[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

=======================================================================

                                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
                                
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        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

                              ----------                              

                               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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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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