[Federal Register Volume 89, Number 203 (Monday, October 21, 2024)]
[Notices]
[Pages 84166-84180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24225]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Final Scientific Integrity Policy of the National Institutes of 
Health

AGENCY: National Institutes of Health, HHS.

ACTION: Notice of final policy.

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SUMMARY: The National Institutes of Health (NIH) is issuing this Final 
NIH Scientific Integrity Policy to promote a continuing culture of 
scientific integrity at NIH. This Policy codifies NIH's long-standing 
expectations to preserve scientific integrity throughout all NIH 
activities, establishes key roles and responsibilities for those who 
will lead the agency's scientific integrity program, and, as 
appropriate, establishes relevant reporting and evaluation mechanisms.

DATES: This Final Policy is effective on December 30, 2024.

FOR FURTHER INFORMATION CONTACT: Jessica Tucker, Ph.D., Acting Deputy 
Director, Office of Science Policy, NIH, at (301) 496-9838 or 
<a href="/cdn-cgi/l/email-protection#84d7e7ede1eae7e1d4ebe8ede7fdc4ebe0aaeaedecaae3ebf2"><span class="__cf_email__" data-cfemail="4c1f2f2529222f291c2320252f350c232862222524622b233a">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Background

    Scientific integrity aims to make sure that science is conducted, 
managed, communicated, and used in ways that preserve its accuracy and 
objectivity and protect it from suppression, manipulation, and 
inappropriate influence (https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf). In 
support of our mission, NIH has always sought to incorporate robust 
scientific integrity principles and practices throughout every level of 
its scientific enterprise. In fostering scientific integrity, NIH aims 
to ensure that (1) scientific findings are objective, credible, and 
readily available to the public, and (2) the development and 
implementation of policies and programs is transparent, accountable, 
and evidence-based. NIH has numerous policies and procedures to ensure 
the Nation's investment in biomedical

[[Page 84167]]

research is scientifically robust and rigorous and that our workforce 
maintains the highest standards of integrity. In supporting the NIH 
mission, all NIH researchers and staff are expected to:
    <bullet> Foster an organizational culture of scientific integrity,
    <bullet> Protect the integrity of the research process,
    <bullet> Communicate science with integrity, and
    <bullet> Safeguard scientific integrity.
    In 2012, NIH summarized its continuing efforts to foster scientific 
integrity in its NIH Policies and Procedures for Promoting Scientific 
Integrity Report (www.nih.gov/sites/default/files/about-nih/nih-director/testimonies/nih-policies-procedures-promoting-scientific-integrity-2012.pdf). In this report, NIH outlines the various roles it 
plays in fostering scientific integrity as a funder of research, a 
research institution, and a policy development agency. In 2021, the 
White House released its Presidential Memorandum on Restoring Trust in 
Government Through Scientific Integrity and Evidence-Based Policymaking 
(www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/). The Memorandum tasks NIH 
and other agencies to update their scientific integrity policies as 
appropriate to ensure agency alignment with the principles set forth 
therein and in Protecting the Integrity of Government Science 
(www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf), a report of the 
Scientific Integrity Fast-Track Action Committee of the National 
Science and Technology Council (NSTC), and A Framework for Federal 
Scientific Integrity Policy and Practice (https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf), a guidance document released by the 
Scientific Integrity Framework Interagency Working Group of the NSTC. 
In response to the Memorandum, and in accordance with its continued 
commitment to promoting scientific integrity, NIH has developed the 
Final NIH Scientific Integrity Policy, which is in alignment with the 
guidance set forth in the Presidential Memorandum and the Final 
Scientific Integrity Policy of the U.S. Department of Health and Human 
Services (https://www.hhs.gov/programs/research/scientificintegrity/index.html). The Final NIH Scientific Integrity Policy articulates the 
procedures and processes in place at NIH that help maintain rigorous 
scientific integrity practices and outlines several new functions to 
further enhance scientific integrity at NIH and throughout the NIH 
biomedical research enterprise.
    NIH accomplishes its mission by funding extramural researchers 
throughout the country, conducting research within its intramural 
research program, and developing policies and programs to responsibly 
advance biomedical research. In 2022, NIH updated its NIH Policies and 
Procedures for Promoting Scientific Integrity (2022) report (https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf), which describes the robust processes in place to 
support scientific integrity for NIH-supported extramural research, 
intramural research, and policies and programs. Building upon this 
existing infrastructure for scientific integrity, the Final NIH 
Scientific Integrity Policy outlines several new functions to further 
enhance existing practices and processes. For example, the Final NIH 
Scientific Integrity Policy includes a Federal definition of scientific 
integrity that is shared across the U.S. Government as outlined in the 
White House Framework. This alignment across the U.S. Government will 
help ensure consistency in guidance and language, lending clarity and 
uniformity to interagency efforts concerning scientific integrity. The 
Final NIH Scientific Integrity Policy also establishes the appointments 
of, and roles and responsibilities for, the positions of the NIH Chief 
Scientist (CS) and the NIH Scientific Integrity Official (SIO). The CS 
and SIO will have prominent and critical responsibilities in steering 
the NIH scientific integrity efforts, advising NIH leadership on 
scientific issues, and playing key roles in NIH adjudication efforts 
related to scientific integrity. The Final NIH Scientific Integrity 
Policy also includes NIH practices that will address important emerging 
topics in biomedical research, such as protecting against political 
interference.

Overview of Public Comments

    NIH released its Request for Information on the Draft NIH 
Scientific Integrity Policy on September 25, 2023 (88 FR 65696: https://www.federalregister.gov/documents/2023/09/25/2023-20733/request-for-information-on-the-draft-scientific-integrity-policy-of-the-national-institutes-of; comment period closed on November 9, 2023). In response 
to the Draft Policy, NIH received 26 responses from interested parties, 
and the comments are publicly available at https://osp.od.nih.gov/policies/scientific-integrity/. The largest group of respondents 
reported no affiliation, followed by affiliation with professional 
societies, with a small percentage of respondents indicating 
affiliation with research institutions, industry, and advocacy 
coalitions. Respondents typically identified themselves as members of 
the public, while another sizeable section self-identified as 
scientific researchers. Remaining respondents identified as 
institutional officials, and smaller percentages self-identified as 
medical providers, government officials, and scholarly publishers. NIH 
considered all feedback in the development of the Final NIH Scientific 
Integrity Policy, and a discussion of the public comments on specific 
topics follows below.

Discussion of Public Comments on the Draft NIH Scientific Integrity 
Policy

Policy Scope

    Draft Policy: The Draft NIH Scientific Integrity Policy explicitly 
outlined the categories of NIH employees and staff with defined roles 
and responsibilities when in the course of their official duties they 
propose, conduct, review, or communicate about science and scientific 
activities on behalf of NIH. It also stated that NIH has implemented 
separate policies for contractors, collaborators, awardees, and 
volunteers to uphold the principles of scientific integrity.
    Public Comments: While commenters were generally supportive of the 
overall scope of the Draft NIH Scientific Integrity Policy, a few 
suggested clarifying how it might impact the extramural community, 
applicability to HHS officials and political appointees, and NIH 
employees engaging in program administrative roles.
    Final Policy: The Final NIH Scientific Integrity Policy clarifies 
that the Policy applies to all NIH employees; Public Health Service 
Commissioned Corps officers assigned to NIH; NIH political appointees; 
NIH intramural clinical, research, and postdoctoral fellows; NIH 
intramural doctoral trainees; advisory committee members in their 
capacity as special Government employees; and all levels of employees 
managing scientific activities, engaging in program administrative 
roles, and using scientific information in decision making when in the 
course of their official duty activities they propose, conduct, review, 
or communicate about science and scientific activities on

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behalf of NIH. Extramural investigators are not encompassed under this 
Policy unless they otherwise meet the qualifications of a covered 
individual (e.g., membership on a Federal Advisory Committee in their 
capacity as a special Government employee); nevertheless, many 
individuals across the entire scientific enterprise have a role in 
supporting scientific integrity more broadly.

Roles and Responsibilities of the Chief Scientist and the Scientific 
Integrity Official

    Draft Policy: The Draft NIH Scientific Integrity Policy proposed 
the appointments as well as roles and responsibilities for the 
positions of NIH Chief Scientist (CS) and NIH Scientific Integrity 
Official (SIO). It indicated that the CS and SIO will have prominent 
and critical responsibilities in steering NIH scientific integrity 
efforts, advising NIH leadership on scientific issues, and playing key 
roles in agency adjudication efforts related to scientific integrity.
    Public Comments: While commenters were generally supportive of the 
establishment and proposed roles and responsibilities of the CS and 
SIO, a few suggested clarifying both roles and adding additional roles 
and responsibilities for other NIH leadership. Suggestions also 
included clearly defining the adjudication processes for losses of 
scientific integrity and ensuring adequate resources are allotted to 
the SIO and staff to implement the Policy and proactively seek out 
potential allegations of losses of scientific integrity.
    Final Policy: The Final NIH Scientific Integrity Policy affirms the 
roles and responsibilities of the CS and SIO required by the 2021 
Presidential Memorandum and includes some additional roles and 
responsibilities suggested by public comments. Detailed processes for 
adjudicating findings of loss of scientific integrity will be outlined 
in a NIH Manual Chapter and/or additional guidance. Additionally, NIH 
will ensure the SIO and other relevant agency offices and staff receive 
adequate support and resources to fulfill the functions outlined in the 
Policy.

Roles and Responsibilities of the Scientific Integrity Council

    Draft Policy: The Draft NIH Scientific Integrity Policy proposed 
the establishment of a NIH Scientific Integrity Council comprising 
career employees from across NIH to be led by the NIH SIO. It indicated 
that the Council would assist the SIO in iterative review, policy 
development, and priority setting to ensure that the existing policies 
and procedures are responsive to issues that arise in the scientific 
integrity space.
    Public Comments: Commenters were generally supportive of the 
establishment and proposed roles and responsibilities of the Council 
and suggested ensuring that it include a well-informed and a high-level 
group of experts on scientific integrity. Among the comments were 
suggestions for including desired areas of expertise for Council 
members, articulating a more explicit role of the Council in the 
adjudication process, and requiring the group to work with offices such 
as the NIH Tribal Health Research Office to consider any potential 
cultural implications. Additionally, a few commenters suggested that 
the NIH Scientific Integrity Council, the CS, and the SIO should 
consult with and/or include external experts to avoid potential 
conflicts of interest.
    Final Policy: The Final NIH Scientific Integrity Policy describes 
desired expertise areas for Council members and affirms the roles and 
responsibilities of the Council. Processes for the role the Council 
will play in adjudicating findings of loss of scientific integrity will 
be outlined in additional implementation guidance. The Council will 
work with all pertinent NIH offices and seek public input when needed 
to ensure appropriate expertise on pertinent topics. All members of the 
Council, the CS, and the SIO will be expected to comply with existing 
conflict of interest policies and procedures.

Promoting a Culture of Scientific Integrity

    Draft Policy: The Draft NIH Scientific Integrity Policy stated that 
diversity, equity, inclusion, and accessibility (DEIA) are integral 
components of the entire scientific process, and that attention to DEIA 
can improve the success of the scientific workforce, foster innovation 
in the conduct and use of science, and provide for more equitable 
participation in science by diverse communities. The Draft Policy 
additionally noted that all NIH employees will receive scientific 
integrity information or training as new employees, and NIH, in concert 
with HHS, will make available training for covered individuals and 
others, as applicable.
    Public Comments: Several commenters expressed support for the 
inclusion of DEIA within scientific integrity principles. Several 
commenters noted the importance of mandatory training for all NIH 
employees, not just the sharing of information on scientific integrity.
    Final Policy: The Final NIH Scientific Integrity Policy affirms the 
NIH stance that a strong culture of scientific integrity begins with 
ensuring a professional environment that is safe, equitable, fair, 
just, impartial, honest, and inclusive; DEIA are integral components of 
the entire scientific process. The Policy also states that scientific 
integrity training will be made available to all covered individuals, 
and some covered individuals may be required to complete role-specific 
training or refresher training as appropriate.

Ensuring Free Flow of Scientific Information

    Draft Policy: The Draft NIH Scientific Integrity Policy affirmed 
NIH's commitment to the broad and equitable dissemination and promotion 
of rigorous and objective scientific information. It highlighted the 
role of the NIH Office of Communications and Public Liaison in 
disseminating objective and evidence-based research findings to the 
public and responding to public inquiries. It also reiterated that NIH 
scientists may communicate their scientific activities objectively 
without political interference or other inappropriate influence.
    Public Comments: While commenters were generally supportive of the 
Draft NIH Scientific Integrity Policy provisions on ensuring the free 
flow of scientific information, a few noted that further delineation of 
scientists' ability to communicate with the media and public freely 
about their areas of expertise was needed and indicated that protection 
from potential bad faith attacks should be provided. Some commenters 
also suggested clarifying the differences between and processes for 
scientific technical review and media review.
    Final Policy: The Final NIH Scientific Integrity Policy provides 
additional guidance on how NIH scientists may communicate scientific 
information while performing official duty activities and defines and 
protects against retaliation. The Final Policy reaffirms that NIH 
scientists and other covered individuals can communicate their personal 
or individual views to the media or the public in their personal 
capacities, including on social media, subject to the limitations of 
government ethics rules, HHS supplemental ethics regulations, social 
media regulations, and obligation to protect nonpublic information. The 
Final Policy also clarifies the requirements and

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protections for scientific technical review processes.

Protections

    Draft Policy: The Draft NIH Scientific Integrity Policy described 
NIH's commitment to prioritizing safe and respectful work environments 
as well as existing protections for employees to disclose information 
that the individual reasonably believes is evidence of a violation of 
law, rule, or regulation; gross mismanagement; gross waste of funds; 
and abuse of authority; or a substantial and specific danger to public 
health or safety. The Draft Policy also affirmed NIH's commitment to 
hiring and retaining candidates for NIH scientific and technical 
positions based on the candidate's scientific and technical knowledge, 
credentials, experience, and integrity.
    Public Comments: Some commenters expressed the need for further 
protections for individuals who report allegations of loss of 
scientific integrity. Several commenters affirmed the importance of 
promoting DEIA with regard to the NIH workforce, grantmaking apparatus, 
and other activities and recommended further elaboration of specific 
groups who should be included and considered in efforts to promote 
diversity.
    Final Policy: The Final NIH Scientific Integrity Policy describes 
protections from reprisal for individuals who report allegations of 
loss of scientific integrity, including whistleblower protections. The 
Final Policy also affirms NIH's commitment to promoting equity in the 
scientific workforce and includes a robust description of the types of 
demographic groups that will be considered regarding efforts to promote 
equity.

Policy Implementation

    Draft Policy: The Draft NIH Scientific Integrity Policy proposed a 
delay between a final policy release and its effective date in order to 
communicate policy expectations to covered individuals and develop 
specific implementation details and plans. Expected implementation 
activities would include the establishment of an evaluation plan to 
regularly measure, monitor, and evaluate ongoing scientific integrity 
activities and outcomes. As part of the monitoring and evaluation plan, 
an annual report on the number and outcomes of investigations involving 
allegations of loss of scientific integrity would be published.
    Public Comments: Several commenters requested that additional 
implementation details be added to the Policy, including information on 
the allegations reporting and appeals processes, applicable 
consequences, an evaluation plan, publication best practices, and plans 
for public input, including meaningful engagements to build trust with 
marginalized communities. Specifically, a comment noted that the annual 
report should include specific details regarding the allegation, the 
inquiry process, and the outcome of the investigation.
    Final Policy: Consistent with other NIH policy development 
activities, additional implementation details will continue to be 
developed and publicly released. Given the bulk of implementation 
activities fall on NIH directly and not on our grantee institutions or 
contractors, NIH has chosen to enact a three-month implementation 
period. All implementation plans will comply with existing policies and 
regulations regarding conflicts of interest, whistleblower protections, 
etc. The Final NIH Scientific Integrity Policy notes that, for 
investigations that have been resolved, the annual report will include 
the types of corrective actions recommended by the investigation panel 
to restore scientific integrity, and the types of actions ultimately 
taken. Additionally, NIH will continue to seek input from the public, 
and the scientific integrity reporting process will also allow 
opportunities for public transparency. NIH is committed to promoting 
equity across the biomedical research enterprise and will consider 
additional methods to engage with communities historically 
underrepresented in biomedical research, including through existing 
robust outreach programs and initiatives.

Additional Changes to Final Policy

    Some additional changes were made to the Final NIH Scientific 
Integrity Policy in response to public comments, for clarity, or to 
maintain consistency with the Final HHS Scientific Integrity Policy. 
Some of these additional changes include slight revisions to the 
definition of ``political interference,'' a new definition of 
``retaliation,'' clarification of training requirements, and under 
``Protecting Scientific Processes,'' a statement noting that early 
termination of extramural awards is prohibited except under certain 
specific circumstances.

Concluding Points

    The Final NIH Scientific Integrity Policy builds upon and 
consolidates NIH's longstanding efforts to foster an organizational 
culture of scientific integrity, protect the integrity of the research 
process, communicate science with integrity, and safeguard scientific 
integrity. This Final NIH Scientific Integrity Policy is another step 
in ensuring that NIH's work as an institution maintains the highest 
standards of integrity and represents the best of the Nation's 
investment in biomedical research.
    NIH looks forward to continuing to work across the U.S. Government 
to support our shared commitment to responsible stewardship of the 
Nation's investment in biomedical research by maintaining and 
bolstering rigorous scientific integrity practices in taxpayer-funded 
biomedical research.
    The Final NIH Scientific Integrity Policy is set forth below.

Scientific Integrity Policy of the National Institutes of Health

Purpose

    The purpose of this policy is to promote a continuing culture of 
scientific integrity at the National Institutes of Health (NIH). This 
policy aims to ensure the integrity of all aspects of NIH scientific 
activities, including proposing, conducting, reviewing, managing, and 
communicating about science and scientific activities, and using the 
results of science to inform policy and program decision making.

Scientific Integrity at NIH

    In support of our mission, NIH funds extramural researchers 
throughout the country, conducts research within its intramural 
research program, and develops policies and programs to responsibly 
advance biomedical research. Embedding principles of scientific 
integrity throughout the NIH enterprise relies on two key elements. The 
first element is an all-hands-on-deck approach in which scientific 
rigor and research quality are prioritized. The second element is 
having inclusive, robust processes that safeguard scientific integrity.
    In fostering scientific integrity, NIH aims to ensure that (1) 
scientific findings are objective, credible, and readily available to 
the public, and (2) the development and implementation of policies and 
programs is transparent, accountable, and evidence-based. NIH has 
numerous policies and procedures to ensure the Nation's investment in 
biomedical research is scientifically robust and rigorous and that our 
workforce maintains the highest standards of integrity.
    Public input and accountability are woven throughout NIH processes 
to assure the public of the credibility of

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our science and our scientific findings. These activities range from 
presenting potential scientific solicitations at public meetings (e.g., 
concept clearance) to soliciting community feedback during decision 
making activities. In supporting the NIH mission, all NIH researchers 
and staff are expected to:
    <bullet> Foster an organizational culture of scientific integrity,
    <bullet> Protect the integrity of the research process,
    <bullet> Communicate science with integrity, and
    <bullet> Safeguard scientific integrity.
    NIH's long-standing commitment to fostering scientific integrity 
was summarized in its 2012 report, NIH Policies and Procedures for 
Promoting Scientific Integrity at https://www.nih.gov/sites/default/files/about-nih/nih-director/testimonies/nih-policies-procedures-promoting-scientific-integrity-2012.pdf. This document was updated in 
2022 at https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf, partly in response to the 2021 
Presidential Memorandum on Restoring Trust in Government Through 
Scientific Integrity and Evidence-Based Policymaking at https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/, to reflect more than a 
decade of updates to agency policies and procedures that support 
scientific integrity. The NIH Scientific Integrity Policy articulates 
expectations to preserve scientific integrity throughout all NIH 
activities, establishes key roles and responsibilities for those who 
will lead the agency's scientific integrity program, and, as 
appropriate, establishes relevant reporting and evaluation mechanisms 
with a goal of ensuring scientific integrity is foundational to all NIH 
activities. The NIH Scientific Integrity Policy is consistent with the 
U.S. Department of Health and Human Services (HHS) Scientific Integrity 
Policy at https://www.hhs.gov/programs/research/scientificintegrity/index.html. The majority of procedures regarding scientific integrity 
described herein are longstanding and foundational to NIH-supported 
research. The NIH Scientific Integrity Policy integrates existing and 
new practices under a single harmonized framework.

Effective Date and Policy Amendments

    This policy goes into effect on December 30, 2024. This policy will 
be evaluated by NIH one year after its effective date and every two 
years thereafter. Proposals to amend this policy will be overseen by 
the NIH Scientific Integrity Official (SIO), in collaboration with the 
NIH Scientific Integrity Council (Council) described below, and any 
such amendments will be communicated to HHS and the Director of the 
White House Office of Science and Technology Policy (OSTP) no later 
than 30 days after adoption.

Applicability & Scope

    All NIH employees; Public Health Service Commissioned Corps 
officers assigned to NIH; NIH political appointees; NIH intramural 
clinical, research, and postdoctoral fellows; NIH intramural doctoral 
trainees; advisory committee members in their capacity as special 
Government employees; and all levels of employees managing scientific 
activities, engaging in program administrative roles, and using 
scientific information in decision making, are expected to adhere to 
this policy when in the course of their official duties they propose, 
conduct, review, or communicate about science and scientific activities 
on behalf of NIH. When relevant, NIH has also implemented separate 
policies for entities who are not covered individuals, such as 
contractors, collaborators, extramural awardees, peer reviewers and 
volunteers, to uphold the principles of scientific integrity 
established by this policy while carrying out activities on behalf of 
NIH or within the scope of NIH support or engagement. The primary focus 
of this policy is on covered individuals' performance of official duty 
activities on behalf of NIH. Federal employees must adhere to the 
Standards of Ethical Conduct for Employees of the Executive Branch,\1\ 
which delineates requirements (and certain restrictions) for Federal 
employees when acting on behalf of the Federal government.
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    \1\ Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635) provide the basic guidelines for official 
duty activities, and NIH sets the policy for implementing the 
guidelines at the agency. Available at: https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635.
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Exceptions

    This policy will be implemented consistent with applicable Federal 
law and Executive Orders.

Definitions

    For the purposes of this policy, NIH adopts the following 
definitions:
    Allegation refers to a disclosure of a suspected loss of scientific 
integrity.
    Chief Scientist (CS) provides oversight of all NIH scientific 
integrity policies and procedures. NIH recognizes organizational 
culture starts with leadership at the highest levels. It has designated 
the NIH Principal Deputy Director as the NIH CS.
    Corrective scientific action refers to actions taken to restore the 
accuracy of the scientific record after a loss of scientific integrity 
has been determined, consistent with this policy, such as correction or 
retraction of published materials.
    Covered individuals include all NIH employees; Public Health 
Service Commissioned Corps officers assigned to NIH; NIH political 
appointees; NIH intramural clinical, research, and postdoctoral 
fellows; NIH intramural doctoral trainees; advisory committee members 
in their capacity as special Government employees; and all levels of 
employees who manage scientific activities, engage in program 
administrative roles, and use scientific information in decision making 
when in the course of their official duty activities they propose, 
conduct, review, or communicate about science and scientific activities 
on behalf of NIH. NIH contractors, partners, permittees, lessees, 
grantees, extramural trainees and fellows (i.e., those supported by NIH 
grants to non-NIH organizations), and volunteers who engage or assist 
in NIH scientific activities are not considered covered individuals but 
are strongly encouraged to uphold the principles of scientific 
integrity described in this policy while carrying out activities on 
behalf of NIH or within the scope of NIH support or engagement, 
particularly those described in the Protecting Scientific Processes, 
Ensuring the Free Flow of Scientific Information, Protections, and 
Professional Development sections of this policy; additionally, 
specific requirements may be incorporated into the terms of their 
engagement with NIH.
    Decision making refers to (1) development of policies or making 
determinations about policy or management; (2) making determinations 
about expenditures of Federal agency funds; (3) implementing or 
managing activities that involve, or rely on, scientific activities.
    Ethical behavior refers to activities that reflect norms for 
conduct that distinguish between acceptable and unacceptable behavior, 
such as honesty, lawfulness, equity, and professionalism, and adherence 
to statutes, regulations, policies, and guidelines governing employee 
conduct.
    Federal agency refers to an Executive department, a U.S. Government 
corporation, or an independent establishment.

[[Page 84171]]

    Inclusivity refers to the practice of providing equal access to 
opportunities for full participation of all people and all groups, 
including marginalized, underserved, and underrepresented contributors, 
without bias or prejudice. Full participation is enabled through 
implementation of strategies that promote equitable access and fair 
treatment in the organization.
    Inappropriate influence refers to the attempt to shape or interfere 
in scientific activities or the communication about or use of 
scientific activities, against well-accepted scientific methods and 
theories and without scientific, legal, programmatic management, or 
security justification.<SUP>2 3</SUP>
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    \2\ Examples may include (1) suppressing a decisionmaker's 
ability to offer the best judgment based on scientific information; 
(2) suppressing, altering or delaying the release of a scientific 
product for any reason other than technical merit, security or legal 
review, review for compliance with existing policies, or providing 
advance notification; (3) removing or reassigning scientific 
personnel for any reason other than performance, conduct, or 
budgetary constraints; (4) using scientific products that are not 
representative of the current state of scientific knowledge and 
research (e.g., because of a lack of appropriate peer review, poor 
methodology, or flawed analyses) to inform decision making and 
policy formulation; or (5) misrepresenting the underlying 
assumptions, uncertainties, or probabilities of scientific products. 
This is not intended to be an exhaustive list.
    \3\ Differences of scientific opinion are not necessarily 
inappropriate influence. Additionally, NIH officials are regularly 
expected to provide agency perspectives when acting in their 
official capacity.
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    Interference refers to inappropriate, scientifically unjustified 
intervention in the conduct, management, communication, or use of 
science. It includes censorship, suppression, or distortion of 
scientific or technological findings, data, information, or 
conclusions; inhibiting scientific independence during clearance and 
review; scientifically unjustified intervention in research and data 
collection; and inappropriate engagement or participation in peer 
review processes or on Federal advisory committees (FACs).
    Loss of scientific integrity refers to the failure to comply with 
this Scientific Integrity Policy or to adhere to objectivity, 
transparency, and ethical behavior when conducting, managing, using the 
results of, and communicating about science and scientific activities. 
This loss may include research misconduct or inappropriate influence in 
the conduct, communication, management, and use of science.
    Official duty activity refers to activities performed by an 
employee as part of, or an extension of, regular official 
responsibilities.\4\
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    \4\ The Standards of Ethical Conduct for Employees of the 
Executive Branch (5 CFR part 2635) provide the basic guidelines for 
official duty activities, and NIH sets the policy for implementing 
the guidelines at the agency. Available at: https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635.
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    Policy refers to laws, regulations, procedures, administrative 
requirements or actions, incentives, or voluntary practices of 
Governments and other institutions.
    Political interference is inappropriately shaping or interfering in 
the conduct, management, communication, or use of science for 
inappropriate partisan advantage such that it undermines impartiality, 
objectivity, nonpartisanship, or professional judgment.
    Research integrity refers to the use of honest and verifiable 
methods in proposing, performing, and evaluating research; reporting 
research results with particular attention to adherence to rules, 
regulations, and guidelines; and following commonly accepted 
professional codes or norms.
    Research misconduct refers to fabrication, falsification, or 
plagiarism in proposing, performing, or reviewing research, or in 
reporting research results. Research misconduct does not include honest 
error or differences of opinion.\5\
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    \5\ Federal Research Misconduct Policy, 65 FR 76260, 76262 (Dec. 
6, 2000) and https://www.ecfr.gov/current/title-42/chapter-I/subchapter-H/part-93/subpart-A/section-93.103.
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    Research security refers to safeguarding the research enterprise 
against the misappropriation of research and development to the 
detriment of national or economic security, related violations of 
research integrity, and foreign Government interference.
    Retaliation refers to, per 5 U.S.C. 2302(b)(8), taking or failing 
to take or threatening to take or fail to take a personnel action with 
respect to any employee or applicant for employment because of any 
disclosure of information that the employee or applicant reasonably 
believes evidences any violation of any law, rule, or regulation or 
gross mismanagement, a gross waste of funds, an abuse of authority, or 
a substantial and specific danger to public health or safety if such 
disclosure is not specifically prohibited by law and if such 
information is not specifically required by Executive Order to be kept 
secret in the interest of national defense or the conduct of foreign 
affairs. An employee or applicant is protected from retaliation for the 
disclosure of information the employee or applicant reasonably believes 
is evidence of censorship related to research, analysis, or technical 
information.<SUP>6 7</SUP>
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    \6\ Protection of Certain Disclosures of Information by Federal 
Employees. Available at: https://home.treasury.gov/system/files/306/WPEA-2012-PL-112-199.pdf.
    \7\ Prohibited personnel practices. Available at: https://www.govinfo.gov/content/pkg/USCODE-2022-title5/pdf/USCODE-2022-title5-partIII-subpartA-chap23-sec2302.pdf.
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    Science refers to the full spectrum of scientific endeavors, 
including basic science, applied science, evaluation, engineering, 
technology, economics, social sciences, and statistics, as well as the 
scientific and technical information derived from these endeavors and 
including multiple forms of evidence (e.g., Indigenous Knowledge).
    Scientific activities refer to activities that involve the 
application of well-accepted scientific methods and theories in a 
systematic manner, and includes, but is not limited to, data 
collection, inventorying, monitoring, evaluation, statistical analysis, 
surveying, observations, experimentation, study, research, integration, 
economic analysis, forecasting, predictive analytics, modeling, 
technology development, and scientific assessment, as well as any 
findings derived from these activities.
    Scientific data refers to recorded factual material commonly 
accepted in the scientific community as of sufficient quality to 
validate and replicate research findings, regardless of whether the 
data are used to support scholarly publications. Scientific data does 
not include laboratory notebooks, preliminary analyses, completed case 
report forms, drafts of scientific papers, plans for future research, 
peer reviews, communications with colleagues, or physical objects, such 
as laboratory specimens.\8\
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    \8\ NIH Data Management and Sharing Policy at: https://sharing.nih.gov/data-management-and-sharing-policy.
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    Scientific integrity is the adherence to professional practices, 
ethical behavior, and the principles of honesty and objectivity when 
conducting, managing, using the results of, and communicating about 
science and scientific activities. Inclusivity, transparency, and 
protection from inappropriate influence are hallmarks of scientific 
integrity. (Note: this is the Official Federal Definition of Scientific 
Integrity, consistent with OSTP and HHS definitions.\9\)
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    \9\ A Framework for Federal Scientific Integrity Policy and 
Practice. Available at: https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf.
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    Scientific Integrity Council will assist the NIH SIO in iterative 
review, policy

[[Page 84172]]

development, and priority setting to ensure that the existing policies 
and procedures are responsive to issues that arise in the scientific 
integrity space.
    Scientific Integrity Official (SIO) is the primary official for 
responsibilities over scientific integrity matters and reports to the 
NIH CS. This policy empowers the NIH SIO with the independence 
necessary to gather and protect information to support the review and 
assessment of scientific integrity concerns. The NIH SIO will also 
advocate for appropriate engagement of scientific leadership in 
decision making. NIH recognizes organizational culture starts with 
leadership at the highest levels. NIH has designated the Associate 
Director of Science Policy as the NIH SIO.
    Scientific record refers to published information resulting from 
scientific activities. NIH is responsible for ensuring the accuracy of 
elements of the scientific record that are published by NIH.
    Scientist refers to an individual whose responsibilities include 
collection, generation, use, or evaluation of scientific and technical 
data, analyses, or products. NIH scientists are NIH employees and other 
covered individuals who conduct these activities. It does not refer to 
individuals with scientific and technical training whose primary job 
functions are in non-scientific roles (e.g., policymakers, 
communicators).

Roles and Responsibilities

Chief Scientist and Scientific Integrity Official

    The Chief Scientist (CS) will:
    1. Provide oversight of all NIH scientific integrity policies and 
procedures, including the periodic updates of those policies and 
procedures;
    2. Engage in agency efforts regarding diversity, equity, inclusion, 
and accessibility;
    3. Provide for the resourcing and staffing needs of the NIH 
scientific integrity program;
    4. Promote scientific integrity across the agency; and
    5. Serve as an alternate in scientific integrity adjudication 
processes if the NIH SIO is alleged to have violated the NIH or HHS 
Scientific Integrity Policies.
    The Scientific Integrity Official (SIO) will:
    1. Report to the CS on all matters related to scientific integrity;
    2. Periodically update the NIH Scientific Integrity Policy;
    3. Provide regular reporting on NIH scientific integrity 
allegations and outcomes to OSTP and the public;
    4. Determine the resourcing and staffing needs of the NIH 
scientific integrity program;
    5. Promote scientific integrity across the agency;
    6. Lead the NIH Scientific Integrity Council, and participate on 
the HHS Scientific Integrity Council and other interagency efforts 
regarding scientific integrity;
    7. Serve as a focal point for the receipt of agency scientific 
integrity allegations (particularly related to political interference) 
that fall outside of existing processes managed by the Office of 
Extramural Research (OER), the Office of Intramural Research (OIR), the 
Office of Management Assessment (OMA), and the HHS Office of the 
Inspector General (OIG) (e.g., as related to waste, fraud, abuse, and 
illegal activities);
    8. Lead the review and adjudication of allegations of loss of NIH 
scientific integrity (particularly related to political interference) 
in cases where such allegations fall outside of existing processes 
managed by OER, OIR, OMA, and OIG (e.g., as related to waste, fraud, 
abuse, and illegal activities); and
    9. Promote agency efforts regarding diversity, equity, inclusion, 
and accessibility.

NIH Scientific Integrity Council

    The NIH SIO will establish and convene an NIH Council comprising 
career employees with expertise in ethics, research integrity, research 
misconduct, communications, whistle blower protections, and other 
relevant administrative areas from across NIH and from relevant NIH 
offices. This committee will assist the SIO in iterative review, policy 
development, and priority setting to ensure that the existing policies 
and procedures are responsive to issues that arise in the scientific 
integrity space.
    The primary responsibilities of the Council are to:
    1. Ensure that a well-informed and high-level group of experts 
supports scientific integrity at NIH;
    2. Ensure that the NIH Scientific Integrity Policy is implemented 
consistently across NIH;
    3. Review, assess, and revise the NIH Scientific Integrity Policy 
as needed;
    4. Engage NIH leadership in upholding the principles of scientific 
integrity and maintaining leadership awareness of scientific integrity 
issues as necessary and appropriate;
    5. As requested, assist the NIH SIO in adjudicating allegations of 
loss of scientific integrity (particularly related to political 
interference) in cases where such allegations fall outside of existing 
processes managed by OER, OIR, OMA, and OIG (e.g., waste, fraud, abuse, 
and illegal activities);
    6. In addition to being composed of relevant experts, confer with 
relevant offices (e.g., Tribal Health Research Office, Chief Officer 
for Scientific Workforce Diversity, and Sexual and Gender Minority 
Research Office) when additional expertise is needed; and
    7. Determine handling of investigation and adjudication proceedings 
from which the NIH SIO is recused.

Background on NIH Functions

Intramural Research

    The Intramural Research Program (IRP) is the internal research 
program of NIH, known for its synergistic approach to biomedical 
science. The IRP is the largest biomedical research program on earth, 
and its unique environment means the IRP can facilitate opportunities 
to conduct both long-term and high-impact science that would otherwise 
be difficult to undertake. The NIH IRP conducts research and training 
within its laboratories and clinics, and when appropriate, collaborates 
with the private sector to develop technologies of importance to public 
health. To help ensure the high quality and integrity of its intramural 
programs, NIH has developed and implemented NIH-wide policies and 
review standards for research, training, and technology transfer. The 
NIH Policy Manual at https://policymanual.nih.gov/is an official 
mechanism of issuing NIH-wide policy and all Manual Chapter issuances. 
More information about the NIH IRP can be found on the NIH OIR website 
at https://oir.nih.gov/.

Extramural Research

    Approximately 80 percent of NIH's investment in biomedical and 
behavioral research supports extramural researchers at institutions in 
every state in the country. Given the size and breadth of this 
investment, NIH has a robust infrastructure to ensure scientific 
integrity is embedded throughout the extramural research continuum and 
its workforce. While the covered individuals for this policy consist 
primarily of NIH employees, the principles of scientific integrity are 
foundational to NIH's role in funding extramural biomedical research, 
and the importance of scientific integrity is integrated throughout all 
NIH does as a funder of biomedical research. As such, existing policies 
to maintain scientific integrity of extramural research will continue. 
More information about the NIH extramural research program can be found 
on the NIH OER website at

[[Page 84173]]

https://grants.nih.gov/aboutoer/intro2oer.htm.

NIH as a Policy Development Agency

    NIH promotes progress in the biomedical research enterprise through 
the development of sound and comprehensive policies. To achieve this, 
NIH engages partners within and outside of NIH to develop policies on a 
wide range of issues including biosafety, biosecurity, genetic testing, 
genomic data sharing, public access to the results of NIH-funded 
research, human subjects and research animal protections, the 
organization and management of NIH, and the outputs and value of NIH-
funded research. This is accomplished through a wide range of analyses 
and reports, commentary on emerging policy proposals, and the 
development of policy proposals for consideration by NIH, the Federal 
Government, and the public. More information about NIH policy 
development can be found on the NIH Office of Science Policy (OSP) 
website at https://osp.od.nih.gov/.

Policy Requirements

Promoting a Culture of Scientific Integrity

    NIH leadership at all levels recognizes, supports, and promotes 
this policy and its underlying principles, and models behavior 
consistent with a strong culture of scientific integrity. NIH works to 
promote a culture of scientific integrity by creating an empowering 
environment for innovation and protecting scientists and the process of 
science from inappropriate interference. Scientific findings and 
products must not be suppressed, delayed, or altered for political 
purposes and must not be subjected to political interference or 
inappropriate influence.
    A strong culture of scientific integrity begins with ensuring a 
professional environment that is safe, equitable, fair, just, 
impartial, honest, and inclusive. Diversity, equity, inclusion, and 
accessibility (DEIA) are integral components of the entire scientific 
process. Attention to DEIA can improve the success of the scientific 
workforce, foster innovation in the conduct and use of science, and 
provide for more equitable participation in science by diverse 
communities. The responsible and ethical conduct of research and other 
scientific activities requires an environment that is equitable, 
inclusive, safe, and free from harassment and discrimination.
    NIH also works to apply scientific integrity practices in ways that 
are inclusive of non-traditional modes of science, such as citizen 
science, community-engaged research, participatory science, and 
crowdsourcing. This may include expanded scientific integrity practices 
and expectations, such as seeking greater input from communities and 
participants into the research questions and design, recognition of 
data and knowledge sovereignty, and inclusion of multiple forms of 
evidence, such as Indigenous Knowledge.
    NIH will prominently post and maintain the NIH Scientific Integrity 
Policy on its website and will ensure education is available for all 
covered individuals, as well as contractors who perform scientific 
activities for the agency, on their rights and responsibilities related 
to scientific integrity. Scientific integrity training will be made 
available to all covered individuals, and some covered individuals may 
be required to complete role-specific training or refresher training as 
appropriate.
    To promote a culture of scientific integrity at NIH, this policy 
outlines seven specific areas:

I. Protecting Scientific Processes
II. Ensuring the Free Flow of Scientific Information
III. Supporting Decision Making Processes
IV. Ensuring Accountability
V. Protections
VI. Professional Development for Government Scientists, and
VII. Federal Advisory Committees
I. Protecting Scientific Processes
    NIH has implemented a suite of complementary efforts to protect the 
integrity of research processes from bias and interference, which is 
essential to upholding public trust and confidence. These efforts rely 
on transparent processes, diverse community engagement, management of 
real or apparent conflicts of interest, and robust and open dialogue. 
NIH utilizes a variety of mechanisms to achieve these aims, such as 
holding policy discussions in open settings, soliciting public input on 
future research directions, and the use of Federal advisory committees 
(FACs) to advise the agency. In addition, for covered individuals, NIH 
explicitly prohibits political interference or inappropriately shaping 
or interfering in the conduct, management, communication, or use of 
science for inappropriate partisan advantage such that it undermines 
impartiality, objectivity, nonpartisanship, or professional judgment. 
Further processes will be developed and documented to support this 
policy in an NIH Manual Chapter and/or additional guidance.
    It is the policy of NIH to:
    1. Prohibit political interference or other inappropriate influence 
in the design, proposal, conduct, review, management, evaluation, 
communication of, and use of scientific activities and scientific 
information conducted by covered individuals.
    2. Prohibit inappropriate restrictions on resources and capacity 
that limit and reduce the availability of science and scientific 
products (e.g., manuscripts for scientific journals, presentations for 
workshops, conferences, and symposia) outside of normal budgetary or 
priority-setting processes or without scientific, legal, or security 
justification.\10\
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    \10\ This provision is further outlined in the NIH Policy Manual 
Chapter 3005 on Review and Evaluation of Intramural Programs. 
Available at: https://policymanual.nih.gov/3005.
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    3. Require that leadership and management ensure that covered 
individuals engaged in scientific activities can conduct their work 
objectively, free from political interference or other inappropriate 
influence, and free from retaliation.
    4. Require reasonable efforts by covered individuals to ensure the 
fidelity of the scientific record and to correct identified 
inaccuracies that pertain to their contribution to any scientific 
records.
    5. Require that covered individuals represent their contributions 
to scientific work fairly and accurately and neither accept nor assume 
unauthorized and/or unwarranted credit for another's accomplishments. 
To be named as an author, contributors should, at a minimum, have (1) 
made a substantial contribution or provided editorial revisions that 
include critical intellectual content, (2) approved the final version, 
and (3) agreed to be accountable for all aspects of the work to which 
they contributed. Prior consent should be obtained from each author to 
be represented on a particular work. Obtaining prior consent for 
acknowledgements is also a good practice.\11\
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    \11\ This provision is further outlined in the 2023 8th Edition 
of Guidelines and Policies for the Conduct of Research in the 
Intramural Research Program at NIH. Available at: https://oir.nih.gov/system/files/media/file/2023-08/guidelines-conduct_research.pdf.
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    6. Ensure independent review of scientific activities conducted by 
covered individuals as appropriate to ensure scientific integrity.\12\
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    \12\ This provision is further outlined in the NIH Policy Manual 
Chapter 3005 on Review and Evaluation of Intramural Programs. 
Available at: https://policymanual.nih.gov/3005.
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    7. Require that covered individuals comply with NIH policies and 
procedures for planning and conducting

[[Page 84174]]

scientific activities and show appropriate diligence toward protecting 
and conserving Federal research resources, such as equipment and other 
property, and records of data and results that are entrusted to them.
    8. Prohibit research misconduct, the deliberate or reckless use of 
improper or inappropriate research methods or processes, and 
noncompliance with practices that safeguard the quality of research and 
other scientific activities or enhance research security for covered 
individuals.\13\
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    \13\ This provision is further outlined in the NIH Policy Manual 
Chapter 3006 on NIH Intramural Research Program (IRP) Research 
Misconduct Proceedings. Available at: https://policymanual.nih.gov/3006.
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    9. Require that covered individuals design, conduct, manage, 
evaluate, and communicate about scientific research and other 
scientific activities honestly and thoroughly, and disclose any 
conflicts of interest to their supervisor or other appropriate NIH 
official(s) for their determination as to whether a recusal, 
disclaimer, or other action is appropriate, consistent with NIH ethics 
policies and procedures.\14\
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    \14\ This provision is further outlined in the NIH Conflict of 
Interest and Confidentiality Certification for Individuals 
Evaluating all NIH Intramural Programs. Available at: https://oir.nih.gov/system/files/media/file/2021-08/conflict_of_interest-bsc_reviews.pdf.
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    10. Require that research conducted by covered individuals 
involving the participation of human subjects and the use of non-human 
animals is conducted in accordance with applicable, established laws, 
regulations, policies, and ethical considerations.\15\
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    \15\ This provision is further outlined in the NIH Policy Manual 
Chapter 3014 on NIH Intramural Human Research Protection Program and 
the NIH Policy Manual Chapter 3040-2 on Animal Care and Use in the 
Intramural Research Program. Available at: https://policymanual.nih.gov/3014 and https://policymanual.nih.gov/3040-2 
respectively.
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    11. Support and enhance scientific integrity with the understanding 
that violations of scientific integrity can have a disproportional 
impact on underrepresented groups or weaken the equitable delivery of 
Federal Government programs.
    12. Consistent with OSTP guidance and relevant HHS and NIH policy, 
prohibit NIH personnel engaged in intramural research from 
participation in foreign talent recruitment programs, unless the 
participation is in an international conference or other international 
exchange, partnership, or program for which such participation has been 
approved by the appropriate authority in NIH.\16\
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    \16\ Health Extenders, Improving Access to Medicare, Medicaid, 
and CHIP, and Strengthening Public Health Act of 2022, Public Law 
117-328, Division FF, Title II, Section 2321 (Jan 3, 2023) at 
https://www.congress.gov/117/plaws/publ328/PLAW-117publ328.pdf and 
Chips and Science Act, Public Law 117-167, Title VI, Subtitle D, 
Section 10631 (Aug 9, 2022) at https://www.congress.gov/117/plaws/publ167/PLAW-117publ167.pdf. OSTP guidance and relevant HHS and NIH 
policies to implement this legislation are available at: https://www.whitehouse.gov/wp-content/uploads/2024/02/OSTP-Foreign-Talent-Recruitment-Program-Guidelines.pdf and https://grants.nih.gov/policy/foreign-interference/requirements-for-disclosure.
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    13. Consistent with OSTP guidance and relevant HHS and NIH policy, 
require disclosure of participation in foreign talent recruitment 
programs, including the provision of copies of all grants, contracts, 
or other agreements related to such programs, and other supporting 
documentation related to such programs, as a condition of receipt of 
Federal extramural research funding awarded through NIH.\17\
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    \17\ Health Extenders, Improving Access to Medicare, Medicaid, 
and CHIP, and Strengthening Public Health Act of 2022, Public Law 
117-328, Division FF, Title II, Section 2321 (Jan 3, 2023) at 
https://www.congress.gov/117/plaws/publ328/PLAW-117publ328.pdf and 
Chips and Science Act, Public Law 117-167, Title VI, Subtitle D, 
Section 10631 (Aug 9, 2022) at https://www.congress.gov/117/plaws/publ167/PLAW-117publ167.pdf. OSTP guidance and relevant HHS and NIH 
policies to implement this legislation are available at: https://www.whitehouse.gov/wp-content/uploads/2024/02/OSTP-Foreign-Talent-Recruitment-Program-Guidelines.pdf and https://grants.nih.gov/policy/foreign-interference/requirements-for-disclosure.
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    14. Prohibit the suspension or early termination of an extramural 
grant awarded by NIH except as consistent with applicable law and 
grants policies.<SUP>18 19</SUP>
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    \18\ https://grants.nih.gov/policy/nihgps/index.htm
    \19\ 45 CFR 75.372. Available at: https://www.govinfo.gov/content/pkg/CFR-2022-title45-vol1/pdf/CFR-2022-title45-vol1-sec75-372.pdf.
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II. Ensuring the Free Flow of Scientific Information
    NIH is committed to the broad and equitable dissemination and 
promotion of rigorous and objective scientific information. The NIH 
Office of Communications and Public Liaison (OCPL) and communication 
offices within the NIH Institutes, Centers, and Offices (NIH ICOs) 
disseminate objective and evidence-based research findings to the 
public through websites, listservs, brochures, videos, social media, 
and other modes of communication as appropriate. NIH OCPL and the ICO 
communication offices also respond to public inquiries and engage with 
technical and non-technical audiences through media and online forums 
to ensure responsible communication regarding the research it funds.
    At the foundation of the NIH mission is the generation of reliable 
and rigorous research results, and their publication in reputable, 
peer-reviewed scientific journals. NIH's IRP researchers adhere to the 
Standards of Ethical Conduct for Employees of the Executive Branch (5 
CFR part 2635) \20\ and the NIH-wide Policy for Manuscript and Abstract 
Clearance Procedures at https://oir.nih.gov/sourcebook/submitting-research-publications/publication-abstract-clearance, and follow 
established guidance to ensure transparency in research findings 
through Processes for Authorship Dispute Resolution at https://oir.nih.gov/sourcebook/ethical-conduct/authorship-guidelines-resources/nih-irp-authorship-conflict-resolution-process if the situation arises.
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    \20\ Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635) provide the basic guidelines for official 
duty activities, and NIH sets the policy for implementing the 
guidelines at the agency. Available at: https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635.
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    It is the policy of NIH to:
    1. Facilitate the free flow of scientific and technological 
information, to the extent permissible by Federal laws and 
regulations.\21\ Consistent with open science expectations, NIH will 
expand and promote access to scientific and technological information 
by making it available freely and without embargo to the public in an 
online digital format.<SUP>22 23 24 25</SUP>
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    \21\ Per the Standards of Ethical Conduct for Employees of the 
Executive Branch (5 CFR part 2635), ``Employees shall not knowingly 
make unauthorized commitments or promises of any kind purporting to 
bind the Government.'' Available at: https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635.
    \22\ White House Office of Science and Technology Policy 
Memorandum for the Heads of Executive Departments and Agencies on 
Increasing Access to the Results of Federally Funded Scientific 
Research. February 22, 2013. Available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf.
    \23\ White House Office of Science and Technology Policy 
Memorandum for the Heads of Executive Departments and Agencies on 
Ensuring Free, Immediate, and Equitable Access to Federally Funded 
Research. August 25, 2022. Available at: https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf.
    \24\ This provision is further outlined in the NIH Policy Manual 
Chapter 1184 on Preparation and Clearance of Scientific, Technical, 
and Public Information Presented by NIH Employees or Produced for 
Distribution by NIH. Available at: https://policymanual.nih.gov/1184.
    \25\ This provision is further outlined in the NIH Data 
Management and Sharing Policy. Available at: https://sharing.nih.gov/data-management-and-sharing-policy.
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    2. Ensure that scientific findings and products created by NIH 
scientists are not unduly suppressed, delayed, or altered for political 
purposes and are not subjected to inappropriate influence.
    3. Encourage, but not require, NIH scientists to participate in 
their official capacities in communications with the

[[Page 84175]]

media regarding their scientific activities and areas of expertise, 
subject to limitations of Government ethics rules (5 CFR part 2635). In 
communicating with the media, NIH scientists must seek advice from 
career NIH communications experts when acting in their official 
capacities.
    4. Allow NIH scientists and other covered individuals to express 
their personal views and opinions to the media with appropriate written 
or oral disclaimers, including on social media, subject to the 
limitations of Government ethics rules, HHS supplemental ethics 
regulations, social media regulations, and obligation to protect 
nonpublic information.\26\ NIH scientists and other covered individuals 
may name NIH as their employer as one biographical fact among several; 
however, their title and position cannot receive more prominence than 
any other biographical fact. They should not be sourced by the media as 
an NIH representative and shall refrain from making or publishing 
statements that could be construed as being judgments of, or 
recommendations on, NIH or any other Federal Government policy, 
including the use of NIH or other U.S. Government seals or logos, 
unless they have secured appropriate prior approval to do so.\27\
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    \26\ Per the Standards of Ethical Conduct for Employees of the 
Executive Branch (5 CFR part 2635), ``Employees shall not knowingly 
make unauthorized commitments or promises of any kind purporting to 
bind the Government.'' Available at: https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635.
    \27\ These provisions are consistent with and do not supersede, 
conflict with, or otherwise alter the employee obligations, rights, 
or liabilities created by existing statute or Executive order 
relating to (1) classified information, (2) communications to 
Congress, (3) the reporting to an Inspector General of a violation 
of any law, rule, or regulation, or mismanagement, a gross waste of 
funds, an abuse of authority, or a substantial and specific danger 
to public health or safety, or (4) any other whistleblower 
protection.
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    5. Require that technical review and clearance processes include 
provisions for timely clearance and expressly forbid censorship, 
unreasonable delay, and suppression of objective communication of data 
and results without valid scientific, legal, or security justification. 
Deviations from clearance policies or procedures that result in 
suppression, delay, or alteration of scientific and technological 
information without scientific, legal, or security justification may 
constitute violations of the NIH Scientific Integrity Policy and may be 
reported under the Addressing Scientific Integrity Concerns section in 
this document.
    6. Prohibit NIH officials, including communications officers, from 
altering, or directing NIH scientists and technology experts to alter, 
scientific and technological research findings or presentation of 
research findings in a manner that may compromise the objectivity or 
accurate representation of those findings.
    7. Ensure that scientific information is accurately represented in 
responses provided by NIH to Congressional inquiries, tribal inquiries, 
testimony, and other requests.
    8. Ensure that the work and conclusions of NIH scientists and the 
work and conclusions of scientists funded or supported by the Federal 
government are accurately represented in NIH communications. If 
communication documents significantly rely on a scientist's research, 
identify them as an author, or represent their scientific opinion, the 
scientist will be given the option to review the scientific content of 
proposed communication documents prior to publication or public 
release.
    9. Accurately represent the work and conclusions of NIH scientists 
in NIH social media communications and provide appropriate guidance to 
NIH scientists on the use of NIH social media. If NIH scientists whose 
work is represented in NIH social media identify any errors in those 
representations regarding their scientific activities and areas of 
expertise, NIH social media managers are responsible for making 
appropriate corrections.
    10. When offering spokespersons in response to media requests, 
offer knowledgeable spokespersons who can, in an objective and 
nonpartisan manner, describe the relevant scientific or technological 
aspects of their work.
    11. Ensure that NIH scientists may communicate their scientific 
activities objectively without political interference or other 
inappropriate influence consistent with HHS \28\ and NIH \29\ 
communication and media policies. Scientific products must adhere to 
relevant NIH technical review procedures.
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    \28\ This provision is further outlined in the HHS Guidelines on 
the Provision of Information to the News Media. Available at: 
https://www.hhs.gov/sites/default/files/media_policy.pdf.
    \29\ This provision is further outlined in the NIH Policy Manual 
Chapter 1184 on Preparation and Clearance of Scientific, Technical, 
and Public Information Presented by NIH Employees or Produced for 
Distribution by NIH. Available at: https://policymanual.nih.gov/1184.
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III. Supporting Decision Making Processes
    NIH utilizes multiple mechanisms for ensuring transparency and 
accountability in developing policy and informing decision making. The 
development of science policy at NIH generally follows procedures set 
forth under the Administrative Procedure Act (5 U.S.C. Subchapter II) 
at https://www.archives.gov/federal-register/laws/administrative-procedure, where applicable, and draft policy proposals are routinely 
issued through the NIH Guide and the Federal Register, as appropriate, 
to obtain early feedback into policy proposals. Once a proposal has 
been issued for public comment, it is often supplemented with 
informational webinars, interactive discussion sessions, and a robust 
public engagement plan to promote broad dissemination and engagement in 
the policymaking process. NIH considers all comments submitted on draft 
polices and policy proposals to ensure final policy proposals are 
informed by the community and capable of responding to emerging 
opportunities and challenges. Final policies are also issued through 
the NIH Guide and the Federal Register, as appropriate, and 
incorporated into the NIH Grants Policy Statement and NIH Policy 
Manual, as appropriate. Policies are also posted to NIH websites with 
additional resources such as Frequently Asked Questions and other 
supplemental resources as needed.
    It is the policy of NIH to:
    1. Ensure the quality, accuracy, and transparency of scientific 
information used to support policy and decision making, including by:
    a. Using scientific information that is subject to well-established 
scientific processes.
    b. Ensuring that scientific data and research used to support 
policy decisions undergo review by qualified experts, where feasible 
and appropriate, and consistent with law.
    c. Adhering to the Office of Management and Budget Final 
Information Quality Bulletin for Peer Review.\30\ For example, as 
described in the Bulletin, when independent peer reviews of scientific 
information products are conducted by contractors, a conflict-of-
interest review will be conducted.
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    \30\ Office of Management and Budget. ``Final Information 
Quality Bulletin for Peer Review.'' Federal Register. Doc. 05-769. 
Available at: https://www.federalregister.gov/documents/2005/01/14/05-769/final-information-quality-bulletin-for-peer-review.
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    d. Reflecting scientific information appropriately and accurately 
and making scientific findings or conclusions considered or relied on 
in policy decisions publicly available online and in open formats, to 
the extent practicable.
    2. Where legally permissible and appropriate, directly consult with

[[Page 84176]]

scientists whose work is being used in policy and management decisions 
to ensure that the science is accurately represented and interpreted.
    3. Ensure, to the extent possible, the accuracy of NIH 
communication of the science upon which a policy decision is based.
    4. Ensure that covered individuals are free to express differing 
scientific opinions free from political interference or inappropriate 
influence.
IV. Ensuring Accountability
    NIH is firmly committed to establishing and formalizing procedures 
to identify and adjudicate allegations regarding compromised scientific 
processes or technological information. NIH has established several 
adjudication processes within distinct offices (i.e., OER, OIR, and 
OMA), to address different ways in which scientific integrity may be 
violated. Each office handles allegations pertaining to its respective 
jurisdiction, but individuals may submit an oral or written allegation 
via email or hotline. When an allegation or complaint is received, the 
appropriate office determines if it is specific, credible, and meets 
the definition of research misconduct or an integrity violation. The 
procedures each office takes for investigating allegations or 
complaints, adjudication, and appeals are further detailed in the 2022 
update to the NIH Policies and Procedures for Promoting Scientific 
Integrity at https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf. The designation of an NIH SIO will allow 
for more centralized interagency communication and coordination 
concerning allegations to help ensure effective oversight and promote 
scientific integrity within the Federal Government. Additionally, the 
NIH SIO will provide review and adjudication of allegations 
(particularly related to political interference) that do not fall under 
the purview of these existing offices.
    It is the policy of NIH to:
    1. Ensure correction of the scientific record and implementation of 
corrective scientific actions when allegations of a loss of scientific 
integrity are substantiated. Corrective actions may include correction 
or retraction of published scientific work or related media releases, 
release of inappropriately suppressed scientific materials, monitoring 
or supervision of future scientific activities, or required validation 
of data sources.
    2. Encourage and facilitate early informal or formal consultation 
between covered individuals and scientific integrity officials to 
advise on preventing loss of scientific integrity, to determine whether 
a loss of scientific integrity has potentially occurred, and to 
ascertain whether an allegation should be referred elsewhere for 
resolution.
    3. Provide clear guidance on how to formally and confidentially 
report concerns and allegations of loss of scientific integrity. Those 
who report concerns and allegations need not be directly involved or 
witness a violation.
    4. Ensure that the NIH SIO or other NIH entities draft procedures, 
as needed, to respond to allegations of loss of scientific integrity in 
a timely, objective, and thorough manner. These procedures will include 
an initial assessment and review, a fact-finding process, an 
adjudication or determination including description of remedies and 
preventative measures to safeguard the science, and reporting.
    5. These procedures will document the necessary aspects for each 
step of the process as well as the roles of the NIH SIO and other 
agency staff in the process.
V. Protections
    NIH prioritizes safe and respectful work environments that are free 
from harassment, including sexual harassment, discrimination, or other 
forms of inappropriate conduct that can result in a hostile work 
environment. Additionally, it is unlawful for NIH to take or threaten 
to take a personnel action against an employee because they made a 
protected disclosure of wrongdoing. A protected disclosure is defined 
as a disclosure of information that the individual reasonably believes 
is evidence of a violation of law, rule, or regulation; gross 
mismanagement; gross waste of funds; and abuse of authority; or a 
substantial and specific danger to public health or safety. Personnel 
actions that are covered by this can include poor performance review, 
demotion, suspension, termination, or revocation or downgrade of a 
security clearance. If staff members believe that whistleblower 
retaliation has occurred, they may get more information from the HHS 
OIG at https://oig.hhs.gov/about-oig/.
    It is the policy of NIH to:
    1. Select and retain candidates for NIH scientific and technical 
positions based on the candidate's scientific and technical knowledge, 
credentials, experience, and integrity, and hold them and their 
supervisors to the highest standards of professional and scientific 
ethics.\31\ Support scientists and researchers including, but not 
limited to, Black, Latino, Indigenous and Native American persons, 
Asian Americans and Pacific Islanders, and other persons of color; 
members of religious minorities; lesbian, gay, bisexual, transgender, 
queer, intersex, and asexual (LGBTQIA+) persons; persons with 
disabilities; persons who live in rural areas; and persons otherwise 
adversely affected by persistent poverty or inequality; and advance the 
equitable delivery of Federal programs.
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    \31\ This provision is further outlined in the NIH Sourcebook on 
Personnel. Available at: https://oir.nih.gov/sourcebook/personnel.
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    2. Promote diversity, equity, inclusion, and accessibility in the 
scientific workforce and create and support the creation of safe 
workspaces that are free from harassment and discrimination.\32\
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    \32\ This provision is further outlined in the NIH Policy Manual 
Chapter 1311 on Preventing and Addressing Harassment and 
Inappropriate Conduct and the NIH Sourcebook Addendum to BSC 
Policies and Procedures. Available at: https://policymanual.nih.gov/1311 and https://oir.nih.gov/sourcebook/processes-reviewing-nih-intramural-science/boards-scientific-counselors/addendum-policies-procedures.
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    3. Protect from reprisal those individuals who report allegations 
in good faith of loss of scientific integrity. Efforts will be made to 
protect the privacy of individuals involved in allegations.
    4. Prevent covered individuals from intimidating or coercing NIH 
scientists to alter scientific data, findings, or professional opinions 
or from inappropriately influencing scientific advisory boards.
    5. Comply with whistleblower protections, specifically:
    a. The requirements of the Whistleblower Protection Act of 1989, 
and its expanded protections enacted by Public Law 103-424 and the 
Whistleblower Protection Enhancement Act of 2012, 5 U.S.C. part 
2302(b)(8)-(9).
    b. The National Defense Authorization Act's expansion of certain 
whistleblower protections to employees of Federal Government 
contractors, subcontractors, and grant recipients in 41 U.S.C. part 
4712.
    c. Presidential Policy Directive 19, which prohibits supervisors 
from taking, failing to take, or threatening to take or fail to take 
any action affecting an employee's eligibility for access to classified 
information in retaliation for making a protected disclosure.
    d. The Military Whistleblower Protection Act (codified at 10 U.S.C. 
1034), which is made applicable to the Public Health Service 
Commissioned

[[Page 84177]]

Corps officers through 42 U.S.C. 213a(a)(18) and implemented by 
Commissioned Corps Directive 121.06.
    6. Ensure scientific integrity staff at NIH are protected by all 
applicable employee rights as required by law. An SIO or other 
scientific integrity staff may only be terminated or reassigned for 
reasons consistent with applicable law.
VI. Professional Development for Government Scientists
    A key aspect of the NIH effort to advance scientific integrity is 
encouraging NIH scientists and covered individuals to engage with the 
broader research community in maintaining the highest ethical standards 
and scientific norms, while adhering to the Standards of Ethical 
Conduct for Employees of the Executive Branch (5 CFR part 2635).\33\ 
Creating an inclusive environment for scientists from all backgrounds, 
including those from traditionally underrepresented groups, is 
essential to supporting scientific integrity. The IRP promotes 
professional development of all researchers from trainees at every 
level, to tenure-track and tenured investigators, and all other 
research staff. Scholarly writing, lecturing, editing, and publishing 
are essential parts of research and professional development. These 
activities are in the public interest and bring credit and distinction 
to both NIH and its employees. In encouraging researchers to share 
information about their official and professional activities, NIH seeks 
to advance scientific knowledge and contribute to its employees' 
professional education.
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    \33\ Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635) provide the basic guidelines for official 
duty activities, and NIH sets the policy for implementing the 
guidelines at the agency. Available at: https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635.
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    It is the policy of NIH to:
    1. Encourage timely publication of research conducted by covered 
individuals such as in peer-reviewed, professional, scholarly journals, 
NIH technical reports and publications, or other appropriate 
outlets.\34\
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    \34\ This provision is further outlined in the NIH Public Access 
Policy. Available at: https://sharing.nih.gov/public-access-policy.
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    2. Encourage the sharing of scientific activities, findings, and 
materials developed by covered individuals through appropriate avenues 
including digital repositories.\35\
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    \35\ This provision is further outlined in the NIH Data 
Management and Sharing Policy. Available at: https://sharing.nih.gov/data-management-and-sharing-policy.
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    3. Encourage covered individuals to participate in and present 
research at professional meetings including workshops, conferences, and 
symposia.\36\
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    \36\ This provision is further outlined in the NIH Sourcebook on 
Tenure in the NIH Intramural Research Program. Available at: https://oir.nih.gov/sourcebook/tenure-nih-intramural-research-program.
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    4. When appropriate, permit covered individuals to serve on 
editorial boards, as peer reviewers, or as editors of professional or 
scholarly journals.
    5. When appropriate, permit covered individuals to participate in 
professional societies, committees, task forces, and other specialized 
bodies of professional societies, including removing barriers to 
serving as officers or on governing boards of such societies, to the 
extent allowed by law.\37\
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    \37\ This provision is further outlined in the NIH Sourcebook on 
Activities with Outside Organizations and the NIH Official Duty 
Activities Chart. Available at: https://oir.nih.gov/sourcebook/ethical-conduct/research-ethics/nih-policies/intramural-extramural-collaborations/activities-outside-organizations and https://ethics.od.nih.gov/sites/default/files/topics/ODA/2-ODA-Chart.pdf.
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    6. Permit NIH scientists to receive honors and awards for 
contributions to scientific activities and discoveries to the extent 
allowed by law, and to accrue the professional recognition of such 
honors or awards.
    7. Permit covered individuals to perform outreach and engagement 
activities, such as speaking to community and student groups, as part 
of their official duties as appropriate.
VII. Federal Advisory Committees
    FACs, as defined by the Federal Advisory Committee Act (FACA) at 
https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/legislation-and-regulations/the-federal-advisory-committee-act, are an important tool within NIH for ensuring the 
credibility, quality, and transparency of NIH science. NIH will adhere 
to FACA and develop policies in coordination with the General Services 
Administration and consistent with the guidance on lobbyists serving on 
FACs when convening FACs tasked with giving scientific advice.
    Consistent with all applicable laws and guidance regarding FACs, it 
is the policy of NIH to:
    1. Promote transparency in the recruitment of new FAC members, 
including, when practical and appropriate, announcing vacancies with a 
notification in the Federal Register.
    2. Select members to serve on a scientific or technical FAC based 
on expertise, knowledge, and contribution to the relevant subject 
area.<SUP>38 39</SUP> Additional factors that may be considered are 
availability of the member to serve, alignment with the relevant 
Federal Advisory Committee Membership Balance Plan, and the ability to 
work effectively on advisory committees.\40\ Ensure committee 
membership is fairly balanced in terms of points of view represented 
with respect to the functions to be performed by the 
FAC.<SUP>41 42</SUP>
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    \38\ This provision is further outlined in How Scientists Are 
Selected to Be Members of a Chartered Review Group. Available at: 
https://public.csr.nih.gov/ForReviewers/BecomeAReviewer/CharteredReviewers.
    \39\ This provision refers to not only FACA Councils that have 
SGE members but also peer review FACA committees that have NIH peer 
review consultants as members.
    \40\ This provision is further outlined in the NIH Selection 
Criteria for NIH Advisory Committees. Available at: https://ofacp.nih.gov/committees/selection_criteria.
    \41\ 2010 Memorandum from the White House Office of Science and 
Technology Policy on Scientific Integrity. Available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf.
    \42\ General Services Administration 41 CFR part 102-3 Federal 
Management Regulation: Federal Advisory Committee Management. 
Available at: https://www.regulations.gov/document/GSA-FMR-2022-0015-0010.
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    3. Comply with current standards governing conflict of interest as 
defined in statutes and implementing regulations.<SUP>43 44</SUP>
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    \43\ This provision is further outlined in the NIH Policy Manual 
Chapter 1810 on Procedures for Avoiding Conflict of Interest for 
Special and other Federal Employees Serving as Advisory Committee 
Members. Available at: https://policymanual.nih.gov/1810-1.
    \44\ The NIH Office of Federal Advisory Committee Policy 
maintains the Special Government Employee (SGE) Portal for those 
interested in serving on an NIH Federal advisory committee as an 
SGE. The Portal contains all the requirements expected of advisory 
committee members who serve on advisory committees as SGEs, 
including ethics training, Foreign Activities and Lobbyist 
Certification, and the Confidential Financial Disclosure Report (OGE 
450) at: https://sgeportal.od.nih.gov/Pages/default.aspx.
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    4. Except when prohibited by law and to the extent practical, 
agencies should appoint members of scientific and technical FACs as 
Special Government Employees.
    5. Treat all reports, recommendations, and products produced by 
FACs solely as the reports, recommendations, and products of such 
committees rather than of the U.S. Government, and thus not subject to 
intra- or inter-agency revision. The role of the FACs is to provide 
advice or recommendations to the agency. The agency may then craft 
policy based on the FACs' advice or recommendations if it chooses to 
adopt those recommendations.

Addressing Scientific Integrity Concerns

    The NIH SIO has primary responsibility for assessing scientific

[[Page 84178]]

integrity concerns and will develop procedures for addressing 
allegations of loss of scientific integrity and concerns that span or 
fall outside existing NIH adjudication mechanisms under the purview of 
OER, OIR, OMA, or OIG (e.g., as related to waste, fraud, abuse, and 
illegal activities).\45\ In particular, the NIH SIO will manage 
scientific integrity concerns related to political interference, if 
they do not fall within existing processes. Procedures for handling 
scientific integrity concerns will be made available on the NIH 
website. For information about rights and remedies against retaliation, 
employees may contact the HHS OIG Whistleblower Protection 
Coordinator.\46\ As noted above, existing procedures under the purview 
of OER, OIR, OMA, and OIG (e.g., as related to waste, fraud, abuse, and 
illegal activities) should continue to be followed. When those existing 
mechanisms do not cover a scientific integrity concern:
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    \45\ OER reviews and refers allegations of research misconduct 
involving extramural researchers and peer review of grant 
applications to the HHS Office of Research Integrity (ORI) and may 
take corrective action against a grantee or peer reviewer based on 
the conduct identified in ORI findings. OIR reviews allegations 
related to research integrity involving NIH IRP researchers. The NIH 
Division of Program Integrity within OMA manages the review of 
allegations involving misuse of NIH grant or contractor funds, 
grantee or contractor conflicts of interest, and other misconduct or 
misuses of NIH resources by NIH employees or others doing business 
with NIH. The HHS OIG investigates allegations of criminal fraud, 
waste, and abuse.
    \46\ As appropriate, employees can also contact the NIH Office 
of Equity, Diversity, and Inclusion for information regarding 
retaliation based on protected equal employment opportunity or the 
HHS Office of Special Counsel for information regarding retaliation 
based on whistleblowing. Further information can be found at: 
https://www.edi.nih.gov/services/federal-EEO-complaint-process and 
https://oig.hhs.gov/fraud/whistleblower/. Additionally, although 
encouraged to use the process detailed herein, employees may also 
disclose wrongdoing to their supervisor or another individual higher 
up in management, the HHS OIG, the Office of Special Counsel, or to 
Congress.
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    1. Concerns about a potential loss of scientific integrity at NIH 
may be reported to the NIH SIO by any individual who has knowledge of 
the situation. Reporting can be done anonymously.
    2. NIH employees are encouraged to seek an informal consultation 
with the NIH SIO or other relevant agency integrity officials to 
discuss whether a concern constitutes a potential loss of scientific 
integrity before submitting a formal complaint. Employees ultimately 
have the discretion to submit a formal complaint as they see fit 
without reprisal.
    3. The SIO will oversee an initial assessment of each reported 
concern and determine whether to request additional information from 
the complainant or others, as appropriate and feasible, and to 
determine whether a formal investigation is warranted. Additionally, if 
any reported concern falls within the purview of existing OER, OIR, 
OMA, or OIG processes, those mechanisms will instead be utilized.
    4. Should an investigation be opened, an investigation committee 
consisting of the NIH SIO and other agency integrity officials 
(including from the NIH Scientific Integrity Council, as appropriate) 
will be convened to develop a factual record by exploring the 
allegation(s) in detail and consulting with subject matter experts, 
interviewing witnesses, and reviewing documentation as needed.
    5. Once the investigation is complete, the NIH SIO will determine 
whether scientific integrity was lost and report findings to the 
appropriate management entity.
    6. The complainant and respondent will be given the opportunity to 
appeal a finding or any corrective scientific actions taken.

Handling Differing Scientific Opinions

    Science and decisions based on science are strengthened by vigorous 
discussion and debate and by considering all available evidence. The 
process of challenging and improving ideas helps to guard against 
inadequate science and flawed analysis. Scientists can hold differing 
opinions without violating scientific integrity, and NIH encourages its 
scientists to respectfully express and engage with differing views as 
an integral part of the scientific process.\47\ Differing scientific 
opinions are diverging views held by researchers who are substantively 
engaged in the science subject area. In some cases, such as when a 
scientific dispute has a significant impact on public health or policy, 
a formal scientific dispute resolution process may be necessary. The 
goal of scientific dispute resolution should be to ensure that all 
perspectives are heard and documented in an unbiased way. A 
satisfactory resolution may involve adopting one opinion over another, 
deciding to conduct additional studies, formulating an alternate theory 
reconciling the differing opinions, or documenting the disagreement for 
the benefit of policymakers and fellow scientists. These steps may be 
completed in any order and are not necessarily an exhaustive list of 
dispute resolution measures. In general:
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    \47\ Further information on the NIH IRP Authorship Conflict 
Resolution Process can be found in the NIH Sourcebook. Available at: 
https://oir.nih.gov/sourcebook/ethical-conduct/authorship-guidelines-resources/nih-irp-authorship-conflict-resolution-process.
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    <bullet> A team member or group of team members with a differing 
opinion may engage with their colleagues to resolve the issue as soon 
as the difference of opinion is known. NIH recommends this type of 
internal discussion as a first step in most dispute resolution 
proceedings.
    <bullet> A team may choose to consult a manager. First-level 
managers may defer to an appropriate higher-level manager if the first-
level manager has a conflict of interest or cannot offer an impartial 
opinion for any reason.
    <bullet> If the matter cannot be satisfactorily resolved by other 
means, a team may request assistance from OIR. The NIH SIO may be 
consulted if their assistance is requested or if there is a conflict of 
interest or perceived conflict of interest with relevant OIR staff.

Monitoring, Evaluating, and Reporting Scientific Integrity Activities 
and Outcomes

    NIH, working through HHS, will develop and implement an evaluation 
plan to regularly measure, monitor, and evaluate ongoing scientific 
integrity activities and outcomes. The plan will include a roadmap of 
activities, evaluation metrics, and methods of measurement for the 
purpose of ongoing improvement of scientific integrity processes, 
procedures, and policies. As part of the monitoring and evaluation 
plan, an annual report on the number and outcomes of investigations 
involving allegations of loss of scientific integrity will be 
published. For investigations that have been resolved, the report will 
include an aggregate summary of the types of corrective actions 
recommended by the investigation panel to restore scientific integrity, 
and a summary of the types of actions ultimately taken. To the extent 
possible, all descriptions of investigations will be anonymized.

Related Policies and Statutes

    Violations of related and supporting policies may result in a loss 
of scientific integrity and it is appropriate for the SIO to coordinate 
across the agency in these matters, as appropriate. The following 
policies and programs intersect with the development of the culture of 
scientific integrity within the agency.

Research Misconduct

<bullet> Federal Research Misconduct Policy: https://
www.federalregister.gov/documents/2000/12/06/00-30852/executive-office-
of-the-president-

[[Page 84179]]

federal-policy-on-research-misconduct-preamble-for-research
<bullet<ls-thn-eq> Public Health Service Policies on Research 
Misconduct: https://www.ecfr.gov/current/title-42/chapter-I/subchapter-
H/part-93
<bullet> NIH Policy Manual Chapter 3006--NIH Intramural Research 
Program (IRP) Research Misconduct Proceedings: https://policymanual.nih.gov/3006
<bullet> NIH IRP Policies and Procedures for Research Misconduct 
Proceedings: https://oir.nih.gov/system/files/media/file/2021-08/policy-nih_irp_research_misconduct_proceedings.pdf

Diversity, Equity, Inclusion, and Accessibility in Addressing and 
Strengthening Scientific Integrity and the Disproportional Impact of 
Scientific Integrity Policy Violations on Underrepresented Groups

<bullet> HHS Equal Employment Opportunity and Anti-Harassment Policy: 
https://www.hhs.gov/about/agencies/asa/eeo/policy/index.html
<bullet<ls-thn-eq> Government-Wide Strategic Plan to Advance Diversity, 
Equity, Inclusion, and Accessibility in the Federal Workforce: https://www.whitehouse.gov/wp-content/uploads/2021/11/Strategic-Plan-to-Advance-Diversity-Equity-Inclusion-and-Accessibility-in-the-Federal-Workforce-11.23.21.pdf
<bullet<ls-thn-eq> HHS Diversity, Equity, Inclusion, and Accessibility 
Strategic Plan 2022: https://www.hhs.gov/sites/default/files/2022-hhs-deia-strategic-plan.pdf
<bullet> NIH-Wide Strategic Plan for Diversity, Equity, Inclusion, and 
Accessibility Fiscal Years 2023-2027: https://www.nih.gov/sites/default/files/about-nih/nih-wide-strategic-plan-deia-fy23-27.pdf

Public Access

<bullet> NIH Public Access Policy: https://sharing.nih.gov/public-access-policy
<bullet> OSTP Memorandum on Increasing Access to the Results of 
Federally Funded Research (2013): https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf
<bullet> OSTP Memorandum on Ensuring Free, Immediate, and Equitable 
Access to Federally Funded Research (2022): https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf
<bullet> 5 U.S.C. part 552--Freedom of Information Act: https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-5

Human and Animal Subject Protections

<bullet> Federal Policy for Protection of Human Research Subjects (the 
Common Rule): https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
<bullet> Animal Welfare Act and Regulations: https://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_508_comp_version.pdf
<bullet> Public Health Service Policy on Humane Care and Use of 
Laboratory Animals: https://olaw.nih.gov/policies-laws/phs-policy.htm
<bullet<ls-thn-eq> Guide for the Care and Use of Laboratory Animals: 
https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf
<bullet<ls-thn-eq> U.S. Government Principles for the Utilization and 
Care of Vertebrate Animals Used in Testing, Research, and Training: 
https://olaw.nih.gov/policies-laws/gov-principles.htm
<bullet<ls-thn-eq> NIH Policy Manual Chapter 3014--NIH Intramural Human 
Research Protection Program: https://policymanual.nih.gov/3014
<bullet<ls-thn-eq> NIH Policy Manual Chapter 3040-2--Animal Care and 
Use in the Intramural Research Program: https://policymanual.nih.gov/3040-2

Research Security

<bullet> National Security Presidential Memorandum 33 (NSPM 33): 
https://trumpwhitehouse.archives.gov/presidential-actions/presidential-memorandum-united-states-government-supported-research-development-national-security-policy/
<bullet<ls-thn-eq> Guidance for Implementing NSPM 33: https://www.whitehouse.gov/wp-content/uploads/2022/01/010422-NSPM-33-Implementation-Guidance.pdf

Whistleblower Protections

<bullet> 5 U.S.C. part 2302--Prohibited personnel practices: https://uscode.house.gov/view.xhtml?req=29&f=treesort&num=125
<bullet> Public Law 101-12--Whistleblower Protection Act of 1989: 
https://www.govinfo.gov/content/pkg/STATUTE-103/pdf/STATUTE-103-Pg16.pdf
<bullet> Public Law 103-424--Expansion of Whistleblower Protection Act 
of 1989: https://www.govinfo.gov/content/pkg/STATUTE-108/pdf/STATUTE-108-Pg4361.pdf#page=3
<bullet> Public Law 112-199--Whistleblower Protection Enhancement Act 
of 2012: https://www.congress.gov/112/statute/STATUTE-126/STATUTE-126-Pg1465.pdf
<bullet> 41 U.S.C. part 4712--Enhancement of contractor protection from 
reprisal for disclosure of certain information: https://uscode.house.gov/view.xhtml?req=(title:41%20section:4712%20edition:prelim)
<bullet<ls-thn-eq> Presidential Policy Directive 19--Protecting 
Whistleblowers with Access to Classified Information: https://www.usda.gov/sites/default/files/documents/ppd.pdf
<bullet<ls-thn-eq> U.S. Office of Special Counsel: https://osc.gov/
<bullet> 10 U.S.C. part 1034, made applicable to the Public Health 
Service Commissioned Corps through 42 U.S.C. 213a(a)(18) and 
implemented by Commissioned Corps Directive (CCD) 121.06: https://dcp.psc.gov/ccmis/ccis/documents/CCD121_06.pdf

 Other Related Policies

<bullet> NIH Data Management and Sharing Policy: https://sharing.nih.gov/data-management-and-sharing-policy
<bullet> Public Law 115-435--Foundations for Evidence-Based 
Policymaking Act (``Evidence Act''): https://www.congress.gov/115/plaws/publ435/PLAW-115publ435.pdf
<bullet> Public Law 107-174--Notification and Federal Employee 
Antidiscrimination and Retaliation Act (``No FEAR Act''): https://uscode.house.gov/statutes/pl/107/174.pdf
<bullet<ls-thn-eq> U.S. Government Policy for Institutional Oversight 
of Life Sciences Dual Use Research of Concern: https://www.phe.gov/s3/dualuse/documents/durc-policy.pdf
<bullet> U.S. Government Policy for Oversight of Life Sciences Dual Use 
Research of Concern: https://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf
<bullet> Public Law 92-463--The Federal Advisory Committee Act: https://uscode.house.gov/statutes/pl/92/463.pdf
<bullet> Public Law 104-13--Paperwork Reduction Act: https://www.congress.gov/104/plaws/publ13/PLAW-104publ13.pdf

Authorities

    Pursuant to the 2021 Presidential Memorandum on Restoring Trust in 
Government Through Scientific Integrity and Evidence-Based Policymaking 
at https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/, and consistent with the 
2009 Presidential Memorandum on Scientific Integrity at https://obamawhitehouse.archives.gov/the-press-office/memorandum-heads-executive-departments-and-agencies-3-9-09 and the 2010 Memorandum from

[[Page 84180]]

the White House Office of Science and Technology Policy on Scientific 
Integrity at https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf, all Federal 
agencies must establish a scientific integrity policy. The requirements 
of this policy are derived from the 2022 National Science and 
Technology Council (NSTC) Report of the Scientific Integrity Fast Track 
Action Committee, Protecting the Integrity of Government Science, at 
https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf, and align with the 
principles set forth in the NSTC guidance document, A Framework for 
Federal Scientific Integrity Policy and Practice, at https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf.
    This policy is established in accordance with:

1. Public Law 111-358--The America COMPETES Reauthorization Act of 
2010, Section 103, as amended
2. Public Law 115-435--The Foundations for Evidence-based Policymaking 
Act of 2018
3. Public Law 106-554--The Information Quality Act of 2000
4. 67 FR 8451--OMB Guidelines for Ensuring and Maximizing the Quality, 
Objectivity, Utility, and Integrity of Information Disseminated by 
Federal Agencies
5. 70 FR 2664--OMB Final Information Quality Bulletin for Peer Review
6. 65 FR 76260-76264--Federal Policy on Research Misconduct
7. Public Law 101-12--The Whistleblower Protection Act (WPA) of 1989, 
as amended
8. 41 U.S.C. part 4712--The National Defense Authorization Act, 
Enhancement of contractor protection from reprisal for disclosure of 
certain information
9. 5 U.S.C. part 13103 et seq.--The Ethics in Government Act of 1978, 
as amended, and 5 CFR parts 2634 and 2635, Executive Branch Financial 
Disclosure, Qualified Trusts, and Certificates of Divestiture and 
Standards of Ethical Conduct for Employees of the Executive Branch
10. 18 U.S.C. parts 201-209--Statutes regarding Bribery, Graft and 
Conflicts of Interest
11. 5 CFR parts 5501 and 5502--Supplemental Standards of Ethical 
Conduct for Employees of the Department of Health and Human Services
12. 5 U.S.C. Ch. 10--The Federal Advisory Committee Act of 1972
13. 45 CFR part 73--Standards of Conduct
14. 5 CFR part 735--Employee Responsibilities and Conduct
15. 45 CFR part 46--HHS Protection of Human Subjects Regulation
16. PPD 19--Protecting Whistleblowers with Access to Classified 
Information, 2012
17. M-20-12--OMB Phase 4 Implementation of the Foundations for 
Evidence-Based Policymaking Act of 2018: Program Evaluation Standards 
and Practices
18. 42 CFR part 93--Public Health Service Policies on Research 
Misconduct
19. 10 U.S.C. part 1034, made applicable to the Public Health Service 
Commissioned Corps through 42 U.S.C. 213a(a)(18) and implemented by 
Commissioned Corps Directive (CCD) 121.06
20. Public Law No 117-328--Health Extenders, Improving Access to 
Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 
2022, Division FF, Title II, Section 2321
21. Public Law No 117-167--CHIPS and Science Act of 2022, Title VI, 
Subtitle D, Section 10631

    Dated: October 15, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-24225 Filed 10-18-24; 8:45 am]
BILLING CODE 4140-01-P


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