Notice2024-24225
Final Scientific Integrity Policy of the National Institutes of Health
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 21, 2024
Effective
December 30, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Institutes of Health (NIH) is issuing this Final NIH Scientific Integrity Policy to promote a continuing culture of scientific integrity at NIH. This Policy codifies NIH's long-standing expectations to preserve scientific integrity throughout all NIH activities, establishes key roles and responsibilities for those who will lead the agency's scientific integrity program, and, as appropriate, establishes relevant reporting and evaluation mechanisms.
Full Text
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<title>Federal Register, Volume 89 Issue 203 (Monday, October 21, 2024)</title>
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[Federal Register Volume 89, Number 203 (Monday, October 21, 2024)]
[Notices]
[Pages 84166-84180]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24225]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Final Scientific Integrity Policy of the National Institutes of
Health
AGENCY: National Institutes of Health, HHS.
ACTION: Notice of final policy.
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SUMMARY: The National Institutes of Health (NIH) is issuing this Final
NIH Scientific Integrity Policy to promote a continuing culture of
scientific integrity at NIH. This Policy codifies NIH's long-standing
expectations to preserve scientific integrity throughout all NIH
activities, establishes key roles and responsibilities for those who
will lead the agency's scientific integrity program, and, as
appropriate, establishes relevant reporting and evaluation mechanisms.
DATES: This Final Policy is effective on December 30, 2024.
FOR FURTHER INFORMATION CONTACT: Jessica Tucker, Ph.D., Acting Deputy
Director, Office of Science Policy, NIH, at (301) 496-9838 or
<a href="/cdn-cgi/l/email-protection#84d7e7ede1eae7e1d4ebe8ede7fdc4ebe0aaeaedecaae3ebf2"><span class="__cf_email__" data-cfemail="4c1f2f2529222f291c2320252f350c232862222524622b233a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
Scientific integrity aims to make sure that science is conducted,
managed, communicated, and used in ways that preserve its accuracy and
objectivity and protect it from suppression, manipulation, and
inappropriate influence (<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
support of our mission, NIH has always sought to incorporate robust
scientific integrity principles and practices throughout every level of
its scientific enterprise. In fostering scientific integrity, NIH aims
to ensure that (1) scientific findings are objective, credible, and
readily available to the public, and (2) the development and
implementation of policies and programs is transparent, accountable,
and evidence-based. NIH has numerous policies and procedures to ensure
the Nation's investment in biomedical
[[Page 84167]]
research is scientifically robust and rigorous and that our workforce
maintains the highest standards of integrity. In supporting the NIH
mission, all NIH researchers and staff are expected to:
<bullet> Foster an organizational culture of scientific integrity,
<bullet> Protect the integrity of the research process,
<bullet> Communicate science with integrity, and
<bullet> Safeguard scientific integrity.
In 2012, NIH summarized its continuing efforts to foster scientific
integrity in its NIH Policies and Procedures for Promoting Scientific
Integrity Report (<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>). In this report, NIH outlines the various roles it
plays in fostering scientific integrity as a funder of research, a
research institution, and a policy development agency. In 2021, the
White House released its Presidential Memorandum on Restoring Trust in
Government Through Scientific Integrity and Evidence-Based Policymaking
(<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
Final NIH Scientific Integrity Policy, which is in alignment with the
guidance set forth in the Presidential Memorandum and the Final
Scientific Integrity Policy of the U.S. Department of Health and Human
Services (<a href="https://www.hhs.gov/programs/research/scientificintegrity/index.html">https://www.hhs.gov/programs/research/scientificintegrity/index.html</a>). The Final NIH Scientific Integrity Policy articulates the
procedures and processes in place at NIH that help maintain rigorous
scientific integrity practices and outlines several new functions to
further enhance scientific integrity at NIH and throughout the NIH
biomedical research enterprise.
NIH accomplishes its mission by funding extramural researchers
throughout the country, conducting research within its intramural
research program, and developing policies and programs to responsibly
advance biomedical research. In 2022, NIH updated its NIH Policies and
Procedures for Promoting Scientific Integrity (2022) report (<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 Final NIH
Scientific Integrity Policy outlines several new functions to further
enhance existing practices and processes. For example, the Final NIH
Scientific Integrity Policy includes a Federal definition of scientific
integrity that is shared across the U.S. Government as outlined in the
White House Framework. This alignment across the U.S. Government will
help ensure consistency in guidance and language, lending clarity and
uniformity to interagency efforts concerning scientific integrity. The
Final NIH Scientific Integrity Policy also establishes the appointments
of, and roles and responsibilities for, the positions of the NIH Chief
Scientist (CS) and the NIH Scientific Integrity Official (SIO). The CS
and SIO will have prominent and critical responsibilities in steering
the NIH scientific integrity efforts, advising NIH leadership on
scientific issues, and playing key roles in NIH adjudication efforts
related to scientific integrity. The Final NIH Scientific Integrity
Policy also includes NIH practices that will address important emerging
topics in biomedical research, such as protecting against political
interference.
Overview of Public Comments
NIH released its Request for Information on the Draft NIH
Scientific Integrity Policy on September 25, 2023 (88 FR 65696: <a href="https://www.federalregister.gov/documents/2023/09/25/2023-20733/request-for-information-on-the-draft-scientific-integrity-policy-of-the-national-institutes-of">https://www.federalregister.gov/documents/2023/09/25/2023-20733/request-for-information-on-the-draft-scientific-integrity-policy-of-the-national-institutes-of</a>; comment period closed on November 9, 2023). In response
to the Draft Policy, NIH received 26 responses from interested parties,
and the comments are publicly available at <a href="https://osp.od.nih.gov/policies/scientific-integrity/">https://osp.od.nih.gov/policies/scientific-integrity/</a>. The largest group of respondents
reported no affiliation, followed by affiliation with professional
societies, with a small percentage of respondents indicating
affiliation with research institutions, industry, and advocacy
coalitions. Respondents typically identified themselves as members of
the public, while another sizeable section self-identified as
scientific researchers. Remaining respondents identified as
institutional officials, and smaller percentages self-identified as
medical providers, government officials, and scholarly publishers. NIH
considered all feedback in the development of the Final NIH Scientific
Integrity Policy, and a discussion of the public comments on specific
topics follows below.
Discussion of Public Comments on the Draft NIH Scientific Integrity
Policy
Policy Scope
Draft Policy: The Draft NIH Scientific Integrity Policy explicitly
outlined the categories of NIH employees and staff with defined roles
and responsibilities when in the course of their official duties they
propose, conduct, review, or communicate about science and scientific
activities on behalf of NIH. It also stated that NIH has implemented
separate policies for contractors, collaborators, awardees, and
volunteers to uphold the principles of scientific integrity.
Public Comments: While commenters were generally supportive of the
overall scope of the Draft NIH Scientific Integrity Policy, a few
suggested clarifying how it might impact the extramural community,
applicability to HHS officials and political appointees, and NIH
employees engaging in program administrative roles.
Final Policy: The Final NIH Scientific Integrity Policy clarifies
that the Policy applies to all NIH employees; Public Health Service
Commissioned Corps officers assigned to NIH; NIH political appointees;
NIH intramural clinical, research, and postdoctoral fellows; NIH
intramural doctoral trainees; advisory committee members in their
capacity as special Government employees; and all levels of employees
managing scientific activities, engaging in program administrative
roles, and using scientific information in decision making when in the
course of their official duty activities they propose, conduct, review,
or communicate about science and scientific activities on
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behalf of NIH. Extramural investigators are not encompassed under this
Policy unless they otherwise meet the qualifications of a covered
individual (e.g., membership on a Federal Advisory Committee in their
capacity as a special Government employee); nevertheless, many
individuals across the entire scientific enterprise have a role in
supporting scientific integrity more broadly.
Roles and Responsibilities of the Chief Scientist and the Scientific
Integrity Official
Draft Policy: The Draft NIH Scientific Integrity Policy proposed
the appointments as well as roles and responsibilities for the
positions of NIH Chief Scientist (CS) and NIH Scientific Integrity
Official (SIO). It indicated that the CS and SIO will have prominent
and critical responsibilities in steering NIH scientific integrity
efforts, advising NIH leadership on scientific issues, and playing key
roles in agency adjudication efforts related to scientific integrity.
Public Comments: While commenters were generally supportive of the
establishment and proposed roles and responsibilities of the CS and
SIO, a few suggested clarifying both roles and adding additional roles
and responsibilities for other NIH leadership. Suggestions also
included clearly defining the adjudication processes for losses of
scientific integrity and ensuring adequate resources are allotted to
the SIO and staff to implement the Policy and proactively seek out
potential allegations of losses of scientific integrity.
Final Policy: The Final NIH Scientific Integrity Policy affirms the
roles and responsibilities of the CS and SIO required by the 2021
Presidential Memorandum and includes some additional roles and
responsibilities suggested by public comments. Detailed processes for
adjudicating findings of loss of scientific integrity will be outlined
in a NIH Manual Chapter and/or additional guidance. Additionally, NIH
will ensure the SIO and other relevant agency offices and staff receive
adequate support and resources to fulfill the functions outlined in the
Policy.
Roles and Responsibilities of the Scientific Integrity Council
Draft Policy: The Draft NIH Scientific Integrity Policy proposed
the establishment of a NIH Scientific Integrity Council comprising
career employees from across NIH to be led by the NIH SIO. It indicated
that the Council would assist the SIO in iterative review, policy
development, and priority setting to ensure that the existing policies
and procedures are responsive to issues that arise in the scientific
integrity space.
Public Comments: Commenters were generally supportive of the
establishment and proposed roles and responsibilities of the Council
and suggested ensuring that it include a well-informed and a high-level
group of experts on scientific integrity. Among the comments were
suggestions for including desired areas of expertise for Council
members, articulating a more explicit role of the Council in the
adjudication process, and requiring the group to work with offices such
as the NIH Tribal Health Research Office to consider any potential
cultural implications. Additionally, a few commenters suggested that
the NIH Scientific Integrity Council, the CS, and the SIO should
consult with and/or include external experts to avoid potential
conflicts of interest.
Final Policy: The Final NIH Scientific Integrity Policy describes
desired expertise areas for Council members and affirms the roles and
responsibilities of the Council. Processes for the role the Council
will play in adjudicating findings of loss of scientific integrity will
be outlined in additional implementation guidance. The Council will
work with all pertinent NIH offices and seek public input when needed
to ensure appropriate expertise on pertinent topics. All members of the
Council, the CS, and the SIO will be expected to comply with existing
conflict of interest policies and procedures.
Promoting a Culture of Scientific Integrity
Draft Policy: The Draft NIH Scientific Integrity Policy stated that
diversity, equity, inclusion, and accessibility (DEIA) are integral
components of the entire scientific process, and that attention to DEIA
can improve the success of the scientific workforce, foster innovation
in the conduct and use of science, and provide for more equitable
participation in science by diverse communities. The Draft Policy
additionally noted that all NIH employees will receive scientific
integrity information or training as new employees, and NIH, in concert
with HHS, will make available training for covered individuals and
others, as applicable.
Public Comments: Several commenters expressed support for the
inclusion of DEIA within scientific integrity principles. Several
commenters noted the importance of mandatory training for all NIH
employees, not just the sharing of information on scientific integrity.
Final Policy: The Final NIH Scientific Integrity Policy affirms the
NIH stance that a strong culture of scientific integrity begins with
ensuring a professional environment that is safe, equitable, fair,
just, impartial, honest, and inclusive; DEIA are integral components of
the entire scientific process. The Policy also states that scientific
integrity training will be made available to all covered individuals,
and some covered individuals may be required to complete role-specific
training or refresher training as appropriate.
Ensuring Free Flow of Scientific Information
Draft Policy: The Draft NIH Scientific Integrity Policy affirmed
NIH's commitment to the broad and equitable dissemination and promotion
of rigorous and objective scientific information. It highlighted the
role of the NIH Office of Communications and Public Liaison in
disseminating objective and evidence-based research findings to the
public and responding to public inquiries. It also reiterated that NIH
scientists may communicate their scientific activities objectively
without political interference or other inappropriate influence.
Public Comments: While commenters were generally supportive of the
Draft NIH Scientific Integrity Policy provisions on ensuring the free
flow of scientific information, a few noted that further delineation of
scientists' ability to communicate with the media and public freely
about their areas of expertise was needed and indicated that protection
from potential bad faith attacks should be provided. Some commenters
also suggested clarifying the differences between and processes for
scientific technical review and media review.
Final Policy: The Final NIH Scientific Integrity Policy provides
additional guidance on how NIH scientists may communicate scientific
information while performing official duty activities and defines and
protects against retaliation. The Final Policy reaffirms that NIH
scientists and other covered individuals can communicate their personal
or individual views to the media or the public in their personal
capacities, including on social media, subject to the limitations of
government ethics rules, HHS supplemental ethics regulations, social
media regulations, and obligation to protect nonpublic information. The
Final Policy also clarifies the requirements and
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protections for scientific technical review processes.
Protections
Draft Policy: The Draft NIH Scientific Integrity Policy described
NIH's commitment to prioritizing safe and respectful work environments
as well as existing protections for employees to disclose information
that the individual reasonably believes is evidence of a violation of
law, rule, or regulation; gross mismanagement; gross waste of funds;
and abuse of authority; or a substantial and specific danger to public
health or safety. The Draft Policy also affirmed NIH's commitment to
hiring and retaining candidates for NIH scientific and technical
positions based on the candidate's scientific and technical knowledge,
credentials, experience, and integrity.
Public Comments: Some commenters expressed the need for further
protections for individuals who report allegations of loss of
scientific integrity. Several commenters affirmed the importance of
promoting DEIA with regard to the NIH workforce, grantmaking apparatus,
and other activities and recommended further elaboration of specific
groups who should be included and considered in efforts to promote
diversity.
Final Policy: The Final NIH Scientific Integrity Policy describes
protections from reprisal for individuals who report allegations of
loss of scientific integrity, including whistleblower protections. The
Final Policy also affirms NIH's commitment to promoting equity in the
scientific workforce and includes a robust description of the types of
demographic groups that will be considered regarding efforts to promote
equity.
Policy Implementation
Draft Policy: The Draft NIH Scientific Integrity Policy proposed a
delay between a final policy release and its effective date in order to
communicate policy expectations to covered individuals and develop
specific implementation details and plans. Expected implementation
activities would include the establishment of an evaluation plan to
regularly measure, monitor, and evaluate ongoing scientific integrity
activities and outcomes. As part of the monitoring and evaluation plan,
an annual report on the number and outcomes of investigations involving
allegations of loss of scientific integrity would be published.
Public Comments: Several commenters requested that additional
implementation details be added to the Policy, including information on
the allegations reporting and appeals processes, applicable
consequences, an evaluation plan, publication best practices, and plans
for public input, including meaningful engagements to build trust with
marginalized communities. Specifically, a comment noted that the annual
report should include specific details regarding the allegation, the
inquiry process, and the outcome of the investigation.
Final Policy: Consistent with other NIH policy development
activities, additional implementation details will continue to be
developed and publicly released. Given the bulk of implementation
activities fall on NIH directly and not on our grantee institutions or
contractors, NIH has chosen to enact a three-month implementation
period. All implementation plans will comply with existing policies and
regulations regarding conflicts of interest, whistleblower protections,
etc. The Final NIH Scientific Integrity Policy notes that, for
investigations that have been resolved, the annual report will include
the types of corrective actions recommended by the investigation panel
to restore scientific integrity, and the types of actions ultimately
taken. Additionally, NIH will continue to seek input from the public,
and the scientific integrity reporting process will also allow
opportunities for public transparency. NIH is committed to promoting
equity across the biomedical research enterprise and will consider
additional methods to engage with communities historically
underrepresented in biomedical research, including through existing
robust outreach programs and initiatives.
Additional Changes to Final Policy
Some additional changes were made to the Final NIH Scientific
Integrity Policy in response to public comments, for clarity, or to
maintain consistency with the Final HHS Scientific Integrity Policy.
Some of these additional changes include slight revisions to the
definition of ``political interference,'' a new definition of
``retaliation,'' clarification of training requirements, and under
``Protecting Scientific Processes,'' a statement noting that early
termination of extramural awards is prohibited except under certain
specific circumstances.
Concluding Points
The Final NIH Scientific Integrity Policy builds upon and
consolidates NIH's longstanding efforts to foster an organizational
culture of scientific integrity, protect the integrity of the research
process, communicate science with integrity, and safeguard scientific
integrity. This Final NIH Scientific Integrity Policy is another step
in ensuring that NIH's work as an institution maintains the highest
standards of integrity and represents the best of the Nation's
investment in biomedical research.
NIH looks forward to continuing to work across the U.S. Government
to support our shared commitment to responsible stewardship of the
Nation's investment in biomedical research by maintaining and
bolstering rigorous scientific integrity practices in taxpayer-funded
biomedical research.
The Final NIH Scientific Integrity Policy is set forth below.
Scientific Integrity Policy of the National Institutes of Health
Purpose
The purpose of this policy is to promote a continuing culture of
scientific integrity at the National Institutes of Health (NIH). This
policy aims to ensure the integrity of all aspects of NIH scientific
activities, including proposing, conducting, reviewing, managing, and
communicating about science and scientific activities, and using the
results of science to inform policy and program decision making.
Scientific Integrity at NIH
In support of our mission, NIH funds extramural researchers
throughout the country, conducts research within its intramural
research program, and develops policies and programs to responsibly
advance biomedical research. Embedding principles of scientific
integrity throughout the NIH enterprise relies on two key elements. The
first element is an all-hands-on-deck approach in which scientific
rigor and research quality are prioritized. The second element is
having inclusive, robust processes that safeguard scientific integrity.
In fostering scientific integrity, NIH aims to ensure that (1)
scientific findings are objective, credible, and readily available to
the public, and (2) the development and implementation of policies and
programs is transparent, accountable, and evidence-based. NIH has
numerous policies and procedures to ensure the Nation's investment in
biomedical research is scientifically robust and rigorous and that our
workforce maintains the highest standards of integrity.
Public input and accountability are woven throughout NIH processes
to assure the public of the credibility of
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our science and our scientific findings. These activities range from
presenting potential scientific solicitations at public meetings (e.g.,
concept clearance) to soliciting community feedback during decision
making activities. In supporting the NIH mission, all NIH researchers
and staff are expected to:
<bullet> Foster an organizational culture of scientific integrity,
<bullet> Protect the integrity of the research process,
<bullet> Communicate science with integrity, and
<bullet> Safeguard scientific integrity.
NIH's long-standing commitment to fostering scientific integrity
was summarized in its 2012 report, NIH Policies and Procedures for
Promoting Scientific Integrity at <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 at <a href="https://www.hhs.gov/programs/research/scientificintegrity/index.html">https://www.hhs.gov/programs/research/scientificintegrity/index.html</a>. The majority of procedures regarding scientific integrity
described herein are longstanding and foundational to NIH-supported
research. The NIH Scientific Integrity Policy integrates existing and
new practices under a single harmonized framework.
Effective Date and Policy Amendments
This policy goes into effect on December 30, 2024. This policy will
be evaluated by NIH one year after its effective date and every two
years thereafter. Proposals to amend this policy will be overseen by
the NIH Scientific Integrity Official (SIO), in collaboration with the
NIH Scientific Integrity Council (Council) described below, and any
such amendments will be communicated to HHS and the Director of the
White House Office of Science and Technology Policy (OSTP) no later
than 30 days after adoption.
Applicability & Scope
All NIH employees; Public Health Service Commissioned Corps
officers assigned to NIH; NIH political appointees; NIH intramural
clinical, research, and postdoctoral fellows; NIH intramural doctoral
trainees; advisory committee members in their capacity as special
Government employees; and all levels of employees managing scientific
activities, engaging in program administrative roles, and using
scientific information in decision making, are expected to adhere to
this policy when in the course of their official duties they propose,
conduct, review, or communicate about science and scientific activities
on behalf of NIH. When relevant, NIH has also implemented separate
policies for entities who are not covered individuals, such as
contractors, collaborators, extramural awardees, peer reviewers and
volunteers, to uphold the principles of scientific integrity
established by this policy while carrying out activities on behalf of
NIH or within the scope of NIH support or engagement. The primary focus
of this policy is on covered individuals' performance of official duty
activities on behalf of NIH. Federal employees must adhere to the
Standards of Ethical Conduct for Employees of the Executive Branch,\1\
which delineates requirements (and certain restrictions) for Federal
employees when acting on behalf of the Federal government.
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\1\ Standards of Ethical Conduct for Employees of the Executive
Branch (5 CFR part 2635) provide the basic guidelines for official
duty activities, and NIH sets the policy for implementing the
guidelines at the agency. Available at: <a href="https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635">https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635</a>.
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Exceptions
This policy will be implemented consistent with applicable Federal
law and Executive Orders.
Definitions
For the purposes of this policy, NIH adopts the following
definitions:
Allegation refers to a disclosure of a suspected loss of scientific
integrity.
Chief Scientist (CS) provides oversight of all NIH scientific
integrity policies and procedures. NIH recognizes organizational
culture starts with leadership at the highest levels. It has designated
the NIH Principal Deputy Director as the NIH CS.
Corrective scientific action refers to actions taken to restore the
accuracy of the scientific record after a loss of scientific integrity
has been determined, consistent with this policy, such as correction or
retraction of published materials.
Covered individuals include all NIH employees; Public Health
Service Commissioned Corps officers assigned to NIH; NIH political
appointees; NIH intramural clinical, research, and postdoctoral
fellows; NIH intramural doctoral trainees; advisory committee members
in their capacity as special Government employees; and all levels of
employees who manage scientific activities, engage in program
administrative roles, and use scientific information in decision making
when in the course of their official duty activities they propose,
conduct, review, or communicate about science and scientific activities
on behalf of NIH. NIH contractors, partners, permittees, lessees,
grantees, extramural trainees and fellows (i.e., those supported by NIH
grants to non-NIH organizations), and volunteers who engage or assist
in NIH scientific activities are not considered covered individuals but
are strongly encouraged to uphold the principles of scientific
integrity described in this policy while carrying out activities on
behalf of NIH or within the scope of NIH support or engagement,
particularly those described in the Protecting Scientific Processes,
Ensuring the Free Flow of Scientific Information, Protections, and
Professional Development sections of this policy; additionally,
specific requirements may be incorporated into the terms of their
engagement with NIH.
Decision making refers to (1) development of policies or making
determinations about policy or management; (2) making determinations
about expenditures of Federal agency funds; (3) implementing or
managing activities that involve, or rely on, scientific activities.
Ethical behavior refers to activities that reflect norms for
conduct that distinguish between acceptable and unacceptable behavior,
such as honesty, lawfulness, equity, and professionalism, and adherence
to statutes, regulations, policies, and guidelines governing employee
conduct.
Federal agency refers to an Executive department, a U.S. Government
corporation, or an independent establishment.
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Inclusivity refers to the practice of providing equal access to
opportunities for full participation of all people and all groups,
including marginalized, underserved, and underrepresented contributors,
without bias or prejudice. Full participation is enabled through
implementation of strategies that promote equitable access and fair
treatment in the organization.
Inappropriate influence refers to the attempt to shape or interfere
in scientific activities or the communication about or use of
scientific activities, against well-accepted scientific methods and
theories and without scientific, legal, programmatic management, or
security justification.<SUP>2 3</SUP>
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\2\ Examples may include (1) suppressing a decisionmaker's
ability to offer the best judgment based on scientific information;
(2) suppressing, altering or delaying the release of a scientific
product for any reason other than technical merit, security or legal
review, review for compliance with existing policies, or providing
advance notification; (3) removing or reassigning scientific
personnel for any reason other than performance, conduct, or
budgetary constraints; (4) using scientific products that are not
representative of the current state of scientific knowledge and
research (e.g., because of a lack of appropriate peer review, poor
methodology, or flawed analyses) to inform decision making and
policy formulation; or (5) misrepresenting the underlying
assumptions, uncertainties, or probabilities of scientific products.
This is not intended to be an exhaustive list.
\3\ Differences of scientific opinion are not necessarily
inappropriate influence. Additionally, NIH officials are regularly
expected to provide agency perspectives when acting in their
official capacity.
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Interference refers to inappropriate, scientifically unjustified
intervention in the conduct, management, communication, or use of
science. It includes censorship, suppression, or distortion of
scientific or technological findings, data, information, or
conclusions; inhibiting scientific independence during clearance and
review; scientifically unjustified intervention in research and data
collection; and inappropriate engagement or participation in peer
review processes or on Federal advisory committees (FACs).
Loss of scientific integrity refers to the failure to comply with
this Scientific Integrity Policy or to adhere to objectivity,
transparency, and ethical behavior when conducting, managing, using the
results of, and communicating about science and scientific activities.
This loss may include research misconduct or inappropriate influence in
the conduct, communication, management, and use of science.
Official duty activity refers to activities performed by an
employee as part of, or an extension of, regular official
responsibilities.\4\
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\4\ The Standards of Ethical Conduct for Employees of the
Executive Branch (5 CFR part 2635) provide the basic guidelines for
official duty activities, and NIH sets the policy for implementing
the guidelines at the agency. Available at: <a href="https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635">https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635</a>.
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Policy refers to laws, regulations, procedures, administrative
requirements or actions, incentives, or voluntary practices of
Governments and other institutions.
Political interference is inappropriately shaping or interfering in
the conduct, management, communication, or use of science for
inappropriate partisan advantage such that it undermines impartiality,
objectivity, nonpartisanship, or professional judgment.
Research integrity refers to the use of honest and verifiable
methods in proposing, performing, and evaluating research; reporting
research results with particular attention to adherence to rules,
regulations, and guidelines; and following commonly accepted
professional codes or norms.
Research misconduct refers to fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or in
reporting research results. Research misconduct does not include honest
error or differences of opinion.\5\
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\5\ Federal Research Misconduct Policy, 65 FR 76260, 76262 (Dec.
6, 2000) and <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.
Retaliation refers to, per 5 U.S.C. 2302(b)(8), taking or failing
to take or threatening to take or fail to take a personnel action with
respect to any employee or applicant for employment because of any
disclosure of information that the employee or applicant reasonably
believes evidences any violation of any law, rule, or regulation or
gross mismanagement, a gross waste of funds, an abuse of authority, or
a substantial and specific danger to public health or safety if such
disclosure is not specifically prohibited by law and if such
information is not specifically required by Executive Order to be kept
secret in the interest of national defense or the conduct of foreign
affairs. An employee or applicant is protected from retaliation for the
disclosure of information the employee or applicant reasonably believes
is evidence of censorship related to research, analysis, or technical
information.<SUP>6 7</SUP>
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\6\ Protection of Certain Disclosures of Information by Federal
Employees. Available at: <a href="https://home.treasury.gov/system/files/306/WPEA-2012-PL-112-199.pdf">https://home.treasury.gov/system/files/306/WPEA-2012-PL-112-199.pdf</a>.
\7\ Prohibited personnel practices. Available at: <a href="https://www.govinfo.gov/content/pkg/USCODE-2022-title5/pdf/USCODE-2022-title5-partIII-subpartA-chap23-sec2302.pdf">https://www.govinfo.gov/content/pkg/USCODE-2022-title5/pdf/USCODE-2022-title5-partIII-subpartA-chap23-sec2302.pdf</a>.
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Science refers to the full spectrum of scientific endeavors,
including basic science, applied science, evaluation, engineering,
technology, economics, social sciences, and statistics, as well as the
scientific and technical information derived from these endeavors and
including multiple forms of evidence (e.g., Indigenous Knowledge).
Scientific activities refer to activities that involve the
application of well-accepted scientific methods and theories in a
systematic manner, and includes, but is not limited to, data
collection, inventorying, monitoring, evaluation, statistical analysis,
surveying, observations, experimentation, study, research, integration,
economic analysis, forecasting, predictive analytics, modeling,
technology development, and scientific assessment, as well as any
findings derived from these activities.
Scientific data refers to recorded factual material commonly
accepted in the scientific community as of sufficient quality to
validate and replicate research findings, regardless of whether the
data are used to support scholarly publications. Scientific data does
not include laboratory notebooks, preliminary analyses, completed case
report forms, drafts of scientific papers, plans for future research,
peer reviews, communications with colleagues, or physical objects, such
as laboratory specimens.\8\
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\8\ NIH Data Management and Sharing Policy at: <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.\9\)
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\9\ 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
[[Page 84172]]
development, and priority setting to ensure that the existing policies
and procedures are responsive to issues that arise in the scientific
integrity space.
Scientific Integrity Official (SIO) is the primary official for
responsibilities over scientific integrity matters and reports to the
NIH CS. This policy empowers the NIH SIO with the independence
necessary to gather and protect information to support the review and
assessment of scientific integrity concerns. The NIH SIO will also
advocate for appropriate engagement of scientific leadership in
decision making. NIH recognizes organizational culture starts with
leadership at the highest levels. NIH has designated the Associate
Director of Science Policy as the NIH SIO.
Scientific record refers to published information resulting from
scientific activities. NIH is responsible for ensuring the accuracy of
elements of the scientific record that are published by NIH.
Scientist refers to an individual whose responsibilities include
collection, generation, use, or evaluation of scientific and technical
data, analyses, or products. NIH scientists are NIH employees and other
covered individuals who conduct these activities. It does not refer to
individuals with scientific and technical training whose primary job
functions are in non-scientific roles (e.g., policymakers,
communicators).
Roles and Responsibilities
Chief Scientist and Scientific Integrity Official
The Chief Scientist (CS) will:
1. Provide oversight of all NIH scientific integrity policies and
procedures, including the periodic updates of those policies and
procedures;
2. Engage in agency efforts regarding diversity, equity, inclusion,
and accessibility;
3. Provide for the resourcing and staffing needs of the NIH
scientific integrity program;
4. Promote scientific integrity across the agency; and
5. Serve as an alternate in scientific integrity adjudication
processes if the NIH SIO is alleged to have violated the NIH or HHS
Scientific Integrity Policies.
The Scientific Integrity Official (SIO) will:
1. Report to the CS on all matters related to scientific integrity;
2. Periodically update the NIH Scientific Integrity Policy;
3. Provide regular reporting on NIH scientific integrity
allegations and outcomes to OSTP and the public;
4. Determine the resourcing and staffing needs of the NIH
scientific integrity program;
5. Promote scientific integrity across the agency;
6. Lead the NIH Scientific Integrity Council, and participate on
the HHS Scientific Integrity Council and other interagency efforts
regarding scientific integrity;
7. Serve as a focal point for the receipt of agency scientific
integrity allegations (particularly related to political interference)
that fall outside of existing processes managed by the Office of
Extramural Research (OER), the Office of Intramural Research (OIR), the
Office of Management Assessment (OMA), and the HHS Office of the
Inspector General (OIG) (e.g., as related to waste, fraud, abuse, and
illegal activities);
8. Lead the review and adjudication of allegations of loss of NIH
scientific integrity (particularly related to political interference)
in cases where such allegations fall outside of existing processes
managed by OER, OIR, OMA, and OIG (e.g., as related to waste, fraud,
abuse, and illegal activities); and
9. Promote agency efforts regarding diversity, equity, inclusion,
and accessibility.
NIH Scientific Integrity Council
The NIH SIO will establish and convene an NIH Council comprising
career employees with expertise in ethics, research integrity, research
misconduct, communications, whistle blower protections, and other
relevant administrative areas from across NIH and from relevant NIH
offices. This committee will assist the SIO in iterative review, policy
development, and priority setting to ensure that the existing policies
and procedures are responsive to issues that arise in the scientific
integrity space.
The primary responsibilities of the Council are to:
1. Ensure that a well-informed and high-level group of experts
supports scientific integrity at NIH;
2. Ensure that the NIH Scientific Integrity Policy is implemented
consistently across NIH;
3. Review, assess, and revise the NIH Scientific Integrity Policy
as needed;
4. Engage NIH leadership in upholding the principles of scientific
integrity and maintaining leadership awareness of scientific integrity
issues as necessary and appropriate;
5. As requested, assist the NIH SIO in adjudicating allegations of
loss of scientific integrity (particularly related to political
interference) in cases where such allegations fall outside of existing
processes managed by OER, OIR, OMA, and OIG (e.g., waste, fraud, abuse,
and illegal activities);
6. In addition to being composed of relevant experts, confer with
relevant offices (e.g., Tribal Health Research Office, Chief Officer
for Scientific Workforce Diversity, and Sexual and Gender Minority
Research Office) when additional expertise is needed; and
7. Determine handling of investigation and adjudication proceedings
from which the NIH SIO is recused.
Background on NIH Functions
Intramural Research
The Intramural Research Program (IRP) is the internal research
program of NIH, known for its synergistic approach to biomedical
science. The IRP is the largest biomedical research program on earth,
and its unique environment means the IRP can facilitate opportunities
to conduct both long-term and high-impact science that would otherwise
be difficult to undertake. The NIH IRP conducts research and training
within its laboratories and clinics, and when appropriate, collaborates
with the private sector to develop technologies of importance to public
health. To help ensure the high quality and integrity of its intramural
programs, NIH has developed and implemented NIH-wide policies and
review standards for research, training, and technology transfer. The
NIH Policy Manual at https://policymanual.nih.gov/is an official
mechanism of issuing NIH-wide policy and all Manual Chapter issuances.
More information about the NIH IRP can be found on the NIH OIR website
at <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
[[Page 84173]]
<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, public access to the results of NIH-funded
research, human subjects and research animal protections, the
organization and management of NIH, and the outputs and value of NIH-
funded research. This is accomplished through a wide range of analyses
and reports, commentary on emerging policy proposals, and the
development of policy proposals for consideration by NIH, the Federal
Government, and the public. More information about NIH policy
development can be found on the NIH Office of Science Policy (OSP)
website at <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. NIH works to
promote a culture of scientific integrity by creating an empowering
environment for innovation and protecting scientists and the process of
science from inappropriate interference. Scientific findings and
products must not be suppressed, delayed, or altered for political
purposes and must not be subjected to political interference or
inappropriate influence.
A strong culture of scientific integrity begins with ensuring a
professional environment that is safe, equitable, fair, just,
impartial, honest, and inclusive. Diversity, equity, inclusion, and
accessibility (DEIA) are integral components of the entire scientific
process. Attention to DEIA can improve the success of the scientific
workforce, foster innovation in the conduct and use of science, and
provide for more equitable participation in science by diverse
communities. The responsible and ethical conduct of research and other
scientific activities requires an environment that is equitable,
inclusive, safe, and free from harassment and discrimination.
NIH also works to apply scientific integrity practices in ways that
are inclusive of non-traditional modes of science, such as citizen
science, community-engaged research, participatory science, and
crowdsourcing. This may include expanded scientific integrity practices
and expectations, such as seeking greater input from communities and
participants into the research questions and design, recognition of
data and knowledge sovereignty, and inclusion of multiple forms of
evidence, such as Indigenous Knowledge.
NIH will prominently post and maintain the NIH Scientific Integrity
Policy on its website and will ensure education is available for all
covered individuals, as well as contractors who perform scientific
activities for the agency, on their rights and responsibilities related
to scientific integrity. Scientific integrity training will be made
available to all covered individuals, and some covered individuals may
be required to complete role-specific training or refresher training as
appropriate.
To promote a culture of scientific integrity at NIH, this policy
outlines seven specific areas:
I. Protecting Scientific Processes
II. Ensuring the Free Flow of Scientific Information
III. Supporting Decision Making Processes
IV. Ensuring Accountability
V. Protections
VI. Professional Development for Government Scientists, and
VII. Federal Advisory Committees
I. Protecting Scientific Processes
NIH has implemented a suite of complementary efforts to protect the
integrity of research processes from bias and interference, which is
essential to upholding public trust and confidence. These efforts rely
on transparent processes, diverse community engagement, management of
real or apparent conflicts of interest, and robust and open dialogue.
NIH utilizes a variety of mechanisms to achieve these aims, such as
holding policy discussions in open settings, soliciting public input on
future research directions, and the use of Federal advisory committees
(FACs) to advise the agency. In addition, for covered individuals, NIH
explicitly prohibits political interference or inappropriately shaping
or interfering in the conduct, management, communication, or use of
science for inappropriate partisan advantage such that it undermines
impartiality, objectivity, nonpartisanship, or professional judgment.
Further processes will be developed and documented to support this
policy in an NIH Manual Chapter and/or additional guidance.
It is the policy of NIH to:
1. Prohibit political interference or other inappropriate influence
in the design, proposal, conduct, review, management, evaluation,
communication of, and use of scientific activities and scientific
information conducted by covered individuals.
2. Prohibit inappropriate restrictions on resources and capacity
that limit and reduce the availability of science and scientific
products (e.g., manuscripts for scientific journals, presentations for
workshops, conferences, and symposia) outside of normal budgetary or
priority-setting processes or without scientific, legal, or security
justification.\10\
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\10\ This provision is further outlined in the NIH Policy Manual
Chapter 3005 on Review and Evaluation of Intramural Programs.
Available at: <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, free from political interference or other inappropriate
influence, and free from retaliation.
4. Require reasonable efforts by covered individuals to ensure the
fidelity of the scientific record and to correct identified
inaccuracies that pertain to their contribution to any scientific
records.
5. Require that covered individuals represent their contributions
to scientific work fairly and accurately and neither accept nor assume
unauthorized and/or unwarranted credit for another's accomplishments.
To be named as an author, contributors should, at a minimum, have (1)
made a substantial contribution or provided editorial revisions that
include critical intellectual content, (2) approved the final version,
and (3) agreed to be accountable for all aspects of the work to which
they contributed. Prior consent should be obtained from each author to
be represented on a particular work. Obtaining prior consent for
acknowledgements is also a good practice.\11\
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\11\ This provision is further outlined in the 2023 8th Edition
of Guidelines and Policies for the Conduct of Research in the
Intramural Research Program at NIH. Available at: <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.\12\
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\12\ This provision is further outlined in the NIH Policy Manual
Chapter 3005 on Review and Evaluation of Intramural Programs.
Available at: <a href="https://policymanual.nih.gov/3005">https://policymanual.nih.gov/3005</a>.
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7. Require that covered individuals comply with NIH policies and
procedures for planning and conducting
[[Page 84174]]
scientific activities and show appropriate diligence toward protecting
and conserving Federal research resources, such as equipment and other
property, and records of data and results that are entrusted to them.
8. Prohibit research misconduct, the deliberate or reckless use of
improper or inappropriate research methods or processes, and
noncompliance with practices that safeguard the quality of research and
other scientific activities or enhance research security for covered
individuals.\13\
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\13\ This provision is further outlined in the NIH Policy Manual
Chapter 3006 on NIH Intramural Research Program (IRP) Research
Misconduct Proceedings. Available at: <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.\14\
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\14\ This provision is further outlined in the NIH Conflict of
Interest and Confidentiality Certification for Individuals
Evaluating all NIH Intramural Programs. Available at: <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, established laws,
regulations, policies, and ethical considerations.\15\
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\15\ This provision is further outlined in the NIH Policy Manual
Chapter 3014 on NIH Intramural Human Research Protection Program and
the NIH Policy Manual Chapter 3040-2 on Animal Care and Use in the
Intramural Research Program. Available at: <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 NIH personnel engaged in intramural research from
participation in foreign talent recruitment programs, unless the
participation is in an international conference or other international
exchange, partnership, or program for which such participation has been
approved by the appropriate authority in NIH.\16\
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\16\ Health Extenders, Improving Access to Medicare, Medicaid,
and CHIP, and Strengthening Public Health Act of 2022, Public Law
117-328, Division FF, Title II, Section 2321 (Jan 3, 2023) at
<a href="https://www.congress.gov/117/plaws/publ328/PLAW-117publ328.pdf">https://www.congress.gov/117/plaws/publ328/PLAW-117publ328.pdf</a> and
Chips and Science Act, Public Law 117-167, Title VI, Subtitle D,
Section 10631 (Aug 9, 2022) at <a href="https://www.congress.gov/117/plaws/publ167/PLAW-117publ167.pdf">https://www.congress.gov/117/plaws/publ167/PLAW-117publ167.pdf</a>. OSTP guidance and relevant HHS and NIH
policies to implement this legislation are available at: <a href="https://www.whitehouse.gov/wp-content/uploads/2024/02/OSTP-Foreign-Talent-Recruitment-Program-Guidelines.pdf">https://www.whitehouse.gov/wp-content/uploads/2024/02/OSTP-Foreign-Talent-Recruitment-Program-Guidelines.pdf</a> and <a href="https://grants.nih.gov/policy/foreign-interference/requirements-for-disclosure">https://grants.nih.gov/policy/foreign-interference/requirements-for-disclosure</a>.
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13. Consistent with OSTP guidance and relevant HHS and NIH policy,
require disclosure of participation in foreign talent recruitment
programs, including the provision of copies of all grants, contracts,
or other agreements related to such programs, and other supporting
documentation related to such programs, as a condition of receipt of
Federal extramural research funding awarded through NIH.\17\
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\17\ Health Extenders, Improving Access to Medicare, Medicaid,
and CHIP, and Strengthening Public Health Act of 2022, Public Law
117-328, Division FF, Title II, Section 2321 (Jan 3, 2023) at
<a href="https://www.congress.gov/117/plaws/publ328/PLAW-117publ328.pdf">https://www.congress.gov/117/plaws/publ328/PLAW-117publ328.pdf</a> and
Chips and Science Act, Public Law 117-167, Title VI, Subtitle D,
Section 10631 (Aug 9, 2022) at <a href="https://www.congress.gov/117/plaws/publ167/PLAW-117publ167.pdf">https://www.congress.gov/117/plaws/publ167/PLAW-117publ167.pdf</a>. OSTP guidance and relevant HHS and NIH
policies to implement this legislation are available at: <a href="https://www.whitehouse.gov/wp-content/uploads/2024/02/OSTP-Foreign-Talent-Recruitment-Program-Guidelines.pdf">https://www.whitehouse.gov/wp-content/uploads/2024/02/OSTP-Foreign-Talent-Recruitment-Program-Guidelines.pdf</a> and <a href="https://grants.nih.gov/policy/foreign-interference/requirements-for-disclosure">https://grants.nih.gov/policy/foreign-interference/requirements-for-disclosure</a>.
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14. Prohibit the suspension or early termination of an extramural
grant awarded by NIH except as consistent with applicable law and
grants policies.<SUP>18 19</SUP>
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\18\ <a href="https://grants.nih.gov/policy/nihgps/index.htm">https://grants.nih.gov/policy/nihgps/index.htm</a>
\19\ 45 CFR 75.372. Available at: https://<a href="http://www.govinfo.gov/content/pkg/CFR-2022-title45-vol1/pdf/CFR-2022-title45-vol1-sec75-372.pdf">www.govinfo.gov/content/pkg/CFR-2022-title45-vol1/pdf/CFR-2022-title45-vol1-sec75-372.pdf</a>.
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II. Ensuring the Free Flow of Scientific Information
NIH is committed to the broad and equitable dissemination and
promotion of rigorous and objective scientific information. The NIH
Office of Communications and Public Liaison (OCPL) and communication
offices within the NIH Institutes, Centers, and Offices (NIH ICOs)
disseminate objective and evidence-based research findings to the
public through websites, listservs, brochures, videos, social media,
and other modes of communication as appropriate. NIH OCPL and the ICO
communication offices also respond to public inquiries and engage with
technical and non-technical audiences through media and online forums
to ensure responsible communication regarding the research it funds.
At the foundation of the NIH mission is the generation of reliable
and rigorous research results, and their publication in reputable,
peer-reviewed scientific journals. NIH's IRP researchers adhere to the
Standards of Ethical Conduct for Employees of the Executive Branch (5
CFR part 2635) \20\ and the NIH-wide Policy for Manuscript and Abstract
Clearance Procedures at <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.
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\20\ Standards of Ethical Conduct for Employees of the Executive
Branch (5 CFR part 2635) provide the basic guidelines for official
duty activities, and NIH sets the policy for implementing the
guidelines at the agency. Available at: <a href="https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635">https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635</a>.
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It is the policy of NIH to:
1. Facilitate the free flow of scientific and technological
information, to the extent permissible by Federal laws and
regulations.\21\ Consistent with open science expectations, NIH will
expand and promote access to scientific and technological information
by making it available freely and without embargo to the public in an
online digital format.<SUP>22 23 24 25</SUP>
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\21\ Per the Standards of Ethical Conduct for Employees of the
Executive Branch (5 CFR part 2635), ``Employees shall not knowingly
make unauthorized commitments or promises of any kind purporting to
bind the Government.'' Available at: <a href="https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635">https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635</a>.
\22\ White House Office of Science and Technology Policy
Memorandum for the Heads of Executive Departments and Agencies on
Increasing Access to the Results of Federally Funded Scientific
Research. February 22, 2013. Available at: <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>.
\23\ White House Office of Science and Technology Policy
Memorandum for the Heads of Executive Departments and Agencies on
Ensuring Free, Immediate, and Equitable Access to Federally Funded
Research. August 25, 2022. Available at: <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>.
\24\ This provision is further outlined in the NIH Policy Manual
Chapter 1184 on Preparation and Clearance of Scientific, Technical,
and Public Information Presented by NIH Employees or Produced for
Distribution by NIH. Available at: <a href="https://policymanual.nih.gov/1184">https://policymanual.nih.gov/1184</a>.
\25\ 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
[[Page 84175]]
media regarding their scientific activities and areas of expertise,
subject to limitations of Government ethics rules (5 CFR part 2635). In
communicating with the media, NIH scientists must seek advice from
career NIH communications experts when acting in their official
capacities.
4. Allow NIH scientists and other covered individuals to express
their personal views and opinions to the media with appropriate written
or oral disclaimers, including on social media, subject to the
limitations of Government ethics rules, HHS supplemental ethics
regulations, social media regulations, and obligation to protect
nonpublic information.\26\ NIH scientists and other covered individuals
may name NIH as their employer as one biographical fact among several;
however, their title and position cannot receive more prominence than
any other biographical fact. They should not be sourced by the media as
an NIH representative and shall refrain from making or publishing
statements that could be construed as being judgments of, or
recommendations on, NIH or any other Federal Government policy,
including the use of NIH or other U.S. Government seals or logos,
unless they have secured appropriate prior approval to do so.\27\
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\26\ Per the Standards of Ethical Conduct for Employees of the
Executive Branch (5 CFR part 2635), ``Employees shall not knowingly
make unauthorized commitments or promises of any kind purporting to
bind the Government.'' Available at: <a href="https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635">https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635</a>.
\27\ These provisions are consistent with and do not supersede,
conflict with, or otherwise alter the employee obligations, rights,
or liabilities created by existing statute or Executive order
relating to (1) classified information, (2) communications to
Congress, (3) the reporting to an Inspector General of a violation
of any law, rule, or regulation, or mismanagement, a gross waste of
funds, an abuse of authority, or a substantial and specific danger
to public health or safety, or (4) any other whistleblower
protection.
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5. Require that technical review and clearance processes include
provisions for timely clearance and expressly forbid censorship,
unreasonable delay, and suppression of objective communication of data
and results without valid scientific, legal, or security justification.
Deviations from clearance policies or procedures that result in
suppression, delay, or alteration of scientific and technological
information without scientific, legal, or security justification may
constitute violations of the NIH Scientific Integrity Policy and may be
reported under the Addressing Scientific Integrity Concerns section in
this document.
6. Prohibit NIH officials, including communications officers, from
altering, or directing NIH scientists and technology experts to alter,
scientific and technological research findings or presentation of
research findings in a manner that may compromise the objectivity or
accurate representation of those findings.
7. Ensure that scientific information is accurately represented in
responses provided by NIH to Congressional inquiries, tribal inquiries,
testimony, and other requests.
8. Ensure that the work and conclusions of NIH scientists and the
work and conclusions of scientists funded or supported by the Federal
government are accurately represented in NIH communications. If
communication documents significantly rely on a scientist's research,
identify them as an author, or represent their scientific opinion, the
scientist will be given the option to review the scientific content of
proposed communication documents prior to publication or public
release.
9. Accurately represent the work and conclusions of NIH scientists
in NIH social media communications and provide appropriate guidance to
NIH scientists on the use of NIH social media. If NIH scientists whose
work is represented in NIH social media identify any errors in those
representations regarding their scientific activities and areas of
expertise, NIH social media managers are responsible for making
appropriate corrections.
10. When offering spokespersons in response to media requests,
offer knowledgeable spokespersons who can, in an objective and
nonpartisan manner, describe the relevant scientific or technological
aspects of their work.
11. Ensure that NIH scientists may communicate their scientific
activities objectively without political interference or other
inappropriate influence consistent with HHS \28\ and NIH \29\
communication and media policies. Scientific products must adhere to
relevant NIH technical review procedures.
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\28\ This provision is further outlined in the HHS Guidelines on
the Provision of Information to the News Media. Available at:
<a href="https://www.hhs.gov/sites/default/files/media_policy.pdf">https://www.hhs.gov/sites/default/files/media_policy.pdf</a>.
\29\ This provision is further outlined in the NIH Policy Manual
Chapter 1184 on Preparation and Clearance of Scientific, Technical,
and Public Information Presented by NIH Employees or Produced for
Distribution by NIH. Available at: <a href="https://policymanual.nih.gov/1184">https://policymanual.nih.gov/1184</a>.
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III. Supporting Decision Making Processes
NIH utilizes multiple mechanisms for ensuring transparency and
accountability in developing policy and informing decision making. The
development of science policy at NIH generally follows procedures set
forth under the Administrative Procedure Act (5 U.S.C. Subchapter II)
at <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.\30\ For example, as
described in the Bulletin, when independent peer reviews of scientific
information products are conducted by contractors, a conflict-of-
interest review will be conducted.
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\30\ Office of Management and Budget. ``Final Information
Quality Bulletin for Peer Review.'' Federal Register. Doc. 05-769.
Available at: <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
[[Page 84176]]
scientists whose work is being used in policy and management decisions
to ensure that the science is accurately represented and interpreted.
3. Ensure, to the extent possible, the accuracy of NIH
communication of the science upon which a policy decision is based.
4. Ensure that covered individuals are free to express differing
scientific opinions free from political interference or inappropriate
influence.
IV. Ensuring Accountability
NIH is firmly committed to establishing and formalizing procedures
to identify and adjudicate allegations regarding compromised scientific
processes or technological information. NIH has established several
adjudication processes within distinct offices (i.e., OER, OIR, and
OMA), to address different ways in which scientific integrity may be
violated. Each office handles allegations pertaining to its respective
jurisdiction, but individuals may submit an oral or written allegation
via email or hotline. When an allegation or complaint is received, the
appropriate office determines if it is specific, credible, and meets
the definition of research misconduct or an integrity violation. The
procedures each office takes for investigating allegations or
complaints, adjudication, and appeals are further detailed in the 2022
update to the NIH Policies and Procedures for Promoting Scientific
Integrity at <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 help ensure effective oversight and promote
scientific integrity within the Federal Government. Additionally, the
NIH SIO will provide review and adjudication of allegations
(particularly related to political interference) that do not fall under
the purview of these existing offices.
It is the policy of NIH to:
1. Ensure correction of the scientific record and implementation of
corrective scientific actions when allegations of a loss of scientific
integrity are substantiated. Corrective actions may include correction
or retraction of published scientific work or related media releases,
release of inappropriately suppressed scientific materials, monitoring
or supervision of future scientific activities, or required validation
of data sources.
2. Encourage and facilitate early informal or formal consultation
between covered individuals and scientific integrity officials to
advise on preventing loss of scientific integrity, to determine whether
a loss of scientific integrity has potentially occurred, and to
ascertain whether an allegation should be referred elsewhere for
resolution.
3. Provide clear guidance on how to formally and confidentially
report concerns and allegations of loss of scientific integrity. Those
who report concerns and allegations need not be directly involved or
witness a violation.
4. Ensure that the NIH SIO or other NIH entities draft procedures,
as needed, to respond to allegations of loss of scientific integrity in
a timely, objective, and thorough manner. These procedures will include
an initial assessment and review, a fact-finding process, an
adjudication or determination including description of remedies and
preventative measures to safeguard the science, and reporting.
5. These procedures will document the necessary aspects for each
step of the process as well as the roles of the NIH SIO and other
agency staff in the process.
V. Protections
NIH prioritizes safe and respectful work environments that are free
from harassment, including sexual harassment, discrimination, or other
forms of inappropriate conduct that can result in a hostile work
environment. Additionally, it is unlawful for NIH to take or threaten
to take a personnel action against an employee because they made a
protected disclosure of wrongdoing. A protected disclosure is defined
as a disclosure of information that the individual reasonably believes
is evidence of a violation of law, rule, or regulation; gross
mismanagement; gross waste of funds; and abuse of authority; or a
substantial and specific danger to public health or safety. Personnel
actions that are covered by this can include poor performance review,
demotion, suspension, termination, or revocation or downgrade of a
security clearance. If staff members believe that whistleblower
retaliation has occurred, they may get more information from the HHS
OIG at <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.\31\ Support scientists and researchers including, but not
limited to, Black, Latino, Indigenous and Native American persons,
Asian Americans and Pacific Islanders, and other persons of color;
members of religious minorities; lesbian, gay, bisexual, transgender,
queer, intersex, and asexual (LGBTQIA+) persons; persons with
disabilities; persons who live in rural areas; and persons otherwise
adversely affected by persistent poverty or inequality; and advance the
equitable delivery of Federal programs.
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\31\ This provision is further outlined in the NIH Sourcebook on
Personnel. Available at: <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 create and support the creation of safe
workspaces that are free from harassment and discrimination.\32\
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\32\ This provision is further outlined in the NIH Policy Manual
Chapter 1311 on Preventing and Addressing Harassment and
Inappropriate Conduct and the NIH Sourcebook Addendum to BSC
Policies and Procedures. Available at: <a href="https://policymanual.nih.gov/1311">https://policymanual.nih.gov/1311</a> and <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
in good faith of loss of scientific integrity. Efforts will be made to
protect the privacy of individuals involved in allegations.
4. Prevent covered individuals from intimidating or coercing NIH
scientists to alter scientific data, findings, or professional opinions
or from inappropriately influencing scientific advisory boards.
5. Comply with whistleblower protections, specifically:
a. The requirements of the Whistleblower Protection Act of 1989,
and its expanded protections enacted by Public Law 103-424 and the
Whistleblower Protection Enhancement Act of 2012, 5 U.S.C. part
2302(b)(8)-(9).
b. The National Defense Authorization Act's expansion of certain
whistleblower protections to employees of Federal Government
contractors, subcontractors, and grant recipients in 41 U.S.C. part
4712.
c. Presidential Policy Directive 19, which prohibits supervisors
from taking, failing to take, or threatening to take or fail to take
any action affecting an employee's eligibility for access to classified
information in retaliation for making a protected disclosure.
d. The Military Whistleblower Protection Act (codified at 10 U.S.C.
1034), which is made applicable to the Public Health Service
Commissioned
[[Page 84177]]
Corps officers through 42 U.S.C. 213a(a)(18) and implemented by
Commissioned Corps Directive 121.06.
6. Ensure scientific integrity staff at NIH are protected by all
applicable employee rights as required by law. An SIO or other
scientific integrity staff may only be terminated or reassigned for
reasons consistent with applicable law.
VI. Professional Development for Government Scientists
A key aspect of the NIH effort to advance scientific integrity is
encouraging NIH scientists and covered individuals to engage with the
broader research community in maintaining the highest ethical standards
and scientific norms, while adhering to the Standards of Ethical
Conduct for Employees of the Executive Branch (5 CFR part 2635).\33\
Creating an inclusive environment for scientists from all backgrounds,
including those from traditionally underrepresented groups, is
essential to supporting scientific integrity. The IRP promotes
professional development of all researchers from trainees at every
level, to tenure-track and tenured investigators, and all other
research staff. Scholarly writing, lecturing, editing, and publishing
are essential parts of research and professional development. These
activities are in the public interest and bring credit and distinction
to both NIH and its employees. In encouraging researchers to share
information about their official and professional activities, NIH seeks
to advance scientific knowledge and contribute to its employees'
professional education.
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\33\ Standards of Ethical Conduct for Employees of the Executive
Branch (5 CFR part 2635) provide the basic guidelines for official
duty activities, and NIH sets the policy for implementing the
guidelines at the agency. Available at: <a href="https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635">https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635</a>.
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It is the policy of NIH to:
1. Encourage timely publication of research conducted by covered
individuals such as in peer-reviewed, professional, scholarly journals,
NIH technical reports and publications, or other appropriate
outlets.\34\
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\34\ This provision is further outlined in the NIH Public Access
Policy. Available at: <a href="https://sharing.nih.gov/public-access-policy">https://sharing.nih.gov/public-access-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.\35\
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\35\ 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.\36\
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\36\ This provision is further outlined in the NIH Sourcebook on
Tenure in the NIH Intramural Research Program. Available at: <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.\37\
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\37\ This provision is further outlined in the NIH Sourcebook on
Activities with Outside Organizations and the NIH Official Duty
Activities Chart. Available at: <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>.
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6. Permit NIH scientists to receive honors and awards for
contributions to scientific activities and discoveries to the extent
allowed by law, and to accrue the professional recognition of such
honors or awards.
7. Permit covered individuals to perform outreach and engagement
activities, such as speaking to community and student groups, as part
of their official duties as appropriate.
VII. Federal Advisory Committees
FACs, as defined by the Federal Advisory Committee Act (FACA) at
<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 will adhere
to FACA and develop policies in coordination with the General Services
Administration and consistent with the guidance on lobbyists serving on
FACs when convening FACs tasked with giving scientific advice.
Consistent with all applicable laws and guidance regarding FACs, it
is the policy of NIH to:
1. Promote transparency in the recruitment of new FAC members,
including, when practical and appropriate, announcing vacancies with a
notification in the Federal Register.
2. Select members to serve on a scientific or technical FAC based
on expertise, knowledge, and contribution to the relevant subject
area.<SUP>38 39</SUP> Additional factors that may be considered are
availability of the member to serve, alignment with the relevant
Federal Advisory Committee Membership Balance Plan, and the ability to
work effectively on advisory committees.\40\ Ensure committee
membership is fairly balanced in terms of points of view represented
with respect to the functions to be performed by the
FAC.<SUP>41 42</SUP>
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\38\ This provision is further outlined in How Scientists Are
Selected to Be Members of a Chartered Review Group. Available at:
<a href="https://public.csr.nih.gov/ForReviewers/BecomeAReviewer/CharteredReviewers">https://public.csr.nih.gov/ForReviewers/BecomeAReviewer/CharteredReviewers</a>.
\39\ This provision refers to not only FACA Councils that have
SGE members but also peer review FACA committees that have NIH peer
review consultants as members.
\40\ This provision is further outlined in the NIH Selection
Criteria for NIH Advisory Committees. Available at: <a href="https://ofacp.nih.gov/committees/selection_criteria">https://ofacp.nih.gov/committees/selection_criteria</a>.
\41\ 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>.
\42\ General Services Administration 41 CFR part 102-3 Federal
Management Regulation: Federal Advisory Committee Management.
Available at: <a href="https://www.regulations.gov/document/GSA-FMR-2022-0015-0010">https://www.regulations.gov/document/GSA-FMR-2022-0015-0010</a>.
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3. Comply with current standards governing conflict of interest as
defined in statutes and implementing regulations.<SUP>43 44</SUP>
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\43\ This provision is further outlined in the NIH Policy Manual
Chapter 1810 on Procedures for Avoiding Conflict of Interest for
Special and other Federal Employees Serving as Advisory Committee
Members. Available at: <a href="https://policymanual.nih.gov/1810-1">https://policymanual.nih.gov/1810-1</a>.
\44\ The NIH Office of Federal Advisory Committee Policy
maintains the Special Government Employee (SGE) Portal for those
interested in serving on an NIH Federal advisory committee as an
SGE. The Portal contains all the requirements expected of advisory
committee members who serve on advisory committees as SGEs,
including ethics training, Foreign Activities and Lobbyist
Certification, and the Confidential Financial Disclosure Report (OGE
450) at: <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
[[Page 84178]]
integrity concerns and will develop procedures for addressing
allegations of loss of scientific integrity and concerns that span or
fall outside existing NIH adjudication mechanisms under the purview of
OER, OIR, OMA, or OIG (e.g., as related to waste, fraud, abuse, and
illegal activities).\45\ In particular, the NIH SIO will manage
scientific integrity concerns related to political interference, if
they do not fall within existing processes. Procedures for handling
scientific integrity concerns will be made available on the NIH
website. For information about rights and remedies against retaliation,
employees may contact the HHS OIG Whistleblower Protection
Coordinator.\46\ As noted above, existing procedures under the purview
of OER, OIR, OMA, and OIG (e.g., as related to waste, fraud, abuse, and
illegal activities) should continue to be followed. When those existing
mechanisms do not cover a scientific integrity concern:
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\45\ OER reviews and refers allegations of research misconduct
involving extramural researchers and peer review of grant
applications to the HHS Office of Research Integrity (ORI) and may
take corrective action against a grantee or peer reviewer based on
the conduct identified in ORI findings. OIR reviews allegations
related to research integrity involving NIH IRP researchers. The NIH
Division of Program Integrity within OMA manages the review of
allegations involving misuse of NIH grant or contractor funds,
grantee or contractor conflicts of interest, and other misconduct or
misuses of NIH resources by NIH employees or others doing business
with NIH. The HHS OIG investigates allegations of criminal fraud,
waste, and abuse.
\46\ As appropriate, employees can also contact the NIH Office
of Equity, Diversity, and Inclusion for information regarding
retaliation based on protected equal employment opportunity or the
HHS Office of Special Counsel for information regarding retaliation
based on whistleblowing. Further information can be found at:
<a href="https://www.edi.nih.gov/services/federal-EEO-complaint-process">https://www.edi.nih.gov/services/federal-EEO-complaint-process</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. Reporting can be done anonymously.
2. NIH employees are encouraged to seek an informal consultation
with the NIH SIO or other relevant agency integrity officials to
discuss whether a concern constitutes a potential loss of scientific
integrity before submitting a formal complaint. Employees ultimately
have the discretion to submit a formal complaint as they see fit
without reprisal.
3. The SIO will oversee an initial assessment of each reported
concern and determine whether to request additional information from
the complainant or others, as appropriate and feasible, and to
determine whether a formal investigation is warranted. Additionally, if
any reported concern falls within the purview of existing OER, OIR,
OMA, or OIG processes, those mechanisms will instead be utilized.
4. Should an investigation be opened, an investigation committee
consisting of the NIH SIO and other agency integrity officials
(including from the NIH Scientific Integrity Council, as appropriate)
will be convened to develop a factual record by exploring the
allegation(s) in detail and consulting with subject matter experts,
interviewing witnesses, and reviewing documentation as needed.
5. Once the investigation is complete, the NIH SIO will determine
whether scientific integrity was lost and report findings to the
appropriate management entity.
6. The complainant and respondent will be given the opportunity to
appeal a finding or any corrective scientific actions taken.
Handling Differing Scientific Opinions
Science and decisions based on science are strengthened by vigorous
discussion and debate and by considering all available evidence. The
process of challenging and improving ideas helps to guard against
inadequate science and flawed analysis. Scientists can hold differing
opinions without violating scientific integrity, and NIH encourages its
scientists to respectfully express and engage with differing views as
an integral part of the scientific process.\47\ Differing scientific
opinions are diverging views held by researchers who are substantively
engaged in the science subject area. In some cases, such as when a
scientific dispute has a significant impact on public health or policy,
a formal scientific dispute resolution process may be necessary. The
goal of scientific dispute resolution should be to ensure that all
perspectives are heard and documented in an unbiased way. A
satisfactory resolution may involve adopting one opinion over another,
deciding to conduct additional studies, formulating an alternate theory
reconciling the differing opinions, or documenting the disagreement for
the benefit of policymakers and fellow scientists. These steps may be
completed in any order and are not necessarily an exhaustive list of
dispute resolution measures. In general:
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\47\ Further information on the NIH IRP Authorship Conflict
Resolution Process can be found in the NIH Sourcebook. Available at:
<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. For investigations that have been resolved, the report will
include an aggregate summary of the types of corrective actions
recommended by the investigation panel to restore scientific integrity,
and a summary of the types of actions ultimately taken. To the extent
possible, all descriptions of investigations will be anonymized.
Related Policies and Statutes
Violations of related and supporting policies may result in a loss
of scientific integrity and it is appropriate for the SIO to coordinate
across the agency in these matters, as appropriate. The following
policies and programs intersect with the development of the culture of
scientific integrity within the agency.
Research Misconduct
<bullet> Federal Research Misconduct Policy: https://
www.federalregister.gov/documents/2000/12/06/00-30852/executive-office-
of-the-president-
[[Page 84179]]
federal-policy-on-research-misconduct-preamble-for-research
<bullet<ls-thn-eq> Public Health Service Policies on Research
Misconduct: https://www.ecfr.gov/current/title-42/chapter-I/subchapter-
H/part-93
<bullet> NIH Policy Manual Chapter 3006--NIH Intramural Research
Program (IRP) Research Misconduct Proceedings: <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<ls-thn-eq> 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<ls-thn-eq> 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://sharing.nih.gov/public-access-policy">https://sharing.nih.gov/public-access-policy</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. part 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<ls-thn-eq> 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<ls-thn-eq> 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<ls-thn-eq> 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<ls-thn-eq> 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<ls-thn-eq> 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. part 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. part 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<ls-thn-eq> 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<ls-thn-eq> U.S. Office of Special Counsel: <a href="https://osc.gov/">https://osc.gov/</a>
<bullet> 10 U.S.C. part 1034, made applicable to the Public Health
Service Commissioned Corps through 42 U.S.C. 213a(a)(18) and
implemented by Commissioned Corps Directive (CCD) 121.06: <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<ls-thn-eq> 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
[[Page 84180]]
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. part 4712--The National Defense Authorization Act,
Enhancement of contractor protection from reprisal for disclosure of
certain information
9. 5 U.S.C. part 13103 et seq.--The Ethics in Government Act of 1978,
as amended, and 5 CFR parts 2634 and 2635, Executive Branch Financial
Disclosure, Qualified Trusts, and Certificates of Divestiture and
Standards of Ethical Conduct for Employees of the Executive Branch
10. 18 U.S.C. parts 201-209--Statutes regarding Bribery, Graft and
Conflicts of Interest
11. 5 CFR parts 5501 and 5502--Supplemental Standards of Ethical
Conduct for Employees of the Department of Health and Human Services
12. 5 U.S.C. Ch. 10--The Federal Advisory Committee Act of 1972
13. 45 CFR part 73--Standards of Conduct
14. 5 CFR part 735--Employee Responsibilities and Conduct
15. 45 CFR part 46--HHS Protection of Human Subjects Regulation
16. PPD 19--Protecting Whistleblowers with Access to Classified
Information, 2012
17. M-20-12--OMB Phase 4 Implementation of the Foundations for
Evidence-Based Policymaking Act of 2018: Program Evaluation Standards
and Practices
18. 42 CFR part 93--Public Health Service Policies on Research
Misconduct
19. 10 U.S.C. part 1034, made applicable to the Public Health Service
Commissioned Corps through 42 U.S.C. 213a(a)(18) and implemented by
Commissioned Corps Directive (CCD) 121.06
20. Public Law No 117-328--Health Extenders, Improving Access to
Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of
2022, Division FF, Title II, Section 2321
21. Public Law No 117-167--CHIPS and Science Act of 2022, Title VI,
Subtitle D, Section 10631
Dated: October 15, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-24225 Filed 10-18-24; 8:45 am]
BILLING CODE 4140-01-P
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