[Senate Hearing 117-181]
[From the U.S. Government Publishing Office]
S. Hrg. 117-181
PROTECTING U.S. BIOMEDICAL RESEARCH:
EFFORTS TO PREVENT
UNDUE FOREIGN INFLUENCE
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING PROTECTING U.S. BIOMEDICAL RESEARCH, FOCUSING ON EFFORTS TO
PREVENT UNDUE FOREIGN INFLUENCE
__________
APRIL 22, 2021
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
___________
U.S. GOVERNMENT PUBLISHING OFFICE
46-761 PDF WASHINGTON : 2022
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont RICHARD BURR, North Carolina,
ROBERT P. CASEY, JR., Pennsylvania Ranking Member
TAMMY BALDWIN, Wisconsin RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut SUSAN M. COLLINS, Maine
TIM KAINE, Virginia BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota MIKE BRAUN, Indiana
JACKY ROSEN, Nevada ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado MITT ROMNEY, Utah
TOMMY TUBERVILLE, Alabama
JERRY MORAN, Kansas
Evan T. Schatz, Staff Director
David P. Cleary, Republican Staff Director
John Righter, Deputy Staff Director
C O N T E N T S
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STATEMENTS
THURSDAY, APRIL 22, 2021
Page
Committee Members
Murray, Hon. Patty, Chair, Committee on Health, Education, Labor,
and Pensions, Opening statement................................ 1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State
of North Carolina, Opening statement........................... 3
Witnesses
Lauer, Michael, M.D., Deputy Director for Extramural Research,
National Institutes of Health, Bethesda, MD.................... 5
Prepared statement........................................... 7
Aguirre, Lisa, Acting Director, Office of National Security, U.S.
Department of Health and Human Services, Washington, DC........ 10
Prepared statement........................................... 12
Cantrell, Gary L., Deputy Inspector General for Investigations,
Office of Inspector General, U.S. Department of Health and
Human Services, Washington, DC................................. 13
Prepared statement........................................... 15
Summary statement............................................ 18
Wright, Candice N., Acting Director, Science, Technology
Assessment, and Analytics, U.S. Government Accountability
Office, Washington, DC......................................... 19
Prepared statement........................................... 22
PROTECTING U.S. BIOMEDICAL RESEARCH:
EFFORTS TO PREVENT
UNDUE FOREIGN INFLUENCE
----------
Thursday, April 22, 2021
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:01 a.m., in
room 430, Dirksen Senate Office Building, Hon. Patty Murray,
Chair of the Committee, presiding.
Present: Senators Murray [presiding], Casey, Hassan,
Hickenlooper, Rosen, Burr, Cassidy, Braun, Marshall, Romney,
and Moran.
OPENING STATEMENT OF SENATOR MURRAY
The Chair. Good morning. The Senate Health, Education,
Labor, and Pensions Committee will please come to order. Today
we are holding a hearing on protecting U.S. biomedical
research. Ranking Member Burr and I will each have an opening
statement and I will introduce today's witnesses. After the
witnesses give their testimony, Senators will each have five
minutes for a round of questions.
Before we begin, I again want to walk through our COVID-19
safety protocols in place. We will follow the advice of the
Attending Physician and the Sergeant-at-Arms in conducting this
hearing. We are very grateful to our Clerks and everyone who
has worked so hard to get this set up and help everyone stay
safe and healthy. Committee Members are seated at least six
feet apart and some Senators are participating by video
conference. And while we are unable to have the hearing fully
open to the public or media for in-person attendance, live
video is available on our Committee website at help.senate.gov.
If you need accommodations, including closed captioning,
you can reach out to the Committee or the Office of
Congressional Accessibility Services. Our Nation has a long
history of leadership when it comes to biomedical research, and
I am proud to say that Washington State has contributed to
several important chapters in that history, with groundbreaking
discoveries related to bone marrow transplants, cell therapies,
and precision medicine to help determine the best treatment for
each patient. And with nearly 1800 NIH awards going to 75
biomedical science organizations in my state last year, we
remain a leader when it comes to life saving research.
Protecting and supporting that research has always been
important to families and patients across the country.
But the COVID-19 pandemic has put a spotlight on the value
of this work in developing treatments and cures for diseases,
the importance of promoting global collaboration and
information sharing in the biomedical research community, and
the need for transparency and accountability to ensure this
work is based on data and science and protected against undue
influence of any kind. That means promoting--protecting
scientific work from political interference like we saw from
the Trump administration, as well as protecting it from undue
foreign influence, which can take many forms.
Global collaboration is critical in biomedical research.
Talented researchers from around the world have played a key
role in some of the major breakthroughs our country has made.
In fact, in recent decades, more than a third of the Nobel
Prizes in medicine, physics, and chemistry awarded to Americans
were awarded to immigrant or foreign-born scientists. Our
ability to lead the world in biomedical research is directly
tied to our ability to work with the world on biomedical
research. But successful collaboration requires trust and trust
requires transparency. It is important that researchers with
foreign affiliations and potential conflicts of interest, for
example, participation in foreign talent programs, or
commitments to file patents in or move laboratories to foreign
nations, fully disclose those issues when applying for Federal
grants.
It is not that researchers can't have other affiliations,
but they must be transparent about them, and the overwhelming
majority of researchers are. The latest report from the
National Institutes of Health on undisclosed conflicts of
interest found cause for concern with only 507 grant
recipients, compared to over 30,000 total grantees in 2020. But
we cannot let the few instances of bad actors undermine the
U.S. biomedical research enterprise, including our ability to
partner with talented researchers around the globe. We also
have to protect confidential information, for example
unpublished research or sensitive human genomic data, from
being improperly shared.
That means protecting against threats like the cyber-
attacks we saw last year when North Korea tried to hack COVID-
19 vaccination data, and bad actors who misuse their access to
research, including during the peer-review process. The
National Institutes of Health has made progress in implementing
policies and procedures to raise awareness of, prevent, and
address undue foreign influence among the biomedical research
community. But as investigations from the Department of Health
and Human Services, Office of the Inspector General, the
Department's Office of National Security, and the Government
Accountability Office made clear, there is more NIH can be
doing here. So, I am pleased to have witnesses from each of
those offices, as well as the NIH Office of Extramural
Research, which investigates grantees who are credibly thought
to have undisclosed conflicts of interest.
I look forward to hearing more from each of you today about
what steps Congress can take to ensure accountability and
transparency in the grant process. Families are counting on us
to get this right, not just to make sure their tax dollars are
not misspent, our intellectual property isn't stolen, and
National Security isn't undermined, but so potentially
lifesaving research on cancer and Alzheimer's and other
diseases is not delayed or derailed by undue influence.
Congress has a long record of bipartisan support for biomedical
research.
I am proud to have fought hard to make necessary
investments in this work, and I hope we will be able to work in
a similarly bipartisan way on this Committee to take steps to
protect those investments. With that, I will recognize Ranking
Member Burr for his opening remarks.
OPENING STATEMENT OF SENATOR BURR
Senator Burr. Thank you, Madam Chair, and I don't know
about you, but I can't wait until witnesses can--and Members
can be back in person. And I might say, given the most recent
vaccine data, over the next four weeks, every American that
wants to have a vaccine will have had the opportunity to have a
vaccine and maybe normalcy will also return to the hearing
rooms. Madam Chair, this is a topic that I know well because
where I spend the other half of my day in the Senate
Intelligence Committee, from where I sit now and how I spend my
time, I want to impress upon my colleagues here today,
virtually, this threat is real, it is credible, and it is
dangerous to our way of life in America. We cannot be
complacent.
This hearing is about the efforts of foreign actors to
influence biomedical research enterprise. The Government of the
people of the Republic of China and the Chinese Communist Party
are the most sophisticated perpetrators, but other foreign
actors are also engaged in efforts to subvert our biomedical
research. Our adversaries are engaging in a systematic effort
to infiltrate the academic research community and siphon away
the results of United States spending on biomedical research.
Last week in the Intelligence Committee's annual world watched
threats hearing, the Director of National Intelligence Avril
Haines said, China's Government, ``is an unparalleled
priority,'' in our intelligence community.
The 2021 annual threat assessment report reads, China will
remain the top threat to U.S. technology competitiveness as the
Chinese Communist Party targets key technology sectors and
research institutions. Our enemies are targeting
vulnerabilities in our biomedical research enterprise. Why?
Because it is easy. They are not going to take us on in a
single straight up fight because they know they will lose. So
instead, they exploit the openness of our society and the
collaborative culture that the academic research community
encourages.
This means that our advancements in biomedical research are
at grave risk. It means that billions of taxpayers' dollars
that are invested each year toward discoveries are leveraged or
outright stolen by our adversaries. And it means that our
enemies can capitalize on the billions of dollars that American
taxpayers invest every year to beat us to the punch on the next
game changing technology to save lives or to cause unimaginable
harm. Because they know it is easier to get to home base when
you steal your way to third. We are here today to focus
specifically on this threat in the context of protecting
biomedical research. This year, Congress appropriated $43
billion to the NIH for biomedical research. And we know that
over time, for every one dollar we spend on basic research at
NIH, the private sector spends eight dollars. What a tremendous
leverage. That is a lot of money in the United States has
historically been the undisputed leader in biomedical
innovation.
It is easy to see why the government of China is trying to
steal our secrets and eliminate our competitive advantage.
Global collaboration has been and will always be the key to our
success in maintaining global leadership and our advancements.
As I have said before, all smart people don't exist just here
in the United States. Innovation is a global race and
competition is good for innovation. So, we must think about how
to foster greater innovation at home, mitigate potential risk
associated with foreign influence, and maintain America's edge
because deception and theft are not a valid competitive tool,
and we need to be aware that this is happening more than we
would like to admit it.
I made this case for Five Eyes partners, the intelligence
alliance comprising Australia, Canada, New Zealand, the United
Kingdom, and the United States, to tackle the issue of 5G for
our cellular technology. And I think it also makes sense that
we discuss our funding and advancements in biomedical research
as well. The NIH partners with academic centers all over the
country to support foundational research that leads to
discoveries that improve, excuse me, the quality of life for
Americans. And the research benefits the rest of the world with
innovative drugs, devices, and treatments best evidenced by
vaccines this year. North Carolina benefits each year from over
$1 billion in NIH funded research.
Along with their accomplishments and discoveries, our
research institutions have seen firsthand what our enemies will
do to steal our most valuable secrets, valuable secrets and
assets in research. There is a concerted effort by individuals
from China, backed by their Government, to be educated in
America, to work here for 10 years, and then to the full extent
possible to bring back to China's Government everything they
can learn, store, or steal. The government of China also worked
to recruit Chinese expatriate and researchers of other
nationalities who may be attracted by the benefits that the
Chinese Government is able to offer them. I have cautioned the
research institutions in my state to prepare for a reality with
different revenue streams and encourage them to rely less on
researchers from countries whose governments seek to do us
harm.
We must balance the rewards of this research with the risks
to our country. HHS and other Federal agencies recognize the
urgency of this issue and the threat it poses to our country.
The NIH has come a long way from the announcement that Dr.
Collins made to this Committee in August 2018, and I am glad
that he took the initiative to form a working group to solve
NIH's blind spots in the undue influence of foreign actors and
adversaries. This is a challenge that will affect all corners
of HHS. Our systems that house Medicare data must be secure
just as our programs to protect priceless COVID vaccine
development data must be fortified. This threat reaches into
many facets of our country.
The private sector is also experiencing this threat and our
solutions to these issues will require their input, their
participation, and more importantly, their partnership. There
is no easy path, but if we concede the innovation race, our
global competitiveness and our National Security will be at
risk. I want to thank the witnesses that are here with us
virtually this morning, for their efforts to inform the
Committee, and for your efforts to keep America safe and in the
forefront of discovery and innovation. I thank the Chair.
The Chair. Thank you, Ranking Member Burr. I will now
introduce today's witnesses. I am pleased to start by welcoming
Dr. Michael Lauer. Dr. Lauer is the Deputy Director for
Extramural Research in the Office of the Director at the
National Institutes of Health and the principal authority and
adviser to the Director of NIH on the quality and effectiveness
of NIH extramural research programs. Dr. Lauer, welcome. Glad
to have you with us today.
Next, I would like to introduce Lisa Aguirre. Ms. Aguirre
is the Acting Director of the Office of National Security for
the Department of Health and Human Services, where she manages
Department wide oversight on issues of National Security, such
as cybersecurity, counterintelligence, and safeguarding
classified information. Welcome, Mrs. Aguirre. Thank you for
joining us today.
Next, I would like to introduce Gary Cantrell. Mr. Cantrell
is the Deputy Inspector General for Investigations at the
Office of the Inspector General for the Department of Health
and Human Services, where he has overseen thousands of civil
and criminal actions to protect HHS programs and program
recipients from fraud. Mr. Cantrell, welcome to you and thank
you for joining us.
Finally, I would like to introduce Candice Wright. She is
the Acting Director of Science, Technology, Assessment and
Analytics at the U.S. Government Accountability Office and is
overseeing GAO's work on federally funded research,
intellectual property protection and management, and
commercializing innovative technologies, and enhancing U.S.
economic competitiveness.
Thank you to all of you for joining us today. We look
forward to your testimony, and Ms. Wright--and Dr. Lauer, we
will begin with your opening statements. Dr. Lauer.
STATEMENT OF MICHAEL LAUER, M.D., DEPUTY DIRECTOR FOR
EXTRAMURAL RESEARCH, NATIONAL INSTITUTES OF HEALTH, BETHESDA,
MD
Dr. Lauer. Thank you. Good morning, Chair Murray, Ranking
Member Burr, and distinguished Members of the Committee. It is
an honor to appear before you today to discuss how NIH works to
protect the integrity of the U.S. biomedical enterprise and
neutralize foreign threats to the integrity of taxpayer funded
research.
The United States is the world leader in biomedical
research, NIH sets the global standards, innovation and
scientific discovery that aims to advance the health of all
Americans while promoting the highest levels of scientific
integrity, public accountability, and social responsibility in
the conduct of science. We promote open collaboration with
scientists and research institutions around the world, which is
imperative to solving the most pressing and perplexing health
challenges that are facing the American public.
Foreign born scientists contribute to improving health,
fostering innovation, and advancing science. Unfortunately, a
few governments have initiated systematic programs to exploit
the collaborative nature of biomedical research and unduly
influence U.S. supported researchers. It is essential for us to
continue our vigilance and take additional actions to protect
the integrity of the U.S. biomedical research enterprise while
also protecting important relationships with foreign scientists
worldwide. NIH has taken and continues to take a proactive
approach to identifying, resolving, and preventing three areas
of concern. First is the failure by some researchers at NIH
funded institutions to disclose substantial contributions of
resources from other organizations, including foreign
governments and businesses.
Second is diversion of proprietary information, including
grant applications or produced by NIH-supported biomedical
research to other entities, including other countries. And
third, failure by some peer reviewers to keep information grant
applications confidential, including in some instances
disclosure to foreign entities or other attempts to influence
funding decisions. NIH identifies and monitors emerging threats
internally and through partnerships with intelligence and law
enforcement colleagues across the Government.
When specific concerns are identified, we work with
leadership within awarding institutions to address the issue as
appropriate. As of April 2021, we have contacted more than 90
awardee institutions regarding concerns involving over 200
scientists. This process is ongoing. While in some instances
our outreach reveals simple misunderstandings, these efforts
have uncovered inappropriate behaviors leading to actions by
awardee institutions who have the authority to take certain
actions as employers, including but not limited to
terminations, suspensions, and relinquishment of NIH funds. In
addition, we are working closely with other Federal agencies
through the Office of Science and Technology Policy, that is
OSTP, to coordinate Federal outreach efforts and standardize
relevant policies and procedures of research funding agencies.
I am privileged to serve as a co-chair of the OSTP
subcommittee on Research Security, and I am pleased that we--I
am pleased to report that we issued government-wide best
practices for research institutions in January of this year.
While we have taken bold and concrete steps to bolster research
integrity and neutralize foreign threats against U.S.
biomedical research, we remain conscious of how these actions
could affect the morale of honest and dedicated foreign
researchers, particularly in the context of the pandemic that
has exacerbated acts of discrimination and harassment against
Asian Americans. The vast majority of Chinese scientists
working in America are committed to the cause of expanding
knowledge for the betterment of humankind and to do so in a
fair and honest way.
We must say this at every opportunity. Importantly, NIH
reviews have also identified concerns involving individuals who
are not foreign born and individuals not of Chinese ethnicity.
The individuals violating laws and policies represent a small
proportion of scientists working in and with U.S. institutions.
We must ensure that our responses to this issue do not
create a hostile environment for colleagues who are deeply
dedicated to advancing human health through scientific inquiry.
We cannot afford to reject brilliant minds working honestly and
collaboratively to provide hope and healing to bridges around
the world.
In closing, I can assure the Committee that the senior
leadership at NIH will continue to diligently protect the
integrity of U.S. taxpayer funded research. Thank you for the
opportunity to testify. I look forward to answering your
questions.
[The prepared statement of Dr. Lauer follows:]
prepared statement of michael lauer
Good morning Chair Murray, Ranking Member Burr, and distinguished
Members of the Committee. It is an honor to appear before you today to
discuss how NIH works to protect the integrity of the U.S. biomedical
enterprise and neutralize foreign threats to the integrity of taxpayer-
funded research.
The United States is the world leader in biomedical research. As
the largest public funder of that research, NIH sets the standard for
innovation and scientific discovery that aims to advance the health of
all Americans. We exemplify and promote the highest levels of
scientific integrity, public accountability, and social responsibility
in the conduct of science. We promote open collaboration by leveraging
formal and informal collaborations with scientists at research
institutions around the world, which is imperative to solving the most
pressing and perplexing health challenges that are facing the American
public. This exchange of knowledge is an essential part of innovation,
and it is critical to our global competitiveness. Foreign-born
scientists contribute to improving health, fostering innovation, and
advancing science.
Many recent scientific advances, such as sequencing the human
genome, or the development of the gene-editing tool kit known as
CRISPR-Cas were predicated upon international collaborations. Since
2000, 38 percent of U.S. Nobel prizes in physics, chemistry, and
medicine have been awarded to foreign-born scientists. \1\ Foreign-born
scientists, trainees, and employees at American universities are hard
at work assisting in the advancement of knowledge. U.S. scientists
routinely collaborate productively with investigators in foreign
countries, resulting in many scientific successes.
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\1\ https://nfap.com/wp-content/uploads/2019/10/Immigrants-and-
Nobel-Prizes.NFAP-Policy-Brief.October-2019.pdf.
Global health and research partnerships have proven their worth in
every phase of the current pandemic. When faced with the universal
threat of the SARS-CoV-2 virus, scientists across the globe were asking
the same questions at the same time--what is the virus, how does it
spread, who is vulnerable, what are the symptoms, how do we prevent and
treat it? Global partnerships made it possible for scientists and
physicians to learn from one another, to take more full advantage of
the research capacity by coordinating research so that more theories
and therapies were studied. For example, NIH's National Institute of
Allergy and Infectious Diseases (NIAID) utilized its existing domestic
and international clinical trials infrastructure, originally
established to conduct research on HIV and influenza, and worked with
partners in the public and private sectors to establish the COVID-19
Prevention Network (CoVPN). The CoVPN has supported multiple COVID-19
vaccine candidates to progress in record time from concept to
authorization for emergency use by the U.S. Food and Drug
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Administration (FDA).
Unfortunately, a few foreign governments have initiated systematic
programs to exploit the collaborative nature of biomedical research and
unduly influence U.S.-supported researchers. It is essential for us to
continue our vigilance and take additional actions to protect the
integrity of the U.S. biomedical research enterprise, while also
protecting important relationships with foreign scientists worldwide.
NIH's three areas of concern are:
(1) failure by some researchers at NIH-funded institutions to
disclose substantial contributions of resources from other
organizations, including foreign governments and businesses,
which threatens to distort decisions about the appropriate use
of NIH funds and accurate evaluation of commitment of effort to
US-supported research;
(2) diversion of proprietary information included in grant
applications or produced by NIH-supported biomedical research
to other entities, including other countries; and
(3) failure by some peer reviewers to keep information in grant
applications confidential; including, in some instances,
disclosure to foreign entities or other attempts to influence
funding decisions.
NIH has taken, and continues to take, a proactive approach to
identifying, resolving, and preventing these issues of concern.
NIH identifies and monitors concerns through several channels. We
regularly partner with colleagues at the Department of Health and Human
Services (HHS), and other Federal agencies, such as the Federal Bureau
of Investigation (FBI), to exchange information on emerging threats. In
addition, NIH maintains an open channel of communication with our
funded research institutions and their investigators, several of which
have proactively contacted us with concerns.
NIH partners with the HHS Office of Inspector General (OIG) in two
ways: we refer cases of concern to the OIG for investigation and
possible debarment, and we participate in audits of our own grant
systems and internal controls by the OIG and the GAO to improve our
approach. In the past 4 years, we have implemented dozens of
recommendations and continue to work through recommendations as they
are issued. We have also actively taken steps to increase awareness
about peer review integrity with our employees who lead scientific
programs and review meetings. For example, NIH staff were specifically
trained to identify and report suspicious activity on the part of key
scientists designated in grant applications and peer reviewers to the
Research Integrity Officer in their NIH Institute or Center, or
directly to our central research integrity official within the Office
of the Director.
When concerns are identified, we work with leadership within the
awardee institution to quickly address the issue as appropriate. As of
April 2021, we have contacted more than 90 awardee institutions
regarding concerns involving over 200 scientists. This process is
ongoing. While in some instances our outreach reveals simple
misunderstandings, these efforts have uncovered inappropriate behaviors
leading to actions by awardee institutions (who have the authority to
take certain actions as employers).
Such actions include:
Terminations or suspensions of scientists who have
engaged in egregious violations of NIH grant terms and
conditions and institutional policies.
Interventions to address previously un-reported
affiliations with foreign institutions.
Relinquishment or refund of NIH funds.
Prohibition of certain individuals from serving as
investigators on NIH grants.
Outreach to FBI for assistance.
Discovery (through acquisition of certain foreign
grants and contracts) of overlapping or duplicative work, or
conflicts in stating committed effort to research projects.
This discovery has led to NIH suspensions of active grants as
appropriate.
Efforts to raise awareness among institutional
faculty about government and institutional policies dealing
with foreign affiliations and relationships (see, for example,
the Penn State website). \2\
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\2\ https://www.research.psu.edu/international-affiliations.
There have also been situations in which honest mistakes were made
by research investigators who were unaware of the requirement to
disclose other funding sources (both domestic and international) or
affiliations with foreign entities. In these cases, we worked with the
institutions, which took steps to help their employees understand
disclosure policies; both why they are important, and how to comply
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with relevant rules.
We will continue to address issues of concern. To mitigate security
breaches, we have improved the electronic systems that are used by
researchers to submit applications to NIH, and that are also used by
peer reviewers to access applications for evaluations. Our security
updates include: two-factor authentication for electronic research
system logins; using an all-electronic conflict-of-interest
certification; and, development of a dashboard.
A major focus of our preventive efforts is proactive communication
to engage the research community as partners. On August 23, 2018, the
NIH Director issued a statement on protecting the integrity of U.S.
Biomedical Research, \3\ and sent a letter to officials at
approximately 10,000 organizations applying for NIH funding. The letter
reinforced that NIH and the U.S. biomedical research community at large
have a vested interest in mitigating these unacceptable breaches of
trust and confidentiality that undermine the integrity of U.S.
biomedical research. NIH has also undertaken a substantial outreach and
training effort. In 2019, NIH launched its series ``Taking Action--Case
Studies in Peer Review Integrity,'' which has drawn attention to review
integrity issues as well as the responsibilities of institutional
officials in the scientific community. \4\ In 2020, NIH (1) issued
internal policy for NIH extramural staff on protecting the
confidentiality of NIH peer review information and provided stewardship
training for extramural staff; (2) the NIH Center for Scientific Review
(CSR) launched the CSR Reviewer Integrity Training module and is
requiring all reviewers to complete the training; \5\ (3) the NIH
Office of Extramural Research produced the Master Class in Review
Integrity as part of the NIH Virtual Seminar; \6\ and (4) NIH
strengthened its reviewer conflict of interest policy. \7\
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\3\ https://www.nih.gov/about-nih/who-we-are/nih-director/
statements/statement-protecting-integrity-us-biomedical-research.
\4\ https://grants.nih.gov/policy/research-integrity/
confidentiality-peer-review/case-studies.htm.
\5\ https://www.csr.nih.gov/RevTrainingPubRevNoSurvey/Home.
\6\ https://www.youtube.com/watch?v=X0yvzUUc9yY.
\7\ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-
019.html.
We are working closely with the Office of Science and Technology
Policy (OSTP) and other Federal agencies to develop coordinated
resources to help awardee institutions understand our expectations
regarding research investigators who--in addition to NIH funding--
receive additional research funding from domestic or foreign sources.
The OSTP convened a Subcommittee on Research Security under the
National Science and Technology Council to coordinate Federal efforts
to effectively communicate and provide outreach to research
institutions, develop guidance and best practices for research
institutions, and standardize conflict of interest and disclosure
policies and procedures of research funding agencies across the Federal
Government. I am privileged to serve as a co-chair of the Subcommittee
and I am pleased to report that we issued government-wide best
practices for research institutions in January of this year. \8\
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\8\ https://trumpwhitehouse.archives.gov/wp-content/uploads/2021/
01/NSTC-Research-Security-Best-Practices-Jan2021.pdf.
While we have taken bold and concrete steps to bolster research
integrity and neutralize foreign threats against U.S. biomedical
research, we remain conscious of how these actions could affect the
morale of honest and dedicated foreign researchers, particularly in the
context of a pandemic that exacerbated acts of discrimination and
harassment against Asian Americans. In March 2019, we responded to a
joint letter \9\ from three Chinese American biomedical professional
societies, in which they expressed concerns that policies designed to
protect biomedical proprietary information may be singling out Chinese
students and scholars working in the United States. Our response,
published in the journal Science, \10\ acknowledged these concerns, and
emphasized that the vast majority of Chinese scientists working in
America are committed to the cause of expanding knowledge for the
betterment of humankind, and to do so in a fair and honest way. We must
say this at every opportunity, and our actions must reflect that
understanding. Importantly, NIH reviews have also identified concerns
involving individuals who are not foreign born and individuals not of
Chinese ethnicity.
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\9\ https://science.sciencemag.org/content/363/6433/1290.
\10\ https://science.sciencemag.org/content/363/6433/1292.full.
The individuals violating laws and policies represent a small
proportion of scientists working in and with U.S. institutions. We must
ensure that our responses to this issue do not create a hostile
environment for colleagues who are deeply dedicated to advancing human
health through scientific inquiry. We cannot afford to reject brilliant
minds working honestly and collaboratively to provide hope and healing
---------------------------------------------------------------------------
to millions around the world.
In closing, I can assure the Committee that the senior leadership
at NIH will continue to diligently protect the integrity of U.S.-
taxpayer funded research. Thank you for the opportunity to testify. I
look forward to addressing any questions.
______
The Chair. Thank you very much.
We will turn to Ms. Aguirre.
STATEMENT OF LISA AGUIRRE, ACTING DIRECTOR, OFFICE OF NATIONAL
SECURITY, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES,
WASHINGTON, DC
Ms. Aguirre. Good morning, Chair Murray, and Ranking Member
Burr, and distinguished Members of the Committee. It is an
honor to appear before you today to discuss the Office of
National Security, ONS' mission. ONS is the Department of
Health and Human Services, HHS, point of contact for the
intelligence community and is responsible for coordination with
the IC for intelligence support to HHS senior policymakers and
consumers of intelligence across the Department.
Additionally, ONS is responsible for safeguarding
classified National Security information across the Department
and for the appropriate sharing of intelligence, homeland
security, and law enforcement information externally and
internally within HHS, among the operating and staff divisions.
ONS is headed by the Director who reports directly to the HHS
Deputy Secretary. The Director also serves as a National
Security adviser to the Secretary, and in this role, as the HHS
Secretary's Senior Intelligence Official on National Security,
intelligence, and counterintelligence issues. The Director also
serves as the Department's Federal Senior Intelligence
Coordinator, or FSIC.
ONS' vision is for HHS personnel to successfully accomplish
missions worldwide in a security informed manner and with the
actionable intelligence needed at the right time for
operational and policy decisions. ONS' responsibilities include
integrating intelligence and security information into HHS
policy and operational decisions, assessing, anticipating, and
warning of potential security threats to the Department and our
National Security, and providing policy guidance on and
managing the Office of the Secretary's implementation of the
Department's security, intelligence, and counterintelligence
programs. ONS' programs include National Security Clearance
Adjudication, Classified National Security Information
Management, Secure Compartmented Information Facilities
Management, Communications Security, Safeguarding and Sharing
of Classified Information, Cyber Threat Intelligence and
Counterintelligence.
ONS' counterintelligence mission is to conduct activities
to identify, detect, deter, neutralize, mitigate, and protect
Department personnel, information technology systems, and
critical assets from insider threats, foreign intelligence
entities, and foreign influence. While not pervasive, some
foreign government actors target top scientific and technical
expertise sectors in the United States in an effort to enhance
their competitive advantage in the fields of research, and
medical, technical innovations. These foreign actors seek to
exploit Government, private sector, and academic development
efforts in order to advance their own national interests while
providing sponsorship to a variety of nontraditional activities
to steal and co-opt U.S. research, specifically targeting
biotechnology companies and university research centers.
Nontraditional collectors can include foreign researchers
who have been recruited by foreign talent recruitment programs,
cyber hackers and foreign students who have been co-opted or
coerced into spying for foreign governments and their
intelligence services. There is substantial reporting
suggesting nontraditional collector activity against U.S.
equities in an effort to--I am sorry, there is substantial
reporting suggesting that nontraditional collector activity
against U.S. equities in an effort to misappropriate sensitive
U.S. research and development data and information. In an
effort to mitigate risk to HHS equities, ONS conducts all
source intelligence analysis on foreign nationals attempting to
obtain positions within HHS and affiliates with HHS equities.
ONS conducts vetting, and research related to grants,
funding overlaps, scholarships, foreign travel, foreign
associations, foreign recruitment activities, and foreign
patents. ONS works jointly with HHS Operating and Staff
Divisions, and interagency partners to assist in determining
risk evaluations and research engagements. ONS' nontraditional
collection research is provided to HHS Office of Inspector
General and the FBI as counterintelligence referrals. Also, ONS
has been working within the Department on a counterintelligence
education and awareness program titled, Safeguarding Science.
We have also begun work on a program planned for extramural
education and awareness training with the National
Counterintelligence Task Force, a multiagency task force led by
the FBI. This training will likely be targeted toward NIH
extramural staff and academic institutions applying for NIH
grants.
While an ONS staff member, on detail to ONS from the FBI,
has also been involved in extramural outreach over the last
year. We are excited about the development of a comprehensive
plan for extramural research. Additionally, ONS has a foreign
visitor vetting program, and we conduct vetting of foreign
national visitors for 10 operating divisions and 14 staff
divisions. ONS also has a counterintelligence review program
where we review material transfer agreements, supply chain risk
management from a counterintelligence angle, CI review of FDA
emergency use authorizations, CFIUS cases which are Committee
on Foreign Investment in the US, as the Department lead. We
work closely in several ways with the NIH as we do with other
operating divisions.
We receive, for example, information from the NIH Deputy
Director for Extramural Research, Dr. Lauer. ONS reviews
correspondence received related to foreign nationals who are
active participants in or seeking to engage in research and
grant activities involving HHS equities. In an effort to
identify and deter potential foreign influence on research
integrity, ONS conducts all source research on foreign
nationals that pose a potential counterintelligence and, or
national--and, or nontraditional collection concerns to HHS
equities. Since July 2020, ONS has received 78 emails from Dr.
Lauer, and from these there were nine findings.
We did intelligence products based on these, passed them
back to Dr. Lauer, passed them on to counterintelligence and
insider threat staff, and when appropriate, referred them to
the OIG. In closing, ONS has worked significantly over the last
few years to further enhance our counterintelligence programs
in coordination with HHS operating and staff divisions. And we
are dedicated to protecting Department personnel, information
technology systems, and critical assets. Thank you very much
and I will be happy to answer any questions.
[The prepared statement of Ms. Aguirre follows:]
prepared statement of lisa aguirre
Good morning Chair Murray, Ranking Member Burr, and distinguished
Members of the Committee. It is an honor to appear before you today to
discuss the Office of National Security's (ONS) mission. ONS is the
Department of Health and Human Services' (HHS) point of contact for the
Intelligence Community (IC), and is responsible for coordination with
the IC and for intelligence support to HHS senior policymakers and
consumers of intelligence across the Department. Additionally, ONS is
responsible for safeguarding classified national security information
across the Department and for the appropriate sharing of intelligence,
homeland security, and law enforcement information externally and,
internally within HHS, among the Operating and Staff Divisions. ONS is
headed by the Director, who reports directly to the HHS Deputy
Secretary. The Director also serves as the National Security Advisor to
the Secretary and in this role is the HHS Secretary's Senior
Intelligence Official on national security, intelligence, and
counterintelligence issues. The Director also serves as the
Department's Federal Senior Intelligence Coordinator (FSIC).
ONS' vision is for HHS personnel to successfully accomplish
missions worldwide in a security-informed manner and with the
actionable intelligence needed, at the right time, for operational and
policy decisions. ONS' responsibilities include: Integrating
intelligence and security information into HHS policy and operational
decisions; assessing, anticipating, and warning of potential security
threats to the Department and our national security; and, providing
policy guidance on and managing the Office of the Secretary's
implementation of the Department's security, intelligence, and
counterintelligence programs. ONS' programs include national security
adjudication, classified national security information management,
secure compartmented information facilities management, communications
security, safeguarding and sharing of classified information, cyber
threat intelligence, and counterintelligence.
ONS' counterintelligence mission is to conduct activities to
identify, detect, deter, neutralize, mitigate and protect Department
personnel, information technology systems, and critical assets from
insider threats, foreign intelligence entities, and foreign influence.
While not pervasive, some foreign government actors target top
scientific and technical expertise sectors in the United States in an
effort to enhance their competitive advantage in the fields of research
and medical/technical innovations. These foreign actors seek to exploit
government, private-sector, and academic development efforts in order
to advance their own national interests while providing sponsorship to
a variety of non-traditional activities to steal and co-opt U.S.
research; specifically, targeting bio-technology companies and
university research centers. Non-traditional collectors can include
foreign researchers who have been recruited by foreign talent
recruitment programs, cyber hackers, and foreign students who have been
co-opted or coerced into spying for foreign governments and their
intelligence services. There is substantial reporting suggesting non-
traditional collector activity against U.S. equities in an effort to
misappropriate sensitive U.S. research and development data and
information.
In an effort to mitigate risks to HHS equities, ONS conducts all-
source intelligence analysis on foreign nationals attempting to obtain
positions within HHS and affiliates with HHS equities. ONS conducts
vetting and research related to grants, funding overlap, scholarships,
foreign travel, foreign associations, foreign recruitment activities,
and foreign patents. HHS ONS works jointly with HHS Operating and Staff
Divisions, and interagency partners, to assist in determining risk
evaluations in research engagements. ONS non-traditional collection
research is provided to HHS Office of Inspector General and the Federal
Bureau of Investigation (FBI) as counterintelligence referrals.
Also, ONS has been working within the Department on a
counterintelligence education and awareness program, titled:
Safeguarding Science. ONS has begun work on a program plan for
extramural education and awareness training with the National
Counterintelligence Task Force, a multi-agency task force led by the
FBI. This training will likely be targeted toward National Institutes
of Health (NIH) extramural staff (employees, contractors, fellows, and
trainees/volunteers) and academic institutions applying for NIH grants
(faculty, staff, post-doctoral associates, graduate research
assistants, trainees/volunteers). While an ONS staff member, on detail
to ONS from the FBI, has been involved in extramural outreach over the
last year, we are excited about the development of a comprehensive plan
for extramural outreach.
Additionally, ONS has a foreign visitor vetting program. ONS
conducts vetting of foreign national visitors for 10 Operating
Divisions and 14 Staff Divisions. ONS also conducts vetting for foreign
national employees who will be authorized access to government systems
and data. In 2020, ONS vetted 13,138 foreign national visitors; 7936
were to NIH. ONS also vetted 2,854 foreign national employees; 1,574
were to be employed in NIH. ONS also has a counterintelligence review
program, where we review:
Material Transfer Agreements (transfers from HHS to foreign
governments);
Supply Chain Risk Management (SCRM) from the
counterintelligence angle;
CI Review of FDA Emergency Use Authorizations; and
Committee on Foreign Investment in the U.S. (CFIUS) cases, as
Department lead.
ONS also has a program that focuses on the non-traditional
collection vulnerabilities within HHS.
ONS has worked closely in several ways with NIH, as we do with
other Operating Divisions. One example: ONS receives information from
the NIH Deputy Director for Extramural Research (Dr. Lauer). ONS
reviews correspondence received related to foreign nationals who are
active participants in or seeking to engage in research and grant
activities involving HHS equities. In an effort to identify and deter
potential foreign influence on U.S. research integrity, ONS conducts
all-source research on foreign nationals that pose a potential
counterintelligence and/or non-traditional collection concern to HHS
equities. If ONS identifies a potential concern, our office produces a
formal product on our findings and presents the data to the appropriate
HHS components. Since July 2020, ONS has received 78 portal emails from
the NIH Deputy Director for Extramural Research, and from these there
were nine findings. Those nine findings were put into intelligence
products and provided to the NIH Deputy Director for Extramural
Research counterintelligence and insider threat staff, and when
appropriate, referred to OIG.
In closing, ONS has worked significantly over the last few years to
further enhance our counterintelligence programs, in coordination with
HHS Operating and Staff Divisions, and we are dedicated to protecting
Department personnel, information technology systems, and critical
assets. I will be happy to answer any questions.
______
The Chair. Thank you.
Mr. Cantrell.
STATEMENT OF GARY L. CANTRELL, DEPUTY INSPECTOR GENERAL FOR
INVESTIGATIONS, OFFICE OF INSPECTOR GENERAL, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Mr. Cantrell. Good morning, Chair Murray, Ranking Member
Burr, and distinguished Members of the Committee. I am Gary
Cantrell, Inspector General for Investigations, HHS, OIG. I
appreciate the opportunity to appear before you to discuss how
we are working in conjunction with our HHS and law enforcement
partners to protect medical research against foreign threats.
OIG has identified the threat of foreign government action
aimed at unduly influencing and capitalizing on taxpayer funded
medical research as a top management challenge for HHS. And we
also suggest doing more to address this vulnerability in OIG's
top 25 recommendations.
OIG takes a multi-pronged approach to foreign influence
related oversight and enforcement activities. We work
collaboratively to minimize vulnerabilities and mitigate grant
fraud through audits, evaluations, and proactive training. And
we investigate allegations of criminal misconduct to make
referrals for criminal, civil, or administrative action as
appropriate. First, I will discuss our investigative and
enforcement efforts. Foreign theft of taxpayer funded medical
research is a high profile, complex issue as the cases under
our purview all involve aspects of traditional grant fraud, a
subject which OIG has extensive experience investigating.
OIG receives allegations of grant fraud or uncovers
potential fraud in a variety of ways, including our OIG
hotline, referrals from HHS, law enforcement partners, and
whistleblower disclosures. Upon receiving an allegation
pertaining to grant fraud, OIG evaluates the allegation and
determines whether we will open an investigation, refer the
matter to another agency of jurisdiction, or send it back to
the originating operating division for administrative review
and potential action. When OIG identifies a potential violation
of civil or criminal law, we present the facts to DOJ for
prosecutorial consideration. As part of the foreign influence
investigative process, OIG coordinates with NIH, the HHS Office
of National Security, the FBI, and U.S. attorneys' offices to
ensure coordinated, efficient, and investigative resolutions.
My testimony highlights two such investigations, one
leading to a criminal plea by a researcher who admitted he lied
on applications in order to use approximately $4.1 million in
NIH grants to enhance China's expertise in the areas of
rheumatology and immunology. Another resulting in a civil
settlement with a research institution to resolve allegations
that violated the False Claims Act by submitting grant
applications and progress reports to NIH which failed to
disclose that two of the institution's researchers were funded
by Chinese Government grants.
OIG also works with stakeholders to increase their ability
to detect and prevent fraud. In proactive training, OIG
increases HHS employee, contractor, and grantee awareness of
how to identify and report allegations pertaining to grant
fraud, including foreign threats. For instance, OIG has
provided numerous grant fraud training sessions at the NIH
regional seminars and town hall meetings. We have also
partnered with several academic institutions to present best
practices for preventing, detecting, and reporting research
fraud to their research integrity, excuse me, compliance
officers. OIG also conducts important oversight of NIH funded
research through audits and evaluations. Our work is informed
by concerns raised by Congress, NIH, and other Federal law
enforcement agencies.
In addition to their existing resources for NIH oversight,
Fiscal Year 2019, OIG began receiving transferred funding of $5
million each year for oversight of grant programs and
operations at NIH. Since this time, OIG has completed nine
reviews focused on protecting the integrity of NIH funded
research, with 12 additional related reviews planned or
underway. This includes but is not limited to assessments of
NIH's vetting and oversight of its peer reviewers, and NIH's
oversight of financial conflicts of interest and other support.
In conclusion, OIG is committed to working collaboratively
to address foreign threats to taxpayer funded medical research,
and we will diligently continue both our preventive efforts to
minimize risk and vulnerabilities in HHS programs, and to
conduct enforcement actions whenever necessary. Thank you for
your ongoing leadership in this area and for affording me the
opportunity to discuss this important topic with you today.
[The prepared statement of Mr. Cantrell follows:]
prepared statement of gary l. cantrell
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 HHS's $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 Government's
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 fraud--something 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.
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
stakeholders--including HHS operating divisions and grant recipient
organizations--on 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 hotline's 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 Investigation's (FBI's) 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 follow-up 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 $4.1 million in NIH grants to
develop China's 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 People's Republic of China's
Thousand Talents Program.
As mentioned earlier, OIG's 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 HHS's 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. OIG's work is independent of ORI's, and ORI
must refer all credible allegations of criminal conduct they uncover to
OIG. In short, OIG's 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 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 OIG's 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 2021-2022
NIH Oversight Plan. The fiscal year 2021-2022 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:
---------------------------------------------------------------------------
\1\ The Consolidated Appropriations Act, 2021 (Public Law No. 116-
260).
Cybersecurity protections. OIG plans to conduct
audits related to cybersecurity controls built into NIH's
---------------------------------------------------------------------------
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. OIG's planned oversight activities will
examine NIH's efforts to ensure the integrity and the effective
management of its grant application and selection processes.
Intellectual property and research integrity. OIG's
oversight will examine NIH's 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 NIH's vetting and oversight of its
peer reviewers. OIG assessed NIH's 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.
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 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.
______
[summary statement of gary l. cantrell]
OIG is responsible for overseeing HHS's $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.
OIG has identified the threat 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 OIG's Top 25 Recommendations
to HHS is that NIH should build on its efforts to identify and mitigate
potential foreign threats to research integrity.
Proactive Grant Fraud Education, With Enforcement When Needed: The
Office of Investigations is the law enforcement component of OIG that
investigates fraud and abuse against HHS programs. Although foreign
theft of taxpayer-funded medical research is a high-profile complex
issue, the cases under our purview all involve aspects of grant fraud--
something which OIG has extensive experience investigating.
We take a two-pronged approach to preventing and acting against
grant fraud. First, OIG works collaboratively to educate key
stakeholders--including HHS operating divisions and grant recipient
organizations--on 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 also works collaboratively with stakeholders to increase their
ability to detect and prevent grant fraud through proactive training.
To educate grant recipient organizations, OIG has partnered with
several academic entities.
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. In addition to existing
resources for NIH oversight, 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. Since this time,
OIG has completed nine related reviews focused on NIH. In addition, OIG
has eight related ongoing reviews and we plan to begin another four
related reviews this fiscal year. Our work includes but is not limited
to assessments of NIH's vetting and oversight of its peer reviewers and
NIH's oversight of financial conflicts of interest and other support.
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.
______
The Chair. Thank you.
We will turn to Ms. Wright.
STATEMENT OF CANDICE N. WRIGHT, ACTING DIRECTOR, SCIENCE,
TECHNOLOGY ASSESSMENT, AND ANALYTICS, U.S. GOVERNMENT
ACCOUNTABILITY OFFICE, WASHINGTON, DC
Ms. Wright. Thank you, Chair Murray, Ranking Member Burr,
and Members of the Committee. Thank you for the opportunity to
discuss undue foreign influence in research funded by U.S.
taxpayers. With research expenditures in recent years amounting
to over $40 billion annually, safeguarding the U.S. research
enterprise is critically important and to ensure that Federal
research is free from undue foreign influence.
This issue is not new and in fact GAO's work in this area
dates back to 1992. What is different today is greater
international collaboration and the concerted efforts to access
sensitive U.S. research and intellectual property, such as
through foreign government talent recruitment programs. Some
countries can create conflicts of interest for researchers by
obligating them to divert intellectual property and U.S. funded
research in exchange for salaries and other incentives.
Agencies and university grantees face the difficult task of
preventing or at least limiting the extent of foreign influence
in federally funded research. Having insight into what
activities constitutes a conflict of interest is key. Federal
grant making agencies such as NIH can address this by
implementing policies and requiring the disclosure of
information that may indicate potential conflicts.
Last year, GAO issued a report that examined conflict of
interest policies and disclosure requirements. We looked at the
Departments of Defense and Energy, as well as NASA and NIH,
which collectively account for 90 percent of funding for
Federal research, mostly through grants. Today, I will share
insights on agency policies and disclosure requirements,
monitoring and enforcement efforts, and the research
community's views on responding to foreign influence. With
regard to the first area, we found that NIH has an agency wide
conflict of interest policy. The policy emphasizes which
financial interest researchers should disclose to the
university receiving the grant.
However, NIH's policy does not address or define non-
financial conflicts, sometimes referred to as conflicts of
commitment. Such conflicts may include foreign academic
appointment and access to laboratory space or biological
materials provided by foreign entities. In light of this, we
recommended that NIH define and address non-financial conflicts
of interest in its policy, as this is a key step to identifying
and mitigating undue foreign influence. NIH concurred with our
recommendation, and since our December 2020 report, NIH has
updated its grant application and forms to require that
applicants more fully disclose non-financial interests,
including foreign activities and resources.
It will be equally important for NIH to reflect such
changes, along with defining non-financial conflicts in its
policy. Regarding the second area on monitoring and
enforcement, we found that NIH and the other agencies we
reviewed rely on universities to monitor and mitigate financial
conflicts of interest. They also collect information such as
foreign collaborations that could be used to identify non-
financial conflicts. In our report, we noted that NIH had
identified over 400 researchers of concern dating back to 2018
and referred such cases for investigation.
For the third area, the research community shared
perspectives on improving the response to foreign influence.
Principal investigators who lead research universities
emphasized the need for clear communications about the specific
threats and risks involving foreign influence. In fact, a
number of the principal investigators we spoke with said that
they were not aware of foreign talent recruitment programs.
University administrators called for more information
sharing to enhance researchers' awareness of the threats and
risks, especially those working on high target research
involving artificial intelligence and quantum computing. For
its part, NIH has conducted training and issued notices and
reminders to researchers on the risks. In closing,
international collaborations have helped to fuel many
scientific advances, including global mapping of infectious
disease. Maintaining an open research environment that promotes
collaboration and transparency should not be done without the
consideration of threats of foreign influence from countries
seeking to undermine U.S. investments and leadership and R&D.
Protecting U.S. biomedical research must begin with having
a common language about the threats and risks. An important
first step is to start with fully and clearly defining and
communicating the types of conflicts that may pose a risk.
Leaving universities to guess what financial or non-
financial conflicts should be reported is akin to asking them
to take a, you will know it when you see it approach, and that
is not prudent, especially given the National Security and
economic implications.
Chair Murray, Ranking Member Burr, and Members of the
Committee, this concludes my prepared statement. I would be
pleased to respond to any questions you may have.
[The prepared statement of Ms. Wright follows:]
prepared statement of candice n. wright
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
______
The Chair. Thank you very much to all of our witnesses. We
are now going to begin a round of five-minute questions of our
witnesses. I ask my colleagues to please keep track of your
clocks. Stay within those five minutes. I will remind all of us
we have a series of votes beginning at 11:30 a.m. We want to
make sure we can be as timely as possible. So, for any Senators
who want to participate today, make sure you are available when
your time slot is ready for you.
With that, I will start with Dr. Lauer. We know scientific
discovery is enhanced when scientists from a variety of
backgrounds, including from foreign nations, work together to
solve complex biomedical research challenges. This diverse
workforce has never been more important as the world combats
the COVID-19 pandemic.
However, the failure of a small number of researchers to
properly disclose relevant financial and non-financial
affiliations can jeopardize NIH's ability to make informed
funding decisions. Talk to us about why failing to disclose
participation in a foreign talent program rather than
participation itself threatens the integrity of our Nation's
biomedical research enterprise.
Dr. Lauer. Thank you, Senator. I can give you a few
examples that I think illustrate what we are seeing. One is
scientists who, unbeknownst to the NIH and to his own
institution, had a laboratory in China and was basically being
funded by the Chinese Government to do the exact same work that
we were funding. Had we known that the same work was being
funded, this fund to support the scientists to do this
particular research, we never would have funded this grant and
some other grant from another scientist would have been funded.
So, one problem is that we are making incorrect funding
decisions and deserving, honest scientists who should be funded
are not being funded.
A second example is, we have seen several cases now of
this, quite a few actually, where a scientist has a business,
let's say in China, and that business is basically leveraging
work that has been paid for by NIH funded research. That is a
clear-cut conflict of interest. And had we known about that, we
might have decided not to fund the grant because that kind of a
conflict would be unmanageable. At the very least, something
would have had to happen. So that is a second problem. And then
the third is exactly, as you say, Senator, is a problem of
trust.
We have seen scientists who have told their American
institutions and the NIH that they are spending 100 percent of
their time here in the US, when in fact they are spending 50 to
60 percent of their time in China. So, they are lying about how
they are spending their time. And that kind of blatant lie
affects the credibility and the integrity of the entire
enterprise.
The Chair. Thank you very much for that. We appreciate it
and take that into consideration. Thank you. You know, in
recent years, the Government Accountability Office has worked
really hard to provide recommendations to help agencies,
including NIH, identify, prevent, and reduce undue foreign
influence in federally funded activities. With respect to NIH,
the GAO concluded the greatest need is addressing non-financial
conflicts of interest. Ms. Wright, explain to us why it is
important to address non-financial conflicts of interest or
conflicts of commitment to prevent and reduce instances of
undue foreign influence in biomedical research.
Ms. Wright. Certainly. And these types of nonfinancial
conflicts can take shape in many ways in terms of appointments
that scientists may have, or it might provide them an
opportunity to get access to critical U.S. research that can
then be diverted.
It may also take shape in the form of being able to get
access to biological materials or other sensitive information,
but that, in doing so, can compromise the integrity of U.S.
research. Making sure, that U.S. biomedical research is
protected and is not being exposed to foreign involvement.
There is really an important message there in terms of not just
identifying the financial conflicts, but also the non-
financial, because those are also great risks, and we just
don't see a lot of attention being paid to the non-financial
conflicts at this point. And I would say that is something that
we found not just with NIH, but certainly the other agencies
that we included in our review.
The Chair. Thank you. And I will reserve the balance of my
time in order to get to as many Senators as possible.
Senator Burr.
Senator Burr. Thank you, Madam Chair. Dr. Lauer, NIH has
taken a number of steps to address foreign actors, and much of
that was highlighted by Ms. Wright's testimony. What are the
biggest gaps today in NIH's capabilities to address these
threats?
Dr. Lauer. I think one big problem, Senator, is that the
threat is significant, exactly as you say. We have identified
over 500 scientists of concern. So far we have reached out to
institutions and, over 200. Each of these require a tremendous
amount of work to figure out what exactly has been happening
and to work carefully with the institution to figure out what
has been going on. In addition, we work very closely with our
partners, including ONS, OIG, the Department of Justice. I
think one of the biggest challenges that we have is simply the
challenge of the workload of dealing with a very large number
of cases.
Senator Burr. Dr. Lauer, do you have any idea how many
employees at NIH have security clearance?
Dr. Lauer. I don't know the exact number, but it is very
few.
Senator Burr. Yet to understand fully the threat, you can't
fully understand that without either full security clearance or
some type of limited security clearance, which we did with
academic institution, Senator Warner and I, on this issue and
other issues and what we found was startling. And I think it
gets to the heart of this next question, Ms. Aguirre. Whose
responsibility is it to ID the researchers who have falsified
their foreign connections in their grant applications? Is it
ONS? Is it the institution? Is it the FBI? Is at NIH, or is it
the IG? Who is responsible?
Ms. Aguirre. Thank you. We all work together, I would say.
Dr. Lauer has been working a tremendous amount and passes on
daily, really, a tremendous amount of information to all the
entities you mentioned. So, it is ONS, OIG, FBI, all the--it is
a very large amount of information sharing.
Everything he does, which is a huge volume, gets passed to
the others. Likewise with the rest of us, as far as I can tell.
If something comes across our radar, we pass it on. And then
same with the law enforcement entities to the extent that they
can based on their investigation.
Senator Burr. I understand if it comes across our radar,
but I am going to go to Ms. Wright's testimony where she said
in our December 2020 report, NIH officials stated that they
rely on universities to identify and monitor financial
conflicts of interest and I believe confidently that we have
got a mechanism in place or protocol in place to follow through
when we think there is a problem.
The question is, what do we have to identify the problem?
Because when Senator Warren and I met with institutions, they
basically said, we believe that when the U.S. Government gives
a visa to these researchers that we have got on a research
branch, they have already completed the security clearance
form, which is 100 percent false.
Institutions have told us, in many cases, these same
individuals who we might have concerns about are their top
researchers, so they are going to be the least likely to turn
in their top researchers. How do we solve this?
Ms. Aguirre. Well, there are several avenues we are working
on in collection--in conjunction with the NIH and the law
enforcement and other agencies to raise awareness. Extramural,
I mentioned. In the last year, we have had an ONS liaison from
the FBI out there talking to academia, private institutions,
other Government agencies. But we are also working with the
National Counterintelligence Task Force to come up with an
awareness program that extramural entities can understand.
You mentioned about security clearances and how it is
really--it is very hard to understand the real issue without
having a clearance and having access to that information. And
so, we are trying to come up with an unclassified way to get
that message across that. That is one way. We also coordinate
with other agencies. For example, you mentioned the visa
process.
We do coordinate, for example, with other--with the IC,
with CBP on their J1 visa when it is relevant to our
activities. And that scientists coming in, for example, to NIH
entities, there is a coordination program there. So, it is
about enhancing our cooperation within HHS, outside of HHS, and
an awareness program.
Senator Burr. Thank you, Madam Chair.
The Chair. Thank you.
Senator Casey.
Senator Casey. Thank you, Chair Murray. I want to thank our
panelists for their testimony and for their presence at the
hearing. I want to start with Acting Director Aguirre, and I
hope I am pronouncing your last name correctly. Aguirre?
Ms. Aguirre. That is fine. I go by Aguirre, but Aguirre is
fine.
Senator Casey. Aguirre, I am sorry. Sorry about that. But
Director Aguirre, in recent testimony by the American Hospital
Association before the Senate Homeland Security and
Governmental Affairs Committee revealed that the expansion of
network connected technologies to manage pandemic response has
increased vulnerabilities in the hospital networks.
The Hospital Association described concerns they have about
cyber-attacks that steal COVID-19 related research, including
both treatment protocols as well as vaccine data. Can you
please describe the unique threat that both hospitals and
health care systems face when it comes to cyber-attacks,
especially those which are a nation-state sponsored which seek
to steal both medical research and innovation?
Ms. Aguirre. Sir, I am not an expert in that area. We do
coordinate heavily with our Office of the Chief Information
Officer who is, in my understanding, the lead for that for us.
And so, we support them from our angle of a counterintelligence
support angle. But I am not an expert in the area that you are
talking about.
Senator Casey. Well, we will do some follow-up. Thanks very
much for the work that you do, because we have heard a good bit
about this in Pennsylvania and I know other states as well. I
wanted to turn next to Dr. Lauer. I know we don't have a lot of
time. I want to make sure I at least get my question for Dr.
Lauer. There is a long predicate to this question. Doctor. I
want to start by thanking you for your work and the work you do
to provide both outreach and guidance on best practices to
research institutions.
The January 2021 report by the--I am sorry, in the January
2021 report, the Joint Committee on the research environment,
they recommended that universities within the biomedical
research enterprise bolster their cybersecurity, put teams in
place to enhance protection of sensitive material, and provide
training to their faculty. However, the December 2020 GAO
report on agencies foreign influence policies recommends
relieving the burden on universities and universities
themselves have spoken out about the need for consultation,
consultation in developing both directives and recommendations.
I worked successfully in the process where the National
Defense Authorization Process, I worked to designate an
academic liaison within the Defense Department to provide both
training and guidance on sensitive but unclassified data to
academic research institutions that carry out critical defense
research. So, there is no doubt that there is overlap between
the universities that are part of the biomedical research
enterprise and those that conduct DOD research.
Given that much of the research carried out by universities
is both unclassified but sensitive, what support does NIH and
HHS offer that is tailored specifically to academic
institutions?
Dr. Lauer. Thank you, Senator. So, we are working closely--
we recognize these tensions. On the one hand, assuring
security, assuring protection of innovation, assuring
intellectual property, both big IP and small IP, but at the
same time keeping administrative burden to a minimum. And we
recognize that there is a balance. And the difficult part is to
try to find the right balance. We are working very closely with
OSTP. And as you say, I am very happy that you noted the
report.
We are working very closely with OSTP to do this in as
coordinated and cohesive way as possible, and also to achieve
the level of consultation and interaction, exactly as you say.
We have engaged in a number of outreach programs that are
targeted toward biomedical research institutions and biomedical
researchers.
We had a very successful one at the University of
California that involved over 2,000 people. We had a more
recent one in upstate New York. We had another one in Utah. And
we anticipate having a number of these types of outreach
events, among other things, in the months ahead.
Senator Casey. Thanks very much.
The Chair. Thank you.
Senator Marshall.
Senator Marshall. Good morning, Chair. Thank you for having
us today. And I want to just start by thanking Chair Murray and
Ranking Member Burr for holding this hearing and emphasizing
the importance to protect biomedical research and federally
funded intellectual property. And if I could just make one
point.
I hope that both sides of the aisle apply the same
principles here to private property, intellectual property of
U.S. innovation in pharmaceutical and medical device
manufacturing in that same regard, especially with our trade
agreements and policies we develop in this prestigious chamber,
and my concern about waiving intellectual property and just
protecting our FDA approved innovation, I have always said that
innovation will do more to drive the cost of health care down
than any legislation we can ever write if we just keep the
Federal Government out of the way.
My first question would be for Ms. Aguirre. Aguirre--Ms.
Aguirre. Sorry, I got that right. And we recently learned that
an Ohio man was sentenced to 33 months in prison from stealing
valuable research from a children's hospital for his own
financial gain incentivized by the Chinese Communist Party.
This is just one example. We certainly have had similar
examples in Kansas and at Kansas State University was stealing
of our intellectual property. How is HHS partnering with the
private sector to develop new solutions?
Ms. Aguirre. Thank you. From our perspective, we--I
mentioned the extramural awareness program that we are working,
and so over the last year, we have been out there, a member of
our staff who is on detail from the FBI has been out there with
other Government entities, academia, private institutions,
within our agency, other agency partners in an awareness
campaign, safeguarding science awareness and bio-economy
awareness.
We are also, I mentioned, working on an interagency way
with the National Counterintelligence Task Force, which is
headed by the FBI, but it is multi-agencies involved, to come
up with a larger plan to be able to spread awareness out there
outside of Government. And I don't know--apologize, Dr. Lauer
may have something to add as well.
Senator Marshall. Dr. Lauer, my follow-up question is
probably kind of the same part of this, but in 2018, Dr.
Collins, Director of the NIH, basically made a plan. He said
this is what we need to do, a plan of action. And I guess maybe
just an update on that plan of action and how are we measuring
success? What metrics are we following to say that we are being
successful, and we are going in the right direction?
Dr. Lauer. Thank you, Senator. Yes, we have absolutely
followed through on what Dr. Collins said in his letter. One
way that we measure success is by results that we have seen
when we identify concerns and see whether or not there are
consequences. There have been over 100 scientists who have been
removed from the NIH ecosystem through a variety of ways,
resignations, terminations, premature retirements, or internal
Departments. Also 34 or so referrals to the OIG. Mr. Cantrell
mentioned some successful prosecutions and several settlements
that have been made.
Another measurement of success is self-disclosures. We are
now seeing a number of institutions that are discovering
problems on their own because they know that this is a problem
that they are looking. Perhaps the one that is most well-known
publicly was Moffitt Cancer Center. They discovered that their
own CEO had a talents' contract and that led to his
resignation, as well as the resignation of five other senior
people.
Over 10 percent of the cases that we are aware have come to
our attention because of self-disclosure. So, I think that is
another important metric of success.
Senator Marshall. Well, the Moffitt Cancer Center sure
takes me back in memories of place I trained at. And Dr. Dennis
Cavanaugh was one of my great mentors as well. I guess this
question is also, probably back to the NIH, is culturally in
this country, medical research, I am a physician, if people
were stealing someone else's research, you would be ashamed.
You would lose your professorship. Just--in other countries
is just the culture that it is okay to steal intellectual
property. Is there a big cultural difference why people keep
trying to rob the bank from us? I just don't even understand it
culturally. And what countries are kind of leading the charge
here and trying to steal our intellectual property?
Dr. Lauer. Senator, that is a great question. There was a
couple of interesting articles in Nature just this past month,
or I think it was in March about problems in China with
scientific research integrity and how our leaders in China
recognize that they have a problem. One example are these paper
mills that generate hundreds of fake papers later and have to
be retracted. And unfortunately, some of those papers are
written by physicians who are eager to achieve academic
advancement without doing real work. And so, it should be noted
that the leadership there is recognizing that they have a very
serious problem, and they need to work on it.
Senator Marshall. Thank you so much and I yield back.
The Chair. Thank you very much. And I would just ask any
Senators who do want to ask questions today to either come to
the Committee hearing room or let us know online as quickly as
possible. We want to make sure anybody who does want to ask a
question makes themselves available fairly quickly here.
With that, Dr. Lauer, NIH and the HHS Office of Inspector
General have investigated an increasing number of cases of
potential undue foreign influence over the past few years. The
HHS Office of Inspector General has issued several reports on
its findings. How have the recommendations that are outlined by
the HHS OIG and adopted by NIH help the agency reduce foreign
influence in biomedical research?
Dr. Lauer. I think they have helped a great deal. We have a
very strong working relationship with OIG, both on the audit
side as well as on the investigation side. Mr. Cantrell
mentioned a couple of the investigations that led to success,
the doctor who lied on his applications and was essentially
siphoning money to support his laboratory in China, or
siphoning expertise, and also the research institute that lied
and had to settle in a False Claims Act.
I think that our discussions between our respective
agencies, OIG and NIH, have helped us both to be more
successful in addressing this problem and understanding the
nature of the risks, and also leveraging each other's expertise
and resources.
The Chair. Thank you. And Mr. Cantrell, what further steps
do you feel we still need to be taking to reduce foreign
influence on our biomedical research?
Mr. Cantrell. Thank you for the question. As mentioned, NIH
has taken our recommendations and made significant progress and
virtually all of them toward adopting and implementing our
recommendations, but I think there is still work to do. There
is still progress to be made on some of the recommendations.
This is a continuous--this has to be a continuous
monitoring and learning situation so that all the different
facets of responsibility and oversight that need to be built
into the system, whether it be at NIH, whether it be research--
academic institutions, or whether it be at the level of the
peer review or the principal investigators, each layer has to
be both educated about the issue, as we have discussed already
in this hearing, as to understand clearly what the requirements
are, and there has to be transparency in that reporting of
potential conflicts of interest foreign or otherwise.
I think it is a big job with multiple actors requiring
action. But I think it is critical that NIH and our office and
ONS continue to look toward solutions that both protect the
research in the physical world through our work, but also in
the cyber world. That is another area where there is definitely
a need for a continued focus to protect our data from theft via
cyber.
The Chair. I think we have lost your sound, Mr. Cantrell.
Mr. Cantrell. I apologize, can you hear me now? My Internet
connection--I am in the office, but unfortunately it must
have--it is going down.
The Chair. Okay, I think we will let your connection get
reestablished and well, while you are doing that, I am going to
turn to Senator Hassan for her questions.
Senator Hassan. Well, thank you, Madam Chair, and to
Ranking Member Burr, and thank you to our witnesses for being
here today. I wanted to start with a question to Dr. Lauer. In
2019, you appeared before another panel on which I sit, the
Homeland Security Committee's Permanent Subcommittee on
Investigations to speak about securing the U.S. research
enterprise from China's talent recruitment plans. That hearing
was part of our ongoing bipartisan work to prevent bad foreign
actors from exploiting loopholes in our laws to steal U.S.
based research and intellectual property.
I am encouraged to hear that there has been some progress
since 2019, including the January report you mentioned on
practices for strengthening the security and integrity of
America's research enterprise. Can you expand on some of the
key elements of that report? And I also want to just follow-up
on what Senator Murray was asking about with regard to
conflicts. Can you talk about the recommendations around
disclosing conflicts of interest, including with foreign
countries?
Dr. Lauer. Thank you, Senator. That particular--I do
remember that hearing and that report, and I want you to know
that report was extremely helpful, and we have distributed that
report quite widely because we think that the information in
there is quite pertinent. So, several things.
There were, I think, 21 identified recommended practices in
the report, and obviously for different institutions with
different kinds of interests, which ones would be most
appropriate to them may vary. But there are recommendations.
Some of them, perhaps the most important is that there should
be strong communications within institutions, and also between
institutions and in Federal agencies.
We provide a number of suggestions for how that
specifically should be done. The report also described in
detail, as you describe what is meant by different types of
problems, conflict of interest, conflict of commitment, the
problems of budgetary and scientific overlap, what is a foreign
intelligence recruitment program, and why is a foreign
intelligence recruitment program a problem. And we do address
those in great detail. Thank you.
Senator Hassan. Thank you very much for that answer. I want
to move on to another question now to both Ms. Aguirre and Dr.
Lauer. When the pandemic first hit, global sharing of the
COVID-19 genomic sequence data helped to jump start the
development of life saving vaccines and therapeutics.
More recently, sharing sequencing information has become
critical to identifying and tracking new COVID-19 variants.
This is just one example of how sharing scientific data can
bolster our response to public health emergencies and
accelerate research.
Ms. Aguirre and Dr. Lauer, how do we balance the need to
share scientific data to improve public health on a global
scale with the importance of mitigating National Security
risks? And we can start with you, Ms. Aguirre.
Ms. Aguirre. Thank you. So, from our perspective as the
counterintelligence lead, we rely on people like Dr. Lauer and
the others to help us with that balance. You know, we are
focused mostly on the risks and concerns, and it can look like
everything is a problem. So, I don't want to take too much time
here because I think Dr. Lauer will have the most thorough
answer.
But from our perspective, we rely on those with that view,
who know the importance of the large picture that not everyone
is a bad actor, that we have to do this collaboration, that the
science is very important. And so, from our perspective, we try
to make sure that we don't get pigeonholed into thinking
everything is bad, especially in the awareness programs. We
want to raise awareness in the right way. And I will defer to
Dr. Lauer now.
Senator Hassan. Thank you.
Dr. Lauer. Yes, thank you. So genomic data sharing has been
a critical part of science for at least the last 30 years. In
2015, NIH issued a genomics data sharing policy in which we
deal with exactly this balancing the benefits of data sharing
with the risk and particularly protecting the risks of research
participants, individuals, groups, and the public trust. We
have a very extensive and thorough process at NIH by which we
review all data sharing requests. All data are identified. We
have a process for making sure that is being done correctly and
that there is appropriate data quality.
Then every data request that comes in goes through an
extensive review. Not every data requested that comes in gets
approved. And then we have a follow-up process to make sure
that there is no problem with compliance. As Ms. Aguirre would
say, our data management problems, our data management
incident, when we have a serious problem has only occurred in
0.1 percent of the projects that we have handled. So, I think
this is a testimony to how well the process is working.
Senator Hassan. Well, thank you very much. Thanks to all
the witnesses, and thank you, Madam Chair.
The Chair. Thank you.
We will turn to Senator Braun.
Senator Braun. Thank you, Madam Chair. This question is for
Ms. Wright. HSGAC Committee issued a report in 2019, Threats to
The U.S. Research Enterprise, China's Talent Recruitment Plan,
after the Committee examined China's propaganda efforts in U.S.
colleges and universities. The report focused on foreign gift
reporting and the lack of data collection that should be done
by the Department of Education and other agencies.
While we have made progress in reporting, there still
exists inadequate data sharing between these agencies and
intelligence agencies posing a National Security threat. Do
intelligence agencies receive the data they need in order to
ensure National Security?
Ms. Wright. Thank you, Senator Braun. So, I will say that
is not an issue that GAO has explicitly looked at in terms of
foreign gifts and what may be reported or tracked and monitored
by the intelligence community. That being said, in terms of the
work that we have looked at with regard to disclosures of
financial conflicts and resources, we think that is really an
important thing to be able to identify what resources
researchers may be getting that could then pose these potential
conflicts.
I will also perhaps just note that identifying the source
of funding can be a challenge. We have certainly seen that in
other work that GAO has done. And so, there is the importance
of ensuring that there is broad information sharing and access
to tools, and information and data bases that can be used to
not just identify but perhaps also verify information that may
exist with regard to gifts.
Senator Braun. Very good. One other question. The DOD and
NIH make up the largest percentage of federally funded
research, 41 percent and 26 percent, respectively. NIH is the
largest public funder of biomedical research in the world and
is a leader in medical discovery, globally. Researchers often
apply for and receive both NIH and DOD grants for the same
research.
Why doesn't the DOD require grant applicants and recipients
to fully disclose those collaborations or affiliations with
foreign entities or individuals, including the exchange of
staff, data, or funding, a foreign employment appointment, or
providing funding for a laboratory space and materials?
Ms. Wright. On that issue, we certainly identified in our
work that DOD, across the agency, across the Department, excuse
me, did not have a policy in place to guide disclosures of
conflicts of interest. Certainly, there is a lot of
information, or focus I should say, on financial conflicts but
we also think nonfinancial conflicts are really important. One
of the things that we heard from the Department at the time
that we were doing our work is that they were waiting for the
guidance from the Joint Committee on the Research Environment
with regard to what steps the agency should be taking to make
sure that there is proper disclosure of information, also what
their conflict-of-interest policy should include.
We made a recommendation to the Department that they needed
to ensure that they did develop an agency wide conflict of
interest policy. We have not yet heard from them what steps
they have taken since that report. They did concur with the
recommendation and noted that they plan to take action, but we
are waiting on the guidance or recommendations that came out of
the Joint Committee on the Research Environment. We will
continue to monitor that, as we do with all of our
recommendations, and look to see what actions they take.
Senator Braun. Thank you.
The Chair. Thank you.
Senator Hickenlooper.
Senator Hickenlooper. Yes, thank you. I think I got myself
on mute there by accident. Thank you all for being on this
panel and clearly think this is of vital importance. I strongly
believe that we need to prioritize research into automation and
artificial intelligence, machine learning, go down the list. We
do need to prioritize research into these issues to remain
competitive, along obviously with the incredible progress we
have made in our life sciences.
But this obviously is all of great interest to other
companies as well, and in particular China. Ms. Aguirre, as we
move forward and continue to prioritize these areas, what more
do we need to do to, I don't know, to fortify, that is the
right word, to fortify our federally funded research to ensure
that our competitiveness, to assure our competitiveness and to
secure our intellectual property as much as we possibly can?
Ms. Aguirre. Thank you. From my perspective, and I agree
with what Dr. Lauer said earlier, I would say our largest
challenge is the volume. I think, I see so much motivation in
the various offices, in mine, in NIH, interagency, and it is
the resources. I think there are great ideas in various ways
for approaching this from many angles in an interagency way.
And so, to me, it is, keep doing what everyone is doing, do
more, and resources can be a constraint.
Senator Hickenlooper. Yes. I wholeheartedly concur. Does
anybody else want to chime in on that? You don't have to. The
other part of that is the other side of the coin there. I just
finished reading Walter Isaacson's wonderful book on Jennifer
Doudna called The Code Breaker. And it really is an exciting
description of science and how it can cross international
boundaries to great beneficial effect.
As we become very aware of the strategic responsibilities
around these frontiers of science, how do you--how do we
safeguard this intellectual property for our country, but at
the same time not lose that essential--the innovation and the
excitement that comes from international collaboration? I
guess--and any of you can answer that, I am sorry.
Dr. Lauer. Alright. Well, I will start. So, I previously
was a practicing scientist and a practicing physician, and I
had the great pleasure of participating in international
research. And I completely agree with you, Senator. So, I think
that part of this is keeping in mind there is a difference
between dishonesty and collaboration.
Collaboration is not secret offshore bank accounts. It is
not stealth employment. It is not duplicative grants. It is not
telling to disclose important financial conflicts of interest.
It is not having two jobs at once. It is not breaking the rules
on peer review. None of that is collaboration. That is
cheating, dishonesty, lying, call it what you want.
I think this is an important part of our messaging here,
which is that legitimate international collaborations are
great. I have experienced them myself. This is something that
is extremely important for science and medicine to move
forward, but that is different from lying, cheating, and
stealing.
Senator Hickenlooper. Anybody else want to chime in on
that?
Ms. Wright. Certainly, I will just jump in by saying that I
think it is really important too to understand and emphasize
the importance of scientific integrity principles and making
sure that everybody is really coming to this issue with those
same values and principles in mind. We have done certainly
quite a bit of work at GAO looking at scientific integrity
across Federal agencies and have some other work ongoing.
I really just think embracing and emphasizing those kinds
of principles that talk about the foundations that are
important, like trust, like transparency, as was mentioned
earlier, are really key to espousing those values so that you
can have that balance between collaboration, but also making
sure that we are protecting research. Thank you.
Senator Hickenlooper. I agree completely. Great. You guys
are terrific, and I want to thank each of you for your public
service, because you are right at the core of so much of what
is really important, so much of what is happening. Anyway, I
will yield the rest of my time. Thank you so much.
The Chair. Thank you.
Senator Cassidy.
Senator Cassidy. I apologize if I am asking questions
others have asked. Splitting between three committees. Dr.
Lauer, the All of Us Precision Medicine Initiative collecting
data from 1 million U.S. residents for genetic diseases, it is
my understanding that a lot of this research, a lot of the
genetic testing is done in China. Similarly, I am told that
like 23 and Me and others, I don't know if it is 23 and me in
particularly, but some of those that do direct consumer
marketing again have their genetic testing done in China, and
then universities are getting their genetic testing done either
in China or by a company with Chinese links.
Again, I apologize if someone else has asked this, but can
you kind of give me a flavor of what we are doing to keep this
incredibly sensitive data from being misused or even absorbed
by those folks in China?
Dr. Lauer. Senator about the specific programs, I would
have to follow-up with you, because I don't know the exact
details of where the genomic sequencing is being done. We do
have an extensive genomics sharing, genomics science policy,
which has evolved over the decades and most recently was put
out in 2015, where we try to balance exactly what the tensions
that you are suggesting.
On the one hand, we want to enhance scientific progress. On
the other hand, we want to make sure that there are no--there
is no misusing the data. That data is being used for exactly
what it is supposed to be used for. That is not being shared
inappropriately with others. And that individuals, groups, U.S.
public trust are appropriately protected.
Senator Cassidy. Do you agree that if knowing that the
NIH--I gather the NIH is doing all of your genomic testing
onsite?
Dr. Lauer. Again, I would have to follow-up with you on the
details. Some of the genomic testing is onsite. Some of it is
happening at specific sequencing centers around the United
States that have expertise in doing this. I would say, it is
fair to say it is a mix.
Senator Cassidy. But none of it is done abroad, I guess the
thrust of my question. Would you also agree, though, that if
some of this is being done in China, say University, X, Y, Z
University is having, is outsourcing their genetic testing, or
if a direct-to-consumer entity is outsourcing their genetic
testing to China, that this could be problematic?
Dr. Lauer. It might be. What we do is any time that a
significant part of NIH funded research is occurring outside of
the United States, we call that a foreign component and we go
through a formal process to make sure that appropriate steps
are being taken.
Senator Cassidy. That is what I am asking, though. It is
not necessarily the results of the testing, but rather the
testing itself. In this case, as we both know, if you correlate
genetic material with others, it gives you a big leg up in
terms of the future of medicine, the future of understanding an
individual's health status, and in fact, their blood relatives
health status. So, I am asking not so much the results of the
testing, but rather the actual test itself, if my genetic code
is being deposited in some place which does not have
protections of privacy that the U.S. takes for granted.
Dr. Lauer. Yes, I hear you, Senator, I think that is part
of the reason why we want to make sure, for example, that all
the data that we use as part of our genomic data sharing is de-
identified because the protection of the individual is
something that is of key importance.
Senator Cassidy. Let me go back to my question. For some
reason, I guess I am not making it clear. Would it be
problematic if universities, hospitals, etc., direct consumer
marketers are having their testing done in China or with an
entity which shares information with the Chinese Government?
Dr. Lauer. Well, it depends upon what we consider the risks
to be. We are particularly concerned about the risk to the
individuals, the research participants, and that is why we have
a variety of steps in place to protect them. One of the most
important is identifying their data. We don't see genetic data
in and of itself as being a National Security risk. But I would
say that we work very closely with our experts and colleagues
in other parts of Government, including OIG and ONS to make
sure that we are doing this as best as we can and doing it
right.
Senator Cassidy. I have been told that there really, there
is no data that which cannot be re-identified. There may be a
function such as the data link, but in terms of truly de-
identifying of medical records or some aspect of medical
records, almost always it can be re-identified. Would you
disagree with that?
Dr. Lauer. We are watching this quite closely, and you are
right that there have been instances where it appears that
researchers have been inappropriately re-identifying people.
One of the key steps that we take whenever we share data is to
discuss exactly what steps will be made to make sure that no
attempt will be made to re-identify participants.
Senator Cassidy. Then it goes back to, I guess, my
question. If we are concerned about foreign interference on our
medical research, everybody you are describing is subject to
the jurisdiction, authority, and potential for penalties from
the NIH or the U.S. Government. But if we are dealing with an
entity overseas, which is not subject to that, does not fear
that, etc., then if they have that same material, they could
handle it differently with all the nefarious consequences that
we fear. That would be correct?
Dr. Lauer. Yes. So, this is the reason why we don't just
automatically process a data sharing request. All the data
sharing requests that we get go through a very extensive
vetting process and we, in fact, reject a fair number of them,
including requests that are coming in from foreign entities.
Because we are worried about that. We are worried about misuse
of the data.
Senator Cassidy. With that, I yield back, Madam Chair.
Thank you.
The Chair. Thank you.
We will turn to Senator Rosen.
Senator Rosen. Thank you, Chair Murray and Ranking Member
Burr. Thank you for holding this very important hearing.
Appreciate the witnesses being here and for all the important
work that you are doing. I would like to build a little bit of
what Senator Casey was talking about earlier, university
research partnerships, because as we have seen from the current
pandemic collaboration among researchers, of course, it is more
important than ever as we race to find solutions. And there is
no doubt we can overcome more diseases and medical conditions
through partnerships together than we can ever do in silos.
We have to foster and protect those partnerships among
universities or valuable research institutions. So, for
example, the University of Nevada, Reno School of Community
Health Sciences, we partner with other universities and
organizations in a number of countries so the students can
receive a variety of research and direct public health
experience. At the University of Nevada Global Health
Initiative, they focus on research to help reduce health
disparities, again, around the world.
For me, ensuring adequate security protocols, some of the
things Senator Cassidy was talking about too, is training
amongst researchers and the students who work with them. It is
challenging to keep up with because they have so many other
things on their plate. So, what federally supported training is
available for the researchers and for their students who assist
and conduct with this research? And I will ask everyone to
respond to this.
Ms. Aguirre, can you please speak first? And Ms. Wright and
Dr. Lauer.
Ms. Aguirre. Sure. I talked--this is Lisa. I talked a
little bit before about an extramural training program. So, we
worked and have been working initially from an internal,
intramural perspective to have awareness training plan and
program. And in terms of a large interagency effort to come up
with sort of a more comprehensive extramural training awareness
plan and program. But that doesn't mean it hasn't been
happening already.
I mentioned that one of our staff members who is on detail
from the FBI, has done numerous training and awareness
interactions over the last year, along with the interagency and
other partners. And so, we hope to just have a more
comprehensive program to get the messaging out there to the--in
an extramural way. And I will defer to Dr. Lauer.
Senator Rosen. Yes. And I would also see if you would like
to add particularly about audits of some of this. So you are
getting the training and we know students are coming in and out
every quarter, every semester, and so how would you--I am
particularly interested if you go in once, but how often are
you going in, how are you auditing that the information is
staying up to date. So, I guess Dr. Lauer, maybe you want to or
if somebody else wants to answer, but that seems problematic to
me as well.
Dr. Lauer. Oh, I am sorry----
Senator Rosen. No, that is Okay. Whoever would like to
answer that, it is fine. It is hard to--we are all here on the
zoom screen, so----
Dr. Lauer. Senator, I thought you addressed that one to me,
but as an example of the best practice, there are some
institutions now that because they are concerned about loss of
data, they no longer allow thumb drives and everything,
therefore, it is a network.
They can see, for example, if an unusually large amount of
data is suddenly disappearing in the middle of the night and
they can immediately put a stop to it. They can also identify
certain kinds of data that they do not want to leave their
institution, and because people cannot use portable drives
anymore, they are able to handle that. And we are talking about
some very large research institutions around the country that
are doing exactly this. And this is just one example of a
practice that might help.
Senator Rosen. Wonderful. Ms. Wright, I didn't mean to--
sorry about that. Sometimes in the zoom screen I don't see
everyone, so I didn't mean to cut you off.
Ms. Wright. Not a problem. Perfectly understandable. So, I
was just going to add that from GAO's perspective, we certainly
reached out to the university community and talked a lot with
principal investigators as well as administrators. And one of
the things that we heard certainly is a need for more
information sharing, the need for more training, more guidance,
particularly in terms of identifying foreign talent recruitment
programs.
We heard from certainly a number of the principal
investigators that many of them either were not aware of
foreign talent recruitment programs or just simply didn't even
know how they would go about identifying such programs. And so,
for them, there is certainly this desire and this need to have
more training and have more continuous information being
provided about what are the threats, what are the things that
they need to be aware of and be on the lookout for.
A lot of the training may be happening at the principal
investigator level, but the extent to which that is done,
flowing down to other people involved in the research, I think
that is something that is really important as well to consider.
Senator Rosen. I think you are right, not just in this
area, but in all others, being sure we have that good cyber
hygiene, that we understand whatever the mission of our job is,
how we protect the information, how we protect our information
and ourselves and those we serve are extremely important. Thank
you all. My time has expired.
The Chair. Thank you very much, Senator.
I will turn to Senator Burr.
Senator Burr. Thank you, Madam Chair. I should have said
this at the beginning of the question period. I believe all of
you who are testifying today take this very seriously. Here is
my concern. There is no single entity that is in charge of
identifying either falsification of the applications or
violation of the rules. This seems to almost be a system that
is reliant on somebody to uncover information that is either
false or somebody's actions that break the rules.
I am going to turn to what Dr. Marshall's questions
centered around and point to just a release from the Department
of Justice yesterday where they have now indicted a mathematics
professor a university in Illinois because of a violation under
his NSF grant. And it said in the indictment that he was
actually on faculty with a university in China from 2018 to
2023 under a contract. Now, he had worked at this institution
in Illinois since 2000. And I personally met with institutions,
and as I said earlier, they don't believe it is their
responsibility to continually update this information. It is
voluntary on the part of the grantee to the university.
To some degree, I am hearing from all of you that there is
no reporting--there is no requirement, and I say that loosely,
because there is no penalty an institution faces if, in fact,
they don't report these things. And so, I guess I would turn to
you, Dr. Lauer, first and say how many cases are currently
under investigation for possible grant concerns at NIH?
Dr. Lauer. Right now, it is over 500, and what you
described is exactly what we have seen.
Senator Burr. Go ahead.
Dr. Lauer. Yes, I would also say that we have required for
a very long time, I would say even decades, that researchers
have to disclose all support that they are receiving to help
their individual research endeavors. And that includes support
from other institutions, not only the institution from which
they are applying.
We have clarified that more recently. And as Ms. Wright
mentioned, we put out a new set of forms, we are putting out
right now, which makes it even more clear that scientists are
responsible for disclosing all forms of support that they are
receiving. Universities are ultimately responsible because we
give grants to institutions, not to individual scientists.
There have been consequences, as Mr. Cantrell said. The
Department of Justice reached a $5.5 million settlement with a
research institute that failed to disclose properly. So, you
are absolutely right, and we are doing everything we possibly
can to make those requirements even more clear and to address
them when problems come up.
Senator Burr. Well, Dr. Lauer, you and Mr. Cantrell, the
most recent National Defense Authorization Act provided the
Federal Government with clear enforcement authorities to take
actions on cases related to foreign influence. How are NIH and
the OIG using these new authorities and, or any additional
enforcement tools needed to ensure that cases of foreign
influence are addressed appropriately and in a manner that
sends a message that this will not be tolerated?
Dr. Lauer. We are working very closely with OSTP and also
with our other colleagues to move that forward. As it has also
been mentioned, I am part of the National Counterintelligence
Task Force, part of the executive committee, and that is being
run by FBI. FBI and OSTP are working in close coordination. So,
we are moving forward with the implementation of the NDAA,
exactly as you say.
Mr. Cantrell. If I could add----
Senator Burr. Yes, sir.
Mr. Cantrell. Yes, we are taking these cases, which we
receive oftentimes from Dr. Lauer and his team, and we have
great cooperation and support from his team as well as ONS and
the FBI. So, these cases are a priority for us. We have gotten
great support from U.S. Attorneys Offices when there is a
matter that we can prove, and we use the tools, all the tools
available to us when there is criminal conduct to pursue
prosecution.
I think, and some of these cases serve as examples. And I
know that through our training seminars that we participate in,
providing examples of these unlawful conduct where individuals
have been convicted can be a wakeup call for those in the
community to serve as a hopefully a deterrent and maybe an
opportunity for self-disclosure, as Dr. Lauer was discussing
earlier, so that we can address these things proactively
without the reactive approach of a criminal prosecution.
Senator Burr. One last question, and probably Dr. Lauer
this probably is you, and it feeds off of Dr. Cassidy's
question, is it currently legal for a U.S. company like 23 and
Me to sell the genetic data that they accumulate from the
customers that they process?
Dr. Lauer. Senator, I don't know the answer to that because
that is out of my area of expertise, but I am happy to follow-
up.
Senator Burr. I would appreciate it if you would, if there
is action that we need to look at from a standpoint of the
protection of genetic data. If that genetic data is actually
being sold, at a minimum, that is something that I think needs
to be disclosed to the millions of Americans that utilize that
service from a standpoint of the jeopardy that it may put the
United States or other places in the world in. I think Dr.
Cassidy raises a great question. And it seems that China has
been rather aggressive at trying to get the genetic data that
they need within the system of innovation there. I thank the
Chair.
The Chair. Thank you very much, Senator Burr. That will end
our hearing today, and I really want to thank all of our
colleagues for a really thoughtful discussion. And I want to
thank all of our witnesses, Dr. Lauer, Director Aguirre,
Inspector General Cantrell, and Director Wright, for sharing
your time and expertise with us. For families across the
country, our leadership on biomedical research is not only a
source of pride, but of hope for them and their loved ones
battling diseases.
I look forward to working in a bipartisan way to take
action based on what we have heard today to make sure we are
protecting this important work. With that, for any Senators who
wish to ask additional questions, questions for the record will
be due in 10 business days on Thursday, May 6th, at 5 p.m.
The hearing record will also remain open until then for
Members who wish to submit additional materials for the record.
The Committee will next meet on Tuesday, April 27th, at 10 a.m.
for a hearing on childcare and supporting children, workers,
and families. With that, the Committee stands adjourned.
[Whereupon, at 11:35 a.m., the hearing was adjourned.]
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