[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

                              ----------                              

                           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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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 
---------------------------------------------------------------------------
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]