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Anonymous Fri 03 Sep 04:52:03 2021 No.13597566 View Reply Original Report

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Department Of Justice Reaches Million-Dollar Settlement With Van Andel Research Institute To Resolve Allegations Of Undisclosed Foreign Ties To Nih Grants

https://www.justice.gov/usao-wdmi/pr/2021_0901_Van_Andel_Research_Institute_Settlement

A copy of the redacted executed settlement agreement is included in this link.
https://www.justice.gov/usao-wdmi/press-release/file/1429341/download

Undisclosed Foreign Ties To Nih Grants

Second Settlement With VARI Brings Total Settlement Proceeds To $6.6 Million As NIH Imposes Specific Award Conditions On All VARI Grants

GRAND RAPIDS, MICHIGAN — The Department of Justice (“DOJ”) announced today that Van Andel Research Institute (“VARI” or the “Institute”) has agreed to pay $1.1 million to resolve allegations that it violated the False Claims Act by failing to disclose a foreign component of a National Institutes of Health (“NIH”) award and by failing to disclose foreign research support for two VARI researchers who served as principal investigators on NIH awards. In addition to this settlement—the second settlement with VARI in two years involving allegations of undisclosed foreign influence in federally-sponsored research—NIH imposed Specific Award Conditions on all of VARI’s NIH grants, including by requiring personal, executive-level certifications to the accuracy of NIH submissions, withdrawing certain of VARI’s expanded grant authorities, and removing all of VARI’s NIH grants from the Streamlined Non-Competing Award Process (“SNAP”).

Anonymous

Anonymous Fri 03 Sep 2021 04:52:25 No.13597568 Report

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“Full disclosure is essential not only in validating scientific research, but also in the intense competition for scientific funding from the federal government,” U.S. Attorney Andrew Birge said. “NIH’s application process is intended to yield information that is critical to the agency’s responsible stewardship of billions of taxpayer dollars. My office will continue to use every available tool to preserve the integrity of that process. The research community should recognize that these cases are not going away.”

“The government’s allegations in this case should remind research institutions of the potential consequences for failing to adequately investigate ‘red flags’ concerning researchers’ relationships and affiliations,” said Lamont Pugh III, Special Agent in Charge of HHS-OIG’s Chicago Region. “HHS-OIG will continue to hold grantees accountable, and protect the government’s investment of taxpayer resources, regardless of the length or complexity of the investigation.”

NIH requires grant recipients to disclose and obtain prior agency approval if a significant scientific element or segment of an NIH-funded project will be performed outside of the United States (a “Foreign Component”). Foreign Components can include collaborations with foreign researchers who perform experiments in support of an NIH grant, regardless of whether those foreign researchers receive any of the NIH funding. NIH also requires grant recipients to disclose “Other Support,” defined as all resources made available to researchers in support of and/or related to all of their research endeavors, regardless of whether such resources have monetary value. Other Support includes high-value materials that are not freely available (biologics, e.g.) and selection to foreign talent recruitment programs.

Anonymous

Anonymous Fri 03 Sep 2021 04:53:26 No.13597574 Report

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In December 2019, VARI paid $5.5 million to resolve allegations that it violated the False Claims Act by submitting grant applications and progress reports to NIH in which VARI failed to disclose Other Support, including Chinese government grants that funded two VARI researchers. Approximately one month later, in January 2020, U.S. Customs and Border Protection (“CBP”) stopped an individual—a former VARI researcher and current professor at the Harbin Institute of Technology (“HIT”) in China (the “HIT Professor”)—at Detroit Metro Airport with undeclared biological research samples in his luggage. The government alleged that the HIT Professor told CBP that the research samples were intended for the laboratory of a professor at VARI (the “VARI Professor”). The CBP stop prompted another investigation of VARI that resulted in the following allegations:

Undisclosed Foreign Component. The government alleged that after submitting a successful grant application to NIH in June 2017, a VARI researcher began negotiating a research collaboration agreement with HIT that overlapped with the NIH grant in research objectives and methods. The government alleged that VARI administrators did not communicate that the recollaboration agreement was never fully executed and, therefore, VARI and HIT faculty collaborated under the terms of the agreement in a manner that resulted in an undisclosed and unapproved “Foreign Composearch nent” of the NIH grant.

Anonymous

Anonymous Fri 03 Sep 2021 04:54:28 No.13597577 Report

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Undisclosed Other Support (Biological Research Samples). The government alleged that VARI knew or should have known that the HIT Professor was providing biological research samples, synthesized in China, to VARI faculty. The government alleged that after VARI rejected a shipment of biological research samples from HIT in May 2018—a shipment that was falsely described as “documents”—the HIT Professor began bringing research samples into the United States on his person and covertly sending research samples to his home address in Grand Rapids, Michigan. The government alleged that VARI did not investigate the foreign-sourced samples after rejecting the May 2018 shipment and thus continued to make “Other Support” disclosures to NIH with deliberate ignorance or reckless disregard for their accuracy.

Undisclosed Other Support (Foreign Talent Program). The government alleged that in August 2018, the VARI Professor accepted an invitation from Nanjing Agricultural University (“NAU”) to join an application to China’s “111 Program”; a program funded by the Chinese government to recruit foreign scientists to work at “innovation centers” established through Chinese universities. The government alleged that VARI knew or should have known about the VARI Professor’s affiliation with the 111 Program, including because, after initially failing to disclose the invitation to VARI, the VARI Professor later told the Institute that he had agreed to contribute to—but declined to participate in—a “111 collaborative research project.” The government alleged that the VARI Professor’s application to join the 111 Program, which also involved an agreement to engage in cooperative research with NAU, constituted “Other Support” that should have been disclosed in VARI’s submissions to NIH.

Anonymous

Anonymous Fri 03 Sep 2021 04:55:47 No.13597581 Report

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The government also expressed concerns that in November 2018, the VARI Professor separately sent his NIH award letter to an NAU professor in China who requested proof that he was collaborating with a researcher funded by the American government.

Approximately one-third of the settlement funds will be returned to NIH, with the remainder going to the United States Treasury. In addition to the $1.1 million settlement, NIH imposed Specific Award Conditions on all of VARI’s NIH grants. Federal regulations allow NIH to impose Specific Award Conditions on grant recipients, including on recipients that have a history of failures to comply with the terms of a federal award. In this case, NIH is requiring an executive-level manager to personally certify the accuracy of all of VARI’s “Other Support” disclosures. NIH is also withdrawing certain of VARI’s expanded budget authorities and removing VARI from SNAP prior to awards. These conditions will remain in place through September 30, 2022 or until NIH assesses and accepts VARI’s completed Corrective Action Plan and summary report.

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