NIH Had Found EcoHealth in Violation of Safety and Stewardship Rules

Washington, D.C. — House Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA), Subcommittee on Health Republican Leader Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Republican Leader Morgan Griffith (R-VA) sent a letter to National Institutes of Health (NIH) Acting Director Lawrence Tabak requesting information regarding why the agency reportedly awarded a new grant and planned on resuming a suspended grant to EcoHealth Alliance, which had been funding coronavirus research at the Wuhan Institute of Virology.

“EcoHealth Alliance shouldn’t get a dime of taxpayer funding unless it comes clean about its well-documented failures and can clearly demonstrate it can be trusted to oversee risky research that has potential to start a pandemic,” said Leaders Rodgers, Guthrie, and Griffith. “The NIH has a responsibility to the American people to ensure research supported by taxpayer dollars is conducted with the highest standard of integrity, transparency, and safety. To that end, agency officials must answer why they are considering restoring funding to EcoHealth Alliance.”

Key Excerpt: “In an October 4, 2022, interview with the Washington Post, in response to a question about funding of this new grant by the National Institute of Allergy and Infectious Diseases (NIAID) to EcoHealth, NIAID Director Dr. Anthony Fauci stated that EcoHealth ‘adequately addressed’ NIH ‘administrative things’ presumably related to noncompliance in the R01 award. He pointed this out to show there would be no mechanism to arbitrarily cut off funding for EcoHealth and that NIH could be legally vulnerable if it took such an action (‘If they [EcoHealth] ever brought that to court, they could sue us, and win that in a microsecond.’). However, this assertion begs the question of how NIH determined EcoHealth had adequately addressed noncompliance issues given the history of this grant.

[…]

“NIH’s own findings and EcoHealth’s own statements and actions suggest EcoHealth violated the False Claims Act (FCA) when it accepted NIH grant terms by drawing down NIH grant funds but materially failed to comply with the terms of the grant. Recent Department of Justice (DOJ) FCA settlements with an NIH grantee demonstrate that these ‘administrative things; include requirements on NIH grantees to make factual representations to NIH without deliberate ignorance or reckless disregard. In addition, NIH grantees must make full disclosure to the NIH. As DOJ has noted, ‘Full disclosure is essential not only in validating scientific research, but also in the intense competition for scientific funding from the federal government. NIH’s application process is intended to yield information that is critical to the agency’s responsible stewardship of billions of taxpayer dollars.’  We are troubled that NIH has not provided, and we are not aware of, any evidence of how EcoHealth provided full disclosure of the experiment without substantiating records and thus adequately addressed these critical requirements with the R01 award.”

The members also raised specific concerns about Dr. Fauci’s assertions given that:

• In 2020, NIH suspended the EcoHealth’s award over avowed concerns about the adequacy of EcoHealth’s oversight of its sub-grantee, the Wuhan Institute of Virology (WIV) and its noncompliance with specific regulatory and NIH grant policy requirements.
• In 2021, NIH confirmed that EcoHealth did not comply with the NIH’s safety rule on excessive virus growth in an experiment involving humanized mice infected with chimeric viruses.
• In 2022, NIH stated that EcoHealth failed to include the terms and conditions required in Federal awards in WIV’s subaward agreement to ensure access to any documents, papers, or other records of the non-Federal entity (WIV) pertinent to the Federal award.
• Ultimately, NIH found that EcoHealth’s deficient subaward agreement represented “material failures to comply with the terms of its award.”
• As a result of these failures, EcoHealth did not secure lab notebooks and electronic files associated with the humanized mice experiment and did not obtain these materials from the WIV after NIH requested them.
• NOTE: Neither of these violations can be remedied by corrective actions.
• EcoHealth has yet to provide evidence that it can comply with what a former NIH senior official has described as the “three basic cornerstones” of the covenant between research institutions and the American people.

The members asked the Acting Director to respond to questions by November 7, 2022 regarding EcoHealth’s non-compliance with NIH grant regulations.

• Name each and every lawyer or law firm(s) involved in advising Dr. Fauci in the legal ramifications associated with not renewing the R01 award.
• What is the NIH precedent for resuming funding to suspended grantees under these circumstances? Please provide details on specific examples.
• How much was EcoHealth paid under the grant to oversee the laboratory work of the WIV during Year 4 and Year 5 of the R01 award?
• Isn’t it true that under the terms and conditions, EcoHealth’s drawdown of grant funds constitutes a claim that EcoHealth would monitor its sub-grantee in compliance with the terms of the grant? What certifications did EcoHealth make to the NIH?
• Did EcoHealth comply with the requirements to monitor the WIV? If so, what is the basis for this conclusion? If not, what is the basis for this conclusion?
• Why has NIH continued to provide funding for EcoHealth Alliance’s international research activities?
• How will NIH validate the information regarding EcoHealth Alliance’s oversight and compliance activities for its subawardees?
• It is unclear how the additional terms and conditions that NIH has described will ensure that future issues with obtaining laboratory notebooks and data resulting from NIH funded activities will not reoccur. How will NIH ensure that EcoHealth Alliance will comply with these additional terms and conditions?
• Did the NIH ever ask EcoHealth why it failed to include the terms and conditions required in Federal awards in WIV’s subaward agreement to ensure access to any documents, papers, or other records of the non-Federal entity (WIV) pertinent to the Federal award? If so, what was EcoHealth’s rationale? Did EcoHealth ever attempt to include such terms and conditions? Did the WIV refuse to agree to the inclusion of the terms and conditions? Did EcoHealth proceed with the subaward despite such a refusal if it occurred? If the NIH did not ask EcoHealth about the rationale for not including these terms and conditions, why did the NIH not ask?
• Did the NIH confer with any other federal agency about EcoHealth Alliance before making the most recent award? If so, please identify the agencies, the date of contact, and the issues discussed.

CLICK HERE to read the letter to Acting Director Tabak.