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Notice2023-20733

Request for Information on the DRAFT Scientific Integrity Policy of the National Institutes of Health

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Published

September 25, 2023

Issuing agencies

Health and Human Services DepartmentNational Institutes of Health

Abstract

The National Institutes of Health (NIH) is soliciting comments and suggestions from the public on the DRAFT "Scientific Integrity Policy of the National Institutes of Health" (DRAFT NIH Scientific Integrity Policy). The DRAFT NIH Scientific Integrity 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.

Full Text

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<title>Federal Register, Volume 88 Issue 184 (Monday, September 25, 2023)</title>
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[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Pages 65696-65707]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20733]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Request for Information on the DRAFT Scientific Integrity Policy
of the National Institutes of Health

AGENCY: National Institutes of Health, HHS.

ACTION: Request for information.

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SUMMARY: The National Institutes of Health (NIH) is soliciting comments
and suggestions from the public on the DRAFT ``Scientific Integrity
Policy of the National Institutes of Health'' (DRAFT NIH Scientific
Integrity Policy). The DRAFT NIH Scientific Integrity 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: The DRAFT ``Scientific Integrity Policy of the National
Institutes of Health'' is open for public comment for a period of 45
days. To ensure consideration, comments must be submitted in writing by
November 9, 2023.

ADDRESSES: Comments may be submitted electronically at <a href="https://osp.od.nih.gov/comment-form-draft-scientific-integrity-policy-for-the-national-institutes-of-health/">https://osp.od.nih.gov/comment-form-draft-scientific-integrity-policy-for-the-national-institutes-of-health/</a>.

[[Page 65697]]

Comments are voluntary and may be submitted anonymously. You may also
voluntarily include your name and contact information with your
response. Other than your name and contact information, please do not
include in the response any personally identifiable information or any
information that you do not wish to make public. Proprietary,
classified, confidential, or sensitive information should not be
included in your response. After the Office of Science Policy (OSP) has
finished reviewing the responses, the responses may be posted to the
OSP website without redaction.

FOR FURTHER INFORMATION CONTACT: Tyrone Spady, Ph.D., Director of the
Science Policy Coordination, Collaboration & Reporting Division, Office
of Science Policy, at (301) 496-9838 or <a href="/cdn-cgi/l/email-protection#88dbebe1ede6ebedd8e7e4e1ebf1c8e7eca6e6e1e0a6efe7fe">[email&#160;protected]</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 (<a href="https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf</a>). In
its mission to seek fundamental knowledge about the nature and behavior
of living systems and apply that knowledge to enhance health, lengthen
life, and reduce illness and disability, 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 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 the key components of its commitment to
fostering scientific integrity in its NIH Policies and Procedures for
Promoting Scientific Integrity Report (<a href="http://www.nih.gov/sites/default/files/about-nih/nih-director/testimonies/nih-policies-procedures-promoting-scientific-integrity-2012.pdf">www.nih.gov/sites/default/files/about-nih/nih-director/testimonies/nih-policies-procedures-promoting-scientific-integrity-2012.pdf</a>), which outlines NIH's role 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
(<a href="http://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/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/</a>). 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
(<a href="http://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf">www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf</a>), 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 (<a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf">https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf</a>), 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
DRAFT Scientific Integrity Policy, which is in alignment with the
guidance set forth in the Presidential Memorandum and the draft
Scientific Integrity Policy of the U.S. Department of Health and Human
Services (<a href="http://www.hhs.gov/sites/default/files/draft-hhs-scientific-integrity-policy.pdf">www.hhs.gov/sites/default/files/draft-hhs-scientific-integrity-policy.pdf</a>). The DRAFT NIH Scientific Integrity Policy
articulates the procedures and processes in place at NIH that help
maintain rigorous scientific integrity practices and proposes 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 at <a href="https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf">https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf</a>,
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 DRAFT NIH Scientific Integrity Policy
proposes several new functions to further enhance existing practices
and processes. For example, the DRAFT NIH Scientific Integrity Policy
includes a Federal definition of scientific integrity that is shared
across the U.S. Government. This alignment across the U.S. Government
will ensure consistency in guidance and language, lending clarity and
uniformity to interagency efforts concerning scientific integrity. The
DRAFT NIH Scientific Integrity Policy also establishes the appointments
of, and roles and responsibilities for, the positions of NIH Chief
Scientist (CS) and Scientific Integrity Official (SIO). The CS and SIO
will have prominent and critical responsibilities in steering NIH's
scientific integrity efforts, advising NIH leadership on scientific
issues, and playing key roles in NIH's adjudication efforts related to
scientific integrity. The DRAFT NIH Scientific Integrity policy also
includes NIH practices that will address important emerging topics in
biomedical research, such as protecting against political interference.
NIH looks forward to working 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.

Request for Information

NIH seeks information regarding the DRAFT NIH Scientific Integrity
Policy from all interested individuals and communities, including, but
not limited to, investigators, research institutions, libraries,
scientific societies, healthcare providers, patients, students,
educators, research participants, and other members of the public.
While comments are welcome on all elements of the DRAFT NIH Scientific
Integrity Policy, input would be most welcome on the specific items
identified below, as they represent additions to existing NIH
scientific integrity practices:
1. Role and Responsibilities of the NIH SIO

[[Page 65698]]

2. Role and Responsibilities of the NIH CS
3. Responsibilities of the NIH Scientific Integrity Council
4. Prohibitions against Political Interference

Draft 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

The mission of NIH is to seek fundamental knowledge about the
nature and behavior of living systems and apply that knowledge to
enhance health, lengthen life, and reduce illness and disability. NIH
accomplishes this 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. 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 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 policymaking 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 <a href="https://www.nih.gov/sites/default/files/about-nih/nih-director/testimonies/nih-policies-procedures-promoting-scientific-integrity-2012.pdf">https://www.nih.gov/sites/default/files/about-nih/nih-director/testimonies/nih-policies-procedures-promoting-scientific-integrity-2012.pdf</a>. This document was updated in
2022 at <a href="https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf">https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf</a>, partly in response to the 2021
Presidential Memorandum on Restoring Trust in Government Through
Scientific Integrity and Evidence-Based Policymaking at <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/">https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/</a> 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. The majority of procedures regarding scientific integrity
described herein are longstanding and foundational to NIH-supported
research. This Scientific Integrity Policy integrates existing and new
practices under a single harmonized framework.

Effective Date and Policy Amendments

This policy goes into effect 12 months after publication of the
final policy in the Federal Register. This policy will be evaluated by
NIH one year after its effective date and regularly thereafter.
Proposals to amend this policy will be overseen by the NIH Scientific
Integrity Officer (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 and Scope

All NIH employees; Public Health Service Commissioned Corps
members; political appointees; clinical, research, and postdoctoral
fellows; doctoral trainees; interns; and advisory committee members in
their capacity as special Government employees, and those managing
scientific activities and using scientific information in policymaking,
are expected to adhere to NIH's policies 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 contractors, collaborators,
awardees, and volunteers to uphold the principles of scientific
integrity established by this policy.

Exceptions

This policy will be implemented consistent with applicable Federal
law.

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. In addition to scientific actions,
administrative actions may also be taken in response to substantiated
violations of this policy.
Covered individuals include all NIH employees; Public Health
Service Commissioned Corps members; political appointees; clinical,
research, and postdoctoral fellows; doctoral trainees; interns; and
advisory committee members in their capacity as special Government
employees, when in the course of their official duties they propose,
conduct, review, or communicate about science and scientific
activities; and all levels of employees who manage or supervise
scientific activities and use scientific information in policymaking.
NIH contractors, partners, permittees, lessees, grantees, and
volunteers who engage or assist in NIH scientific activities are not
considered covered individuals but are expected to uphold

[[Page 65699]]

the principles of scientific integrity described in this policy, as
incorporated into the terms of their engagement with NIH.
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 to
adherence to statutes, regulations, policies, and guidelines governing
employee conduct.
Federal agency refers to an Executive department, a U.S. Government
corporation, and an independent establishment.
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.1 2
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\1\ 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 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 (for example 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.
\2\ 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.\3\
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\3\ A report by the Scientific Integrity Fast-Track Action
Committee of the National Science and Technology Council.
``Protecting the Integrity of Government Science.'' January 11,
2022. Available at: <a href="https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf</a>.
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Policy refers to laws, regulations, procedures, administrative
actions, incentives, or voluntary practices of Governments and other
institutions.
Policymaking refers to the (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.
Political interference is inappropriately shaping or interfering in
the conduct, management, communication, or use of science for
inappropriate partisan advantage or such that it undermines
impartiality, nonpartisanship, or professional judgement.
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.\4\
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\4\ Federal Research Misconduct Policy, 65 FR 76260, 76262 (Dec.
6, 2000) and <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-H/part-93/subpart-A/section-93.103">https://www.ecfr.gov/current/title-42/chapter-I/subchapter-H/part-93/subpart-A/section-93.103</a>.
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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.
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.
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.\5\
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\5\ NIH Data Management and Sharing Policy at: <a href="https://sharing.nih.gov/data-management-and-sharing-policy">https://sharing.nih.gov/data-management-and-sharing-policy</a>.
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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.\6\)
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\6\ A Framework for Federal Scientific Integrity Policy and
Practice. Available at: <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf">https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf</a>.
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Scientific Integrity Council will assist the NIH 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.
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
policymaking. NIH recognizes organizational culture starts with
leadership at the highest levels. NIH has designated the Associate

[[Page 65700]]

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 CS shall:
1. Provide oversight of all NIH scientific integrity policies and
procedures, including the periodic updates of those policies and
procedures;
2. Engage 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 NIH or HHS
Scientific Integrity Policies.
The SIO shall:
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, participate on the
HHS 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 Analysis (OMA), and the HHS Office of the
Inspector General (OIG);
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; and
9. Promote agency efforts regarding diversity, equity, inclusion,
and accessibility.

NIH Scientific Integrity Council

The NIH SIO shall establish an NIH Council comprising career
employees from across the 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 SIO in adjudicating allegations of
losses 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; and
6. Determine handling of investigation and adjudication proceedings
from which the HHS 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 <a href="https://oir.nih.gov/">https://oir.nih.gov/</a>.

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 <a href="https://grants.nih.gov/aboutoer/intro2oer.htm">https://grants.nih.gov/aboutoer/intro2oer.htm</a>.

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, human subjects protections, the organization and
management of the 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 <a href="https://osp.od.nih.gov/">https://osp.od.nih.gov/</a>.

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.

[[Page 65701]]

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, discrimination, and
exploitation.
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 has posted the NIH Scientific Integrity Policy prominently on
its website and ensures 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. 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.
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 Policymaking Processes
IV. Ensuring Accountability
V. Protecting Scientists
VI. Professional Development for Government Scientists, and
VII. Federal Advisory Committees
I. Protecting Scientific Processes
NIH has implemented a suite of 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 or such that it undermines
impartiality, nonpartisanship, or professional judgement. Further
processes will be developed and documented to support this policy in an
NIH manual chapter.
It is the policy of NIH to:
1. Prohibit political interference or other inappropriate influence
in the design, proposal, conduct, management, evaluation, communication
of, and use of scientific activities conducted by covered individuals.
2. Prohibit inappropriate restrictions on resources and capacity
that limit and reduce the availability of science and scientific
products outside of normal budgetary or priority-setting processes or
without scientific, legal, or security justification.\7\
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\7\ This provision is further outlined in the NIH Policy Manual
Chapter 3005 on Review and Evaluation of Intramural Programs.
Available at: <a href="https://policymanual.nih.gov/3005">https://policymanual.nih.gov/3005</a>.
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3. Require that leadership and management ensure that covered
individuals engaged in scientific activities can conduct their work
objectively and free from political interference or other inappropriate
influence.
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 have made a substantial
contribution or provided editorial revisions that include critical
intellectual content, approved the final version, and 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.\8\
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\8\ 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: <a href="https://oir.nih.gov/system/files/media/file/2023-08/guidelines-conduct_research.pdf">https://oir.nih.gov/system/files/media/file/2023-08/guidelines-conduct_research.pdf</a>.
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6. Ensure independent review of scientific activities conducted by
covered individuals as appropriate to ensure scientific integrity.\9\
---------------------------------------------------------------------------

\9\ This provision is further outlined in the NIH Policy Manual
Chapter 3005 on Review and Evaluation of Intramural Programs.
Available at: <a href="https://policymanual.nih.gov/3005">https://policymanual.nih.gov/3005</a>.
---------------------------------------------------------------------------

7. Require that covered individuals comply with NIH policies and
procedures for planning and conducting 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.\10\
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\10\ This provision is further outlined in the NIH Policy Manual
Chapter 3006 on NIH Intramural Research Program (IRP) Research
Misconduct Proceedings. Available at: <a href="https://policymanual.nih.gov/3006">https://policymanual.nih.gov/3006</a>.
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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.\11\
---------------------------------------------------------------------------

\11\ This provision is further outlined in the NIH Conflict of
Interest and Confidentiality Certification for Individuals
Evaluating all NIH Intramural Programs. Available at: <a href="https://oir.nih.gov/system/files/media/file/2021-08/conflict_of_interest-bsc_reviews.pdf">https://oir.nih.gov/system/files/media/file/2021-08/conflict_of_interest-bsc_reviews.pdf</a>.
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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,

[[Page 65702]]

established laws, regulations, policies, and ethical
considerations.\12\
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\12\ 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: <a href="https://policymanual.nih.gov/3014">https://policymanual.nih.gov/3014</a> and <a href="https://policymanual.nih.gov/3040-2">https://policymanual.nih.gov/3040-2</a>
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 personnel of NIH 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.\13\
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\13\ 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) and Chips
and Science Act, Public Law 117-167, title VI, subtitle D, section
10631 (Aug 9, 2022). OSTP guidance and relevant HHS and NIH policies
to implement this legislation are forthcoming at the time of
publication of this policy.
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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.\14\
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\14\ 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) and Chips
and Science Act, Public Law 117-167, title VI, subtitle D, section
10631 (Aug 9, 2022). OSTP guidance and relevant HHS policies to
implement this legislation are forthcoming at the time of
publication of this policy.
---------------------------------------------------------------------------

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,
rigorous, research results, and their publication in reputable, peer-
reviewed scientific journals. NIH's IRP researchers adhere to a NIH-
wide Policy for Manuscript and Abstract Clearance Procedures at <a href="https://oir.nih.gov/sourcebook/submitting-research-publications/publication-abstract-clearance">https://oir.nih.gov/sourcebook/submitting-research-publications/publication-abstract-clearance</a> and follow established guidance to ensure
transparency in research findings through Processes for Authorship
Dispute Resolution at <a href="https://oir.nih.gov/sourcebook/ethical-conduct/authorship-guidelines-resources/nih-irp-authorship-conflict-resolution-process">https://oir.nih.gov/sourcebook/ethical-conduct/authorship-guidelines-resources/nih-irp-authorship-conflict-resolution-process</a> if the situation arises.
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.
Consistent with open science expectations, NIH shall 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.15 16 17 18
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\15\ 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: <a href="https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf">https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf</a>.
\16\ 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: <a href="https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf</a>.
\17\ 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: <a href="https://policymanual.nih.gov/1184">https://policymanual.nih.gov/1184</a>.
\18\ This provision is further outlined in the NIH Data
Management and Sharing Policy. Available at: <a href="https://sharing.nih.gov/data-management-and-sharing-policy">https://sharing.nih.gov/data-management-and-sharing-policy</a>.
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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 media regarding
their scientific activities and areas of expertise, subject to
limitations of Government ethics rules. In communicating with the
media, NIH scientists are encouraged to seek advice from career NIH
communications experts.
4. Allow, subject to limitations of Government ethics rules, NIH
scientists to express their personal views and opinions with
appropriate written or oral disclaimers, including on social media.\19\
NIH scientists may name NIH as their employer in the context of
biographical information but 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.
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\19\ This provision is further outlined in the United States
Office of Government Ethics Standards of Conduct and 18 U.S.C. 208
as Applied to Official Social Media Use. Available at: https://
oge.gov/web/oge.nsf/News+Releases/EAE37A7DA3C38BF38525894700775339/
$FILE/LA-23-
03%20The%20Standards%20of%20Conduct%20and%2018%20U.S.C.%20%C2%A7%2020
8%20as%20Applied%20to%20Official%20Social%20Media%20Use.pdf.
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5. 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 shall be given the option to review the scientific content of
proposed communication documents.
6. Ensure that NIH scientists may communicate their scientific
activities objectively without political interference or other
inappropriate influence. Scientific products (e.g., manuscripts for
scientific journals, presentations for workshops, conferences, and
symposia) shall adhere to relevant NIH technical review procedures.
7. Require that NIH officials, including communications officers,
shall not alter, nor direct 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.
8. 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

[[Page 65703]]

without scientific, legal, or security justification.
9. Ensure that scientific information is accurately represented in
responses provided by NIH to Congressional inquiries, testimony, and
other requests.
10. 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.
11. Violations of clearance policies that result in suppression,
delay, or alteration of scientific and technological information
produced by NIH scientists without scientific, legal, or security
justification constitute violations of the NIH Scientific Integrity
Policy and may be reported under the procedures for Addressing
Scientific Integrity Concerns.
III. Supporting Policymaking Processes
NIH utilizes multiple mechanisms for ensuring transparency and
accountability in developing policy. The development of science policy
at NIH generally follows procedures set forth under the Administrative
Procedure Act (5 U.S.C. Subchapter II) at <a href="https://www.archives.gov/federal-register/laws/administrative-procedure">https://www.archives.gov/federal-register/laws/administrative-procedure</a>, 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.\20\ For example, as
described in the Bulletin, when independent peer reviews of scientific
information products are conducted by contractors, a conflict-of-
interest review shall be conducted.
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\20\ Office of Management and Budget. ``Final Information
Quality Bulletin for Peer Review.'' Federal Register. Doc. 05-769.
Available at: <a href="https://www.federalregister.gov/documents/2005/01/14/05-769/final-information-quality-bulletin-for-peer-review">https://www.federalregister.gov/documents/2005/01/14/05-769/final-information-quality-bulletin-for-peer-review</a>.
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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
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 with 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 anyone 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 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
<a href="https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf">https://osp.od.nih.gov/wp-content/uploads/2023/09/SI_Compendium-2022Update.pdf</a>. The designation of an NIH SIO will allow for more
centralized interagency communication and coordination concerning
allegations to 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.
2. Encourage and facilitate early informal or formal consultation
between NIH employees 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 shall
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 shall document the necessary aspects for each
step of the process as well as the roles of 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 he or she 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

[[Page 65704]]

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 <a href="https://oig.hhs.gov/about-oig/">https://oig.hhs.gov/about-oig/</a>.
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.\21\
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\21\ This provision is further outlined in the NIH Sourcebook on
Personnel. Available at: <a href="https://oir.nih.gov/sourcebook/personnel">https://oir.nih.gov/sourcebook/personnel</a>.
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2. Promote diversity, equity, inclusion, and accessibility in the
scientific workforce and to create and support the creation of safe
workspaces that are free from harassment, discrimination, and
exploitation.\22\
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\22\ This provision is further outlined in the NIH Sourcebook
Addendum to BSC Policies and Procedures. Available at: <a href="https://oir.nih.gov/sourcebook/processes-reviewing-nih-intramural-science/boards-scientific-counselors/addendum-policies-procedures">https://oir.nih.gov/sourcebook/processes-reviewing-nih-intramural-science/boards-scientific-counselors/addendum-policies-procedures</a>.
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3. Protect from reprisal those individuals who report allegations
of loss of scientific integrity in good faith. Efforts will also be
made to protect from inappropriate actions those covered individuals
alleged to have compromised scientific integrity.
4. Prevent NIH employees 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. 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 reprisal 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 Corps officers through section 1129 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), and
implemented by Commissioned Corps Directive 121.06.
6. Scientific integrity staff at NIH are protected by all
applicable employee rights as required by law. Consistent with
applicable law, an SIO or other scientific integrity staff may not be
terminated or reassigned without good cause or legitimate
organizational reason. Possible good cause reasons include, but are not
limited to, consistent poor performance, inefficiency, neglect of duty,
malfeasance, conviction of a felony, conduct involving moral turpitude,
knowing violation of a law, rule, or regulation, gross mismanagement,
gross waste of funds, and abuse of authority.
VI. Professional Development for Government Scientists
A key aspect of the NIH effort to advance scientific integrity is
encouraging NIH IRP researchers to engage with the broader research
community in maintaining the highest ethical standards and scientific
norms. 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.
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.\23\
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\23\ This provision is further outlined in the NIH Data
Management and Sharing Policy. Available at: <a href="https://sharing.nih.gov/data-management-and-sharing-policy">https://sharing.nih.gov/data-management-and-sharing-policy</a>.
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2. Encourage the sharing of scientific activities, findings, and
materials developed by covered individuals through appropriate avenues
including digital repositories.\24\
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\24\ This provision is further outlined in the NIH Data
Management and Sharing Policy. Available at: <a href="https://sharing.nih.gov/data-management-and-sharing-policy">https://sharing.nih.gov/data-management-and-sharing-policy</a>.
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3. Encourage covered individuals to participate in and present
research at professional meetings including workshops, conferences, and
symposia.\25\
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\25\ This provision is further outlined in the NIH Sourcebook on
Tenure in the NIH Intramural Research Program. Available at: <a href="https://oir.nih.gov/sourcebook/tenure-nih-intramural-research-program">https://oir.nih.gov/sourcebook/tenure-nih-intramural-research-program</a>.
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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.\26\
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\26\ This provision is further outlined in the NIH Sourcebook on
Activities with Outside Organizations and the NIH Official Duty
Activities Chart. Available at: <a href="https://oir.nih.gov/sourcebook/ethical-conduct/research-ethics/nih-policies/intramural-extramural-collaborations/activities-outside-organizations">https://oir.nih.gov/sourcebook/ethical-conduct/research-ethics/nih-policies/intramural-extramural-collaborations/activities-outside-organizations</a> and <a href="https://ethics.od.nih.gov/sites/default/files/topics/ODA/2-ODA-Chart.pdf">https://ethics.od.nih.gov/sites/default/files/topics/ODA/2-ODA-Chart.pdf</a>,
respectively.
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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 NIH scientists 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
<a href="https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/legislation-and-regulations/the-federal-advisory-committee-act">https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/legislation-and-regulations/the-federal-advisory-committee-act</a>, are an important tool within NIH for ensuring the
credibility, quality, and transparency of NIH science. NIH shall 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,

[[Page 65705]]

including, when practical and appropriate, announcing vacancies with a
notification in the Federal Register.
2. Select members to serve on a scientific or technical FACs based
on expertise, knowledge, and contribution to the relevant subject
area.27 28 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.\29\ Ensure committee
membership is fairly balanced in terms of points of view represented
with respect to the functions to be performed by the
FAC.30 31
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\27\ This provision is further outlined in How Scientists Are
Selected to Be Members of a Chartered Review Group. Available at:
<a href="https://public.csr.nih.gov/ForReviewers/BecomeAReviewer/CharteredReviewers">https://public.csr.nih.gov/ForReviewers/BecomeAReviewer/CharteredReviewers</a>.
\28\ 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.
\29\ This provision is further outlined in the NIH Selection
Criteria for NIH Advisory Committees. Available at: <a href="https://ofacp.nih.gov/sites/default/files/SelectionCriteria.pdf">https://ofacp.nih.gov/sites/default/files/SelectionCriteria.pdf</a>.
\30\ 2010 Memorandum from the White House Office of Science and
Technology Policy on Scientific Integrity. Available at: <a href="https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf">https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf</a>.
\31\ General Services Administration 41 CFR parts 101-6 and 02-3
Federal Advisory Committee Management; Final Rule. Available at:
<a href="https://www.gsa.gov/system/files/FACAFinalRule_R2E-cNZ_0Z5RDZ-i34K-pR.pdf">https://www.gsa.gov/system/files/FACAFinalRule_R2E-cNZ_0Z5RDZ-i34K-pR.pdf</a>.
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3. Comply with current standards governing conflict of interest as
defined in statutes and implementing regulations.32 33
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\32\ 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: <a href="https://policymanual.nih.gov/1810-1">https://policymanual.nih.gov/1810-1</a>.
\33\ 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: <a href="https://sgeportal.od.nih.gov/Pages/default.aspx">https://sgeportal.od.nih.gov/Pages/default.aspx</a>.
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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
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.\34\ 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.\35\ As noted above, existing procedures under the purview
of OER, OIR, OMA, and OIG should continue to be followed. When those
existing mechanisms do not cover a scientific integrity concern:
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\34\ 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. Further information about these processes and
offices will be provided in a manual chapter.
\35\ 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
Office of Special Counsel for information regarding retaliation
based on whistleblowing. Further information can be found at:
<a href="https://www.edi.nih.gov/resolutions/resources/faqs">https://www.edi.nih.gov/resolutions/resources/faqs</a> and <a href="https://oig.hhs.gov/fraud/whistleblower/">https://oig.hhs.gov/fraud/whistleblower/</a>. 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.
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.
3. The SIO will oversee an initial assessment of each reported
concern and determine whether to request additional information from
the complainant or others 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 from the
NIH Scientific Integrity Council 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. NIH encourages its scientists
to respectfully express and engage with differing views as an integral
part of the scientific process.\36\ 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

[[Page 65706]]

resolution measures among NIH scientists. In general:
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\36\ Further information on the NIH IRP Authorship Conflict
Resolution Process can be found in the NIH Sourcebook. Available at:
<a href="https://oir.nih.gov/sourcebook/ethical-conduct/authorship-guidelines-resources/nih-irp-authorship-conflict-resolution-process">https://oir.nih.gov/sourcebook/ethical-conduct/authorship-guidelines-resources/nih-irp-authorship-conflict-resolution-process</a>.
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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. 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. 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: <a href="https://www.federalregister.gov/documents/2000/12/06/00-30852/executive-office-of-the-president-federal-policy-on-research-misconduct-preamble-for-research">https://www.federalregister.gov/documents/2000/12/06/00-30852/executive-office-of-the-president-federal-policy-on-research-misconduct-preamble-for-research</a>
<bullet> 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: <a href="https://policymanual.nih.gov/3006">https://policymanual.nih.gov/3006</a>
<bullet> NIH IRP Policies and Procedures for Research Misconduct
Proceedings: <a href="https://oir.nih.gov/system/files/media/file/2021-08/policy-nih_irp_research_misconduct_proceedings.pdf">https://oir.nih.gov/system/files/media/file/2021-08/policy-nih_irp_research_misconduct_proceedings.pdf</a>

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:
<a href="https://www.hhs.gov/about/agencies/asa/eeo/policy/index.html">https://www.hhs.gov/about/agencies/asa/eeo/policy/index.html</a>
<bullet> Government-Wide Strategic Plan to Advance Diversity, Equity,
Inclusion, and Accessibility in the Federal Workforce: <a href="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">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</a>
<bullet> HHS Diversity, Equity, Inclusion, and Accessibility Strategic
Plan 2022: <a href="https://www.hhs.gov/sites/default/files/2022-hhs-deia-strategic-plan.pdf">https://www.hhs.gov/sites/default/files/2022-hhs-deia-strategic-plan.pdf</a>
<bullet> NIH-Wide Strategic Plan for Diversity, Equity, Inclusion, and
Accessibility Fiscal Years 2023-2027: <a href="https://www.nih.gov/sites/default/files/about-nih/nih-wide-strategic-plan-deia-fy23-27.pdf">https://www.nih.gov/sites/default/files/about-nih/nih-wide-strategic-plan-deia-fy23-27.pdf</a>

Public Access

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

Human and Animal Subject Protections

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

Research Security

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

Whistleblower Protections

<bullet> 5 U.S.C. 2302--Prohibited personnel practices: <a href="https://uscode.house.gov/view.xhtml?req=29&f=treesort&num=125">https://uscode.house.gov/view.xhtml?req=29&f=treesort&num=125</a>
<bullet> Public Law 101-12--Whistleblower Protection Act of 1989:
<a href="https://www.govinfo.gov/content/pkg/STATUTE-103/pdf/STATUTE-103-Pg16.pdf">https://www.govinfo.gov/content/pkg/STATUTE-103/pdf/STATUTE-103-Pg16.pdf</a>
<bullet> Public Law 103-424--Expansion of Whistleblower Protection Act
of 1989: <a href="https://www.govinfo.gov/content/pkg/STATUTE-108/pdf/STATUTE-108-Pg4361.pdf#page=3">https://www.govinfo.gov/content/pkg/STATUTE-108/pdf/STATUTE-108-Pg4361.pdf#page=3</a>
<bullet> Public Law 112-199--Whistleblower Protection Enhancement Act
of 2012: <a href="https://www.congress.gov/112/statute/STATUTE-126/STATUTE-126-Pg1465.pdf">https://www.congress.gov/112/statute/STATUTE-126/STATUTE-126-Pg1465.pdf</a>
<bullet> 41 U.S.C. 4712--Enhancement of contractor protection from
reprisal for disclosure of certain information: <a href="https://uscode.house.gov/view.xhtml?req=">https://uscode.house.gov/view.xhtml?req=</a>(title:41%20section:4712%20edition:prelim)
<bullet> Presidential Policy Directive 19--Protecting Whistleblowers
with Access to Classified Information: <a href="https://www.usda.gov/sites/default/files/documents/ppd.pdf">https://www.usda.gov/sites/default/files/documents/ppd.pdf</a>
<bullet> U.S. Office of Special Counsel: <a href="https://osc.gov/">https://osc.gov/</a>

[[Page 65707]]

<bullet> 10 U.S.C. 1034, made applicable to the Public Health Service
Commissioned Corps through section 1129 of the Food and Drug
Administration Safety and Innovation Act, Public Law 112-144, and
implemented by Commissioned Corps Directive (CCD) 121.06: <a href="https://dcp.psc.gov/ccmis/ccis/documents/CCD121_06.pdf">https://dcp.psc.gov/ccmis/ccis/documents/CCD121_06.pdf</a>

Other Related Policies

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

Authorities

Pursuant to the 2021 Presidential Memorandum on Restoring Trust in
Government Through Scientific Integrity and Evidence-Based Policymaking
at <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/">https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/27/memorandum-on-restoring-trust-in-government-through-scientific-integrity-and-evidence-based-policymaking/</a>, and consistent with the
2009 Presidential Memorandum on Scientific Integrity at <a href="https://obamawhitehouse.archives.gov/the-press-office/memorandum-heads-executive-departments-and-agencies-3-9-09">https://obamawhitehouse.archives.gov/the-press-office/memorandum-heads-executive-departments-and-agencies-3-9-09</a> and the 2010 Memorandum from
the White House Office of Science and Technology Policy on Scientific
Integrity at <a href="https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf">https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/scientific-integrity-memo-12172010.pdf</a>, 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
<a href="https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf</a>, and align with the
principles set forth in the NSTC guidance document A Framework for
Federal Scientific Integrity Policy and Practice at <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf">https://www.whitehouse.gov/wp-content/uploads/2023/01/01-2023-Framework-for-Federal-Scientific-Integrity-Policy-and-Practice.pdf</a>.

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. 4712--The National Defense Authorization Act, Enhancement
of contractor protection from reprisal for disclosure of certain
information
9. 5 U.S.C. 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. 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. HHS Protection of Human Subjects Regulation (45 CFR part 46).
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. 1034, made applicable to the Public Health Service
Commissioned Corps through section 1129 of the Food and Drug
Administration Safety and Innovation Act, Public Law 112-144, and
implemented by Commissioned Corps Directive (CCD) 121.06
20. 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)
21. Chips and Science Act, Public Law 117-167, title VI, subtitle D,
section 10631 (Aug 9, 2022)

Dated: September 19, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2023-20733 Filed 9-22-23; 8:45 am]
BILLING CODE 4140-01-P

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