported concerns or foreign collaborations and broad training for faculty, allow institutions to ferret out concerns internally and self-disclose as necessary, to avoid getting caught in the cross-hairs of a federal investigation.
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[1] NIHGPS 8.1.2.10.
[2] NIHGPS 2.5.1.
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