U.S. Department of Health and Human Services 
Office of Inspector General 
 
 
NIH Has Acted To 
Protect Confidential 
Information 
Handled by Peer 
Reviewers, But It 
Could Do More 
 
OEI-05-19-00240  Suzanne Murrin 
MOaErcI-h0 250-1209 -00240  Deputy Inspector General 
  August 2019  for Evaluation and Inspections 
o ig.hhs.gov 
oig.hhs.gov  Report in Brief  U.S. Department of Health and Human Services 
March 2020 
Office  of Inspector General 
OEI-05-19-00240 
 
 
NIH Has Acted To Protect Confidential 
Why OIG Did This Review 
Information Handled by Peer Reviewers, But 
Congress, NIH, and Federal 
intelligence agencies have raised 
It Could Do More 
concerns about foreign threats to 
the integrity of U.S. medical 
Each year the National Institutes of Health (NIH)  Key Takeaway 
research and intellectual property.  
relies on thousands of peer reviewers to review  NIH enforces policies 
This includes foreign programs that 
tens of thousands of extramural grant  and procedures that 
may unduly influence and capitalize 
applications, helping NIH determine the most  protect confidential 
on NIH-funded research.  In August 
promising research to fund.  information in grant 
2018, NIH Director Dr. Francis 
applications handled by 
Collins raised concerns that peer 
What OIG Found  peer reviewers, but it 
reviewerswho have unique access 
NIH has policies and procedures to protect the  could do more to 
to confidential information in grant 
confidentiality of the peer review process and  address the risk that 
applicationswere, in some cases, 
takes action against reviewers who disclose  undue foreign influence 
inappropriately sharing this 
information.  To prevent disclosures, NIH requires  poses to maintaining 
information with foreign entities.  
all peer reviewers to sign electronic nondisclosure  confidentiality. 
Subsequently, Congress 
certifications and trains peer reviewers to keep the 
appropriated funding for the Office 
information in grant applications private.  To detect potential disclosures, NIH 
of Inspector General to conduct 
relies primarily on peer reviewers to report suspicious activity by other 
oversight of NIH grant programs 
reviewers, but the agency is starting to use technology to detect disclosures.  
and operations, including examining 
NIH has taken a range of actions against peer reviewers found to have 
the effectiveness of NIHs efforts to 
disclosed confidential information, including terminating the reviewers 
protect intellectual property derived 
service or referring the reviewer to law enforcement for investigation. 
from NIH-supported research.  This 
NIH actively responds to instances of suspected undue foreign influence in  study describes and assesses NIHs 
peer review, but the agency is in the early stages of addressing this threat  oversight of peer reviewers 
systemically.  NIH learns of instances of potential undue foreign influence in  handling of confidential 
peer review primarily from its national security partners and from NIH staff.  It  information. 
has responded to these instances on a case-by-case basis.  NIH is developing 
an approach to address foreign-influence concerns systemicallythrough  How OIG Did This Review 
general oversightin addition to responding to specific incidents.  We interviewed NIH staff at the 
Office of Extramural Research, the 
What OIG Recommends  Center for Scientific Review, the 
NIH is taking steps to address concerns about foreign threats to research  Office of Management Assessment, 
integrity, and has an opportunity to more directly addressin a systemic  and the Office of Federal Advisory 
wayconcerns about foreign threats to the confidentiality of the peer review  Committee Policy about their roles 
process.  We recommend that NIH conduct targeted, risk-based oversight of  in setting and implementing policy 
peer reviewers using risk indicators identified from analysis of research  related to peer reviewers handling 
integrity threats.  In addition, NIH should update its training materials  of confidential information.  We also 
routinely with information about confidentiality breaches and undue foreign  reviewed NIH policies, guidance, 
influence, and the agency should require all peer reviewers to attend periodic  and training materials related to 
trainings about these risks.  NIH should also continue consulting with  oversight of peer reviewers.  Lastly, 
national security experts about peer review risks and mitigation to inform a  we collected information from NIH 
risk-based oversight approach.  NIH concurred with all four of our  about its investigations of peer 
recommendations. reviewers and about any actions it 
has taken against reviewers who 
Full report can be found at oig.hhs.gov/oei/reports/oei-05-19-00240.asp  disclosed confidential information.   
TABLE OF CONTENTS 
BACKGROUND  1 
Methodology  6 
   
FINDINGS   
NIH protects the confidentiality of the peer review process through efforts to prevent  8 
disclosures, identify potential breaches, and take action against reviewers who disclose 
confidential information 
NIH actively responds to instances of suspected undue foreign influence in peer review, but  12 
is in the early stages of addressing it systemically 
   
CONCLUSION AND RECOMMENDATIONS   
NIH should conduct targeted, risk-based oversight of peer reviewers using analysis of  15 
information about threats to research integrity 
NIH should update its training materials routinely to include information about breaches of  15 
peer reviewer confidentiality and possible undue foreign influence 
NIH should require all peer reviewers to attend periodic trainings about peer review  16 
integrity 
NIH should consult with Federal law enforcement and national security experts to  17 
determine what additional steps it might take to identify and address potential risks to the 
confidentiality of the peer review process, including possible undue foreign influence 
   
AGENCY COMMENTS AND OIG RESPONSE  18 
APPENDIX: AGENCY COMMENTS  19 
ACKNOWLEDGMENTS  22 
ENDNOTES  23 
   
BACKGROUND 
Objective 
To describe and assess the National Institutes of Healths (NIH) 
oversight of peer reviewers handling of confidential information. 
 
Concerns About  For fiscal year 2019, the U.S. Department of Health and Human Services 
(HHS) Office of Inspector General (OIG) received $5 million in congressional 
Foreign Threats 
appropriations to conduct oversight of NIH grant programs and operations.1  
to Research 
As indicated by the conference report that accompanied the legislation, the 
Integrity  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.  OIGs work is reviewing 
(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.   
Congress directed OIG to examineas part of this oversight work(1) NIHs 
efforts to ensure the integrity of its grant evaluation and selection 
processes; and (2) the effectiveness of NIHs and grantee institutions efforts 
to protect intellectual property derived from NIH-supported research.3 
This evaluation and a companion report issued in September 2019 examine 
NIHs efforts to mitigate risks to research integrity and intellectual property 
posed by peer reviewers.  Specifically, the first evaluation examined NIHs 
process for vetting prospective peer reviewers and found that NIH focuses 
its vetting of peer reviewer nominees on scientific skills and preventing 
undue influence generally, but does not focus its vetting specifically on 
undue foreign influence.4  This report focuses on NIHs oversight of peer 
reviewers handling of confidential information. 
NIH recognizes that threats to the security of intellectual property and the 
integrity of peer review are increasing.  In his August 2018 statement on 
protecting the integrity of U.S. biomedical research, NIH Director 
Dr. Francis Collins expressed concern about the inappropriate sharing of 
confidential information by peer reviewers with others, including foreign 
entities.5  At the same time, Dr. Collins wrote to NIH grantee institutions to 
alert them to these foreign threats, noting that foreign entities have 
mounted systematic programs to influence NIH researchers and peer 
reviewers.6  As an example of these programs, NIHs Advisory Committee 
to the Director warned NIH of Chinas Thousand Talents plan, which is 
intended to attract talented scientists while facilitating access to intellectual 
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OEI-05-19-00240   
property (see the box on this page).7  In both his statement on the integrity 
of biomedical research and his letter to grantee institutions, Dr. Collins 
stated that in response to these increasing risks, NIH would work with other 
government agencies, institutions, and organizations to identify robust 
methods to protect the integrity of peer review. 
Additionally, congressional committees have expressed concerns and 
requested information about potential threats to the integrity of taxpayer-
funded research, including the theft of intellectual property and its diversion 
to foreign entities.8, 9  In a June 2019 Senate hearing, NIH Principal Deputy 
Director Dr. Lawrence Tabak testified that NIH was aware that a few foreign 
governments have initiated systematic programs to capitalize on the 
collaborative nature of biomedical research and unduly influence U.S.-based 
researchers.10 
NIH also has raised concerns about possible unintended consequences that 
foreign threats may have on scientific collaborations.  Specifically, NIH staff 
have stated concerns about protecting relationships with foreign scientists 
because of the perception of racial/ethnic profiling and stigmatization.11  
NIH further indicated that it seeks to mitigate risks to intellectual property 
security while continuing its tradition of international collaboration.12 
 
Chinas Thousand Talents Plan 
Chinas central government announced the Thousand Talents plan in 
2008.  One aspect of the plan provides financial incentives for Chinese 
scientists living abroad to return to China.13  According to NIH, access 
to foreign intellectual property is key to a scientists selection for the 
Thousand Talents program.  In a 2018 meeting of NIHs Advisory 
Committee to the Director, NIH identified several concerns related to 
talent recruitment programs such as the Thousand Talents plan: 
  undisclosed foreign financial conflicts; 
  undisclosed conflicts of commitment; and 
  peer review violations, including the inappropriate sharing of 
confidential information.14 
 
The peer review process is central to the integrity of evaluating and 
selecting grants.  According to NIH policy, the peer review process is 
intended to ensure that applications for funding submitted to NIH are 
evaluated on the basis of a process that is fair, equitable, timely, and 
conducted in a manner that strives to eliminate bias.15  However, as 
Dr. Collins statement suggested, peer reviewers also present a potential risk 
to intellectual property or other confidential information contained in grant 
applications if they inappropriately share that information.16 
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OEI-05-19-00240   
Because peer reviewers review research-grant applications submitted to 
NIH, they have a unique opportunity to access confidential information in 
the applications.  Accordingly, NIH policy seeks to ensure that peer 
reviewers do not inappropriately disclose or divert confidential information, 
including information related to intellectual property.17 
 
NIH Efforts  In response to concerns about foreign threats to research integrity, NIH has 
taken steps to protect the integrity of the grantmaking and peer review 
To Address 
process.  To raise awareness of confidentiality in peer review, NIH has 
Concerns About 
communicated with its staff, the research community, and grantee 
Foreign Threats  institutions, some of which have proactively raised concerns with NIH.18  NIH 
to Research  convened a new working group for the Advisory Committee to the Director 
to explore additional steps to protect the integrity of peer review.  The 
Integrity 
working group released its findings and recommendations in December 
2018.19  NIH also has conducted a fraud risk assessment of its extramural 
grant program to identify strengths and weaknesses.  Additionally, NIH is 
working with law enforcement and national security partnersFederal 
agencies inside HHS (e.g., the HHS Office of National Security and OIG), as 
well as outside agencies (e.g., the Federal Bureau of Investigation (FBI))to 
identify and follow up on scientists of possible concern among NIH 
grantees.20  NIH staff reported that the agency will not invite individuals to 
serve as peer reviewers if it has strong evidence that an individual is linked 
to Chinas Thousand Talents program.  Furthermore, NIH has worked to 
improve the security of the electronic systems that researchers use to 
submit grant applications and that peer reviewers use to access these 
applications.21 
 
NIHs Peer  Each year, NIH receives more than 80,000 extramural grant applications 
from outside researchers and organizations and evaluates them using a 
Review Process 
two-level review process.22  For about 75 percent of those applications, 
NIHs Center for Scientific Review (CSR) manages the first level of peer 
review.  For the remaining applications, NIHs institutes and centers (ICs) 
manage the first level of review.  An Advisory Council or Board at each IC 
conducts the second level of review.23  The director of each IC or a 
designated individual makes the final funding decision.24  In fiscal year 2018, 
NIH awarded $31.5 billion in extramural funding.25 
At CSR, peer reviewers who serve on study sections (also known as scientific 
review groups) conduct the first level of review of grant applications.  
During this review, peer reviewers evaluate proposed projects based on 
their scientific and technical merit.26  Each study section includes between 
12 and 25 peer reviewers, all of whom are recognized as experts in their 
fields.  Study sections usually hold three meetings per year, during which 
peer reviewers discuss multiple grant applications on the same scientific 
topic and give each application a preliminary score based on the proposed 
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projects likelihood of creating a major scientific impact.27  Study sections 
are grouped by topic into Integrated Review Groups. 
NIH engages both temporary and appointed peer reviewers to review grant 
applications.  Temporary reviewers join study section meetings on a one-off 
basis when there is a need for their area of expertise.  By contrast, 
appointed reviewers serve 4-year terms and are expected to attend all 
meetings of their respective study sections.28  Both temporary and 
appointed peer reviewers typically have received NIH grants in the past or 
have active grants, although this is not a requirement.  NIH staff reported 
that the agencys oversight of peer reviewers does not vary with respect to 
peer reviewers status as temporary or appointed.  NIH considers both 
temporary and appointed peer reviewers to be professional service 
consultants.29 
Nearly all of CSRs peer reviewers work at research institutions located in the 
United States, according to NIH.  Reviewers include both U.S. citizens and 
foreign nationals.  CSR vets all of these reviewers in the same way. 
Peer Review Integrity 
NIH seeks to ensure that its approximately 27,000 peer reviewers review 
grant applications in a manner free from inappropriate influence.  NIH 
identifies the following core values for its peer reviewers: (1) expert 
assessment, (2) transparency, (3) impartiality, (4) fairness, (5) confidentiality, 
(6) security (added in 2018), (7) integrity, and (8) efficiency.30  NIH vets peer 
reviewer nominees for their alignment with these values, focusing on 
nominees scientific expertise and ability to effectively use that expertise in a 
peer review setting.  OIG evaluated NIHs vetting of peer reviewer nominees 
in a previous report.31 
NIH also conducts ongoing oversight of peer reviewers to verify that 
reviewers uphold NIHs core values throughout the terms of their 
participation.  Scientific Review Officers (SROs) convene study section 
meetings and train peer reviewers on NIH policies regarding peer review 
integrity, including confidentiality and conflict-of-interest rules.  NIH also 
collaborates with grantee institutions and other Federal agencies to respond 
to peer review integrity issues.  (See the box on the next page for more 
information about NIH offices involved in peer review oversight.) 
Additionally, before and after each meeting of a study section, peer 
reviewers must examine the grant applications they are reviewing and 
self-assess for conflicts of interest.  Conflicts of interest could include, 
among other things, working at the same institution as the applicant or 
collaborating with any person listed in a major role on the application.  
Following their self-assessment, reviewers must electronically sign a 
conflict-of-interest certification through NIHs online peer review system.  
Reviewers who do not sign the certification cannot submit critiques or 
scores for grant applications.  If reviewers identify conflicts with any 
applications, they are to notify their SROs and recuse themselves from 
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discussing those applications.  In some instances, reviewers are not 
permitted to attend the study section meeting at allfor instance, if they 
are named on a grant application in a major professional role or if they 
would receive a direct financial benefit if an application were funded.32 
NIH Offices Involved in Peer Review 
Several NIH offices participate in the management and oversight of 
the peer review process. 
The Center for Scientific Review (CSR) receives all grant applications 
submitted to NIH and determines whether the first round of review 
will be conducted by CSR or by an IC.  CSR reviews about 75 percent 
of the applications; ICs review the rest.  
The Office of Extramural Research (OER) oversees the integrity of 
the extramural peer review process and writes policies governing peer 
review operations, including the nondisclosure and conflict-of-interest 
certifications that peer reviewers must sign.33  OER is further charged 
with following up on most allegations of peer-review violations.34 
The Office of Management Assessment advises NIH on matters 
relating to program integrity and risk management and is NIHs 
central liaison to OIG and the FBI.  The Office of Management 
Assessment conducts internal risk assessments and investigates 
misconduct allegations, including those involving peer reviewers.35, 36 
 
Related Work  OIG has conducted two previous evaluations related to NIHs peer review 
process.  Most recently, in 2019, OIG evaluated the strengths and limitations 
of CSRs initial vetting of peer reviewer nominees.  OIG found that CSR 
focused its vetting on nominees scientific credentials and preventing undue 
influence generally, but did not specifically focus on preventing undue 
foreign influence.  OIG recommended that NIH, in consultation with national 
security experts, update its guidance on vetting peer reviewer nominees to 
identify potential foreign threats to research integrity and develop 
a risk-based approach for identifying nominees who warrant additional 
vetting.  NIH concurred with both recommendations.37  Also, in 2017, in 
response to a congressional request, OIG found that NIHs National Institute 
of Environmental Health Sciences (NIEHS) met the requirements of the peer 
review processes for funding on research related to bisphenol-A (BPA).  
However, we also found that for 14 percent of grants for BPA-related 
researchversus 4 percent of grants for research on other topicsNIH 
used its funding discretion to fund grant applications that had less favorable 
scores than competing applications.  OIG concluded that although NIEHS 
has discretion to fund grant applications with less favorable scores ahead of 
competing applications with higher scores, NIEHSs application of its 
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discretion frequently or disproportionately in one research area may invite 
scrutiny to its funding decisions.38 
Additionally, OIG has examined NIHs oversight of extramural researchers 
financial conflicts of interest.  OIG found that over the last decade, NIH has 
improved its tracking and review of researchers financial conflicts, but that 
additional actions would further strengthen its oversight of researchers 
conflicts and its monitoring of conflicts involving foreign interests.39  OIG 
recommended that NIH perform quality assurance reviews of the 
financial-conflict information and consider revising its financial-conflict 
review process to address concerns regarding foreign threats.  NIH 
concurred with both recommendations.  In a related report, OIG found that 
NIH has limited policies, procedures, and controls in place to help ensure 
that research institutions report all sources of support, financial interests, 
and affiliations.  OIG recommended that NIH enhance its financial-conflict 
monitoring to ensure that policies are publicly available and that it 
implement procedures to ensure that research institutions have 
financial-conflict policies.40  NIH also concurred with these 
recommendations. 
OIG is continuing to conduct oversight of NIH.  Ongoing OIG work includes 
examining NIHs process for assessing and overseeing risks associated with 
grant applications and recipients; conducting an inventory of NIHs 
information technology resources; and determining whether NIHs internal 
controls effectively prevent duplication of grant funding. 
Methodology 
Scope 
This report focuses on NIHs oversight policies and procedures in 2019 
related to protecting the confidentiality of grant applications handled by 
peer reviewers serving on study sections organized by CSR.  These study 
sections review about 75 percent of all NIH grant applications.  This report 
does not include first-level reviews that are organized by individual ICs 
(e.g., the National Cancer Institute) rather than by CSR; special emphasis 
panels; or the second level of grant application review.  Scientific and 
disease experts who are appointed as Special Government Employees 
largely conduct the second level of review.  This report also does not cover 
the initial screening of peer reviewer nominees, as that is addressed in 
another OIG report. 
Data Collection 
We requested from NIH its policies, procedures, and training materials 
governing and related to peer reviewer oversight in 2019.  Some of the 
procedures were specific to CSR, and some policieslike those from OER
applied to all of NIH.  We collected information regarding peer review 
policies and procedures already in effect, as well as policies and procedures 
that NIH plans to implement shortly. 
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We also interviewed staff at CSR and OER about how they oversee peer 
reviewers.  We interviewed five SROs; four Integrated Review Group Chiefs; 
the Research Integrity Officers at CSR and OER; and staff from the Office of 
the Director of CSR.  We interviewed SROs because they train peer 
reviewers, conduct study section meetings, and may identify suspicious 
activities by peer reviewers.  We interviewed Integrated Review Group 
Chiefs because they also may identify reviewers suspicious activities.  
Additionally, we interviewed NIH staff at OER, the Office of Management 
Assessment, and the Office of Federal Advisory Committee Policy about 
their roles in setting and implementing policy regarding the oversight of 
peer reviewers. 
Lastly, we collected information from NIH about its investigations of peer 
reviewers known or alleged to have disclosed confidential information from 
grant applications, as well as any enforcement actions that the agency has 
taken against peer reviewers who were found to have disclosed confidential 
information in grant applications. 
Data Analysis 
We analyzed the documents and interviews to identify NIHs approach to 
overseeing peer reviewers and the extent to which NIH considered undue 
foreign influence during its oversight. 
Limitations 
Our analysis relied on interviews, self-reported data, and documents 
provided by NIH staff.  We did not independently verify the data we 
received.  We also did not verify staffs compliance with NIH oversight 
policies. 
 
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. 
   
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FINDINGS 
NIH protects the  This report focuses on peer reviewers serving in study sections organized by 
NIHs CSR, which manages the first-level review process for 75 percent of 
confidentiality of 
NIH grants.  The rules that govern CSR study sections are formulated and/or 
the peer review 
executed by both CSR and NIHs OER.  Although these rules may also apply 
process through  to reviews conducted by study sections that are organized by NIH ICs, we 
efforts to prevent  limited this study to focus on policies and procedures that apply only to 
CSR. 
disclosures, identify 
NIH has policies and procedures to prevent peer reviewers in 
potential breaches, 
CSR-organized study sections from breaching confidentiality, to detect 
and take action 
breaches of confidentiality when they do occur, and to enforce 
against reviewers  consequences against violators.  Peer reviewers who breach confidentiality 
who disclose  by disclosing information from grant applications or associated materials
all of which is confidentialviolate NIHs core values of peer review 
confidential 
integrity. 
information 
NIH works to prevent breaches of confidentiality in the peer 
review process by requiring nondisclosure certifications, 
training reviewers to protect grant application information, 
and implementing technological safeguards  
NIH tries to prevent breaches of confidentiality by peer reviewers in three 
main ways.  First, NIH requires peer reviewers to electronically sign 
nondisclosure certifications before they can access application materials.  
Second, NIH provides training for peer reviewers to inform them of their 
responsibilities to protect information and report suspicious activity by other 
reviewers.  Third, NIH has introduced technological safeguards to increase 
the security of peer review systems.  
Nondisclosure certifications.  NIH requires reviewers to certify prior to each 
study section meeting that they agree not to disclose grant applications; 
meeting materials; or information discussed in the meeting, all of which is 
confidential.41, 42  When signing NIHs nondisclosure certification, reviewers 
must certify that they will not disclose confidential information, give 
nondesignated individuals access to materials, or use any information 
contained in an application for personal gain.43 
Training and guidance.  NIH provides training and guidance to peer 
reviewers regarding their responsibilities for maintaining confidentiality.  
Prior to each meeting, SROs hold teleconferences with peer reviewers about 
maintaining confidentiality and upholding other core values of review 
integrity.  These teleconferences are mandatory for new reviewers; existing 
reviewers are not required to attend.  In the teleconferences, SROs inform 
reviewers that they cannot share review materials, discussions, or scores and 
cannot discuss applications in the SROs absence.44  At the start of each 
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study section meeting, SROs remind reviewers of these policies in their 
opening remarks. 
NIH also created several informational documents on confidentiality and 
nondisclosure for peer reviewers, including a Guide Notice that outlines 
reviewers responsibilities.45  The Guide Notice reiterates peer reviewers 
responsibility to maintain confidentiality and articulates the consequences 
that reviewers may face if they breach confidentiality.  NIH instructs SROs to 
provide peer reviewers with a link to this Guide Notice if reviewers contact 
SROs with questions or concerns regarding the confidentiality of peer 
review. 
Finally, NIH reported that it is developing two new trainings for peer 
reviewersincluding one that will be publicly available on NIHs website
to help raise awareness about the confidentiality of grant applications that 
peer reviewers handle.  These trainings will include examples of breaches of 
the peer-review processs integrityincluding the disclosure of confidential 
informationthat range from the low-level to the egregious. 
Technological safeguards.  To protect the confidentiality of grant 
applications that peer reviewers handle, NIH has implemented several 
technological safeguards and is in the process of implementing at least one 
additional safeguard.  Currently, through its online peer review system, NIH 
blocks access to grant application materials for reviewers who have not 
electronically signed the nondisclosure certification.  The agency also blocks 
reviewers access to any grant application with which reviewers electronically 
reported a conflict.  NIH reports that in the future, it will also require 
reviewers to use two-factor authenticationi.e., to provide two pieces of 
information, such as a passcode and a verification codeto access grant 
application materials through the peer review system. 
NIH relies primarily on peer reviewers to identify and report 
potential breaches of confidentiality by other reviewers, but 
the agency is starting to employ technology to identify 
possible breaches 
NIH relies on peer reviewers to monitor each other because it would be 
difficult for the agency to directly oversee all of the thousands of reviewers 
whom it engages each year.  Additionally, NIH staff indicated that the 
agency relies on peer reviewers to monitor each other, stating that 
reviewers have a vested interest in ensuring that the review process is fair 
and in keeping application materials private because reviewers themselves 
generally have received NIH grants in the past or have active grants.  
Although NIH relies primarily on reviewers to report each other, it has also 
started to employ technological tools to identify possible breaches. 
Reporting suspicious activity.  Peer reviewers are uniquely positioned to 
identify suspicious or inappropriate behavior by other reviewers because 
they work closely with one another during study section meetings and may 
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know each other through their professional and scientific networks.  
However, NIHs trainings for peer reviewers do not currently include 
examples of suspicious or inappropriate behavior.  (NIH reported that it 
plans to add case studies to future peer reviewer trainings.)  NIH staff stated 
that instead, they encourage reviewers to report any suspicious activity, 
including possible breaches of confidentiality, by emphasizing a culture of 
If you see something, say something.  SROs reinforce this message to peer 
reviewers during their pre-meeting teleconferences and in their opening 
remarks for each study section meeting.  NIH encourages peer reviewers to 
report suspicious behavior to any NIH staff members involved in peer 
review, including reviewers own SROs, an Integrated Review Group Chief, or 
a Research Integrity Officer.  
NIH also trains SROs and Integrated Review Group Chiefs to report any 
suspicious activities by peer reviewers to a Research Integrity Officer.  SROs 
typically monitor reviewers behavior in study section meetings.  In some 
cases, Integrated Review Group Chiefs also may attend these meetings to 
watch reviewers behavior.  
NIH provides SROs with examples rather than clear definitions of 
suspicious or inappropriate activity or behavior that may indicate 
a breach of confidentiality by peer reviewers.  NIH staff reported that such 
a definition would include a long list of the many ways in which peer 
reviewers have breached confidentiality, and said that NIH cannot anticipate 
every possible way in which a reviewer could disclose confidential 
information.  NIH staff said that instead, the agency attempts to raise 
awareness that any suspicious activity should be reported.  For instance, in 
its trainings for SROs, NIH provides examples of inappropriate behavior by 
peer reviewers so that SROs may watch for these behaviors.   
NIH evaluates allegations before taking action against accused reviewers.  
According to NIH, when a peer reviewer reports suspicious activity, NIH staff 
report the allegation to a Research Integrity Officer.  The Research Integrity 
Officer gathers evidence from the accuser, which may include emails, 
voicemails, and text messages.  Research Integrity Officers store these 
allegations and supporting information in a case management system.  
When allegations involve violations of peer review integrity, NIH may 
request that the accused reviewers institution gather evidence (e.g., 
searching his or her work emails). 
Technological tool.  To supplement its reliance on peer reviewers, NIH is 
expanding a technological toolnamely, its Forensics Dashboardto help 
identify breaches of peer review integrity, including peer reviewers 
disclosure of confidential information.  NIH is further developing the 
Dashboard to facilitate fact-finding within the agency.  The Dashboard 
allows NIH staff to retrieve information from NIHs computer systems, such 
as the identities of reviewers who downloaded grant applications and other 
related documents, like scores and meeting notes, and the dates and times 
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they did so.  For example, NIH staff can view system logs in the Dashboard 
to quickly identify which reviewers accessed confidential information from 
a study section at the time of the breach.  Although NIH currently uses the 
Dashboard on a limited basis, it plans to use the Dashboard more widely 
and to make it more comprehensive.  NIH reported that it is also 
considering whether it is feasible to use the Dashboard to identify evidence 
of potential breaches in real time. 
NIH has taken a range of actions against peer reviewers found 
to have breached confidentiality 
OIGs analysis of NIH-provided data indicates that NIH has taken action 
against peer reviewers who breached confidentiality.  NIHs actions also 
have extended more broadly than a single reviewer. 
  As of November 2019, NIH had flagged 77 peer reviewers across 
both CSR- and IC-organized study sections as Do Not Use because 
of a breach of peer review confidentiality.46  A reviewer who is 
flagged as Do Not Use may not participate in further study section 
meetings or review future applications until the flag is removed. 
  Between February 2018 and November 2019, NIH terminated the 
service of 10 peer reviewers who not only had undisclosed foreign 
affiliations, but had also disclosed confidential information from 
grant applications.  For example, some of these reviewers shared 
critiques of grant applications with colleagues or shared their NIH 
account passwords with colleagues. 
  Between April 2018 and November 2019, NIH contacted more than 
70 institutions with concerns about possible undue foreign 
influence.  For 1 of these 70 institutions, NIH had concerns about 
possible undue foreign influence specifically among peer reviewers.  
NIH may communicate with peer reviewers institutions to discuss 
concerns or request that institutionsas reviewers employers
enforce additional consequences.  In response to NIHs 
communications, at least two institutions terminated the 
employment of faculty members found to have disclosed 
confidential information from grant applications while serving as 
peer reviewers.  Other institutions responded to NIHs concerns by 
temporarily prohibiting reviewers who had breached confidentiality 
from serving as principal investigators on NIH grants for a certain 
time. 
  Between January 2018 and November 2019, OIG received 
23 referrals from NIH that alleged that researchers had not 
complied with the terms and conditions of NIH's grants.  According 
to NIH, a majority of the agencys referrals include individuals who 
are actively serving as peer reviewers.  NIH also reported that two 
of its referrals involved reviewers who also breached the 
NIH Has Acted To Protect Confidential Information Handled by Peer Reviewers, But It Could Do More  11 
OEI-05-19-00240   
confidentiality of peer review.  NIH can refer peer reviewers to OIG 
or other law enforcement when it determines that cases warrant 
further investigation. 
  As of November 2019, NIH had referred one reviewer to the HHS 
Suspension and Debarment Official for that reviewer to be 
suspended or debarred across the Federal Government.  This 
referral occurred in October 2019.  An individual who is suspended 
or debarred cannot receive Federal funds, including NIH grants.  
NIH reported that it plans to refer additional individuals to the 
Suspension and Debarment Official. 
  As of November 2019, NIH dissolved two study sections because of 
evidence of systemic collusion among the reviewers in the section.  
At least one instance involved the disclosure of confidential 
information.  NIH dissolved the first study section in 2017 and the 
second in 2018.  All grant applications that the study sections 
reviewed were reassessed by different reviewers. 
Finally, NIH told us that if it observes that multiple confidentiality breaches 
originate with peer reviewers from the same institution, NIH may consider 
excluding that institution from future funding opportunities. 
 
NIH actively  Recognizing that undue foreign influence could lead peer reviewers to 
breach confidentiality, NIH has started to take steps to address it.  Undue 
responds to 
foreign influence in peer review could involve foreign entities encouraging 
instances of 
NIH peer reviewers to disclose confidential information.  NIH has learned of 
suspected undue  instances of undue foreign influence in peer review largely by following up 
foreign influence in  on intelligence from its national security partners or from NIH program staff 
working directly on the grants.  NIH has responded to these incidents on a 
peer review, but is 
case-by-case basis.  However, NIHs efforts to systemically address concerns 
in the early stages 
of undue foreign influence are more preliminary.  NIHs training materials 
of addressing it  about peer review currently include little information about undue foreign 
influence, and its planned revisions to these materials include only one 
systemically 
reference to this topic. 
NIH becomes aware of instances of potential undue foreign 
influence primarily from its national security partners and NIH 
staff 
One way NIH learns about instances of possible undue foreign influence is 
through its national security partners.  Since 2017, NIH has increasingly 
worked with the FBI on emerging foreign threats to NIH-funded research.  
NIH reported that in 2018, the FBI provided it with referrals of researchers
some of whom were also peer reviewerswho had NIH grants and were 
alleged to have undisclosed foreign affiliations.  NIH also works with other 
law enforcement agencies, such as the HHS Office of National Security, 
to address potential foreign threats.  The Office of National Security 
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OEI-05-19-00240   
provides guidance to HHS programs on intelligence, information security, 
and safeguarding classified information.47 
NIH also learns about instances of possible undue foreign influence through 
its staff.  Specifically, NIH Program Officers, who manage specific NIH 
grants, may notice affiliations or funding awards listed in a grantees 
publication that had not been disclosed to NIH as required by NIH policy.48  
For instance, program staff may notice that a grantees publication lists 
undisclosed foreign grants in addition to NIH funding.  NIH program staff 
then report these findings to NIHs OER, which conducts additional research.  
In these instances, OER staff may confirm through NIHs grant management 
systems that the grantee did not disclose the foreign affiliation and then 
determine how to follow up on the issue.  Additionally, NIH may receive 
allegations of possible undue foreign influence from anonymous 
complaints, grantee institutions, or peer reviewers. 
Once NIH learns of instances of possible undue foreign influence, it 
examines the allegations by further researching possible foreign affiliations.  
NIH reviews referralsfrom the FBI and other sourcesof researchers 
alleged to have undisclosed foreign affiliations.  As of November 2019, NIH 
determined that allegations against 207 researchers were potentially 
substantiated.  Of those 207 researchers, NIH determined that 129 had 
served as peer reviewers in 2018 and/or 2019.  NIH designated 47 of these 
129 peer reviewers as Do Not Use.  When OIG asked NIH about the 
remaining 82 peer reviewersi.e., those who had potentially substantiated 
allegations but who had not been designated as Do Not UseNIH did not 
respond. 
NIH has confirmed a small number of peer reviewer 
confidentiality breaches related to foreign influence 
Between February 2018 and November 2019, NIH confirmed 10 cases 
involving peer reviewers who were stealing or disclosing confidential 
information from grant applications or related materials and who also had 
undisclosed foreign affiliations.49  Two of these 10 cases involved peer 
reviewers who were selected for Chinas Thousand Talents program.  The 
breaches of confidentiality included disclosing scoring information, sharing 
study section critiques, and forwarding grant application information to 
third parties.  In some of these instances, reviewers shared confidential 
information with foreign entities.  NIH learned about these breaches from 
the FBI and from NIH staff, as well as through reports from grantee 
institutions and peer reviewers. 
NIH responded to these breaches of confidentiality by disciplining the 
involved peer reviewers.  NIH terminated the peer review service of the 
individuals involved in the 10 cases.  NIH also contacted the reviewers 
institutions to alert them to the allegations and gather further information 
about the reviewers.  NIH referred some cases to the Office of Management 
Assessment for further investigation.  In two cases, NIH dissolved a study 
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OEI-05-19-00240   
section and assembled a new study section with different reviewers to 
re-review the affected grant applications. 
NIH training materials about the peer review process rarely 
include information about undue foreign influence 
NIH has not systemically incorporated concerns about undue foreign 
influence into its oversight of peer reviewers.  NIHs training materials for 
peer reviewers and SROs rarely include discussions of undue foreign 
influence.  Currently, training materials specifically for peer reviewers do not 
cover undue foreign influence at all.  Additionally, training materials 
specifically for SROsthe NIH staff members responsible for managing the 
peer review processinclude only one discussion of foreign affiliation.  
Those training materials ask SROs to consider whether they should select a 
researcher who has academic appointments in both the United States and 
China to serve as a peer reviewer.50, 51  At the time of our data collection, no 
training materials for SROs included information about how to recognize 
signs of undue foreign influence among active peer reviewers.  NIH 
reported that it considers this to be outside the scope of SROs duties; 
indeed, the SROs whom we interviewed reported that they would not know 
how to identify possible undue foreign influence among peer reviewers. 
Although peer reviewers and SROs are not responsible for identifying undue 
foreign influence among reviewers, NIH staff indicated that the agency 
expects peer reviewers and SROs to be aware of emergent foreign threats 
to peer review.  NIH is trying to address this by updating its training 
materials for peer reviewers and SROs to raise awareness of potential undue 
foreign influence.  The revised training materials will include at least one 
example related to undue foreign influence among peer reviewers.   
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CONCLUSION AND RECOMMENDATIONS 
NIH places a high value on peer reviewers evaluating NIH grant applications 
in a fair, independent, and expert manner that is free of undue influence.  
Recently, the confidentiality of the peer review process has been 
compromised, putting the integrity of NIHs review of grant applications 
at risk.  A small number of peer reviewers are known to have violated peer 
review integrity by disclosing or stealing confidential information from grant 
applicationsin some cases, at the behest of foreign research institutions.  
This can put U.S. taxpayer-funded intellectual property at risk, undermine 
confidence in the integrity of peer review, and diminish NIHs reputation.  
To address some of these risks, NIH has been working with grantee 
institutions and national security partnerssuch as the HHS Office of 
National Security and Federal law enforcement (including the FBI and 
OIG)to address concerns about foreign threats to research integrity in 
other contexts, such as researchers who have active NIH awards and who 
fail to disclose their foreign financial interests as required.  NIH also has 
worked to better secure the systems that peer reviewers use when they 
access grant applications. 
We found that NIH has taken steps to try to prevent, detect, and respond to 
breaches of confidential information by peer reviewers; that it has worked 
with law enforcement and other entities to address instances of suspected 
undue foreign influence among peer reviewers; and that it is starting to 
incorporate concerns about undue foreign influence into its general 
oversight of peer reviewers.  However, we concluded that NIH can do more 
to systemically and directly address concerns about foreign threats to the 
confidentiality of the peer review process.  Previous OIG work that looked at 
NIHs vetting of peer reviewer nominees found similar resultsthat NIHs 
vetting process focuses on preventing undue influence generally, but not 
specifically on undue foreign influence. 
NIH has opportunities to strengthen its oversight of peer reviewers to 
further protect the confidential information in grant applications in two 
important ways: (1) enhancing training for peer reviewers and SROs and 
(2) developing a risk-based approach to target the agencys oversight of 
peer reviewers.  With a measured, risk-based approach, NIH can focus its 
oversight efforts on those circumstances or reviewers shown to pose the 
greatest risk to peer review integrity.  Therefore, we recommend that as 
NIHs approach to oversight of peer reviewers evolves, NIH should:  
Conduct targeted, risk-based oversight of peer reviewers using 
analysis of information about threats to research integrity 
NIH should conduct targeted oversight of peer reviewers using risk 
indicators identified from analysis of research integrity threats and peer 
NIH Has Acted To Protect Confidential Information Handled by Peer Reviewers, But It Could Do More  15 
OEI-05-19-00240   
review integrity violations.  To identify risk indicators to target its oversight, 
NIH first should analyze information about research integrity threats 
identified by law enforcement and national security partners as well as 
specific violations of peer review integrityincluding cases of confidentiality 
breaches related to possible foreign affiliationsand data from its Forensics 
Dashboard.  For example, if NIHs analysis indicates that grant applications 
containing particularly sensitive information or having highly lucrative 
commercial purposes pose greater risks to research integrity, NIH could 
target its oversight attention on peer reviewers reviewing those applications.  
As new cases are identified or as threats evolve, NIH should update and 
refine its risk indicators.  Using a risk-based approach to oversight would 
also address potential concerns about the burden of increasing oversight 
for the approximately 27,000 peer reviewers. 
Update its training materials routinely to include information 
about breaches of peer reviewer confidentiality and possible 
undue foreign influence 
NIH should routinely update its training materials for peer reviewers and 
SROs with the most relevant and up-to-date information about 
confidentiality breaches and undue foreign influence.  NIH should include 
relevant information from newly identified cases and/or the results of its 
analysis of Forensics Dashboard data.  At the time of our data collection, 
NIHs training materials for peer reviewers included information about 
maintaining confidentiality but did not include any sample scenarios of 
undue foreign influence.  NIH reported that it is in the process of updating 
its peer reviewer training materials to include at least one scenario of undue 
foreign influence.  We encourage NIH to follow through on this update, 
and, to ensure that its trainings are updated regularly, NIH should establish 
a policy or procedures outlining how often and under what circumstances 
it will update its training materials. 
Require all peer reviewers to attend periodic trainings about 
peer review integrity 
NIH should require all peer reviewers to attend periodic trainings that 
convey the most relevant and up-to-date information about confidentiality 
breaches and undue foreign influence.  NIH currently requires only new 
peer reviewers to attend a training, but NIH should instead require all 
reviewers to attend periodic trainings that remind them of their 
responsibilities to ensure the integrity of the peer review process.  NIH 
should determine how frequently such trainings for all peer reviewers 
should occur.  For example, NIH could require all peer reviewers to attend 
an annual training that includes the most recent, relevant information. 
   
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OEI-05-19-00240   
Consult with Federal law enforcement and national security 
experts to determine what additional steps it might take to 
identify and address potential risks to the confidentiality of the 
peer review process, including possible undue foreign influence 
NIH has already collaborated with Federal law enforcement and national 
security partners to respond to instances of undue foreign influence in peer 
review.  NIH should continue to consult law enforcement or national 
security partners to bolster its efforts and to support a risk-based approach 
to oversight in this area.  As part of this consultation, NIH should specifically 
seek advice from law enforcement and national security experts about 
identifying and mitigating peer review risks.  For example, NIH could work 
with law enforcement and national security experts to identify potential red 
flags that could indicate undue foreign influence in the peer review process.   
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OEI-05-19-00240   
AGENCY COMMENTS AND OIG RESPONSE 
NIH concurred with all four of our recommendations. 
In response to our first recommendation, NIH stated that it is coordinating 
with Federal partners to explore approaches to conduct targeted, risk-based 
oversight of peer reviewers using analysis of information about threats to 
research integrity and peer review.  NIH also said that it will provide OIG 
with an action plan to address this recommendation. 
In response to our second recommendation, NIH stated that it has released 
a series of reports and case studies about maintaining integrity in peer 
review and provided links to the blog posts in which it did so.  NIH added 
that it will continue to assess its training materials for peer reviewers three 
times a year.  NIHs actions are encouraging, and we recommend that when 
NIH next assesses its training materials for peer reviewers, it should 
incorporate the concepts from its blog posts into the training materials to 
raise awarenessamong all peer reviewersof possible threats to the 
integrity of peer review. 
Regarding our third recommendation, NIH reported that CSR has 
developed a new online training module about peer review integrity.  
Additionally, NIH stated that by April 2020, OER will revise instructions for 
peer reviewers about protecting the security of NIH grant applications.  We 
believe these are positive steps.  However, NIHs new online training module 
does not address undue foreign influence.  Therefore, we continue to 
recommend that NIH require all peer reviewersnot only new peer 
reviewersto take periodic trainings that provide the most relevant and 
up-to-date information about confidentiality breaches and undue foreign 
influence. 
In response to our fourth recommendation, NIH stated that it is working 
with Federal partners to develop a systematic, risk-based, data-driven 
approach to identifying peer reviewer nominees who warrant additional 
scrutiny.  These actions address concerns about peer reviewer nominees, 
but they do not address concerns about the oversight of existing peer 
reviewers or about the integrity of the peer review process as a whole.  We 
continue to recommend that NIH consult Federal law enforcement and 
national security partners to identify and address potential risks to the 
confidentiality of the peer review process, including possible undue foreign 
influence. 
For the full text of NIHs comments, see the Appendix. 
   
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APPENDIX A: Agency Comments 
 
 
 
 
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ACKNOWLEDGMENTS 
Melissa Baker served as the team leader for this study.  Others in the Office 
of Evaluation and Inspections who conducted the study include 
Lauren Anderson, Sarah Vogel, and Abigail Wydra.  Office of Evaluation and 
Inspections staff who provided support include Clarence Arnold, 
Christine Moritz, and Melicia Seay. 
We would also like to acknowledge the contributions of other Office of 
Inspector General staff, including Matt Blackburn, Joyce M. Greenleaf, 
Shakye Jones, Diana Merelman, Kenneth R. Price, Geeta Taylor, and 
Ivan Troy. 
This report was prepared under the direction of Laura Kordish, Regional 
Inspector General for Evaluation and Inspections in the Chicago regional 
office; and Kelly Waldhoff, 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-05-19-00240   
ENDNOTES 
1 Department of Defense and Labor, Health and Human Services, and Education Appropriations Act of 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, pp. 531-532. 
3 Ibid, p. 532. 
4 OIG, Vetting Peer Reviewers at NIHs Center for Scientific Review: Strengths and Limitations, OEI-01-19-00160, 
September 2019. 
5 NIH, Statement on Protecting the Integrity of U.S. Biomedical Research, August 23, 2018.  Accessed at 
https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-protecting-integrity-us-biomedical-
research on June 6, 2019. 
6 NIH, Letter to grantee institutions, August 20, 2018.  Accessed at https://www.research.ucla.edu/ora/wp-
content/uploads/nih-letter-francis-collins-2018-08-20.pdf on August 21, 2019. 
7 NIH Advisory Committee to the Director (ACD), ACD Working Group for Foreign Influences on Research Integrity: 
December 2018 Report, p. 6-7.  Accessed at 
https://acd.od.nih.gov/documents/presentations/12132018ForeignInfluences_report.pdf on August 9, 2019. 
8 Senator Charles Grassley, Chair, Senate Committee on the Judiciary, letter to Dr. Francis Collins, October 23, 2018.  
Accessed at https://www.grassley.senate.gov/sites/default/files/constituents/2018-10-
23%20CEG%20to%20NIH%20(Research%20Threats).pdf on February 14, 2019. 
9 Association of American Medical Colleges, NIH Describes for Senate Panel Efforts to Protect Research Integrity, 
August 24, 2018.  Accessed at 
https://www.aamc.org/advocacy/washhigh/highlights2018/490948/082418nihdescribesforsenatepaneleffortstoprotect
researchintegrit.html on February 14, 2019. 
10 Testimony of Dr. Lawrence A. Tabak, Principal Deputy Director, NIH, before Senate Committee on Finance, June 5, 
2019, p. 3.  Accessed at https://www.finance.senate.gov/imo/media/doc/05JUN2019TabakSMNT.pdf on June 20, 2019. 
11 Ibid, p. 7. 
12 NIH, Letter to grantee institutions, August 20, 2018.  (See Endnote 6 for URL information.) 
13 Jia, Hepeng, What is Chinas Thousand Talents Plan?  Accessed at https://www.nature.com/magazine-
assets/d41586-018-00538-z/d41586-018-00538-z.pdf on June 20, 2019. 
14 NIH, Foreign Influences on Research Integrity: 117th Meeting of the Advisory Committee to the Director, December 13, 
2018, slides 2 and 4.  Accessed at https://acd.od.nih.gov/documents/presentations/12132018ForeignInfluences.pdf.  
Accessed on June 20, 2019. 
15 NIH, Grants Policy Statement, October 2018,  2.4, p. I-67I-68.  Accessed at 
https://grants.nih.gov/grants/policy/nihgps/nihgps.pdf on July 9, 2019. 
16 NIH, Statement on Protecting the Integrity of U.S. Biomedical Research, August 23, 2018.  (See Endnote 5 for URL 
information.) 
17 NIH, Maintaining Confidentiality in NIH Peer Review, Guide Notice NOT-OD-14-073, March 28, 2014.  Accessed at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-073.html on January 17, 2019. 
18 Testimony of Dr. Lawrence A. Tabak, Principal Deputy Director, NIH, before Senate Committee on Finance, June 5, 
2019, p. 4-5.  (See Endnote 10 for URL information.) 
19 NIH Advisory Committee to the Director, ACD Working Group for Foreign Influences on Research Integrity: December 
2018 Report.  (See Endnote 7 for URL information.) 
20 Testimony of Captain Michael Schmoyer, Assistant Deputy Secretary for National Security, Director, Office of 
National Security, before Senate Committee on Finance, June 5, 2019, p. 6-7.  Accessed at 
https://www.finance.senate.gov/imo/media/doc/05JUN2019SchmoyerSMNT.pdf on August 13, 2019. 
 
NIH Has Acted To Protect Confidential Information Handled by Peer Reviewers, But It Could Do More  23 
OEI-05-19-00240   
 
21 Testimony of Dr. Lawrence A. Tabak, Principal Deputy Director, NIH, before Senate Committee on Finance, June 5, 
2019, p. 5.  (See Endnote 10 for URL information.) 
22 NIH, Peer Review: Grants and Cooperative Agreements, 2019, p. 3.  Accessed at 
https://grants.nih.gov/grants/peerreview22713webv2.pdf on June 5, 2019. 
23 NIH, Grants Policy Statement, October 2018,  2.3, p. I-72.  (See Endnote 15 for URL information.) 
24 Ibid, p. I-73. 
25 NIH, CSR Advisory Council Update, September 2018, slide 11.  Accessed at 
https://public.csr.nih.gov/AboutCSR/Organization/CSRAdvisoryCouncil/Presentations on January 2, 2020. 
26 Ibid,  2.4.1.3, p. I-69. 
27 Ibid. 
28 NIH, How Scientists are Selected to Be Members of a Chartered Review Group.  Accessed at 
https://public.csr.nih.gov/ForReviewers/BecomeAReviewer/CharteredReviewers on January 25, 2019. 
29 NIH, New Process for Reimbursement of NIH Peer Reviewers, Guide Notice NOT-OD-05-062, August 5, 2005.  
Accessed at https://grants.nih.gov/grants/guide/notice-files/not-od-05-062.html on July 10, 2019. 
30 NIH, Peer Review: Grants and Cooperative Agreements, 2019, p. 3.  (See Endnote 22 for URL information.) 
31 OIG, Vetting Peer Reviewers at NIHs Center for Scientific Review: Strengths and Limitations, OEI-01-19-00160, 
September 2019. 
32 NIH, Conflict of Interest Rules, October 2018.  Accessed at 
https://grants.nih.gov/grants/peer/NIH_Conflict_of_Interest_Rules.pdf.  on July 30, 2019. 
33 NIH, About the Office of Extramural Research at NIH, November 9, 2017.  Accessed at 
https://grants.nih.gov/aboutoer/intro2oer.htm on August 22, 2019. 
34 NIH Advisory Committee to the Director (ACD), ACD Working Group for Foreign Influences on Research Integrity: 
December 2018 Report, p. 10.  (See Endnote 7 for URL information.) 
35 NIH, About OMA. Accessed at https://oma.od.nih.gov/Pages/About-OMA.aspx on July 25, 2019. 
36 NIH, About the Division of Program Integrity.  Accessed at https://oma.od.nih.gov/DPI/Pages/Home.aspx on 
August 22, 2019. 
37 OIG, Vetting Peer Reviewers at NIHs Center for Scientific Review: Strengths and Limitations, OEI-01-19-00160, 
September 2019. 
38 OIG, As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its 
Discretion, OEI-01-15-00150, August 2017. 
39 OIG, NIH Has Made Strides in Reviewing Financial Conflicts of Interest in Extramural Research, But Could Do More, 
OEI-03-19-00150, September 2019. 
40 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. 
41 NIH, Policy Manual 4204-240bPeer Review Process (document provided to OIG), pp. 29-30. 
42 NIH, NIH Confidentiality and Nondisclosure Rules: Information for Reviewers of NIH Grant Applications and R&D 
Contract Proposals, July 2015.  Accessed at 
https://grants.nih.gov/grants/peer/guidelines_general/Confidentiality_CertificationsPR.pdf on July 17, 2019. 
43 Ibid. 
44 NIH, CSR Core Reviewer Training Slides (document provided to OIG), slide 3, August 19, 2017. 
45 NIH, Maintaining Integrity in NIH Peer Review: Responsibilities and Consequences, Guide Notice NOT-OD-18-115, 
December 22, 2017.  Accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-115.html on August 21, 
2019. 
46 NIH may designate a reviewer as Do Not Use for reasons unrelated to NIH policy violations (e.g., if the reviewer is 
taking an extended leave).  
47 U.S. Department of Health and Human Services, Office of National Security (ONS), February 25, 2019.  Accessed at 
https://www.hhs.gov/about/agencies/staff-divisions/immediate-office-secretary/ons/index.html on October 29, 2019. 
48 NIH, Grants Policy Statement, October 2018,  2.5.1, p. I-74.  (See Endnote 15 for URL information.) 
 
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OEI-05-19-00240   
 
49 Because of data limitations, NIH did not provide OIG with information on the total number of breaches of peer 
reviewer confidentiality.  NIH provided OIG only with information on the number of breaches of peer reviewer 
confidentiality that were also related to undisclosed foreign affiliations. 
50 NIH, SRO Training, Integrity in Peer Review: Front Line Success (document provided to OIG), slides 29-31, January 31, 
2019. 
51 In the training, NIH advises that all reviewers are to serveat the discretion of the SROunless they have been 
designated Do Not Use. 
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OEI-05-19-00240   
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 
Services 
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 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 Inspections 
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.   
Office of  The Office of Investigations (OI) conducts criminal, civil, and 
administrative investigations of fraud and misconduct related to HHS 
Investigations 
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. 
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 
the Inspector 
and operations and providing all legal support for OIGs internal 
General 
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.