Testimony Before the United States Senate Committee on Health, Education, 
Labor and Pensions 
 
 
 
 
Protecting U.S. Biomedical Research:  
Efforts to Prevent Undue Foreign Influence  
 
Testimony of: 
Gary Cantrell 
Deputy Inspector General for Investigations 
   
Office of Investigations 
Office of Inspector General  
Department of Health and Human Services 
 
 
 
 
April 22, 2021 
10:00 a.m. 
430 Dirksen Senate Office Building Testimony of: Gary Cantrell 
Deputy Inspector General for Investigations 
   Office of Inspector General, U.S. Department of Health and Human Services 
 
Good morning, Chair Murray, Ranking Member Burr, and distinguished members of the 
Committee.  I am Gary Cantrell, Deputy Inspector General for Investigations with the 
Department of Health and Human Services (HHS) Office of Inspector General (OIG).  I 
appreciate the opportunity to appear before you to discuss how HHS-OIG is diligently 
working, in conjunction with our HHS and law enforcement partners, to protect taxpayer-
funded medical research.   
 
OIG is responsible for overseeing HHSs $2.2 trillion in expenditures made in fiscal year 
2020, and our work spans the over 100 programs at HHS.  We combat fraud, waste, and 
abuse in those programs; promote their efficiency, economy, and effectiveness; and protect 
the beneficiaries they serve.  To accomplish this, OIG employs tools such as data analysis, 
audits, evaluations, and investigations.  We are a multidisciplinary organization comprised 
of investigators, auditors, evaluators, analysts, clinicians, and attorneys.  We depend on our 
strong public and private partnerships to ensure coordinated enforcement success. 
The Office of Investigations is the law enforcement component of OIG that investigates 
fraud and abuse against HHS programs.  Our special agents have full law enforcement 
authority and effect a broad range of actions, including the execution of search warrants and 
arrests.  We use traditional as well as state-of-the art investigative techniques and innovative 
data analysis to fulfill our mission.   
 
INTRODUCTION 
Today, I will cover how OIG enhances the Federal Governments ability to detect, deter, and 
take enforcement action to ensure the integrity of taxpayer-funded medical research against 
foreign threats. 
 
To date, the National Institutes of Health (NIH) has referred to OIG for investigation 
numerous allegations of noncompliance with its terms and conditions for receiving a medical 
research grant.  The allegations primarily deal with the failure of grantee principal 
investigators to disclose foreign government affiliations.  Because most of these referrals are 
still active, to avoid compromising ongoing investigations, I cannot provide much further 
specific details at this time.  However, I can cover how we generally handle grant fraud 
allegations related to taxpayer-funded medical research.  
 
Although foreign theft of taxpayer-funded medical research is a high-profile complex issue, 
the cases under our purview all involve aspects of grant fraudsomething which OIG has 
extensive experience investigating.  HHS is the largest grant-making organization and 
second-largest contracting agency in the Federal Government.  It is also the second-largest 
payer under the Small Business Innovation Research (SBIR) and Small Business 
Technology Transfer (STTR) programs.  Given this nexus, OIG has made oversight and 
enforcement of grant fraud and related grant program integrity a priority. 
 
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  PROACTIVE GRANT FRAUD EDUCATION, WITH ENFORCEMENT WHEN 
NEEDED 
We take a two-pronged approach to preventing and acting against grant fraud.  First, OIG 
works collaboratively to educate key stakeholdersincluding HHS operating divisions and 
grant recipient organizationson ways to detect and prevent grant fraud through proactive 
training.  Second, we take action, when needed, against grant fraud by investigating 
allegations of criminal misconduct and making appropriate referrals for criminal, civil, or 
administrative action.   
 
OIG receives allegations of grant fraud or uncovers potential fraud in a variety of ways, 
including OIG hotline complaints, referrals from HHS operating divisions and law 
enforcement partners, whistleblower disclosures, and proactive data analysis.  Our hotlines 
mobile compatible web form is specifically designed to easily collect grant and contract 
fraud complaints from the public and/or HHS employees, and we also have an Operating 
Division portal that is only available to our HHS operating division partners so they can 
quickly refer grant and contract related matters to OIG for immediate review.  
 
Upon receiving an allegation pertaining to grant fraud involving NIH or other HHS 
operating division, OIG evaluates the allegation and determines whether we will open an 
investigation; refer the matter to another agency with appropriate authorities; or, when 
appropriate, refer the matter back to the HHS operating division involved for administrative 
review and potential action.   
 
When evaluating referrals involving allegations of foreign threats to taxpayer-funded 
medical research, OIG is sensitive to the fact that academic and professional reputations 
could easily be damaged by erroneous allegations.  All complaints are treated with 
confidentiality and discretion, and we only proceed with investigations when sufficient 
factual information supports such investigative activity.  When OIG identifies a potential 
violation of civil or criminal law during an investigation, OIG presents the facts to the 
Department of Justice for prosecutorial consideration.   
 
To protect the integrity of medical research, OIG coordinates with the HHS Office of 
National Security (ONS).  In some instances, OIG works on matters with the Federal Bureau 
of Investigations (FBIs) Joint Terrorism Task Forces and National Cyber Investigative 
Joint Task Force, the Department of Homeland Security, and components at FBI 
Headquarters and local field offices.  When appropriate, we work together with NIH and 
ONS to develop followup approaches and mitigation strategies for such cases. 
 
To illustrate the types of grant fraud investigations OIG conducts, I will offer summaries of 
two recent research integrity investigations. 
 
A professor of internal medicine and researcher who led a team conducting 
autoimmune research at The Ohio State University and Pennsylvania State 
University, pled guilty in late 2020 to making false statements to Federal authorities 
as part of an immunology research grant fraud scheme.  As part of his plea, the 
professor/researcher admitted he lied on applications in order to use approximately 
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  $4.1 million in NIH grants to develop Chinas expertise in the areas of rheumatology 
and immunology.  According to his plea, he submitted materially false and 
misleading statements on NIH grant applications, seeking to hide his participation in 
a Chinese Talent Plan and his affiliation and collaboration with a Chinese university 
controlled by the Chinese government.  He is now awaiting sentencing. 
 
In late 2019 Van Andel Research Institute (VARI) agreed to pay $5.5 million to 
resolve allegations that it violated the False Claims Act by submitting Federal grant 
applications and progress reports to NIH in which VARI failed to disclose Chinese 
government grants that funded two VARI researchers.  The settlement further 
resolves allegations that in a Dec. 21, 2018, letter, VARI made certain factual 
representations to NIH with deliberate ignorance or reckless disregard for the truth 
regarding the Chinese grants.  The Government specifically alleged that between 
January 2012 and December 2018, one of the researchers received grants and 
research support from a variety of Chinese sources, including the Peoples Republic 
of Chinas Thousand Talents Program. 
 
As mentioned earlier, OIGs approach to addressing grant fraud includes working 
collaboratively with stakeholders to increase their ability to detect and prevent grant fraud 
through proactive training.  OIG works with representatives of the Federal law enforcement 
community and HHSs Office of Research Integrity (ORI) to promote awareness of research 
misconduct and improve efforts to protect against such conduct.  In addition to joint training 
efforts, ORI notifies OIG when conduct that might be criminal arises in the course of a 
research misconduct investigation.  OIGs work is independent of ORIs, and ORI must refer 
all credible allegations of criminal conduct they uncover to OIG.  In short, OIGs enhanced 
collaboration with ORI adds a layer of scrutiny to ensure that both ORI and OIG can take 
appropriate actions to protect U.S. biomedical research investments. 
 
OIG increases HHS employee, contractor, and grantee awareness of how to identify and 
report allegations pertaining to grant fraud as well as foreign threats to taxpayer-funded 
medical research through training and presentations.  For instance, OIG has provided 
numerous grant fraud training sessions at NIH Regional Seminars and NIH SBIR and STTR 
Town Hall meetings.  
 
To educate grant recipient organizations, OIG has partnered with several academic entities to 
address best practices to ensure Research Integrity Officers and Compliance Officers are 
informed on the roles, responsibilities, and authorities of OIG.  We tailor our efforts for each 
grant recipient organization to address what best practices are most helpful to serve its 
unique needs.  
 
 
RISK MITIGATION THROUGH MINIMIZING VULNERABILITIES 
OIG conducts oversight of NIH through audits and evaluations, some of which relate to 
protecting the integrity of NIH-funded research.  Our work is informed by concerns raised 
by Congress, NIH, and other Federal law enforcement agencies about foreign threats to the 
integrity of U.S. medical research and intellectual property.  OIG has identified the threat 
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  of foreign government action aimed at unduly influencing and capitalizing on medical 
research programs funded and overseen by the Department as part of the 2020 Top 
Management Challenges Facing HHS.  Furthermore, one of OIGs Top 25 
Recommendations to HHS is that NIH should build on its efforts to identify and mitigate 
potential foreign threats to research integrity.  
 
In fiscal year 2019, OIG began receiving transferred funding of $5 million for oversight of 
grant programs and operations of NIH, including NIH efforts to ensure the integrity of its 
grant application evaluation and selection processes.   This funding has been provided in 
addition to existing resources for NIH oversight, and has continued through fiscal year 
2021.1  As an associated requirement attached to this funding each year, OIG must submit an 
NIH oversight plan to the Committee on Appropriations of the House of Representatives and 
the Senate.  OIG recently submitted to Congress its fiscal year 20212022 NIH Oversight 
Plan.  The fiscal year 20212022 plan was developed, as required, in consultation with the 
Committees on Appropriations in the House of Representatives and the Senate and focuses 
on four key areas: 
 
  Cybersecurity protections.  OIG plans to conduct audits related to cybersecurity 
controls built into NIHs enterprise network and IT contracts. 
  Compliance with requirements for grants, contracts, and other transactions.  
Our oversight activities will help ensure NIH-funded research institutions comply 
with Federal requirements and NIH policies that establish controls for NIH grants, 
contracts, and other transactions. 
  Integrity and management of grant application and selection processes.  OIGs 
planned oversight activities will examine NIHs efforts to ensure the integrity and the 
effective management of its grant application and selection processes.  
  Intellectual property and research integrity.  OIGs oversight will examine NIHs 
efforts and grantee institutions implementations of internal controls and effective 
oversight practices in response to threats, including foreign threats, to intellectual 
property and research integrity.  
 
Since the beginning of fiscal year 2019, utilizing both this supplemental funding as well as 
our permanent funding streams, OIG has completed nine related reviews focused on NIH.  In 
addition, OIG has eight related ongoing reviews that have started since the beginning of 
fiscal year 2020.  This work includes, but is not limited to: 
 
  Assessments of NIHs vetting and oversight of its peer reviewers.  
OIG assessed NIHs vetting and oversight of the 27,000 peer reviewers who review 
grant applications for NIH each year.  Peer reviewers have access to confidential 
information in grant applications.  NIH has raised concerns about some peer 
reviewers inappropriately disclosing confidential information, including to foreign 
entities. 
 
1 The Consolidated Appropriations Act, 2021 (Public Law No. 116-260).   
 
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  We found that NIH focuses its vetting of peer reviewer nominees on scientific skills 
and preventing undue influence generally, but it has not focused its vetting 
specifically on undue foreign influence.  We recommended that NIH: (1) update its 
guidance on vetting peer reviewer nominees to identify potential foreign threats to 
research integrity, in consultation with national security experts as needed, and (2) 
work with HHS Office of National Security to develop a risk-based approach for 
identifying nominees who warrant additional vetting.  NIH agreed with both 
recommendations. 
 
With respect to NIH oversight of peer reviewers, we found that NIH enforces 
policies and procedures that protect confidential information in grant applications 
handled by peer reviewers, but it could do more to address the risk that undue foreign 
influence poses to maintaining confidentiality.  We recommended that NIH: (1) 
conduct targeted, risk-based oversight of peer reviewers using analysis of 
information about threats to research integrity; (2) update its training materials 
routinely to include information about breaches of peer reviewer confidentiality and 
possible undue foreign influence; (3) require all peer reviewers to attend periodic 
trainings about peer review integrity; and (4) consult with Federal law enforcement 
and national security experts to determine what additional steps it might take to 
identify and address potential risks to the confidentiality of the peer review process, 
including possible undue foreign influence.  NIH agreed with all of these 
recommendations and has implemented the fourth one. 
 
  NIH oversight of financial conflicts of interest and other support.  
OIG has also examined how NIH ensures that grantee institutions report all sources 
of research support, financial interests, and affiliations, as well as how NIH reviews 
financial conflicts of interests that are reported to them.  With respect to required 
reporting, we found NIH has limited policies, procedures, and controls in place for 
helping to ensure that institutions report all sources of research support, financial 
interests, and affiliations.  Of the 1,875 institutions that received NIH funding in 
fiscal year 2018 and were required to have financial conflict of interest (FCOI) 
policies, 1,013 did not have FCOI policies posted on their websites.  We 
recommended that NIH: (1) ensure that the 1,013 institutions we identified as not 
having FCOI policies on their website post those policies as required, (2) enhance its 
FCOI monitoring program to ensure that institutions resolve identified deficiencies 
and to review all grantee websites to ensure that FCOI policies are publicly 
accessible, and (3) implement procedures to ensure that all institutions required to 
have FCOI policies actually have FCOI policies.  NIH concurred with all of our 
recommendations.  Although NIH has made progress with implementing these 
recommendations, they all remain unimplemented.  
 
In addition, we found that NIH has improved its tracking and review of investigators 
financial conflicts of interest (FCOIs) over the last decade.  However, it could 
improve the consistency and quality assurance over these reviews.  Further, NIH has 
no mechanism to identify FCOIs that involve foreign entities and is not planning to 
expand its FCOI reporting requirements to include such a designation.  We 
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  recommended that NIH: (1) perform periodic quality assurance reviews of 
information to ensure the adequacy of oversight of reported FCOIs; and (2) use 
information regarding foreign affiliations and support collected during the pre-award 
process to decide whether to revise its FCOI review process to address concerns 
regarding foreign influence.  NIH agreed with both recommendations and has 
implemented the first one. 
 
In the second half of fiscal year 2021, OIG plans to begin another four reviews, and our 
work plan will be updated as individual report designs are finalized.  We would be more than 
happy to brief the Members of this Committee and staff on this work on an ongoing basis.  
 
CONCLUSION 
OIG is committed to working collaboratively to address foreign threats to taxpayer-funded 
medical research through preventive efforts to mitigate risk and minimize vulnerabilities in 
HHS programs and conducting enforcement actions whenever necessary.  In cooperation 
with our HHS and law enforcement partners, OIG will continue to leverage our grant fraud 
investigative work and capabilities to maximize our efforts in this area as authorities, 
resources, and funding allow.  
 
Thank you for your ongoing leadership in this area and for affording me the opportunity to 
discuss this important topic with you.  
 
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