U.S. Department of Health and Human Services 
Office of Inspector General  
 
 
NIH Has Made Strides in 
Reviewing Financial 
Conflicts of Interest in 
Extramural Research, 
 
But Could Do More
 
OEI-03-19-00150 
Suzanne Murrin 
September 2019 
Deputy Inspector General  
 
for Evaluation and Inspections 
oig.hhs.gov  Report in Brief  U.S. Department of Health and Human Services 
September 2019 
Office  of Inspector General 
OEI-03-19-00150 
 
 
NIH Has Made Strides in Reviewing Financial  Why OIG Did This Review 
NIH awards more than 70 percent of its 
Conflicts of Interest in Extramural Research, 
$37  billion budget  to universities  and 
But Could Do More  other grantee institutions.  Identifying 
and managing investigators FCOIs is 
What OIG Found  critical to safeguarding the integrity of 
The National Institutes of Health (NIH) has made progress in overseeing  financial conflicts  NIH-funded research. 
of interest (FCOIs) that extramural grantee  institutions (institutions) report for their research 
In 2008, OIG identified serious gaps in 
investigators.  Over the last decade, NIH has  strengthened  its reporting requirements and 
NIHs oversight of investigators FCOIs.  
developed an  online  system for collecting, reviewing, and storing FCOIs that institutions  
More recently, failures  by some 
report.  These changes have resulted in  improvements in how NIH tracks and reviews FCOIs 
investigators to disclose  substantial  
that institutions report.   
contributions of resources from other 
Because of its  improved tracking, NIH is now able  to provide the number and types of  organizationsincluding foreign 
FCOIs that institutions  report.  Overall, 3 percent of NIH grants in fiscal year (FY) 2018  had  governmentshave raised  new concerns 
investigators with FCOIs.  These grants received  about threats  to research integrity.  This 
Key Takeaway  $1 billion in  funding during FY 2018,  and institutions  failure highlights (1) the need for 
NIH has improved its tracking  reported a total of 2,755 FCOIs.    institutions to accurately identify and  
report investigators FCOIs, and (2) the 
and review of investigators  
Although NIH  has made substantial  strides in  
need for NIH to have robust oversight of 
financial conflicts of interest  
reviewing each reported FCOI for completeness and 
institutions management of these  FCOIs.   
(FCOIs) over the last decade, 
compliance, as  well as  to ensure the  reasonableness 
and  additional actions would   of institutions management  plans, we  found  This report focuses  on the need for this 
further  strengthen its  inconsistencies  in the depth of  its oversight reviews.   robust oversight, follows up on OIGs 
oversight of investigators  Across the three NIH Institutes and Centers (ICs) that  prior work, and seeks to determine 
FCOIs and its  monitoring of  we reviewed, staff differed in the level of scrutiny they  whether NIH has addressed the gaps that 
FCOIs involving foreign  applied to their review of FCOIs.  Furthermore, NIH  OIG previously identified  in the oversight 
interests.   lacks  quality  assurance procedures in  its review  of investigators FCOIs.  It also provides
process.  Specifically, NIH central management and  for the first timeinformation about the 
the three ICs that we  reviewed do not perform any systematic analyses or even ad-hoc  total  number and types of FCOIs that 
checks to determine whether  staff accurately and consistently review reported FCOIs, and  institutions are reporting to NIH.  In 
OIG found a small  number of inconsistencies in the  FCOI data that institutions  reported,  a separate review, OIG examined NIHs  
which might highlight the need for more oversight of the review process.   policies, procedures, and controls 
regarding institutions reporting of 
Lastly, NIH was  unable to identify FCOIs involving foreign interests because U.S. 
investigators FCOIs. 
Department of Health and Human Services (HHS) regulations do not require institutions to 
indicate whether an investigators FCOI involves an entity (e.g., a company, university, or  How OIG Did This Review 
government) that is based outside the United States.  NIH has no plans to require  We collected from NIH the number and 
institutions to designatewhen reporting their investigators FCOIswhether those FCOIs  type of FCOIs that institutions  reported in 
involve foreign  entities.  Instead, NIH is collecting information regarding investigators  FY 2018.  We sent a  questionnaire and 
foreign associations through a clarification of  its requirements for pre-award reporting.    conducted an interview with staff from 
NIHs Office of Extramural Research.  We 
What OIG Recommends 
also reviewed guidance and training 
NIH has  taken  many steps within the last decade to improve its  tracking and review of 
documents related to investigators 
investigators FCOIs, and additional actions would further strengthen the consistency and 
FCOIs.  Finally, we interviewed  staff at 
rigor of its oversight process.  We recommend that NIH (1)  perform periodic quality 
three NIH ICs  regarding their procedures 
assurance  reviews of the FCOI information  in its online system  to ensure  the  adequacy of its 
for reviewing FCOIs that institutions  
oversight, and (2) use information regarding  foreign affiliations and support that it collects 
reported.  
during the pre-award reporting process to decide whether to revise  its FCOI review process 
to address  concerns regarding foreign threats.  NIH concurred with both recommendations. 
Full report can be found at  oig.hhs.gov/oei/reports/oei-03-19-00150.asp    
TABLE OF CONTENTS 
BACKGROUND  1 
Methodology  7 
LANDSCAPE   
Landscape of Reported FCOIs in FY 2018  9 
FINDINGS   
NIH has improved the process for reporting and tracking FCOIs over the last decade  11 
NIH has made strides in its review of reported FCOIs, but it could do more to ensure the  12 
adequacy and consistency of its reviews 
NIH cannot identifyand does not plan to identifywhether FCOIs involve foreign entities,  15 
but is identifying foreign affiliations through a clarification of its pre-award reporting 
requirements   
CONCLUSION AND RECOMMENDATIONS   
NIH should perform periodic quality assurance reviews of FCOI information in its online system  16 
to ensure the adequacy of its oversight regarding FCOIs 
NIH should use information regarding foreign affiliations and support that it collects during  16 
the pre-award process to decide whether to revise its FCOI review process to address 
concerns regarding foreign threats 
AGENCY COMMENTS AND OIG RESPONSE  18 
   
APPENDICES   
A:  Detailed Methodology  19 
B:  Detailed Summary Counts, by Institute and Center   21 
C:  Significant Financial Interests That Grantee Institutions Reported in 2018  23 
D:  Staff Information for Three Select Institutes and Centers   24 
E:  Agency Comments  25 
ACKNOWLEDGMENTS  27 
 
   
BACKGROUND 
 
Objectives 
1.  Describe the number and types of financial conflicts of interest 
(FCOIs) reported in fiscal year (FY) 2018 to the National Institutes 
of Health (NIH) by extramural grantee institutions. 
2.  Identify the actions that NIH has taken to track and review FCOIs 
reported by extramural grantee institutions. 
3.  Determine whether and how NIHs FCOI review process 
addresses recent concerns regarding investigators financial 
interests with foreign entities.  
For FY 2019, the U.S. Department of Health and Human Services (HHS) 
Office of Inspector General (OIG) received $5 million in congressional 
appropriations to conduct oversight of NIH grant programs and operations.1  
As indicated by the conference report that accompanied the legislation, the 
conferees direct[ed] the OIG to examine NIHs oversight of its grantees 
compliance with NIH policies.2  
This review is part of a larger body of HHS OIG work focused on oversight 
of NIH grant programs and operations.  Our work will review (1) intellectual 
property and cybersecurity protections; (2) compliance with Federal 
requirements and NIH policies for grants and contracts; and (3) integrity of 
grant application and selection processes.  OIG is issuing two reports 
directly related to FCOIs: one that examines NIHs policies, procedures, and 
controls regarding institutions reporting of investigators FCOIs;3 and this 
report, which addresses NIHs tracking and review of FCOIs that extramural 
grantee institutions report.  
More than 70 percent of NIHs $37 billion budget in FY 2018 went toward 
extramural grants4 to support investigators working in universities and other 
 
1 Department of Defense and Labor, Health and Human Services, and Education 
Appropriations Act, 2019 and Continuing Appropriations Act, 2019, P.L. No. 115-245 (Sept. 28, 
2018). 
2 Department of Defense for the Fiscal Year Ending September 30, 2019, and for Other 
Purposes. Conference Report to Accompany H.R. 6157, H.R. Rep. No. 115-952, 2018. 
3 OIG, NIH Has Limited Policies, Procedures, and Controls in Place For Helping To Ensure That 
Institutions Report All Sources of Research Support, Financial Interests, and Affiliations,  
A-03-19-03003, September 2019. 
4 Extramural grants are grants that NIH awards to external organizations, including 
universities, medical schools, hospitals, and other research facilities.  
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OEI-03-19-00150   
grantee institutions (hereinafter institutions).  These institutions play a key 
role in protecting the integrity and security of U.S. biomedical research by 
managing their investigators FCOIs and reporting them to NIH.   
In August 2018, NIH issued a statement that raised concerns about 
increasing risks to the security of intellectual property in its biomedical 
research enterprise.5  Among NIHs concerns was the failure by some 
investigators to disclose substantial contributions of resources from other 
organizations, including foreign governments, which threatens to distort 
decisions about the appropriate use of NIH funds.  NIH stated that it was 
addressing these concernsin partby taking steps to improve accurate 
reporting of all sources of research support, financial interests, and 
affiliations.    
A 2008 OIG report identified serious gaps in NIHs oversight of extramural 
investigators FCOIs.6  In light of NIHs stated concerns about protecting the 
integrity of U.S. biomedical research, this evaluation follows up on our 
previous work and describes the FCOIs that institutions reported in FY 2018, 
as well as how NIH tracks and reviews FCOIs that institutions reported.  
 
FCOIs of NIH-Funded  The HHS regulations at 42 CFR Part 50, Subpart F establish standards to 
provide a reasonable expectation that the design, conduct, and reporting of 
Investigators 
NIH-funded research will be free from bias resulting from investigators 
  FCOIs.7, 8  An FCOI exists when an institution reasonably determines that an 
investigators significant financial interest could directly and significantly 
affect the design, conduct, or reporting of NIH-funded research.9          
Investigators Significant Financial Interests 
HHS regulations define a significant financial interest as any financial 
interest of the investigator10 (and those of the investigators spouse and 
dependent children) that reasonably appears to be related to the 
 
5 NIH, Statement on Protecting the Integrity of U.S. Biomedical Research, August 2018.  
Accessed at https://www.nih.gov on June 6, 2019. 
6 OIG, National Institutes of Health: Conflicts of Interest in Extramural Research,  
OEI-03-06-00460, January 2008.   
7 42 CFR  50.601. 
8 These regulations do not apply to Phase I Small Business Innovation Research (SBIR) 
Program or Small Business Technology Transfer (STTR) Program applications.  76 Fed. Reg. 
53256, 53261 (Aug 25, 2011). 
9 42 CFR  50.604(f). 
10 An investigator is defined as 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.  See NIH Grants Policy Statement, ch. 4.1.10, 
October 2018.   
NIH Has Made Strides in Reviewing Financial Conflicts of Interest in Extramural Research, But Could Do More   2 
OEI-03-19-00150   
investigators institutional responsibilities.11  Intellectual property rights and 
interests (e.g., patents and copyrights) may constitute a significant financial 
interest.  Other examples include remuneration (e.g., salary, consulting fees, 
honoraria, paid authorship) and/or equity interest received from an entity 
that exceeds $5,000 in the aggregate in the year prior to disclosure with 
regard to any publicly traded entity.12 
 
Requirements for  Prior to expending any funds under the NIH-funded research project, 
institutions must review all investigator disclosures of significant financial 
Reporting 
interests and determine whether any FCOIs exist.13  If an institution determines 
Investigators FCOIs 
that an FCOI exists, it must develop and implement a management plan that 
to NIH  specifies the actions that have been taken and will be taken to manage the 
FCOI to protect the design, conduct, and reporting of research from bias.14  
 
The FCOI and the key elements of the institutions management plan must be 
reported to NIH.15  If an institution identifies any FCOIs after the expenditure 
of NIH funds has begun, it must report those to NIH within 60 days of 
identifying the FCOI.16 
Reporting of FCOIs to NIH 
HHS revised regulations in 2011 to expand on the information that 
institutions must report to NIH about FCOIs.  Specifically, institutions must 
include sufficient information to enable NIH to (1) understand the nature 
and extent of the investigators FCOI and (2) assess the appropriateness of 
the institutions plan to manage the FCOI to protect the research from 
bias.17  After initially reporting an FCOI, an institution must submit annual 
reports to inform NIH of the status of the FCOI and any changes, if 
applicable, to the management plan.18, 19   
Noncompliance With FCOI Reporting 
If an investigator does not disclose a significant financial interest, or an 
institution does not manage an FCOI in a timely manner, or an investigator 
does not comply with the management plan, this constitutes 
 
11 42 CFR  50.603. 
12 Ibid. 
13 42 CFR  50.605(a)(1). 
14 Ibid. 
15 42 CFR  50.605(b)(1). 
16 42 CFR  50.605(b)(2). 
17 42 CFR  50.605(b)(3). 
18 An institution must submit these annual reports to NIH each year within a competitive 
segment or until the institution reports that the FCOI no longer exists.   
19 42 CFR  50.605(b)(4). 
NIH Has Made Strides in Reviewing Financial Conflicts of Interest in Extramural Research, But Could Do More   3 
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noncompliance with the FCOI regulations.20  Within 120 days of determining 
noncompliance, the institution must conduct a retrospective review to 
determine whether the investigators NIH-funded project conducted during 
the time period of the noncompliance was biased in the design, conduct, or 
reporting of the research.21  If the institution finds bias, it must submit to 
NIH a mitigation report that describes the impact that the bias had on the 
research.  The mitigation plan also must detail the institutions plan of action 
to eliminate or mitigate the effect of the bias.22      
Enforcement Actions   
If at any time NIH determines that an institution has failed to comply with 
the terms and conditions of awardincluding failure to report or manage 
an investigators FCOI NIH may take one or more enforcement actions.23  
These enforcement actions include disallowing costs, withholding of further 
awards, suspending the grant (wholly or partially), and terminating the 
grant.24, 25 
Investigators Foreign Investments   
In March 2018, NIH released a Guide Notice that reminds and clarifies for 
the extramural research community that investigators must disclose all 
financial interests received from a foreign institution of higher education or 
a foreign government.26  In December 2018, NIHs ACD [Advisory 
Committee to the Director] Working Group for Foreign Influences on 
Research Integrity recommended that NIH implement a broad education 
campaign to raise awareness about the need to disclose other research 
support, international affiliations, international collaborations, and foreign 
financial interests.  This group also recommended that NIH consider 
expanding its current regulatory approach concerning investigators FCOIs 
to expressly account for interest in which no financial remuneration is 
indicated but which overlaps with the scope of the NIH-funded research.27   
 
 
20 42 CFR  50.605(a)(3)(ii)(A). 
21 Ibid. 
22 42 CFR  50.605(a)(3)(iii). 
23 42 CFR  50.606(a). 
24 42 CFR  50.606(b). 
25 NIH, NIH Grants Policy Statement, ch. 8.5.2, October 2018.   
26 NIH, Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests,  
NOT-OD-18-160, March 2018.  Accessed at https://grants.nih.gov on May 28, 2019. 
27 NIH Advisory Committee to the Director, ACD [Advisory Committee to the Director] Working 
Group for Foreign Influences on Research Integrity, December 2018.  Accessed at 
https://acd.od.nih.gov on December 28, 2018.    
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NIHs  NIH awards grants to institutions through its 24 Institutes and Centers (ICs) 
that have grant-making authority.28  Each IC is responsible for the daily 
Responsibilities for 
management and oversight of its grants,29 and each has its own grants 
Tracking and 
management office and program office.  ICs follow the FCOI regulations, 
Reviewing  which are outlined in the NIH Grants Policy Statement.30  Institutions must 
Reported FCOIs  follow this policy statement as a term and condition of their respective NIH 
grant awards.  The NIH Grants Policy Statement is maintained by NIHs 
  Office of Extramural Research (OER).31  OER and ICs share responsibility for 
ensuring that institutions are reporting and managing investigators FCOIs 
according to the regulations.  
OERs Responsibilities for Overseeing the FCOI Review Process  
Within NIHs Office of the Director, OER supports the entire NIH extramural 
research community by providing policy, guidance, systems and other 
support to grant recipients and to the grant-making ICs.32  OER provides 
leadership and oversight to the extramural research community and NIH 
extramural staff, including matters relating to FCOIs.33  OER has established 
(based on governing regulations) training and guidance regarding the 
monitoring and reviewing of FCOIs.34     
NIH ICs Responsibilities for Tracking and Reviewing Reported 
FCOIs 
The NIH IC that awards a grant is responsible for the administration and 
monitoring of grant-supported activities.  Within each IC, grants 
management staff are responsible for the business management aspects of 
grants, while program office staff are responsible for the programmatic, 
scientific, and/or technical aspects of grants.  Grants management staff and 
program office staff each play a role in reviewing FCOI reports that 
institutions submit, as shown in Exhibit 1.  Although all ICs adhere to the 
FCOI regulations, ICs may develop their own internal procedures for 
reviewing reported FCOIs in addition to those established by OER. 
 
28 NIH, About the Office of Extramural Research (OER) at NIH.  Accessed at https://grants.nih.gov 
on January 11, 2019.   
29 NIH, NIH Grants Policy Statement, ch. 1.2, October 2018.   
30 NIH, NIH Grants Policy Statement, ch. 4.1.10, October 2018.   
31 NIH, Office of Policy for Extramural Research Administration (OPERA).  Accessed at 
https://grants.nih.gov on January 11, 2019. 
32 NIH, About the Office of Extramural Research (OER) at NIH.  Accessed at https://grants.nih.gov 
on January 11, 2019. 
33 Within OERs Office of Policy for Extramural Research Administration, the Division of Grants 
Compliance and Oversight is the focal point to advance external institutions compliance with 
policy and legislative mandates.  NIH, Office of Policy for Extramural Research Administration 
(OPERA).  Accessed at https://grants.nih.gov on January 11, 2019.  
34 NIH, Financial Conflict of Interest.  Accessed at https://grants.nih.gov on May 28, 2019.   
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OEI-03-19-00150   
Exhibit 1: NIH Staff Roles and Responsibilities for Reviewing FCOIs, 
as Outlined in NIH Guidance 
 
Program Official  FCOI Manager 
FCOI Manager  FCOI Manager  
reviews report   requests additional 
reviews FCOI report  notifies program 
and determines if   information, if 
for completeness and  official that report is 
compliance  ready for review  the management  needed, and marks 
plan appears  the review as 
reasonable  complete 
   
Source:  NIH, OER Training for NIH Program and Grants Management Staff, April 2014, and NIH, Q&As: 
Implementation of the 2011 Revised Financial Conflict of Interest Regulation, p. 5. 
Role of Grants Management Staff.  Within ICs, grants management staff
typically, FCOI Managersare responsible for tracking the receipt of FCOIs 
that institutions report.35  According to NIH training documents, once an 
institution reports an FCOI, an FCOI Manager is responsible for checking the 
report for completeness and compliance.  Following this review, the FCOI 
Manager notifies the program official that the report is ready for their 
review.  Each IC also has a Chief Grants Management Officer (CGMO), who 
is responsible for the business and fiscal management of an ICs grant 
portfolio.36   
Role of Program Official Staff.  Program officials are responsible for 
reviewing a reported FCOI and determining whether the institutions 
management plan appears reasonable to protect the research from bias 
given the nature of the significant financial interest and the role of the 
investigator.37  If a program official determines that additional information is 
needed from the institution, the program official notifies the FCOI Manager, 
who then submits a request for additional information to the institution.  
NIH recommends that program officials complete their review within 
30 days.  
     
Related Office of  Previous OIG studies examined NIHs policies and procedures with regard to 
extramural investigators FCOIs.  In a 2008 report, OIG found that NIH could 
Inspector General 
not provide an accurate count of the FCOIs that institutions reported during 
Work 
FYs 2004 through 2006.  OIG also found that NIH was not aware of the 
  
35 NIH, OER Training for NIH Program and Grants Management Staff, April 2014. 
36 Within each IC, there also is an individual who serves as the FCOI Liaison.  This individual 
serves as a consultant if an FCOI Manager or program office staff have questions regarding a 
FCOI report or issue.  The FCOI Liaison also coordinates with OER to resolve specific FCOI 
questions or concerns, if necessary.  The roles of CGMO, FCOI Manager, and FCOI Liaison 
may be held by one or more individuals.   
37 NIH, OER Training for NIH Program and Grants Management Staff, April 2014. 
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OEI-03-19-00150   
types of significant financial interests that existed among extramural 
investigators or how FCOIs were being managed by the institutions.38  In 
2009, OIG reported that vulnerabilities existed in how institutions identified, 
managed, and monitored investigators FCOIs.39  The findings of these 
studies raised serious concerns about NIHs oversight of institutions and 
how well these institutions were reporting and managing FCOIs.  On the 
basis of these findings, subsequent recommendations, and other 
information, HHS revised the FCOI regulations to enhance oversight and 
accountability.  NIH developed a tracking system and monitoring system 
and it updated and developed procedures to more accurately track the 
FCOIs that institutions report.   
This report is the first OIG evaluation regarding NIH oversight of FCOIs that 
institutions report since NIH revised its reporting requirements for 
institutions in 2011.   
 
Methodology  We collected several types of information from OER.  OER provided 
aggregated counts of the number and types of FCOIs that institutions 
 
reported in FY 2018, as well as the total number of grants, institutions, and 
grant dollars awarded in FY 2018.  We calculated the percentage of grants 
with an associated FCOI that was reported in FY 2018 and the percentage of 
institutions that reported at least one FCOI.  We also sent a questionnaire to 
OER requesting detailed information about the role that OER plays in the 
review and monitoring of FCOIs.  We then conducted a followup interview 
to clarify and obtain more details on OERs written responses.  We also 
reviewed OERs guidance, training, and procedural documents pertaining to 
the tracking and reviewing of reported FCOIs.    
In addition, we conducted interviews with staff from three of the ICs to 
determine the roles of OER and IC staffs in reviewing and monitoring 
reported FCOIs.  We selected these ICs based on their size and the number 
of FCOIs that their institutions reported in FY 2018.  We also reviewed 
IC-specific documents, where applicable.   
Lastly, we analyzed information on reported FCOIs from NIHs online system 
to determine the average number of days that staff took to review a 
reported FCOI, as well as whether inconsistences were present in the data.     
Appendix A contains a detailed description of our methodology.  
 
 
38  OIG, National Institutes of Health: Conflicts of Interest in Extramural Research, 
OEI-03-06-00460, January 2008.  
39  OIG, How Grantees Manage Financial Conflicts of Interest in Research Funded by the 
National Institutes of Health, OEI-03-07-00700, November 2009.   
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Limitations 
Although each of the 25 ICs40 must adhere to NIH-wide policies and 
procedures for reviewing FCOIs, ICs may develop their own procedural 
documents to effectuate NIH-wide policies and procedures.  We interviewed 
three ICs and collected IC-specific procedural documents from these ICs 
only.  Also, this evaluation focused on how NIH reviewed the FCOIs that 
institutions reported; we did not determine whether institutions reported all 
FCOIs that they were required to report.  Another OIG report examines 
NIHs policies, procedures, and controls regarding institutions reporting of 
investigators FCOIs.41  While we collected information about how NIH 
assesses the sufficiency of institutions plans for managing the FCOIs that 
they report, we did not independently assess the adequacy of institutions 
management plans.   
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.   
 
40 There are 24 ICs that have grant-making authority.  In addition, awards also are made on 
behalf of NIHs Office of the Director.  In this report, we refer collectively to these 24 ICs and 
the Office of the Director as 25 ICs.  
41 OIG, NIH Has Limited Policies, Procedures, and Controls in Place For Helping To Ensure That 
Institutions Report All Sources of Research Support, Financial Interests, and Affiliations,  
A-03-19-03003. 
 
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Landscape of Reported FCOIs in FY 2018 
 
In FY 2018, only a small percentage of NIHs extramural grants had 
investigators with reported FCOIs, as shown in Exhibit 2.  
Exhibit 2: Landscape of FCOIs reported to NIH in FY 2018 
  
 
 
 
 
 
 
 
 
 
 
 
Source:  OIG analysis of FCOIs reported to NIH in FY 2018. 
   
There was variability across ICs in the proportion of NIH-funded grants that 
had investigators with reported FCOIs, but no IC had more than 7 percent.  For 
most ICs (18 of 25), 3 percent or fewer of their grants involved investigators 
with reported FCOIs, as shown in Exhibit 3.    
Exhibit 3: For most ICs, 
3 percent or fewer of 
the ICs grants had 
investigators with 
reported FCOIs  
Source:  OIG analysis of FCOIs reported to NIH in FY 2018.  Appendix B provides the name of each IC 
and the detailed summary counts of reported FCOIs and grant awards for each IC. 
 
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Institutions reported equity interest as the most common significant 
financial interest associated with FCOIs that investigators disclosed.42   In 
total, 49 percent of reported significant financial interests entailed the 
investigator holding equity (e.g., stock, stock options, or other ownership 
interests) in either nonpublicly or publicly traded entities, as shown in 
Exhibit 4.  Appendix C presents the overall counts and percentages of all 
types of significant financial interests associated with the FCOIs reported in 
FY 2018.       
Exhibit 4: Almost half of the significant financial interests associated 
with FCOIs were equity interests held by investigators  
1 
2 
Source:  OIG analysis of FCOIs reported  to NIH in  FY 2018.  
1 Payment  for services may include consulting fees, honoraria, and  paid authorship.  
2 Examples of other financial interests included being an  advisory board  member  or being  the  owner  or 
cofounder of  a  company.   
 
Exhibit  5: Institutions could not  readily determine the  Institutions reported that they could not 
dollar  value  for nearly half of significant financial interests    readily determine the dollar value for 
nearly half of the significant financial 
interests that they reported in FY 2018, as 
shown in Exhibit 5.  Although this 
occurred mainly when institutions 
reported equity interests in nonpublicly 
traded companies, some included 
financial interests for which a dollar value 
likely could be determinedsuch as 
salary, travel  reimbursement, and 
payment for services.  Among the 
significant financial interests with a 
reported dollar value, 71 percent were 
valued in the  range of $0 to $39,999.43   
Source:  OIG analysis of FCOIs reported  to NIH in  FY 2018.  
 
42 In NIHs online system, an investigator may have one FCOI that includes multiple types of significant financial interests received 
from the same entity.  The 2,755 reported FCOIs were associated with 3,978 significant financial interests.   
43 In NIHs online system, institutions must select a dollar-value range (e.g., $0-$39,999) or a statement that a value cannot be 
readily determined for each significant financial interest reported.  
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Findings 
NIH has improved  NIH can now readily determine the number and types of FCOIs 
the process for  reported because it expanded its reporting requirements and 
developed an online tracking system 
reporting and 
In contrast to what we found in our 2008 reportthat NIH was unable to 
tracking FCOIs over 
provide the number or types of FCOIs associated with its extramural grants
the last decade 
NIH is now able to provide the total number of FCOIs that institutions report 
as well as a detailed count of the types of significant financial interests 
associated with these FCOIs, as shown in Exhibit 6.   
Exhibit 6: NIH has improved its tracking of  To accomplish these improvements, HHS revised 
FCOIs in the decade since OIGs last review  regulations requiring institutions to report to NIH 
  additional information regarding the nature and extent 
of investigators FCOIs.44  NIH now requires institutions 
to submit FCOI reports electronically, instead of 
through paper submissions to the awarding IC.  To 
streamline and track the reporting of FCOIs, NIH 
implemented an online reporting, tracking, and 
monitoring systemthe electronic Research 
Administration (eRA) Commons FCOI Module.  In 
addition to streamlining the process that institutions 
use to report FCOIs, the FCOI Module also has made 
FCOI information readily available for NIH review.  The 
FCOI Module provides NIH staff with the ability to 
access, review, and perform searches of reported 
FCOIs.         
Source:  OIG analysis of FCOIs reported to NIH between FYs 2004 
through 2006 and in FY 2018. 
 
NIH now has information regarding how institutions are 
managing investigators FCOIs   
NIH now requires institutions to report the key elements of their plan to 
manage FCOIs, which should ensure a reasonable expectation that the 
research is free from bias.  As OIG reported in 2008, for 89 percent of FCOIs 
that institutions reported between FYs 2004 through 2006, the institutions did 
not explain how they were managing the FCOIs.  Since 2012, HHS regulations 
have required institutions to includewhen reporting an investigators 
FCOI(s) to NIHinformation about the key elements of their plan to manage 
the FCOI(s).  These key elements include the following: the role of the 
conflicted investigator in the research, details of the management plan, how 
the management plan will safeguard research objectivity, confirmation of the 
 
44 42 CFR  50.605(b)(3). 
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investigators agreement to the management plan, and how the institution will 
monitor the management plan to ensure investigator compliance. 
NIH has made  NIH reviewed each reported FCOIthe vast majority within the 
strides in its review  recommended timeframe 
of reported FCOIs,  NIH has improved its process for reviewing investigators FCOIs.  Following 
but it could do more  publication of OIGs 2008 report, NIHs OER developed written guidance that 
outlines the responsibilities for staff reviewing FCOIs, as well as the actions 
to ensure the 
that staff should take once an institution submits an FCOI report in the FCOI 
adequacy and 
Module.  NIH now has a process to review each reported FCOI for 
consistency of its  completeness and compliance as well as to ensure the reasonableness of 
institutions management plans.  This differs from what OIG found in 2008
reviews 
that NIH relied on institutions assurances that they were following the FCOI 
  regulations, rather than directly overseeing or reviewing institutions 
management of the FCOIs they reported.   
 
For 87 percent of FCOIs reported in FY 2018, program officials completed their 
 
reviews within 30 daysthe recommended timeline established for reviewers.  
However, for 13 percent of reported FCOIs, NIH staff completed their reviews 
 
after 30 days, with the longest period of review lasting 260 days. 
Not all ICs opted to develop internal written guidance to assist 
staff in their reviews of FCOIs, and NIH staff differed in the depth 
of their reviews 
Fifteen of the 25 ICs reported having written procedures to supplement the 
guidance from OER.  The documents shared by the three ICs we reviewed 
differed in their level of detail and instruction.  Only one of the three guidance 
documents provided IC staff with specific criteria aimed at standardizing the 
review of FCOIs.  For example, this guidance included questions for program 
officials to consider during their review to identify concerns in one or more 
high-risk areas, such as clinical trials.  This guidance also suggested that 
reviewers use any other information to help determine if more information is 
needed to understand whether the reported FCOI may adversely impact the 
research.   
Program officials across the three ICs that we reviewed differed in their 
respective approaches and the level of scrutiny they applied when assessing 
whether institutions plans to manage FCOIs were reasonable.  For example, 
program officials in two of the ICs use external resourcessuch as 
investigators publications, Google Patents, or the United States Patent and 
Trademark Office websiteto assist in their review of institutions reported 
information and to strengthen their oversight of FCOI reports.  The program 
official at the third IC reported not seeking out any additional information 
other than what the institution had reported in the FCOI Module.    
Program officials also reported wide-ranging review times, with two ICs 
program officials generally spending 5 to 30 minutes per review and the other 
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ICs staff spending several hours.  They reported that the length of review can 
depend on the complexity of the review as well as whether they are reviewing 
an initial report or an annual report, with annual reports needing less time for 
review.  Program officials must rely heavily on their scientific knowledge and 
expertise when assessing whether a management plan appears reasonable to 
protect the research from bias.  Given the unique nature of each research 
project, and any significant financial interest associated with it, some 
differences in the scope of review are to be expected.  However, the program 
officials who reported using external sources in their reviews reported that 
they spent more time conducting their reviews.   
Although program officials differed in their review approaches, all mentioned 
that they pay particular attention to the management of an FCOI if human 
subjects are involved in the research.  For example, one program official 
stated that if human subjects or a clinical trial is involved, program officials 
put more effort to ensure that essential information is not missing from the 
FCOI report.   
NIH staff seldom requested additional information from institutions to assist in 
their review of FCOIs.  In FY 2018, NIH staff requested additional information 
for 76 of the 2,755 reported FCOIs.  NIH staff at the three ICs reviewed 
confirmed that they also rarely requested additional information during their 
reviews of reported FCOIs.  Although NIH has not taken any enforcement 
actions regarding missing or late information, NIH has delayed grant awards 
while awaiting responses to requests for additional information.  NIH was 
unable to provide the number of grants for which awards were delayed. 
NIH provides mentorship and support to staff who review FCOIs, 
but it does not conduct quality assurance of reviewers oversight 
of FCOIs 
Program officials are supported in their role as reviewers through general 
guidance available from OER as well as through informal on-the-job 
mentorship within the IC.  New program officials undergo training (known as 
the Core Curriculum) that includes information about institutions 
requirements for reporting FCOIs and NIHs responsibilities for reviewing the 
FCOIs that institutions report.  Program officials also may access pertinent 
webinars and other guidance materials through OERs website.  Additionally, 
staff from two ICs mentioned that newer staff have access to ongoing 
mentorship and training from seasoned program officials.   
NIH staff do not perform any quality assurance to ensure the adequacy or 
consistency of program officials reviews of FCOIs.  Neither OER nor IC 
management staff perform any systematic analyses or ad-hoc checks to 
determine whether NIH staff accurately and consistently review the FCOIs that 
institutions report.  OER staff reported that they had a process in place to 
provide oversight of ICs reviews of reported FCOIs and proactively provide 
guidance to ICs, but that they no longer have sufficient staff to continue this 
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oversight.  With this being the case, OER now relies on IC staff to seek 
guidance when needed and does not conduct regular oversight of the ICs.  
Similarly, none of the three ICs we reviewed perform quality checks to ensure 
the thoroughness or consistency of review by program officials.  Staff 
members from one IC stated that while they do not conduct quality checks, 
the IC provides newer program officials more guidance during their first few 
reviews.  Staff from another IC stated that ensuring consistency is more of an 
informal process, with program officials seeking guidance or advice from 
other staff when necessary. 
Some FCOIs in the FCOI Module contained inconsistencies that may indicate 
noncompliance with the FCOI regulations.  OIG conducted a cursory quality 
check of the FCOI Module that uncovered inconsistences in a small number of 
the 2,755 reported FCOIs.  Within the FCOI Module, there were 43 reported 
FCOIs for which institutions indicated noncompliance with the FCOI 
regulations.45  In these cases, institutions were required to complete a 
retrospective review within 120 days to determine whether the FCOI biased 
the research.  However, for 25 of these 43 cases, the institution indicated that 
it did not complete a retrospective review.46  Although 6 of these 25 cases 
specifically noted that the retrospective review was underway, this was not the 
case for the other 19.   It is not known whether these institutions completed 
the required retrospective reviews, and NIH does not require institutions to 
update the FCOI Module once they complete the retrospective review.47  In 
addition, NIH does not instruct its staff to follow up with institutions to ensure 
that these retrospective reviews have been completed. 
Only one of the three ICs we reviewed had any of these inconsistencies.  This 
IC had one of the largest numbers of inconsistencies across all ICs, and the 
FCOI Manager indicated that this IC passes the FCOI report to the program 
official without checking the report for completeness and compliance.  In 
contrast, the FCOI Managers at the other two ICs reported that they did a 
review for completeness and compliance review prior to sending the report to 
the program official.   
 
45 Noncompliance can include a failure by the investigator to disclose a significant financial 
interest that the institution determines to be an FCOI; a failure by the institution to review or 
manage an FCOI; or a failure by the investigator to comply with the management plan.  
42 CFR  50.605(a)(3). 
46 For these 25 cases, we reviewed the description of the noncompliance that the institution 
provided in the FCOI Module.  The description provided for 23 of these cases appeared to 
indicate that a retrospective review would be required.  In two cases, there was either no 
descriptive information or too little information to make a determination.     
47 The FCOI regulation does not require institutions to report to NIH when a retrospective 
review is completed or on the results of the retrospective review unless bias is found or when 
additional information is discovered during the retrospective review that was not previously 
reported.   
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NIH cannot  NIH was unable to provide OIG with the number of FCOIs reported in FY 2018 
that involved a significant financial interest in a foreign entity (e.g., the 
identifyand does 
investigator with the FCOI was conducting research in the United States but 
not plan to 
had a significant financial interest in a foreign entity).  Although NIH released 
identifywhether  a notice in March 201848 to remind the NIH extramural research community 
FCOIs involve  that investigators must disclose all financial interests received from a foreign 
institution of higher education or the government of another country, NIH has 
foreign entities, but 
no mechanism within the FCOI Module to identify foreign entities.  
is identifying 
The HHS regulations on FCOIs do not require institutions to designate 
foreign affiliations 
whether FCOIs involve foreign entities, and NIH reported that it has no plans 
through a 
to expand these regulations to include such a requirement.  Instead, NIH 
clarification of its 
released a notice in July 2019 that clarifies its policy regarding other support, 
pre-award reporting  including foreign affiliations.49, 50  Specifically, NIH clarifies that institutions are 
required to provide information during the pre-award process about 
requirements  
investigators other active and pending supportregardless of whether or not 
that support has monetary valuefrom all foreign and domestic entities.  NIH 
believes that collecting information regarding an investigators foreign 
interests is most appropriately captured as part of the pre-award reporting 
process rather than as part of the FCOI reporting process.   
 
   
 
48 NIH, Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests, 
NOT-OD-18-160, March 2018.  Accessed at https://grants.nih.gov on June 3, 2019. 
49 Other support includes information on all resourceswhether Federal, non-Federal, 
commercial or institutionalavailable in direct support of an investigators project.  NIH 
Grants Policy Statement, ch. 2.5.1, October 2018.   
50 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 on July 16, 2019. 
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CONCLUSION AND RECOMMENDATIONS 
Congress and NIH have raised concerns about threats to research integrity, 
including foreign threats.  We found that, overall, NIH has made progress in 
overseeing extramural investigators FCOIsbut has made no changes to its 
FCOI review process in light of recent concerns about foreign threats.  Since 
our previous report in 2008, NIH has expanded and standardized the 
collection of investigators FCOIs.  In addition, NIH now reviews all reported 
FCOIs.  However, NIH staff have approached these reviews with different 
levels of scrutiny, and NIH management does not conduct quality assurance 
reviews.  Furthermore, NIH was unable to identify whether any of the 
reported FCOIs involved foreign entities.  As such, additional actions would 
enhance the consistency and rigor of NIHs oversight of investigators FCOIs.  
Therefore, OIG recommends that: 
NIH should perform periodic quality assurance reviews of 
information in the FCOI module to ensure the adequacy of 
oversight regarding FCOIs 
Given the variability across ICs in their approaches to, and scrutiny of, the 
information in the FCOI Module, NIH would be well-served to heighten its 
oversight.  Conducting quality assurance reviews could identify shortfalls in 
ICs approaches and opportunities to add consistency to their review of 
reported FCOIs.  For example, OER staff could perform an annual review of 
a subset of all reported FCOIs from each IC (or from selected ICs) to ensure 
that IC staff are adequately reviewing FCOI information that institutions 
report.  In addition, ICs could implement periodic quality checks of the FCOI 
reviews that their staff perform.  These reviews could identify any data 
inconsistencies that might indicate institution noncompliance with 
requirements for reporting and managing FCOIs.   
NIH also should consider following up with institutions that report 
noncompliance within the FCOI Module but do not indicate that they 
completed a retrospective review.  Although an institution is not required to 
report its findings of a retrospective review to NIH unless it finds bias, NIH 
should have a mechanism in place to ensure that institutions are completing 
required retrospective reviews.     
NIH should use information regarding foreign affiliations and 
support that it collects during the pre-award process to decide 
whether to revise its FCOI review process to address concerns 
regarding foreign influence 
NIH released a notice in July 2019 that reminds institutions about the need 
to report investigators foreign affiliations during the pre-award process.  
NIH should use this information on investigators foreign affiliations to 
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OEI-03-19-00150   
evaluate whether the requirements regarding investigators FCOIs also need 
to be updated to fully address concerns about investigators foreign 
affiliations.  If NIH decides that revisions are needed, it should consider 
modifying the FCOI Module to require institutions to report whether 
investigators significant financial interests involve foreign entities.  Such a 
modification would remedy this potential gap in information and increase 
transparency for the parties involved, which may help safeguard against 
potential risks to the security of intellectual property and the integrity of 
NIH-funded research. 
 
   
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AGENCY COMMENTS AND OIG RESPONSE 
NIH concurred with both of our recommendations but did not provide 
details of its implementation plans.  Rather, NIH stated that it will provide  
detailed corrective action plans in 6 months when it submits its final 
management decision to the OIG.   
Appendix E provides the full text of NIHs comments.  
   
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APPENDIX A: Detailed Methodology 
FCOI Data from OER  
From OER, we requested aggregated counts of the number and types of 
FCOIs that institutions reported in FY 2018, as well as the total number of 
grants, institutions, and grant dollars awarded in FY 2018.51  In addition, we 
requested the following information about the reported FCOIs:  
  the number of institutions that reported at least one FCOI; 
  the number of grants for which institutions reported at least one 
FCOI;  
  the number of reported FCOIs for which NIH staff requested 
additional information from institutions and the number of reported 
FCOIs that were revised as a result of this additional information;  
  the number of reported FCOIs submitted between October 1, 2014, 
and September 30, 2018, for which institutions performed 
retrospective reviews because of noncompliance with reporting 
requirements, and, of these, how many had a finding of bias;  
  the number of reported FCOIs that involved a significant financial 
interest in a foreign entity;   
  the number of reported FCOIs that NIH reviewed; and 
  the number of grants for which NIH took enforcement actions as a 
result of its review of FCOIs.   
From these aggregated counts, we calculated the percentage of grants that 
had an associated FCOI reported in FY 2018 and the percentage of institutions 
that reported at least one FCOI.  We performed these calculations for reported 
FCOIs overall and by IC.  We also calculated the percentage of total grant 
dollars associated with reported FCOIs and summarized the types of significant 
financial interests reported as FCOIs. 
Data from NIHs Online System.  NIH provided OIG with access to NIHs 
online system that contains reported FCOIs.  We used data from this system 
to analyze the range and average number of days between the date an 
institution reported an FCOI (i.e., the submission date) and the date NIH 
staff completed their review (i.e., the completion date) for FCOIs reported in 
FY 2018.   
 
51 We excluded FCOIs that were reported for research on Phase I SBIR/STTR Program grants, 
as these are not required to be reported.  If an FCOI was initially reported and then updated 
or revised within FY 2018, we requested that OER count only the most recent submission. 
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OEI-03-19-00150   
We also reviewed the FY 2018 data to determine whether there were 
instances in which institutions indicated that there was noncompliance with 
reporting requirements but did not indicate that they completed a 
retrospective review.  For these cases, we reviewed the description of the 
noncompliance that the institution provided in the FCOI Module, and we 
(1) assessed whether the noncompliance would have required a 
retrospective review, and (2) determined whether the institution reported 
that a retrospective review was in progress.    
OER Questionnaire, Interview, and Supporting Documents 
We sent a questionnaire to OER requesting detailed information about the 
role that OER plays in the review and monitoring of FCOIs.  We then 
conducted a followup interview to clarify and obtain more details on OERs 
written responses.   
We also reviewed OERs guidance, training, and procedural documents 
pertaining to the tracking and reviewing of reported FCOIs.  OER also 
provided a list of the ICs that have their own written policies and procedures 
regarding FCOIs.   
Interviews With Select ICs 
We selected three ICs to review based on their size and the number of 
FCOIs that their institutions reported in FY 2018.  To do this, we divided the 
ICs into thirds (i.e., top third, middle third, and bottom third) according to 
the total dollars that each awarded to institutions in FY 2018.  After 
excluding the National Cancer Institute (NCI) and the National Eye Institute 
(NEI), we determined which ICs in each third had the highest number of 
reported FCOIs in FY 2018.52  These were the National Heart, Lung, and 
Blood Institute (NHLBI); the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases (NIAMS); and the National Institute of 
Biomedical Imaging and Bioengineering (NIBIB).   
We conducted interviews with staff from each of the three ICs and 
summarized their responses regarding the roles of grants management staff 
and program official staff in reviewing FCOIs; how staff review FCOIs and 
management plans; the training and guidance that ICs provide to staff; how 
ICs consult with OER staff; and any challenges that staff face in reviewing 
reported FCOIs.  We also reviewed IC-specific documents, where applicable.  
 
Appendix D provides staffing information for NHLBI, NIAMS, and NIBIB.  
 
52 We excluded NCI and NEI because of other ongoing OIG work involving these ICs.   
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APPENDIX B: Detailed Summary Counts, by 
Institute and Center  
 
Exhibit B-1: FCOI reports and award information by NIH Institute and Center (IC) for FY 2018 
Number of  Number of 
Number of  institutions  unique grants 
Total FY 2018   Number of  Number of 
NIH IC  reported  reporting at  associated 
award funding  grants1  institutions  
FCOIs  least one  with reported 
FCOI  FCOIs 
National Cancer Institute (NCI)  $4,027,936,852  7,059  548  676  96  409 
National Institute of General 
$2,719,507,073  6,670  602  167  48  113 
Medical Sciences (NIGMS) 
National Heart, Lung, and Blood 
$2,770,124,029  5,547  460  344  75  213 
Institute (NHLBI) 
National Institute of Allergy and 
$3,927,572,369  5,483  572  301  67  191 
Infectious Diseases (NIAID) 
National Institute of 
Neurological Disorders and  $1,764,232,217  4,274  382  167  57  122 
Stroke (NINDS) 
National Institute of Diabetes 
and Digestive and Kidney  $1,674,298,120  4,064  380  211  52  135 
Diseases (NIDDK) 
National Institute on Aging 
$2,083,959,712  3,284  409  134  42  89 
(NIA) 
National Institute of Mental 
$1,461,046,514  3,131  358  86  34  74 
Health (NIMH) 
National Institute of Child 
Health and Human  $1,153,533,942  2,591  395  71  36  53 
Development (NICHD) 
National Institute on Drug 
$1,019,028,868  2,155  331  50  20  32 
Abuse (NIDA) 
National Eye Institute (NEI)  $610,056,340  1,625  237  125  29  59 
National Institute of Arthritis 
and Musculoskeletal and Skin  $501,409,156  1,415  224  69  28  44 
Diseases (NIAMS) 
      continued on next page 
 
 
 
 
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Exhibit B-1: FCOI reports and award information by NIH Institute and Center (IC) for FY 2018 
(continued) 
Number of 
Number of 
Number of  institutions 
Total FY 2018   Number of  Number of  unique grants 
NIH IC  reported  reporting at 
award funding  grants1  institutions   associated with 
FCOIs  least one 
reported FCOIs 
FCOI 
National Institute on Alcohol 
$384,117,862  1,146  236  44  10  28 
Abuse and Alcoholism (NIAAA) 
National Institute on Deafness 
and Other Communication  $380,070,366  1,134  212  28  14  25 
Disorders (NIDCD) 
National Institute of 
Environmental Health Sciences  $568,885,087  1,117  242  17  13  14 
(NIEHS) 
National Institute of 
Biomedical Imaging and  $371,512,799  982  209  112  35  64 
Bioengineering (NIBIB) 
National Institute of Dental and 
$333,455,993  876  186  29  12  16 
Craniofacial Research (NIDCR) 
Office of the Director (OD)  $828,877,926  601  193  16  8  11 
National Human Genome 
$457,249,652  531  135  29  14  26 
Research Institute (NHGRI) 
National Institute on Minority 
Health and Health Disparities  $263,237,403  431  183  10  5  6 
(NIMHD) 
National Institute of Nursing 
$132,081,511  344  109  5  3  3 
Research (NINR) 
National Center for Advancing 
$596,068,934  331  107  42  18  22 
Translational Sciences (NCATS) 
John E. Fogarty International 
$80,666,953  320  140  2  2  2 
Center (FIC) 
National Center for 
Complementary and  $126,819,616  292  128  13  6  8 
Integrative Health (NCCIH) 
National Library of Medicine 
$84,165,571  194  87  7  7  7 
(NLM) 
        TOTAL  $28,319,914,865  55,597  2,0642  2,755  2022  1,766 
Source:  OIG analysis of FCOIs reported to NIH in FY 2018 and NIH Awards by Location and Organization from the NIH Research 
Portfolio Online Report Tools (RePORT). 
1 Excluding Phase 1 Small Business Innovation Research (SBIR) Program or Small Business Technology Transfer (SBTT) Program applications. 
2 The total provided is the unique number of institutions and not the aggregated total of numbers provided in each row. 
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APPENDIX C: Significant Financial Interests 
That Institutions Reported in 2018 
Exhibit C-1: Type, number, and value of significant financial interests that institutions reported to NIH 
in FY 2018  
Significant Financial Interest (SFI) Type 
 Equity  Equity 
Reimbursed  Salary not 
Value of  interest in  interest in  Intellectual  Payment 
or  from the 
significant  nonpublicly  publicly  property  Investments3   Other  for 
sponsored  awardee 
financial interest  traded  traded  rights2  services4  
travel   institution 
entity1   entity1 
$0-$39,999  402  41  132  16  284  625  25  38 
$40,000-$99,999  53  15  16  1  18  180  0  20 
$100,000-$149,999  15  4  2  0  10  57  0  8 
$150,000-$199,999  6  4  1  0  5  35  0  4 
$200,000-$249,999  8  8  0  0  3  6  0  5 
$250,000-$299,999  6  0  7  0  0  7  0  8 
$300,000-$349,999  4  1  1  0  2  2  0  3 
$350,000-$399,999  3  2  2  0  2  0  0  2 
$400,000-$449,000  0  0  2  0  0  0  0  1 
$450,000-$499,999  2  0  0  0  0  0  0  1 
$500,000-$549,999  6  0  1  0  5  1  0  0 
$550,000-$599,999  1  1  0  0  0  0  0  1 
>$600,000  32  39  3  0  0  4  0  0 
Value cannot be 
readily determined  1,286  29  165  40  210  42  6  1 
TOTAL  1,824  144  332  57  539  959  31  92 
Source:  OIG analysis of FCOIs reported to NIH in FY 2018.  
1 Examples include stock, stock options, or other ownership interest. 
2 Examples include royalties, patents, and copyrights. 
3 Examples include mutual funds and retirement accounts controlled by the investigator. 
4 Examples include consulting fees, honoraria, and paid authorship. 
 
 
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APPENDIX D: Staff Information for Three Select 
Institutes and Centers (ICs) 
Exhibit D-1: Number of grants management and program office staff at NIBIB, NIAMS, and NHLBI 
Number of  Number of  Number of 
Number of  Number of  Number of  Grants  Grants  Chief Grants 
NIH IC  FCOI  FCOI  Program  Management  Management  Management 
Managers  Liaisons  Officials  Specialists  Officers  Officers 
(GMSs)  (GMOs)  (CGMOs) 
National Institute of 
Biomedical Imaging and  1  1  14  1  7  1 
Bioengineering (NIBIB) 
National Institute of Arthritis 
and Musculoskeletal and Skin  1  1  17  10  6  1 
Diseases (NIAMS) 
National Heart, Lung, and 
4  4  131  9  22  1 
Blood Institute (NHLBI) 
Source:  OIG analysis of IC staffing information provided by NIH, 2019.  
 
 
 
   
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APPENDIX E: Agency Comments 
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ACKNOWLEDGMENTS 
Maria S. Johnson served as the team leader for this study.  Others in the 
Office of Evaluation and Inspections who conducted the study include 
Karolina Hill, Anjali Bushan, and Robert Kirkner.  Office of Evaluation and 
Inspections staff who provided support include Clarence Arnold, 
Christine Moritz, and Melicia Seay. 
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.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To obtain additional information concerning this report or to obtain copies, 
contact the Office of Public Affairs at Public.Affairs@oig.hhs.gov.  
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OEI-03-19-00150   
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: 
Office of Audit  The Office of Audit Services (OAS) provides auditing services for HHS, either 
by conducting audits with its own audit resources or by overseeing audit 
Services 
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 assessments help reduce waste, 
abuse, and mismanagement and promote economy and efficiency 
throughout HHS. 
Office of Evaluation  The Office of Evaluation and Inspections (OEI) conducts national evaluations 
to provide HHS, Congress, and the public with timely, useful, and reliable 
and Inspections 
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.   
Office of  The Office of Investigations (OI) conducts criminal, civil, and administrative 
investigations of fraud and misconduct related to HHS programs, 
Investigations 
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. 
Office of Counsel to  The Office of Counsel to the Inspector General (OCIG) provides general 
legal services to OIG, rendering advice and opinions on HHS programs and 
the Inspector 
operations and providing all legal support for OIGs internal operations.  
General 
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.