[Senate Hearing 116-250]
[From the U.S. Government Publishing Office]
S. Hrg. 116-250
FOREIGN THREATS TO TAXPAYER-FUNDED
RESEARCH: OVERSIGHT OPPORTUNITIES
AND POLICY SOLUTIONS
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON FINANCE
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
FIRST SESSION
__________
JUNE 5, 2019
__________
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Finance
___________
U.S. GOVERNMENT PUBLISHING OFFICE
41-156-PDF WASHINGTON : 2020
COMMITTEE ON FINANCE
CHUCK GRASSLEY, Iowa, Chairman
MIKE CRAPO, Idaho RON WYDEN, Oregon
PAT ROBERTS, Kansas DEBBIE STABENOW, Michigan
MICHAEL B. ENZI, Wyoming MARIA CANTWELL, Washington
JOHN CORNYN, Texas ROBERT MENENDEZ, New Jersey
JOHN THUNE, South Dakota THOMAS R. CARPER, Delaware
RICHARD BURR, North Carolina BENJAMIN L. CARDIN, Maryland
JOHNNY ISAKSON, Georgia SHERROD BROWN, Ohio
ROB PORTMAN, Ohio MICHAEL F. BENNET, Colorado
PATRICK J. TOOMEY, Pennsylvania ROBERT P. CASEY, Jr., Pennsylvania
TIM SCOTT, South Carolina MARK R. WARNER, Virginia
BILL CASSIDY, Louisiana SHELDON WHITEHOUSE, Rhode Island
JAMES LANKFORD, Oklahoma MAGGIE HASSAN, New Hampshire
STEVE DAINES, Montana CATHERINE CORTEZ MASTO, Nevada
TODD YOUNG, Indiana
Kolan Davis, Staff Director and Chief Counsel
Joshua Sheinkman, Democratic Staff Director
(ii)
C O N T E N T S
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OPENING STATEMENTS
Page
Grassley, Hon. Chuck, a U.S. Senator from Iowa, chairman,
Committee on Finance........................................... 1
Wyden, Hon. Ron, a U.S. Senator from Oregon...................... 4
WITNESSES
Schmoyer, Captain Michael, Ph.D., Assistant Deputy Secretary for
National Security; and Director, Office of National Security,
Department of Health and Human Services, Washington, DC........ 6
Tabak, Lawrence A., D.D.S., Ph.D., Principal Deputy Director,
National Institutes of Health, Bethesda, MD.................... 8
Hollie, Leslie W., Chief of Investigative Operations, Office of
Inspector General, Department of Health and Human Services,
Washington, DC................................................. 9
Rodi, Louis A., III, Deputy Assistant Director, National Security
Investigations Division, Immigration and Customs Enforcement,
Department of Homeland Security, Washington, DC................ 11
Gray, Joe W., Ph.D., Gordon Moore chair of biomedical
engineering; and associate director for biophysical oncology,
Knight Cancer Institute, Oregon Health and Science University,
Portland, OR................................................... 27
ALPHABETICAL LISTING AND APPENDIX MATERIAL
Grassley, Hon. Chuck:
Opening statement............................................ 1
Prepared statement........................................... 31
Gray, Joe W., Ph.D.:
Testimony.................................................... 27
Prepared statement........................................... 33
Responses to questions from committee members................ 35
Hollie, Leslie W.:
Testimony.................................................... 9
Prepared statement........................................... 37
Responses to questions from committee members................ 40
Rodi, Louis A., III:
Testimony.................................................... 11
Prepared statement........................................... 43
Responses to questions from committee members................ 50
Schmoyer, Captain Michael, Ph.D.:
Testimony.................................................... 6
Prepared statement........................................... 55
Responses to questions from committee members................ 57
Tabak, Lawrence A., D.D.S., Ph.D.:
Testimony.................................................... 8
Prepared statement........................................... 62
Responses to questions from committee members................ 64
Wyden, Hon. Ron:
Opening statement............................................ 4
Prepared statement with attachment........................... 73
Communications
American Association of Immunologists (AAI)...................... 75
Federation of American Scientists................................ 76
Future of Research, Inc.......................................... 82
FOREIGN THREATS TO TAXPAYER-FUNDED
RESEARCH: OVERSIGHT OPPORTUNITIES
AND POLICY SOLUTIONS
----------
WEDNESDAY, JUNE 5, 2019
U.S. Senate,
Committee on Finance,
Washington, DC.
The hearing was convened, pursuant to notice, at 9:45 a.m.,
in room SD-215, Dirksen Senate Office Building, Hon. Chuck
Grassley (chairman of the committee) presiding.
Present: Senators Cornyn, Thune, Toomey, Cassidy, Daines,
Wyden, Cantwell, Carper, Cardin, Brown, Bennet, Casey,
Whitehouse, Hassan, and Cortez Masto.
Also present: Republican staff: Daniel Boatright,
Investigative Counsel; Joshua Flynn-Brown, Deputy Chief
Investigative Counsel; and Delisa Ragsdale, Chief Investigative
Counsel. Democratic staff: David Berick, Chief Investigator;
Sal Christ, Fellow; and Joshua Sheinkman, Staff Director.
OPENING STATEMENT OF HON. CHUCK GRASSLEY, A U.S. SENATOR FROM
IOWA, CHAIRMAN, COMMITTEE ON FINANCE
The Chairman. I welcome everybody to today's hearing on
foreign threats to taxpayer-funded research. Normally I do not
start until Senator Wyden gets here, but he said we could go
ahead and he will be here shortly. Also, another reason for
starting on time is because we have some votes that are going
to interfere with exactly how much of this committee's work I
do not know, so we want to keep it moving.
Taxpayer-funded research has been integral in keeping
America's medical, defense, information technology, and many
other products at the forefront of our world's market. Simply
said, the United States is the best of the best when it comes
to conducting cutting-edge medical research. Our scientists
push the envelope to make crucial discoveries and better
products, whether it is vaccines or medical treatments
generally, and they all fall into the category of great
development of the intellectual property.
These projects can produce important breakthroughs for
patients and industry, for the United States, and the entire
world. We did not develop this reputation overnight. We earned
it through the persistent hard work and dedication of
researchers across the country.
I would like to call that a good old-fashioned American
work ethic. I thank them for their service to our country. I
want them to know that this committee's oversight is not
designed to interfere with the pursuit of knowledge and the
free exchange of information by researchers. Rather, this
committee's oversight is intended to strengthen the integrity
of taxpayer-funded research, and especially to preserve our
valuable work product. Truly free collaboration and exchange of
information is only possible when data and sources are credible
and the research process can be trusted.
That trust is destroyed when foreign governments or other
entities interfere in our research for their gain and to our
detriment. Accordingly, Congress, the executive branch, and
research institutions must work together to properly balance
the robust development and exchange of ideas in the research
field with reasonable and proportionate common-sense efforts to
protect the integrity of the research.
That is why I have engaged in oversight efforts in this
field. Beginning in October of last year, I wrote to the
National Institutes of Health, the Department of Health and
Human Services, and the Health and Human Services Inspector
General about threats to taxpayer-funded research. Since then,
I have also written to the National Science Foundation and the
Department of Defense.
Today we will focus on foreign threats to research funded
by the National Institutes of Health, its granting process, and
downstream grantees. Those threats include spying, theft of
intellectual property, the disclosure of confidential
information, and other related efforts that undermine the
integrity of research. The National Institutes of Health spend
$39 billion of taxpayer money each year on medical research.
So the American people have worked hard for that money, and
the people deserve to know how the government is working to
protect that research and the resulting intellectual property
from foreign threats.
We know that China is by far the most prolific offender.
However, they are not the only country acting against our
interests. In October 2018, while chairman of the Judiciary
Committee, I held a hearing on China's non-traditional
espionage against the United States. During that hearing, I
broached the issue of China's focus on our research
institutions and taxpayer-funded research. Today we can get
into more detail regarding the threats. It is without dispute
that China has focused its energy on leveraging our hard work
for their benefit, and of course to our detriment.
One example hits home for me. In 2011, Chinese nationals
tried to steal genetically modified corn seeds from an Iowa
field. They tried to ship that seed back to China. Those seeds
were the product of years of research and development. The
Chinese Government says that they are, quote, ``picking flowers
in foreign lands to make honey in China,'' end of quote. And of
course we believe them.
Whether we are talking about Confucius Institutes'
spreading propaganda on college campuses, China's ``Talent
Programs'' that are being called ``brain gain'' programs, or
China planting spies in our industries, the Government of China
is a serious problem. In 2013, Chinese nationals were charged
with conspiring to steal research funded by a multi-million-
dollar NIH grant for the benefit of the Chinese Government and
a direct competitor of the American university where the
research was conducted.
In an August 20, 2018, letter to NIH grantee institutions,
NIH called attention to a series of threats posed by foreign
entities to the integrity of U.S. biomedical research. In that
letter, NIH warned that foreign actors have ``mounted
systematic programs to influence NIH researchers and peer
reviewers,'' may have worked to divert intellectual property
produced by NIH-supported research to other countries, and may
have contributed resources to NIH-funded researchers in ways
that could impact the integrity of that research.
In January of this year, the HHS Inspector General notified
me that NIH recently made 12 referrals in this area to the
Inspector General. Those referrals primarily involved principal
investigators--essentially the prime researchers--on NIH grants
conducting medical research at U.S. universities. Those
researchers allegedly failed to meet NIH requirements to
disclose foreign affiliations on their grant applications,
which turns out to be a very serious problem. Researchers who
are secretly supported by a foreign government while working in
our research projects can be more susceptible to the influence
and control of the foreign parent.
We must know who is financially supporting researchers to
better understand whether they might be more dedicated to
securing the interests of an adversary than to rigorous
scientific and medical advancement. Our witnesses can speak to
those specific threats and the government's capability to
detect and deter them.
Today we have witnesses from the National Institutes of
Health, the Health and Human Services Office of National
Security, the Health and Human Services Inspector General, and
the Department of Homeland Security.
Now you can see an empty chair at the table. The FBI was
invited by the committee, given that they are a critical aspect
of counterintelligence in this field. The committee invited the
FBI April 30th. That is 26 business days before the hearing
date.
On May 6th, the FBI said that it would be unable to
participate in the hearing, but failed to explain why. My staff
followed up via email and phone. On May 7th, the FBI reiterated
that they were not able to appear, but again failed to explain
why. On May 16th, the FBI responded via email and said the
``Counterintelligence Division respectfully declines the
hearing invite,'' yet again failing to explain why.
On May 23rd, I wrote a letter to the FBI again inviting
their attendance. On May 29th, the FBI responded in writing and
stated that it ``does not have a witness available to attend
the hearing and the briefing.''
After just about 1 month of communications between the FBI
and my staff, the FBI failed at every turn to explain why the
entire Counterintelligence Division did not have a single
employee available to attend today's hearings. That is
inexcusable and, quite frankly, it is a shame because of their
responsibilities. What a wasted opportunity for the FBI to
explain to this committee and the American people what they are
doing to help these agencies detect and deter threats to our
research. The American people deserve more than a stiff arm
from the FBI. However, I appreciate the cooperation of expert
witnesses who are here today, and I look forward to a robust
conversation.
Generally speaking, there are four main issues related to
taxpayer-funded research.
First, the failure to disclose. Some researchers hired to
work on U.S. research projects have not disclosed that they
have received financial contributions from foreign countries.
Number two, espionage. Some researchers are spies, and
their only purpose is to infiltrate taxpayer-funded research
projects to steal intellectual property and bring it to their
home country.
Third is vetting. The Federal Government does not vet all
researchers hired by U.S. institutions to work on taxpayer-
funded research, and neither do the institutions.
Lastly, the issue of integrity. Some peer reviewers have
shared confidential information from grant applications with
foreign governments which would allow them to potentially skip
research steps. Some have also attempted to influence funding
decisions, undermining the integrity of this taxpayer-funded
research.
These threats to our research are ongoing, aggressive, and
real. The question is: does the government have the capability
to detect threats, combat threats, and determine how to protect
our research and any financial intellectual property created
from that research?
Today is an opportunity for our witnesses to engage in a
frank discussion about what that threat is and what we in
Congress and the executive branch can do all together to solve
the problem.
So the two branches must be on the same page. So if you
believe that there are legislative and policy solutions that
will assist you with your already difficult jobs, now is the
time to bring them forward. And I hope you can do that at this
hearing.
I look forward to a robust discussion today on these
matters. After this morning's hearing, the committee will then
move this afternoon to a classified briefing on the same
subject matter. I strongly encourage the witnesses to take
advantage of the highly classified environment to provide as
much information to the committee as possible.
When Ranking Member Wyden gets here, I will call on him,
and now I will introduce the witnesses.
[The prepared statement of Chairman Grassley appears in the
appendix.]
The Chairman. I just called on you. Are you ready?
OPENING STATEMENT OF HON. RON WYDEN,
A U.S. SENATOR FROM OREGON
Senator Wyden. I am. Mr. Chairman, you are ever gracious,
and I thank you and always appreciate the chance to work
together.
Just a couple of points I would like to make as we begin
this morning's inquiry. Our country is more entrepreneurial,
our economy is stronger, and our lives are better because the
scientific community in America is able to attract so many of
the world's brightest minds. That is a strength to be
protected, a part of our national security that we must always
bolster.
Foreign-born scientists put Americans on the moon. They
worked for the Manhattan Project. Nearly a third of all
American Nobel Laureates were born outside the United States.
If you look back at 2016, that year six U.S.-based scientists
won Nobel Prizes. There were many born in other countries.
It goes without saying that individuals and governments
outside the United States are always going to be out there
looking at chipping away at our lead. That is particularly true
when it comes to scientific breakthroughs that lead to valuable
IP and entrepreneurship. Academic institutions and other
research organizations based in this country must understand
this, and must respond to those concerns just like Federal
agencies and private companies do.
But let us be careful not to over-reach with barriers that
turn away bright students, or cut off lines of communication
with scientists from other countries that can end up doing more
harm than good. And targeting Americans who happen to be
descendants of recent immigrants in my view would just be a
major mistake.
Dr. Verita Currie, a distinguished professor at Iowa State
University, put it this way, and I will quote: ``Without
foreign-born researchers, the entire system of higher education
in the United States would collapse in a minute.''
This morning we are going to hear from Dr. Joe Gray of our
very own Oregon Health and Science University. I had a chance
to visit with Dr. Gray yesterday, and nobody knows better than
he how vitally important foreign-born researchers and
international collaboration are to America and to American
institutions. Our country would not be able to achieve some of
the scientific breakthroughs without them, period.
Second, all breakthroughs in medicine or technology are to
be cheered as long as they result in better lives for the
American people. And if our country suspects that American IP
or technology is being stolen, is being ripped off from us, we
have the power to do something about it.
Finally, while the committee examines the issues today, it
is also important to take a step back to look at the broader
context of our commitment to scientific research. When you take
inflation into account, Federal investments in science and
research have unfortunately been declining, and declining
steadily for decades.
State investments in higher education have also dropped,
which in a lot of instances can end up really almost starving
research universities of the funds they need. The quickest way
to turn the lights out in healthy research laboratories across
America, in my view, would be to actually enact into law the
Trump administration's proposed cuts to the National Institutes
of Health.
A few months ago the President also signed an executive
order threatening to cut off research funding for universities,
in my view over an unwarranted panic dealing with speech on
campus. Fortunately, the order was toothless.
So when you take the broader view of threats to research in
America, it is clear that we have substantial dangers from
within, and too often they stem from the administration taking
anti-science positions.
With regard to foreign threats, what is true with private
businesses and government agencies is true for research
institutions. They can and must take responsible steps to
protect themselves. I intend to work with all of my colleagues
on both sides of the aisle to ensure that they have the tools
to do so. But I also do not want to close the door or place
undue burdens on foreign-born students and scientists who can
make life-changing discoveries because they work together with
Americans.
Mr. Chairman, I look forward to working with you and
appreciate the chance to be here.
[The prepared statement of Senator Wyden appears in the
appendix.]
The Chairman. I am now going to introduce our witnesses. I
will introduce all four now. First, Captain Michael Schmoyer,
Assistant Deputy Secretary for National Security at HHS.
Captain Schmoyer serves as the Secretary's Senior Intelligence
Official and Federal Senior Intelligence Coordinator for HHS.
The Office of National Security functions as a Federal
Intelligence Coordinating Office for the Department. As the
FICO, the Office of National Security provides departmental
oversight to areas of intelligence, counterintelligence,
personnel security, and the safeguarding of classified
information.
Dr. Lawrence Tabak is Principal Deputy Director of the
National Institutes of Health. Dr. Tabak was appointed
Principal Deputy Director at NIH in 2010. Previously he served
as Acting Principal Deputy Director at NIH between 2008 and
2009.
Mr. Les Hollie is Chief of Investigative Operations at the
Department of HHS, Office of Inspector General. He is the
senior-level executive responsible for coordinating OIG's
national initiative pertaining to research integrity. Under his
leadership, the OI has recovered more than $5 billion through
investigations.
Mr. Louis Rodi is Deputy Assistant Director of Homeland
Security Investigations at the Department of Homeland Security.
In this capacity, Mr. Rodi is responsible for strategic
planning, national policy implementation, and the development
and execution of operational initiatives. He oversees the
Department's national security programs, including the national
security unit that partners with FBI's Joint Terrorism Task
Force, the Human Rights Violators and War Crimes Unit, and the
Counter Terrorism and Criminal Exploitation Unit. He also
oversees the student and exchange visitors program.
So we are going to start with Captain Schmoyer.
STATEMENT OF CAPTAIN MICHAEL SCHMOYER, Ph.D., ASSISTANT DEPUTY
SECRETARY FOR NATIONAL SECURITY; AND DIRECTOR, OFFICE OF
NATIONAL SECURITY, DEPARTMENT OF HEALTH AND HUMAN SERVICES,
WASHINGTON, DC
Dr. Schmoyer. Good morning, Mr. Chairman, Ranking Member
Wyden, and distinguished members of the committee.
It is an honor to appear before you today to discuss the
U.S. Department of Health and Human Service's efforts to
address foreign threats. My testimony today will focus on the
threats foreign governments and foreign agents present to U.S.
Government-funded medical research; the efforts undertaken by
HHS to detect the threats and protect the integrity of medical
research--an area that is critical for our Nation's ability to
provide health care and for bio-defense; and the role of HHS's
Office of National Security, or ONS, and its capabilities.
My name is Captain Michael Schmoyer, and I am the Assistant
Deputy Secretary for National Security, and the Director of
HHS's ONS. I report directly to the HHS Deputy Secretary and
also serve as the Secretary's Senior Intelligence Official on
intelligence and counterintelligence issues.
ONS's responsibilities include integrating intelligence and
security information into HHS policy and operational decisions;
assessing, anticipating, and warning of potential security
threats to HHS, and national security in general; and providing
policy guidance on and managing the implementation of the
Department's national security intelligence and
counterintelligence programs.
In coordination with the Director of National Intelligence,
ONS is the Department's Federal intelligence coordination
office, and I serve as the Department's Federal Senior
Intelligence Coordinator.
I am also the designated senior official within the
Department who is responsible for countering threats from
foreign intelligence agencies. ONS has a critical mission that
focuses on protecting HHS's ability to conduct research that
will lead to the development of treatments, diagnostics, and
vaccines to address public health needs, including the ever-
evolving threat of newly emerging and re-emerging infectious
disease caused by pathogens that could be biological threats to
the homeland.
While appreciating the value of scientific advancement, HHS
has an equal interest in maintaining the integrity of the
Department's scientific enterprise. Similarly, HHS embraces the
contributions that foreign partnerships have made to expanding
scientific knowledge that protects, promotes, and advances
public health and medical research pursuits worldwide.
Through work with our national security partners over the
past 2 years, ONS became aware of threats to the grants process
and intellectual property that is a cornerstone of the
Department's core values and biomedical research integrity. ONS
quickly worked with NIH, the OIG, the FBI, and the National
Counterintelligence and Security Center to identify steps to
mitigate these threats to U.S. biomedical research. We mitigate
threats in three fundamental ways.
First, identifying foreign intelligence threats and sharing
of threat information with our agencies, including NIH, the
FBI, and the broader intelligence community. Second,
safeguarding HHS's sensitive information, relationships,
property, and activities. And third, preventing and detecting
insider threats.
ONS takes full advantage of the resources and authorities
that we currently have to build interdisciplinary partnerships,
both internally and externally, to conduct assessments of HHS's
sensitive information, property, and activities. We have found
these assessments are the cornerstone for all of our
corresponding security and counter-threat activities.
ONS also works closely with the Department of Justice and
the broader intelligence community to identify researchers who
may have engaged in problematic practices with foreign entities
that may have unduly influenced and capitalized on U.S.-
conducted research. ONS has access to a variety of databases
that enable us to vet employees, as well as visitors to HHS
facilities, including NIH. These database results are linked to
our national security partners to ensure the results we have
are both reliable and valid.
Additionally, we have recently initiated new efforts within
ONS that will be dedicated to working with universities to
empower their programs to address threats to research
integrity. We have been excited to work with NIH, FBI, OIG, and
NCSC to see this new effort grow.
ONS will continue to ensure our national security-related
efforts support successful relationships with foreign
scientists in all countries, supporting the research enterprise
while simultaneously protecting national security equities.
In closing, thank you for the opportunity to review the
national security role and work of ONS and our efforts to
address foreign threats to research.
[The prepared statement of Dr. Schmoyer appears in the
appendix.]
The Chairman. Dr. Tabak?
STATEMENT OF LAWRENCE A. TABAK, D.D.S., Ph.D., PRINCIPAL DEPUTY
DIRECTOR, NATIONAL INSTITUTES OF HEALTH, BETHESDA, MD
Dr. Tabak. Thank you, Chairman Grassley, Ranking Member
Wyden, and committee members.
I am honored to be here today to represent the National
Institutes of Health as its Principal Deputy Director. As this
is not a committee before which we frequently appear, I think
it would be helpful to say a bit about the work we do to
provide some context for the hearing.
NIH is the world's leading public funder of the global
biomedical research enterprise, supporting more than 300,000
researchers and staff across the Nation. Groundbreaking
research funded by NIH conducted at institutions in each of
your home States has transformed the health of America. Every
generation has benefited from the scientific advances and
increased life expectancy that NIH helps usher in.
To support the very best science, NIH pioneered the gold
standard for peer review of research grant applications. In
fiscal year 2018, we asked more than 26,000 peer reviewers to
assess the scientific merit of more than 80,000 applications
that were being considered for funding.
Unfortunately it has become apparent that a small
proportion of scientists have received foreign research support
that they did not properly disclose on their grant
applications, have obligations to institutions other than those
identified in their grant applications, and have attempted to
subvert the peer review process to improve their own funding
chances.
In all instances, these behaviors may lead to inappropriate
funding decisions and ultimately the diversion of proprietary
information from American institutions. As of May 2019, we have
contacted 61 awarding institutions about specific concerns we
have related to this issue, and this process is ongoing.
Partnering with research institution leadership is a key,
as our awards are made to institutions, not to individuals. Our
efforts have led to specific personnel being removed from
grants or even being terminated from their institutions. And
increasingly, institutions are adopting better monitoring and
reporting systems.
NIH staff has been explicitly trained to identify
suspicious activity of peer reviewers and of key personnel
listed in grant applications, and to report this to NIH
research integrity officers. We regularly partner with
colleagues at the Department of Health and Human Services and
other Federal agencies, such as the FBI, to exchange
information on emerging threats. We also engage our stakeholder
community in a variety of forums, including the Advisory
Committee of the NIH Director, which next week will meet to
continue the public discussion about best practices to prevent
and detect untoward foreign influences in our system.
That stated, we remain conscious of how these actions could
affect the morale of honest and dedicated foreign-born
researchers who are hard at work assisting and often leading
the advancement of scientific knowledge. Since 2000, 39 percent
of U.S. Nobel Prizes in physics, chemistry, and medicine have
been awarded to foreign-born scientists. U.S. scientists
routinely collaborate productively with investigators in
foreign countries. Furthermore, because disease emerges from
many parts of the world, we must rely on productive research
collaborations with foreign entities to share information on
seasonal and pre-pandemic influenza or emergent or re-emerging
infectious diseases such as SARS, MERS, Zeka, and Ebola.
The individuals violating laws and policies represent a
small proportion of scientists in and with U.S. institutions.
We cannot afford to reject brilliant minds working honestly and
collaboratively to provide hope and healing to millions around
the world.
In closing, we at NIH are devoted to ensuring that American
taxpayers get the full benefit of their investment in NIH: the
very best science conducted in the most ethical way that leads
to improvements in health for them and their families.
Thank you, and I look forward to your questions.
[The prepared statement of Dr. Tabak appears in the
appendix.]
The Chairman. Mr. Hollie?
STATEMENT OF LESLIE W. HOLLIE, CHIEF OF INVESTIGATIVE
OPERATIONS, OFFICE OF INSPECTOR GENERAL, DEPARTMENT OF HEALTH
AND HUMAN SERVICES, WASHINGTON, DC
Mr. Hollie. Good morning, Chairman Grassley, Ranking Member
Wyden, and distinguished members of the committee. I am Les
Hollie, Chief of Investigative Operations with the Department
of Health and Human Services Office of Inspector General.
I appreciate the opportunity to appear before you to
discuss how OIG is working in conjunction with our HHS and law
enforcement partners to protect taxpayer-funded medical
research. Today I will cover how OIG enhances the Federal
Government's ability to detect, deter, and take enforcement
action to ensure integrity of
taxpayer-funded medical research against foreign threats.
The National Institutes of Health have recently referred to
OIG for investigation 16 allegations of noncompliance with its
terms and conditions for receiving a medical research grant.
The allegations primarily deal with the failure of principal
investigators to disclose foreign government affiliations.
These referrals are still active. To avoid compromising ongoing
investigations, I cannot provide further details at this time.
However, I can cover how we generally handle grant fraud
allegations.
Although the foreign threat to research is a high-profile,
complex issue, the cases under our purview all involve aspects
of grant fraud, a subject which OIG has extensive experience
investigating.
HHS is the largest grant-making organization and third
largest contracting agency in the Federal Government. Given
this nexus, OIG has made oversight and enforcement of grant and
grant-
related program integrity a priority. We take a two-pronged
approach to preventing and acting against grant fraud.
First, OIG works collaboratively to mitigate grant fraud
through efforts to minimize vulnerabilities, including audits,
evaluations, and proactive training.
Second, we investigate allegations of criminal misconduct
and make appropriate referrals for criminal, civil, and
administrative action. OIG receives allegations of grant fraud
or uncovers potential grant fraud in a variety of ways,
including OIG hotline complaints, referrals from HHS operating
divisions, law enforcement partners, whistleblower disclosures,
and proactive data analysis.
Upon receiving an allegation pertaining to grant fraud
involving NIH or another 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 OIG identifies a violation of civil or criminal law
during an investigation, OIG presents the facts to the
Department of Justice for consideration. To protect the
integrity of medical research, OIG coordinates with the HHS
Office of National Security and works together on matters with
the FBI and the Department of Homeland Security when
appropriate.
OIG also works collaboratively with stakeholders to
increase their ability to prevent and detect grant fraud
through proactive training. OIG increases HHS employee,
contractor, and grantee awareness of how to identify and report
allegations pertaining to grant fraud, including foreign
threats, through training and presentations.
For instance, OIG has provided numerous grant fraud
training sessions at the NIH regional seminars and 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.
OIG also conducts oversight of NIH through audits and
evaluations. Utilizing the $5 million in fiscal year 2019
appropriations we received for oversight of grant programs and
operations of NIH, we have ongoing work looking into NIH's
cybersecurity, pre-award processes, and peer review procedures
and controls.
In 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 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.
[The prepared statement of Mr. Hollie appears in the
appendix.]
The Chairman. Thank you as well. Now, Mr. Rodi?
STATEMENT OF LOUIS A. RODI III, DEPUTY ASSISTANT DIRECTOR,
NATIONAL SECURITY INVESTIGATIONS DIVISION, IMMIGRATION AND
CUSTOMS ENFORCEMENT, DEPARTMENT OF HOMELAND SECURITY,
WASHINGTON, DC
Mr. Rodi. Chairman Grassley, Ranking Member Wyden, and
distinguished members of the committee, thank you for the
opportunity to discuss the role U.S. Immigration and Customs
Enforcement's Homeland Security Investigations (HSI) plays in
addressing foreign threats to taxpayer-funded research.
The threat posed by nation-states illegally or subversively
seeking to exploit legitimate educational research
opportunities in the United States is evolving. HSI is well-
positioned to mitigate this threat through the programs I will
highlight today, all of which provide a multi-layered level of
security aimed at protecting the homeland from illicit
transnational activities of its adversaries.
Each year, thousands of foreign nationals seek visas to
travel to the United States to pursue educational degrees or
conduct research, and thousands more are already present in the
United States engaged in such activity. While openness in
international collaboration in academia and research is
important, it can also create an environment that U.S.
adversaries exploit as a means to gain access to sensitive
technology and information.
The largest number of ongoing HSI Counter-Proliferation
Investigations, or CPI, on controlled exports, including
intangible exports, involve China, Iran, and Russia. From these
investigations, and based on trend analysis, HSI knows that
these countries are actively working to illicitly or
subversively acquire and transfer
export-controlled military and dual-use technology and
commodities.
Exploitation of academia and U.S. research institutions is
just one of the schemes these countries are employing to obtain
access to sensitive research in export-controlled information
and technology and facilitate its transfer abroad. Foreign
nationals from China, Iran, and Russia represent a sizeable
portion of the overall non-immigrant student population
currently in the United States. As of May 2019, there are over
350,000 F-1 Chinese students, over 11,000 F-1 Iranians, and
over 6,100 F-1 Russians in the United States, many of whom are
enrolled in STEM-related programs.
HSI has established a multi-dimensional approach to combat
these efforts. HSI's first line of effort is preventative and
executed by the HSI-led Visa Security Program, or VSP, through
which HSI and interagency partners screen, vet, and investigate
potential applicants, including those applying for student or
exchange visitor visas, prior to admission into the United
States. If sufficient derogatory information is uncovered
relating to the intentions of these applicants, HSI, working in
conjunction with the Department of State, can recommend
refusals of visas on a number of grounds, including suspected
involvement in the elicit procurement of controlled technology.
HSI also has multiple programs to identify and protect
against foreign entities already present in the United States.
The Student Exchange Visitor Program, SEVP, fulfills a
compliance-centric role and is responsible for monitoring
certified educational institutions and the nonimmigrant
students they enroll.
SEVP also regularly conducts compliance site visits to
schools to ensure that the programs are functioning as reported
in SEVIS, the Student and Exchange Visitor Information System.
HSI actively identifies and initiates enforcement action on
nonimmigrant visa overstay violators who pose a concern for
national security, border security, or public safety, and works
closely with SEVP and CPI to mitigate risks.
HSI's Counterterrorism and Criminal Exploitation Unit,
CTCEU, conducts outreach as well as in-depth analysis on
potential school fraud violations, focusing attention on a
number of indicators to include schools receiving Federal
funding for sensitive research. HSI has also initiated the
Domestic Mantis Program, which identifies students who have
changed their field of study from a nonsensitive to a sensitive
area and evaluates those individuals against risk-based
targeting criteria. If students or exchange visitors appear to
be involved in efforts to acquire and transfer sensitive
information or technology obtained during the course of their
research or academic pursuits, HSI's CPI program coordinates an
investigative and enforcement response to those activities.
HSI is designated as a primary law enforcement agency for
investigating violations of the U.S. export laws. Many of these
laws are being circumvented by state actors who are making a
concerted effort to take advantage of academic openness in the
name of fundamental research to acquire U.S. technology,
processes, and other intellectual property. To mitigate this
threat, HSI's CPI program has recently taken proactive steps to
increase outreach to export control officers and other
officials within the academic community, particularly at
universities or research institutions with large foreign
student populations enrolled in STEM-related programs.
These outreach efforts, conducted in conjunction with SEVP
and CTCEU, are designed to raise awareness of the potential
proliferation risks posed by students and researchers to help
institutions recognize potential instances of elicit
procurement, intellectual property theft, or other possible
violations of U.S. laws, and to provide a conduit to report any
suspicious activities detected by universities or research
institutes.
Together these programs form the backbone of HSI's efforts
to identify and mitigate the threats posed by foreign entities
seeking to exploit legitimate academic and research
opportunities within the United States. Enhancements and
expansion of these programs, combined with enhanced
administrative and criminal enforcement authorities, will only
improve HSI's ability to identify and thwart the efforts of
foreign actors who pose national security or public safety
concerns to the United States.
HSI looks forward to continuing to work with the committee
regarding its HSI programs.
[The prepared statement of Mr. Rodi appears in the
appendix.]
The Chairman. Thank you all very much.
My first three questions are to all of you, and I hope I
can get a one- or two-word answer from each. So the first one
is kind of a ``yes'' or ``no.''
Is the foreign threat to the integrity of taxpayer-funded
research real, aggressive, and ongoing? Captain?
Dr. Schmoyer. Sir, thank you for your question. HHS Office
of National Security and the Department in general is concerned
about any threats, whether they are foreign or domestic. We
spend a very large amount of our resources addressing any of
those threats that would be coming in. And so we work very
closely with our counterparts across the table, as well as the
intelligence community. We use their guidance and their
intelligence that they provide us, and address our efforts in
that particular fashion.
The Chairman. You cannot separate foreign, whether foreign
is a threat? Because you mixed it up with everything else. I am
kind of getting at an answer. I want to know what you think
about foreign. Is it a threat to taxpayer-funded research,
real, aggressive, and ongoing?
Dr. Schmoyer. We do appreciate the intelligence that we
receive from the intelligence community, as well as our law
enforcement partners, which does provide us these particular
types of data that allow us to tailor our efforts to those
threats that are focused on specific behaviors in the
Department. In a more sensitive environment, sir, I am more
than happy to go into specifics.
The Chairman. Thank you. We will do that. Dr. Tabak?
Dr. Tabak. So again, sir, I would concur with my colleague
and, in a more sensitive environment, we can go into more
detail.
The Chairman. Okay; let us go to question number two. Based
on your experience, which country is the greatest threat to the
integrity of taxpayer-funded research?
Dr. Schmoyer. Thank you for your question, sir. Again, in a
more sensitive environment--thank you, sir.
The Chairman. Thank you. Let us go to a whole different
subject, then. According to the NIH, it operates the intramural
program and the extramural program for research activities.
Within the intramural program--this is for Dr. Tabak--NIH
employees, contractors, affiliates who are U.S. citizens
undergo background investigations. Further, prior to that
background check, a special agency check is conducted requiring
fingerprints to be cross-checked with the FBI criminal
database, including the terrorist watch list.
According to NIH, in the extramural program, a grantee
institution such as a university is responsible for any
vetting, not your agency.
So the first question to you: NIH has said U.S. citizens in
the intramural program are subject to background checks. Do
foreign nationals working in the NIH intramural program undergo
the same screening as U.S. citizens?
Dr. Tabak. Yes, sir, they do.
The Chairman. Okay. Also to you, with respect to the
extramural program, more than 8 dollars out of 10 appropriated
to the NIH go to this program. Does NIH conduct background
checks, including a review for counterintelligence purposes, on
principal investigators prior to awarding a grantee institution
taxpayer money?
Dr. Tabak. No, sir, we do not, as they are employees of
their home institutions.
The Chairman. Okay. According to HHS OIG, NIH has recently
referred for investigation 16 allegations of noncompliance
related to medical research. The IG stated the allegations
primarily deal with the failure of principal researchers to
disclose foreign government affiliations.
So again to you, how is NIH discovering these cases for
referral? And is NIH doing its own review? Or are the research
institutions fighting potential problems for your agency?
Dr. Tabak. We flag these in various ways. Our own staff
uses algorithms to detect potential untoward behavior. We also
receive referrals from our colleagues at HHS and the FBI. And
increasingly universities, as they become more and more aware
of the issue, are alerting us to potential issues as well.
The Chairman. Then finally for you, but you will have to do
it in writing, because I do not think you are prepared to do
this now. Would you provide us in writing to the committee a
specific breakdown of how each referral originated, whether by
NIH or a research institution?
Dr. Tabak. We would provide that for the record, but it
would have to go in concert with the IG. We have already made
those referrals, and they are ongoing investigations.
The Chairman. Okay; thank you.
Senator Wyden?
Senator Wyden. Thank you, Mr. Chairman. I was just looking
at my friend, Senator Cornyn. The two of us are on the
Intelligence Committee, and so we have watched you all try to
respond to Chairman Grassley's questions, his always good
questions.
Let me, if I could, kind of see if--because we are not
going to be able to ask some important questions in a
classified session in a way that the American people are going
to actually learn something about the important questions being
raised here. So I am going to see if I can tease out some
answers to these issues that also are sensitive to what Senator
Cornyn and I know are classified matters of what are called
sources and methods.
At page 3 of your testimony, Dr. Tabak--and you are at NIH,
a crown jewel for health-care research--you say: ``A few
foreign governments have initiated systematic programs to in
effect capitalize on research and unduly influence U.S.-based
researchers.''
What is ``a few''? Are we talking about three? Are we
talking about seven? How many are we talking about? That is not
something that compromises sources and methods or American
security.
Dr. Tabak. Again, sir, I think that is best discussed in a
more sensitive environment.
Senator Wyden. Senator Cornyn and I deal with classified
materials. I mean, giving a range of the number of countries is
not something that would damage American security. So three?
Seven? Five? How many?
Dr. Tabak. Sir, again I think that is just something that
we should discuss in a more sensitive----
Senator Wyden. I do not share your view. Then you say that
these foreign governments unduly influence U.S.-based
researchers. How do they do that?
Dr. Tabak. So this is done in a variety of ways, sir. They
provide financial remuneration to individuals. In some
instances these individuals have signed contracts which require
them to spend a certain percent of their time in a foreign
government, in a foreign country. They might set up a
laboratory in that situation.
In other instances, they expect that the individual will
share with that government grant applications, which obviously
is a theft of intellectual capital. And in some instances,
because they are interested in recruiting additional
individuals to this process, they will set up cabals, if you
will, in peer review to have sort of a quid pro quo.
Senator Wyden. Okay. In the area of genomic research, you
all did not agree with the HHS Inspector General's
recommendations to develop a new kind of security framework. I
gather that you felt that existing procedures are adequate to
address the concerns that were raised by the Inspector General.
Is that true? Do you by and large think that existing
procedures are adequate to address those issues that you just
described to me are problems?
Dr. Tabak. Sir, it is important to note that the OIG report
was on genomic data sharing specifically.
Senator Wyden. Let's talk about that. Do you think the
existing procedures are adequate there?
Dr. Tabak. We continue to work on these to enhance them.
The main reason for our nonconcurrence on that report, sir, was
the specific indication that by sharing genomic data, human
genomic data, we were putting the Nation at risk. And frankly,
sir, that was based on speculation that was unsubstantiated.
And I will quote from the report directly, sir, on page 3 of
that report, and I quote: ``We have not performed audit work to
verify the FBI's conclusions.''
Senator Wyden. Okay. Let me ask you one other question, if
I might, because again--and I do not want to be deliberately
obstreperous, but the American people want answers in open
session to these kinds of issues in a way that does not
compromise, as Senator Cornyn and I know, sources and methods
and classified information.
Tell us, if you would, how prevalent a problem you think
this is. In other words, you made that statement at page 3, a
few foreign governments have these systematic programs. You
outlined some things which certainly strike me as wrong.
But I think, before I wrap up my first round--how serious a
problem is this? Tell us that in English so people have a sense
of what we are dealing with here.
Dr. Tabak. So the numbers are relatively small, but the
problem is important. Thus far, as I indicated in my testimony,
we have been working with 61 institutions, and that number
changes. That number will undoubtedly increase as we learn
more.
Senator Wyden. Okay. Thank you. Thank you, Mr. Chairman.
The Chairman. Now, Senator Cornyn?
Senator Cornyn. Mr. Chairman, thank you for holding this
hearing today. Among all the issues that we deal with here in
Washington, DC, and particularly in Congress, this ranks right
up there as one of the most urgent and important issues to our
economy and our national security. China's aggressive plan to
dominate the United States economically, militarily, and
technologically includes the willingness to use whatever means
are necessary, legal or not, overt or covert, to achieve its
goals.
As the FBI has previously told us--and I agree with you,
Mr. Chairman, it is a shame that they are not here today, the
FBI, because of course they are the primary counterintelligence
investigation arm of the Federal Government. No longer are
challenges so much as they were in the cold war, spy versus
spy. Now we have spy versus nontraditional collectors. And this
is what Director Wray of the FBI said in February. He said the
use of nontraditional collectors, especially in the academic
setting, whether it is professors, scientists, students--we see
it in almost every field office that the FBI has around the
country. It is not just in major cities. It is in small ones as
well, and it is across basically every discipline. And I think
the level of naivete on the part of the academic sector about
this creates its own issues.
As a leader of a major research institution in my State
told me recently, he said, ``We are under attack.'' And I think
after today those of us in attendance will come to concur with
that statement.
Our universities and other research institutions are under
threat by both human actors and by the cyber-threat. American
institutes of higher education and the agencies that provide
billions of dollars in taxpayer dollars to conduct research
every year must work together to confront this very real
danger.
According to my statistics here, the U.S. Government alone
spends about $120 billion in research and development grants,
the private sector, another $500 billion. And if China or any
adversary can simply steal it, obviously that is a huge threat
not only to us from a security standpoint but from an economic
standpoint. Because China is not--they are not unclear about
what their goals are. Their goals are to dominate the United
States militarily and economically.
Well, next week I am going to introduce a piece of
legislation that I would hope my colleagues would join me in
working on called the ``Secure Our Research Act.'' This will
establish an interagency working group to develop an agency-
wide compliance framework to enhance cybersecurity protocols
and protect federally funded research from foreign
interference, espionage, and exfiltration.
I simply will not be able to vote in good conscience for
any taxpayer dollars to be used for research at public
institutions unless these institutions up their game
significantly and can give us some confidence that those
taxpayer dollars are not only being well spent in research and
development, but that that research information is not being
stolen right under our nose.
It is high time we address this threat and find solutions
to fix the vulnerabilities that exist today. U.S. colleges and
universities, I agree with the ranking member, have long been a
Mecca for foreign nationals because of the high quality of the
education we provide, and the academic and cultural freedoms
that exist in our country.
But that same sort of open society and these institutions
represent a vulnerability that we can protect against. I think
we can continue to be that Mecca for foreign students to study
at our colleges and universities and, at the same time, protect
the taxpayer and the important scientific research that is
generated from these institutions. Because we are in a global
competition, whether we like it or not, and it is, to use the
words of the FBI Director, naive of any of us to think that it
does not exist and that it is not an urgent matter that
deserves our attention.
Thank you, Mr. Chairman.
The Chairman. Senator Cassidy?
Senator Cassidy. Mr. Rodi, long before I was in politics, I
remember reading about Russian, Soviet scientists coming here,
going to our different resources, and they had been trained to
memorize, to notice detail. So industrial espionage is not new.
I have read about French sitting behind our scientists on
airplanes and looking over their shoulder to see the notes that
they are reading. So whether that is true or not, it makes a
great story, doesn't it?
So this is not new. I am assuming that we have established
protocols: these folks are at high risk; these are not. The
grad student who is doing finance presumably has less access to
patentable research than the one who is doing advanced carbon
technology for weaponry sort of thing. Is that a fair
statement?
Mr. Rodi. Yes, sir.
Senator Cassidy. So, as Senator Cornyn expresses his
concerns, I can imagine the university administrators being a
little nervous. How do we isolate the subset of folks we need
to be aware of, if we have this many hardworking, very
talented, bright students, but most of them in fields where
really you could steal it, but who cares, as opposed to the few
who are a concern? Do we have a mechanism that allows that
university administrator to begin to make a judgment as to whom
they should have under closer watch, and those whom you can
kind of not spend your scarce resources on?
Mr. Rodi. Yes, sir. That is the whole purpose of our
outreach program. Our Project Shield America, it is our
Counter-Proliferation Investigation's outreach program. We have
a certain subset Project Shield America for Academia to meet
with academia and address these issues, to inform them of some
of the threats and the concerns that are out there, what to
look for. What are the proliferation concerns of the United
States? What should they be looking for? What should they not
be sharing with foreign students, and the like? So, yes, we
have a very robust outreach program to address these issues.
Senator Cassidy. Dr. Tabak, I am a physician. I am a liver
doctor, and I remember there was a pathologist I worked with, a
very talented young man, and this was years ago, 30 years ago,
and he just took a job back in Hong Kong, or Taiwan, or maybe
the mainland, probably Hong Kong or Taiwan at the time, and he
was just a talented doc. He had done research, all clinically
oriented, and he just got a great job offer.
Now in one sense I can see that could be seen as a threat,
because he was very involved in research, but in reality it was
just a great job offer. How do we differentiate that from
systematic espionage?
Dr. Tabak. Senator, that is a success story. Unless the
individual is not playing by the rules and tries to divert work
that was supported by the U.S. Government to a foreign----
Senator Cassidy. Now let me ask, because some of that work
is now in his neurons. And so wherever he goes, he is
influenced by the fact that he has learned--at the time, PCR
was cutting-edge technology. So he is familiar with the
implications of PCR. We cannot erase his neurons. So again, how
do we differentiate that which is just organic and that which
is espionage?
Dr. Tabak. So again, what you described in the former case
is how science advances, building upon building. In the latter
case, people diverting things inappropriately for untoward
purposes, that can be espionage.
Senator Cassidy. Now, I accept that. So is the bright line
here, okay, I am going to put in a thumb drive and download a
lot of material and try to sneak it across, or send it over on
my gmail account as opposed to my official account, is that the
bright line versus, I just know this because I have been
working very hard in the lab in 18-hour days and now, wherever
I go, I am going to bring that body of knowledge?
Dr. Tabak. How that knowledge is transferred can make a
difference, sir, yes.
Senator Cassidy. So it can make a difference--no offense,
but a little bit of a wiggle word. I am actually looking for
some guidance for those university administrators.
So I learned it. It is in my brain. It may be in my notes,
because I kept notes as I did experiments. That is okay.
Downloading on my thumb drive and/or otherwise trying to
electronically communicate or bring huge stacks is not okay.
Dr. Tabak. As you know, sir, that information that is
gathered while you are employed by the university supported by
U.S. Government grants is the property of the university, not
the individual. So they would have to have that conversation as
to what is being taken and not taken.
Senator Cassidy. I get that. I can still imagine the--I
mean, because classically the post-doc who is so bright might
be a Chinese national, but he might be employing Chinese
nationals because you have a lot of bright kids over here who
work so hard. So I am trying to give some guidance to our
institutions as to when they should say, ``Okay, we need to
vigilant.'' Captain, did you have something to say to that? May
I go over a little bit, Mr. Chairman? I am over my time. Can I
have a minute more?
The Chairman. Yes.
Senator Cassidy. Okay, Captain.
Dr. Schmoyer. Yes, sir. I had mentioned in my remarks that
we are excited to be working with the National Institutes of
Health and a variety of our law enforcement partners on some
efforts to address the work that we are doing with institutes
of higher education.
A specific element of that work, sir, is looking at these
particular factors that are out there, being able to look at
what type of methodology that individuals are using, looking at
lessons learned that we use with NIH as well as the other parts
of our department to determine, when you are addressing these
types of issues, these are the things to look for. Being able
to train those institutes to be able to look at those
particular factors is critical for their success in being able
to prevent them.
Senator Cassidy. So we have guidelines that we can give the
university that they follow--or at least they are doing due
diligence?
Dr. Schmoyer. Yes, sir. We have these guidelines that we
use within the Department. We have these guidelines that we
have done in conjunction with the NCSC as well as FBI. Our goal
over the next couple of months is to be able to continue those
activities to expand that educational process to our funded
partners.
Senator Cassidy. Thank you all.
The Chairman. Let's see. Senator Whitehouse, if you are
ready. You are not ready. [Laughter.]
I have one question of Mr. Rodi. The focus of our hearing
today is on the theft of our research and intellectual property
by China and others. What other countries or governments are
you concerned about that are exploiting loopholes in our
immigration system to further that theft? And could you give
some specific examples of the exploitation?
Mr. Rodi. Yes, sir. Well the top three, as I have stated,
are China, Iran, and Russia, but there are other countries of
concern as well. We look at the empirical data of the
investigations that are being conducted by our counter-
proliferation investigations unit. Other countries of concern
include India and Pakistan. There are other countries as well.
And I have some specific examples that I will give later
today in the classified setting, but just off the top of my
head, a really good example that I like to highlight is someone
who is coming here from Iran to study civil engineering. And as
we delve deeper into what the person is here actually studying,
we learn that they are here to study about concrete, and the
effects of concrete, and the uses of concrete. Well, we all
know that Iran is building tunnels to hide their nuclear
program, their nuclear missile launching pads, their entire
nuclear program. So when we are looking into an Iranian student
who is here to learn applied techniques of concrete, that is of
concern to me and to my agency, the fact that they are using
that technology to build these bunkers. And there are other
examples as well.
The Iranian students who come here to study welding. And
then as we dig deeper into their theses and their
dissertations, what type of welding are they actually looking
at? And you look at, well, they are looking at learning how to
weld titanium, titanium for air frames. Well, we gave the
Iranians their air force back in the 1970s, and those planes
are falling apart now because they cannot get spare parts. But
they are coming here to learn how to fix those planes by
learning welding techniques to salvage the planes that they do
have.
The Chairman. Senator Whitehouse?
Senator Whitehouse. Thank you very much, Mr. Chairman.
Probably this is a question more for Homeland Security, but
I will take an answer from anyone, and that is: have you seen
any efforts to try to obscure the true identity of a foreign
country or interest in this effort to expropriate American
scientific research or talent to a foreign country, along the
lines of shell corporations, or any devices for masking real
identities? Or is it just, students come here, study things, go
home?
Mr. Rodi. I do not have any specific examples to address
that specific question. We are focused mainly on students, what
they are here to study, and what we can do to address that
threat.
Senator Whitehouse. So it is basically, students come here,
study, go home? That is the plot that you are looking for?
Mr. Rodi. Yes, sir.
Senator Whitehouse. Okay. If anybody else has anything to
add, you are welcome to. If not, I would just like to make it a
question for the record, if you could check with your staffs
and see if, in your experience in dealing with this concern,
whether or not you have seen any efforts to try to mask or
conceal identities in any way, or whether it really is just as
simple as student comes, student studies, student goes home.
Okay?
Thank you. Thank you, Mr. Chairman.
The Chairman. Okay. Thank you. Senator Carper?
Senator Carper. Thanks, Mr. Chairman. Welcome one and all.
As you know, there is a lot going on on Capitol Hill today. We
are glad you could visit with us and spend at least a short
time with us.
Early in my life I was a naval flight officer, 5 years
active duty, three tours in the Vietnam War, and top secret
clearances, and I understand the need to protect that which is
sensitive. And it sounds like we have been asking some
questions and you are unable to discuss the answers to some of
those questions in a setting like this. We understand that. I
understand we may have the opportunity to meet some of you in a
classified setting in the SCIF later today, and hopefully we
can more fully question you on some of these issues.
In the meantime, I want to steer away from things we should
not be talking about in an open setting and see what we can
talk about in this open setting that would be informative to
our committee and informative to the people we represent across
this Nation.
I will start with Mr. Hollie. Hi, Mr. Hollie. Where are you
from?
Mr. Hollie. Originally from Texas.
Senator Carper. Okay. I used to be stationed at Corpus
Christi Naval Air Station. It is nice to see you.
Mr. Hollie, you note in the cases that your office has
looked into, they all involve grant fraud. And I just want to
know, are there certain things that you would recommend that
the NIH and other grant-making agencies look for to spot
instances where a foreign actor might be trying to take
advantage of a Federal research grant program? And are there
best practices in grant management that you would direct
agencies to turn to to get some assistance and guidance? A two-
part question, please.
Mr. Hollie. Thank you for your question, sir.
Senator Carper. You are welcome. Mr. Chairman, do you know
what I love? I love hearings where all the witnesses say
``thank you for your question.'' [Laughter.]
And do you know what I say when they say that? ``You're
welcome.''
Mr. Hollie. Speaking not on topic today, but with regards
to grant fraud as a general topic, we see the foreign influence
as a subset of our general grant fraud portfolio, those best
practices. And we are currently engaged with NIH and have been
over a number of years, as I expressed in oral testimony. With
regards to when we can speak about closed case investigations
coming back to the operating divisions and speaking on the
vulnerabilities that were discussed, or examined, or observed
in the investigation process, we think that is a very important
process of closing the loop and educating not only the awarding
agency but the sub-grantees as well, about things that we have
seen in an investigation after it has been concluded that we
could speak on. The educational process, having a proactive
training program in place when we are conducting outreach at
the various seminars around the country for not only NIH but
other operating divisions within the HHS portfolio, is very,
very important.
Another area is being there actually to have the grantees
and the grant management officials ask, ``What can we do best?
What are we doing, or what should we be doing?'' I think it is
very important to be accessible to those individuals, and that
has been something that has been very robust within the IG
community, because, in law enforcement generally speaking, not
only within HHS and OIG as law enforcement arms, there is a
level of anxiety with regards to individuals reaching out to
law enforcement and speaking openly and freely. And we believe
in the principles of, you know--we do think of those areas, and
reducing those anxieties, so those engagements give us the
opportunity to be accessible.
We have one-on-one sessions with individuals----
Senator Carper. I am going to ask you to hold it right
there. That is good. That is great. Let me just ask the others.
I am not going to ask you to say ``yes'' or ``no,'' but do any
of you agree with anything that he has just said? Raise your
hand if you do.
[Hands are raised.]
Senator Carper. All right, let the record show that
everybody except Mr. Rodie agreed. Is there anybody who agrees
with everything that he has just said? Raise your hand.
[Hand raised.]
Senator Carper. Let the record show that one witness has
raised two hands. [Laughter.]
Okay, fair enough. Here is my second question. My second
question is for the retired Navy Captain, Dr. Tabak, and Mr.
Hollie.
What role does poor information security and failure to
protect sensitive information produced through Federal research
play here? Is there more that NIH and grant recipients need to
do to protect their work? Is there more that the Congress can
do to empower you to protect the work that is being done? So,
Captain?
Dr. Schmoyer. Thank you, sir. A couple of things. Number
one, we are very grateful for the resources that we have for
our small office to be able to address a very large need within
the Department, as well as the overall Federal Government.
When we look at this particular challenge, we are making
fantastic strides as far as being able to balance both security
as well as science. And the work that we have been doing in
conjunction with NIH as well as the other elements of the
Department could not be done unless that balance was there.
I think as we continue to go forward, we would continue to
also be interested to speak with you, as well as your staff, to
be able to provide technical assistance as you are looking at
potential legislation or other areas and how they might affect
any organization like the Department of Health and Human
Services and our mission to be able to preserve national
security efforts.
Senator Carper. I know, Mr. Chairman, I am over time. Can
we ask these other two witnesses to just briefly respond to my
question, please?
The Chairman. Yes.
Senator Carper. Thanks. All right, Dr. Tabak, same
question.
Dr. Tabak. So we work very closely with our colleagues at
HHS. The oversight that Mr. Hollie spoke to makes us better,
points out things that we can enhance and improve.
In turn, we reach out to our grantee organizations to make
sure that what they are doing at the local level is as robust
as possible. So it is a partnership, sir.
Senator Carper. Good. Thank you. Very briefly, Mr. Hollie,
same question, please.
Mr. Hollie. Yes, sir. We are currently engaged in work in
Audit and Evaluation Division to look at internal controls at
the NIH. I would like to get back with the committee when that
work is mature and completed to speak on it with a level of
specificity.
Senator Carper. Good. Thank you, Mr. Chairman. Senator
Portman, who is not able to be here with us today, he and I are
the senior Republican and senior Democrat on the Senate
Permanent Committee on Investigations, and he and I both sent a
letter to Secretary Azar on May 17th for information on foreign
efforts to exploit NIH-funded research. We have asked to have a
response by, I think July 7th. It looks like it is going to be
delayed. When we get to July 7th, what I want to ask is--this
is for the DHS people, Health and Human Services people--I am
going to ask, if we do not have an answer to the letter by July
7th, I want, for him and for me, I want you to give us a date
by which we will have a response to our question. Thank you,
Mr. Chairman, for your generosity.
The Chairman. I was told Senator Daines is coming, and if
he comes in, we will go to him. In the meantime, Mr. Hollie,
where do the 16 referrals from NIH currently stand? Were any
investigations opened or matters referred to other agencies
such as the FBI? And you should be able to answer to at least
what agencies they were referred to.
Mr. Hollie. Mr. Chairman, I refer you back to my oral
testimony. We have the 16 referrals. They are currently in our
portfolio. I cannot make any comments beyond that.
The Chairman. Okay.
Senator Wyden. Mr. Chairman, before we go to Senator
Daines, could I just ask unanimous consent to put a statement
from the Association of American Universities into the record?
The Chairman. Yes, without objection.
[The statement appears in the appendix on page 74.]
The Chairman. Okay. Senator Daines?
Senator Daines. Thank you, Mr. Chairman, Ranking Member
Wyden. Chairman Grassley, I want to thank you for holding this
hearing. I want to thank the witnesses for coming before this
committee to help us address threats to taxpayer-funded
research.
As someone who personally spent over 5 years living and
working in China--we were expats in Guangzhou; I was working
for Proctor & Gamble. In fact, I had two children born in Hong
Kong during that time. I have led multiple codels to visit
China and its neighbors over the past 4 years. I have seen the
rapid rise of the Chinese economy and seen the progress they
have made.
When I first went to China in 1991, it was a $500-billion
economy. Today, depending on whose numbers you believe, it is
somewhere probably north of $13 trillion in GDP. Unfortunately,
a lot of the progress that has been made has been made through
illegal acquisition of intellectual property from United States
companies. We need to ensure this valuable information is not
just protected for DoD, but for other critical areas including
biotech and health services.
Over the past 5 years, the State of Montana has received
nearly $300 million worth of grants from the Department of
Health and Human Services. It is critical that we ensure that
the valuable work being performed by Montanans is directly
benefiting the United States and not China.
Dr. Tabak, as the title of this hearing suggests, there are
real concerns that China is seeking to steal research funded by
American taxpayers. And with the improvement that China has
proposed to its intellectual property system for new medicines,
a part of ``Made in China 2025,'' the country could be in a
strong position to commercialize that research.
What do we need to do to ensure that American researchers,
American inventors, remain competitive and that intellectual
property is protected?
Dr. Tabak. It starts with making people aware of the
problem. Our grantee institutions are increasingly partnering
with us to ensure that their faculty, the researchers that
receive our grants, are appropriately indicating all levels of
support, regardless of where it is from--all commitments to
institutions if they are outside of the one that they work at--
and are serious about maintaining the integrity of the peer
review process.
And if institutions ensure those three things, that will go
a long way in protecting the NIH equities that you are speaking
to.
Senator Daines. So, Dr. Tabak, a follow-up question. China
appears to have taken some important steps to open up its
pharmaceutical markets by reforming its industry to better
align with international drug standards and reducing some
tariffs on imported drugs. However, when you look at the ``Made
in China 2025,'' it is pretty clear that China's goal is not to
build an open market, but to build its own domestic industry.
What actions are being taken to ensure that China is not
reverse-engineering these technologies and, frankly, stealing
intellectual property?
Dr. Tabak. Well again, sir, it is the diligence that we all
have to have to ensure that that which is supported by U.S.
taxpayer money not be bled off into foreign countries. That
which is in the open market, obviously, can be reverse-
engineered. You are quite right. But the nefarious,
inappropriate behavior, those are things that we have to detect
and stop at the earliest possible intervention.
Senator Daines. Yes. I have a question for you, Captain,
here next, but I am a chemical engineer myself. I may be the
only one in Congress, actually. Most are smarter than to run
for Congress than anyone here. China is graduating eight times
more STEM grads right now than we are here in the United
States. They are building an innovation ecosystem that is very,
very powerful. And I think the rate of the acceleration in
their innovation ecosystem is something that we are
underestimating, in my opinion, here in the United States. I
think of it as a competitive threat short-term and long-term
here in the U.S.
I want to shift to Captain Schmoyer. The Chinese Government
is active in gaining access to health-care and genomic data on
U.S. persons, which not only allows them to drive new
discoveries by analyzing large data sets but also creates risk
of blackmail and potential exploitation.
What steps is your department taking to ensure the
protection of Americans' health records from the Chinese
Government?
Dr. Schmoyer. Sir, we looked at that mission in a couple of
different ways. Number one, we are a very active partner in the
CFIUS process. And so HHS over the last year has had several
dozen CFIUS cases that we have been involved in that have been
looking at foreign acquisitions in general to be able to
determine whether or not there is a potential risk to national
security. It is a huge area of involvement that our office has
in our portfolio.
Secondly, looking at the overall importance, as I think the
panel had mentioned earlier on, of education. Being able to let
people know that there needs to be that balance again between
science, research and development, and security. Being able to
work with the NIH faculty members, as well as the rest of the
parts of the Department, to be able to educate their subject
matter experts on the need to be aware of how those challenges
created by the work they may be doing, while it seems
innocuous, maybe very benign, can actually potentially threaten
national security.
So that education is really the second part.
And then the third part, sir, is our interagency
collaboration with the intelligence community, as well as
Federal law enforcement, to be able to determine whether or not
there are potential risks in those areas to our department and
the overall biomedical research field.
Senator Wyden. Senator Daines, I feel badly. We are just in
the middle of a vote, and I want to get Senator Cantwell in----
Senator Daines. Yes, thank you.
Senator Wyden. Senator Cantwell?
Senator Cantwell. Mr. Chairman, thank you very much for
this important hearing. What I would like to focus on--
obviously we have a lot of research institutions in the State
of Washington--is how the Federal agencies are working with
those local counterparts on threat assessment. I am not sure
that we are painting a broad enough picture if we are not
sharing actual threat assessment information with them.
So is the White House Office of Science and Technology, or
some other body, coordinating this policy area? And what can we
do to make sure there is a comprehensive approach to that,
particularly when it is Federal research and development? So,
anybody on the panel. Yes, go ahead.
Dr. Schmoyer. Ma'am, we do work very closely with the
National Security Council on those particular matters, looking
at the overall impact as far as the broader Nation. In
addition, we work very closely with our Federal law enforcement
partners. Their regional offices are engaging, for example,
with institutes of higher education and corporate partners that
are in those areas.
A third important partner for us is the work that we do
with Homeland Security. And so we are very delighted that we
actually have a liaison that sits over in Mr. Rodi's area, so
we can make sure that the information that they are getting is
getting sent to the Department as well.
Senator Cantwell. Yes?
Dr. Tabak. If I may add, the NIH Director in August 2018
sent out a ``Dear Colleague'' letter to every one of our
grantee institutions to alert them to this issue. And we have
been working very closely with the professional organizations,
APLU and AAMC and so forth, to ensure that their membership is
increasingly aware. And again, in partnership with my
colleagues here, we are doing more and more outreach to
university communities to make sure that they understand these
issues.
Senator Cantwell. Since we are involved in this on a broad
scale with cybersecurity issues, one of the things that we
constantly face is ever-changing landscape and tactics that
people are using. So I am more interested in what is the--
instead of the ``Dear Colleague'' letter, what is the ongoing
infrastructure for threat assessment? That is what I would like
to know. And if we have one, that is good to know. If we do not
have one, what can we do to create one?
Dr. Schmoyer. Ma'am, a couple of quick things. Number one
would be mentioning--I had earlier--the developing program in
conjunction with NIH as well as our OIG partners, looking at
working with institutes of higher education, especially those
that are specifically funded by NIH, is a huge part of that.
Secondly, in the afternoon briefing I will be able to
provide you specific details on what we are doing and how we
are doing it.
Senator Cantwell. Okay; so you are the ongoing coordinating
entity?
Dr. Schmoyer. So we work with a variety of different
partners. The primary one at the larger level is the National
Security Council. At other levels, the National
Counterintelligence and Security Center in conjunction with the
FBI is a coordinating part. And then when it comes to NIH-
funded partners, we are the coordinating element in that body.
Senator Cantwell. So, Senator Wyden and our colleagues
here, for the utility sector there are organizations that play
this role in coordinating with everybody, so I would hope that
we would figure out some formal way to make sure that these
institutions are working on this collaboratively with us. But I
think we have to give them some ongoing information. In the
utility sector, NERC plays that role. And so they continue to
monitor and feed that information. Because a lot of our
utilities are hacked on a daily basis by state actors. So we
just have to up our game here, and so I appreciate working with
all of you on how we do that to communicate to the local
entities about what is happening.
Thank you, Mr. Chairman.
Senator Wyden. Thank you, Senator Cantwell and colleagues.
I very much share Senator Cantwell's view. I am kind of calling
some audibles here because we have some votes.
Senator Cornyn is going to ask some things briefly, and
then I am going to see if I can start the next process with the
chairman coming back. Senator Cornyn?
Senator Cornyn. Dr. Tabak, is there a gold standard by
which an institution, a research institution, can be certified
by either a professional association or by the Federal
Government to have met certain minimum standards to protect the
integrity of their data and their research?
Dr. Tabak. Part of the terms and conditions for all of our
awards--there are standards that every institution needs to
meet and attest to. And if they fail to meet those standards,
then they are put under a more careful watch.
Senator Cornyn. Because it strikes me that once the cat is
out of the bag, it is pretty hard to get it back in. I am
familiar with--and this is my last point. The Defense Security
Service issues recognitions--for example they had a ceremony
for Texas A&M that got a Defense Security Service Award for
Excellence in Counterintelligence, which is the highest honor
given by the DoD to defense contractors who demonstrate
extraordinary results in enhancing national security.
What I am looking for is, is there some standard Congress
could set or we could recognize so everybody would know sort of
how they need to up their game in order to keep this
information safe? That is my last question.
Dr. Schmoyer. Yes, we would work with you on that, sir.
Senator Cornyn. That is a great answer.
Senator Wyden. Senator Cornyn quits while he is ahead.
What we are going to do now is, we will excuse all of you
gentlemen. Thank you, and I believe we are going to see you a
bit later. So we will excuse you at this time.
I would like to have Dr. Joe W. Gray come forward. He is an
Oregonian. We are delighted to have him from the Oregon Health
Sciences Center. And I want to just describe what will happen
now. There are only a couple of minutes left in the vote.
Dr. Gray is a distinguished professor and chair of the
Department of Biomedical Engineering, director of the Center
for Spatial Systems Biomedicine, associate director for
biophysical oncology at the Knight Cancer Institute at OHSU,
and he is also a principal investigator on some important
projects at the NCI Center for Cancer Systems Biology. He works
at the NIH Library of Integrated Network-Based Cellular
Signature Center, the NCI Human Tumor Atlas Network Research
Center, and is co-director of the Serial Measurement of
Molecular and Architectural Responses to Therapy.
That is a mouthful, but in plain English, Dr. Gray is a
very distinguished scientist, and he is from my home State. We
are delighted to have him.
I am going to be juggling not just the vote, but also I
have a meeting coming up. Chairman Grassley will be coming
back. And I would just like for the record, Dr. Gray--apropos
of what we talked about--I am going to give you some questions
in writing. I hope you will also talk with Chairman Grassley
about the points behind these questions, because I think you
made an important case with respect to the essential value of
foreign researchers to the enterprises you are involved with.
I think you have made a critical point with respect to the
role of foreign researchers in developing U.S. patents and
intellectual property, and have also had important comments
about the very damaging consequences of the Trump NIH budget
cuts.
So I am going to ask you to respond to those questions in
writing for all issues that you and I have talked about. I hope
you will discuss them with the chairman when he comes back, and
we will make your remarks part of the record in their entirety.
I am going to run and vote, and Chairman Grassley will be
coming right back after the vote. So, thank you for your
patience. I am sorry that it is bedlam, even by traditional
Senate bedlam standards, and we will stand in a brief break at
this time until the chairman comes back. We will have those
questions for the record, and I hope you will highlight those
important points with the chairman as well. We will be taking a
quick break. The chairman will be back in just a couple of
minutes.
[The questions appear in the appendix.]
The Chairman. Before you give your testimony, I want to
apologize. For people like you who travel as far as you did to
do this, and then to get in an environment where we have four
votes, and I am probably going to be the only one to hear you
and the only one to ask questions, it is very rude of us. But I
do not know what we can do about it, because we do not run the
Senate floor, we just run this committee.
You have been introduced by Senator Wyden, so would you
proceed with your testimony, please, and then I will have some
questions. And I imagine I am the only one who is going to ask
you any questions, but you may get questions in writing from
some of us.
STATEMENT OF JOE W. GRAY, Ph.D., GORDON MOORE CHAIR OF
BIOMEDICAL ENGINEERING; AND ASSOCIATE DIRECTOR FOR BIOPHYSICAL
ONCOLOGY, KNIGHT CANCER INSTITUTE, OREGON HEALTH AND SCIENCE
UNIVERSITY, PORTLAND, OR
Dr. Gray. Senator Grassley, I appreciate the invitation
from you and Senator Wyden and the other members for the
opportunity to present my views as an academic scientist on the
foreign threats to taxpayer-funded research.
My formal training is in engineering and physics, but I
have spent the last 40 years of my research career doing
biomedical research, basically working to improve the detection
and treatment of cancers and other diseases. I began my career
at the Lawrence Livermore National Laboratory, where I held a
top secret clearance. I then moved to positions at the
University of California San Francisco, Lawrence Berkeley
National Laboratory, and now Oregon Health and Sciences
University. And I participated in several large international
research programs, including the Human Genome and the Cancer
Genome Atlas projects.
During the course of my career, I have co-authored almost
500 papers, and I am co-inventor on 80 U.S. patents. It is
important to note that foreign nationals made key contributions
to many of these, including inventions that were successfully
commercialized by U.S. companies.
As a consequence of my employment at the Lawrence Livermore
National Lab, I am well aware of the need to protect
information that is of strategic importance to the United
States. I am also aware of the constraints that strict control
of information imposes on scientific exchange, innovation, and
biomedical translation.
During my time at Livermore, the entry and movement of
foreign nationals within the laboratory was strictly
controlled, as were my trips to foreign meetings and my
exchanges with individuals there. I certainly consider my time
at Livermore to have been scientifically productive. Indeed,
several inventions that have been successfully commercialized
by U.S. companies were initiated at Livermore, so innovation
can and does occur in controlled environments. However, the
full development and exploitation of these inventions required
national and international interactions that would have been
difficult in the constrained Livermore environment. Moreover,
the cost in money, time, and efficiency of research in that
controlled environment was extraordinarily high. My move from
Livermore to the University of California-San Francisco was
motivated in part by my desire to escape those constraints.
Innovation drives scientific and economic growth, and I am
a strong proponent of the idea put forth by Steven Johnson in
his book ``Where Good Ideas Come From'' that innovation results
from planned and unplanned interactions between individuals,
and that the level of innovation increases with the number and
diversity of those interactions. Foreign nationals bring
different educational backgrounds, new skill sets, new ways of
thinking, and access to new resources and technologies. Their
participation in U.S. research programs increases intellectual
diversity and, in so doing, increases innovation. We run the
risk of stifling innovation whenever we impose constraints.
Sometimes that is necessary, but I think it needs to be kept to
an absolute minimum.
Scientists in the U.S. today face many challenges:
uncertain funding, burdensome requirements for reporting,
increasing workplace regulations, and keeping up with the
daunting flow of new ideas and data that are being generated
worldwide. We are successfully dealing with these challenges,
but just barely. If additional requirements are put into place
that regulate interactions with foreign nationals, the natural
tendency of many scientists will be to avoid the interactions.
This may significantly diminish innovation within the United
States.
Mining the unprecedented amount of rich data that are now
being generated worldwide is especially challenging. It is
impossible to anticipate at this point how these data might be
most effectively used for societal and economic benefit. We
rely heavily on the international community for help in that.
It is equally impossible to anticipate how they might be
misused. The controls on data sharing that are now in place do
protect against many forms of misuse, and I believe that
further efforts to control access to these data will not have a
measurable impact on their misuse but might have a significant
negative impact on their effective use.
Instead of imposing constraint on interactions, which would
be very expensive to implement, I think that we should make it
easier to protect our intellectual property, accelerate its
transfer to the U.S. private sector, and aggressively protect
the intellectual property that we do generate using existing
legal and political means.
The best and brightest scientists in the world come to the
U.S. to study and work because of our free and open system. I
believe that adding constraints will not effectively deter
nefarious activities but will diminish innovation, slow the
development of solutions to important societal problems, and
slow U.S. economic growth.
I think it is very important not to let the transgressions
of the few, which are real, inhibit the successes of the many.
Thank you.
[The prepared statement of Dr. Gray appears in the
appendix.]
The Chairman. Thank you, and I will have three questions.
And then I assume that, with four votes, nobody else is going
to come back to ask questions.
We wrote a letter on August 20, 2018, to NIH grantee
institutions. NIH called attention to a series of threats posed
by foreign entities to the integrity of our biomedical
research. In that letter, NIH warned that foreign actors have,
quote, ``mounted systematic programs to influence NIH
researchers and peer reviewers,'' end of quote, but may have
also worked to divert intellectual property produced by NIH-
supported research to other countries and may have contributed
resources to NIH-funded researchers in ways that could impact
the integrity.
So with that background, Dr. Gray, given the strong
evidence presented by the first panel that foreign governments
and foreign actors have succeeded in efforts to improperly
influence researchers and taxpayer-funded research, would you
agree that we need more robust vetting procedures and
processes?
Dr. Gray. I certainly acknowledge that there have been
misuses of data and intellectual property. And I do agree that
there needs to be vigorous enforcement of laws that punish
individuals and countries that participate in that.
The issue of whether or not we should impose additional
vetting is a difficult one, because the process of doing this
vetting in essence stigmatizes the whole community that is
being vetted. And so in doing that, it decreases their
enthusiasm for actually coming to the United States to work
with us to advance our scientific ideas.
In essence, what I am worried about is that it will
diminish our own ability in the United States to innovate. And
that is a problem. The United States comprises 5 percent of the
population of the world, and we draw the best minds from all of
the world. And what we do not want to do is to diminish our
brain gain by making it unattractive for those individuals to
come to the United States and work with us to solve our
societal problems and to help us form the companies that are
really, quite frankly, driving the U.S. economy today.
The Chairman. My second question may be a little easier for
you to answer, and I know the sincerity of your answer. I guess
you know where I am coming from. I believe that there needs to
be more vetting.
The second question is: have you personally experienced any
of those foreign-government efforts?
Dr. Gray. So I have not personally experienced any efforts
on the part of a foreign government, to my knowledge, to
illegally acquire any information that I have been in the
process of generating. That said, we go out of our way to make
genomic and other comparable data available to the world.
And the reason for that is that we are in the very early
stages of even beginning to understand how to interpret those
data. And it takes the minds of many, many people to come up
with the best ways of wringing the knowledge that one can get
out of that data, and there are a lot of international efforts
in which we participate, actually, that deliberately make the
data available and ask the scientific community to help us
solve vexing problems.
And one of the things that becomes clear from those efforts
is that the wisdom of the crowd is smarter than the wisdom of
any individual. And so having more minds think about these
complex data sets is actually advantageous to us in trying to
solve the problems that we generated the data to solve in the
first place.
The Chairman. The last question. If you found that one of
your researchers on a taxpayer-funded project failed to
disclose foreign financial contributions, what would you do?
Dr. Gray. I think that one of the things that is not clear
today, to me at least, is the extent to which information needs
to be disclosed. The rules on that are changing, and have
changed over the last while, and so I think at this point in
time the answer would be, I would counsel them on how to do a
better job of disclosing the information.
If I thought that the information was being disclosed for
some nefarious activity, I think that that would be grounds for
termination. But for the most part, people are often not clear
about the exact rules about what needs to be disclosed, about
the extent to which it needs to be disclosed. And so, until
that gets clarified, then I think that we are going to be
unable to probably comply with what you would like to see
disclosed.
The Chairman. Okay. I thank you for your testimony and for
coming a long distance, and thank you for your research and
what you are doing.
The hearing is adjourned.
Dr. Gray. Thank you for the opportunity.
The Chairman. You bet.
[Whereupon, at 11:35, a.m., the hearing was concluded.]
A P P E N D I X
Additional Material Submitted for the Record
----------
Prepared Statement of Hon. Chuck Grassley,
a U.S. Senator From Iowa
Good morning. I'd like to welcome everyone to the Finance
Committee's hearing on foreign threats to taxpayer-funded research.
Taxpayer-funded research has been integral in keeping American medical,
defense, information technology, and many other products at the
forefront of the world's market.
Simply said, the United States is the best of the best when it
comes to conducting cutting edge medical research. Our scientists push
the envelope to make crucial discoveries and better products, whether
it be vaccines, or other medical treatments and intellectual property.
These projects can produce important breakthroughs for patients and
industry--for the United States and the world.
We didn't develop this reputation overnight. We earned it, through
the persistent hard work and dedication of researchers across the
country. I'd like to call that a good old-fashioned American work
ethic.
I thank them for their service to our country and want them to know
that this committee's oversight isn't designed to interfere with the
pursuit of knowledge and the free exchange of information in the
research field. Rather, this committee's oversight is intended to
strengthen the integrity of taxpayer-funded research and to preserve
our valuable work product.
Truly free collaboration and exchange of information is only
possible when data and sources are credible and the research process
can be trusted. That trust is destroyed when foreign governments and
other entities interfere in our research for their gain and to our
detriment. Accordingly, Congress, the executive branch, and research
institutions, must work together to properly balance the robust
development and exchange of ideas in the research field with reasonable
and proportionate common-sense efforts to protect the integrity of the
research.
That's why I've engaged in oversight efforts in this field.
Beginning in October of last year, I wrote to the National Institutes
of Health, the Department of Health and Human Services, and the Health
and Human Services Inspector General about threats to taxpayer-funded
research. Since then, I've also written to the National Science
Foundation and the Department of Defense.
Today, we will focus on foreign threats to research funded by the
National Institutes of Health, its granting process, and downstream
grantees. Those threats include spying, theft of intellectual property,
disclosure of confidential information, and other related efforts that
undermine the integrity of research.
The NIH spends $39 billion of taxpayer money each year on medical
research. The American people worked hard for that money. And the
people deserve to know how the government is working to protect that
research and the resulting intellectual property from foreign threats.
We know that China is by far the most prolific offender; however
they aren't the only country acting against our interests. In October
2018, while chairman of the Judiciary Committee, I held a hearing on
China's non-traditional espionage against the United States. During
that hearing, I broached the issue of China's focus on our research
institutions and taxpayer-funded research. Today, we can get into more
detail regarding those threats.
It's without dispute that China has focused its energy on
leveraging our hard work for their benefit--and to our detriment. One
example hits home for me. In 2011, Chinese nationals tried to steal
genetically modified corn seeds from Iowa. They tried to ship them back
to China. Those seeds were the product of years of research and
development. The Chinese Government says they're ``picking flowers in
foreign lands to make honey in China.'' I believe them.
Whether we're talking about Confucius Institutes spreading
propaganda on college campuses, China's ``Talent Programs'' that have
been called ``brain gain'' programs, or China planting spies in our
industry, the government of China is a serious problem. In 2013,
Chinese nationals were charged with conspiring to steal research funded
by a multi-million dollar NIH grant for the benefit of a Chinese
governmental entity and a direct competitor of the American university
where the research was conducted.
In an August 20, 2018, letter to NIH grantee institutions, NIH
called attention to a series of threats posed by foreign entities to
the integrity of U.S. biomedical research. In that letter, NIH warned
that foreign actors have ``mounted systematic programs to influence NIH
researchers and peer reviewers,'' may have worked to divert
intellectual property produced by NIH-supported research to other
countries, and may have contributed resources to NIH-funded researchers
in ways which could impact the integrity of the research.
In January of this year, the HHS Inspector General notified me that
NIH recently made 12 referrals in this area to the Inspector General.
Those referrals primarily involved principal investigators--essentially
the primary researchers--on NIH grants conducting medical research at
U.S. universities. Those researchers allegedly failed to meet NIH
requirements to disclose foreign affiliations on their grant
applications. That's a serious problem.
Researchers who are secretly supported by a foreign government
while working on U.S. research projects can be more susceptible to the
influence and control of the foreign parent. We must know who is
financially supporting researchers to better understand whether they
might be more dedicated to securing the interests of an adversary than
to rigorous scientific and medical advancement.
Our witnesses can speak to those specific threats and the
government's capabilities to detect and deter them. Today, we have
witnesses from the National Institutes of Health, the Health and Human
Services Office of National Security, the Health and Human Services
Inspector General, and the Department of Homeland Security.
The FBI was invited by the committee, given that they are a
critical aspect to counterintelligence efforts in this field. The
committee invited them on April 30th. That's 26 business days before
the hearing date. On May 6th, the FBI said it would be ``unable to
participate'' in the hearing but failed to explain why. My staff
followed up via email and phone. On May 7th, the FBI reiterated that
they would not be able to appear but again failed to explain why. On
May 16th, the FBI responded via email and said the
``Counterintelligence Division respectfully declines the hearing
invite,'' yet again failing to explain why. On May 23rd, I wrote a
letter to the FBI again inviting their attendance. On May 29th, the FBI
responded in writing and stated that it ``does not have a witness
available to attend the hearing and briefing.''
After just about 1 month of communications between the FBI and my
staff, the FBI failed at every turn to explain why the entire
Counterintelligence Division did not have a single employee available
to attend today's hearing. That's inexcusable, and it's a shame. What a
wasted opportunity for them to explain to this committee and the
American people what they're doing to help these agencies detect and
deter threats to our research.
The American people deserve more than a stiff-arm from the FBI.
However, I appreciate the cooperation of the expert witnesses who are
here today and I look forward to a robust conversation.
Generally speaking, there are four main issues relating to
taxpayer-funded research that we will touch on:
1. Failure to Disclose: Some researchers hired to work on U.S.
research projects haven't disclosed that they've received
financial contributions from foreign countries.
2. Espionage: Some researchers are spies, and their only
purpose is to infiltrate taxpayer-funded research projects to
steal intellectual property and bring it to their home country.
3. Vetting: The Federal Government doesn't vet all researchers
hired by U.S. institutions to work on taxpayer-funded research,
and neither do the institutions.
4. Integrity: Some peer reviewers have shared confidential
information from grant applications with foreign governments,
which would allow them to potentially skip research steps. Some
have also attempted to influence funding decisions, undermining
the integrity of taxpayer-funded research.
These threats to our research are ongoing, aggressive, and real.
The question is, does the government have the capabilities to detect
these threats, combat them, and deter them to protect our research and
any intellectual property created from it?
Today is an opportunity for the witnesses to engage in a frank
discussion about what that threat is and what we in Congress and the
executive branch can do together to solve the problem. Congress and the
executive branch must be on the same page. So, if you believe there are
legislative and policy solutions that will assist you with your already
difficult jobs, now is the time to bring them forward.
I look forward to a robust discussion today on these matters. After
this morning's hearing, the committee will move this afternoon to a
classified briefing on the same subject matter. I strongly encourage
the witnesses to take advantage of the highly classified environment to
provide as much information to the committee as possible.
______
Prepared Statement of Joe W. Gray, Ph.D., Gordon Moore Chair of
Biomedical Engineering; and Associate Director for Biophysical
Oncology, Knight Cancer Institute, Oregon Health and Science University
Senator Grassley and members of the committee, thank you for the
opportunity to present my views on aspects of foreign threats to
taxpayer-funded research. I am the Gordon Moore chair of biomedical
engineering and associate director for biophysical oncology in the
Knight Cancer Institute at Oregon Health and Science University. My
formal training is in engineering and physics, but I have spent my
research career of more than 40 years in biomedical research,
developing and deploying advanced measurement technologies to elucidate
the mechanisms that are important in the development and treatment of
cancer and other diseases.
I have participated in aspects of several large-scale international
research programs such as the Human Genome Sequencing Project, the NIH
Cancer Genome Atlas project, NCI Cancer Systems Biology projects, and
the NCI Cancer Moonshot program. All of these projects have benefited
from the work of foreign nationals and from robust international data
exchange. During the course of my career, I have published nearly 500
papers, and I am a co-inventor on 80 U.S. patents. Importantly, foreign
nationals made key contributions to many of these. In fact, scientists
from Finland, Canada, Japan, and Russia were co-inventors on some the
most important including several that were successfully commercialized
by U.S. companies.
I began my career at the Lawrence Livermore National Laboratory
where I held a top-secret security clearance. I then moved to faculty
and research positions at the University of California San Francisco,
the Lawrence Berkeley National Laboratory and now Oregon Health and
Science University.
As a consequence of my employment at the Lawrence Livermore
National Laboratory, I am well aware of the need to protect information
that is of strategic importance to the United States. I am also aware
of the constraints that the strict control of information imposes on
scientific exchange, innovation and translation to improved patient
outcomes. During my time at Livermore, the entry and movement of
foreign nationals within the laboratory was strictly controlled as were
my trips to meetings in foreign countries. The administrative and
financial cost of these monitoring efforts was substantial.
I certainly consider my time at Livermore to have been
scientifically productive. Indeed, several of my most significant
inventions that have been successfully commercialized by U.S. companies
were initiated at Livermore. So, innovation can and does occur in
controlled environments.
However, the full development and exploitation of these inventions
required national and international interactions that would have been
difficult in the constrained Livermore environment. It was also clear
that the cost in money, time and efficiency of doing research in this
controlled environment was extraordinarily high. In fact, my move from
Livermore to the University of California San Francisco was motivated
in part by my desire to achieve relief from these controls.
I am a strong proponent of the idea put forth by Steven Johnson in
his book, ``Where Good Ideas Come From,'' that innovation results from
the integration of ideas and facts that arise through planned and
unplanned interactions with other individuals. I also support his
contention that the level of innovation increases with the number and
diversity of those interactions. We run the risk of stifling innovation
whenever we constrain interactions. Sometimes that is necessary but it
should be kept to an absolute minimum.
It has been my experience that the way people approach problems is
colored strongly by their past experiences and by the nature of their
education. It is also my experience that individuals educated in other
countries bring different ways of thinking and different facts.
Further, these individuals undergo extensive vetting to ensure a high
level of education and potential. Thus, I believe that innovative
solutions to the complex problems we are trying to solve throughout the
biomedical community today will occur most rapidly through the free and
open exchange of information and ideas, including with a broad range of
foreign nationals.
I believe that scientific innovation is one of the cornerstones of
economic growth in the United States. I also believe that regulatory
constraints that interfere with the free exchange of information and
ideas will substantially decrease our level of innovation and therefore
our economic and scientific competitiveness.
Scientists in the United States today face many challenges. These
include uncertain funding, burdensome requirements for reporting,
increasing workplace regulations and keeping up with the daunting flow
of new ideas and data that are being generated worldwide. We are still
successfully dealing with these challenges but just barely. Should
additional requirements be put in place that regulate interactions with
foreign nationals, the natural tendency of many scientists will be to
avoid the interactions. I believe that this will significantly diminish
innovation within the United States.
It is also important to know that many remarkable measurement tools
now being developed around the world are providing an unprecedented
amount of rich information about normal and diseased tissues,
information that can be mined to yield new insights into disease
prevention, detection and treatment. It is impossible to anticipate at
this point how these data might be most effectively interpreted. It is
equally impossible to anticipate how these data might be misused. The
controls on data sharing that are now in place do protect against most
forms of data misuse and I believe that efforts to further control
access to these data will not have a measurable impact on data misuse
but will have a significant negative impact on innovation.
In sum, I believe that the economic strength of the United States
depends on innovation and on the speedy implementation and
commercialization of innovative ideas. I believe that the controls that
are already in place provide a workable balance between protecting data
and intellectual property and allowing the free exchange of data and
information needed for effective innovation. I believe that additional
efforts to control interactions with foreign nationals will decrease
innovation and, in so doing, will diminish the economic power of the
United States and will have little impact on foreign misappropriation
and misuse of information and ideas. Most innovative ideas and data
will in any case eventually become available through the published
literature and in published patents and so will be available for
misuse. Instead of imposing constraints on innovation, which would be
very expensive to implement, I advocate for adding supports to make it
easier to protect the intellectual property that is generated with
taxpayer dollars. I also recommend supporting the rapid and efficient
transfer of information from academia to the private sector as well as
between researchers worldwide so that maximum benefit can occur from
the massive new technological advances and the big data being
generated.
There are many barriers now in place to the kinds of technology
transfer that will enable us to rapidly exploit academic innovations. I
believe that our efforts would be best spent in reducing these
barriers. This includes providing support for intellectual property
development and substantially increasing support for early-phase
business developments. In the end, economic success will come from
rapid innovation and development, and aggressive protection of
intellectual property using existing legal and political tools. The
misappropriation of data and ideas is serious but should be dealt with
through already existing legal and political means and not by placing
constraints on the free information and idea exchange on which the U.S.
competitive advantage depends.
I believe the best and most intelligent scientists in the world
come to the United States to study and work because of our free and
open system. Additional constraints will not effectively deter
nefarious activities but will diminish innovation and U.S. economic
growth. It is very important to not let the transgressions of a few
inhibit the successes of the many.
______
Questions Submitted for the Record to Joe W. Gray, Ph.D.
Questions Submitted by Hon. Ron Wyden
Question. Essential Value of Foreign Researchers: Dr. Alicia
Carriquiry, president's chair in statistics and distinguished professor
at Iowa State University, has stated that ``without foreign-born
researchers, the entire system of higher education in the United States
would collapse in a minute.'' Do you agree with Dr. Carriquiry's
assessment of the importance of foreign-born researchers for U.S.
medical science and our system of higher education?
Answer. I do agree with Dr. Carriquiry's assessment. The importance
of foreign-born researchers to the United States scientific and health-
care enterprise cannot be overstated. Since World War II, the United
States has been the most popular destination for science and
engineering students who choose to study abroad. Many of these
individuals stay in the United States and make their lives here,
contributing in profound ways both to society and to the U.S. economy.
This openness to immigration has helped make the U.S. a world leader in
science and technology. However, short-sighted domestic policy
threatens both our research and development system and our economy.
Foreign-born entrepreneurs helped start one-fourth of all new U.S.
engineering and technology businesses between 1995 and 2005, including
Google and eBay. As I stated in my testimony, the best and most
intelligent scientists in the world come to the U.S. today to study and
work because of our free and open system. Importantly, we keep the best
and most impactful here after they complete their training. They serve
as a key part of the U.S. ``innovation engine'' that drives our
economy. In my view, additional constraints will not effectively deter
nefarious activities but will diminish innovation and U.S. economic
growth.
Question. Role of Foreign Researchers in Developing U.S. Patents/
Intellectual Property: The most recent data from the U.S. Patent and
Trademark Office shows that more than 50 percent of patents granted are
held by foreigners--either as the primary inventor or co-inventor. Your
own work is described in more than 80 patents. To what extent would
that work and those patents have been possible without the aid of
foreign researchers and what discoveries might have remained unearthed
in the absence of those researchers?
Answer. Foreign researchers were co-inventors and key innovators on
approximately half of my issued U.S. patents. The foreign researchers
were key to our being first and to the issuance of U.S. patents that
were subsequently licensed to U.S. companies. Had we not been first, it
is likely that the discoveries would have been made by researchers in
other countries and led to their commercial development there. The key
contribution of foreign researchers is also apparent in many of the
high-impact scientific research programs I have had the opportunity to
contribute to in my career. These include the Human Genome Sequencing
Project, the National Institutes of Health's Cancer Genome Atlas
project, the National Cancer Institute's Cancer Systems Biology
projects, and the Cancer Moonshot program. The innovations taking place
in these important programs are advancing our ability to understand and
mitigate the impact of many aspects of human disease. This is important
to the well-being of U.S. citizens and citizens of the world. The
solutions are, of course, enabled by commercial developments and these
will be made by companies that learn about them first and that have the
skilled leaders and workers to execute on development. This now happens
in the U.S. because the discoveries are made here and because we have
the skilled workers for development. Foreign scientists and
technologists in U.S. laboratories and companies are essential to these
activities.
Question. Other Threats to U.S. Research: Foreign students are
becoming a more and more important source of tuition for U.S. colleges
and universities due to State and Federal funding cuts. A recent study
by the Association of International Educators noted that over a million
foreign students attended U.S. colleges and universities in the 2017-
2018 academic year and contributed an estimated $39 billion to the U.S.
economy. On the other hand, President Trump's fiscal year 2020 budget
request would cut NIH funding by nearly $5 billion compared to fiscal
year 2019 funding levels. Given that the bulk of OHSU's research awards
come from NIH, what kind of an effect would decreased NIH funding have
on the scientific output of your laboratory, your university and U.S.
universities overall?
Answer. Approximately half of the research in my research program
comes from the NIH. This research is directed primarily at developing
more durable and tolerable treatments for metastatic cancers. The work
is quite promising and takes advantage of the remarkable amount of new
data being generated around the world. However, converting data into
knowledge and biomedical insight requires a lot of ``thinking time.''
I, like most scientists in the U.S. today, spend far too much time
writing grant proposals, preparing progress reports for successful
grants, worrying about job security and complying with an increasing
number of regulatory requirements instead of thinking about science so
we can make progress. Young U.S.-born scientists see this and are
shying away from science as a consequence. Decreasing the NIH budget
will continue this trend so that discoveries that we could be making
will be discovered first in other countries by foreign researchers who
are better supported.
This is being played out at OHSU and in universities across the
country. OHSU, Oregon's only academic medical center, relies heavily on
NIH funding to carry out life-saving research. In 2018, OHSU scientists
received more than $245 million in NIH funding, across 486 awards.
While Congress has increased NIH funding in recent years, total funding
as a share of GDP is still 12 percent below that of 2003. Far from
cutting NIH funding, it is critical that we increase support for basic
and translational research, which in turn drives economic growth in
communities across the country. NIH funding supported nearly 380,000
jobs and $65 billion in economic activity in 2016 alone.
While it is tempting to focus on the direct value to foreign
students and U.S. research, I believe that it is more important to
focus on the larger value that these students make to the U.S. economy.
Many of the best and brightest of these students stay in the U.S. and
contribute to academic medicine and to the development of biotechnology
and pharmaceutical industries--the combined market value of which is
approaching $1 trillion.
Question. Administrative Burden: You mentioned the administrative
burden additional regulatory constraints could have on innovation in
your lab. We know that, according to the National Science Foundation,
top researchers in the United States spend 50 percent of their time
writing grants. Yet, in 2016, only 17 percent of NIH grant applications
were approved. Can you give examples of current administrative burdens
you face and please explain the amount of time you and researchers in
your lab spend on paperwork (grants, etc.), as well as the additional
costs you anticipate should the Federal Government impose additional
constraints--like vetting requirements--on your research?
Answer. My research is heavily oriented toward ``translation.''
That is, elucidation of aspects of biology and technology that we need
to improve cancer care. This is fundamentally a team science effort and
requires organization of and participation in local, national, and
international meetings that are needed to move projects forward. The
interactions that occur during these meetings are both planned and
spontaneous with all participants contributing new ideas as they occur.
Many good ideas occur spontaneously during the course of discussions
and so are impossible to anticipate. The ideas are innovative only in
the context of the discussion and so are impossible to vet. It seems
the only way to ensure that individuals do not receive information
deemed sensitive would be to exclude them from meetings where sensitive
topics would be discussed. This would then require a detailed
assessment of topics that might be sensitive. I expect compiling such a
list would be enormously time consuming and would require a detailed
assessment of future U.S. economic strategy. This is certainly not
something that universities have the resources to undertake. If such a
list were compiled by a collection of Federal agencies, it would have
to be updated continuously and the information communicated to all
universities and other research institutions so that risk assessment
could be made. This would be an enormous and ongoing risk education
process. Any time spent learning about risk would be time not spent
thinking.
In direct answer to the question, I estimate conservatively that I
already spend 75 percent of my time on aspects of science
administration. That time includes preparing grant proposals; preparing
progress reports for grants that are successful; clinical trials
reporting; complying with FDA guidelines; seeking support from industry
and philanthropy to supplement, extend, or commercialize our research
findings; participating or coordinating phone calls and face-to-face
meetings; and organizing data and managing data sharing rules so it can
be analyzed by ourselves and by the international community. Adding
continual risk assessment to the set of tasks I now do would bring my
scientific program to a halt. The only practical way around that would
be to exclude foreign researchers from the laboratory which I believe
would eliminate access to some of the best minds in the world, reduce
access to important data and destroy our ability to compete with the
best and brightest in the world.
______
Question Submitted by Hon. Sheldon Whitehouse
Question. The competition for global scientific talent is growing.
Does the United States risk falling behind other countries if our visa
rules and processes diminish our ability to recruit the best and
brightest global talent?
Answer. The United States absolutely risks falling behind other
nations. In order to maintain its competitive edge, the U.S. must do
more to attract international talent, not less. Policy measures that
discourage foreign researchers from fully contributing to our
scientific endeavors will reduce American competiveness. The economic
strength of the United States depends on innovation and on the speedy
implementation and commercialization of innovative ideas. The controls
that are already in place provide a workable balance between protecting
data and intellectual property and allowing the free exchange of data
and information. Additional efforts to control interactions with
foreign nationals will decrease innovation and, in so doing, will
diminish the economic power of the U.S., while having little impact on
foreign misappropriation and misuse of information and ideas. The best
way to make the U.S. more competitive economically is to increase the
innovation engine through increased NIH funding, to make funds
available to support protection of intellectual property and to
encourage early phase startup companies in the U.S. so that discoveries
are translated rapidly and successfully. The small loss to nefarious
activities will be far outweighed by the resulting economic gain.
I will close with an analogy: people speed when they drive. We
don't solve that problem by putting governors on cars. We enact laws to
punish those who speed.
______
Prepared Statement of Leslie W. Hollie, Chief of Investigative
Operations, Office of Inspector General, Department of Health and Human
Services
Good morning, Chairman Grassley, Ranking Member Wyden, and
distinguished members of the committee. I am Leslie W. Hollie, Chief of
Investigative Operations 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,
protect taxpayer-funded medical research.
OIG is charged with overseeing all HHS programs and operations. 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.
The National Institutes of Health (NIH) has recently referred to
OIG for investigation 16 \1\ allegations of noncompliance with its
terms and conditions for receiving a medical research grant. The
allegations primarily deal with the failure of principal investigators
to disclose foreign government affiliations. Because these referrals
are all still active, to avoid compromising ongoing investigations, I
cannot provide further details at this time. However, I can cover how
we generally handle grant fraud allegations related to taxpayer-funded
medical research.
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\1\ This number includes four additional referrals from NIH since
our January 31, 2019 letter of response to Chairman Grassley's January
17, 2019 letter on the topic in which we reported having a dozen such
complaints on hand.
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 third-
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. In addition to our standard
hotline, we also provide a ``grant and contract portal'' especially for
HHS employees to refer grant and contract matters to OIG.
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 violation of civil or criminal law during an
investigation, OIG presents the facts to the Department of Justice
(DOJ) 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 two summaries of recently resolved research integrity
investigative cases.
A doctor who worked in a laboratory at Iowa State University,
which received research grants for an experimental HIV/AIDS
vaccine, falsified scientific data to make it appear an
experimental HIV/AIDS vaccine neutralized, or controlled, the
HIV/AIDS virus in rabbits, and contaminated rabbit blood
samples with human antibodies to make it appear the rabbits
produced neutralizing antibodies against the HIV/AIDS virus.
The data from these actions were used in a grant application
and progress reports to NIH. The doctor was sentenced to 57
months in Federal prison, 3 years of supervised release, and
$7.2 million restitution.
Another doctor founded two companies, GenPhar and Vaxima, to
perform research and produce a vaccine for diseases such as
Ebola, Marburg Virus, and Dengue Virus. GenPhar and Vaxima
obtained Federal grant money (including NIH SBIR funds) for
biodefense research and vaccine development, but actually used
the funds for other purposes, including construction of a
commercial office building and to pay lobbyists and others who
were seeking to secure more Federal funding on the doctor's
behalf. The doctor was sentenced to 70 months in Federal prison
and ordered to pay over $3 million in restitution.
As mentioned earlier, OIG's approach to preventing and enforcing
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 intelligence
community and HHS's Office of Research Integrity (ORI) to promote
awareness of research misconduct and helps with efforts to improve
protections. For instance, before I received the invitation to testify
here today, I was scheduled to deliver a joint presentation along with
an ORI colleague entitled ``When Research Misconduct Involves Potential
Criminal Behavior: New Collaboration Strengthens Protection of U.S.
Biomedical Research Funding.'' In addition to such joint training
efforts, ORI notifies OIG when conduct that might be criminal activity
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. In
fiscal year 2019, OIG received $5 million in appropriations for
oversight of grant programs and operations of NIH, including NIH
efforts to ensure the integrity of its grant application evaluation and
selection processes.\2\ We have evaluations underway to assess NIH's
vetting and oversight of its peer reviewers, including its efforts to
prevent or identify inappropriate disclosure of information by peer
reviewers, and an evaluation of how NIH monitors the financial
conflicts of interest (including foreign financial interests) reported
by grantee institutions. In addition, we are examining NIH's adherence
to its policies for evaluating and selecting grant applications.
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\2\ The Department of Defense and Labor, Health and Human Services,
and Education Appropriations Act, 2019 and Continuing Appropriations
Act, 2019 (Public Law No. 115-245). As required by this law, OIG
submitted a comprehensive NIH oversight plan to the Committee on
Appropriations of the House of Representatives and the Senate; the
Senate Committee on Health, Education, Labor, and Pensions; and the
House Committee on Energy and Commerce.
OIG is also initiating audits that will assess NIH's Institutes and
Centers to review their (1) pre-award process for assessing risk of
potential recipients of Federal funds; (2) policies, procedures, and
controls in place for ensuring that both foreign and domestic grantees
disclose all relevant affiliations, sources of support, and financial
interests, including intellectual property interests; (3) internal
controls for identifying and addressing potentially duplicative grant
funding and overlap; (4) testing of select cybersecurity controls
within the NIH Electronic Health Records system; and (5) controls to
ensure that NIH has an accurate inventory of hardware, software, and
Internet Protocol resources.
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.
______
Questions Submitted for the Record to Leslie W. Hollie
Questions Submitted by Hon. Chuck Grassley
Question. According to the Health and Human Services Inspector
General, NIH has recently referred for investigation a 16 allegations
of noncompliance related to medical research. The Inspector General
stated the allegations primarily deal with the failure of principal
researchers to disclose foreign government affiliations.
Where do those referrals from NIH currently stand? Were any
investigations opened or matters referred to other agencies, such as
the FBI? If so, how many and to what agency?
Answer. The referrals that OIG received from the National
Institutes of Health (NIH) have all become open and active
investigations. Therefore, we cannot provide further details at this
time.
Question. According to NIH, it operates both the intramural program
and the extramural program for research activities. Within the
intramural program, NIH's employees, contractors, and affiliates who
are U.S. citizens undergo background investigations. Further, prior to
that background check, a Special Agency Check is conducted requiring
fingerprints to be cross-checked with FBI criminal databases including
terrorist watch lists. According to NIH, a grantee institution in the
extramural program, such as a university or other research institution,
is responsible for any vetting, not NIH.
More than $8 out of $10 appropriated to NIH goes to the extramural
program. At the committee hearing, I asked Dr. Tabak whether NIH
conducts background checks, including a review for counter-intel
purposes, on Principal Investigators prior to awarding a grantee
institution taxpayer money. He answered, ``No sir, we do not, as they
are employees of their home institution.''
If principal investigators were subject to the same background
check as NIH employees, and were also subject to a review for
counterintelligence purposes, how would those checks help strengthen
grant integrity?
Answer. OIG has found that background checks can be an important
tool for program integrity in certain contexts, such as for high-risk
providers in Medicare. We have not assessed the costs and benefits of
requiring background checks for NIH principal investigators. Given the
number of principal investigators funded by NIH, conducting background
checks for all of them would likely present logistical and resource
challenges. In general, OIG supports using risk-based approaches to
maximizing the impact of program integrity investments.
Question. If principal investigators were subject to the same
background check as NIH employees, and were also subject to a review
for counterintelligence purposes, would those checks improve the
government's security posture? If so, how? If not, why not?
Answer. OIG defers to the Department of Health and Human Services'
(HHS's) Office of National Security because the question being asked
falls under their purview.
Question. What additional changes would improve the integrity of
the grant system and taxpayer funded research? For example, should any
changes be made to government grant forms?
Answer. OIG conducts oversight of NIH through audits and
evaluations, some of which relate to protecting the integrity of NIH-
funded research. In fiscal year 2019, OIG received $5 million in
appropriations for oversight of grant programs and operations of NIH,
including NIH efforts to ensure the integrity of its grant application
evaluation and selection processes. We have evaluations underway to
assess NIH's vetting and oversight of its peer reviewers, including its
efforts to prevent or identify inappropriate disclosure of information
by peer reviewers, and an evaluation of how NIH monitors the financial
conflicts of interest (including foreign financial interests) reported
by grantee institutions. In addition, we are examining NIH's adherence
to its policies for evaluating and selecting grant applications.
OIG is also initiating audits that will assess NIH's Institutes and
Centers to review their (1) pre-award process for assessing risk of
potential recipients of Federal funds; (2) policies, procedures, and
controls in place for ensuring that both foreign and domestic grantees
disclose all relevant affiliations, sources of support, and financial
interests, including intellectual property interests; (3) internal
controls for identifying and addressing potentially duplicative grant
funding and overlap; (4) testing of select cybersecurity controls
within the NIH Electronic Health Records system; and (5) controls to
ensure that NIH has an accurate inventory of hardware, software, and
Internet protocol resources.
OIG would be happy to brief you on this body of work as these
reports are completed.
In February 2019, OIG released a report, Opportunities Exist for
the National Institutes of Health to Strengthen Controls in Place to
Permit and Monitor Access to Its Sensitive Data. Several of our
recommendations address improvements that NIH could make to bolster the
integrity of taxpayer-funded research.
Regarding government grant forms, we would encourage NIH to require
principal investigators and project directors to sign forms with
attestations and to require information about ``other income'' from
these individuals at an appropriate point in the process. OIG would be
happy to consult with NIH or provide further technical assistance to
Congress on this issue.
Question. What foreign governments pose the greatest threats to
intellectual property created by taxpayer-funded research at American
universities? How are they working to exploit our academic institutions
to steal critical IP? Can you share any specific examples of that
exploitation?
Answer. HHS-OIG defers to the Federal Bureau of Investigations'
(FBI's) Counterintelligence Division, because the question being asked
is one that falls within the scope of their jurisdiction.
Question. Have foreign nationals, acting surreptitiously on behalf
of foreign governments, penetrated critical U.S. industries, including
but not limited to health-care and pharmaceutical research,
infrastructure, financial services, defense, robotics and advanced chip
processing? If yes, please explain what changes, including legislative
changes, are needed to stop or slow these incursions.
Answer. HHS-OIG defers to HHS's Office of National Security and to
FBI's Counterintelligence Division, because the question being asked
falls under their purview.
______
Questions Submitted by Hon. Ron Wyden
Question. How Prevalent Is the Problem: In a January 31, 2019
letter to Chairman Grassley, HHS Inspector General Daniel Levinson
responded to several questions the chairman raised about foreign
threats to taxpayer funded medical research. Among the IG's responses:
in the past 5 years, OIG conducted one investigation of failure to
disclose foreign government funding and did not conduct any
investigations involving researchers who were allegedly foreign
government agents; in the past 5 years, OIG conducted one investigation
of alleged theft of intellectual property created by taxpayer-funded
research; and in the past 5 years, OIG made two referrals for possible
prosecution for failure to disclose receipt of foreign government
funding.
In your testimony, you say that OIG is now investigating 16
allegations of non-compliance by grantees. Has there been a dramatic
increase in the number of violations of these types of activities since
the IG wrote his response to Chairman Grassley on January 31st? If not,
does the OIG have reason to believe that these types of activities are
much more widespread than the handful of these incidents that were
reported to Chairman Grassley in the IG's letter? If so, what are the
reasons for this increase?
Answer. In our January 31st letter to Chairman Grassley, we
explained that we had recently received 12 referrals from NIH that
primarily involve principal investigators on NIH grants conducting
medical research at U.S. universities who allegedly have failed to
disclose foreign affiliations on their grant applications. Since that
time, we have received another 4 such referrals from NIH, bringing the
total to 16 allegations, which OIG is now investigating. Over the past
6 months, we have seen a very small increase in OIG hotline complaints
received primarily involving allegations of principal investigators on
NIH grants conducting medical research at U.S. universities who
allegedly have failed to disclose foreign affiliations on their grant
applications. We attribute this very small increase to both NIH's
ramped-up efforts to address such allegations over the past year as
well as greater awareness of the issue among other stakeholders due to
both increasing and widespread media reports and the Senate Finance
Committee's oversight efforts.
Question. Policy on Mixed Government and Non-Government Witnesses
on Panels: Your agency told the Finance Committee that its witness
would not participate on a panel at this hearing that included both
government and non-government witnesses, claiming there is a
longstanding OMB policy prohibiting this. However, there are numerous
examples where your agency has allowed witnesses to testify on ``mixed
panels.'' Over the past 10 years, Federal Government witnesses,
including those from your agency, have testified before the Finance
Committee on panels with non-government witnesses more than 40 times.
This has also been the case with other Senate committees. In April
2019, an NIH witness testified on a panel with non-government witnesses
before the Senate Aging Committee. An NIH witness also testified on a
panel with non-government witnesses before this same committee in July
2017. In March 2018, the Secretary of DHS herself testified on a panel
with non-government witnesses before the Senate Select Committee on
Intelligence. Why were these witnesses permitted to testify before
other Senate Committees on mixed panels, but your witness was not
permitted to do so at the Finance Committee's June 5th hearing? If
waivers were granted for witnesses to testify on mixed panels at other
committee hearings, why were those waivers granted for the other
hearings but not the June 5th hearing? Please provide copies of (1) the
OMB policy that allegedly prevents government witnesses from testifying
on panels with non-government witnesses; (2) any waivers granted for
the recent Aging and Intelligence hearings where government witnesses
from NIH and DHS respectively testified with non-government witnesses;
and (3) any request submitted to OMB for your witness to testify at the
June 5th hearing and the OMB response along with an explanation why a
waiver was not granted for the June 5th Finance Committee hearing?
Answer. This discussion was between HHS's Office of the Assistant
Secretary for Legislation and the committee. Therefore, HHS-OIG defers
to the Department.
Question. Source of Foreign Threats: During the hearing, Senator
Wyden asked Dr. Tabak and the first panel of government witnesses to
identify the general number, or a range, of countries that currently
constituted the source of the foreign threat. Dr. Tabak responded that
he could not do so in an unclassified setting and would do so in the
classified briefing. Would you please provide a separate, classified
response that identifies the specific countries that you believe
currently present a threat to U.S. research and describe the nature of
that threat?
Answer. HHS-OIG defers to HHS's Office of National Security and
FBI's Counterintelligence Division, because the question being asked
falls under their purview.
______
Question Submitted by Hon. John Thune
Question. Mr. Hollie, as you know, the HHS Office of Inspector
General recently released a report stating that NIH did not concur with
the inspector general's recommendation to develop a security framework,
conduct a risk assessment, and implement additional controls for
sensitive data in the context of NIH Genomic Data. In your view, why
did NIH not concur with this recommendation? In your view, does NIH
have valid reasons for rejecting your office's recommendation?
Answer. NIH's written response to our report indicated that they
believed additional internal controls were not necessary based on our
findings. We explained to NIH that, consistent with Federal
regulations, NIH should document its acceptance of the risks we
presented. Further, the NIH Advisory Committee to the Director, issued
a report, ACD Working Group for Foreign Influences on Research
Integrity (December 2018). This report identifies similar risk and
includes recommendations that are consistent with our recommended
actions. We are hopeful that NIH will adopt its internal Working Group
recommendations, which will likely address the findings in our report.
We are still waiting for the OIG Clearance Document response from NIH.
That document will provide any action that NIH has taken to address the
recommendations in the report and provide the basis for OIG to
determine whether a recommendation is close or is unimplemented.
______
Question Submitted by Hon. Todd Young
five eyes intelligence alliance
Question. The Five Eyes is widely regarded as the world's most
significant intelligence alliance. The origins of it can be traced back
to the context of the Second World War and by its necessity of sharing
vital information mainly between Britain and the United States so both
countries could enhance the allied war effort. ``Five Eyes'' was
formally founded in the aftermath of the Second World War, through the
multilateral agreement, known as the UKUSA Agreement, on 5 March 1946.
Initially, compromising only the UK and the United States, it
expanded to also include Canada in 1948 and Australia and New Zealand
in 1956. Thereby, the ``Five Eyes'' term was created from the lengthy
``Australia/Canada/New Zealand/United Kingdom/United States Eyes Only''
classification level that included the ``eyes'' that could have access
to high-profile papers and information. For more than 70 years this
alliance of like-minded allies has served our intelligence community
well.
Just like sharing access to sensitive intelligence information,
should we think similarly about opening up certain programs or research
areas to certain students or professors depending on their home
country?
Is there a model here for academia that is worth following?
Should we be limiting what countries we conduct sensitive research
and development with?
Answer. HHS-OIG defers to HHS's Office of National Security, NIH,
and FBI's Counterintelligence Division, because the questions being
asked all fall within the scope of their respective jurisdictions and
are beyond the purview of HHS-OIG.
______
Prepared Statement of Louis A. Rodi III, Deputy Assistant Director,
National Security Investigations Division, Immigration and Customs
Enforcement, Department of Homeland Security
introduction
Chairman Grassley, Ranking Member Wyden, and distinguished members
of the committee, thank you for the opportunity to discuss the role
U.S. Immigration and Customs Enforcement (ICE) Homeland Security
Investigations (HSI) plays in addressing foreign threats to taxpayer-
funded research. The threat posed by nation-states illegally and/or
subversively seeking to exploit legitimate educational and research
opportunities in the United States is evolving. ICE HSI plays a pivotal
role in identifying the avenues, methods, and strategies that foreign
nationals use to attack our research institutions. State actors
routinely engage in or facilitate the procurement of U.S. technology
and theft of intellectual property, sometimes in violation of Federal
laws and regulations. Combatting these activities is at the forefront
of HSI's priorities, with multiple divisions and mission sets within
the agency collaborating to identify and uncover foreign actors and
networks exploiting U.S. academic and research institutions and to
strategically disrupt their operations.
HSI is the principal investigative arm of the U.S. Department of
Homeland Security, responsible for investigating a wide range of
domestic and international activities arising from the illegal movement
of people and goods into, within, and out of the United States. As part
of its mission, HSI oversees a diverse portfolio of investigative and
administrative programs that safeguard the United States against
national security and public safety threats, and against the violation
of customs and immigration laws of the United States. As part of
today's testimony, I would like to highlight some of the initiatives
HSI has implemented and is seeking to further enhance.
current state of play/nature of the threat
The United States is home to thousands of universities and
colleges, many of which are among the most advanced institutions in the
world for higher education and scientific, technological, and medical
research. As a result, each year thousands of foreign nationals seek to
obtain nonimmigrant visas to enable them to travel to the United States
to pursue educational degrees or research at these institutions.
Thousands more are already present in the United States attending U.S.
colleges and universities or conducting advanced research in a
multitude of fields.
As of May 2019, there are just over 1.13 million nonimmigrant
students present in the United States. This includes 1,129,816 active
F-1 students and 9,755 active M-1 students. There are 558,784 F-1
students who are studying or engaged in research in science,
technology, engineering, and mathematics (STEM)-related fields.
While openness and international collaboration in academia and
research are important aspects of facilitating significant enhancements
in science and technology, they also can create an environment that
U.S. adversaries exploit as a means to gain access to sensitive
technology and information, some of which is controlled for export, and
transferred to foreign entities. The largest number of ongoing HSI
Counter Proliferation Investigations (CPI) cases on controlled exports,
including intangible exports (i.e., the transmission of technical data
from the United States, or transfer to foreign nationals within the
United States) involves China, Iran, and Russia. From these
investigations and based on trend analysis, HSI knows that these
countries are actively implementing a multitude of schemes to illicitly
or subversively acquire and transfer export-controlled military and
dual use technology and commodities, and are employing myriad schemes
to circumvent U.S. export control laws.
Exploitation of academia and U.S. research institutions is just one
of the schemes these countries are employing to obtain access to
sensitive research and export-
controlled information and technology, and to facilitate its transfer
abroad. These countries are attempting to obtain this information, in
many instances in an illegal or subversive manner, in order to advance
their own military capabilities or economic goals, many times in
contravention to the national security of the United States.
Foreign nationals from China, Iran, and Russia represent a sizeable
portion of the overall nonimmigrant student population currently in the
United States. As of May 2019, there are 357,863 F-1 Chinese students
in the United States with 181,980 such students enrolled in STEM-
related academic programs at U.S. institutions. There are also 11,323
F-1 Iranian students and 6,196 F-1 Russian students, with the
respective STEM student breakdown of 9,057 for Iran and 2,008 for
Russia.
hsi efforts to identify and mitigate the threat
HSI has established a multi-dimensional approach to safeguarding
the homeland against transnational threats of this nature. HSI's first
line of effort is preventative, and aims to identify and disrupt the
ability of known or suspected national security or public safety
threats from obtaining nonimmigrant visas to lawfully travel to, and
obtain entry into, the United States. A core component of this effort
is the HSI-led Visa Security Program (VSP). Through the VSP, HSI
analysts and special agents work in conjunction with U.S. interagency
and foreign government partners to maximize the opportunity to screen,
vet, and investigate potential threats prior to the U.S. Department of
State (DOS) making a visa determination and well before the applicant
presents for admission to the United States. This includes those
applying for student or exchange visitor visas. If sufficient
derogatory information is uncovered relating to the intentions of visa
applicants, HSI--working in conjunction with DOS--can recommend
refusing visas on a number of grounds, including for suspected
involvement in the illicit procurement or attempted procurement of
controlled technology.
In addition to these preventative measures, HSI also implements
multiple programs to identify and protect against foreign entities
already in the United States who may seek to exploit legitimate
academic and research opportunities for the ultimate benefit of
adversarial state actors. The Student and Exchange Visitor Program
(SEVP) fulfills a compliance-centric role, and is responsible for
monitoring certified educational institutions and the nonimmigrant
students they enroll. The Counterterrorism and Criminal Exploitation
Unit (CTCEU) coordinates investigative and enforcement actions in cases
in which nonimmigrant visa holders, including students and exchange
visitors, overstay their visas or violate the terms of their visas and
are suspected of posing a concern to U.S. national security or public
safety. If students or exchange visitors appear to be involved in
efforts to acquire and transfer sensitive information or technology
obtained during the course of their research or academic pursuits,
HSI's CPI plays a role in coordinating an investigative and enforcement
response to those activities.
Together, these programs form the backbone of HSI's efforts to
identify and mitigate the threats posed by foreign entities seeking to
exploit legitimate academic and research opportunities within the
United States. Each of these programs is described in more detail
below.
HSI Visa Security Program:
The HSI VSP leverages resources in the United States and abroad to
screen and vet non-immigrant visa applicants, identify and prevent the
travel of those who constitute potential national security or public
safety concerns, and launch investigations into transnational criminal-
and terrorist-affiliated networks operating around the globe. The VSP
was formed in response to the September 11, 2001 attacks, authorized by
section 428 of the Homeland Security Act of 2002 and implemented by a
2003 Memorandum of Understanding between the Secretaries of State and
Homeland Security.
Currently, HSI VSP operations are conducted at 36 visa-issuing
posts in 27 countries. In FY 2018, VSP screened 2,196,708 visa
applications, made 1,251 nominations or enhancements to the terrorist
watchlist, and recommended the refusal of 9,007 visa applications.
Additionally, deployed special agents conducted 5,101 interviews and
initiated 348 investigations in support of VSP operations. One key
facet of VSP operations is the overseas assignment of HSI Special
Agents to diplomatic posts worldwide. Embedded within American
Embassies and Consulates, these agents work alongside DOS Consular
Affairs personnel, other partner agencies at post, and appropriate host
country officials to identify and investigate terrorists, criminals, or
other individuals who pose a threat to the United States.
A second critical component to VSP is the Pre-Adjudicated Threat
Recognition Intelligence Operations Team (PATRIOT), administered by HSI
International Operations (IO) in collaboration with U.S. Customs and
Border Protection (CBP), which conducts centralized screening and
vetting in the National Capital Region (NCR) in support of VSP
operations. PATRIOT enables the automated screening of visa application
information against DHS holdings, as well as holdings of other U.S.
agencies, at the earliest point in the visa process, well in advance of
the visa applicant's interview and visa adjudication. Derogatory
information discovered during automated screening process is manually
vetted by PATRIOT personnel utilizing law enforcement techniques, open
source information, and classified systems. PATRIOT analysts then
provide HSI Special Agents assigned to VSP posts with relevant
information to use during interviews of visa applicants or other
investigative activities conducted abroad prior to visa adjudication.
Following the analysis of all known derogatory information, HSI Special
Agents at VSP posts provide a unified DHS recommendation to DOS on visa
eligibility.
In addition to the PATRIOT process, VSP personnel also participate
in other U.S. government screening and vetting efforts focused on
protecting the homeland from diverse national security and public
safety threats. Generally, these processes entail collaboration between
HSI, DOS, and other partner agencies involved in screening and vetting.
This includes conducting intensive reviews of visa applications from
visa-issuing posts worldwide that are considered high risk for the
applicant's potential involvement in the unlawful procurement,
transfer, or export of sensitive military or dual-use U.S. information
and technology. At times, these applications may involve individuals
seeking to exploit the U.S. educational system by enrolling in graduate
level studies or engaging in research, teaching, or exchange programs
as a way to acquire and transfer sensitive, export-controlled
technology or information on behalf of adversaries or organizations
that pose a national security risk to the United States. In some
instances, a more intensive screening and vetting of a visa application
is prompted by risk factors indicative of a visa applicant's potential
involvement in activities related to the unlawful procurement,
transfer, or export of sensitive U.S.-origin military or dual-use goods
or technology on behalf of foreign adversaries or criminal
organizations. After such reviews, VSP personnel then provide consular
officers advice and background information to properly adjudicate
immigrant and nonimmigrant visa applications of security or foreign
policy interest.
Whether through the PATRIOT process or other screening and vetting
efforts in which the VSP is engaged, the VSP ultimately provides
recommendations for visa issuance or refusal to DOS based on
information uncovered during the review, vetting, and investigative
process. In all cases where the VSP team recommends the refusal of a
visa, the VSP coordinates in advance with CBP's National Targeting
Center-Passenger (NTC-P) regarding the applicant's admissibility or
inadmissibility, per the Immigration and Nationality Act (INA). This
ensures that DHS presents a single, uniform position on visa
eligibility and admissibility to DOS.
The combination of the international and domestic dimensions of VSP
equips HSI with a unique capability to investigate suspicious
travelers, enhance existing information, and identify previously
unknown threats, rather than simply denying visas and potential travel
of these applicants. These efforts allow VSP to operate as a
counterterrorism tool that mitigates threats posed by transnational
terrorist and criminal networks. Utilizing information obtained through
the visa application process, the VSP enhances the national security
and border security of the United States by identifying national
security or public safety concerns at the earliest part of the visa
lifecycle and preventing their travel to and admission into the United
States.
HSI Student and Exchange Visitor Program:
Foreign nationals who receive nonimmigrant visas to pursue
educational, vocational, or research programs in the United States will
interact with the Student and Exchange Visitor Program (SEVP). As of
May 2019, there are 1,139,571 nonimmigrant students attending 6,410
SEVP-certified schools.
SEVP uses the Student and Exchange Visitor Information System
(SEVIS) to monitor F and M students and the schools that enroll them
while in the United States. SEVIS also contains the information for the
Exchange Visitor program (J-visas), which is administered by DOS. SEVIS
contains information such as a student's name, physical and mailing
addresses, date of birth, phone number, email address, academic major,
and employment information (if applicable). SEVIS information is
updated by Designated School Officials (DSOs), but the system will
auto-terminate a student's record if the student fails to enroll or
report to school, meaning the student must depart the United States or
he or she may be put into removal proceedings.
SEVP is also responsible for the school certification process. The
certification process is rigorous and continual. To obtain initial
certification, schools must submit required evidence and applications,
undergo site visits, and recommend DSOs. These school officials must be
U.S. citizens or lawful permanent residents and must affirm their
knowledge and intent to comply with all Federal regulations. The
schools are furthermore subject to biennial recertification,
unannounced site visits and out-of-cycle reviews at any time. Schools
that do not comply with the regulations may be withdrawn and,
subsequently, ineligible to enroll nonimmigrant students until
successfully re-petitioning for approval and meeting all certification
standards.
Beyond the certification process, SEVP uses SEVIS data to engage in
risk management and has enhanced its risk management framework by
developing a compliance dashboard to identify schools with risk
indicators. SEVP employs this risk analysis tool to identify schools
that may have violated SEVP regulations when conducting recertification
reviews, adjudicating school updates, and determining whether to
initiate out-of-cycle reviews. SEVP regularly conducts compliance site
visits to schools to ensure that approved programs are functioning as
reported in SEVIS. In addition, SEVP continuously vets leads reported
by the public concerning both schools and students, acting decisively
to protect public safety and the integrity of the immigration system.
While many of SEVP's processes and programs have proven to be
effective, HSI strives to improve and enhance these programs. For
example, SEVP has mitigated previously identified national security
gaps and system vulnerabilities within SEVIS and is using an adaptive
maintenance approach to continuously add enhancements to the system.
These enhancements have improved data integrity and the stability of
the system. SEVP is currently working towards transforming SEVIS into a
person-centric database. In March 2018, SEVP launched the SEVP Portal
for students participating in Optional Practical Training (OPT) related
to STEM degrees. The Portal allows nonimmigrant students to directly
upload their required SEVIS information, including their employer's
name and address, as well as other key information for monitoring
purposes. The portal interfaces with SEVIS and shares information but
does not give students direct access to SEVIS. The Portal has been a
success with more than 166,402 registered portal users (i.e., 74.7
percent of the students eligible for Portal Accounts). The portal will
be expanded to all F and M students, resulting in SEVIS data that is
more accurate, captures changes in a student's information quicker and
ensures students are accountable for the data inputted.
Additionally, SEVP started conducting criminal background checks on
proposed DSOs in May 2017, due to the fact that these individuals have
access to a secure government database and a role in reporting
information in that database. HSI is actively working to expand this
process and incorporate such vetting as part of its regular review of
approved schools and DSOs, both to safeguard against potential
vulnerabilities and to ensure the integrity of the information in
SEVIS. SEVP's current programs, ongoing enhancements, and proposed
expansion will further secure our Nation from those wishing to exploit
the Nation's education system. For more information about the privacy
risks that HSI takes on while operating SEVP and the subsequent
mitigations, please view the SEVIS privacy impact assessment (PIA) and
subsequent updates available at mitigations, please view the SEVIS
privacy impact assessment (PIA) and subsequent updates available at
mitigations, please view the SEVIS privacy impact assessment (PIA) and
subsequent updates available at
HSI Counterterrorism and Criminal Exploitation Unit:
HSI's CTCEU actively identifies and initiates enforcement action on
nonimmigrant visa overstay violators, and works closely with SEVP and
CPI to ensure leads and other information related to potential status
violators are referred to HSI field offices for appropriate action.
Within the agency, CTCEU focuses on overstay violators who pose a
national security, border security, or public safety concern. This
includes individuals who entered the United States as nonimmigrant
students or exchange visitors. CTCEU leverages special agents,
analysts, information systems, and interagency partnerships to
determine viable national security related overstay leads to pursue.
In an average year, CTCEU analyzes over one million potential
status violator records, incorporating data from various government
systems, such as SEVIS and CBP's Arrival and Departure Information
System (ADIS). CTCEU conducts both batch and manual vetting against
government databases, public indices, and open source information. The
vetting helps determine whether an individual who overstayed has
departed the United States, adjusted to a lawful status, has a pending
immigration benefit application, or would be appropriate for an
enforcement action.
CTCEU proactively develops cases for investigation, monitors the
latest threat reports, and addresses emergent issues. This practice is
designed to detect and identify individuals and schools exhibiting
specific risk factors; it is formulated based on intelligence
reporting, travel patterns, and in-depth criminal research and
analysis. It has contributed to the counterterrorism mission by
initiating and supporting high-priority national security initiatives,
based on specific intelligence. CTCEU considers several fraud
indicators when reviewing schools, such as a high volume of students
engaged in OPT or Curriculum Practical Training (CPT), low completion
rates, over-enrolled schools with student populations exceeding
indicated I-17 amount, schools receiving Federal funding for sensitive
research, or schools exhibiting various other fraud indicators. CTCEU
also reviews SEVP Analysis Operation Center (SAOC) Tip Logs and HSI Tip
Line information to further enhance or corroborate information received
on schools or school officials.
LeadTrac is the database owned by CTCEU and is used to vet and
manage leads pertaining to visitors in the United States who are
suspected of overstaying their period of admission or otherwise
violating the terms of their admission, as well as organizations
suspected of immigration violations. LeadTrac's structure supports a
subject-centered data model, ensuring multiple leads about a single
subject are linked within the system. For more information about the
privacy risks that HSI CTCEU takes on while operating LeadTrac and the
subsequent mitigations, please view the LeadTrac PIA available at
www.dhs.gov/privacy.
In FY 2018, CTCEU reviewed 1,429,395 leads regarding potential
overstays. Numerous leads were closed through an automated screening
process, most commonly due to subsequent departure from the United
States. A total of 8,968 leads were sent to HSI field offices for
investigation. Of these, 2,212 were pending further investigation,
2,795 were closed for being in compliance (pending immigration benefit
application, granted asylum, approved adjustment of status application,
or departed the United States) and the remaining leads were returned to
CTCEU for continuous vetting and further investigation. In FY 2018
alone, HSI made 1,808 arrests pursuant to visa violator leads. In FY
2019 through March 31, 2019, CTCEU has reviewed 765,543 leads regarding
potential overstays and sent 4,940 leads to HSI field offices for
further investigation. HSI has made 1,025 arrests pursuant to visa
violator leads in FY 2019.
CTCEU refers leads that do not meet HSI criteria for further
investigation to ICE Enforcement and Removal Operations (ERO) National
Criminal Analysis and Targeting Center (NCATC) which works in close
coordination with CTCEU for further vetting. If necessary, the lead is
forwarded to the respective ERO field office for enforcement action.
Key Initiatives on Overstay Enforcement
Outreach is an important component of CTCEU's operations. HSI
special agents have been conducting outreach visits to SEVP-certified
institutions as part of HSI's Project Campus Sentinel (PCS) program.
This outreach program, which was established in 2011, aims to build a
mutual partnership between local HSI special agents and SEVP-certified
institutions by collaboratively preventing the criminal exploitation of
SEVP through direct and open communication. It furthermore creates an
avenue for improved direct communication between DSOs and local HSI
special agents. In recent years, this outreach program has been
expanded to include SEVP field representatives and campus public safety
entities. This partnership provides all stakeholders the opportunity to
openly exchange information, improve cooperation, and bolster the
safety and security of students, faculty, and institutions. Since
inception, HSI special agents have conducted over 4,000 PCS outreaches.
Other key initiatives in HSI's overstay enforcement efforts include
the Domestic Mantis and Visa Lifecycle programs. The Domestic Mantis
and Visa Lifecycle programs help identify nonimmigrant students who
have access to sensitive technology, better capture the overarching
visa lifecycle, provide another layer of security for the Nation, and
serve as innovative investigative tools to support the enforcement of
U.S. immigration laws.
CTCEU developed the Domestic Mantis Program in response to a
Government Accountability Office (GAO) assessment that identified a
potential vulnerability with nonimmigrant students who enter the United
States to study in a non-sensitive field of study and subsequently
transfer to a sensitive field of study. These individuals could pose a
substantial risk related to the diversion of sensitive technology,
materials, or information.
The Domestic Mantis Program aims to enhance national security by
preventing the export of goods, technology, or sensitive information
through activities such as graduate-level studies, teaching, research,
training, or employment. The program works by identifying students that
have changed their field of study to a sensitive area and evaluates
those individuals against risk-based targeting criteria. To accomplish
this, CTCEU manually extracts and reviews SEVIS data pertaining to
students from countries that have an elevated risk of proliferation
activity. The potential leads are analyzed using a comprehensive
vetting process, including a review against intelligence community
holdings for additional derogatory information, open source
information, and academic journals. These Domestic Mantis checks are
performed twice a year to identify new students who enroll at varying
times within the school year.
Visa Lifecycle Program
The Visa Lifecycle Program tracks nonimmigrant visitors from the
time they file visa applications to the time they depart from the
United States, become overstays, or otherwise fail to comply with their
terms of admission (i.e., become ``out-of-
status''). This program allows HSI to continuously vet and identify
derogatory information on nonimmigrant visitors for the validity of the
visa. In instances where violators are identified, appropriate
enforcement actions are initiated.
The Visa Lifecycle Program focuses on nonimmigrants seeking
business/tourist (i.e., B1/B2) or student/exchange (i.e., F, J, and M)
visas from five DOS visa issuing posts. These posts were selected to
complement existing HSI screening efforts in response to recent global
acts of terrorism perpetrated in those countries. Working in
coordination with HSI's VSP, CTCEU receives information on these visa
applicants pulled from PATRIOT and the DOS Consular Consolidated
Database (CCD). CTCEU ingests this data into its lead management system
and continuously vets these nonimmigrant visa holders using an
automated open source vetting platform in conjunction with intelligence
community holdings.
HSI Counter Proliferation Investigations Program:
Cases involving the attempted acquisition and transfer of
sensitive, export-
controlled commodities, technology, or information fall within the
purview of the HSI CPI program. HSI is designated as the primary law
enforcement agency for investigating violations of U.S. export laws
related to military items, controlled dual-use goods, and sanctioned/
embargoed countries. HSI, through its CPI program, has statutory
authority to investigate violations of U.S. export control laws , and
is uniquely equipped--as the only agency enforce with border search
authority, undercover authority, forfeiture authority, and an extensive
international footprint--to combat the trafficking of weapons and
technology, to include chemical, biological, radiological, nuclear
materials, and other items required to produce weapons of mass
destruction (WMD).
HSI's CPI mission is directly aligned with U.S. national security
and defense strategies, as they pertain to protecting the American war
fighter and the homeland from having sensitive U.S.-origin military and
WMD technology fall into the hands of U.S. adversaries; securing the
U.S. border from firearms being smuggled to transnational criminal
organizations; disrupting the supply chains of illicit procurement
networks by preventing terrorist groups and hostile nations from
acquiring U.S. military hardware, firearms, sensitive technical data,
dual-use technology, and materials used to develop weapons of mass
destruction; protecting U.S. industry from sensitive intangible
technology transfers; and keeping U.S. industry's intellectual
property, as well as ground breaking research and development, from
being exploited by U.S. adversaries.
HSI, and its predecessor agency, the U.S. Customs Service, has been
exercising its export enforcement authority for over 100 years.
Although other Federal law enforcement, regulatory, intelligence, and
military agencies are involved in the overall U.S. export control
efforts, HSI is empowered with full statutory authority to investigate
violations of all U.S. export control laws, such as the Arms Export
Control Act (AECA) and International Traffic in Arms Regulations
(ITAR); the Export Controls Act of 2018 (ECRA) and the Export
Administration Regulations (EAR); the International Emergency Economic
Powers Act (IEEPA); and Trading with the Enemy Act (TWEA). From 2012 to
2018, HSI CPI investigations have resulted in over 17,000 cases
initiated, 4,006 arrests, and 8,288 seizures.
U.S. export control laws are comprehensive and include restrictions
on tangible exports (i.e., the actual shipment of items from the U.S.),
intangible exports (i.e., the transmission of technical data from the
United States, or transfer to foreign nationals within the United
States), re-exports and transshipments (i.e., exports from one foreign
country to another), and controls on services and other business
activities (i.e., training, brokering, and financing services). Because
of the complexity of U.S. export control laws and the multiple
licensing agencies involved, HSI CPI special agents conduct outreach
visits and provide presentations to private industry and academic
institutions. This program, known as Project Shield America (PSA), is
designed to increase public awareness of export control laws and
regulations, and to equip private industry and the academic community
with the knowledge needed to aid in recognition, detection, and
resolution of attempted illegal acquisitions of sensitive, export-
controlled goods and technology. Since 2001, HSI special agents have
conducted more than 32,000 PSA outreach presentations, resulting in
successful HSI criminal investigations worldwide.
Currently, the United States is facing an unprecedented threat from
foreign governments, such as Iran, China, and Russia, who have launched
far-reaching campaigns to illicitly acquire sensitive, and in some
cases export-controlled, commodities, technology, research, and/or
information needed to further their strategic military and economic
goals. One area targeted by these state actors is academia. These
adversarial nations take advantage of academic openness in the name of
``fundamental research'' to target U.S. institutions of higher learning
to capture U.S. technology, processes, and other intellectual property.
This process is generally labeled non-traditional collection. In the
context of academia, this entails foreign adversaries facilitating or
supporting academic research and expertise development in sensitive
fields by student and exchange visitor nonimmigrant visa holders.
Through this process, these students and researchers acquire, export,
or transfer information or technology to foreign entities in a
subversive manner and without licenses, if the information or
technology is export controlled. These activities pose a threat to U.S.
national security and compromise the integrity of the U.S. academic and
research system.
To mitigate this threat, HSI has recently taken proactive steps to
increase outreach to export control officers and other officials within
the academic community, particularly at universities or research
institutions with large foreign student populations enrolled in STEM-
related programs. These outreach efforts are conducted in conjunction
with SEVP and CTCEU representatives. The goal of this increased focus
on academia outreach is to raise awareness of the potential
proliferation risk posed by students and researchers seeking to acquire
and transfer sensitive research, technology, and/or intellectual
property (some of which may be export controlled) on behalf of foreign
governments or sanctioned entities. This initiative also aims to
enhance the capacity of academic institutions to recognize potential
instances of potential illicit procurement, intellectual property
theft, or other possible violations of U.S. laws, and to provide a
conduit to report any suspicious activities detected by universities or
research institutes.
While raising awareness within the U.S. academic sector and the
private sector is an important step, HSI is also making a concerted
effort to prevent the acquisition and transfer of technology by foreign
nationals through non-traditional collection means. To that end, HSI
has initiated efforts to combine and coordinate resources and
information available to CPI, CTCEU, SEVP, and VSP in a joint effort to
identify, investigate, and prevent destination-controlled technology
and export-controlled technology transfers out of the United States
that violate U.S. laws and/or weaken the U.S. technological advantage
in key fields. This effort will focus on the role foreign students,
primarily from sensitive countries, studying at U.S. universities and
colleges play in these activities, and will aim to utilize the full
breadth of HSI's administrative and criminal authorities to combat the
threat posed by these foreign actors.
HSI is committed to free and open academic environment, but this
must be balanced against national security measures; if not, these
institutions will be taken advantage of and critical U.S. technology
and research can be acquired easily by adversaries.
conclusion
In closing, mindful of the United States' historical role in the
development of critical technology in coordination with foreign
partners and U.S. academic institutions, HSI remains committed to
maintaining a free and open academic environment within the United
States; however, this must be balanced with an appropriate focus on
national security and public safety. The threat posed by adversarial
nation-states illegally and subversively seeking to exploit legitimate
educational and research opportunities in the United States, many of
which are funded with U.S. taxpayer dollars, is real, and the United
States must continue to pursue all appropriate means to combat it.
HSI will continue to work with academia, law enforcement partners,
and other agency partners, to use its extensive administrative and
criminal authorities to identify and disrupt the activities of
individuals or organizations who seek to harm the United States in this
arena and the multitude of others in which HSI is engaged. HSI is well
positioned to mitigate this threat through the many programs
highlighted today, all of which provide a multi-layered level of
security aimed at protecting the homeland from illicit transnational
activities of its adversaries. From the preventative angle of the VSP,
to the compliance focus of SEVP, and through the investigative and
enforcement programs executed by the CTCEU and CPI programs, HSI is and
will continue to be engaged in countering this critical problem.
Enhancements and expansion of these programs, combined with enhanced
administrative and criminal enforcement authorities, will only improve
HSI's ability to identify and thwart the efforts of foreign actors who
pose national security or public safety concerns to the United States.
HSI looks forward to continuing to work with the committee regarding
these HSI programs.
Thank you again for inviting me today to explain HSI's critical
role in protecting the national security and public safety of the
United States. I would be pleased to answer your questions.
______
Questions Submitted for the Record to Louis A. Rodi III
Questions Submitted by Hon. Chuck Grassley
other countries
Question. Since 2008, the Chinese military has sponsored more than
2,500 Chinese military scientists and engineers to travel to
universities in the U.S. and elsewhere as students or visiting
scholars. According to the Australian Strategic Policy Institute, these
arrangements have empowered China to make significant advances in
developing military technology by leveraging U.S. and other countries'
experience, facilities, and resources in high-tech industries. In fact,
the United States has been the number one destination for PLA
scientists since 2006. Chinese state media proudly refer to this
strategy as ``picking flowers in foreign lands to make honey in
China.''
What other countries and governments are you concerned about
exploiting loopholes in our immigration system to further that theft?
Can you share any specific examples of that exploitation? Please
indicate which of the responses will be classified.
Answer. The three primary countries of concern are China, Iran, and
Russia. Based on U.S. Immigration and Customs Enforcement (ICE)
Homeland Security Investigations (HSI) reporting, students from India
and South Korea have also exhibited risk factors for exploiting
loopholes in the U.S. immigration system to further sensitive
technology and intellectual property theft. Other countries
experiencing instability and/or threats at home may also be of
significant concern for immigration fraud.
The following examples relate to China's policy and direction for
Chinese students to function ``as intelligence collectors'' for the
benefit of the Chinese government:
The Federal Bureau of Investigation arrested a Chinese
student attending the Illinois Institute of Technology for
providing information to China's Ministry of State Security
officials in Nanjing City regarding U.S. scientists and
engineers. The Department of Defense and Department of Homeland
Security (DHS) helped identify the student through
collaboration on the Military Accessions Vital to National
Interest program.
A Chinese student who was studying musicology through a
summer exchange program was detained for having wandered onto a
U.S. Naval Station in Key West, FL and taking photos of antenna
fields and various military installations.
Other examples of ICE HSI investigations related to this threat
would be Law Enforcement Sensitive or classified, and more
appropriately briefed in a closed setting.
course changes
Question. Are foreign students entering the U.S. to study something
that isn't suspicious, like English literature, then changing their
course of study to an area that is highly sensitive, such as biomedical
or semiconductor research for nefarious purposes? Do these course
changes pose a national security risk, and are these changes often at
the direction of foreign governments? If yes, what actions are needed
to close these loopholes?
Additionally, if action is needed to close these loopholes, will
HSI work with Congress to draft potential legislative fixes? Can we
close loopholes and protect national security without limiting our
ability to attract the best and brightest talent from around the world?
Answer. There have been instances in which nonimmigrant students
who were approved to study non-sensitive fields pursuant to F-1
nonimmigrant status entered the United States and subsequently
transferred into programs of study in sensitive fields. Some foreign
nationals have also obtained tourist visas and, once in the United
States, changed their nonimmigrant status to attend U.S. colleges and
universities without going through the traditional visa-vetting process
applied to prospective nonimmigrant students seeking to study sensitive
fields. In 2016, ICE HSI established the Domestic Mantis Program (DM)
to monitor any national security and public safety risks posed by
foreign students who transferred into programs to study in sensitive
fields. ICE HSI had initiated Project Steady Stare (PS2), aimed at
building on the DM Program and equipping ICE HSI with the capability to
conduct a targeted intelligence and investigative analysis on those
foreign students who pose the highest risk for nontraditional
collection, unapproved technology transfer, and/or potential criminal
or administrative violations of law. Since the inception of this
project, ICE HSI has partnered with DHS in a Department-wide effort and
rebranded this initiative as the Stellar Sunrise Project (SSP).
As the principal investigative arm of DHS, ICE HSI plays a pivotal
role in safeguarding national security and is committed to working with
Congress to develop potential legislative fixes that enable the United
States to maintain a free and open academic environment, balanced with
an appropriate focus on national security and public safety. In
response to prior questions for the record and requests for
congressional technical assistance on this subject, ICE HSI provided
its assessment of potential legislative action that may be considered
to help close loopholes that are being exploited in this space.
In general, these recommendations entail a combination of:
Ensuring DHS has full discretionary authority to review and
recommend that the Department of State revoke the nonimmigrant
visas of students deemed to be high risk for sensitive
technology transfer and strengthening the legal authority and
ability for DHS and the U.S. Department of State to execute
revocations;
Increased administrative removal authorities for students
posing a proliferation risk;
When deemed appropriate by DHS, the mandatory re-evaluation
of the nonimmigrant visa status of foreign students studying in
the United States in sensitive fields;
The ability to implement nonimmigrant visa debarment for
violators; and
Connected administrative sanctions for non-compliance by
academic and research institutions.
DHS needs express and specific additional law enforcement
authorities to address these incursions. ICE HSI needs reinstatement of
HSI's export subpoena authority for Export Control Reform Act
investigations, which was lost when the Export Administration Act was
repealed and replaced. This authority could directly contribute to ICE
HSI's ability to investigate Export Administration Regulations
controlled research violations.
critical industries
Question. Have foreign nationals, acting surreptitiously on behalf
of foreign governments, penetrated critical U.S. industries, including
but not limited to health care and pharmaceutical research,
infrastructure, financial services, defense, robotics, and advanced
chip processing? If yes, please explain what changes are needed to stop
or slow these incursions.
Answer. Foreign nationals are functioning in all the listed areas
and have access to uncontrolled research, as well as to potentially
controlled research. Controlled research is typically defined by those
items or information regulated under the International Traffic in Arms
Regulations (ITAR) or the Export Administration Regulations (EAR).
However, with the advent and expediency of new or emerging
technologies, there could be items that are not explicitly controlled
under ITAR or EAR. The manner in which foreign governments might be
directing their citizens falls into classified channels.
DHS needs express and specific additional law enforcement
authorities to address these incursions. First, ICE HSI needs a
reinstatement of HSI's export subpoena authority for Export Control
Reform Act investigations, which was lost when the Export
Administration Act was repealed and replaced. This authority could
directly contribute to ICE HSI's ability to investigate ITAR and/or EAR
controlled research violations. Second, ICE HSI needs discretionary,
administrative removal authority vested to the Secretary of Homeland
Security and delegated to ICE HSI. These new authorities would give ICE
HSI the ability to administratively remove non-
immigrant visa holders who may be involved in the unlawful or
surreptitious collection and/or transfer of sensitive technology or
research to foreign governments or their proxies. The visa categories
most likely to pose a substantial risk related to the diversion of
sensitive technology, materials, or information are academic students
(F-1) and exchange visitors (J-1) but are not limited to these two visa
categories.
detect and monitor threats
Question. Are we, as a government, doing enough to detect and
monitor efforts by foreign nationals to improperly influence or
appropriate sensitive research funded by U.S. Government grants? If
not, what changes are needed to more effectively identify and remove
these threats?
Answer. As the principal investigative arm of DHS, ICE HSI plays a
pivotal role in safeguarding U.S. national security. With unique and
wide-ranging criminal and administrative authorities, combined with
access to all nonimmigrant foreign student visa information, ICE HSI is
well-positioned to detect, monitor, and disrupt efforts by foreign
nationals to exploit U.S. academic and research institutions.
Leveraging the existing operations of the ICE HSI Counter-
Proliferation Investigations Program, the Counter-Terrorism and
Criminal Exploitation Unit, the Student and Exchange Visitors Program,
and the Visa Security Program, ICE HSI initiated Project Steady Stare
(PS2), a proactive and holistic agency effort to target and prevent the
potential illicit procurement and theft of technology and intellectual
property by foreign students, researchers, and professors involved in
science, technology, engineering, and mathematics programs at U.S.
colleges and universities across the Nation. Since the commencement of
this project, ICE HSI has partnered with DHS and created an interagency
task force that would give analysts access to additional data sets to
analyze and help further identify and detect more threats, and would
streamline and facilitate coordination among interagency partners to
take action against these threats. This initiative is called the
Stellar Sunrise Project (SSP).
SSP equips ICE HSI with the capability to conduct comprehensive law
enforcement intelligence and investigative analysis on those foreign
students who raise national security concerns to determine potential
risk for nontraditional collection, unapproved technology transfer,
and/or potential criminal or administrative violations of law.
SSP builds on ICE HSI's DM, which was established as part of the
2016 overstay enhancements. DM reviews F-1 visa holders who have
switched from a non-
sensitive field of study to a sensitive field of study and are
publishing at their U.S. institution on sensitive topics. DM
consequently does not review the following populations that may also be
at a heightened risk of facilitating illicit technology transfer:
F-1 nonimmigrants who were admitted to the United States to
study sensitive fields of study;
J-1 nonimmigrants (research associates and professors),
including visiting researchers studying in the United States
for short periods of time; and
Spouses or other dependents of F and J nonimmigrants who
change visa classification to study or research sensitive
majors themselves.
Despite ICE HSI programs and initiatives designed to identify these
threats, additional steps could be taken to enhance ICE HSI's ongoing
efforts. This includes:
Additional resources specifically dedicated to this issue,
which would enable ICE HSI to comprehensively vet more foreign
students who pose a nontraditional collection or technology
transfer risk.
However, even with additional resources and interagency
coordination, ICE HSI and its partners may still be limited in the
action they are able to take to mitigate foreign student threats,
particularly since in many cases the conduct of foreign students may
not be illegal. Through prior questions for the record and technical
assistance provided to Congress on other proposed bills, ICE HSI
provided its assessment of potential legislative action that could be
considered to help close loopholes that are being exploited in this
space. In general, these recommendations entail a combination of:
When a potential risk is identified, DHS will conduct an
evaluation of options impacting the nonimmigrant status of
foreign students studying in sensitive fields of study in the
United States to include visa cancellation and expedited
removal from the U.S.;
Increased administrative removal authorities related to
students posing a proliferation risk;
A reinstatement of ICE HSI's export subpoena authority for
Export Control Reform Act Investigations; and
Connected administrative sanctions for non-compliance by
academic and research institutions.
Questions Submitted by Hon. Ron Wyden
panels
Question. Your agency told the Finance Committee that its witness
would not participate on a panel at this hearing that included both
government and non-government witnesses, claiming there is a
longstanding OMB policy prohibiting this. However, there are numerous
examples where your agency has allowed witnesses to testify on ``mixed
panels.'' Over the past 10 years, Federal Government witnesses,
including those from your agency, have testified before the Finance
Committee on panels with non-government witnesses more than 40 times.
This has also been the case with other Senate committees. In April
2019, an NIH witness testified on a panel with non-government witnesses
before the Senate Aging Committee. An NIH witness also testified on a
panel with non-government witnesses before this same committee in July
2017. In March 2018, the Secretary of DHS herself testified on a panel
with non-government witnesses before the Senate Select Committee on
Intelligence. Why were these witnesses permitted to testify before
other Senate committees on mixed panels but your witness was not
permitted to do so at the Finance Committee's June 5th hearing? If
waivers were granted for witnesses to testify on mixed panels at other
committee hearings, why were those waivers granted for the other
hearings but not the June 5th hearing? Please provide copies of (1) the
OMB policy that allegedly prevents government witnesses from testifying
on panels with non-government witnesses; (2) any waivers granted for
the recent Aging and Intelligence hearings where government witnesses
from NIH and DHS respectively testified with non-government witnesses;
and (3) any request submitted to OMB for your witness to testify at the
June 5th hearing and the OMB response along with an explanation why a
waiver was not granted for the June 5th Finance Committee hearing.
Answer. DHS welcomes the opportunity to testify before Congress to
discuss our programs, challenges, and need, and to address any
questions the legislative branch may have. Upon receiving an invitation
to testify, DHS works with the requestor, in most cases the chairman or
ranking member of the committee, to determine the most appropriate
witness available to provide the testimony and expertise desired, in
the most appropriate environment. Except under extraordinary
circumstances, DHS observes the historical practice of not appearing
with non-federal witnesses on a single panel. In almost all cases, the
appropriate environment to receive DHS testimony is on a government-
only panel. While DHS cannot speak for other Departments, agencies, or
officials who have chosen to appear on mixed panels before Congress in
the past, presently, DHS officials do not testify alongside non-
governmental witnesses.
In making its determination, the Department considers whether such
appearance would: (1) draw the DHS witness into conflicts that may
compromise the legal, commercial, or security interests of the United
States; (2) introduce subject matter beyond the scope of the hearing or
expertise of the witness; and/or (3) undermine the DHS witness's
ability to communicate clearly with the committee.
source of foreign threats
Question. During the hearing, I asked Dr. Tabak and the first panel
of government witnesses to identify the general number, or a range, of
countries that currently constituted the source of the foreign threat.
Dr. Tabak responded that he could not do so in an unclassified setting
and would do so in the classified briefing. Would you please provide a
separate, classified response that identifies the specific countries
that you believe currently present a threat to U.S. research and
describe the nature of that threat?
Answer. For ICE HSI, the largest number of active criminal counter-
proliferation investigations on controlled exports, including
intangible exports (i.e., the transmission of technical data from the
United States or transfer to foreign nationals within the United
States), involves China, Iran, and Russia. These three countries are
actively implementing a myriad of schemes to illicitly or subversively
acquire and transfer export-controlled military and dual-use technology
and commodities and are employing numerous ways to circumvent U.S.
export control laws.
ICE HSI National Security Investigations Division provided a
classified briefing on the referenced topic on June 5, 2019.
Questions Submitted by Hon. Todd Young
five eyes expansion
Question. The Five Eyes is widely regarded as the world's most
significant intelligence alliance. The origins of it can be traced back
to the context of the Second World War and by its necessity of sharing
vital information mainly between Britain and the United States so both
countries could enhance the allied war effort. ``Five Eyes'' was
formally founded in the aftermath of the Second World War, through the
multilateral agreement known as the UKUSA Agreement, on March 5, 1946.
Initially, compromising only the UK and the United States, it
expanded to also include Canada in 1948 and Australia and New Zealand
in 1956. Thereby, the ``Five Eyes'' term was created from the lengthy
``Australia/Canada/New Zealand/United Kingdom/United States Eyes Only''
classification level that included the ``eyes'' that could have access
to high-profile papers and information.
For more than 70 years this alliance of like-minded allies has
served our intelligence community well.
Just like sharing access to sensitive intelligence information,
should we think similarly about opening up certain programs or research
areas to certain students or professors depending on their home
country?
Is there a model here for academia that is worth following?
Should we be limiting what countries we conduct sensitive research
and development with?
Answer. As many research areas fall under fundamental research, the
data is already open to Five Eyes (FVEY) partners and others.
Restrictions placed on sensitive fields of study are limited and
generally do not impact foreign nationals from FVEY partners. We need
to strike a delicate, albeit necessary, balance between the open
academic environment that is necessary for fundamental research, while
also mitigating threats from foreign actors that pose a risk to U.S.
national security. This may include placing limitations on which
countries we partner with to conduct sensitive research and
development.
______
Prepared Statement of Captain Michael Schmoyer, Ph.D., Assistant Deputy
Secretary for National Security; and Director, Office of National
Security, Department of Health and Human Services
Good morning, Mr. Chairman, Ranking Member Wyden, and distinguished
members of the committee. It is an honor to appear before you today to
discuss the U.S. Department of Health and Human Services' (HHS) efforts
to address foreign threats. My testimony today will focus on the
threats foreign governments and foreign agents present to U.S.
Government-funded medical research, the efforts undertaken by HHS to
detect the threats and protect the integrity of medical research--an
area that is critical for our Nation's ability to provide healthcare
and for biodefense; and the role of HHS's Office of National Security
(ONS), formerly known as the Office of Security and Strategic
Information (OSSI), and its capabilities.
My name is Captain Michael Schmoyer, the Assistant Deputy Secretary
for National Security and Director of HHS's ONS. ONS is headed by the
Assistant Deputy Secretary for National Security, who reports directly
to the Department's Deputy Secretary and also serves as the Secretary's
Senior Intelligence Official on intelligence and counterintelligence
issues. ONS's vision is for HHS personnel to successfully accomplish
missions worldwide in a security-informed manner and with the
actionable intelligence needed for operational and policy decisions.
ONS's responsibilities include: integrating intelligence and security
information into HHS policy and operational decisions; assessing,
anticipating, and warning of potential security threats to HHS and
national security in general; and providing policy guidance on and
managing the implementation of the Department's national security,
intelligence, and counterintelligence programs.
ONS's programs include handling national security clearances for
employees, classified national security information management, secure
area (i.e., Sensitive Compartmented Information Facilities) management,
communications security, safeguarding and sharing of classified
information, cyber-threat intelligence, insider threat, and
counterintelligence. In coordination with the Director of National
Intelligence, ONS has been designated since 2012 as the Department's
Federal Intelligence Coordination Office, and I serve as the
Department's Federal Senior Intelligence Coordinator. ONS has
responsibilities to establish implementing guidance, provide oversight,
and manage the Department's policy for the sharing, safeguarding, and
coordinated exchange of information relating to national or homeland
security with other Federal departments and agencies, including law
enforcement organizations and the intelligence community, in compliance
with the HHS polices and applicable laws, regulations, and Executive
Orders.
the threats foreign governments and foreign agents present
to taxpayer-funded research
ONS has an important mission that focuses on supporting HHS's
ability to conduct research that will lead to the development of
treatments, diagnostics, and vaccines to address public health needs,
including medical countermeasures to address the ever-evolving threat
of newly emerging and re-emerging infectious disease caused by
pathogens, including those that are select agents and other biological
threats to the homeland. While appreciating the value of scientific
advancement, HHS has an equal interest in maintaining the integrity of
the Department's scientific enterprise. Similarly, HHS embraces the
contributions that foreign partnerships have made to expanding
scientific knowledge that protects, promotes, and advances public
health and medical pursuits worldwide.
Through work with our national security partners over the past 2
years, ONS became aware of threats to the grant process and
intellectual property that is a cornerstone of the Department's,
including the National Institutes of Health (NIH), core values and
biomedical research integrity. After becoming aware of foreign
entities' systematic approaches to influence NIH researchers and peer
reviewers, ONS quickly worked with NIH, the Office of the Inspector
General (OIG), the Federal Bureau of Investigation (FBI), and the
National Counterintelligence and Security Center (NCSC) to identify
steps to mitigate these threats to U.S. biomedical research.
ONS is a supporter of NIH's initiative to stand up a working group
of the Advisory Committee to the NIH Director that addresses ways to
mitigate risks to intellectual property as well as measures to protect
the peer review process. In fact, ONS provided a briefing to the
Director's working group on the risks that U.S. Government-funded
partners face as well as strategies that we are using, together, to
mitigate those risks.
the role of hhs's office of national security and its capabilities to
detect threats and protect the integrity of medical research
As mentioned previously, a large part of the ONS mission is to
counter foreign intelligence entity threats. ONS does this in three
fundamental ways:
identification of foreign intelligence threats and sharing
of threat information with our agencies (including NIH), the
FBI, and the broader intelligence community;
safeguarding HHS's sensitive information, relationships,
property, and activities; and
prevention and detection of insider threats.
I am the designated senior official within the Department who is
responsible for countering threats from foreign intelligence entities.
Utilizing the resources and authorities that we currently have, ONS
builds interdisciplinary partnerships throughout HHS, including NIH, in
a variety of areas that include, but are not limited to, physical
security, chief information officers, human resources, and acquisition/
procurement. We have worked with partners, both internally and
externally, to conduct assessments of HHS's sensitive information,
property, and activities; we have found that these periodic risk
assessments are the cornerstone for all of our corresponding security
and counter-threat activities.
We have also developed measures and strategies that are
commensurate with the risk assessment-identified threats to HHS and
have specifically focused on elements such as information security
measures, personnel security practices, foreign contact and visitor
vetting, supply chain risk management, Committee for Foreign Investment
in the U.S. proposed acquisitions, and prevention of unauthorized
disclosures. Specific examples of these measures and strategies
include: (1) implementing long-standing policies relating to
distribution of badges, vetting visitors, coordination with the
intelligence community, and addressing insider threats; (2) regularly
evaluating the application of adjudication suitability standards
relating to onboarding new personnel (civil service, contractors,
detailees and fellows); (3) utilizing existing mechanisms to share
threat and vulnerability information across the enterprise; (4)
continually promoting workforce awareness of the threat from foreign
intelligence entities and providing awareness and reporting
instructions to HHS personnel; and (5) implementing specific measures
to detect intrusions.
the efforts undertaken by hhs and nih to vet researchers
ONS works closely with the Department of Justice, including the
FBI; with other HHS components, including the OIG and NIH; and with the
broader intelligence community to identify NIH-employed researchers who
may have engaged in problematic practices with foreign entities that
may have unduly influenced and capitalized on U.S.-conducted research.
ONS has access to a variety of databases that enable us to vet
employees, as well as visitors, to HHS facilities (including NIH).
These database results are linked with National Security partners to
ensure the results we have are both reliable and valid.
Our conversations relating to vetting for derogatory information
occur with the FBI and others (both in and outside of the intelligence
community) on a daily basis. In addition, we share our results with
other departments which often have similar missions to HHS. Currently,
HHS vets new civilian employees, U.S. Public Health Service
Commissioned Corps officers, contractors, research fellows, interns,
and foreign national visitors to HHS properties. We have had both
onboarding-related policies as well as a foreign visitor policy in
place since at least 2011; these policies are updated as needed. HHS
does not vet funded research partners who are not employees, or
contractors, of HHS (for example, NIH-funded university principal
investigators).
Additionally, we have initiated a new focus within ONS that will be
dedicated to working with universities to empower their programs to,
among other things, conduct vetting similar to what we do for
employees/contractors within HHS. We have been excited to work with
NIH, FBI, OIG, and NCSC to see this new national security-related
effort comes to fruition. With this focus we are better able to address
potential threats of foreign influences on research integrity at the
grantee level.
the role the fbi plays in assisting hhs and its sub-agencies in
detecting and combating foreign threats
Over the past 2 years, all of the efforts undertaken by ONS to
prevent, detect, and mitigate threats to the integrity of medical
research have been done in conjunction with national security partners
across the government. We have worked especially closely with the FBI,
including instituting a formalized full-time detailing of a Supervisory
Special Agent to our office.
Since the spring of 2017, ONS became acutely aware of specific
challenges relating to the threat of foreign influences on HHS, and
specifically NIH, research integrity. We became involved in two whole-
of-government working groups, led by the FBI, to address the challenges
since some foreign governments have initiated systematic programs to
unduly influence and capitalize on U.S.-conducted research, including
that funded by NIH. We became aware that some HHS-funded scientists had
not been disclosing foreign grant support, affiliation with
laboratories outside of the U.S., or even faculty appointments with
foreign nations. Additionally, we learned about threats to the NIH
grant peer review process where confidentiality was compromised and
information shared that attempted to alter the NIH funding decision
process.
While the relationship with FBI and ONS had existed since the early
2000s, our work in early 2017 with the FBI surrounding the threats
posed to the NIH campus and its extramural grant process galvanized our
relationship even further. HHS quickly became even more active with the
Baltimore FBI field office and the Washington field office's
counterintelligence programs. Together, in close coordination with our
OIG, NIH, and NCSC colleagues, we quickly worked on a strategy to
address the threat of foreign nontraditional counterintelligence
collection. Our main focus was to ensure that our national security-
related efforts continued to support successful relationships with
foreign scientists in all countries supporting the research enterprise
while simultaneously protecting the Nation's, and HHS's research
integrity.
In closing, thank you for the opportunity to review the national
security role and work of the HHS ONS and our efforts to address
foreign threats in research.
______
Questions Submitted for the Record to Captain Michael Schmoyer, Ph.D.
Questions Submitted by Hon. Chuck Grassley
Question. If principal investigators were subject to the same
background check as NIH employees, and were also subject to a review
for counterintelligence purposes, how would those checks help
strengthen grant integrity?
Answer. Standard background checks for new Federal employees
involve a criminal records check, as well as inquiring about the
prospective employee with their former employers. The average NIH
employee is not reviewed for counterintelligence purposes as many do
not hold national security clearances.
Reviewing all principal investigators (PIs) (both NIH PIs and
extramural investigators) for counterintelligence purposes could
strengthen grant integrity, but must be pursued as a whole-of-
government solution as opposed to a fragmentary approach. This is
largely due to the sheer number of applications involved in the effort.
For example, just handling PIs on NIH grants alone would require the
ability to process over 20,000 applications quarterly. An additional
consideration is that the above only covers NIH; it does not include
other Federal departments and agencies who conduct research.
ONS recently stood up an NIH-focused branch with a team
specifically focused on working directly with NIH-funded extramural
entities to train institutes of higher education staff on how to
identify counterintelligence threats. As noted above, if deemed
appropriate, such approaches could be considered from a whole-of-
government perspective, rather than remaining solely focused on NIH-
funded entities.
Question. If principal investigators were subject to the same
background check as NIH employees, and were also subject to a review
for counterintelligence purposes, would those checks improve the
government's security posture? If so, how? If not, why not?
Answer. For the same reasons cited above, while usage of
counterintelligence screenings in the grants process would improve the
government's security posture, performing such checks would increase
the administrative burden behind every grant, slowing down important
research.
Question. How many people within the Office of National Security
work on vetting foreign visitors and other individuals within your
office's purview? Is your staffing sufficient?
Answer. The HHS/Division of Operations (DO), within ONS, has one
individual designated full time for vetting of foreign visitors to the
Department and several agencies (including NIH). DO has one NIH
detailee who assists with the function, and DO flexes the other staff
if a particularly sensitive or urgent matter occurs (four additional
personnel)--but can only do this for short periods of time before
suffering mission degradation in other areas (such as Committee on
Foreign Investment in the United States, Supply Chain Risk Management,
Technical Surveillance Countermeasures, Foreign Travel, and
counterintelligence reviews of other employee types and incidents).
Two additional FTEs will be coming onboard to assist, full-time,
with vetting foreign visitors. At DO's current staffing level, DO can
conduct counterintelligence checks on just over 20,000 visitors
annually without mission degradation; thus, DO's current staffing is
sufficient for steady-state operations. Staffing is not sufficient to
vet other areas, such as principal investigators of research programs.
Lastly, by the end of the fiscal year, the new NIH-focused team
mentioned above will have two to three new individuals to assist with
vetting NIH-specific visitors, employees, and contractors.
Question. How are you leveraging your resources to improve vetting
for individuals running critical projects?
Answer. Please see the memo depicting classified responses to
unclassified QFRs.
Question. What foreign governments pose the greatest threats to
intellectual property created by taxpayer-funded research at American
universities? How are they working to exploit our academic institutions
to steal critical IP? Can you share any specific examples of that
exploitation?
Answer. Please see the memo depicting classified responses to
unclassified QFRs.
Question. Have foreign nationals, acting surreptitiously on behalf
of foreign governments, penetrated critical U.S. industries, including
but not limited to health-care and pharmaceutical research,
infrastructure, financial services, defense, robotics, and advanced
chip processing? If yes, please explain what changes, including
legislative changes, are needed to stop or slow these incursions.
Answer. Yes. This requires a whole-of-government approach to
strengthen the ability of individual agencies to examine
counterintelligence concerns throughout the entirety of the supply
chains for products and services procured. Additionally, government-
funded intellectual property must be better protected when developed in
tandem with private industry; while public-private cooperation is
critical to maintaining the current pace of scientific advancement, the
ability of the government to safeguard particularly critical
information, while balancing the need for collaboration, must remain a
priority.
Question. Should NIH consider the risks presented by foreign
principal investigators when permitting access to United States genomic
data? If so, why ? If not, why not?
Answer. ONS supports both the NIH and HHS/OIG to address security
issues so that all NIH-funded assets, including data, are appropriately
protected.
ONS is aware that NIH is clarifying policies that require
disclosure of all other support (including support from foreign
entities), foreign components, and significant financial conflict of
interest. NIH is in the process of implementing other risk mitigation
recommendations from the ACD, as described by the NIH ACD Working
Group, and is also collaborating closely with ONS and the security and
intelligence communities to broadly assess and dedicate resources to
address risks related to NIH equities.
Specific to genomic data, ONS is aware that the NIH Genomic Data
Sharing Policy (GDS) sets forth expectations and responsibilities to
ensure the timely, broad and responsible sharing of genomic data. NIH
oversight and control procedures have been implemented to verify that
investigators and entities using such data do so in a manner consistent
with the NIH mission.
Question. Should NIH assess the risks to national security and
intellectual property when permitting data access to foreign principal
investigators? If so, why? If not, why not?
Answer. HHS/ONS will continue to work with NIH to address
scientific data misuse. NIH could strengthen its controls by continuing
to support ONS's effort as it relates to counterintelligence and
insider threat activities, conducting a risk assessment, and
implementing additional appropriate security controls designed to
safeguard sensitive data. We also recommend that NIH continue its
development and implementation of mechanisms to ensure data security
policies keep current with emerging threats. Lastly, we concur with
HHS/OIG that NIH make security awareness training and security plans a
requirement for its funded PIs.
ONS is aware that NIH is working with Federal security and
intelligence agencies to address security issues appropriately for
protection of all NIH-funded assets, including data.
It is imperative that risk assessments are conducted and
commensurate with emerging threat issues. This is exemplified by the
fact that China has instituted policies that regulate access to
biological data and materials. The new Chinese regulations implement
new requirements for the use of human genetic resources that come from
Chinese participants. The rules, which went into effect on July 1,
2019, require international scientists using biomaterials from China to
have a Chinese collaborator. Article 21 states that foreign
organizations that use the materials must abide by Chinese law and work
in cooperation with Chinese institutes. Article 24 states that all data
and patents derived from such a collaboration must be shared with the
Chinese institution [www.the-scientist.com/news-opinion/china-clamps-
down-on-foreign-use-of-chinese-genetic-material-and-data-66016]. This
development could exacerbate the lack of data access reciprocity and
negatively impact future research partnerships and collaborations
Question. Can genomic information be used to track or surveil
individuals?
Answer. ONS would be delighted to, in conjunction with NIH, respond
to this question in a more secure environment.
Question. What is the most effective unclassified tool you have to
detect the threat to taxpayer-funded research and deter that threat?
What additional tools do you need?
Answer. NIH conducts outreach on a variety of policy issues of
importance to the biomedical research enterprise. Initiatives and
programs are continually refined to educate, improve situational
awareness, and develop a mechanism to report suspicious activities at
research entities that could represent an emerging national security
threat. Continued efforts are needed to improve and expand efforts to
educate and provide training on security issues, elaborate on the
``real world'' threat, and provide resources for mitigating identified
risks. We can provide a more thorough response within the accompanying
classified memo responding to unclassified QFRs.
______
Questions Submitted by Hon. Ron Wyden
Question. What are HHS and NIH, respectively, doing to prevent
racial bias and a talent drain in their efforts to address foreign
threats to U.S.-funded research?
Answer. HHS/ONS applies the same screening standards for all non-
U.S. person visitors, regardless of origin. Further examination is
based on identified risk factors which are best discussed in a secure
setting.
Question. Policy on Mixed Government and Non-Government Witnesses
on Panels: Waivers and waivers granted.
Answer. ONS is not positioned to answer this question.
Question. Source of foreign threats.
Answer. This was covered in HHS/ONS prior response on appropriately
classified systems.
______
Questions Submitted by Hon. Todd Young
Question. Just like sharing access to sensitive intelligence
information, should we think similarly about opening up certain
programs or research areas to certain students or professors depending
on their home country?
Answer. Identification of national security threats can be done in
a number of ways; shortcuts such as national origin, however, tend to
introduce serious errors that undermine the process and may lead to a
chilling effect on research cooperation. Focus should be on the
individual, rather than the country, in order to ascertain legitimacy
of access, verification of professional bona fides, competencies, and
references.
Question. Is there a model here for academia that is worth
following?
Answer. Recent proposed legislation and other policy shifts in the
works may provide a good foundation for academia to follow; however,
all systems have vulnerabilities and flaws. The 2012 revision of the
U.S. Select Agents and Toxins Regulations required the implementation
of a personnel security program for vetting and continuously monitoring
personnel holding or seeking access to thirteen pathogens and toxins
classified as significant public safety and security risks to the
United States (referred to as ``Tier 1 agents''). In response, several
institutions that support research with these pathogens have
independently established behavioral threat assessment teams; these
teams help institutional officials evaluate the suitability and
reliability of incoming and existing laboratory personnel that work
with Tier 1 agents. These teams draw on the institutional offices of
human resources, general counsel, security and law enforcement,
environmental health and safety, and occupational health.
Personnel threats come in two forms: insider threats and external
threats. The overall effectiveness and acceptance of personnel security
programs hinges on sensitizing employees to the possibility that people
in their workplace might harm others for personal reasons or be
recruited or manipulated by outside groups.
Representatives from the research community agreed that addressing
personnel security in practice relies on employers:
A. Identifying individuals who pose a threat prior to hiring;
B. Identifying existing employees whose risk potential changes
over time;
C. Identifying a threat when it arises; and
D. Managing threats safely and effectively after they are
detected.
While these strategies can provide a baseline for risk mitigation
as institutions begin to develop their personnel security programs,
each institution should carefully consider all possible strategies and
incorporate those approaches that best fit their facilities, threats,
and community. The key is to develop programs that focus on minimizing
and effectively mitigating the threat without limiting creativity and
unconventional thinking, or creating a risk averse environment that
might be detrimental to scientific advancement.
Question. Should we be limiting what countries we conduct sensitive
research and development with?
Answer. HHS/ONS does not recommend such limitations, as they are
based on a security threat identification shortcut that has,
historically, led to significant errors that undermine processes and
minimize international cooperation based on temporary trends and
political changes. Rather than limiting the countries, which is already
reviewed by the visa application process, a risk assessment should be
conducted to determine vulnerabilities and security concerns as a means
to ascertain ``need to-know.'' This would facilitate proper vetting of
individuals and further the research effort.
______
Questions Submitted by Hon. Robert Menendez
Question. How do we make sure that the United States maintains a
competitive edge in an age of increased cooperation with hostile
actors/countries?
Answer. Ensuring a competitive edge while maintaining open and
continuous contact with potentially hostile actors and countries
requires the individuals involved in that contact to be acutely aware
of the potential risks involved with the contact, and how to respond to
those risks once actualized.
An example could involve researchers focusing on influenza
variants. Certain variants of influenza arise in natural reservoirs
that are outside the United States--such as certain phenotypes of Swine
and Avian flu. Simply closing off research to countries in direct
competition to the United States would also shut off the ability to
access those other phenotypes--leaving the United States particularly
vulnerable should those phenotypes become involved in a pandemic. Thus,
shutting off other countries itself becomes a national security
concern. Instead, researchers in this (and similar) spaces should be
continuously educated on the risks to intellectual property inherent in
the places they conduct their research, as well as with whom they
conduct their research. This education must include more than simply
advising the researchers of the risk; it must also include how to
handle that risk--specifically, reporting and safeguarding. This will
vary based on the details of each project. However, a whole-of-
government approach will simplify reporting of such concerns when
actualized, and may help identify such risks at an earlier stage when
mitigation is simpler and more likely to protect the intellectual
property. Further, connecting the requirement for this education with
the receipt of grant funding from any source will help ensure
saturation of the information throughout the research community.
Question. What tools does Congress have to help our domestic
pharmaceutical industry and protect them from foreign influence?
Answer. The Committee on Foreign Investment in the United States,
provides certifications to Congress regarding cases that do not pose a
national security concern. HHS/ONS is also happy to work with Congress
to ensure we have the tools to address this issue.
Question. What additional efforts are needed in new and cutting-
edge fields like genomics?
Answer. NIH is exploring different options for dealing with this
important issue, and we are engaged in conversations with relevant
partners. Working with ONS to have continued outreach, both internally
and externally to NIH, and education on this topic is also essential.
We are looking at many different approaches, and it should be said that
restricting access to genomic data risks delaying the advancement of
important research that could lead to treatment or cures for many
diseases, and could hinder the U.S., and global, bioeconomy, so the
risks and benefits of restricting access to genomic data must be
weighed carefully. Consideration of negative impacts should go beyond
just genomics, as restricting access to other scientifically valuable
resources (e.g., biospecimens, other data types) also has the potential
to delay important research and life-saving cures, and significantly
affect our competitiveness on a global scale.
______
Question Submitted by Hon. Sheldon Whitehouse
Question. How are Federal agencies working together to assist
universities in safeguarding their data? What more can agencies do to
coordinate better with each other?
Answer. HHS/ONS works closely with NIH to discuss the risks they
and their academic partners face. Additionally, HHS/ONS works closely
with both FBI and the ODNI/National Counterintelligence and Security
Center to assist universities in safeguarding their data. Additionally,
ONS's new NIH-focused branch has an external team that will work
directly with universities.
______
Prepared Statement of Lawrence A. Tabak, D.D.S., Ph.D.,
Principal Deputy Director, National Institutes of Health
Good morning, Mr. Chairman, Ranking Member Wyden, and distinguished
members of the committee. Thank you for your long-standing support of
the biomedical research enterprise and of the National Institutes of
Health (NIH) specifically. 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, 39 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/2017/10/DAY-OF-
RELEASE.Nobel-Prize.October-20171.pdf.
Partnerships with numerous foreign entities are also essential for
predicting, and rapidly identifying and responding to threats from
emerging infectious diseases and pathogens. For example, a joint
working group made up of NIH and National Natural Science Foundation of
China (NSFC) representatives developed a strategic research program
that identifies, reviews, and jointly funds bilateral projects that
address high priority infectious disease concerns, including
antimicrobial resistant bacteria and evolving strains of influenza that
could cause global epidemics.\2\ Furthermore, because diseases can and
do occur in many parts of the world, we must rely on productive
research collaborations and partnership programs with foreign entities
to share information on seasonal and pre-pandemic influenza viruses,
and to access strains of emerging infectious diseases such as SARS and
MERS, Zika, Ebola, and many others.
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\2\ https://www.niaid.nih.gov/research/us-china-collaborative-
biomedical-research-program.
Unfortunately, we are aware that a few foreign governments have
initiated systematic programs to capitalize on the collaborative nature
of biomedical research and unduly influence U.S.-based researchers. It
is essential for us to continue 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, which threatens
to distort decisions about the appropriate use of NIH funds;
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 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 the Federal Bureau of
Investigation (FBI), to exchange information on emerging threats. A new
dashboard is being developed to assist NIH in responding to data
requests needed for its reviews in this context. 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.
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
May 2019, we have contacted more than 55 awardee institutions related
to this issue, and this process is ongoing. Our efforts have directly
or indirectly led 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).\3\
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\3\ 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. For example, on August 23, 2018, the NIH
Director issued a statement on protecting the integrity of U.S.
biomedical research,\4\ 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.
---------------------------------------------------------------------------
\4\ https://www.nih.gov/about-nih/who-we-are/nih-director/
statements/statement-protecting-integrity-us-biomedical-research.
We are developing resources to help awardee institutions understand
our expectations regarding research investigators who--in addition to
NIH funding--receive additional research funding from domestic or
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foreign sources.
As I mentioned, the U.S. biomedical research community at-large has
a vested interest in mitigating these unacceptable breaches of trust
and confidentiality. Community engagement is such an important part of
our activities. Last year, we convened a working group of the Advisory
Committee to the NIH Director (ACD) to develop recommendations related
to foreign Influences on research integrity.\5\ We charged them to
identify robust methods to: (1) improve accurate reporting of all
sources of research support, financial interests, and affiliations; (2)
mitigate the risk to security of proprietary information while
continuing NIH's long tradition of collaborations, including foreign
scientists and institutions; and, (3) explore additional steps to
protect the integrity of peer review. Many of their recommendations,
which were considered and adopted by the ACD, and conveyed to NIH
through the ACD, have already been acted upon by NIH, as described
above. As recommended by the ACD, following input from the working
group, we are working with key stakeholders to figure out how best to
collate and disseminate best practices, with the Association of
American Universities and the Association of Public and Land-Grant
Universities taking a lead role in these efforts. An update on these
activities will be presented and discussed publicly at the June 2019
meeting of the Advisory Committee to the NIH Director. We also
recognize that we will not be successful in our domestic efforts to
protect the integrity of the R&D enterprise if we do not work together
internationally with allies and like-minded partners to take
coordinated action. As such, we are working with the Department of
State to engage key allies and partners to identify effective
approaches to promote U.S. scientific and technological advances
through international S&T cooperation, while simultaneously identifying
and minimizing improper influence on the integrity of the American R&D
enterprise.
---------------------------------------------------------------------------
\5\ https://acd.od.nih.gov/working-groups/foreign-influences.html.
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. In March 2019, we
responded to a joint letter \6\ 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. In our
response, published in the journal Science,\7\ we acknowledge these
concerns, and 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.
Importantly, NIH reviews have identified concerns involving individuals
who are not of Chinese ethnicity
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\6\ https://science.sciencemag.org/content/363/6433/1290.
\7\ 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
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to millions around the world.
In closing, as Principal Deputy Director of NIH, 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, Mr. Chairman.
______
Questions Submitted for the Record to Lawrence A. Tabak, D.D.S., Ph.D.
Questions Submitted by Hon. Chuck Grassley
Question. According to NIH, it operates both the intramural program
and the extramural program for research activities. Within the
intramural program, NIH's employees, contractors and affiliates who are
U.S. citizens undergo background investigations. Further, prior to that
background check, a Special Agency Check is conducted requiring
fingerprints to be cross-checked with FBI criminal databases, including
terrorist watch lists. According to NIH, a grantee institution in the
extramural program, such as a university or other research institution,
is responsible for any vetting, not NIH.
More than $8 out of $10 appropriated to NIH goes to the extramural
program. At the committee hearing, I asked Dr. Tabak whether NIH
conducts background checks, including a review for counter-intel
purposes, on principal investigators prior to awarding a grantee
institution taxpayer money. He answered, ``No sir, we do not, as they
are employees of their home institution.''
Can NIH condition the receipt of taxpayer money on the principal
investigator passing the same background check that NIH employees must
pass? If so, why has NIH not made that a condition?
Answer. Through ongoing discussions with the extramural community,
the Department's Office of National Security, and our Federal partners,
in particular those in security and law enforcement, NIH is actively
exploring options and additional actions to address research integrity
concerns. If extramural investigators have long term (more than six
month) access to Federal facilities or information systems, they are
required to undergo background investigation for a determination of
eligibility for a PIV credential. The standards for this determination
is whether the issuance of a credential would pose an unacceptable risk
to people, property or information systems. At this time, we do not
know whether implementing such a background check requirement for
extramural investigators that do not have long-term access to Federal
facilities or systems would be feasible or helpful. We must consider
adverse effects on university administrative burden, especially if such
an effort were to be taken at scale (involving hundreds of thousands of
scientists every year).
Question. If principal investigators were subject to the same
background check as NIH employees, and were also subject to a review
for counterintelligence purposes, how would those checks help
strengthen grant integrity?
Answer. It is unclear whether this would strengthen grant
integrity. There is a risk that institutions might see these background
checks as a rationale for loosening their oversight.
Question. If principal investigators were subject to the same
background check as NIH employees, and were also subject to a review
for counterintelligence purposes, would those checks improve the
government's security posture? If so, how? If not, why not?
Answer. This question is outside the purview of the NIH.
Question. What additional changes would improve the integrity of
the grant system and taxpayer-funded research? For example, should any
changes be made to government grant forms?
Answer. NIH understands and supports interest in modifying
government grant forms and/or application information, e.g., to include
an assurance/certification from the authorized organization
representative (AOR) that the investigator(s) designated in the grant
application do(es) not have a criminal background or findings of sexual
harassment, and that the investigator(s) fully disclosed all
affiliations and other research support. This additional assurance/
certification would be governed by the existing, express
acknowledgement by the AOR that any intentional or negligent
misrepresentation of the information contained in the certification may
result in criminal, civil or administrative sanctions, including but
not limited to: (1) fines, restitution and/or imprisonment under 18
U.S.C. Sec. 1001; (2) treble damages and civil penalties under the
False Claims Act (31 U.S.C. Sec. 3729 et seq.); (3) double damages and
civil penalties under the Program Fraud Civil Remedies Act (31 U.S.C.
Sec. 3801 et seq.); (4) civil recovery of award funds; (5) suspension
and/or debarment from all Federal procurement and non-procurement
transactions (FAR Subpart 9.4 or 2 CFR part 180); and (6) other
administrative penalties.
Question. According to the Health and Human Services Inspector
General, NIH has recently referred for investigation 16 allegations of
noncompliance related to medical research. The Inspector General stated
the allegations primarily deal with the failure of principal
researchers to disclose foreign government affiliations.
At the committee hearing, I asked Dr. Tabak how NIH discovered
cases for referral to the Inspector General. In response, he stated,
``We flagged these in various ways, our own staff use algorithms to
detect potential untoward behavior. We also receive referrals from our
colleagues at HHS and the FBI and, increasingly, universities as they
become more and more aware of this issue, are alerting us to potential
issues as well.'' I also asked Dr. Tabak whether he would provide this
committee a specific breakdown of how each referral originated, whether
by NIH or a research institution. Dr. Tabak stated, ``We would provide
that for the record, but it would have to go in concert with the IG.
We've already made those referrals and they are ongoing
investigations.''
In the past 5 years, how many referrals have HHS and the FBI sent
to NIH? Please list each institution, all researchers subject to the
referral, and the reason for the referral.
Answer. NIH is not positioned to provide this information due to
dynamic, ongoing investigations.
Question. For those referrals that NIH sent to the Health and Human
Services Inspector General, how many originated with NIH and how many
originated with a research institution or another agency? In your
response, please provide the name of each research institution and
agency. In addition, did any of the grantees receive new NIH grants or
have NIH grants renewed after NIH decided to refer the cases? If so,
what was the total value of those grants?
Answer. From the current list of referrals to the OIG, two thirds
originated at NIH and one-third came to NIH from the FBI. We have put
all new grant funding and renewals associated with these investigators
on administrative hold as questions are being addressed.
Question. What foreign governments pose the greatest threats to
intellectual property created by taxpayer-funded research at American
universities? How are they working to exploit our academic institutions
to steal critical IP? Can you share any specific examples of that
exploitation?
Answer. This question falls outside of NIH's purview.
Question. Have foreign nationals, acting surreptitiously on behalf
of foreign governments, penetrated critical U.S. industries, including
but not limited to health-care and pharmaceutical research,
infrastructure, financial services, defense, robotics, and advanced
chip processing? If yes, please explain what changes, including
legislative changes, are needed to stop or slow these incursions.
Answer. This question is outside the purview of the NIH.
Question. A recent Inspector General report raised concerns with
the fact that NIH gave access to U.S. genomic data to for-profit
companies from China ``even though the FBI has identified those
companies as having ties to the Chinese Government.'' The report also
found that ``NIH did not consider the risk presented by foreign
principal investigators when permitting access to United States genomic
data and has not assessed the risks to national security when
permitting data access to foreign principal investigators.''
Is NIH still providing companies with ties to the Chinese
Government access to U.S. genomic data? If so, why?
Answer. NIH does not verify affiliations of principal investigators
beyond that of their home institution. NIH oversight and control
procedures, such as data access request review by Data Access
Committees and ongoing tracking of data use, allow NIH to verify that
stewardship of the data by investigators and responsible entities is
consistent with the terms and conditions for use of the data.
Recognizing the importance of transparency in how these data are
being used, NIH does publicly provide information related to data
submitted to dbGaP, such as a list of all approved users for each
dataset, their institutional affiliations, and their proposed research
use of those data.
Question. Has NIH changed its policy to now consider the potential
national security risks in giving foreign Principal Investigators
access to U.S. genomic data? If not, why not?
Answer. NIH continues to take national security risks into
consideration regarding all of its assets and is working with our
partners in the Federal security and intelligence agencies to address
these issues appropriately. NIH notes that these risks are not limited
to (or even typically focused on) human genomic data.
NIH's commitment to tackling these important challenges are
reflected in a variety of recent actions, including the convening of a
NIH Advisory Committee to the Director (ACD) Working Group for Foreign
Influences on Research Integrity. From this engagement, the ACD
recommended that NIH should increase communication and awareness with
institutions and organizations, mitigate and prevent risks, and work
with partners across the government to monitor, report, and enhance
security to protect America's research integrity.
As it pertains to risk mitigation, NIH is clarifying policies that
require disclosure of all other support (including support from foreign
entities), foreign components, and significant financial conflict of
interest. NIH is in the process of implementing other risk mitigation
recommendations from the ACD, as described by the NIH ACD Working
Group, and is also collaborating closely with the HHS Office of
National Security and the security and intelligence communities to
broadly assess and dedicate resources to address risks related to NIH
equities.
Question. What particular areas of genomic data did NIH provide to
WuXi Nextcode Genomics, Shenzhen BGI Technology Company, and other
genomics entities associated with the Chinese Government? Have the FBI
and the intelligence community received relevant information about the
type of genomic information these entities accessed? How many
Americans' genomic information was provided to these foreign entities?
Answer. The table below provides the study name, number of
participants, and type(s) of data that were accessed by Shenzen BGI
Technology Company, BGI Americas, BGI Research, and WuXi Nextcode
Genomics. Given that the majority of the security conversations on this
topic have taken place in classified settings, we cannot speak to the
spectrum of briefings received by the FBI and the intelligence
community.
------------------------------------------------------------------------
Data Types
Study Name and Number of Participants Disease Area Included
------------------------------------------------------------------------
The Cancer Genome Atlas (TCGA) Cancer Whole Genome
(11,429 Participants) Genotyping
Whole Genome
Sequencing
Whole Exome
Sequencing
RNA Sequencing
------------------------------------------------------------------------
Foundation Medicine Adult Cancer Cancer Targeted
Clinical Dataset (FM-AD) (18,004 Genomic
Participants) Sequencing
------------------------------------------------------------------------
Genotype-Tissue Expression (GTEx) Normal tissue, Whole Genome
(752 Participants) no disease Genotyping
Exome
Genotyping
Whole Exome
Sequencing
RNA Sequencing
Gene
PExpression
Whole Genome
Sequencing
------------------------------------------------------------------------
Whole-Genome Sequencing of Acute Acute Myeloid Whole Genome
Myeloid Leukemia (170 Participants) Leukemia Genotyping
------------------------------------------------------------------------
Transcriptome Sequencing of Pediatric Acute Myeloid Whole Genome
AML FAB-M7 (15 Participants) Leukemia Genotyping
Whole Genome
Sequencing
------------------------------------------------------------------------
Sequencing of Medulloblastoma (93 Medulloblastoma Whole Genome
Participants) (type of brain Genotyping
cancer)
------------------------------------------------------------------------
Estrogen Receptor Positive Breast Breast Cancer Whole Genome
Cancer: Aromatase Inhibitor Response Genotyping
Study (115 Participants)
------------------------------------------------------------------------
Question. What is the most effective unclassified tool you have to
detect the threat to taxpayer-funded research and deter that threat?
What additional tools do you need?
Answer. NIH is employing a multi-pronged approach to develop
proactive programs to minimize the likelihood of problems in the
future. To date, informing the research community and the extramural
staff at NIH to raise awareness, and partnering with other agencies
have been effective strategies.
Informing the research community: Raising awareness of the threat
at awardee institutions has been a powerful tool. We continue to urge
universities to look closely at their organizations to mitigate
unscrupulous practices by individuals that aim to capitalize on the
collaborative nature of the U.S. biomedical enterprise. Regular
communications to the extramural community over the last several years
have focused on protecting the integrity of U.S. biomedical research
and the imperative to inform NIH of any foreign support. These
communications have included a number of notices and statements to the
community, including the unprecedented step of the NIH Director issuing
a letter to officials at 10,000 recipient institutions. This letter
informed the research community that the agency is aware that some
foreign entities have mounted systematic programs to influence NIH-
supported researchers and peer reviewers, as well as to take advantage
of the long tradition of trust, fairness, and excellence of NIH
supported research activities.\1\ Furthermore, NIH convened a working
group of the Advisory Committee to the NIH Director (ACD) on Foreign
Influences on Research Integrity. This panel comprised leaders in
higher education, members of the extramural community, and experts in
security, and was charged with assisting the ACD, which made
recommendations to the agency which are currently being implemented.
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\1\ https://www.nih.gov/about-nih/who-we-are/nih-director/
statements/statement-protecting-integrity-us-biomedical-research.
NIH regularly communicates with grantees to provide training and
compliance support for issues involving conflict of interest
requirements at NIH-led conferences such as the NIH Regional Seminars.
This information is also communicated by NIH through professional
organizations such as the Federal Demonstration Partnership, Society
for Research Administrators, American Association of Universities,
Council on Governmental Relations, Association of Public and Land-grant
Universities, and the National Council of University Research
Administrators. There have been a number of special meetings involving
these groups and others to address the recent concerns on foreign
influence. In addition, NIH recently developed an online training
module \2\ on Financial Conflict of Interest as a resource for both NIH
staff and the extramural community. NIH's outreach and engagement have
facilitated extensive faculty outreach at research organizations as
well as led to developing and sharing best practices.
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\2\ https://nexus.od.nih.gov/all/2018/12/03/new-financial-conflict-
of-interest-training-module-available/.
NIH has also been reaching out to recipient institutions directly.
NIH has contacted over 60 institutions regarding specific scientists
who may have failed to disclose substantial foreign research support or
financial conflicts of interest or who may have engaged in substantial
breaches of peer review integrity. This outreach has led to referrals
to OIG, communications with FBI, disciplinary actions by the relevant
institutions (including terminations or resignations), revisions of
grant terms, and new efforts on the part of institutions to enhance
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oversight and security of their research operations.
We have strong indication that these communication strategies are
working. A report on Actions Taken by Universities to Address Growing
Concerns about Security Threats and Undue Foreign Influence on
Campus,\3\ issued by the American Association of Universities (AAU) and
the Association of Public and Land-grant Universities and updated in
April 2019, shares practices that universities are employing to
``ensure the security of research, protect against intellectual
property theft and academic espionage, and prevent actions or
activities by foreign governments and/or other entities that seek to
exert undue foreign influence or which infringe on core academic
values.''
---------------------------------------------------------------------------
\3\ https://www.aplu.org/members/councils/governmental-affairs/
Effective-Sci-Sec-Practices-What-Campuses-are-Doing.pdf.
Partnering with other agencies: NIH is actively partnering with
other Federal departments and agencies to address concerns related to
undue foreign influence on the biomedical research enterprise. These
Federal partners include the Central Intelligence Agency, Federal
Bureau of Investigation, HHS Office of Inspector General, HHS Office of
National Security (ONS), Department of Defense, Department of State,
Department of Energy, and the National Science Foundation. Staff within
the intelligence community, FBI, DOE, and NSF, for example, have noted
that NIH is well ahead of other Federal agencies in addressing and
communicating concerns of possible undue foreign influence on research
---------------------------------------------------------------------------
funding.
The most effective unclassified tool we've used to date has been
close work and partnership with institutions and with law enforcement
on specific cases. These partnerships have led to extensive discovery
about the nature of the threats, to actions by the relevant
institutions against certain investigators, to referrals to the OIG,
and to institutional implementation of additional internal systems
control measures.
We look forward to ongoing work with institutions, with OIG, and
with other agency offices/contacts (including FBI, DNI, DOE, NSF, DOD,
HHS/ONS, and State).
Questions Submitted by Hon. Ron Wyden
Question. Potential Damage to U.S. Research from Attacks on Foreign
Researchers: The Houston Chronicle recently reported that over the past
18 months, three MD Anderson senior researchers or administrators of
Chinese descent have retired, resigned, or been placed on
administrative leave. Some believe a toxic climate and perception of
racial profiling hastened their departures. Two of the researchers
subsequently took positions at Chinese institutions. In March, a group
of Chinese American scientists voiced concern in a strongly worded
letter in the journal Science that recent rhetoric and proposals by the
NIH and FBI could lead to unjust targeting of Chinese scientists. In
May, the magazine ran an editorial entitled ``Two Threats to U.S.
Science.'' The two threats it identified were inadequate research
funding and disparagement of foreign scientists working in the U.S. and
the immigration roadblocks to their staying in the U.S. What are HHS
and NIH, respectively, doing to prevent racial bias and a talent drain
in their efforts to address foreign threats to U.S.-funded research?
Answer. NIH has a responsibility, in coordination with other
Federal agencies and with institutions, to strive to assure an
environment of compliance and ethical conduct of research. Stealth
employment and research support in foreign countries and egregious
violations of peer review norms pose a serious threat to the integrity
and credibility of the entire research enterprise.
NIH is focusing its efforts on enhancing research integrity across
all our processes and systems. The extraordinary contributions of
foreign nationals to American science are indisputable. As just one
example, 24 percent of U.S. Nobel prizes have been awarded to foreign-
born scientists. The biomedical research workforce continues to be
greatly enriched and strengthened by scientists who come to our shores
from many parts of the world. The overwhelming majority of researchers
participating in NIH grants, whether U.S.- or foreign-born, are honest
contributors to the advancement of knowledge that benefits us all.
Driving away talented scientists from other countries would have a
profoundly negative effect on American productivity. See NIH Director
Statement in Science \4\ responding to concerns of Chinese scientists.
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\4\ https://science.sciencemag.org/content/363/6433/1292.
The Hoover Report \5\ highlights a systematic effort to keep
American employers in the dark about Thousand Talents awards. Our
observations are consistent with the Hoover Report statement.
---------------------------------------------------------------------------
\5\ https://www.hoover.org/research/chinas-influence-american-
interests-promoting-constructive-vigilance.
The challenge is to find ways to build and continue important and
successful relationships with foreign scientists around the world while
simultaneously protecting the Nation's biomedical innovations and
proprietary information. The Advisory Committee to the Director, with
the assistance of a working group,\6\ has made recommendations to NIH
on best approaches to deal with this issue, and NIH is taking action on
these recommendations. Also, NIH is working with other Federal
agencies, scientific professional societies, and grantee institutions
to address this challenge. NIH is making clear statements about the
importance of international collaboration with each statement \7\ or
presentation \8\ on the topic of threats to the U.S. biomedical
research enterprise.
---------------------------------------------------------------------------
\6\ https://acd.od.nih.gov/working-groups/foreign-influences.html.
\7\ https://science.sciencemag.org/content/363/6433/1292.
\8\ https://acd.od.nih.gov/documents/presentations/
06142019Foreign.pdf.
Question. Policy on Mixed Government and Non-Government Witnesses
on Panels: Your agency told the Finance Committee that its witness
would not participate on a panel at this hearing that included both
government and non-government witnesses, claiming there is a
longstanding OMB policy prohibiting this. However, there are numerous
examples where your agency has allowed witnesses to testify on ``mixed
panels.'' Over the past 10 years, Federal Government witnesses,
including those from your agency, have testified before the Finance
Committee on panels with non-government witnesses more than 40 times.
This has also been the case with other Senate committees. In April
2019, an NIH witness testified on a panel with non-government witnesses
before the Senate Aging Committee. An NIH witness also testified on a
panel with non-government witnesses before this same committee in July
2017. In March 2018, the Secretary of DHS herself testified on a panel
with non-government witnesses before the Senate Select Committee on
Intelligence. Why were these witnesses permitted to testify before
other Senate Committees on mixed panels, but your witness was not
permitted to do so at the Finance Committee's June 5th hearing? If
waivers were granted for witnesses to testify on mixed panels at other
committee hearings, why were those waivers granted for the other
hearings but not the June 5th hearing? Please provide copies of (1) the
OMB policy that allegedly prevents government witnesses from testifying
on panels with non-government witnesses; (2) any waivers granted for
the recent Aging and Intelligence hearings where government witnesses
from NIH and DHS respectively testified with non-government witnesses;
and (3) any request submitted to OMB for your witness to testify at the
June 5th hearing and the OMB response along with an explanation why a
---------------------------------------------------------------------------
waiver was not granted for the June 5th Finance Committee hearing?
Answer. The Department of Health and Human Services received
guidance stating this administration would continue the longstanding
practice of prior administrations by allowing executive branch
officials to testify at a congressional hearing only on a first panel
that is separate from non-executive branch witnesses. Accommodations
may be made on a case-by-case basis, as appropriate. HHS and NIH are
appreciative that we could agree to an arrangement that provided for
our testimony at the hearing alongside other executive branch
witnesses.
Question. Source of Foreign Threats: During the hearing, Senator
Wyden asked Dr. Tabak and the first panel of government witnesses to
identify the general number, or a range, of countries that currently
constituted the source of the foreign threat. Dr. Tabak responded that
he could not do so in an unclassified setting and would do so in the
classified briefing. Would you please provide a separate, classified
response that identifies the specific countries that you believe
currently present a threat to U.S. research and describe the nature of
that threat?
Answer. We defer to the Department of State, as this question falls
within their jurisdiction.
______
Questions Submitted by Hon. John Thune
Question. One of the purposes of this hearing is to explore how
foreign countries may be exploiting our open research institutions.
What countries would you say are the top three or four countries that
engage in this activity? Do you see these countries primarily targeting
the larger research universities, or do you see them targeting small
universities in the Midwest, for example?
Answer. We defer to the Department of State, as this question falls
within their jurisdiction.
Question. The HHS Office of Inspector General recently released a
report stating that NIH did not concur with the Inspector General's
recommendation to develop a security framework, conduct a risk
assessment, and implement additional controls for sensitive data in the
context of NIH Genomic Data. Why did NIH not concur with this
recommendation?
Answer. NIH is sensitive to the concerns raised in the OIG report.
As stated in NIH's agency comments, NIH did not concur with OIG's
finding and corresponding recommendation in regard to its specificity
to foreign investigator access to genomic data in particular. NIH did
not concur with the OIG's recommendations for several reasons, listed
below.
The principal documentation cited by OIG in their report is
based on a single congressional testimony that speculates a
``theoretical risk'' of negative implications for the U.S. by
the open sharing of genomic information. This argument seems
specious, since it is not limited to human genomic data
maintained in controlled access.
The current NIH process includes institutional sign-off and
agreement to follow certain norms and standards practices which
is the standard NIH process to establish controls for many
mechanisms such as the submission of funding applications,
contracts, and other types of agreements. Thus, institutions
maintain the responsibility to follow these norms and
standards. NIH does not independently administer policies to
different types of investigators as this would be inefficient,
burdensome, and difficult to monitor and enforce, ultimately
leading to inconsistent policy implementation.
A robust security framework is already in place in the form
of dbGaP. When requesting access to human genomic data in
dbGaP, all institutions, whether foreign or domestic, must sign
off and agree to the same participant protection principles and
data security practices described in the NIH Genomic Data
Sharing Policy, thus assuring their responsible stewardship and
appropriate use of human genomic data. Also, a NIH Data Access
Committee will only approve a request if the proposed research
use is consistent with the appropriate uses of the data, as
delineated by the institution that submitted the data. Such
policies and guidelines have been established to control the
access or transfer of human genomic data, irrespective of
whether the investigator is foreign or domestic.
In addition, the NIH Security Best Practices document outlines
expectations and best practices for key provisions such as security
guidelines, controls for servers, controls for copies of data and their
destruction, and guidance for cloud computing. The document also
references the Center for Internet Security, NIST, and the U.S.G.
Configuration Baseline for benchmarks and best practices for security
configurations, standards, and baselines, which are widely accepted by
Federal agencies. Thus, based on process and guidelines that have been
established for data submission, access, management, and security, NIH
has mechanisms and controls in place that have successfully addressed
the risks associated with the sharing of human genomic data through
controlled-access repositories.
______
Questions Submitted by Hon. Todd Young
five eyes intelligence alliance
Question. The Five Eyes is widely regarded as the world's most
significant intelligence alliance. The origins of it can be traced back
to the context of the Second World War and by its necessity of sharing
vital information mainly between Britain and the United States so both
countries could enhance the allied war effort. ``Five Eyes'' was
formally founded in the aftermath of the Second World War, through the
multilateral agreement, known as the UKUSA Agreement, on March 5, 1946.
Initially, compromising only the UK and the United States, it
expanded to also include Canada in 1948 and Australia and New Zealand
in 1956. Thereby, the ``Five Eyes'' term was created from the lengthy
``Australia/Canada/New Zealand/United Kingdom/United States Eyes Only''
classification level that included the ``eyes'' that could have access
to high-profile papers and information.
For more than 70 years this alliance of like-minded allies has
served our intelligence community well.
Just like sharing access to sensitive intelligence information,
should we think similarly about opening up certain programs or research
areas to certain students or professors depending on their home
country?
Is there a model here for academia that is worth following?
Should we be limiting what countries we conduct sensitive research
and development with?
Answer. We defer to the Federal Bureau of Investigation, the HHS
Office of National Security, or the Office of the Inspector General for
the U.S. Department of State, as this question falls within their
jurisdiction.
______
Questions Submitted by Hon. Robert Menendez
Question. U.S. versus Global Research: The United States'
leadership role is being threatened as other countries are pouring more
and more money into research, with some estimates claiming that China
will outspend the United States in total research and development by
the end of this decade. Combine this with the fact that China has
continuously tried and succeeded in infiltrating our publicly funded
research initiatives, it is not hard to see the U.S. ceding more ground
to our adversaries when it comes to innovation and technology.
How do we make sure that the U.S. maintains a competitive edge in
an age of increased cooperation with hostile actors/countries?
Answer. Provision of support for biomedical research is crucial to
ensuring the U.S. position. However, it is more than money that drives
the biomedical research system; it is also the integrity of the system
and the flexibility of independent investigators balancing scientific
opportunities with public health needs.
Question. What tools does Congress have to help our domestic
pharmaceutical industry and protect them from foreign influence?
Answer. This question is outside the purview of the NIH.
Question. What additional efforts are needed in new and cutting-
edge fields like genomics?
Answer. NIH's current system for protecting against the risks and
emerging threats identified by NIH for the sharing of human genomic
data has been successful thus far. This system involves rigorous NIH
controls, such as access request review by Data Access Committees, that
verify investigators and entities using genomic data are doing so (1)
in a manner consistent with the NIH mission, (2) to advance science and
health, and (3) to enable NIH to maximize its return on investment.
Data Access Committees also provide ongoing tracking of who has access
to data and how it is used over the course of the project. Recognizing
the importance of transparency in how these data are being used, NIH
provides information and statistics accessible by the public on the
data submitted to the NIH database of Genotypes and Phenotypes (dbGaP),
as well as a list of all approved users for each dataset, their
institutional affiliations, and their proposed research use of those
data.
As technologies progress, there may be a need to further refine
NIH's system of providing access to human genomic data. The Novel and
Exceptional Technology and Research Advisory Committee, or NExTRAC, may
be able to assist NIH with such efforts. The NExTRAC is a Federal
advisory committee that provides transparent advice to the NIH Director
about the scientific, safety, ethical, and social issues associated
with emerging biotechnologies. The NExTRAC will be an important tool to
help NIH make sure that its policies, guidance, and oversight systems
keep pace with the rapidly accelerating landscape of biomedical
research.
Question. Budget: We've seen a reoccurring theme from this
administration of abdicating our global leadership on a broad range of
issues.
What is the current President's budget request for our research and
development agencies/institutions, including NIH, NASA, the Department
of Energy's Science Office, the EPA, and the National Science
Foundation?
Answer. The President's FY 2020 budget request included a proposed
budget for NIH of $34.4 billion. While NIH cannot speak on behalf of
NASA, DOE, EPA, and NSF, the ``Research and Development'' chapter of
the Analytical Perspectives volume of the President's budget includes a
table showing Federal R&D funding by agency. Note that figures in that
table for NIH do not include NIH research training and research funded
by program evaluation financing resources.
Question. While protecting intellectual property and our scientific
research and technology is critical, how does cutting the funding of
these programs allow the United States to remain competitive?
Answer. The President's FY 2020 budget request includes funding for
NIH to support the highest priority biomedical research. This funding
is also key to ensuring a strong biomedical research workforce that can
effectively advance discovery.
______
Prepared Statement of Hon. Ron Wyden,
a U.S. senator From Oregon
A few key points to make this morning on taxpayer-funded research
in America. First, our country is more entrepreneurial, our economy is
stronger, and our lives as Americans are better because our scientific
community attracts so many of the world's brightest minds. That is a
strength to be protected--a part of our national character that must
not be diminished.
Foreign-born scientists put Americans on the moon. They worked on
the Manhattan Project. Nearly a third of all American Nobel laureates
were born outside the U.S. Look back at 2016, when six U.S.-based
scientists won Nobel Prizes. All were born in other countries.
It goes without saying that individuals and governments outside the
U.S. are going to want to chip away at our lead. That's particularly
true when it comes to scientific breakthroughs that lead to valuable IP
and entrepreneurship. Academic institutions and other research
organizations based in this country need to understand and respond to
those concerns--just like Federal agencies and private companies do.
But overreaching with barriers that turn away bright students or
cut off lines of communication with scientists from other countries
would do a lot more harm than good. And targeting Americans who happen
to be descendants of recent immigrants is as bone-headed as it gets.
Dr. Alicia Carriquiry, distinguished professor at Iowa State
University, put it this way: ``Without foreign-born researchers, the
entire system of higher education in the United States would collapse
in a minute.''
Later this morning, the Finance Committee will hear from Dr. Joe
Gray of the Oregon Health and Science University. Nobody knows better
than Dr. Gray how vitally important foreign-born researchers and
international collaboration are to this country and our institutions.
The U.S. would not be capable of scientific breakthrough without them--
period.
Second, any breakthrough in medicine or technology ought to be
cheered as long as it leads to better lives for Americans. And if the
U.S. suspects that American IP or technology has been stolen, this
Nation has the power to do something about it.
Finally, while the committee examines this issue today, it's also
important to take a step back to look at the broader context of our
commitment to scientific research.
When you take inflation into account, Federal investments in
science and research have steadily declined for decades. State
investments in higher ed have also dropped, starving research
universities of funding.
The quickest way to turn the lights out in health research
laboratories across America would be to enact the Trump
administration's proposed budget cuts to NIH.
And just a few months ago, the president also signed an executive
order threatening to cut off research funding for universities over a
baseless panic dealing with speech on campus. Fortunately, the order
was toothless.
So when you take the broader view of threats to research in
America, it's clear the biggest danger comes from within, especially
with an administration that often takes anti-science positions.
With respect to foreign threats, what's true with private
businesses and government agencies is true for research institutions.
They need to take responsible steps to protect themselves and their
work. That doesn't mean closing the door to or placing undue burdens on
the foreign-born students and scientists who make life changing
discoveries together with Americans.
I want to thank our witnesses for joining the committee today, and
I look forward to questions.
______
Association of American Universities
1200 New York Avenue, NW, Suite 550
Washington, DC 20005
P: 202-408-7500
www.aau.edu
America's leading research universities take national security threats
posed by international actors seriously and are actively working to
mitigate those threats. Universities share a vested interest with the
federal government in protecting intellectual property, proprietary
information, trade secrets, and classified or otherwise controlled
government information resulting from federally funded research.
Striking the right balance between controlling sensitive technological
information and maintaining the free flow of fundamental scientific
knowledge and international talent is vital to protecting America's
national security, maintaining the nation's role as the world's leader
in science and innovation, and continuing the economic growth enabled
by scientific and technological advances.
In light of recent concerns about foreign security threats, AAU and
other higher-education associations are working together with law
enforcement, the intelligence community, federal science agencies, and
Congress to secure research on our university campuses. For example,
last September AAU, along with the American Council on Education, the
Association of Public and Land-grant Universities, and the FBI, held a
summit on security that brought together high-level university
administrators, key FBI leadership, and representatives from agencies
that fund federal scientific initiatives. This April, Senator Mark
Warner (D-VA) and Marco Rubio (R-FL) convened representatives from the
Office of the Director of National Intelligence, the FBI, and the
Department of Homeland Security in two classified briefings that
engaged over 75 university presidents and chancellors. APLU plans to
hold a similar briefing at its upcoming Counsel of Presidents meeting.
AAU and other higher education associations have also actively engaged
our members in discussions about how better to secure academic
research. Last fall, AAU and APLU conducted a survey of universities on
effective practices for securing research and guarding against undue
foreign interference. In April, our two associations sent a report on
these effective practices to our institutions to help improve how they
secure the important research they perform on behalf of the federal
government.
Even as we continually improve our security protocols, we must guard
against measures that would stifle the very openness and collaboration
that are necessary to advance science and technology. This is key to
maintaining America's scientific and technological preeminence--itself
critical to our national security, economic competitiveness, and
quality of life.
Likewise, we must guard against measures that would unnecessarily stem
the flow of foreign research talent to our shores. America has remained
on the cutting edge of science because U.S. institutions attract and
retain the best and brightest foreign researchers. U.S. visa and
immigration policies must continue to encourage talented students and
scholars from around the world to come to this country and actively
contribute to advancing American science and the U.S. economy.
Finally, the United States must invest more in critical areas of
scientific research and scientific talent development to ensure that we
do not fall behind China and other competitors who are currently making
such investments. We must commit to developing stronger domestic STEM
talent; making strong investments in the research programs supported by
the National Science Foundation, the NIH, NASA, the Departments of
Defense and Energy, and other major federal research agencies; and
increasing funding for emerging areas of science such as quantum
information, artificial intelligence, robotics, advanced manufacturing,
and biotechnology.
In 2006 AAU released a report calling for the creation of a new
National Defense Education and Innovation Initiative that highlighted
the need for major investments in domestic research and talent
development. The report envisioned modern-day investments similar in
magnitude to federal investments in science during the years following
the launch of Sputnik in 1957. It's thanks to this forward-looking leap
in investment that we have the Defense Advanced Research Projects
Agency, NASA, and the National Defense Education Act. AAU urges
Congress to consider the report's recommendations to bolster our
nation's security, strength, and competitiveness on an ever-changing
global stage.
Communications
----------
American Association of Immunologists (AAI)
1451 Rockville Pike, Suite 650
Rockville, MD 20852
(301) 634-7743
Statement of JoAnne L. Flynn, Ph.D., President
The American Association of Immunologists (AAI), the nation's
largest professional association of research scientists and physicians
who study the immune system, appreciates having this opportunity to
submit testimony for the record regarding the Senate Finance
Committee's June 5, 2019, hearing on ``Foreign Threats to Taxpayer-
Funded Research: Oversight Opportunities and Policy Solutions.'' AAI
members are research scientists and physicians who live and work in the
United States and in countries throughout the world. What they share is
an academic expertise in, and professional commitment to, understanding
the immune system and to advancing ways to prevent, treat, and cure
disease.
AAI recognizes and greatly appreciates the strong support--and robust
funding--that Congress and American taxpayers have provided for
biomedical research. Most AAI members receive funding from the National
Institutes of Health (NIH) to support their research, and are gratified
that their work is strongly supported on a bipartisan basis. Our
members know that, with this funding, comes the responsibility to work
hard to both advance our research and protect the integrity of science
and the scientific enterprise. AAI has been made aware in recent months
by the NIH, this Committee, and press reports, among other sources, of
concerns about threats posed by foreign countries and foreign nationals
to U.S. national security and U.S. intellectual property. AAI looks
forward to working with Congress and the NIH to address threats to the
research and innovations to which our members devote their professional
lives.
It is essential, however, before moving forward, for Congress to
understand fully the collaborative nature of science and the urgent
need for international collaborations if the U.S. is to advance
science, foster innovation, and remain the world's leader in biomedical
research. I can best illustrate this, I believe, by describing my own
experience. As a professor in the Department of Microbiology and
Molecular Genetics at the University of Pittsburgh School of Medicine,
I have spent most of my career studying tuberculosis (TB), an infection
caused by a bacterium. With 10 million cases and 1.3 million deaths in
2017, TB causes even more deaths than HIV. According to the Centers for
Disease Control and Prevention (CDC), 25 percent of the world's
population is currently infected with TB; if left untreated, about 5-10
percent of those infected will develop the disease. Preventing TB
globally not only protects the U.S. from this disease, but also
improves the health of people in some of the poorest nations in the
world.
As a result of--and to further--my research, I have developed extensive
ties in the international research community. I have deep experience
collaborating with scientific partners in other countries through
research projects sponsored by both the NIH and the Bill and Melinda
Gates Foundation. In my view, it is essential for U.S. researchers
studying TB to work with scientists in countries where the incidence of
TB is high. Therefore, while TB research is performed in many
countries, I have worked closely with scientists in Asia and Africa,
where several poor countries have the largest number of cases. My lab
has partnered with outstanding scientists in South Africa, where the
incidence of TB is very high; by coordinating our efforts, we are
working to identify new methods for treatment and prevention of this
disease. My colleagues and I are also working with scientists in the
United Kingdom and Denmark, where new drugs, diagnostics, and vaccines
against TB are being developed, providing these collaborators with an
important avenue for testing potential interventions. I have also
traveled to many different countries around the world, speaking about
my research at seminars and international meetings, and discussing with
individual scientists our shared interests. These interactions are
critical to maintaining collaborative relationships and promoting
outstanding science in all countries.
In conjunction with my research, I have trained more than a dozen young
researchers from many different countries (including Bosnia and
Herzegovina, Canada, China, Iceland, India, Malaysia, Moldova, New
Zealand, Nigeria, and the former Soviet Union). I believe strongly that
these young scientists are critical not only to the advancement of TB
research, but also to the scientific enterprise of the U.S. While some
of these scientists return to their home countries to perform research
there (and may collaborate with U.S. scientists), others stay in the
U.S. to run their own labs or work in the broader research enterprise.
Although AAI does not have sufficient expertise to recommend ways to
promote national security or prevent the theft of intellectual
property, we believe that better educating NIH funded scientists and
the institutions where they work about required disclosures (including
of foreign grant support or faculty appointments, and affiliations with
foreign labs); prohibited commercial and institutional relationships;
and appropriate handling of proprietary or other confidential
information; will go a long way towards addressing the Committee's
concerns. Providing clear, specific guidance will help prevent
inadvertent missteps by well-intentioned scientists and institutions,
and may help limit increased scrutiny to those individuals and areas of
the scientific or technological enterprise that pose a genuine threat.
AAI strongly believes that the vast majority of NIH-funded scientists
are conducting research in a fair and transparent manner, and are
abiding by rules governing the safeguarding of data and confidential
manuscript or grant information. It is essential, therefore, that any
steps that Congress takes to address these few bad actors do no harm to
the ability of U.S. and foreign scientists to exchange ideas, work
collaboratively, or travel freely. The U.S. must continue to be an
open, welcoming place that will attract the most talented scientists
and students from all over the world. If we lose those qualities, or if
we impose burdensome rules that deter U.S. or foreign scientists or
institutions from pursuing international collaborations, then our
adversaries--who strive to surpass us and from whom Congress rightly
seeks to protect us--will have won.
______
Federation of American Scientists
1112 16th Street, NW, Suite 400
Washington, DC 20036
The Federation of American Scientists has engaged with the U.S.
research community on the issue of foreign interference in federally
funded research and development. For U.S. leadership in science and
technology, competitiveness, economic opportunity, and national
security, it is important that we do not diminish the U.S.' status as
the most desirable country for the best minds from around the world to
come to and do research, nor harm collaborations with expert research
groups abroad. We have collated stories from the U.S. research
community that are related to these concerns.
The personal experiences of U.S. researchers
I was born and raised in Iran and came to the U.S. for graduate school
in 2006. I received a Ph.D. from Princeton University and after a 5-
year long postdoctoral training at Rockefeller University in New York
City, I joined University of California, San Francisco in 2016. At
UCSF, I am a member of the Helen Diller Family Comprehensive Cancer
Center and the Bakar Computational Health Sciences Institute, and I
lead a lab devoted to cancer research. I have received numerous awards
for my work in cancer research, most recently the AAAS Martin and Rose
Wachtel Cancer Research Award and the AACR Nextgen Stars in
Transformative Cancer Research Award. Throughout my training, I have
learned from, worked with, and mentored many international students and
scholars. Both my Ph.D. advisor and postdoc mentors were immigrants.
For many years I trained alongside brilliant scientists from Iran,
Greece, Chile, Korea, China, and Germany. Even now, more than half of
my lab hail from countries other than the U.S. The contribution of
international community to scientific progress is not limited to
immigrants and visiting scholars who relocate to the U.S. to both take
advantage of and contribute to our scientific enterprises. As the
scientific gap between the U.S. and other countries closes, there are
areas of research that are in fact led by research groups outside of
the U.S.
Modern science is multidisciplinary and sprawling. Therefore, we rely
on collaborative teams, often spanning multiple countries, to take on
fundamental scientific questions. My lab collaborates with a number of
computational groups outside of the U.S. and some of these works have
already been published. Grand scientific and biomedical challenges that
face the humanity today are borderless, and we need every help we can
get to tackle them. This is not to say that we should not safeguard our
national interests and strive to maintain our edge in modern
technologies, but the reality is that scientific progress, for the most
part, has no immediate impact on technology. Rather, it is a form of
investment for our future and those of our children for generations to
come. Strict rules and policies that seek to limit and regulate
academic interactions and collaborations will surely impede scientific
progress and the policy makers should think hard about such
ramifications. Moreover, uneven implementation of restrictive policies
will result in the exclusion of scientists and academics from specific
backgrounds or countries. This is simply not acceptable. We have no
control over our countries of birth and there is no evidence that the
use of nationality for risk stratification is an effective solution.
Scientists everywhere are over-worked and underpaid, but they choose to
devote their lives for the betterment of humanity. Safeguarding the
world-wide collaborative environment where scientists can share ideas
and work as teams towards the common good is crucial for our long term
survival.
- Dr. Hani Goodarzi, Assistant Professor, Department of
Biochemistry and Biophysics, UC San Francisco
Since joining our faculty just a few years ago, Hani Goodarzi has
become a driving creative force within UCSF, helping to both pushing
the boundaries of discovery and its translation into new insights into
cancer. If we want to develop a new generation of scientific insight
and cures for deadly diseases, we need a new generation of
groundbreaking scientists, regardless of where they might have been
born. True breakthroughs in science are rare, and we need to assemble
the best team of bright, young scientists we can, scientists just like
Dr. Goodarzi.
- Dr. Jeremy Reiter, Professor and Chair, Department of
Biochemistry and Biophysics, UC San Francisco
I grew up in China and received my training there. After receiving my
Ph.D. degree and completing several years of postdoctoral training in
various laboratories around the world, I came to the U.S. in 1999. I
worked for six years at Harvard Medical School (HMS) in Boston as a
research associate and an Instructor with Professor Thomas Walz, who
himself came to HMS from Switzerland. Together, we established a cryo-
electron microscopy (cryo-EM) facility to study the structures of
proteins with important biological functions. I was recruited to the
University of California San Francisco (UCSF) in 2006 as a tenure track
faculty member in the Department of Biochemistry and Biophysics. My
laboratory at UCSF focuses on methodological developments of single
particle cryo-EM and structural studies of many challenging biological
macromolecules that play important biological and pharmacological roles
in health and diseases. Together with my colleagues at UCSF, our work
facilitated some major technological breakthroughs in structural
biology. I became an Investigator of Howard Hughes Medical Institute
(HHMI) in 2015, and was elected to the American Academy of Arts and
Sciences in 2019.
Throughout my scientific career, I have worked in different countries
and worked with scientists from many more countries. Here at UCSF, some
of our best trainees are international students and scholars. Just to
name a few examples: Dr. Xueming Li developed an algorithm to correct
the image blurring caused by a high-energy electron beam, a critical
technological progress that enables us to determine protein atomic
structure by single particle cryo-EM. Ors. Maofu Liao and Erhu Cao
determined the first atomic structure of a membrane protein by using
single particle cryo-EM, work that triggered the so-called ``resolution
revolution'' in structural biology that is being driven by this new
type of cryo-EM. The above three were postdoctoral fellows at UCSF who
came from China originally. They are now faculty members at Tsinghua
University (Xueming Li), Harvard Medical School (Maofu Liao) and
University of Utah (Erhu Cao), respectively. During their time at UCSF,
each made important contributions to scientific discoveries and
technological developments in our research field, increasing our
university's attractiveness for more such talent from around the world.
And as is normal for such postdocs, they are continuing their
scientific careers at other institutions.
The U.S. has been a world model for scientific openness and
international collaboration. For that reason, this nation has attracted
large numbers of the most talented and gifted young trainees from
around the world. Here, they not only receive training, but also to
contribute in major ways to scientific discoveries and technological
developments. Many tens of thousands, like me, have chosen to remain in
the U.S. The few examples that I mention here demonstrate the
importance of continuing such openness and international collaborations
for the future vitality of U.S. science.
- Dr. Yifan Cheng, Professor, UC San Francisco Department of
Biochemistry and Biophysics; Investigator, Howard Hughes
Medical Institute
Yifan Cheng is a major reason why I moved my lab to UCSF and why UCSF
is a world-leading center for structural biology. Yifan is a world-
leading expert in
atomic-resolution electron microscopy. Among his many accomplishments,
Dr. Cheng led the effort to apply electron microscopy to determine the
structure of the TRP-family of ion channels, with the structure of
TRPV1 (Nature, 2013) being the first near-atomic resolution structure
of a transmembrane ion channel determined by single particle cryoEM.
Yifan also led the effort that led to the structure of TRPV1 and other
TRP-family channels in lipid nanodiscs, a hugely important step forward
in studying these nanoscopic machines in their near-native state
embedded in a lipid bilayer. Both of these landmark accomplishments
were facilitated by Yifan's work, together with UCSF professor David
Agard, on the use of direct electron detectors to improve the
information content of cryo-electron micrographs. Yifan Cheng's work
changed the way we study membrane protein structure and function, and
the methods his lab developed are now used throughout the world.
- Dr. Adam Frost, Associate Professor, UC San Francisco
Biochemistry and Biophysics
Some examples from our (University of Iowa) faculty born outside the
U.S., all with histories of NIH funding:
Azeez Butali, born in Nigeria: Has collected DNA samples across
Africa with a focus on genes associated with cleft lip and palate.
Long-term intent for the African and U.S. samples: develop genetic
interventions for facial anomalies. He also has developed and App for
expectant mothers in Nigeria regarding prenatal care.
Liu Hong, Born in China: Has an R01 regarding ability to grow
bone using micro RNA technology. Implications are for places were bone
is deficient with wide potential: clefts, periodontal disease, trauma,
post cancer surgery, etc.
Satheesh Elangovan, born in India: Using non-viral gene delivery
technology to develop scaffolds for bone growth.
Isabelle Denry, born in France: International expert on ceramics
to improve characteristics of ceramic dental restorative materials.
(Receiving the IADR Distinguished Scientist Award for Materials this
year).
Karen Weber-Gasparoni, born in Brazil, Head of Pediatric
Dentistry: Behavioral interventions for children at high risk for early
childhood caries.
Lina Moreno, born in Colombia: Genetics of facial morphology and
dismorphology with long-term intent of interventions for facial
morphologies with functional deficiencies.
Jun Cao, born in China: Research on inflammation with
collaborations in our Diabetes Center. Implications with the strong
connection between diabetes and periodontal disease.
- From University of Iowa College of Dentistry Dean, David
Johnsen
I am an immigrant to this country who teaches, does research, and owns
a small biotechnology company. Over the past 20 years, my research
efforts as a faculty member and chief scientific officer (CSO) have
brought in $20 million in grant money to the state of Iowa. I was the
principal investigator or company CSO responsible for bringing in $12
million. For the remainder, I contributed as a co-principal
investigator. Most of this money has moved into the Iowa economy
through wages and taxes. I hope to contribute a lot more to the economy
as developments in my company move into the market.
- Dr. Marit Nilsen-Hamilton, Professor, Iowa State University
I emigrated to the U.S. 11 years ago as a postdoctoral fellow and have
since made significant contributions to its research enterprise and
educational system. I am currently an associate professor and director
of a laboratory at an R1 university. I have published over 40 peer-
reviewed articles and trained more than 35 individuals from
undergraduate students to postdoctoral fellows who have gone on to
research and industry careers. I have received several awards for my
science outreach, service, promotion of diversity, and scientific
achievements. I have collaborated with colleagues around the world in
our common efforts to reduce mortality resulting from air pollution
exposures. I have also represented the U.S. as a young science leader
in international gatherings.
- Dr. Patricia Silveyra, Associate Professor and Biobehavioral
Laboratory Director, The University of North Carolina at Chapel
Hill
I am a Hispanic immigrant, moved to the United States in 1982. In 1989
I received a Ph.D. in Statistics and Animal Breeding, and joined the
faculty in Statistics at Iowa State University in 1990. Since then, I
have mentored the doctoral work of 24 students (at least half of them,
American), taught class for thousands of other students, attracted
approximately $30 million in sponsored research funding to Iowa, was
elected member of the National Academy of Medicine, and was honored
with fellowships from most major statistical organizations in the U.S.
and abroad. Without foreign-born researchers, the entire system of
higher education in the United States would collapse in a minute.
- Dr. Alicia Carriquiry, President's Chair in Statistics and
Distinguished Professor, Iowa State University; Member,
National Academy of Medicine
I came to the U.S. in 1982 from New Zealand after obtaining my Ph.D. in
Biochemistry from Massey University. I came for additional training in
the sciences, and in 1988 I was hired to the faculty of Iowa State
University. I rose through the ranks and am currently the Frances M.
Craig Professor of Biochemistry at Iowa State University. I became a
U.S. citizen and my research program has been continuously funded since
1988 by the National Science Foundation, the U.S. Department of Energy,
the U.S. Department of Agriculture, or the National Institutes of
Health. Currently I am serving at the National Science Foundation, as a
Division Director in the Biological Sciences Directorate. In the past
30 years I have trained and mentored over 50 Ph.D. and MSc graduates,
who have matriculated from Iowa State University. And through this body
of work, my group has published over 130 peer-reviewed research
manuscripts. During this period, I have had the pleasure of
collaborating with colleagues from Japan, Korea, France, the United
Kingdom, India, New Zealand, and Australia.
- Dr. Basil Nikolau, Frances M. Craig Professor of
Biochemistry, Iowa State University
I was born in Central America and came to the USA for college. I
received a BA from Harvard and a Ph.D. from UC Berkeley. I've been at
Rice University for the last 10 years and have supervised 6 doctoral
students, all of whom are U.S. citizens, as well as 8 post-doctoral
scholars, 6 of whom are U.S. citizens. Several of these students and
post-docs have continued in academia, and are training the next
generation of STEM students. Others have moved into important
industrial positions (data science, medical fields). While my research
has been largely theoretical, it has found application in the
construction of cloud storage systems. I am incredibly grateful for the
opportunities I have been afforded in the USA, and expect to continue
to contribute to the development of its STEM workforce.
- Dr. Anthony Varilly-Alvarado, Professor of Mathematics, Rice
University
I moved to Iowa in 2001 from Norway, but I had taught at the University
of Maine and received my Doctor of Natural Sciences degree from the ETH
Zurich in Switzerland. I had moved to Zurich from Italy, my home
country, to study geology. I spent the last 35 years of my life working
with people from all over the world, and my research has been made
stronger and richer by my multicultural background and what I learned
from the many people I have worked with. I have educated thousands of
Iowa and U.S. students at Iowa State University, and taught them about
our planet, how it works, and how humankind interacts with it and
depends on it. I strive to show them how their choices and decisions
impact the rest of the world, and share with them the astonishing
beauty and power of the planet we live on.
My professional experience and successful career in science and
education research are an example of the benefits of living and working
in a multicultural and diverse society, and am grateful for the
opportunities to work with colleagues in Europe and elsewhere that I
had while a faculty member at Iowa State University.
- Dr. Cinzia Cervato, Morrill Professor, Iowa State University
Nanshu Lu (originally from China; graduated from Harvard; now professor
of biomedical engineering at University of Texas-Austin), http://
www.nafsa.org/Policy_and_Advocacy/What_We_Stand_For/
Welcoming_International_Students/Meet_
International_Students/Nanshu_Lu/.
Anirban Sen Gupta (originally from India; graduated from University of
Akron; now professor in biomedical engineering at Case Western Reserve
University), http://www.nafsa.org/Policy_and_Advocacy/
What_We_Stand_For/Welcoming_Internation
al_Students/Meet_International_Students/Anirban_Sen_Gupta/.
Yu Takahashi (originally from Japan; graduate of Embry-Riddle
Aeronautical University and University of Colorado Boulder; now a
navigation engineer at NASA's Jet Propulsion Laboratory working on the
Dawn, Juno, and OSIRIS-REx missions), http://www.nafsa.org/
Policy_and_Advocacy/What_We_Stand_For/Welcoming_Inter
national_Students/Meet_International_Students/Yu_Takahashi/.
I have collaborations with several groups around the world. Over the
years this has included labs located in Japan, Spain and Korea, as well
as 3 in Germany, 3 in England, and 10 in China. This has provided
complimentary expertise to the biochemical studies that are the
expertise of my own group, and allowed us to not only remain
competitive, but also develop new areas of research, with important
implications for not only agriculture, but health (medicinal natural
products) as well.
- Dr. Reuben Peters, Professor, Iowa State University
Non-U.S. citizens and international collaborations are essential to
innovation and progress within the U.S. scientific community. I am a
Ph.D. candidate in biomedical engineering at the University of
Virginia. I work with numerous non-U.S. citizens who contribute greatly
to the work that I do. A postdoctoral researcher in our lab is a
citizen of Iran and is working here on a visa. He completed his Ph.D.
at Tulane University and is now working as a postdoctoral researcher at
UVA. He is pursuing novel research to identify more effective
treatments for diabetes. Additionally, our lab collaborates with a
company based in Sweden that allows us to develop and test a novel drug
to accelerate diabetic wound healing. Our research and the future of
medical therapies would suffer tremendously without the benefit of
international talent and collaboration.
- Ms. Michaela Rikard, Ph.D. Candidate in Biomedical
Engineering, University of Virginia
About 15 years ago, the National Science Foundation offered a program
called the Materials World Network, which was a program to initiate and
develop international collaborations. Some of my research efforts in
magnetic materials were supported through this program, in an effective
collaboration with a group in Germany at the RWTH-Aachen, one of the
premier universities in Germany. The scientific effort led to the
discovery of new magnets along with chemical interpretations of how
their structures and properties are related. A part of the project
supported graduate student exchange between our groups. During these
exchanges, students learned new techniques not available at their
respective home institution as well as how academic life in the other
location compared with their own. As a result, some important
fundamental science about magnetic solids emerged from this
collaborative research and many of the student participants are now
filling faculty positions across the U.S. The experiences for both
groups were outstanding and led to further interactions between us
after the program ended. I feel that these experiences for our students
were a vital part of their subsequent professional success because
science has always been an international effort, relying on discussion
and collaboration among people with very different perspectives and
goals.
- Dr. Gordon Miller, University Professor of Chemistry, Iowa
State University
I study machine learning algorithms and how they help us understand
social media data. As part of this work, I traveled to North Korea in
2015 and 2016 to teach North Korean citizens how to work with social
media data. I taught classes at the Pyongyang University of Science and
Technology (PUST), and had North Korean students collaborating with
U.S. citizens to make the first North Korean contributions to open
source software. This was a great thing for those students personally,
but also for the relationship between our two countries. This gave the
North Korean students a chance to better understand American culture
first hand, and gave Americans like me a first-hand understanding of
the real North Korea. Unfortunately, recent federal policy with North
Korea has prevented me from visiting North Korea to teach at PUST. This
means that these North Korean students are no longer getting to learn
firsthand about American culture, and American citizens no longer get
to learn about North Korea. Rather than limiting our academic exchange
programs, I believe we should be extending them.
- Dr. Mike Izbicki, Assistant Professor, Claremont McKenna
College
About 20 years ago, an interdisciplinary research group at Iowa State
University developed a new way to analyze and design large electric
power systems. The new design incorporates nonlinear elements into the
formerly linear world of power systems design using a mathematical
theory known as ``normal forms.'' This approach was approved by the
IEEE about 10 years ago, and is now being used by many U.S. utilities.
It makes stressed systems more stable and reliable and thus supports
important safety considerations for our national infrastructure. At
this moment, researchers are incorporating statistical elements into
this design model to account for alternative sources of generation,
such as sun or wind, which are not always available.
Key investigators on these projects were engineers born in India,
Egypt, and Chile, with substantial support from German mathematicians.
IEEE stands for the U.S. Institute of Electrical and Electronics
Engineers. It is the world's largest technical professional
organization dedicated to advancing technology for the benefit of
humanity, with U.S. headquarters and a global presence of seven
international offices.
- Dr. Wolfgang Kliemann, Professor of Mathematics, Iowa State
University
I have worked with many foreign-born researchers. In every case they
were highly skilled, imaginative and essential to the success of my
projects. Talent is agnostic to geopolitical boundaries and I believe
the U.S. should welcome with open arms top researchers and engineers
from any country.
- Dr. Matthew Gruner, Postdoctoral Fellow, UC San Francisco
I am an American scientist with a basic research background, who
volunteers with grassroots science policy groups, and is now a AAAS S&T
Policy Fellow. In all these pursuits I have witnessed how scientific
research hinges upon the principles of open science--the public and
transparent sharing of knowledge in collaboration with any scientist
regardless of nationality. My Ph.D. research was in lab with a majority
of international researchers, coming from France, India, China, and
Japan. Their presence contributed novel ways of thinking, different
cultures and experiences in life, and new ways to approach challenging
scientific obstacles. The participation of the international research
community within the American research ecosystem is vital for the
continued preeminence of our country's research enterprise. I recognize
the concern over the welfare and security of our country, and the risks
involved in the unwanted dissemination of technology. But this is a
balancing act, not a decisive unilateral action. American research
thrives with the open exchange of ideas and unhindered communication.
- Dr. Avital Percher, National Science Policy Network
(opinions are his own)
This information is to give background information about the
professoriate in the mathematical sciences. All numbers following, are
for the period July 1, 2015 through June 30, 2016, and are as reported
in http://www.ams.org/2016Survey-NewDoctorates-Report.pdf. In the
mathematical sciences, 1,921 Ph.D.s were awarded by 279 doctoral-
granting departments in the U.S. The mathematical sciences includes
mathematics and applied mathematics, as well as statistics and
biostatistics.
The proportion of Ph.D.s awarded to U.S. citizens is at a 6-year high,
49% (937). While this is a 7% increase from last year, it is the same
percentage as in fall 2010-11. Non-U.S. citizen counts decreased 4% to
984 from 1,021 last year. While this is the first year-to-year drop in
six-years the non-U.S. citizen count has increased 16% over that in
2010-11.
- Karen Saxe, Associate Executive Director, American
Mathematical Society
Suggestions for questions for the record
(1) How many cases of foreign-born researchers accused of various
violations or even fired by their institutions are specifically due to
the theft or inappropriate sharing of intellectual property?
(2) Are there currently clear and uniform policies in place across
U.S. research institutions that would permit constructive responses to
the accusations by the National Institutes of Health and Department of
Justice?
(3) Have the National Institutes of Health and the Department of
Justice sufficiently supported U.S. research institutions to give
transparent education to their researchers on clearly what to do and
not do before accusing any researcher?
(4) Does the National Institutes of Health believe its policies and
guidelines for international collaboration and sharing scientific
knowledge are clear and accessible enough for all researchers to
interpret? What needs to be done by the National Institutes of Health,
federal law enforcement, and research institutions to improve their
education of researchers?
(5) A bill, the Securing American Science and Technology Act of 2019--
H.R.3038--has been introduced in the House, which would (1) require the
Director of the Office of Science and Technology Policy to establish an
interagency working group for improved coordination, reporting, and
policy among the federal science and security agencies on the issue and
(2) establish a new National Academy of Science, Engineering and
Medicine (NASEM) ``Science, Technology, and Security Roundtable'' so
that the research community can provide input as the government works
toward the proper balance of security and the open exchange of
scientific information and knowledge. How rapidly would such working
groups and roundtables have to mobilize in order to have a productive
impact on the challenges you face?
(6) Foreign-born researchers in the U.S., including American citizens,
are being accused of transgressions such as violating peer-review
confidentiality, incompletely disclosing ties to foreign research
programs or other foreign entities, and failing to disclose foreign
sources of research funding. Some research institutions, such as MD
Anderson and Emory, have moved to terminate researchers' positions.
Others, such as Baylor, have worked with their researchers to amend
disclosures and foregone disciplinary action. How are research
institutions, NIH, and DOJ making these decisions?
(7) The Houston Chronicle recently reported that over the past 18
months, 10 MD Anderson senior researchers or administrators of Chinese
descent have retired, resigned, or been placed on administrative leave.
Some believe a toxic climate and perception of racial profiling
hastened their departures. Two of the researchers subsequently took
positions at Chinese institutions. In March, a group of Chinese-
American scientists voiced concern in a strongly worded letter in
Science that recent rhetoric and proposals by the NIH and FBI could
lead to unjust targeting of Chinese scientists. What are HHS, NIH, and
DHS doing to prevent racial bias and a talent drain?
(8) Recent data show that the number of new international students
choosing to study in the United States is in decline, dropping 6.6% in
the fall of 2017. The significant presence especially of international
graduate students and researchers makes it possible for many colleges
and universities to support STEM departments and courses that also
benefit the education of U.S. students in these fields; if we were to
restrict international students and researchers from our campuses, what
impact do you believe this would this have on our nation's capacity to
lead in science and innovation?
(9) Many nations, like Canada and China, have whole-of-government
strategic plans in place to invest in creating an academic, scientific,
and immigration environment that attracts and welcomes talent from
around the world. Do we have a strategic plan that achieves this, and
if so, who is leading it within the government?
______
Future of Research, Inc.
848 Brockton Avenue
Abington, MA 02351
http://futureofresearch.org
The Importance of Foreign Researchers to U.S. Research
The resources and intellectual freedom that are hallmarks of the United
States research enterprise attract talented scientists from across the
globe. For example, it is estimated that \2/3\ of current biomedical
postdocs in the United States are foreign-born.\1\ Using U.S. Census
data, we found that by 2014, 52% of the Ph.D.-holding U.S. biomedical
workforce was composed of foreign-born workers, having increased
dramatically from only 22% in 1990.\2\
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\1\ Postdoctoral Researchers--Facts, Trends, and Gaps, NIH Office
of Extramural Research, https://nexus.od.nih.gov/all/2012/06/29/
postdoctoral-researchers-facts-trends-and-qaps/.
\2\ ``The New Face of U.S. Science,'' Nature, https://
www.nature.com/news/the-new-face-of-us-science-1.21229 (working paper:
http://sjscience.org/article?id=570).
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Research in the U.S. is highly dependent on the labor of foreign-born
researchers. Studies have shown that foreign-born researchers are
highly productive and increase the scientific output of the U.S.,
producing more publications than their domestic counterparts.\3\ The
importance of foreign-born researchers to the U.S. economy was also
recently demonstrated in an open letter signed by 150 biotech leaders
citing concerns about immigration policy in 2017.\4\
---------------------------------------------------------------------------
\3\ ``Exceptional contributions to U.S. science by the foreign-born
and foreign-educated,'' Population Research and Policy Review, https://
link.sprinqer.com/article/10.1023/A:1010682017950.
\4\ ``U.S. immigration order strikes against biotech,'' http://
blogs.nature.com/tradesecrets/2017/02/07/us-immigration-order-strikes-
aqainst-biotech.
It is therefore in the national interest to ensure that there is not a
loss of foreign talent by overly burdening the research enterprise with
arduous vetting processes, by appropriately reacting to, and
preventing, the efforts a minority involved in foreign interference.
However, we recognize that there are opportunities to strengthen
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oversight.
Current Rhetoric and Plans for Increased Vetting May Do More Harm to
the U.S. Than Good
As discussed in the NIH's Foreign Influences Working Group report \5\
and a recent study,\6\ countries reap most benefit from investment by
funding the best science, regardless of where it takes place, or who
performs it, and ensuring that their domestically based scientists are
involved. Recruiting and retaining foreign talent is one facet of
ensuring that the NIH is maximizing its chance to produce the best
science in the U.S.
---------------------------------------------------------------------------
\5\ NIH Advisory Committee to the Director (ACD) ACD Working Group
for Foreign Influences on Research Integrity, https://acd.od.nih.gov/
documents/presentations/12132018Foreign
Influences_report.pdf.
\6\ ``Open countries have strong science,'' Nature, https://
www.nature.com/news/open-countries-have-strong-science-1.22754.
A greater hostility to the foreign-born researchers, in concert with
other countries increasing investment in their own research
infrastructure and in attracting their citizens back home, foreign-born
but U.S.-trained scientists could be inclined to return to their home
countries to conduct research, or even feel disinclined to train in
science in the U.S., in the absence of efforts to train and sustain
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their work.
As a group studying and advocating for those early in their research
careers, we are particularly concerned about the effects of increased
vetting of foreign-born researchers. Recent changes in immigration
policy already have the potential to dissuade foreign-born researchers,
such as those with spouses, from carrying out study or research in the
U.S.
The Committee may wish to consider that the current reaction to threats
from foreign influences, the swift reaction of the intelligence
community, and the failure of agencies to issue clear guidance to
institutions, thus causing confusion and panic among the research
community, may be playing exactly into the strategy of foreign actors
keen to absorb the fruits of U.S. taxpayer-funded research.
Below we wish to particularly highlight that, while the biomedical
research enterprise is particularly dependent on foreign labor, a lack
of attention to populations such as the postdoctoral research community
is failing to capitalize on the potential brain gain from foreign-born
researchers, and may even provide an opportunity for exploitation from
foreign influences.
Opacity in the Biomedical NIH-Funded Training Enterprise
Despite the fact that \2/3\ of the NIH's extramural and intramural
workforces are
foreign-born, it is unclear what the return is on the NIH's investment
in training foreign-born researchers, as (in the NIH's own words) ``we
do not collect much information about foreign-trained Ph.D.s who come
to the U.S. to do a postdoc, and we have no idea how long they stay or
how many leave after their training.''\7\ It is clearly not appropriate
for a federal agency to be unable to provide such basic data about
taxpayer-funded researchers, not least when possible foreign influences
are under consideration.
---------------------------------------------------------------------------
\7\ Postdoctoral Researchers--Facts, Trends, and Gaps, NIH Office
of Extramural Research, https://nexus.od.nih.gov/all/2012/06/29/
postdoctoral-researchers-facts-trends-and-gaps/.
With little attention to the training of foreign-born scientists, and
subsequent efforts to benefit from the ``brain gain'' of retaining the
best foreign-born talent, the NIH are missing an opportunity to ensure
long-term investment in the best science. It is also possible that by
paying little to no attention to the workforce they support,
particularly postdoctoral researchers, NIH is providing an opportunity
for foreign interference through generating opacity in the biomedical
---------------------------------------------------------------------------
workforce.
As a result of the unavailability of NIH training support, the majority
of foreign-born researchers are funded from research project grants,
which currently provide no assessment of training nor evaluation of
scientific ability. It is therefore not only very difficult to identify
talented, foreign-born investigators to be retained in the U.S.; it
also difficult to discern whether labs are being staffed by cheaper
foreign labor to the detriment of domestically trained talent.
By placing foreign researchers at a disadvantage relative to their
domestic counterparts, the U.S., which currently leads in training the
world's scientists, may face more fierce competition in coming years
for the world's best talent. In addition, by placing their own
researchers at a disadvantage in competing against a cheaper labor
force for positions in the U.S., we may be dissuading homegrown talent
from entering the NIH workforce.
NIH has claimed that it is unable to support foreign researchers on
training and fellowship mechanisms--which could allow oversight into
research activities of
foreign-born researchers while ensuring the potential brain gain is
developed to the benefit of the research enterprise--due to legal
barriers. Requests to NIH, including to their legal counsel, have not
resulted in a clarification of what these ``legal barriers'' are, or
whether they exist. The existence of legal barriers is contradicted by
the existence of mechanisms to support foreign-born talent, such as the
NCI- and NIDDK-specific Predoctoral to Postdoctoral Fellow Transition
Award (F99/KOO) and the NIH Pathway to Independence Award (K99/ROO).
These mechanisms facilitate transitions to independence into the
postdoctoral experience, and into an independent faculty position,
respectively. Foreign postdocs compete with U.S. citizens and permanent
residents in application for these awards.
Summary
Ultimately, we urge the Senate Finance Committee to consider that there
should be more support for the foreign-born research population, not
less. It is clearly in the interests of foreign states to cause the
United States to drive out foreign-born talent, which they can then
absorb. The Committee may consider that the current reaction to threats
from foreign influences and the swift reaction of the intelligence
community may be playing exactly into the strategy of foreign actors
keen to absorb the fruits of U.S. taxpayer-funded research.
We thank the U.S. Senate Finance Committee for their work and interest
in the role of foreign researchers in the U.S.
[all]