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<h1><strong><span class="field field--name-title field--type-string field--label-hidden">Integrity and Confidentiality in NIH Peer Review </span>
</strong></h1>
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<div class="field__label visually-hidden">Scope Note</div>
<div class="field__item"><p>Every stakeholder and participant in the NIH peer review process—researcher, reviewer, institutional officials, and NIH staff—shares responsibility in maintaining and upholding the integrity of review.&nbsp;</p></div>
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</style><!--header3 or 4.cfm reference gone--><!---CONTENT AREA START---><p>Maintaining confidentiality throughout the peer review process is essential to allow for the candid exchange of scientific opinions and evaluations; and to&nbsp;protect trade secrets, commercial or financial information, and information that is privileged or confidential. NIH has multiple safeguards to protect the integrity of and to maintain confidentiality in peer review. See Guide Notice&nbsp;<a href="/grants/guide/notice-files/NOT-OD-22-044.html">NOT-OD-22-044</a>.</p><p><span>NIH understands that some professional interactions between applicants and reviewers often continue while an application is undergoing peer review, but discussions or exchanges that involve the review of that application are not allowed.</span></p><h2 id="Reviewers">Reviewers</h2><h3 id="prohibitions">Prohibitions</h3><p>Confidentiality in NIH peer review <em><strong>prohibits </strong></em>a peer reviewer&nbsp;member from:</p><ul><li>Sharing applications, proposals, or meeting materials with anyone who has not been officially designated to participate in the peer review process.</li><li>Granting access to any NIH secure computer system or advisory committee meeting to anyone who has not been officially designated to participate in the peer review process .</li><li>Disclosing, in any manner, information about the committee deliberations, discussions, evaluations, or documents to anyone who has not been designated to participate in the peer review process or who has a declared conflict of interest.</li><li>Using information contained in an application or proposal for his/her personal benefit or making such information available for the personal benefit of any other individual or organization.</li><li>Disclosing procurement information prior to the award of a contract.</li><li>Participating in NIH peer review without signing a confidentiality certification.</li></ul><h3 id="cert">Signing Certification</h3><p>Reviewers must sign, under penalty of perjury, 18 U.S.C. §1001, a confidentiality certification before gaining access to applications, proposals, and meeting materials.</p><ul><li>See the screenshot of the <a href="http://era.nih.gov/images/confidentiality_button.png">Confidentiality Agreement</a> screen in the Internet Assisted Review (IAR) module.</li></ul><p><a href="https://www.gpo.gov/fdsys/pkg/USCODE-2011-title18/html/USCODE-2011-title18-partI-chap47-sec1001.htm">18 USC § 1001</a> states:</p><p>"Except as otherwise provided in this section, whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully—</p><div style="margin-left:50px;"><!--OldBlockquote--><p>(1) falsifies, conceals, or covers up by any trick, scheme, or device a material fact;<br>(2) makes any materially false, fictitious, or fraudulent statement or representation; or<br>(3) makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry;</p></div><!--OldBlockquote--><p>shall be fined under this title, imprisoned not more than 5 years or, if the offense involves international or domestic terrorism (as defined in section 2331), imprisoned not more than 8 years, or both."</p><h3 id="consequences">Consequences</h3><p><span lang="EN">If NIH determines that a situation involves a breach of confidentiality in the peer review process on the part of a reviewer, the NIH may:</span></p><ul><li>notify the reviewer in question and/or his institutional Research Integrity Officer or other similar, senior, institutional official.</li><li>terminate the reviewer's term of service in peer review.</li><li>refer the matter to the NIH Office of Management Assessment and possibly to the Department of Health and Human Services Office of the Inspector General.</li><li>Pursue a referral for government-wide suspension or debarment.</li></ul><h2 id="Applicants">Applicants</h2><h3 id="applprohibitions">Prohibitions</h3><p>An official of an applicant institution, Program Director/Principal Investigator (PD/PI), or individual named in an application (or “applicants”), unless contacted by a government official:</p><ul><li>Should <em><strong>not</strong></em> contact reviewers on the study section evaluating his or her application to request or provide information about the review or to otherwise attempt to influence the outcome of the review or the reviewer(s).&nbsp; The only acceptable process for such communication is through the Scientific Review Officer (SRO) who is managing the study section.</li><li>Should <em><strong>not</strong></em> send information or data directly to a reviewer on the study section evaluating his or her application.&nbsp; The only acceptable processes for submitting post-submission materials are outlined in <a href=" /grants/guide/notice-files/NOT-OD-19-083.html">NOT-OD-19-083</a>, <a href="/grants/guide/notice-files/NOT-OD-12-141.html">NOT-OD-</a><a href="/grants/guide/notice-files/NOT-OD-23-106.html">23-106</a>, and related notices.</li><li>Should <em><strong>not</strong></em> attempt to access information related to the review of that application in secure NIH computer systems.</li></ul><p>An official of an applicant institution, PD/PI, or individual named in an application who is contacted by a reviewer for purposes of obtaining or exchanging information outside of the channels described above <em><strong>should</strong></em> contact the SRO who is managing the review of his or her application.</p><h3 id="applconsequences">Consequences</h3><p>Depending on the specific circumstances, the NIH may take additional steps to ensure the integrity of the peer&nbsp;review process, including but not limited to:</p><ul><li>notifying or requesting information from the applicant institution or the individuals institution.</li><li>pursuing a referral for government-wide suspension or debarment</li><li>notifying the NIH Office of Management Assessment with possible referral to the U.S. Department of Health and Human Services Office of Inspector General.</li></ul></div>
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<div class="clearfix text-formatted field field--name-field-body-2 field--type-text-long field--label-hidden field__item"><h2>Applicable Laws and Regulations</h2>
<table class="h-100" data-ds-id="jyy8ojkr">
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<td><i class="bi bi-1-circle h2"></i></td>
<td class="ps-4"><strong class="h4">Privacy</strong></td>
</tr>
<tr class="h-100">
<td class="h-100 py-1">
<div class="bg-opacity-25 bg-primary h-100 mx-auto w-25">&nbsp;</div>
</td>
<td class="ps-4">
<p>The Privacy Act specifies that no agency shall disclose any record which is contained in a system of
records, such as NIH Systems Listing <a
href="https://oma.od.nih.gov/forms/Privacy%20Documents/PAfiles/0036.htm"
target="_blank">09-025-0036</a> (which contains NIH grant applications, summary statements,
R&amp;D contract proposals and related documents), by any means of communication to any person, or
to another agency, except pursuant to a written request by, or with the prior written consent of,
the individual to whom the record pertains, unless certain conditions apply. Agencies may disclose
Privacy Act records to employees (including Special Government Employees) of the agency which
maintains the record who have a need for the record in the performance of their duties. Disclosures
may also be made pursuant to a routine use identified in the applicable System of Records Notice.
Systems Listing <a href="https://oma.od.nih.gov/forms/Privacy%20Documents/PAfiles/0036.htm"
target="_blank">09-025-0036</a> provides for routine use disclosures to peer reviewers of grant
applications and contract proposals as follows: "to qualified experts not within the definition of
Department employees as prescribed in Department regulations for opinions as a part of the
application review process."</p>
<p>The Privacy Act also prohibits employees of an agency (including Special Government Employees), who
by virtue of their employment, have possession of, or access to Privacy Act protected records, from
willfully disclosing the material in any manner to any person not entitled to receive it.</p>
</td>
</tr>
<tr>
<td><i class="bi bi-2-circle h2"></i></td>
<td class="ps-4"><strong class="h4">Meeting Access</strong></td>
</tr>
<tr class="h-100">
<td class="h-100 py-1">
<div class="bg-opacity-25 bg-primary h-100 mx-auto w-25">&nbsp;</div>
</td>
<td class="ps-4">Many NIH advisory committee meetings are closed or partially closed to the public under the
Government
in the Sunshine Act, <a href="https://www.gpo.gov/fdsys/pkg/USCODE-2011-title5/pdf/USCODE-2011-title5-partI-chap5-subchapII-sec552b.pdf" target="_blank">5
U.S.C. § 552b</a> <i class="bi bi-file-earmark-pdf-fill"></i></td>
</tr>
<tr>
<td><i class="bi bi-3-circle h2"></i></td>
<td class="ps-4"><strong class="h4">Procurement Integrity</strong></td>
</tr>
<tr class="h-100">
<td>
<div class="bg-opacity-25 bg-primary h-100 mx-auto w-25">&nbsp;</div>
</td>
<td class="ps-4">The <a href="https://www.acquisition.gov/" target="_blank">Federal Acquisitions
Regulation</a> (FAR) is
the primary regulation for use by all Federal Executive agencies in their acquisition of supplies and
services with appropriated funds, and governs the NIH's procurement of research and development through
R&amp;D contracts. According to <a href="https://www.acquisition.gov/far/3.104-3"
target="_blank">Section 3.104-3</a> "Statutory and Related Prohibitions, Restrictions, and
Requirements" of the FAR, a person who is advising or has advised the United States with respect to, a
Federal agency procurement must not, other than as provided by law, knowingly disclose contractor bid or
proposal information or source selection information before the award of a Federal agency procurement
contract to which the information relates. (See <a href="https://www.acquisition.gov/far/3.104-4"
target="_blank">Section 3.104.4</a>). Criminal and civil penalties, and administrative remedies, may
apply to conduct which violates the Act (see <a href="https://www.acquisition.gov/far/3.104-3"
target="_blank">3.104-3</a>)."</td>
</tr>
<tr>
<td><i class="bi bi-4-circle h2"></i></td>
<td class="ps-4"><strong class="h4">Confidentiality Agreements</strong></td>
</tr>
<tr class="h-100">
<td class="h-100 py-1">
<div class="bg-opacity-25 bg-primary h-100 mx-auto w-25">&nbsp;</div>
</td>
<td class="ps-4">
<p>When signing the Confidentiality Agreements, each peer reviewer agrees, under penalty of perjury, 18
U.S.C. §1001, to maintain confidentiality in peer review. <a href="https://www.gpo.gov/fdsys/pkg/USCODE-2011-title18/html/USCODE-2011-title18-partI-chap47-sec1001.htm" target="_blank">18 U.S.C. § 1001</a> states:</p>
<div class="card" data-ds-id="pb43iac5">
<div class="card-body">
<p class="card-text">"Except as otherwise provided in this section, whoever, in any matter
within the jurisdiction of the executive, legislative, or judicial branch of the Government
of the United States, knowingly and willfully—</p>
<ol>
<li>falsifies, conceals, or covers up by any trick, scheme, or device a material fact;</li>
<li>makes any materially false, fictitious, or fraudulent statement or representation; or
</li>
<li>makes or uses any false writing or document knowing the same to contain any materially
false, fictitious, or fraudulent statement or entry;</li>
</ol>
<p>shall be fined under this title, imprisoned not more than 5 years or, if the offense involves
international or domestic terrorism (as defined in section 2331), imprisoned not more than 8
years, or both."</p>
</div>
</div>
</td>
</tr>
<tr>
<td><i class="bi bi-5-circle h2"></i></td>
<td class="ps-4"><strong class="h4">Federal Employees</strong></td>
</tr>
<tr class="h-100">
<td class="h-100 py-1">&nbsp;</td>
<td class="ps-4">
<p>Federal employees involved in peer review, including NIH employees, Federal employees serving as
reviewers or Council members, and Special Government Employees (SGEs) are subject to:</p>
<ul>
<li>The <a href="https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635"
target="_blank">Standards of Ethical Conduct for Employees of the Executive Branch</a> <i
class="bi bi-file-earmark-pdf-fill"></i> (5 C.F.R. 2635), which state that an employee has a
duty to protect and conserve Government property and to not use such property, or allow its use,
for other than authorized purposes. Government property in this context includes Government
records. 5 C.F.R. 2635.704. Employees are also prohibited from using nonpublic information, or
allowing the improper use of nonpublic information, to further their own private interests or
that of another, whether through advice or recommendation, or by knowing unauthorized
disclosure. Non-public information includes confidential information gained in peer review. 5
C.F.R. 2635.703. Appropriate corrective or disciplinary action may be taken under applicable
Government wide regulations or agency procedures, for a violation. <a
href="https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635/subpart-A/section-2635.106"
target="_blank">5 C.F.R. 2635.106</a> <i class="bi bi-file-earmark-pdf-fill"></i></li>
<li>The Privacy Act, which, as discussed above, prohibits employees from willfully disclosing
Privacy Act records in any manner to any person not entitled to receive it. Violations may be
subject to criminal penalties, including fines of not more than $5,000. <a
href="http://www.law.cornell.edu/uscode/text/5/552a" target="_blank">5 U.S.C. Sec.
552a(i)</a>.</li>
<li>The Trade Secrets Act (<a href="https://www.gpo.gov/fdsys/pkg/USCODE-2010-title18/html/USCODE-2010-title18-partI-chap93-sec1905.htm" target="_blank">Title
18, U.S.C., Sec. 1905</a>), which provides that an employee of an United States agency who
publishes, divulges, discloses, or makes known information that comes to him in the course of
his employment or official duties and concerns or relates to trade secrets, processes,
operations, style of work, or apparatus, or to the identity, confidential statistical data,
amount or source of any income, profits, losses, or expenditures of any person, firm,
partnership, corporation, or association shall be fined, or imprisoned not more than one year,
or both; and shall be removed from office or employment.</li>
</ul>
</td>
</tr>
</tbody>
</table></div>
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I thought you might be interested.\n\/learning-center\/conference \n#NIHgrantsconf \nTwitter: @NIHgrants \nLinkedIn: National Institutes of Health Office of Extramural Research"},"registration":{"label":"Register","link":null,"closed":true},"hostedBy":{"label":"Office of Extramural Research (OER)","code":"OER"},"hostedByOther":null,"objective":"<p>During this event, participants will learn about:<\/p><ul><li>Public Health Service (PHS) Regulations on handling research misconduct allegations;<\/li><li>Responsibilities of an institution receiving PHS funds;<\/li><li>Red flags that may help to avoid misconduct in research.<\/li><\/ul>","audience":null,"scope":null,"sections":[{"id":"5a244c18-a9c4-4a21-9ddc-90779f156281","title":"Past PreCon Events","body":"<ul><li>Aug. 25&nbsp;&nbsp; <a href=\"https:\/\/grants.nih.gov\/learning-center\/conference\/precon-events\/loan-repayment-programs\">NIH Loan Repayment Programs: Supporting the Next Generation of Researchers<\/a><\/li><li>Sept. 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I thought you might be interested.\n\/learning-center\/conference \n#NIHgrantsconf \nTwitter: @NIHgrants \nLinkedIn: National Institutes of Health Office of Extramural Research"},"registration":{"label":"Register","link":null,"closed":true},"hostedBy":{"label":"Office of Extramural Research (OER)","code":"OER"},"hostedByOther":null,"objective":"<p>During this event, participants will learn about:<\/p><ul><li>Public Health Service (PHS) Regulations on handling research misconduct allegations;<\/li><li>Responsibilities of an institution receiving PHS funds;<\/li><li>Red flags that may help to avoid misconduct in research.<\/li><\/ul>","audience":null,"scope":null,"sections":[{"id":"5a244c18-a9c4-4a21-9ddc-90779f156281","title":"Past PreCon Events","body":"<ul><li>Aug. 25&nbsp;&nbsp; <a href=\"https:\/\/grants.nih.gov\/learning-center\/conference\/precon-events\/loan-repayment-programs\">NIH Loan Repayment Programs: Supporting the Next Generation of Researchers<\/a><\/li><li>Sept. 15&nbsp; <a href=\"https:\/\/grants.nih.gov\/learning-center\/conference\/precon-events\/early-career-funding\">Navigating Early Career Funding Opportunities<\/a><\/li><li>Nov. 9&nbsp;&nbsp; <a href=\"https:\/\/grants.nih.gov\/learning-center\/conference\/precon-events\/international-collaborations\">International Collaborations: Policies, Processes, &amp; Partnerships<\/a><\/li><li>Dec. 6 &amp; 7&nbsp;<a href=\"https:\/\/grants.nih.gov\/learning-center\/conference\/precon-events\/human-subjects-research\">Human Subjects Research: Policies, Clinical Trials, &amp; Inclusion<\/a><\/li><\/ul>"}],"resourcesVisibility":"V","seeAlso":"<p><strong>Websites:<\/strong><\/p><ul><li><a href=\"https:\/\/researchtraining.nih.gov\/\">Welcome to Research Training<\/a><\/li><li><a href=\"https:\/\/ori.hhs.gov\/\">HHS Office of Research Integrity<\/a><\/li><li><a href=\"https:\/\/grants.nih.gov\/policy\/research-integrity.htm\">NIH Office of Research Integrity<\/a><\/li><\/ul><p><strong>Podcasts:<\/strong><\/p><ul><li><a href=\"https:\/\/grants.nih.gov\/podcasts\/All_About_Grants\/episodes\/Podcast-Confidentiality-in-Peer-Review.mp3\">Maintaining Confidentiality in Peer Review<\/a><\/li><li><a href=\"https:\/\/grants.nih.gov\/podcasts\/All_About_Grants\/episodes\/Podcast%20-%20COI%20in%20Peer%20Review%20-%202019-10-25.mp3\">Managing Conflicts of Interest in Peer Review<\/a><\/li><li><a href=\"https:\/\/nexus.od.nih.gov\/all\/2020\/09\/15\/new-all-about-grants-podcast-research-misconduct\/\">Research Misconduct<\/a><\/li><li><a href=\"https:\/\/grants.nih.gov\/news\/virtual-learning\/podcasts.htm\">All About Grants Podcasts<\/a><\/li><\/ul><p><strong>Documents:<\/strong><\/p><ul><li><a href=\"https:\/\/grants.nih.gov\/policy\/research-misconduct\/index\">Research Misconduct<\/a><\/li><li><a href=\"http:\/\/ori.hhs.gov\/ORI_PHS_alert.html\">PHS Administrative Action Bulletin Board<\/a><\/li><li><a href=\"http:\/\/ori.hhs.gov\/case_summary\">PHS Research Misconduct Case Summaries<\/a><\/li><li><a href=\"https:\/\/grants.nih.gov\/grants\/peerreview22713webv2.pdf\">NIH Peer Review: Grants and Cooperative Agreements<\/a><\/li><li><a href=\"https:\/\/nexus.od.nih.gov\/all\/2019\/06\/25\/breaches-of-peer-review-integrity\/\">Open Mike Blog:<\/a>&nbsp;Breaches of Peer Review Integrity<\/li><li><a href=\"https:\/\/nexus.od.nih.gov\/all\/2018\/11\/15\/working-together-to-protect-the-integrity-of-nih-funded-research\/\">Open Mike Blog:<\/a>&nbsp;Working Together to Protect the Integrity of NIH-funded Research<\/li><\/ul>","agenda":[{"id":"aef0d1d0-74e4-42b7-a177-e9490fc2494b","title":"ORI & NIH Case Studies: What Do You Think?","body":"<p><strong>Presenter:&nbsp;<\/strong>Patricia Valdez, Ph.D.<\/p><p>Chief Extramural Research Integrity Officer<\/p><p>Office of Extramural Research (OER), NIH<\/p><p><strong>Presenter:&nbsp;<\/strong>Ranjini Ambalavanar, Ph.D.<\/p><p>Scientist 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<p>NIH also addresses the following topics as part of our efforts to foster a culture of research integrity:</p><ul><li><a href="/policy-and-compliance/policy-topics/foreign-interference">Foreign Interference Integrity</a></li><li><a href="/policy-and-compliance/policy-topics/harassment">Harassment, Discrimination, and Other Forms of Inappropriate Conduct</a></li><li><a href="https://oma.od.nih.gov/DPI/Pages/Allegations.aspx" target="_blank">Fraud, Abuse, Waste and Misconduct</a></li></ul>
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