U.S. Department of Health and Human Services 
Office of Inspector General 
Opportunities Exist To 
Strengthen NIH Grantees 
Oversight of Investigators 
Foreign Significant Financial 
Interests and Other Support 
 
Suzanne Murrin 
Deputy Inspector General for Evaluation and Inspections 
June 2022, OEI-03-20-00210  U.S. Department of Health and Human Services 
 
Office of Inspector General 
 
Report in Brief 
June 2022, OEI-03-20-00210 
Why OIG Did This Review 
Opportunities Exist To Strengthen NIH 
In fiscal year (FY) 2020, the 
National Institutes of Health  Grantees Oversight of Investigators 
(NIH) awarded $31 billion to 
Foreign Significant Financial Interests and 
grantee institutions (hereafter 
grantees) to support biomedical  Other Support  
research.  These grantees play 
key roles in protecting the 
NIH grantees are responsible 
integrity and security of U.S.  Key Takeaway  for ensuring that the 
biomedical research by requiring 
investigators who conduct 
Most grantees failed to meet at 
investigators to report 
NIH-funded research disclose 
least one Federal requirement 
(1)significant financial interests
all required types of foreign 
related to their investigators 
(hereafter financial interests) and
financial interests and support.  
foreign financial interests and 
(2)all sources of their other
Grantees are also responsible 
support.  In addition, many grantees 
support (hereafter support),
for reviewing these disclosures; 
lacked oversight practices that 
which includes all resources in
reporting them, as necessary, 
would help ensure that all materials 
support of and/or related to all
to NIH; and managing any 
submitted to NIH are complete and 
of their research endeavors.  This
associated conflicts.  Failure to 
accurate.  At the same time, some 
includes foreign financial
comply with these 
grantees reported promising 
interests and support.  Failures
requirements hinders grantees 
practices that, if more widely 
by some investigators at these
and NIHs ability to conduct 
adopted, present additional 
grantees to disclose substantial
effective oversight and may 
opportunities to strengthen 
contributions of resources from
leave NIH-funded research 
oversight of investigators foreign 
foreign entities (including
vulnerable to foreign influence. 
financial interests and support.   
foreign governments) have
raised concerns about threats to
the integrity of NIH-supported What OIG Found 
research.
Noncompliance with Federal requirements.  More than two-thirds of 
grantees failed to meet one or more requirements for investigators 
How OIG Did This Review 
disclosure of all foreign financial interests and support.  These problems 
To determine how grantees 
often involved requirements to disclose nonpublicly traded equity 
(1)ensure that investigators
interests from foreign entities and to disclose in-kind resources, 
disclose all foreign financial
professional affiliations, or participation in a foreign talents program.  
interests and support and
Some grantees also were unsure about whether or how disclosure 
(2)review this information prior
requirements applied to R13 grants, which specifically support 
to reporting information to NIH,
conferences and scientific meetings.   
we administered online surveys
to 773 grantees that (as of July 1, In addition, some grantees did not comply with Federal requirements to 
2020) received NIH funding for train investigators regarding disclosure of foreign financial interests.  
FY 2020.  We administered Further, 10 percent of grantees did not perform required reviews to 
online surveys from determine whether investigators foreign financial interests were conflicts 
October 2020 to January 2021. that could bias their research. 
We received responses from
617 grantees. Additional opportunities to strengthen oversight.  In addition to having 
specific oversight requirements, grantees have general responsibilities for 
overseeing the disclosure and management of investigators financial   
interests and support.  We found that many grantees could strengthen 
their oversight practices to better ensure that all materials submitted to 
NIH are complete and accurate.  At the same time, some grantees have 
implemented promising practices thatif more widely adoptedwould 
strengthen oversight of foreign financial interests and support.  These 
practices include the following: 
  Providing written guidance and training regarding investigators 
disclosures of foreign support.  (Only a quarter of grantees 
reported providing this guidance and/or training.)  
  Distinguishing whether the sources of investigators financial 
interests or support were from a foreign entity.  (Less than 
two-thirds of grantees reported doing this.)  
  Taking steps to validate investigators reports or to identify 
financial interests and support that investigators failed to report.  
(Seventy-nine percent of grantees reported taking such steps.) 
What OIG Recommends and How the Agency Responded 
To address gaps in grantees procedures regarding investigators foreign 
financial interests and support, NIH should (1) ensure that grantees 
comply with Federal requirements to train investigators regarding 
disclosure of significant financial interests; (2) ensure that grantees 
conduct the required review of investigators significant financial interests 
to determine whether conflicts exist; (3) specifically require grantees to 
provide trainings and to maintain a written policy regarding investigators 
disclosure of other support; (4) modify its reporting mechanisms to 
require grantees to report whether investigators significant financial 
interests and other support involve foreign entities; (5) conduct outreach 
to grantees with R13 conference grants to clarify requirements regarding 
the disclosure and review of investigators significant financial interests 
and other support; (6) clarify whether and how grantees should verify 
investigators significant financial interests and other support prior to 
submitting information to NIH; and (7) establish a method for grantees 
to share their best practices for identifying and reviewing investigators 
foreign significant financial interests and other support.  NIH concurred 
with all recommendations.  
   
TABLE OF CONTENTS 
 
 
BACKGROUND ................................................................................................................................................ 1 
FINDINGS ......................................................................................................................................................... 9 
NONCOMPLIANCE WITH FEDERAL REQUIREMENTS ........................................................................... 9 
More than two-thirds of grantees failed to require investigators to disclose at least one required type 
of foreign financial interest or support ............................................................................................................................. 9 
Some grantees did not comply with Federal requirements to train investigators regarding disclosure 
of foreign financial interests ............................................................................................................................................... 11 
Ten percent of grantees did not perform required reviews to determine whether investigators foreign 
financial interests were conflicts that could bias their research ............................................................................ 12 
ADDITIONAL OPPORTUNITIES TO STRENGTHEN OVERSIGHT ....................................................... 12 
Most grantees lacked written guidance and/or training for investigators about disclosing foreign 
support ........................................................................................................................................................................................ 12 
Fourteen percent of grantees did not issue written guidance regarding requirements for investigators 
disclosure of foreign financial interests .......................................................................................................................... 13 
Grantees did not always implement practices that could strengthen their identification of 
investigators foreign financial interests and support ............................................................................................... 13 
More than a third of grantees did not distinguish whether the sources of investigators financial 
interests or support were foreign or domestic entities ............................................................................................ 15 
Some grantees did not implement certain practices that could strengthen their review of 
investigators foreign financial interests and support ............................................................................................... 16 
Almost all grantees reported that they had the ability to take action if an investigator failed to 
disclose foreign financial interests or support ............................................................................................................. 17 
CONCLUSION AND RECOMMENDATIONS ........................................................................................... 19 
Ensure that grantees comply with Federal requirements to train investigators regarding disclosure of 
significant financial interests .............................................................................................................................................. 20 
Ensure that grantees conduct the required review of investigators significant financial interests to 
determine whether conflicts exist ..................................................................................................................................... 20 
Specifically require grantees to provide trainings and maintain a written policy regarding 
investigators disclosure of other support ..................................................................................................................... 21 
Modify reporting mechanisms to require grantees to report whether investigators significant financial 
interests and other support involve foreign entities ................................................................................................. 21 
   
Conduct outreach to grantees with R13 conference grants to clarify requirements regarding the 
disclosure and review of investigators significant financial interests and other support ........................... 22 
Clarify whether and how grantees should verify investigators significant financial interests and other 
support prior to submitting information to NIH ......................................................................................................... 22 
Establish a method for grantees to share their best practices for identifying and reviewing 
investigators foreign significant financial interests and other support ............................................................. 22 
OIG RESPONSE TO AGENCY COMMENTS ............................................................................................ 24 
APPENDICES ................................................................................................................................................. 26 
Appendix A: Percentage of Grantees Not In Compliance With NIHs Disclosure Requirements For 
Investigators Foreign Financial Interests or Support ................................................................................................ 26 
Appendix B: Methods Grantees Used To Distinguish Whether the Source of an Investigators Financial 
Interest or Support Was a Foreign Entity ....................................................................................................................... 28 
Appendix C: Agency Comments ........................................................................................................................................ 29 
ACKNOWLEDGMENTS AND CONTACT ................................................................................................ 36 
Acknowledgments .................................................................................................................................................................. 36 
Contact ........................................................................................................................................................................................ 36 
ABOUT THE OFFICE OF INSPECTOR GENERAL ..................................................................................... 37 
ENDNOTES ................................................................................................................................................... 38 
 
 
   
   
 
B ACKGROUND 
 
OBJECTIVES 
1.  To determine how grantee institutions that are funded by the National 
Institutes of Health (NIH) ensure that investigators disclose all foreign 
significant financial interests and other support. 
2.  To determine how NIH-funded grantee institutions review investigators 
disclosures of foreign significant financial interests and other support prior 
to reporting information to NIH. 
 
In fiscal year (FY) 2020, NIH awarded $31 billion for extramural research conducted by 
investigators working in universities and other grantee institutions (hereafter 
grantees).  These grantees play a key role in protecting the integrity and security of 
U.S. biomedical research by requiring investigators1 to report significant financial 
interests and other support (hereafter referred to as financial interests and support); 
identifying, managing, and reporting their investigators financial conflicts of interest 
(FCOIs), and also reporting investigators supportwhich includes all resources made 
available to an investigator in support of and/or related to their research endeavors.2     
Concerns about foreign threats to research integrity 
Despite Federal requirements for NIH-funded investigators to disclose financial 
interests and support to grantees, there have been instances in which some 
investigators failed to disclose substantial contributions of resources from other 
entities, including foreign governments, resulting in law enforcement action.  For 
example, one grantees NIH-funded investigators failed to disclose their Chinese 
government research grants and the grantee failed to adequately investigate 
information it had concerning the investigators relationships and affiliations, 
resulting in the grantee paying False Claims Act settlements of $6.6 million.3  In 
another example, an investigator was convicted on charges that included making 
false statements to NIH about funding he received from Chinas Thousand Talents 
Plan, a government-run program aimed at attracting scientists to further Chinas 
scientific development, economic prosperity, and national security.4  In August 2018, 
NIH issued a statement about its concerns about increasing risks to the security of 
intellectual property in its biomedical research enterprise.5  NIH stated that it would 
address these concernsin partby identifying ways to improve accurate reporting 
of all sources of financial interests and support.    
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Background | 1   OIG received congressional appropriations in FYs 2019, 2020, and 2021 to conduct 
oversight of NIH grant programs and operations.6  The Appropriations Committees 
have specifically identified foreign threats to research integrity as among the 
concerns for which they are looking for OIG oversight.  This review is part of that 
larger body of OIG work.  
Federal requirements for investigators disclosure of financial 
interests and support 
The NIH Grants Policy Statement and Department of Health and Human Services 
(HHS) regulations specify the types of information that investigators must disclose to 
grantees and which information grantees must then report to NIH during the grant 
application and awarding process.  For significant financial interests, HHS regulations 
require disclosure so that NIH can ensure that the research will be free from bias 
resulting from any investigators FCOIs.  For other support, NIH policy requires 
disclosure so that NIH can ensure that all resources made available to an investigator, 
including any foreign activities, are considered prior to making an award. 
Required disclosure of significant financial interests 
Investigators must disclose to grantees all of their 
significant financial interests (hereafter financial 
interests) that reasonably appear to be related to 
the investigators institutional responsibilities, 
including those shown in Exhibit 1.7  Grantees must 
review these financial interests and determine 
whether a financial conflict of interest exists.8  If an 
FCOI exists, the grantee must develop and 
implement a plan that specifies how it will manage 
the FCOI to safeguard objectivity in the research 
project.  Once NIH has awarded a grant, but prior 
to expending any funds, grantees must report 
investigators FCOIs and the key elements of the 
corresponding management plans to NIH through 
the electronic Research Administration (eRA) 
Commons FCOI Module.9, 10  NIH reviews this 
information to ensure, in part, that the grantees 
Source: 42 CFR  50.603. 
management plan is designed to safeguard 
objectivity in the research project. 
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Support 
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Required disclosure of other support 
Investigators also must disclose to grantees all 
sources of their other support (hereafter support), 
which includes all resources made available to an 
investigator in support of and/or related to all of 
their research endeavors, including those shown in 
Exhibit 2.11  Once a grant application is under 
consideration for funding, but before funds are 
awarded, the grantee must report investigators 
support to NIH on the Biographical Sketch 
(Biosketch) Format Page and the Other Support 
Format Page.12  NIH reviews this information to 
ensure, in part, that there is no scientific, budgetary, 
or commitment overlap.13  If an investigator obtains 
support after the initial NIH award period, the 
details must be disclosed in the annual research 
performance progress report.14         Sources: NIH Grants Policy Statement and 
NOT-OD-19-114. 
Types of grant awards subject to these 
requirements 
Investigators must disclose financial interests and support to grantees for a variety of 
funding mechanisms, including research grants, center grants, individual fellowship 
awards, infrastructure awards, and research resources awards.15  Within these 
categories, there are specific types of grant awards.  For example, research grants 
include (but are not limited to) R01 grants, which support a discrete, specified 
research project; R03 grants, which provide limited funding for a short period of time 
to support a variety of types of projects; and R13 grants, which support high-quality 
conferences and scientific meetings.16  The only types of grant awards that are not 
subject to Federal requirements for disclosure of investigators financial interests are 
applications for Phase I Small Business Innovative Research (SBIR) Program and Small 
Business Technology Transfer Research (STTR) Program funding.17 
Federal requirements for grantee oversight of investigators 
financial interests and support 
General requirements for grantee oversight  
As the applicants for and recipients of NIH funding, grantees are responsible for 
ensuring that all materials submitted to NIH are complete and accurate.  This includes 
ensuring that investigators make all appropriate disclosures regarding foreign 
financial interests and support.18  In addition, grantees must have systems, policies, 
and procedures to manage funds and activities.19  These include written policies and 
procedures, training, management controls, and other internal controls to ensure 
compliance with all Federal requirements.  
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Specific requirements for grantee oversight of financial interests 
There also are specific requirements for grantee oversight of financial interests, 
including ensuring that each grantee: 
  establishes and maintains a written FCOI policy that includes investigators 
responsibilities to disclose financial interests to grantees and posts this policy 
on its publicly accessible website;20  
  requires investigators to complete FCOI training that includes training 
regarding the disclosure of financial interests prior to engaging in NIH-funded 
research and at least every 4 years thereafter;21 and   
  take actions as necessary to identify, manage, and report FCOIs.22 
NIH oversight activities 
The NIH Division of Grants Compliance and Oversight (DGCO) monitors grantee 
compliance with NIH policy and legislative mandates and enhances compliance 
oversight by grantees.23  DGCO can use various types of activities to ensure grantee 
compliance, including:  
  Proactive Compliance Site Visits, which assess grantees understanding of 
Federal policies and regulations, minimize or eliminate areas of 
noncompliance, and nurture partnerships between NIH and grantees; and 
  Targeted Site Reviews, which focus specifically on assessing grantees 
compliance with the FCOI regulations.24    
NIH enforcement actions 
If a grantee fails to comply with Federal statutes, regulations, or the terms and 
conditions of an award, NIH may take one or more enforcement actions which include 
disallowing costs; withholding further awards; or wholly or partly suspending the 
grant.25  NIH may also terminate the grant in whole or in part.26    
NIHs response to concerns regarding foreign influence 
NIH is committed to international collaborative research and has highlighted that 
many recent scientific advancements were predicated upon international 
collaborations.  At the same time, NIH has raised concerns since 2018 about foreign 
threats to the integrity of medical research and intellectual property in NIH-funded 
biomedical enterprises.  In response, NIH has increased its efforts to strengthen and 
enforce reporting requirements regarding investigators foreign financial interests and 
support, including the following actions:   
  In March 2018, NIH issued a notice to clarify that investigators must disclose 
all financial interests received from a foreign institution of higher education or 
the government of another country.27 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Background | 4    
  In July 2019, NIH issued a notice to remind grantees that support includes all 
resources and financial support made available to an investigator from all 
foreign and domestic entities in support of and/or related to all of the 
investigators research endeavors, regardless of whether or not those 
endeavors have monetary value and regardless of whether the endeavors are 
based at the grantee institution that the investigator identifies for the current 
grant.28  This notice specifically reminded grantees that they must report 
investigators participation in foreign talents programs, foreign in-kind 
resources, and foreign professional affiliations as support.    
  In September 2020, NIH notified grantees that, effective November 2020, they 
are required to submit their publicly assessible FCOI policy to NIH.29  In this 
notice, NIH stated that a grantees failure to comply with this requirement by 
December 1, 2020, may cause NIH to delay issuance of awards, impose 
specific award conditions, or take other enforcement actions to address 
compliance.   
  In March 2021, NIH issued a notice related to support to remind grantees of 
disclosure requirements and to introduce new requirements.30  The notice 
reminds grantees that an item or service given to an investigator with the 
expectation of an associated time commitment is not a gift and must be 
reported as support.  This notice also reminds grantees that they must 
establish and maintain effective policies and procedures to ensure that 
investigators disclose all support.  As part of this notice, NIH released an 
updated Biosketch Format Page and Other Support Format Page that 
applicants and recipients must use beginning in January 2022.31, 32  These 
updated forms contain specific instructions for investigators to disclose all 
current positions and scientific appointments both domestic and foreign, as 
well as in-kind contributions.  The updated Other Support Format Page also 
contains a signature block for investigators to certify the accuracy and 
completeness of information submitted.  In addition, effective January 2022, 
grantees must submit supporting documentation (e.g., copies of contracts, 
grants, or other agreements) for all foreign activities and resources reported 
in the updated Other Support Format Page.     
Related OIG work 
Over the past decade, OIG has conducted numerous studies and made many 
recommendations regarding NIHs FCOI policies and procedures.  In 2008 and 2009, 
OIG released reports that found, respectively, (1) that NIH lacked accurate records 
regarding the number or type of FCOIs reported by grantees; and (2) that 
vulnerabilities existed in how grantees were identifying, managing, and overseeing 
investigators FCOIs.33  Subsequently, NIH implemented multiple OIG 
recommendations to improve FCOI policies, and HHS regulations were revised to 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Background | 5    
strengthen the reporting and management of investigators FCOIs related to 
NIH-funded research.34       
In FYs 2019, 2020, and 2021, OIG received congressional appropriations to conduct 
oversight of NIH grant programs and operations, including oversight of foreign 
threats to research integrity.35  OIG released several reports as part of a body of work 
focusing on NIHs oversight of grant programs and operations.  One 2019 report 
found that some NIH-funded investigators may not have been aware of their 
responsibility to report all sources of financial interests and not all grantees had their 
policies publicly posted, as required.36  In response to a recommendation from this 
report, NIH implemented procedures to ensure that all grantees have FCOI policies by 
requiring all NIH-funded grantees to submit their publicly accessible FCOI policy to 
NIH as of December 2020.  NIH also concurred with this reports recommendation to 
enhance its monitoring of grantees FCOI policies but has not yet implemented this 
recommendation.  Another 2019 OIG report found that NIH could notand did not 
plan toidentify whether investigators FCOIs involved foreign entities.37  Instead, 
NIH believed investigators foreign financial interests are most appropriately captured 
as part of the support reporting process, rather than as part of the FCOI reporting 
process.38  Therefore, OIG recommended that NIH use information that it collects 
regarding investigators foreign support to decide whether to revise its FCOI review 
process to address concerns regarding foreign influence.  NIH concurred with this 
recommendation and is working to implement it.  
Methodology 
Survey of Grantees 
We requested and obtained from NIH a list of contact information and funding 
amounts for grantees that met the following criteria: (1) they were U.S.-based;39 
(2) they received NIH funding for FY 2020 as of July 1, 2020; and (3) they were not 
grantees with only SBIR Program or STTR Program grants (because SBIR Program and 
STTR Program grants have different reporting requirements).  From this list, we 
excluded five grantees that were no longer operating as of fall 2020 or were part of 
ongoing OIG audits.  Our final list of 773 grantees collectively received $20.4 billion in 
NIH funding for FY 2020 as of July 1, 2020.  Of these 773 grantees, 244 each received 
more than $10 million and collectively accounted for 95 percent of the total funding.   
We categorized grantees by total funding received into the following two groups: 
(1) 244 grantees with more than $10 million each in NIH grants (hereafter larger 
grantees) and 
(2) 529 grantees with less than $10 million each in NIH grants (hereafter smaller 
grantees).40   
We administered either a detailed or shorter survey to all 773 grantees.  We sent a 
detailed survey, which contained closed-ended and open-ended questions and 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Background | 6    
requested relevant policies and procedures, to a simple random sample of 100 larger 
grantees.41  A total of 673 grantees (144 larger grantees and all 529 smaller grantees) 
received a shorter survey that contained the same closed-ended questions and select 
open-ended questions, but did not request documentation.   
Both versions of the grantee survey asked questions about the extent to which 
grantees have policies, procedures, and practices in place to ensure that investigators 
disclose all foreign financial interests and support.  We also asked questions about 
whether and how grantees review investigators disclosures of foreign financial 
interests and support prior to reporting this information to NIH, as well as questions 
about the actions, if any, that grantees take to address instances of nondisclosure by 
investigators.  Only the version of the survey that went to our random sample of 
100 larger grantees contained questions about the actions that grantees took when 
they identified investigators who failed to disclose foreign financial interests and 
support in the last 2 years.   
From October 2020 to January 2021, we administered online surveys to 773 grantees.  
We received responses from a total of 617 grantees, for an overall response rate of 
80 percent.42  Of the 617 responding grantees, 207 were larger grantees and 410 were 
smaller grantees.  In addition, some respondents were Department of Veteran Affairs 
Nonprofit Corporations.  Investigators at these grantees are Federal employees and 
are not subject to HHSs FCOI regulations.  Therefore, eight of these grantees opted to 
complete only the section of our survey that pertained to support.  As a result, our 
total number of respondents was reduced from 617 to 609 throughout the report for 
any findings pertaining only to financial interests. 
We summarized survey responses and reviewed procedures across grantees to 
determine whether they complied with Federal requirements and to identify certain 
best practices and challenges.  We counted grantees as having procedures in place for 
foreign financial interests and support if they had procedures that applied to 
foreign-only or to both domestic and foreign sources of financial interests and 
support.  In addition, we did not evaluate whether certain practices were more 
effective than others, but only evaluated whether grantees performed certain 
practices more often than other practices.        
Limitations 
We used self-reported data from grantees and did not independently verify the 
accuracy of the information presented by the grantees.  However, when possible, we 
reviewed responses for consistency and possible data entry errors.  We also did not 
independently verify the grant information that NIH sent to us.  Our results apply only 
to the 617 grantees that responded to our surveys and cannot be generalized to all 
NIH-funded grantees.    
 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
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Standards 
We conducted this study in accordance with the Quality Standards for Inspection and 
Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency. 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Background | 8    
FINDINGS 
Overall, we found that many grantees failed to meet at least one requirement related 
to investigators foreign financial interests or support.  In addition, many grantees 
lacked oversight practices that would help ensure that all materials submitted to NIH 
are complete and accurate.  At the same time, some grantees reported promising 
practices that, if more widely adopted, present additional opportunities to strengthen 
oversight of investigators foreign financial interests and support.   
NONCOMPLIANCE WITH FEDERAL REQUIREMENTS 
The security and integrity of NIH-funded research relies, in part, on grantees 
oversight of their investigators foreign financial interests and support.  HHS 
established specific requirements to ensure that NIH-funded grantees are providing 
adequate oversight, including that grantees must (1) require their investigators to 
disclose all required types of foreign financial interests and support; (2) train 
investigators about their responsibility to disclose foreign financial interests; and 
(3) perform reviews to determine whether investigators foreign financial interests are 
conflicts that could bias their research.  Grantees lack of compliance with these 
Federal requirements may leave NIH-funded research vulnerable to foreign influence.       
More than two-thirds of grantees failed to require investigators 
to disclose at least one required type of foreign financial 
interest or support 
Sixty-nine percent of the NIH-funded grantees in our review (428 of 617) did not 
require their investigators to disclose at least 1 required type of foreign financial 
interest or support.43  This is despite NIH emphasizing the importance of accurate 
reporting of all sources of financial interests and support.  Among the 428 grantees 
that were noncompliant with at least 1 disclosure requirement, three-quarters were 
smaller grantees, i.e., those with less than $10 million in grant funding.44  Appendix A 
contains detailed information on the percentage of grantees that do not require 
investigator disclosure for each type of foreign financial interest and support.  By and 
large, when grantees did not require disclosure of foreign financial interests and 
support, they also did not require disclosure of the same types of financial interests 
and support received from domestic entities.     
 
 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support  
OEI-03-20-00210   Findings | 9    
Almost half of grantees did not comply with disclosure 
requirements for nonpublicly traded equity interests from foreign 
entities 
For Federal FCOI purposes, investigators must disclose to grantees all of their equity 
interests (e.g., stock, stock option, or other ownership interests) in nonpublicly traded 
entities; however, 45 percent of grantees (277 of 609) were not compliant with this 
disclosure requirement for equity interests in nonpublicly traded foreign entities.  
Further, 80 of these noncompliant grantees did not require any disclosure of equity 
interests from nonpublicly traded foreign entities. 
Grantees lack of compliance may stemin partfrom differences in requirements 
across other Federal entities that grant research awards.  For example, NIH makes a 
distinction between publicly and nonpublicly traded equity interestsrequiring 
disclosure of all nonpublicly traded equity interests, but requiring disclosure of 
publicly traded equity interests that, when combined with other remuneration, exceed 
a dollar threshold.45  In contrast, the National Science Foundation does not make a 
distinction between publicly versus nonpublicly traded entities.46  Among the 
277 grantees that did not require investigators to disclose all nonpublicly traded 
equity interests from foreign entities, 191 did require this disclosure at a dollar 
threshold that was the same as their requirement for publicly traded equity interests 
from foreign entities.  Across all grantees, 59 percent reported that a lack of 
consistency in requirements across Federal entities was a challenge related to 
identifying investigators foreign financial interests.  In addition, 60 percent of 
grantees reported this was a challenge related to identifying investigators support.     
Despite NIHs 2019 reminder, grantees often did not require 
investigators to disclose in-kind resources, professional 
affiliations, or participation in foreign talents programs 
Nearly half of grantees (273 of 617) reported in October 2020 through January 2021 
that they did not require their investigators to disclose at least 1 of the 3 types of 
foreign support that NIH requires to be reported.  Of the 273 grantees, 96 did not 
require investigators to disclose any of these 3 types of foreign support.  In July 2019, 
NIH specifically clarified that grantees must report investigators participation in 
foreign talents programs (e.g., Chinas Thousand Talents Plan), foreign in-kind 
resources (e.g., laboratory space, equipment, or employees), and foreign professional 
affiliations (e.g., positions and scientific appointments).  Notably, just over a third of 
the 273 grantees mentioned above reported that staying up to date with changes in 
NIH guidance and/or requirements was a challenge with regard to identifying 
investigators foreign support. 
Since January 2021, NIH has made further efforts to clarify the requirements for these 
three types of foreign support, including updating the Biosketch Format Page and 
Other Support Format Page used to disclose this information. 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support  
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Grantees that receive only R13 grants may be unaware that they 
must adhere to Federal requirements regarding investigators 
disclosure of foreign financial interests and support 
Across all grantees in our review that received only R13 grants, almost all (26 of 28) 
did not require their investigators to disclose at least 1 NIH-required type of foreign 
R13-only grantee:   financial interest or support.47  R13 grants specifically support high-quality 
It would be helpful  conferences and scientific meetings that are relevant to NIH's mission and to public 
to provide guidance  health.  Grantees that receive only R13 grants (hereafter R13-only grantees) are 
for how this applies  subject to Federal requirements for reporting investigators financial interests and 
to these [R13]  support.  Appendix A contains detailed information on the percentage of R13-only 
grants as compared  grantees that do not require investigator disclosure for each type of foreign financial 
to other grant  interest and support.  Some R13-only grantees were unaware that these requirements 
types.    apply to R13 awards.  For example, one R13-only grantee incorrectly stated that the 
survey questions were not applicable because the grantee did not receive research 
 
funding.  Another R13-only grantee was unclear of how an investigator is defined 
for R13 grants.   
Some grantees did not comply with Federal requirements to 
train investigators regarding disclosure of foreign financial 
interests  
Nearly a quarter of grantees were not in compliance with Federal requirements to 
train investigators about their responsibility to disclose foreign financial interests.  
Specifically, 23 percent of grantees (140 out of 609) did not require investigators to 
complete all NIH-required training, and over half of these (81 out of 140) also did not 
require or offer any other training regarding disclosure of foreign financial interests.  
HHS regulations require grantees to ensure that investigators complete FCOI training 
that includes training regarding the disclosure of financial interests prior to engaging 
in NIH-funded research and at least every 4 years thereafter.  Some grantees may also 
offer voluntary trainings (e.g., presentations, online resources, or education materials) 
to investigators about disclosing their foreign financial interests.  Of the 81 grantees 
that did not require all NIH-required training and did not require or offer other 
training, almost all were smaller grantees.  For most of the 140 grantees, if they did 
not require trainings for foreign financial interests, they also did not require them for 
domestic financial interests.  
Overall, 18 percent of grantees did not require investigators to complete the initial 
training and 20 percent did not require investigators to complete the recurring 
training.  Furthermore, almost all (24 out of 28) of the R13-only grantees in our review 
did not require all NIH-required trainings regarding disclosure of foreign financial 
interests, and 21 also did not require other training or offer other training to their 
investigators.   
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Ten percent of grantees did not perform required reviews to 
determine whether investigators foreign financial interests 
were conflicts that could bias their research 
One in 10 grantees did not conduct a required review of investigators foreign 
financial interests to protect NIH-funded research from potential bias.  Prior to 
expending funds under an NIH grant, grantees must review all investigator disclosures 
of financial interests and determine whether an FCOI exists.48  However, 10 percent of 
grantees (61 of 609) reported that they did not review each foreign financial interest 
to identify whether it is a potential FCOI.  Of the noncompliant grantees, 93 percent 
were smaller grantees.   
 
ADDITIONAL OPPORTUNITIES TO STRENGTHEN OVERSIGHT 
In addition to complying with NIHs specific oversight requirements, grantees have 
general responsibilities for overseeing the disclosure and management of 
investigators foreign financial interests and support.  We found that many grantees 
could strengthen their oversight practices to better ensure that all materials 
submitted to NIH are complete and accurate.  At the same time, there are certain 
promising practices thatalthough they are not requiredmay present opportunities 
for grantees to strengthen their oversight.  
Most grantees lacked written guidance and/or training for 
investigators about disclosing foreign support 
Seventy-four percent of grantees (455 of 617) lacked written guidance and/or did not 
require their investigators to complete training regarding the disclosure of foreign 
support.  This is despite Federal requirements for grantees to have policies and 
proceduresincluding written policies and trainingto manage funds and 
activities.49  Although HHS has specific requirements for grantees to maintain written 
FCOI policies and provide investigators with training about disclosure of financial 
interests, it does not have the same specific requirements for support.  Overall, 
35 percent of grantees did not issue written guidance and 71 percent of grantees did 
not require investigators to complete training regarding disclosure of their foreign 
support.  Further, 41 percent of grantees did not offer voluntary trainings, such as 
presentations, online resources, or education materials.  Overall, a quarter of grantees 
(156 of 617) had no written guidance, did not require trainings, and did not offer 
voluntary trainings regarding the disclosure of foreign support.   
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Fourteen percent of grantees did not issue written guidance 
regarding requirements for investigators disclosure of foreign 
financial interests 
Fourteen percent of grantees (84 of 609) did not choose to issue written guidance 
about their requirements for investigators disclosure of foreign financial interests.  
Most of these grantees were smaller grantees (76 of 84).  Of the R13-only grantees in 
our review, most (20 of 28) did not choose to issue written guidance.  Overall, when 
grantees did not issue written guidance regarding disclosure requirements for foreign 
financial interests, most (81 percent) also did not do so for domestic financial 
interests. 
Grantees did not always implement practices that could 
strengthen their identification of investigators foreign financial 
interests and support  
In addition to having the required procedures for investigators disclosures of foreign 
financial interests and support, some grantees used such practices as requiring 
investigator attestation, using electronic reporting systems, and providing detailed 
instructions to investigators.  However, 82 grantees (13 percent) did not choose to use 
any of these practices to ensure that investigators disclosed foreign support, and 
51 grantees (8 percent) did not use any of these practices to ensure disclosure of 
foreign financial interests.    
Only a few grantees reported having specific or additional practices related to foreign 
(versus domestic) financial interests and support.  For example, one grantee asked 
investigators additional questions related to foreign funding or relationships on 
disclosure forms.  Another grantee reported that it conducted internet searches for 
information about foreign affiliations that may be tied to financial interests from 
foreign entities.        
Grantees did not always use the same practices for disclosures of support as they 
used for disclosures of financial interests, as shown in Exhibit 3.  For example, half of 
grantees used an electronic reporting system (e.g., an online reporting tool or specific 
software) for investigators disclosure of foreign financial interests compared to nearly 
a quarter that did so for foreign support.  These electronic systems have the potential 
to improve the efficiency and completeness of investigators disclosures.  As one 
grantee explained, its system can create support documentation from known grants 
and proposals, which the investigator and grantee then reviews and updates to ensure 
that all known support is listed. 
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Exhibit 3.  With regard to ensuring that investigators disclose all required 
information, grantees used certain practices more often for foreign financial 
interests than for support. 
Source: OIG analysis of 617 NIH grantees responses to survey administered from October 2020 to January 2021.   
a Some examples of other practices included providing individualized guidance to investigators who have questions or 
concerns about the support-related section of the application; surveying investigators just prior to issuing an award to 
determine whether all support has been disclosed; and providing investigators with a customized report that is 
populated with previously self-reported information and then working with the investigator to review or update the 
information. 
Most grantees took at least one step beyond relying on 
investigators disclosures to identify investigators foreign 
financial interests and support, but many could do more 
Although 79 percent of grantees had at least 1 procedure to identify foreign financial 
interests and/or support beyond relying on investigators disclosure, many grantees 
could be doing more.  Aside from operating a hotline, less than a third of grantees 
had any other types of procedures in place, as shown in Exhibit 4.  Overall, 21 percent 
of grantees did not take any steps to identify investigators foreign financial interests 
and support that went beyond relying on investigators disclosures.     
Just 29 percent of grantees requiredas a way to identify foreign financial interests 
and supportthat their investigators provide copies of all contracts and agreements 
with outside entities.  Many grantees may need to change their procedures to comply 
with new requirements to submit certain documentation when reporting 
investigators foreign support.  These requirementswhich became effective May 25, 
2021require grantees to provide NIH with copies of investigators contracts, grants, 
or any other agreements related to foreign appointments or foreign employment 
when reporting these types of other support to NIH.50  As of January 2021, less than a 
third of grantees required investigators to submit copies of all grants from outside 
entities for their disclosures of foreign support, and just a quarter of grantees 
required this for disclosures of foreign financial interests.   
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Exhibit 4. With regard to identifying investigators foreign financial interests 
or support, some grantees implemented practices beyond relying on 
investigators disclosure. 
 
 
 
 
 
 
 
 
 
 
 
 
Source: OIG analysis of 617 NIH grantees responses to survey administered from October 2020 to January 2021. 
a This question was asked only with regard to financial interests, not with regard to support. 
More than a third of grantees did not distinguish whether the 
sources of investigators financial interests or support were 
foreign or domestic entities 
Thirty-seven percent of grantees reported that when they identified their 
investigators support, they did not distinguish whether the source of support was a 
foreign entity.  Furthermore, 40 percent of grantees did not capture this information 
for investigators financial interests, as shown in Exhibit 5.  In 2019, OIG found that 
NIH could not identify whether investigators financial conflicts involved foreign 
interests using the information that grantees reported to NIH about FCOIs.51  At that 
time, NIH believed that this information was most appropriately captured in the 
information that grantees report to NIH regarding investigators support.  However, 
from October 2020 through January 2021, many grantees reported that they were not 
capturing data that would enable them to report to NIH whether the sources of 
investigators financial interests or support were foreign entities. 
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Exhibit 5. Many grantees did not distinguish whether the sources of 
investigators' financial interests and support were foreign or domestic 
entities. 
Source: OIG analysis of 617 NIH grantees responses to survey administered from October 2020 to January 2021. 
Among grantees that did distinguish whether the source of an investigators financial 
interest or support is a foreign entity, their most common method was to require the 
investigator to provide an address for the entity.  Some grantees also reported having 
a checkbox on the form used by investigators to distinguish whether the source is a 
foreign entity.  Appendix B lists the other ways that grantees identify whether financial 
interests and support involve foreign entities.  
Some grantees did not implement certain practices that could 
strengthen their review of investigators foreign financial 
interests and support 
Grantees must have internal controls related to ensuring compliance with all Federal 
requirements, yet some grantees did not perform certain reviews that could help 
strengthen their internal controls.  Most grantees followed up with the investigator for 
more information or clarification as needed.  However, some grantees did not 
perform any other types of reviews or checks of investigators disclosures prior to 
reporting this information to NIH.  (Exhibit 6 shows the types of reviews or checks that 
grantees performed before reporting information to NIH.)  For example, more than 
one-third of grantees did not compare the disclosed financial interest information to 
the investigators external contracts or agreements.  Similarly, 40 percent of grantees 
did not compare the disclosed financial interest information to information identified 
in external searches (e.g., general web searches or searches of affiliations and/or 
conflicts listed in journal articles).  Furthermore, 36 granteesor 6 percent of all 
granteesreported that they did not perform any review of investigators disclosures 
of foreign interests and support prior to reporting this information to NIH.   
 
 
 
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Exhibit 6.  Some grantees did not perform certain types of reviews of investigators foreign 
financial interests and support prior to submitting this information to NIH. 
Type of Review   Percentage of Grantees That 
Performed This Review:  
Financial Interests  Support 
Follow up with the investigator for more information or clarification, as needed  90%  86% 
Review investigators support to identify whether it may cause scientific,  NA  80% 
budgetary, or commitment overlap to investigators research 
Identify gaps or inconsistencies in the disclosed information without performing  67%  62% 
comparisons to external information 
Compare disclosed information to investigators contracts, agreements, and  64%  54% 
intellectual property rights 
Compare disclosed information to other external disclosures (e.g., financial  60%  62% 
interest or support disclosures; Biographical Sketch; routing and approval forms; 
or other Just-in-Time approvals) 
Compare disclosed information to information identified in external searches  52%  38% 
(e.g., general web searches or affiliations/conflicts listed in journal articles) 
Compare disclosed information to information in grant documents for outside  48%  45% 
research at other institutions  
Contact entities with which an investigator reports an agreement, contract, or  42%  35% 
grant to confirm the nature of the entitys relationship with the investigator 
Use translation services to review documents or online content that is not in  40%  35% 
English 
Operate a centralized electronic system that integrates information across offices  31%  24% 
or departments within the grantee institution for ease of review and comparison 
Verify disclosed information (e.g., physical address and website) against a list of  18%  18% 
international organizations/entities maintained by the grantee 
Source:  OIG analysis of 617 NIH grantees responses to survey administered from October 2020 to January 2021. 
Notably, 54 percent of grantees indicated that a challenge they face is a lack of 
guidance from NIH on methods they could use to verify information disclosed by 
investigators when reviewing investigators disclosures of foreign financial interests.  
Similarly, 57 percent of grantees reported this same challenge with regard to 
reviewing investigators disclosures of foreign support.  One grantee expressed 
a desire for NIH to provide further guidance, saying: Provide guidance on what 
constitutes 'due diligence' [so that grantees have a better understanding of how 
much review is needed] to prove a persons disclosures are accurate and complete.     
Almost all grantees reported that they had the ability to take 
action if an investigator failed to disclose foreign financial 
interests or support 
Almost all grantees (578 of 617) reported that they had at least 1 kind of action 
available to them under their institutions policies and procedures that they could take 
if an investigator failed to disclose either foreign financial interests or support.  Across 
grantees, the most common actions were to follow up with the investigator to request 
additional information/clarification and to report the incident to NIH, as shown in 
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Exhibit 7.  However, some grantees reported that they did not have the ability to take 
certain actions if an investigator failed to disclose information.  For example, 
30 percent of grantees stated that they would not have the ability to postpone a 
promotion if an investigator failed to disclose a foreign financial interest.   
Exhibit 7.  Grantees reported a variety of actions they could take if investigators failed to 
disclose foreign financial interests or support.  
Type of Action   Percentage of Grantees That 
Could Take This Action:  
Financial Interests  Support 
Follow up with investigator  95%  95% 
Report incident to NIH or other Federal entity  92%  92% 
Review previously undisclosed support for possible scientific, budgetary, or  NA  90% 
commitment overlap with the investigators' research 
Require investigator to take training  91%  89% 
Determine whether the integrity of the research was impacted by the  NA  88% 
nondisclosed support 
Complete a retrospective review to determine whether any NIH-funded  89%  NA 
research was biased in its design, conduct, or reporting  
Suspend investigator from research project  88%  87% 
Bar investigator from submitting additional grant applications  86%  84% 
Determine whether information about the research was inappropriately shared  80%  78% 
with outside entities 
Formally counsel investigator regarding the breach of policies  82%  77% 
Suspend investigator from employment   74%  72% 
Terminate investigator  73%  70% 
Postpone promotion of investigator (including tenure track)  70%  67% 
Source: OIG analysis of 617 NIH grantees responses to survey administered from October 2020 to January 2021. 
In general, the actions that grantees could take in instances of nondisclosure were the 
same for both foreign and domestic financial interests or support.  Some grantees 
reported that they could take specific actions that applied only to nondisclosures of 
foreign financial interests or support, such as escalating their actions more quickly for 
nondisclosures of foreign financial interests and support compared to those from 
domestic entities.  
Fifteen percent of 565 responding grantees52 identified investigators who failed to 
disclose foreign financial interests in the 2 years prior to the survey, and 18 percent of 
575 responding grantees identified investigators who failed to disclose foreign 
support during that time period.  Among grantees that reported investigator 
nondisclosures, a small number of larger grantees that received the detailed survey 
described the actions they took in response to these nondisclosures.  These actions 
included following up with investigators to request additional information or 
clarification, suspending investigators from the research project, and postponing an 
investigators promotion (including tenure track). 
   
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CONCLUSION AND RECOMMENDATIONS 
NIH is committed to international collaborative research, but at the same time, it has 
raised concerns about foreign threats to the integrity of medical research and 
intellectual property in NIH-funded biomedical enterprises.  Research integrity and 
security relies, in part, on NIH-funded grantees oversight of their investigators 
relevant foreign financial interests and support.  However, some grantees reported 
gaps in their procedures for identifying and reviewing these financial interests and 
support, and some of these gaps resulted in noncompliance with Federal 
requirements.  In general, these gaps also applied to grantees procedures regarding 
investigators domestic financial interests and support.  These gaps were more 
frequent among smaller grantees, i.e., those that (as of July 1, 2020) received less than 
$10 million in NIH funding.  Furthermore, some grantees that received only 
R13 grantsi.e., grants for conferenceswere unaware that they must adhere to 
Federal requirements regarding investigators disclosure of foreign financial interests 
and support. 
The gaps identified in this evaluationincluding that more than two-thirds of 
grantees did not require their investigators to disclose all foreign financial interests 
and supporthighlight the need to strengthen grantees oversight of investigators 
disclosures.  The lack of full disclosure of investigators foreign financial interests and 
support limits grantees and NIHs ability to perform reviews and ensure protection 
from potential undue foreign influence.  Opportunities also exist for the use and 
sharing of best practices across grantees.  Although some grantees implemented 
practices that may strengthen their ability to identify investigators foreign financial 
interests and support, more grantees could benefit from adapting these types of 
practices.  This could further mitigate the risk of undue foreign influence and ensure 
more uniform and robust review practices across grantees. 
Since the time of our review, NIH has taken steps that may address some of the gaps 
identified in this review.  These steps include further clarifying requirements for 
disclosing investigators support, requiring investigators to certify to the accuracy of 
their disclosures of support, requiring grantees to submit supporting documentation 
for investigators foreign activities, and requiring grantees to submit their FCOI 
policies to NIH.  These are important steps toward promoting research integrity and 
security.  We recommend that NIH take additional steps to ensure grantees 
compliance with existing Federal requirements, to develop new requirements to 
strengthen grantee oversight, and to support the sharing of promising practices 
implemented by grantees.    
 
 
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We recommend that NIH: 
Ensure that grantees comply with Federal requirements to train 
investigators regarding disclosure of significant financial 
interests  
We found that despite Federal requirements, not all grantees required investigators to 
complete training regarding disclosure of significant financial interests.  To ensure 
maximum transparency in disclosure of all investigators foreign financial interests, NIH 
should ensure that grantees are complying with all Federal requirements regarding 
investigator training, as outlined in the NIH Grants Policy Statement.  Specifically, NIH 
should ensure that grantees consistently train their investigators regarding disclosure 
of significant financial interests.  Methods that NIH could use to ensure that grantees 
comply with the training requirement include, but are not limited to: 
  reviewing grantees training requirements during site visits; 
  requiring investigators to annually certify that they have fulfilled the training 
requirements and comply with the terms of their awards; and 
  surveying grantees periodically about their training procedures. 
Ensure that grantees conduct the required review of 
investigators significant financial interests to determine 
whether conflicts exist  
We found that despite Federal requirements, not all grantees were reviewing all 
significant financial interests once investigators had disclosed them.  To ensure 
maximum transparency in disclosure of all investigators foreign FCOIs, NIH should 
ensure that grantees are performing all required actions, as outlined in the NIH Grants 
Policy Statement.  Specifically, NIH should ensure that grantees consistently review all 
disclosed significant financial interests to identify whether a potential FCOI exists.  
Methods that NIH could use to ensure that grantees consistently review all disclosed 
significant financial interests include, but are not limited to: 
  advising grantees during site visits on their reviewing procedures; 
  issuing reminders to grantees regarding their responsibility to review all 
significant financial interests that their investigators disclose; and 
  targeting additional outreach to smaller grantees to confirm that they 
understand this requirement.     
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Specifically require grantees to provide trainings and maintain a 
written policy regarding investigators disclosure of other 
support 
Grantees must have policies and procedures to manage funds and activities.  For 
financial interests, there also are specific requirements for investigator training and 
maintaining a written policy.  In the absence of these specific requirements for other 
support, we found that most grantees did not require investigators to complete 
training regarding the disclosure of their foreign support, and some grantees did not 
issue written guidance about their requirements for investigators to disclose foreign 
support.  To help ensure that investigators receive written guidance and training, NIH 
should update the NIH Grants Policy Statement to specifically require grantees to:  
  ensure that investigators complete training regarding the disclosure of other 
support prior to engaging in NIH-funded research and at least every 4 years 
thereafter; and 
  establish and maintain a written policy on other support that includes 
investigators responsibilities to disclose information about other support.  
Modify reporting mechanisms to require grantees to report 
whether investigators significant financial interests and other 
support involve foreign entities 
A 2019 OIG report found that NIH could not identifyand did not plan to identify 
whether investigators FCOIs involve foreign entities.  At that time, NIH believed 
that collecting information regarding an investigators foreign interests was most 
appropriately captured as part of the other support reporting process rather than as 
part of the FCOI reporting process.  However, this evaluation found that more than a 
third of grantees did not distinguish investigators foreign sources of financial 
interests and support from their domestic sources of financial interests and support.  
To increase transparency of the sources of investigators financial interests and 
support, NIH should require grantees to identify which financial interests and support 
are from a foreign source.53
  To do this, NIH may consider: 
  modifying the eRA Commons FCOI Module, Biosketch Format Page, and/or 
Other Support Format Page to require grantees to report whether 
investigators significant financial interests and other support involve foreign 
entities; or 
  implementing a new reporting mechanism that will allow grantees to indicate 
whether disclosed financial interests and support are from foreign sources.  
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Conduct outreach to grantees with R13 conference grants to 
clarify requirements regarding the disclosure and review of 
investigators significant financial interests and other support 
Grantees that received only R13 grantsi.e., grants for conferenceshad a higher 
noncompliance rate for requirements for reporting investigators financial interests 
and support.  These grantees also expressed confusion about the applicability of 
Federal requirements to R13 grants.  NIH should conduct outreach to all grantees 
with R13 grants to ensure that they are aware that these grants are subject to these 
requirements for reporting investigators financial interests and support.  As part of 
this outreach, NIH should clarify how grantees should define an investigator for the 
purposes of R13 grants.  In addition to contacting grantees that have R13 grants, NIH 
could dedicate a section on its website outlining requirements for R13 grants or 
communicate these requirements to grantees (e.g., through email, blog posts, 
newsletters, etc.). 
Clarify whether and how grantees should verify investigators 
significant financial interests and other support prior to 
submitting information to NIH 
Grantees must have internal controls related to ensuring compliance with all Federal 
requirements.  However, we found that many grantees did not perform reviews that 
could help strengthen their internal controls.  Also, some grantees indicated that a 
lack of guidance from NIH on methods they could use to verify the information 
disclosed by investigators was a challenge.  Therefore, NIH should develop more 
detailed guidance for grantees about reviewing investigators disclosures prior to 
submitting information to NIH.  For example, NIH may consider developing a checklist 
that outlines when grantees should perform a review and provides suggested 
methods that grantees may use in performing these reviews.      
Establish a method for grantees to share their best practices for 
identifying and reviewing investigators foreign significant 
financial interests and other support 
Not all grantees are leveraging practices that could reduce vulnerabilities related to 
foreign influence.  Several grantees indicated that it would be helpful if NIH 
disseminated best practices implemented at other grantee institutions.  To encourage 
grantees to learn about and potentially adopt best practices and strategies that have 
worked for their peers, NIH should establish a method such as an interactive virtual 
webinar that is held at least once per year.  The method that NIH establishes should 
promote grantees sharing their best practices for (1) ensuring that investigators 
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disclose all foreign significant financial interests and other support; and (2) reviewing 
disclosed information prior to submitting it to NIH.   
 
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OIG RESPONSE TO AGENCY COMMENTS 
NIH concurred with all recommendations and has planned actions for 
implementation.   
In response to our first recommendation, NIH plans to take several actions to ensure 
that grantees comply with Federal requirements to train investigators regarding 
disclosure of significant financial interests.  These actions include issuing a notice that 
reminds grantees about the FCOI training requirements for investigators; updating 
webpages and communications to grantees with additional information and 
reminders about the FCOI training requirement; and enhancing the eRA Commons 
FCOI Module to require grantees to certify their compliance with FCOI training 
requirements.    
In response to our second recommendation, NIH plans to issue a notice that reminds 
grantees that they are required to review investigators significant financial interests 
to determine whether an FCOI exists.  NIH also plans to enhance the eRA Commons 
FCOI Module to require grantees to certify their compliance with this requirement. 
In response to our third recommendation, NIH highlighted a January 2022 
memorandum issued by the National Science and Technology Council.  The 
memorandum requires certain grant recipients to certify their implementation of a 
research security program, which may include other support disclosure training.  NIH 
also stated that it will provide necessary extramural training and training for NIH staff 
on disclosure of other support.  OIG continues to recommend that in addition to 
these actions, NIH update the NIH Grants Policy Statement to specifically require 
grantees to complete training regarding the disclosure of other support and to 
establish a written policy that outlines investigators responsibilities to disclose other 
support.         
In response to our fourth recommendation, NIH will look into modifying reporting 
mechanisms to require grantees to report whether investigators significant financial 
interests and other support involve foreign entities.  NIH will also issue a notice that 
reminds grantees about their responsibility to disclose all foreign financial interests. 
In response to our fifth recommendation, NIH plans to clarify disclosure and review 
requirements for recipients of R13 conference grants by issuing a notice to grantees.   
In response to our sixth recommendation, NIH will work with grantees to ensure that 
they understand how significant financial interests and other support disclosures are 
verified.  OIG suggests that NIH provide grantees with guidance that could include 
specific instructions about how grantees could perform additional reviews when 
verifying information related to foreign financial interests and support. 
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In response to our seventh recommendation, NIH will take actions to facilitate  
grantees sharing their best practices for identifying and reviewing investigators 
foreign significant financial interests and other support.  These actions will include 
providing the venue for the first forum for grantees to share FCOI and other support 
best practices at its 2022 Regional Seminar and dedicating a session of the seminar to 
discuss this topic.   
OIG believes NIHs planned actions will implement these recommendations and 
improve grantee oversight of foreign significant financial interests and other support. 
Appendix C provides the full text of NIHs comments. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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APPENDICES 
Appendix A: Percentage of Grantees Not In Compliance With 
NIHs Disclosure Requirements For Investigators Foreign 
Financial Interests or Support 
The NIH Grants Policy Statement and HHS regulations specify the types of information that 
investigators must disclose to grantees and which information grantees must then report 
to NIH.  The exhibits below show the overall percentage of grantees not in compliance 
with these disclosure requirements for financial interests or support from foreign entities.    
Among the 617 grantees that responded to our survey, 28 received only R13 conference 
grants (i.e., they were R13-only grantees) in FY 2020 as of July 1, 2020.  R13 grants support 
high-quality conferences and scientific meetings that are relevant to NIH's mission and to 
the public health.  Although grantees that receive this type of grant are subject to Federal 
requirements for reporting investigators financial interests and support, most of the 
R13-only grantees that responded to our survey failed to meet at least one of the Federal 
disclosure requirements.  Additionally, some R13-only grantees were unaware that these 
requirements apply to them.  The tables below show the percentage of R13-only grantees 
that were not in compliance with Federal disclosure requirements. 
Exhibit A-1. Percentage of Grantees Not in Compliance With Federal Disclosure 
Requirements For Investigators Foreign Financial Interests 
Percentage of Grantees That Did Not 
Require Investigators To Disclose 
Type of Foreign Financial Interest  Information 
R13-Only 
Total Grantees   Grantees  
Any equity interest in nonpublicly traded foreign entities1  45%  79% 
Equity interest in publicly traded foreign entities that  14%  75% 
exceeds $5,000 
Salaries from foreign entities that exceed $5,000   13%  75% 
Sponsored or reimbursed travel paid for by foreign entities  13%  75% 
Payments for services not otherwise identified as salary  11%  64% 
(e.g., consulting fees, honoraria, paid authorship) from 
foreign entities that exceed $5,000  
Intellectual property rights and interests (e.g., patents and  6%  74% 
copyrights) from foreign entities 
Source: OIG analysis of 617 NIH grantees responses to survey administered from October 2020 to January 2021.   
1 Among the 277 grantees that did not require investigators to disclose all nonpublicly traded equity interests from foreign entities, 
197 (71 percent) did require disclosure of nonpublicly traded equity interests from foreign entities that met a dollar threshold.  Of 
these 197 grantees, 191 required this disclosure at a dollar threshold that was the same as their requirement for publicly traded 
equity interests from foreign entities.
Opportunities Exist to Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Appendix A | 26    
Exhibit A-2. Percentage of Grantees Not in Compliance With Federal Disclosure 
Requirements For Investigators Foreign Support 
Percentage of Grantees 
That Did Not Require 
Investigators To Disclose 
Type of Foreign Support  
Information 
Total  R13-Only 
Grantees  Grantees  
Participation in foreign talents or similar types of programs  36%  68% 
In-kind resources (e.g., office or laboratory space, equipment,  31%  68% 
supplies, employees, students, and visiting scholars) from foreign 
entities 
Items or funds given with conditions attached or deliverables  25%  71% 
expected in return from foreign entities 
Professional affiliations (e.g., positions and scientific appointments)  21%  50% 
with foreign entities 
Financial support through pending grants from foreign entities  14%  57% 
Financial support through cooperative agreements from foreign  11%  61% 
entities 
Financial support through contracts from foreign entities  11%  61% 
Financial support through active grants from foreign entities  10%  50% 
Source: OIG analysis of 617 NIH grantees responses to survey administered from October 2020 to January 2021.
Opportunities Exist to Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Appendix A | 27   Appendix B: Methods Grantees Used To Distinguish Whether 
the Source of an Investigators Financial Interest or Support Was 
a Foreign Entity  
Exhibit B-1. Methods To Distinguish Whether the Source of a Financial Interest or 
Support Is a Foreign Entity 
Percentage of Grantees That 
Method  Used This Method: 
Financial Interests  Support
Require investigator to provide the address of the source  24%  25% 
Use other method(s) to distinguish whether the source is from a  21%  25% 
foreign entity1 
Have a checkbox on the form used by investigators to distinguish  20%  18% 
whether the source is a foreign entity 
Compare the name of the source to a list of international entities  12%  17% 
Require investigators to complete a separate form for reporting  5%  6% 
financial interests/support from foreign entities versus from domestic 
entities 
Source: OIG analysis of 617 NIH grantees responses to survey administered from October 2020 to January 2021. 
1 Examples of other methods include using a single form for reporting all support but requiring investigators to identify whether the 
support is domestic or foreign through the use of "Domestic" and "Foreign" subcategories; conducting individualized followup with 
the investigator concerning the nature of the financial interest and other relevant information; and conducting online searches of 
disclosed entities to identify potential foreign affiliations. 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210  Appendix B | 28  Appendix C: Agency Comments 
Following this page are the official comments from NIH. 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210  Appendix C | 29  DATE:  April 20, 2022 
TO:  Suzanne Murrin 
Deputy Inspector General for Inspection and Evaluations, HHS 
FROM:  Acting Principal Deputy Director, National Institutes of Health 
SUBJECT:  NIH Comments on Draft Report, Opportunities Exist To Strengthen 
NIH Grantees Oversight of Investigators Foreign Significant 
Financial Interests and Other Support (OEI-03-20-00210) 
Attached are the National Institutes of Healths (NIH) comments on the draft Office of 
Inspector Generals (OIG) report, Opportunities Exist To Strengthen NIH Grantees 
Oversight of Investigators Foreign Significant Financial Interests and Other Support 
(OEI-03-20-00210). 
NIH appreciates the review conducted by OIG and the opportunity to provide the 
comments on this draft report.  If you have questions or concerns, please contact 
Tiffany Brown in the Office of Management Assessment at 301-496-2464. 
/s/ Tara A. Schwetz, Ph.D. 
Tara A. Schwetz, Ph.D. 
Attachments 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210  Appendix C | 30  GENERAL COMMENTS OF THE NATIONAL INSTITUTES OF HEALTH (NIH) ON 
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) OFFICE OF 
INSPECTOR GENERAL (OIG) DRAFT REPORT ENTITLED: OPPORTUNITIES 
EXIST TO STREGNTHEN NIH GRANTEES OVERSIGHT OF INVESTIGATORS 
FOREIGN SIGNIFICANT FINANCIAL INTERESTS AND OTHER SUPPORT 
 (OEI-03-20-00210) 
The National Institutes of Health (NIH) appreciates the review conducted by the Office of 
Inspector General (OIG) and the opportunity to provide clarifications on this draft report.  NIH 
respectfully submits the following general comments.   
OIG Recommendation 1:   
We recommend that the National Institutes of Health ensure that grantees comply with Federal 
requirements to train investigators regarding disclosure of significant financial interests. 
NIH Response:  
NIH concurs with OIG's finding and corresponding recommendation to ensure that grantees 
comply with Federal requirements to train investigators regarding disclosure of significant 
financial interests. 
In addition to the extensive training and resources NIH has provided to its grant recipients on the 
requirements of the Financial Conflict of Interest (FCOI) regulation, including the requirements 
and responsibilities surrounding the disclosure and review of significant financial interests and 
investigator training, the NIH will take the following actions to address this recommendation: 
 During FY 2022, NIH will publish a Guide Notice in the NIH Guide for Grants and
Contracts to remind the extramural community about the FCOI training requirements for
Investigators.  The Guide Notice will also alert the community to the training resources
NIH has made available on its FCOI webpage.  The FCOI tutorial slide set on the FCOI
webpage satisfies the requirement that institutions train Investigators about the FCOI
regulation, including financial disclosure requirements.
 During FY 2022, NIH anticipates that it will begin to develop the requirements for Phase
II enhancements to the eRA Commons Institution Profile (IPF) Module as announced in
NIH Guide Notice NOT-OD-21-002, Required Submission of Financial Conflict of
Interest Policy into the eRA Commons IPF Module, dated September 30, 2020.  We
anticipate that the enhancements will require institutions to submit a compliance
certification that their FCOI policy implements the identified FCOI requirements,
including Investigator training and disclosure requirements.
 During FY 2022, NIH will update the FCOI webpage to include additional outreach
resources that address Investigator training requirements, including presentations and
webcasts.
 NIH will continue to provide FCOI training for the extramural community as part of
NIHs outreach program.
 During FY 2022, NIH will publish a blog to remind NIH applicants and recipients about
FCOI requirements, including the applicability of the FCOI regulation, the requirement to
have a written, enforced policy on FCOI, the requirement to submit a FCOI policy to the
NIH via the eRA Commons IPF Module per the NIH Guide Notice NOT-OD-21-002,
and to provide FCOI training to Investigators.  The blog will also remind the extramural
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210  Appendix C | 31  GENERAL COMMENTS OF THE NATIONAL INSTITUTES OF HEALTH (NIH) ON 
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) OFFICE OF 
INSPECTOR GENERAL (OIG) DRAFT REPORT ENTITLED: OPPORTUNITIES 
EXIST TO STREGNTHEN NIH GRANTEES OVERSIGHT OF INVESTIGATORS 
FOREIGN SIGNIFICANT FINANCIAL INTERESTS AND OTHER SUPPORT 
 (OEI-03-20-00210) 
community about the need to submit other support information consistent with NIH 
policy requirements.   
 During FY 2022, NIH will update its Foreign Grant and SBIR/STTR Webpages to
include information about FCOI requirements, including the requirement to train
Investigators on the FCOI regulation and the Investigators responsibility to disclose their
significant financial interests.
 During FY 2022, NIH will update its Welcome Wagon letter for new recipient
organizations to include information about the requirement to submit FCOI policy in the
eRA Commons IPF Module and to inform institutions of the resources available on the
NIH FCOI webpage, including a training module (FCOI Tutorial) for Investigators.
 During FY 2022, NIH will send a letter to the SBIR/STTR community to remind them
about the applicability of the FCOI regulation, the need to submit their institutions FCOI
policy in the eRA Commons IPF Module, and the requirement to provide FCOI training
to Investigators, among other things.
OIG Recommendation 2:  
We recommend that the National Institutes of Health ensure that grantees conduct the required 
review of investigators significant financial interests to determine whether conflicts exist. 
NIH Response:  
NIH concurs with OIG's finding and corresponding recommendation to ensure grantees conduct 
the required review of investigators significant financial interests to determine whether conflicts 
exist.   
 During FY 2022, NIH will include in the above-referenced Guide Notice a reminder that
institutions are required to review investigators significant financial interests to
determine whether a FCOI exists.
 During FY 2022, NIH anticipates that it will begin to develop the requirements for Phase
II enhancements that we anticipate will require institutions to certify that they are in
compliance with all identified FCOI requirements, including the requirement that
institutions review Investigators SFIs to determine FCOIs.
 The above-referenced letter to the SBIR/STTR community will also include information
on the requirement to review investigators SFIs to determine FCOIs.
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210  Appendix C | 32  GENERAL COMMENTS OF THE NATIONAL INSTITUTES OF HEALTH (NIH) ON 
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) OFFICE OF 
INSPECTOR GENERAL (OIG) DRAFT REPORT ENTITLED: OPPORTUNITIES 
EXIST TO STREGNTHEN NIH GRANTEES OVERSIGHT OF INVESTIGATORS 
FOREIGN SIGNIFICANT FINANCIAL INTERESTS AND OTHER SUPPORT 
 (OEI-03-20-00210) 
OIG Recommendation 3:   
We recommend that the National Institutes of Health specifically require grantees to provide 
training and written policy regarding investigators disclosure of other support. 
NIH Response:  
NIH concurs with OIG's finding and corresponding recommendation to require grantees to 
provide trainings and written policy regarding investigators disclosure of other support.   
 The Guidance for Implementing National Security Presidential Memorandum 33
(NSPM-33) on National Security Strategy for United States Government-Supported
Research and Development published by National Science and Technology Council in
January 2022, requires recipients that are awarded more than $50 million/year to certify
their implementation of a research security program, which may include other support
disclosure training.
 NIH will continue to work with our Federal partners to provide necessary extramural
training and training for NIH staff on disclosure of other support.
OIG Recommendation 4:   
We recommend that the National Institutes of Health modify reporting mechanisms to require 
grantees to report whether investigators significant financial interests and other support involve 
foreign entities. 
NIH Response:  
NIH concurs with OIG's finding and corresponding recommendation to modify reporting 
mechanisms.  
 Beginning in FY 2022, NIH will look into modifying reporting mechanisms to require
grantees to report whether investigators significant financial interests and other support
involve foreign entities.
 The Guide Notice referenced above will also include a FCOI reminder that Investigators
are required to disclose all foreign financial interests.  The Guide Notice will also include
another support reminder that investigators must disclose all resources made available to
them in support of and/or related to all of their research endeavors, regardless of whether
or not they have monetary value and regardless of whether they are based at the
institution the researcher identifies for the current grant, which includes resources and/or
financial support from all foreign and domestic entities.
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210  Ap pendix C | 33  GENERAL COMMENTS OF THE NATIONAL INSTITUTES OF HEALTH (NIH) ON 
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) OFFICE OF 
INSPECTOR GENERAL (OIG) DRAFT REPORT ENTITLED: OPPORTUNITIES 
EXIST TO STREGNTHEN NIH GRANTEES OVERSIGHT OF INVESTIGATORS 
FOREIGN SIGNIFICANT FINANCIAL INTERESTS AND OTHER SUPPORT 
 (OEI-03-20-00210) 
OIG Recommendation 5:   
We recommend that the National Institutes of Health conduct outreach to grantees with R13 
conference grants to clarify requirements regarding the disclosure and review of investigators 
significant financial interests and other support. 
NIH Response:  
NIH concurs with OIG's finding and corresponding recommendation to provide guidance to 
recipients of NIH conference grants regarding the disclosure and review of investigators 
significant financial interests and other support.   
During FY 2022, NIH will develop a Guide Notice to be published in the NIH Guide to Grants 
and Contracts providing guidance for recipients of NIH conference grants on the disclosure and 
review of investigators significant financial interest and other support. 
OIG Recommendation 6:   
We recommend that the National Institutes of Health clarify whether and how grantees should 
verify investigators foreign significant financial interests and other support prior to submitting 
this information to NIH. 
NIH Response:  
NIH concurs that grantees should verify investigators foreign significant financial interests and 
other support prior to submitting this information to NIH.  
Investigators make their disclosures to their institutions which, in turn, report to NIH.  It is the 
recipient institution that is responsible for ensuring that the information submitted to NIH is 
complete and accurate.  Therefore, NIH will work with grantees to ensure that they understand 
how foreign significant financial interests and other support disclosures are verified. 
OIG Recommendation 7:   
We recommend that the National Institutes of Health establish a method for grantees to share 
their best practices for identifying and reviewing investigators foreign significant financial 
interests and other support. 
NIH Response:  
NIH concurs with the OIGs finding that opportunities exist for the sharing of best practices 
across grantees that could strengthen their identification of investigators foreign financial 
interests and support. 
NIH believes that the recipient community should establish a collaborative forum for recipients 
to discuss best practices and strategies for identifying and reviewing investigators significant 
financial interests and other support.   
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210  Appendix C | 34  GENERAL COMMENTS OF THE NATIONAL INSTITUTES OF HEALTH (NIH) ON 
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) OFFICE OF 
INSPECTOR GENERAL (OIG) DRAFT REPORT ENTITLED: OPPORTUNITIES 
EXIST TO STREGNTHEN NIH GRANTEES OVERSIGHT OF INVESTIGATORS 
FOREIGN SIGNIFICANT FINANCIAL INTERESTS AND OTHER SUPPORT 
 (OEI-03-20-00210) 
Each year, the Office of Extramural Research sponsors the NIH Regional Seminars on Program 
Funding and Grants Administration.  These seminars are intended to help demystify the 
application and review process, clarify Federal regulations and policies, and highlight current 
areas of special interest or concern.  The seminars serve the NIH mission of providing education 
and training for the next generation of biomedical and behavioral scientists.  NIH policy, grants 
management, review and program staff provide a broad array of expertise and encourage 
personal interaction between themselves and seminar participants.  There were over 24,000 
registered attendees for the 2021 NIH Virtual Seminar on Program Funding and Grants 
Administration from all 50 states, including Washington, D.C., and Puerto Rico, as well as 118 
foreign countries.  Approximately 58% of the attendees had Administrators/Financial roles in 
their institutions (e.g., Office of Sponsored Programs, Departmental Administrators) and 
approximately 26% had Research-Related roles (e.g., Principal Investigators, Research 
Trainees).  Attendees represented non-profits, small businesses, hospitals, foreign organizations, 
and institutions of higher education, among others. 
NIH supports the formation of a forum for institutions that receive Federal funding to share 
FCOI and other support best practices and recognizes the need to engage a broad representation 
of the appropriate level of institutional officials in such discussions to ensure that best practices 
are duly considered within the institutional framework, including how they can be implemented.  
NIH will provide the venue for the first forum for grant recipients to share FCOI and other 
support best practices at its 2022 Regional Seminar.  We envision dedicating a session to this 
discussion to be led by a representative(s) from a grantee institution with NIH participation.  
There are professional organizations, such as the Federal Demonstration Partnership, composed 
of officials from institutions that receive Federal funds and Federal agency representatives that 
would provide an appropriate venue for recipients to work collaboratively with Federal agency 
officials to develop and share best practices. 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210  Appendix C | 35  ACKNOWLEDGMENTS AND CONTACT 
Acknowledgments 
Maria Johnson served as the team leader for this study, and Karolina Hill served as the 
lead analyst.  Others in the Office of Evaluation and Inspections who conducted the 
study include Robert Kirkner.  Office of Evaluation and Inspections headquarters staff 
who provided support include Joe Chiarenzelli, Althea Hosein, and Christine Moritz.  
This report was prepared under the direction of Linda Ragone, Regional Inspector 
General for Evaluation and Inspections in the Philadelphia regional office, and 
Joanna Bisgaier, Deputy Regional Inspector General. 
Contact 
To obtain additional information concerning this report, contact the Office of Public 
Affairs at Public.Affairs@oig.hhs.gov.  OIG reports and other information can be found 
on the OIG website at oig.hhs.gov. 
Office of Inspector General 
U.S. Department of Health and Human Services 
330 Independence Avenue, SW 
Washington, DC 20201 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210  Acknowledgments and Contact | 36   
ABOUT THE OFFICE OF INSPECTOR GENERAL 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 
95-452, as amended, is to protect the integrity of the Department of Health and 
Human Services (HHS) programs, as well as the health and welfare of beneficiaries 
served by those programs.  This statutory mission is carried out through a nationwide 
network of audits, investigations, and inspections conducted by the following 
operating components: 
The Office of Audit Services (OAS) provides auditing services for HHS, 
either by conducting audits with its own audit resources or by overseeing audit work 
done by others.  Audits examine the performance of HHS programs and/or its 
grantees and contractors in carrying out their respective responsibilities and are 
intended to provide independent assessments of HHS programs and operations.  
These audits help reduce waste, abuse, and mismanagement and promote economy 
and efficiency throughout HHS. 
The Office of Evaluation and Inspections (OEI) conducts national 
evaluations to provide HHS, Congress, and the public with timely, useful, and reliable 
information on significant issues.  These evaluations focus on preventing fraud, waste, 
or abuse and promoting economy, efficiency, and effectiveness of departmental 
programs.  To promote impact, OEI reports also present practical recommendations 
for improving program operations. 
The Office of Investigations (OI) conducts criminal, civil, and administrative 
investigations of fraud and misconduct related to HHS programs, operations, and 
beneficiaries.  With investigators working in all 50 States and the District of Columbia, 
OI utilizes its resources by actively coordinating with the Department of Justice and 
other Federal, State, and local law enforcement authorities.  The investigative efforts 
of OI often lead to criminal convictions, administrative sanctions, and/or civil 
monetary penalties. 
The Office of Counsel to the Inspector General (OCIG) provides 
general legal services to OIG, rendering advice and opinions on HHS programs and 
operations and providing all legal support for OIGs internal operations.  OCIG 
represents OIG in all civil and administrative fraud and abuse cases involving HHS 
programs, including False Claims Act, program exclusion, and civil monetary penalty 
cases.  In connection with these cases, OCIG also negotiates and monitors corporate 
integrity agreements.  OCIG renders advisory opinions, issues compliance program 
guidance, publishes fraud alerts, and provides other guidance to the health care 
industry concerning the anti-kickback statute and other OIG enforcement authorities.  
 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   About the Office of Inspector General | 37    
ENDNOTES  
 
1 In this report, we use the term investigator to refer to all individuals required to submit information to grantees relating to 
significant financial interests and/or other support.  The requirement to disclose significant financial interests applies to the 
Program Director/Principal Investigator and any other personregardless of title or positionwho is responsible for the 
design, conduct, or reporting of research that NIH funds.  The requirement to disclose other support applies to all individuals 
designated as senior/key personnelthose devoting measurable effort to a project.   
2 NIH, Reminders of NIH Policies on Other Support and on Policies Related to Financial Conflicts of Interest and Foreign 
Components, NOT-OD-19-114, July 2019.  Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html 
on June 23, 2021.    
3 Department of Justice, Department of Justice Reaches Million-Dollar Settlement with Van Andel Research Institute to Resolve 
Allegations of Undisclosed Foreign Ties to NIH Grants, September 2021.  Accessed at Department Of Justice Reaches Million-
Dollar Settlement With Van Andel Research Institute To Resolve Allegations Of Undisclosed Foreign Ties To Nih Grants | USAO-
WDMI | Department of Justice on January 21, 2022. 
4 Established by the Chinese government in 2008, the Thousand Talents Plan (also referred to as the Thousand Talents 
Program) incentivizes individuals engaged in research and development in the United States to transmit the knowledge and 
research they gain in the U.S. to China in exchange for salaries, research funding, laboratory space, and other incentives.  See 
United States Senate, Permanent Subcommittee on Investigations Staff Report, Threats to the U.S. Research Enterprise: Chinas 
Talent Recruitment Plans, p. 2.  Accessed at https://www.hsgac.senate.gov/imo/media/doc/2019-11-
18%20PSI%20Staff%20Report%20-%20China's%20Talent%20Recruitment%20Plans%20Updated2.pdf on August 16, 2021.        
5 NIH, Statement on Protecting the Integrity of U.S. Biomedical Research, August 2018.  Accessed at https://www.nih.gov/about-
nih/who-we-are/nih-director/statements/statement-protecting-integrity-us-biomedical-research on June 6, 2021. 
6 Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019, and Continuing 
Appropriations Act, 2019, P.L. No. 115-245; Further Consolidated Appropriations Act, 2020, P.L. No. 116-94; Consolidated 
Appropriations Act, 2021, P.L. No. 116-260. 
7 Investigators must disclose salary and payments (not otherwise identified as salary) received in the prior 12 months from a 
publicly traded entity as well as any equity interest (as of the date of disclosure) in a publicly traded entity when the total 
value when aggregatedexceeds $5,000.  Investigators also must disclose this information for salary, payments, and 
interests received from a nonpublicly traded entity.  However, the $5,000 threshold applies only to the aggregated value of 
salary and payments received from a nonpublicly traded entity; investigators must also disclose all equity interests in a 
nonpublicy traded entityregardless of value.  In addition, investigators must disclose any reimbursed or sponsored travel 
related to their institutional responsibilities, with some exceptions (42 CFR  50.603).   
8 42 CFR  50.605(a)(1).   
9 42 CFR  50.605(b)(1) and (b)(3)(viii)(C). 
10 The FCOI module in eRA Commons is an online interface that allows NIH-funded grantees to report the existence of any 
identified FCOI to NIH, as required by the Federal regulations.   
11 NIH, Reminders of NIH Policies on Other Support and on Policies Related to Financial Conflicts of Interest and Foreign 
Components, NOT-OD-19-114, July 2019.  Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html on 
June 23, 2021.  NIH, NIH Grants Policy Statement, section 2.5.1, October 2018.  Accessed at 
https://grants.nih.gov/grants/policy/nihgps/nih_gps_2018.pdf on January 24, 2022.  We are citing the NIH Grants Policy Statement 
issued in October 2018 because our review focused on grantees that received NIH funding for FY 2020, and this version of the 
 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Endnotes | 38    
 
NIH GPS was in effect during the first part of the FY 2020 award period.  In March 2021, NIH issued a notice that reminded 
grantees that an item or service given to an investigator with the expectation of an associated time commitment is not a gift and 
must be reported as support.  See NIH, Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due 
Dates on or After May 25, 2021, NOT-OD-21-073, March 2021.  Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-
OD-21-073.html on August 24, 2021. 
12 Investigators use the Biosketch Format Page and the Other Support Format Page as templates, which then are used as 
attachments in grant applications and progress reports.  The Biosketch Format Page contains biographical information (e.g., 
education and training, current position, personal statement, and other positions or scientific appointments).  The Other 
Support Format Page contains information about all resources made available to a researcher in support of and/or related to 
all of their research endeavors.  Both format pages were updated as of March 2021, and grantees must use the updated format 
pages beginning January 2022.  
13 NIH, NIH Grants Policy Statement, section 2.5.1, October 2018.  Accessed at 
https://grants.nih.gov/grants/policy/nihgps/nih_gps_2018.pdf on January 24, 2022.   
14 NIH, Reminders of NIH Policies on Other Support and on Policies Related to Financial Conflicts of Interest and Foreign 
Components, NOT-OD-19-114, July 2019.  Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html 
on June 23, 2021.  
15 42 CFR  50.602. NIH, NIH Grants Policy Statement, section 2.5.1, October 2018.  Accessed at 
https://grants.nih.gov/grants/policy/nihgps/nih_gps_2018.pdf on January 24, 2022.     
16 NIH, Types of Grant Programs.  Accessed at https://grants.nih.gov/grants/funding/funding_program.htm on 
October 28, 2021.     
17 42 CFR  50.602 and  50.603.   
18 NIH, Clarifying Long-Standing NIH Policies on Disclosing Other Support, July 2019.  Accessed at 
https://nexus.od.nih.gov/all/2019/07/11/clarifying-long-standing-nih-policies-on-disclosing-other-support/ on  
August 24, 2021.   
19 45 CFR Part 75.  NIH, NIH Grants Policy Statement, sections 8.3 and 2.5.1, October 2018.  Accessed at 
https://grants.nih.gov/grants/policy/nihgps/nih_gps_2018.pdf on January 24, 2022.   
20 42 CFR  50.604(a).   
21 42 CFR  50.604(b).  
22 42 CFR  50.604(f)-(h).    
23 NIH, Grants Compliance & Oversight.  Accessed at https://grants.nih.gov/policy/compliance.htm#activities on  
November 3, 2021.   
24 Ibid.   
25 42 CFR  75.371.    
26 42 CFR  75.371-.372.    
27 NIH, Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests, NOT-OD-18-160, March 2018.  
Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-160.html on April 25, 2022.    
 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Endnotes | 39    
 
28 NIH, Reminders of NIH Policies on Other Support and on Policies Related to Financial Conflicts of Interest and Foreign 
Components, NOT-OD-19-114, July 2019.  Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html 
on June 23, 2021.    
29 NIH, Required Submission of Financial Conflict of Interest Policy into the eRA Commons Institution Profile (IPF) Module, 
NOT-OD-21-002, September 2020.  Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-002.html on 
August 24, 2021.  
30 NIH, Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or After May 25, 2021, 
NOT-OD-21-073, March 2021.  Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-073.html on  
August 24, 2021.   
31 Ibid.    
32  NIH expects applicants and grantees to use the updated Biosketch Format Page and Other Support Format Page for 
applications, Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs) as of May 25, 2021 but does not 
require these format pages until January 25, 2022.  See NIH, Implementation of Changes to the Biographical Sketch and Other 
Support Format Page, NOT-OD-21-110, April 2021.  Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-
110.html on August 24, 2021.    
33 OIG, National Institutes of Health: Conflicts of Interest in Extramural Research, OEI-03-06-00460, January 2008; OIG, How 
Grantees Manage Financial Conflicts of Interest in Research Funded by the National Institutes of Health, OEI-03-07-00700, 
November 2009.    
34 HHS, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and 
Responsible Prospective Contractors, Final Rule, 76 Fed. Reg. 53256 (August 25, 2011).  These amendments to the regulations at 
42 CFR Part 50, Subpart F, apply to institutions applying for or receiving Public Health Service funding, which includes funding 
from NIH.   
35 Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019, and Continuing 
Appropriations Act, 2019, P.L. No. 115-245; Further Consolidated Appropriations Act, 2020, P.L. No. 116-94; Consolidated 
Appropriations Act, 2021, P.L. No. 116-260.   
36 OIG, The National Institutes of Health Has Limited Policies, Procedures, and Controls in Place for Helping to Ensure That 
Institutions Report All Sources of Research Support, Financial Interests, and Affiliations, A-03-19-03003, September 2019.    
37 OIG, NIH Has Made Strides in Reviewing Financial Conflicts of Interest in Extramural Research, But Could Do More, 
OEI-03-19-00150, September 2019.   
38 Ibid.     
39 We removed eight grantees from the list that NIH provided that were not U.S.-based.     
40 None of the grantees received exactly $10 million in NIH funding for FY 2020 as of July 1, 2020.   
41 We randomly selected these 100 grantees from a sampling frame of 233 larger granteesthe 244 larger grantees excluding 
11 grantees included in Government Accountability Office (GAO) work.  We removed these 11 grantees from the sampling 
frame so as not to overburden them with a detailed survey and documentation request, but we kept them in our overall 
grantee population.  See GAO, Federal Research, Agencies Need to Enhance Policies to Address Foreign Influence, GAO-21-130, 
December 2020.  Accessed at https://www.gao.gov/assets/gao-21-130.pdf on January 26, 2022.    
42 Among larger grantees, the response rate was 79 percent for the detailed survey compared to 89 percent for the short 
survey.   
 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Endnotes | 40    
 
43 There were eight grantees that did not answer survey questions regarding financial interests because their investigators are 
Federal employees and are not subject to HHSs FCOI regulations.  Therefore, we asked these eight grantees to complete only 
the section of our survey that pertained to other support.  As a result, our total number of respondents was reduced from 617 
to 609 throughout the report for any calculations pertaining only to financial interests.     
44 These grantees received less than $10 million in NIH funding for FY 2020 as of July 1, 2020.   
45 42 CFR  50.603.  
46 The National Science Foundation, Proposal and Award Policies and Procedures Guide, NSF 20-1, June 2020.  Accessed at 
https://www.nsf.gov/pubs/policydocs/pappg20_1/nsf20_1.pdf on July 19, 2021.   
47 To identify grantees in our review that received only R13 conference grants in FY 2020 as of July 1, 2020, we used data from 
the FY 2020 RePORTER Project Data file.  Accessed at https://exporter.nih.gov/ExPORTER_Catalog.aspx on January 13, 2021.   
48 42 CFR  50.605(a)(1).   
49 45 CFR Part 75; NIH. NIH Grants Policy Statement, sections 8.3 and 2.5.1, October 2018.  Accessed at 
https://grants.nih.gov/grants/policy/nihgps/nih_gps_2018.pdf on January 24, 2022.   
50 NIH, Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or After May 25, 2021, 
NOT- OD-21-073, March 2021.  Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-073.html on  
August 24, 2021.    
51 OIG, NIH Has Made Strides in Reviewing Financial Conflicts of Interest in Extramural Research, But Could Do More, 
OEI-03-19-00150, September 2019.    
52 Grantees had the option to skip the questions about whether, in the last 2 years, they had identified any investigator(s) who 
failed to disclose support or financial interests from a foreign entity and the followup questions regarding what actions were 
taken in response to the nondisclosure.   
53 OIG, NIH Has Made Strides in Reviewing Financial Conflicts of Interest in Extramural Research, But Could Do More, 
OEI-03-19-00150, September 2019.  
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant Financial Interests and Other 
Support 
OEI-03-20-00210   Endnotes | 41